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A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage (Purchaser’s

Guide) is an information source for employers on clinical preventive service benefit design.

This document provides guidance for the selection of clinical preventive services shown to

be effective by the U.S. Preventive Services Task Force (USPSTF), the Centers for Disease

Control and Prevention (CDC), and other authoritative organizations.

The Purchaser’s Guide builds upon the National Business Group on Health’s previous

publication, sponsored by the Robert Wood Johnson Foundation (RWJF) and reviewed by

the Agency for Healthcare Research and Quality (AHRQ): An Employer’s Guide to Clinical

Preventive Services — Improving Health. Improving Business (referred to as the Employer’s

Guide). 

The Purchaser’s Guide provides several new and important components that will assist

employers in improving coverage for clinical preventive services. Namely, the Purchaser’s

Guide includes the scientific evidence and detailed benefit language employers need to

implement comprehensive and structured clinical preventive service benefits.

Below is an annotated table of contents that describes

the information, resources, and tools provided in each

part of the Purchaser’s Guide. 

Introduction

Provides an overview of how the Purchaser’s Guide was

developed and background on the sources of its

recommendations.

Part I: The Role of Clinical Preventive

Services in Disease Prevention and Early

Detection

Provides information for employers on improving

beneficiary health and reducing healthcare costs

through the implementation of comprehensive and

structured clinical preventive service benefits within a

medical benefit plan.

A Purchaser’s Guide to

Clinical Preventive Services:

Moving Science into Coverage

Overview of a Purchaser’s Guide to 

Clinical Preventive Services

In order to protect and promote 

beneficiary health and control

healthcare costs, employers must

provide coverage for clinical 

preventive services.

Within a given benefit plan, employers

may select which preventive services

are covered and at what level. Many

preventive services are available. Some

are known to be effective; others are

known to be relatively ineffective or even

harmful; others may be effective but the

proof of effectiveness is weak. The

Purchaser’s Guide provides guidance for

the selection of clinical preventive 

services proven to be clinically effective

and of value to employers.

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i Introduction

2

Part II: Summary Plan Description (SPD) Language Statements for

Recommended Clinical Preventive Service Benefits

Provides 46 condition specific summary plan description (SPD) language statements

designed to assist benefits staff as they design benefit structures, discuss clinical preventive

services with a healthcare consultant, set coverage guidelines with a health plan, or negotiate

covered services with a union or consumer group. The SPD language statements were

adapted from recommendations of the U.S. Preventive Services Task Force (USPSTF), the

Centers for Disease Control and Prevention (CDC), and other authoritative organizations. 

Each preventive service SPD statement contains detailed benefit language regarding the:

• Necessary content of the recommended clinical preventive service.

• Age at which the service should be initiated and ceased.

• Recommended frequency of the service. 

Applicable current procedural terminology (CPT) codes are provided for employers and health

plans to facilitate the implementation and reimbursement of clinical preventive service benefits.

Part III: Evidence-Statements for Recommended Clinical Preventive 

Service Benefits

Provides evidence-statements for each of the 46 recommended clinical preventive service

benefits. Each evidence-statement includes information about the:

• Prevalence and/or incidence of the condition.

• Risk factors associated with the condition.

• Economic burden of the condition and the economic benefit of early

identification/intervention.

• Cost-benefit/cost-effectiveness of the recommended intervention.

• Cost of the recommended preventive intervention. 

• Purpose of the preventive intervention.

• Benefits and risks of the preventive intervention.

Part IV: The Prioritization and Strategic Implementation of Clinical

Preventive Service Benefits 

Provides practical “how-to” information on the development and implementation of

structured clinical preventive service benefits. Real-world examples of each prioritization

method are provided. 

Part V: I Statements and C and D Recommendations and of the U.S.

Preventive Services Task Force (USPSTF) 

Provides information on clinical preventive services that were reviewed by the USPSTF, but

were not included in the Purchaser’s Guide because the USPSTF:

1. Found that there was insufficient evidence to make a recommendation either for or

against providing the service (I statement);

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3

4

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2. Made no recommendation regarding the provision of the service based on an analysis

of evidence of effectiveness, benefits, and harms (C recommendation); or

3. Recommended against routine provision of the service for asymptomatic patients

based on an analysis of the evidence of effectiveness, benefits, and harms (D

recommendation).

This information may assist benefits staff in determining which clinical preventive services

currently offered in their health plan(s) should be re-evaluated and, possibly, eliminated.

Part VI: Leveraging Benefits: Opportunities to Promote the Delivery and

Use of Preventive Services

The Purchaser’s Guide is designed to help employers select and implement clinical preventive

services that are delivered by healthcare providers. Employers can strengthen prevention

efforts by supporting public health interventions that may occur in the workplace or

communities. Part VI provides information and tips for employers on promoting the

delivery and use of clinical and community-based preventive services, including:

• An overview of the Community Guide to Preventive Services. 

• A crosswalk between the recommendations proposed in the Purchaser’s Guide and the

Community Guide. 

• Case examples of large employers who have successfully implemented worksite health

promotion programs and/or supported community-based interventions.

Part VII: Resources & Tools

Provides additional information and resources on clinical preventive service benefit design,

including:

• The Life Course Charts — visual guides to clinical preventive services across the

lifespan

> Recommended Schedule of Preventive Care for Adults

> Recommended Schedule of Preventive Care for Children and Adolescents

> Recommended Schedule of Preventive Preconception, Prenatal, and 

Postpartum Care

• A crosswalk between the Purchaser’s Guide, the U.S. Preventive Services Task Force’s

A/B recommendations, the 2007 HEDIS® Measures, the NCQA State of Healthcare

Quality Report, and the U.S. Department of Health and Human Service’s Healthy

People 2010 Goals.

• Clinical Preventive Services Glossary

• Links to additional resources and cost-calculators.

• A CD containing PDF versions of all the materials included in the Purchaser’s Guide.

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7
An Introduction to A Purchaser’s Guide to Clinical

Preventive Services

Clinical Preventive Service Topic Selection

The clinical preventive services recommended for coverage in the Purchaser’s Guide were

selected by the National Business Group on Health with the technical assistance of experts

from two federal agencies, the Centers for Disease Control and Prevention (CDC) and the

Agency for Healthcare Research and Quality (AHRQ).

The Purchaser’s Guide coverage recommendations are mainly

based on the U.S. Preventive Services Task Force (USPSTF)

recommendations on clinical preventive services for the

general asymptomatic population. The USPSTF, sponsored by

the Agency for Healthcare Research and Quality (AHRQ)

(part of the U.S. Department of Health and Human

Services), is an independent panel of experts in primary care

and prevention that makes recommendations regarding

clinical preventive services after a careful review of the

scientific literature. The Purchaser’s Guide includes all of the

USPSTF “A” and “B”-rated recommendations published

before March 2006.

Recommendations from sources other than the USPSTF were

added to support USPSTF recommendations, or inserted in place of a USPSTF

recommendation, when:

1. No current USPSTF recommendation was available (e.g., screening for elevated

blood lead levels); or 

2. When a newer recommendation superseded the existing USPSTF recommendation

(e.g., lipids screening). 

In order to be included in the Purchaser’s Guide, clinical preventive service recommendations

were required to meet the following criteria:

1. Be based on medical evidence or recommended guidance.

2. Address a serious health threat in terms of morbidity (illness), mortality (death), or

quality of life (including risk of disability). 

3. Address a condition that results in substantial direct (e.g., treatment costs) or indirect

costs (e.g., absenteeism, lost productivity) for payers. 

i Introduction

4

The Purchaser’s Guide also 

includes clinical preventive service 

recommendations from other 

recognized sources such as the Centers

for Disease Control and Prevention

(CDC); other Federal agencies such as

the National Health, Lung, and Blood

Institute (NHLBI), a division of the

National Institutes of Health (NIH); and

professional organizations such as the

American Academy of Pediatrics (AAP).
Forty-six (46) services met the inclusion criteria outlined on the previous page. These

services are discussed in further detail in Part II: Summary Plan Description (SPD) 

Language Statements for Recommended Clinical Preventive Service Benefits and Part III:

Evidence-Statements for Recommended Clinical Preventive Service Benefits. 

The evidence for clinical preventive services is growing. Purchasers are encouraged to

periodically check the U.S. Preventive Services Task Force (USPSTF) website

(www.ahrq.gov/clinic/uspstfix.htm) for up-to-date recommendations on clinical preventive

services.

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• Advisory Committee on Childhood Lead Poisoning Prevention (ACCLP)

• Advisory Committee on Immunization Practices (ACIP)

• Agency for Healthcare Research and Quality (AHRQ)

• Agency for Toxic Substances and Disease Registry (ATSDR)

• Alliance for Cervical Cancer Prevention; Program for the Appropriate use of Technology in 

Health (PATH)

• American Academy of Audiology

• American Academy of Bariatric Surgery

• American Academy of Family Physicians (AAFP)

• American Academy of Neurology

• American Academy of Pediatric Dentistry (AAPD)

• American Academy of Pediatrics (AAP)

• American Association of Clinical Endocrinologists (AACE)

• American Cancer Society (ACS)

• American College of Cardiology

• American College of Emergency Physicians (ACEP)

• American College of Obstetricians and Gynecologists (ACOG)

• American College of Preventive Medicine (ACPM)

• American College of Surgeons (ACS)

• American Dental Association (ADA)

• American Diabetes Association (ADA)

• American Heart Association (AHA)

• American Medical Association (AMA)

• American Psychological Association (APA)

• American Society of Addiction Medicine (ASAM)

• American Society of Clinical Oncology (ASCO)

• American Speech, Language, and Hearing Association

• Center for Medicare & Medicaid Services (CMS)

• Centers for Disease Control and Prevention (CDC)

• Committee on Educational Interventions for Children with Autism, National Research Council,

National Academies

• Directors of Speech and Hearing Programs in State Health and Welfare Agencies

• Employee Benefits Institute

• Food and Drug Administration (FDA)

• George Washington University, Center for Health Services Research and Policy

• Harvard Medical School

Figure A: Sources of Information Used in the Purchaser’s Guide 
i Introduction

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• Health Resources and Services Administration (HRSA)

• Healthy People 2010, U.S. Department of Health and Human Services

• Institute of Medicine (IOM)

• Internal Revenue Service (IRS), Department of Treasury

• International Agency for Research on Cancer (IARC)

• Jacobs Institute of Women’s Health (JIWH)

• Joint Committee on Infant Hearing (JCIH)

• Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood

Pressure

• March of Dimes

• Maternal Child Health Bureau (MCHB)

• National Academy of Sciences (NAS)

• National Academy of Sciences, Institute of Medicine (IOM)

• National Association of Pediatric Nurse Practitioners (NAPNAP)

• National Business Group on Health

• National Cancer Institute (NCI)

• National Center for Education in Maternal and Child Health

• National Center for Health Statistics (NCHS)

• National Center for Hearing Assessment and Management (NCHAM)

• National Center for Injury Prevention and Control

• National Cholesterol Education Program (NCEP)

• National Cholesterol Education Program Adult Treatment Expert Panel-III

• National Health and Nutrition Examination Survey (NHANES)

• National Heart, Lung, and Blood Institute (NHLBI)

• National Highway Traffic Safety Administration (NHTSA)

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

• National Institutes of Health (NIH)

• National Institutes of Mental Health (NIMH)

• National March of Dimes Birth Defects Foundation

• National Osteoporosis Foundation (NOF)

• National Research Council, Committee on Educational Interventions for Children with Autism,

Division of Behavioral and Social Sciences and Education

• Partnership for Prevention

• Peer-reviewed research

• Preeclampsia Foundation

• Royal College of Obstetricians and Gynecologists

• Substance Abuse and Mental Health Services Administration (SAMHSA)

• U.S. Department of Agriculture (USDA)

• U.S. Department of Health and Human Services (USDHHS)

• U.S. Department of Transportation (DOT)

• U.S. Environmental Protection Agency (EPA)

• U.S. Preventive Services Task Force (USPSTF)

• U.S. Public Health Service (USPHS)

• U.S. Surgeon General

• World Health Organization (WHO)

Figure A: Sources of Information Used in the Purchaser’s Guide (Continued)
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The Evidence for Clinical Preventive Services

All of the recommendations in the Purchaser’s Guide are based on science. 

The U.S. Preventive Services Task Force (USPSTF)

Most of the recommendations featured in the Purchaser’s Guide were adapted from the U.S.

Preventive Services Task Force (USPSTF). The USPSTF is recognized as the gold-standard

in clinical preventive service recommendations; it is an independent panel of experts in

primary care and prevention that conducts rigorous, impartial assessments of the scientific

evidence for the effectiveness of clinical preventive services.1

The USPSTF is mandated by Congress to evaluate preventive services and publishes

recommendations and evidence synthesis, which are the culmination of an extensive

literature review, debate, and analysis of critical comments from expert reviewers.1 USPSTF

recommendations are based on an objective process that weighs the benefits and the harms

of a preventive service. Each recommendation is given a letter grade (A-D, I) based on the

strength of evidence available to support the particular clinical preventive service and the

magnitude of net benefit for that service. The net benefit of a clinical preventive service is

defined as the benefits of the service (e.g., years of life saved through early cancer detection)

minus the harms of the service (e.g., risks associated

with false-positive test results). 

By definition, the foundational source of USPSTF

recommendations is research published in peer review

journals. USPSTF recommendations are therefore

limited to clinical preventive services that have been

systematically studied and published. Services that are

commonly provided in clinical practice but have not

been well-studied or have been poorly documented in

the literature may not be reviewed. For instance, some

interventions have not been systematically studied due

to ethical concerns (e.g., withholding treatment) or

lack of funding for research. In other cases, evidence

exists but it is conflicting. These interventions are

given an “I” rating (“I” for insufficient evidence) by

the USPSTF.

Evidence-Based Recommendations, Evidence-Based Medicine, 

and Evidence-Based Benefits

Many of the clinical preventive service recommendations presented in the Purchaser’s Guide

are evidence-based. Evidence-based services have a longer and stronger base of research to

support their efficacy, safety, and cost-effectiveness. Generally, the term “evidence-based”

refers to medical interventions that scientific studies have evaluated and determined to be

effective and to have a measurable effect on health outcomes. 

THE USPSTF publishes the annual

Guide to Clinical Preventive Services,

which includes abridged versions of the

USPSTF’s recommendations on screening,

counseling, and preventive medication

presented in a user friendly format for 

clinicians. The complete USPSTF 

recommendations and reviews are 

available on the web and provide 

information about which clinical 

preventive services should be delivered 

by prudent clinicians in the course of 

routine clinical care. For more information

on the USPSTF please visit:

www.ahrq.gov/clinic/prevenix.htm
To make the sources, types, and strength of scientific evidence used in the Purchaser’s Guide

fully transparent, each evidence-statement featured in Part III: Evidence-Statements for

Recommended Clinical Preventive Service Benefits contains an evidence-box as a summary. 

Each evidence-box contains the following information: 

• A description of where the information used in the recommendation originated from

(e.g., the American Academy of Family Physicians (AAFP), CDC, or the USPSTF).

i Introduction

8

All of the recommendations derived from the

USPSTF are evidence-based. Other recommendations

featured in the Purchaser’s Guide are based on

“recommended guidance.” Recommended guidance is

based on the best-available information for a given

topic, but lacks the scientific research support needed

to be considered evidence-based. 

Evidence-based medicine: Two common definitions of evidence-based medicine include

the following:

1. “Evidence-based medicine is the conscientious, explicit, and judicious use of current

best-evidence in making decisions about the care of individual patients. The practice of

evidence-based medicine means integrating individual clinical expertise with the best

available external clinical evidence from systematic research.”2

2. Evidence-based recommendations require, “First, good evidence that each test or procedure recommended is medically effective in reducing morbidity or mortality; second,

the medical benefits must outweigh the risks; third, the cost of each test or procedure

must be reasonable compared to its expected benefits; and finally, the recommended

actions must be practical and feasible.”2 [Note: The USPSTF does not consider cost as

a factor in its recommendations.] 

Recommended guidance: A recommendation or guideline that is based on the best

available information for a condition, disease, or health service, but that does not yet have

the scientific research support in order to be considered evidence-based (as determined

by a systematic review process). Expert opinion, expert judgment, and consensus opinion,

are considered forms of recommended guidance.

Evidence-based benefit design: Aims to promote healthcare with demonstrated 

effectiveness by providing “...more generous coverage for services supported by strong

evidence of effectiveness and less generous coverage for services that are unproven or

evidence indicates may be ineffective or unsafe, given patient characteristics and

history.”3

Definition Box B: Evidence

There is strong scientific evidence 

to support the provision of a broad

range of clinical preventive 

services for normal-risk children,

adolescents, and adults.
• The level of evidence used in constructing the recommendation:

> Evidence-based research

> Recommended guidance

• The strength of the evidence. For example, the USPSTF grades each of its clinical

preventive service recommendations on a 5-point scale (A-D, I). The grade is

determined by the strength of scientific evidence supporting a clinical preventive

service and the magnitude of net benefit (defined as benefits minus harms).4

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Figure C: Sample Evidence-Boxes

Strength of Evidence for the Clinical Preventive Service

(Colorectal Cancer Screening)

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research: 

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence) 

• The USPSTF found fair to good evidence that several screening methods

are effective in reducing mortality from colorectal cancer. The USPSTF

concluded that the benefits from screening substantially outweigh potential

harms, but the quality of evidence, magnitude of benefit, and potential

harms vary with each method.

Strength of Evidence for the Clinical Preventive Service

(Immunizations) 

The level of evidence supporting the recommendations contained in this 

chapter is described below

Recommended Guidance:

Advisory Committee on Immunization Practices (ACIP) 

Centers for Disease Control and Prevention (CDC)

Strength of Evidence: Expert Consensus

• The ACIP and CDC recommend that all children and adolescents with

no contraindications receive all routinely recommended childhood

vaccinations. Children and adolescents who fall into high-risk groups

because of health conditions, behaviors, or membership in certain

communities should receive additional immunizations.

• The ACIP and CDC recommend that all adults with no contraindications

receive three routinely recommended vaccines (age-dependent). Adults

who fall into high-risk groups because of health conditions, behaviors or

exposures, as well as those without a history of immunization for certain

diseases, should receive additional immunizations.
i Introduction

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Figure D: U.S. Preventive Services Task Force (USPSTF) Strength of Evidence Scale5

Figure E: American Academy of Family Physicians (AAFP) Strength of Evidence Scale6

A Strongly Recommended

The USPSTF strongly recommends that clinicians provide the service to eligible

patients. The USPSTF found good evidence that the service improves important

health outcomes and concludes that the benefits substantially outweigh harms.

B Recommended

The USPSTF recommends that clinicians provide the service to eligible patients.

The USPSTF found at least fair evidence that the service improves important

health outcomes and concludes that the benefits outweigh harms.

C No Recommendation Either For or Against

The USPSTF makes no recommendation either for or against routine provision of

the service. The USPSTF found at least fair evidence that the service can improve

health outcomes but concludes that the balance of benefits and harms is too close

to justify a general recommendation.

D Recommend Against

The USPSTF recommends against routinely providing the service to asymptomatic

patients. The USPSTF found at least fair evidence that the service is ineffective or

that the harms associated with the service outweigh benefits 

I Insufficient Evidence in Order to Make a Recommendation

The USPSTF concludes that the evidence is insufficient to recommend for or

against routinely providing the service. Evidence that the service is effective is

lacking, of poor quality, or conflicting, and the balance of benefits and harms

cannot be determined.

SR Strongly Recommended

Good quality evidence exists which demonstrates substantial net benefit over

harm; the intervention is perceived to be cost-effective and acceptable to nearly all

patients. 

R Recommended

Although evidence exists which demonstrates net benefit, either the benefit is only

moderate in magnitude or the evidence supporting a substantial benefit is only

fair. The intervention is perceived to be cost-effective and acceptable to most

patients.

NR No Recommendation Either Either For or Against

Either good or fair evidence exist of at least a small net benefit. Cost-effectiveness

may not be known or patients may be divided about acceptability of the

intervention. 

RA Recommend Against

Good or fair evidence exist which demonstrates no net benefit over harm.

I Insufficient Evidence to Recommend Either For or Against

No evidence of even fair quality exists or the existing evidence is conflicting.

IHB Healthy behavior is identified as desirable, but the effectiveness of physician's

advice and counseling is uncertain.
References: 

1. U.S. Preventive Services Task Force. Questions and answers. Background: What is the USPSTF? Agency 

for Healthcare Research and Quality. [cited 2005 Dec 5]. Available from: 

http://www.ahrq.gov/clinic/uspsfaqs.htm. 

2. Eddy DM. Evidence-based medicine: A unified approach. Health Aff 2005; 24(1): 9-17.

3. National Business Group on Health. National Committee on Evidence-Based Benefits. Washington, DC: 

National Business Group on Health; 2005.

4. Agency for Healthcare Research and Quality. The Guide to Clinical Preventive Services: Recommendations 

of the U.S. Preventive Services Task Force. Rockville, MD: Agency for Healthcare Research and Quality; 

2005.

5. Agency for Healthcare Research and Quality. The Pocket Guide to Clinical Preventive Services 2005. 

AHRQ Publication No. 05-0570. Rockville, MD: Agency for Healthcare Research and Quality; 2005.

6. American Academy of Family Physicians. Summary of Policy Recommendations for Periodic Health 

Examinations. AAFP Policy Action. Revision 6.0; August 2005.

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13

This Purchaser’s Guide is the culmination of a partnership between the Center for Prevention

and Health Services at the National Business Group on Health and the Division of

Partnerships and Strategic Alliances within the National Center for Health Marketing

(NCHM) at the Centers for Disease Control and Prevention (CDC). Over 100 individuals

were involved in the development, authorship, and review of the Purchaser’s Guide. Without

the commitment and effort of these individuals, the Purchaser’s Guide would not have been

possible. 

Editors, Authors, and Project Coordinators: 

Kathryn Phillips Campbell, MPH Andrew Lanza, MPH, MSW

Center for Prevention and Health Services Division of Partnerships and National 

National Business Group on Health National Center for Health Marketing 

Centers for Disease Control and Prevention

Senior Science Advisor:

Richard E. Dixon, MD, FACP

Division of Partnerships and Strategic Alliances

National Center for Health Marketing

Centers for Disease Control and Prevention

Economic Advisors: 

Sajal Chattopadhyay, PhD

Division of Health Communication and Marketing Strategy

National Center for Health Marketing

Centers for Disease Control and Prevention

Noelle-Angelique M. Molinari, PhD

Immunization Services Division

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Acknowledgements

Strategic Alliances
14

a Acknowledgements

CDC Authors:

We gratefully acknowledge the contributions of the Centers for Disease Control and

Prevention (CDC) authors. All of the information contained in the Purchaser’s Guide was

reviewed by the CDC. The findings and conclusions in this report are those of the author(s)

and do not necessarily represent the views of the CDC/ATSDR.

Pamela Allweiss, MD, MPH (co-author of the Diabetes chapter) 

Division of Diabetes Translation

National Center for Chronic Disease Prevention and Health Promotion

Faculty, University of Kentucky

Achal Bhatt, PhD (co-author of the Child, Adolescent, and Adult Immunizations chapter

and the Hepatitis B Virus, Influenza, Rubella, and Tetanus subsections of the Healthy

Pregnancy chapter)

Immunization Services Division (formerly)

National Center for Immunization and Respiratory Disease 

Mary Jean Brown, ScD, RN (co-author of the Elevated Blood Lead Levels chapter)

Division of Emergency and Environmental Health Services

National Center of Environmental Health 

William Bailey, DDS, MPH (co-author of the Dental Caries subsection of the Child

Health Promotion chapter)

Division of Oral Health

National Center for Chronic Disease Prevention and Health Promotion

Krista Biernath, PhD (co-author of the Vision subsection of the Child Health Promotion

chapter)

Division of Human Development and Disability

National Center on Birth Defects and Developmental Disabilities

Robert D. Brewer, MD, MSPH, CAPT U.S. Public Health Services (co-author of the

Alcohol Misuse chapter)

Division of Adult and Community Health

National Center for Chronic Disease Prevention and Health Promotion 

Sajal Chattopadhyay, PhD (co-author of The Role of Clinical Preventive Services In Disease

Prevention and Early Detection, Evidence-Statements for Recommended Clinical Preventive

Service Benefits, and the Alcohol Misuse, Breast Cancer, Cervical Cancer, Colorectal

Cancer, Hypertension, Obesity, and Tobacco Use Treatment chapters and various

subsections of the Child Health Promotion and Healthy Pregnancy chapters)

Division of Health Communication and Marketing Strategy

National Center for Health Marketing

Clay Cooksey, MEd (co-author of the Diabetes chapter) 

Division of Diabetes Translation

National Center for Chronic Disease Prevention and Health Promotion
Ralph J. Coates, PhD (co-author of the Breast, Cervical, and Colorectal Cancer chapters)

Division of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion

Phaedra Corso, PhD (author of the Motor Vehicle-Related Injury Prevention chapter)

Division of Violence Prevention (formerly) 

National Center for Injury Prevention and Control

Scott Grosse, PhD (author of the Newborn Screening for Genetic and Endocrine Disorders

and the Newborn Hearing and Vision subsections of the Childhood Health Promotion

chapter; co-author of the Folic Acid Supplementation and Prenatal Diagnosis of Chromosomal

Abnormalities and Neural Tube Defects subsections of the Healthy Pregnancy chapter) 

Office of the Director

National Center on Birth Defects and Developmental Disabilities

Dyann Matson Koffman, DrPH (author of the Lipids and Hypertension chapters)

Division of Heart Disease and Stroke Prevention

National Center for Chronic Disease Prevention and Health Promotion

Andrew Lanza, MPH, MSW (co-author of the Abdominal Aortic Aneurysm, Asprin

Therapy for the Prevention of Cardiovascular Disease, Breast Cancer, Healthy Diet, and

Osteoporosis chapters and the Dental Caries subsection of the Healthy Pregnancy chapter)

Division of Partnerships and Strategic Alliances

National Center for Health Marketing

Danni Lentine, MPH (co-author of the STI chapter and the HIV and Hepatitis B Virus

subsections of the Healthy Pregnancy chapter) 

Division of HIV AIDS Prevention

National Center for HIV, STD, and TB Prevention

Megan C. Lindley, MPH (co-author of the Child, Adolescent, and Adult Immunizations

chapter and the Hepatitis B Virus, Influenza, Rubella, and Tetanus subsections of the

Healthy Pregnancy chapter)

Immunization Services Division

National Center for Immunization and Respiratory Diseases (proposed)

Anne Looker, PhD (co-author of the Oseoporosis chapter)

Division of Health and Nutrition Examination Statistics

National Center for Health Statistics

Don Lollar, EdD (co-author of the Depression chapter and the Child Development

subsection of the Childhood Health Promotion chapter)

Office of the Director

National Center on Birth Defects and Developmental Disabilities

William Maas, DDS, MPH (co-author of the Dental Caries subsection of the Childhood

Health Promotion chapter)

Division of Oral Health

National Center for Chronic Disease Prevention and Health Promotion

15
Suzanne M. Marks, MPH, MA (author of the Tuberculosis chapter)

Division Tuberculosis Elimination

National Center for HIV, STD, and TB Prevention

Timothy S. Naimi, MD, MPH, CDR, U.S. Public Health Service (co-author of the Alcohol

Misuse chapter and the Alcohol Misuse subsection of the Healthy Pregnancy chapter)

Division of Adult and Community Health

National Center for Chronic Disease Prevention and Health Promotion 

Abby C. Rosenthal, MPH (co-author of Tobacco Use Treatment chapter and the Tobacco

Use Treatment subsection of the Healthy Pregnancy chapter)

Office on Smoking and Health 

National Center for Chronic Disease Prevention and Health Promotion 

Sergey Sotnikov, PhD (co-author of the Abdominal Aortic Aneurysm and

Aspirin Therapy for the Prevention of Cardiovascular Disease chapters)

Division of Partnerships and Strategic Alliances

National Center for Health Marketing

Beth Carlton Tohill, PhD, MSPH (co-author of the Obesity and Healthy Diet chapters)

Division Nutrition and Physical Activity

National Center for Chronic Disease Prevention and Health Promotion

Robin E. Soler, PhD (co-author of Leveraging Benefits: Opportunities to Promote the Use

and Delivery of Clinical Preventive Services)

Division of Health Communication and Marketing Strategy

National Center for Health Marketing and Strategy

Kay Phillips Vandiver, BBA (co-author of the Abdominal Aortic Aneurysm chapter)

Division of Partnerships and Strategic Alliances

National Center for Health Marketing

Contributing Staff from the National Business Group on Health:

Jordana Choucair, MPH Layout Editor, Research Assistant

Center for Prevention and Health Services Chapter Author

Ronald A. Finch, EdD Project Development and Oversight 

Center for Prevention and Health Services SPD Editor

Elizabeth C. Greenbaum, MPH Research Assistant

Center for Prevention and Health Services

Kristen G. Kraczkowsky Reference Editor, Research Assistant

Center for Prevention and Health Services

Andrew Lundeen Preventive Medication Consultant

Institute on Healthcare Costs and Solutions 

16

a Acknowledgements
Contributing Staff from the Centers for 

Disease Control and Prevention (CDC):

Rick L. Hull, PhD Editorial Support

Office of the Director

National Center for Chronic Disease Prevention and Health Promotion

Lisa M. Koonin, MN, MPH Project Concept and Design

Division of Partnerships and Strategic Alliance

National Center for Health Marketing 

Toby L. Merlin, MD Project Support and Leadership

Division of Partnerships and Strategic Alliance

National Center for Health Marketing

Freda Parker Administrative Support

Division of Partnerships and Strategic Alliances

National Center for Health Marketing 

Contributing Health Economists:

We gratefully acknowledge the contributions of the Centers for Disease Control and

Prevention (CDC) health economists who assisted with the economic analyses presented in

the chapters and/or the introductory pieces.

Kaafee Billah, PhD

Division of Viral Hepatitis, Prevention Branch

National Center for Infection Diseases 

Harrell Chesson, PhD

Division of STD Prevention 

National Center for HIV, STD, and TB Prevention

Donatus U. Ekwueme, PhD

Division of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion

Scott Grosse, PhD 

Office of the Director

National Center on Birth Defects and Developmental Disabilities

Mark L. Messonnier, MS, PhD

Immunization Services Division

National Center for Immunization and Respiratory Diseases (proposed)

17
18

Sergey Sotnikov, PhD

Division of Partnerships and Strategic Alliances

National Center for Health Marketing

Trevor Woolery, PhD

Office of Smoking and Health

National Center for Chronic Disease Prevention and Health Promotion

Ping Zhang, PhD

Division of Diabetes Translation

National Center for Chronic Disease Control and Prevention and Health Promotion

Agency for Healthcare Research and 

Quality Technical Assistance Team:

We gratefully acknowledge the contributions of staff from the Center for Primary Care,

Prevention, and Clinical Partnerships at the Agency for Healthcare Research and Quality

(AHRQ) who reviewed the Purchaser’s Guide and provided substantive technical assistance

that improved its quality and comprehensiveness. 

Janice L. Genevro, PhD 

Senior Prevention Integration Manager 

Claire Kendrick, MSEd, CHES

Program Analyst, Prevention Portfolio

Tricia L. Trinité, MSPH, APRN, CAPT U.S. Public Health Service

Director, Prevention, Dissemination & Implementation

Tracy A. Wolff, MD, MPH

Medical Officer, U.S. Preventive Services Task Force Program

Current Procedural Terminology (CPT) Coding Consultants:

Susan Gatehouse, RHIT, CCS, CPC

Gatehouse Consulting

Indya Miller, CCS

Gatehouse Consulting

a Acknowledgements
CDC Content Contributors and Reviewers:

We gratefully acknowledge the assistance of the following content contributors and reviewers. 

Science Advisor:

Hani Atrash, MD, MPH (editor of the Health Pregnancy chapter and the Contraceptive

Use chapters)

Office of the Director

National Center on Birth Defects and Disabilities (NCBDD)

External Reviewers:

We also thank the individuals who reviewed sections of the Purchaser’s Guide for accuracy

and utility. 

Jennifer Bachtel, MS

Policy Analyst

Partnership for Prevention

Wayne Burton, MD

Corporate Medical Director

JP Morgan Chase

Ashley Coffield, MPA

Senior Fellow

Partnership for Prevention

Elizabeth Edgerton, MD, MPH

Director of Prevention Portfolio (formerly)

Agency for Healthcare Research and Quality

19

Carma Ayala, PhD

Carolyn B. Bridges, MD

Peter Briss, MD

Kenneth Castro, MD

Pamela Costa, MA

Ann Dellinger, PhD, MPH 

John Eichwald, MA

Kurt J. Greenlund, PhD 

Susan Griffin, PhD 

Erika Haller-Stevenson, CHES

Michael Iademarco, MD

Katrina Kretsinger, MD, MA

Rebecca Lozman, MPH

Lynne McIntyre, MALS

Mark L. Messonnier, PhD, MS

Richard Olney, MD, MPH

Michele Reyes, PhD

Danielle Ross, PhD

Marissa Scalia, MPH

Katherine Shealy, MPH

Abigail Shefer, MD, FACP

Diane M. Simpson, MD, PhD

David Sleet, PhD

Ron Van Duyne, BA

Andrew Vernon, MD, MHS 

Cathleen M. Walsh, DrPH

Jennifer Weissman, MPH

Carla White, MPH
Gary Lindsay, MPH, CHES

Director of Business Partnerships

Partnership for Prevention

Jack Mahoney, MD, MPH

Medical Director & Director of Global Health Care Management

PittenyBowes

Steven Teutsch, MD, MPH

Executive Director 

Outcomes Research and Management

Merck & Co.

Terry Womack

Executive Director, Employee Services/Programs

BellSouth Corporation

Don Weber

Healthcare Consultant

PricewaterhouseCoopers

Lew Yeouze, MHA

Healthcare Consultant

Mercer Healthcare Consulting

Purchaser’s Guide Workgroup:

We gratefully acknowledge the contributions of the Centers for Disease Control and

Prevention (CDC) Purchaser’s Guide to Clinical Preventive Services Workgroup who

provided guidance on the development, design, and content of the Purchaser’s Guide.

Pamela Allweiss, MD, MPH

Division of Diabetes Translation

National Center for Chronic Disease Prevention and Health Promotion

Faculty, University of Kentucky

Achal Bhatt, PhD

Immunization Services Division (formerly)

National Center for Immunization and Respiratory Diseases (proposed) 

Mary Jean Brown, ScD, RN

Division of Emergency and Environmental Health Services

National Center of Environmental Health 

William Bailey, DDS, MPH

Division of Oral Health

National Center for Chronic Disease Prevention and Health Promotion

20

a Acknowledgements
Robert D. Brewer, MD, MSPH CAPT U.S. Public Health Services 

Division of Adult and Community Health

National Center for Chronic Disease Prevention and Health Promotion

Kathryn Phillips Campbell, MPH (co-chair)

Center for Prevention and Health Services

National Business Group on Health

Sajal Chattopadhyay, PhD

Division of Health Communication and Marketing Strategy

National Center for Health Marketing

Centers for Disease Control and Prevention

Clay Cooksey, MEd 

Division of Diabetes Translation

National Center for Chronic Disease Prevention and Health Promotion 

Ralph J. Coates, PhD

Division of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion 

Phaedra Corso, PhD

Division of Violence Prevention (formerly)

National Center for Injury Prevention and Control 

Richard E. Dixon, MD, FACP

Division of Partnerships and Strategic Alliances

National Center for Health Marketing

Ronald A. Finch, EdD

Center for Prevention and Health Services

National Business Group on Health

Scott Grosse, PhD 

Office of the Director

National Center on Birth Defects and Developmental Disabilities

R. DeLon Hull, PhD

Office of the Director

National Institute for Occupational Safety and Health

Dyann Matson Koffman, DrPH, CHES

Division of Heart Disease and Stroke Prevention

National Center for Chronic Disease Prevention and Health Promotion

Lisa M. Koonin, MN, MPH 

Division of Partnerships and Strategic Alliances 

National Center for Health Marketing 

21
Andrew Lanza, MPH, MSW (co-chair)

Division of Partnerships and Strategic Alliances 

National Center for Healthcare Marketing

Danni Lentine, MPH

Division of HIV AIDS Prevention

National Center for HIV, STD, and TB Prevention

Megan C. Lindley, MPH

Immunization Services Division

National Center for Immunization and Respiratory Diseases (proposed)

Don Lollar, EdD 

Office of the Director

National Center on Birth Defects and Developmental Disabilities

Suzanne M. Marks, MPH, MA 

Division Tuberculosis Elimination

National Center for HIV, STD, and TB Prevention

Timothy S. Naimi, MD, MPH, CDR, U.S. Public Health Service 

Division of Adult and Community Health

National Center for Chronic Disease Prevention and Health Promotion

Abby C. Rosenthal, MPH 

Office on Smoking and Health

National Center for Chronic Disease Prevention and Health Promotion 

Beth Carlton Tohill, PhD, MSPH

Division Nutrition and Physical Activity

National Center for Chronic Disease Prevention and Health Promotion

Robin E. Soler, PhD

Division of Health Communication and Marketing Strategy

National Center for Health Marketing 

Sergey Sotnikov, PhD

Division of Partnerships and Strategic Alliances

National Center for Health Marketing

22

a Acknowledgements
Clinical Preventive Services: Disease

Prevention and Early Detection

The Role of Clinical Preventive

Services in Disease Prevention

and Early Detection

Overview:

Information for employers on

improving beneficiary health and

reducing healthcare costs 

through the implementation of 

comprehensive and structured

clinical preventive service

benefits within a medical 

benefit plan. Sections include:

• Promoting Health and

Reducing Costs 

• The Importance of Preventing

Chronic Disease

• The Value of Prevention:

Cost-Effective, Cost-Saving,

and High-Value Clinical

Preventive Services

• Promoting Effective 

Clinical Preventive Services

1

23

Clinical Preventive Services: Preventing Disease, 

Promoting Health, and Reducing Healthcare Costs

The goals of prevention are to:

• Encourage individuals to avoid or delay disease by practicing healthy lifestyles;

• Identify individuals who could benefit from treatment for a condition or

complication about which they are unaware; and

• Prevent further disability among individuals with established disease. 

There are three types of prevention: primary prevention, secondary prevention, and tertiary

prevention. Primary prevention is the prevention of a disease before it occurs; secondary

prevention is the early detection and treatment of disease to prevent progression; and tertiary

prevention is an intervention to reduce the amount of disability caused by a disease.1-2

The Role of Clinical

Preventive Services in

Disease Prevention and 

Early Detection

Prevention Helps Individuals Avoid Disease

Primary prevention is aimed at preventing the onset of disease. One way of doing

this is by controlling risk factors in healthy people that may lead to disease.

Examples of primary prevention include 1) immunizations to prevent communicable 

diseases such as influenza or polio, and 2) the promotion of physical activity to 

prevent conditions such as obesity that can lead to disease (e.g., type 2 diabetes).

Prevention Modifies Risk

Secondary prevention is aimed at treating a disease after its onset, but before it

causes serious complications. Secondary prevention includes 1) identifying 

individuals with established disease, and 2) treating those individuals in a timely way

so as to prevent further problems (e.g., mammography screening to detect and treat

breast cancer in its earliest stages).

Prevention Reduces Disability

Tertiary prevention is aimed at treating the late or final stages of a disease so as to

minimize the degree of disability caused by that disease (e.g., administering a foot

check to a person with diabetes to identify infections that would require amputation

if left untreated).1-2

Definition Box 1.0: Prevention

1
24

1 The Role of Clinical Preventive Services in Disease Prevention and Early Detection

There are several different approaches to providing preventive services:

Clinical preventive services, the focus of this guide, include those services that are typically

performed in a clinical setting and are conducted by a health professional such as a

physician, nurse practitioner, physician assistant, or health educator. Although most clinical

preventive services should be conducted during individual face-to-face office visits, some

services may be conducted in groups, via the telephone, or by email communication.

Community-based preventive services (also known as population-based preventive services)

include any kind of planned activity or group of activities (including programs, policies, and

laws) designed to prevent disease or injury or promote health in a group of people (e.g.,

fluoridation of drinking water, bans on tobacco use in public places).3

Worksite-based preventive services are health promotion programs provided to employees

and their dependents. The expressed purpose of these services is to improve employee health

and prevent disease by providing an opportunity for employees to engage in primary

prevention activities. Examples include:

• Employer-sponsored worksite fitness centers or healthy cafeteria programs that

encourage healthy lifestyles. 

• Employer-sponsored health risk appraisals (HRAs) that identify employees at risk for

certain conditions and diseases (e.g., type 2 diabetes, heart disease, or hypertension)

and refer those employees to their health plan for continuing care.

• Employer-sponsored services such as employee assistance programs (EAPs) that can

help employees address health / lifestyle concerns, such as stress or substance use,

before the problems escalate into a clinical disorder (e.g., substance abuse, depression).

• Employer-initiated worksite smoking bans. 

• Employer-sponsored worksite influenza immunization clinics.

Preventive Interventions

There are several types of preventive interventions: screening, testing, counseling,

immunization, preventive medication, and preventive treatment. 

• Screening is best described as tests that assess the likelihood of the presence of a

disease or condition in an apparently healthy individual. Screening methods include

laboratory, X-ray, and similar technical methods; they also include questions asked by

a clinician. Screening may be targeted to people at increased risk due to age, gender,

family or personal history, or other factors. Each screening tool is different in design

and method, affecting the sensitivity (ability to correctly identify those with the

disease), specificity (ability to correctly identify those without the disease), and

positive and negative predictive values of the tool. Ideally, screening tests are rapid,

simple, and safe. It is important to note that, in most instances, screening is not a

definitive diagnostic test and that a positive result on a screening test merely indicates

that the screened individual has a higher likelihood of having the disease than a peer

with a negative result. Individuals who screen positive on such tests should have

confirmatory diagnostic tests to ensure an accurate diagnosis.4
• Testing refers to any process used to determine whether a condition is present (or not)

or to assess the status of a condition. Testing may involve questioning patients (e.g., a

mental status examination to determine whether thought processes are appropriate),

physical examination (e.g., examining a heart to detect a murmur or performing a

neurologic examination to detect nerve damage), or examining blood, body fluids, or

tissues (e.g., to detect anemia, to monitor levels of blood sugar, or to see if a cancer is

present in a biopsy sample). Testing may also require sophisticated technology, such as

CT or MRI scans and other X-rays, or invasive procedures, such as heart

catheterization to detect blockage of coronary arteries. Tests may be used to:

> Screen individuals who have risk factors, but no indication of having the

condition;

> Diagnose individuals who have symptoms and signs of a condition but where a

test will add certainty about the diagnosis; or 

> Monitor the progress of an individual who is being treated or being considered

for treatment, such as monitoring blood pressure over time.

• Counseling refers to a discussion between a clinician and patient about ways that

changes in personal behavior can reduce risk of illness or injury. The goal of

counseling is for clinicians to educate patients about their health risks as well as to

provide them with the skills, motivation, and knowledge they need to address their

risk behaviors (e.g., 5A framework for tobacco cessation: Ask, Advise, Assess, Assist,

Arrange). A special kind of counseling, “informed decision making,” recognizes that

people make different decisions even though their situations may seem to be similar.

Informed decision making is structured to give an individual all the information

needed to choose among different clinical options, such as whether or not to undergo

genetic testing.

• Immunization protects an individual from a specific communicable disease (e.g.,

measles) by exposing the individual to an antigen or a trace amount of inactivated

disease-causing agent, spurring the development of natural immunity.

• Preventive Medications are used to prevent the onset of disease (e.g., aspirin therapy

to prevent cardiovascular events).

• Preventive Treatment involves a procedure intended to prevent the occurrence of a

disease or to prevent the progression of a disease from one stage to another. Preventive

treatments usually refer to the use of prescription or over-the-counter (OTC)

medications, but they may also involve prescriptions for lifestyle changes (e.g.,

exercise, diet change) or other interventions. Some surgical procedures may be

considered “preventive treatment,” such as when polyps in the colon identified during

a screening colonoscopy are removed in order to prevent their progression to cancer

lesions.

25
The Importance of Preventing

Chronic Disease

Chronic diseases result in a significant amount of

preventable morbidity and mortality in the

United States. In 2000, 46.7% of all deaths in the

United States were caused by modifiable health

behaviors (see Table 1.1).5 The U.S. Department

of Health and Human Services estimates that

approximately 33% of all deaths in the United

States are attributable to just three modifiable health behaviors: smoking, physical inactivity,

and poor eating habits.2

Chronic diseases are the leading cause of direct

healthcare costs. In fact, researchers estimate that

75% of all healthcare costs directly stem from

preventable chronic health conditions such as type 2

diabetes, hypertension, and obesity.7-8 Chronic

diseases are also a major cause of lost productivity

and disability. For example:

• In 2002, the average annual healthcare cost for

a person with diabetes was $13,243 as opposed

to $2,560 for a person without diabetes.9

• It is estimated that the indirect cost of

cardiovascular disease will total over $145 billion in 2006.10

• Each year, an estimated 39 million work days are lost to obesity-related illnesses.11

• In 1999, lost productivity due to smoking, and smoking-related illnesses cost

employers $1,897 per smoking employee.12 Excess medical expenses due to smoking

and smoking related illnesses cost employers $1,850 per smoking employee (both

figures adjusted to year 2002 dollars).12

26

1 The Role of Clinical Preventive Services in Disease Prevention and Early Detection

In 2005, NCQA identified 44.5 million

sick days due to suboptimal care 

for hypertension and diabetes, two

preventable chronic diseases. The

lost productivity associated with

these disorders exceeded $7 billion.6

Each individual’s health is shaped by many factors including medical care, social 

circumstances, and behavioral choices. Increasingly, there is clear evidence that the major

chronic conditions that account for so much of the morbidity and mortality in the United States,

and the enormous direct and indirect costs associated with them, in large part are preventable

— and that to a considerable degree they stem from, and are exacerbated by, individual 

behaviors..... As Americans see healthcare expenditures continue to increase, it is important to

focus on strategies that reduce the prevalence and cost of preventable diseases.5

– U.S. Department of Health and Human Services, 2003

Prevention Makes Common “Cents”

Researchers estimate that 75% of 

all healthcare costs directly stem

from preventable chronic health 

conditions, yet only 1% of the 

$1.9 trillion dollars spent on

health care in the United States is

devoted to protecting health and

preventing illness and injury.7-8
27

HEALTH BEHAVIOR PERCENT OF DEATHS, 1990 PERCENT OF DEATHS, 2000

Tobacco use

Poor diet/physical inactivity

Alcohol use

Infectious agents

Toxic agents

Motor vehicle injuries

Firearms

Sexual behavior

Illicit drug use

TOTAL

19%

14%

5%

4%

3%

1%

2%

1%

<1%

50%

18.1%

15.2%*

3.5%

3.1%

2.3%

1.8%

1.2%

0.8%

0.7%

46.7%

Table 1.1: Percent of all Deaths in the United States Attributable to Selected Modifiable

Health Behaviors, 1990-200013

Figure 1.2: Underlying Causes of Death in the United States, 200013

Tobacco use

Poor diet/lack of exercise

Alcohol use

Infectious agents

Toxic agents

Motor vehicle injuries

Firearms

Sexual behavior

Illicit drug use

435,000

365,000*

85,000

75,000

55,000

43,000

29,000

20,000

17,000

Source: Mokdad A, Marks JS, Stroup DE, Gerberding JL. Actual causes of death in the United States. JAMA

2004; 291(10): 1238-1245. * Correction published: Mokdad A, Marks JS, Stroup DE, Gerberding JL.

Correction: Actual causes of death in the United States 2000. JAMA 2005; 293(3): 293-294.

Source: Mokdad A, Marks JS, Stroup DE, Gerberding JL. Actual causes of death in the United States. JAMA

2004; 291(10): 1238-1245.* Correction published: Mokdad A, Marks JS, Stroup DE, Gerberding JL.

Correction: Actual causes of death in the United States 2000. JAMA 2005; 293(3): 293-294.
28

The Value of Prevention

Purchasers can avoid or reduce the costs associated with preventable conditions by offering

coverage for — and promoting the use of — clinical preventive services. 

• Clinical preventive services can help individuals avoid disease altogether (e.g., tobacco

use treatment).

• Clinical preventive services can also catch disease it in its earliest stages (e.g., cervical

cancer screening). Identifying patients with early stage disease allows clinicians to

begin treatment sooner, when interventions are generally more effective and less

expensive. Early detection and treatment of some important infectious diseases can

also prevent spread of infection to others (e.g., influenza).

• Disease avoidance and early identification have financial benefits for employers

including: 

> Averted medical costs; and

> Reductions in absenteeism, lost productivity, turnover, and disability.

Like any investment aimed at keeping a workforce

healthy and productive, clinical preventive services

offer value. The value of a preventive service is

determined by its ability to prevent a significant

amount of morbidity and mortality in relation to

the cost of offering the service. Because offering a

clinical preventive service has a real (monetary)

cost and an opportunity cost (there is a finite amount of services that can be delivered and

received in a given period of time), it is important for purchasers to quantify the value of

clinical preventive services in relation to one another when making coverage decisions.

The effectiveness of most clinical preventive services, particularly those considered evidencebased, is well-documented. The effectiveness of clinical preventive services recommended in

the Purchaser’s Guide is detailed in Part III: Evidence-Statements for Recommended Clinical

Preventive Service Benefits. The cost-effectiveness (or economic value) of clinical preventive

services is described below. More information on the economic value of preventive

intervention can be found in each evidence-statement.

1 The Role of Clinical Preventive Services in Disease Prevention and Early Detection

Research shows that employees 

who take advantage of preventive

services have lower absenteeism,

higher productivity, and a stronger

commitment to their employer.14

Examples of Avoided Costs

The average dollar spent on:

• Alcohol misuse screening and brief counseling interventions saves $4 in healthcare costs.15-16

• The Hib vaccine (to prevent invasive bacterial infections) saves $1.40 in direct medical

costs and $2.00 in indirect costs.17

• The hepatitis B vaccine saves 50 cents in direct medical costs and $3.10 in indirect costs.17

• The varicella vaccine (to prevent chickenpox) saves 90 cents in direct medical costs and

$5.40 in indirect costs.17

• Chlamydia testing and treatment saves $12 in complications arising from chlamydia.17
Cost-Saving Clinical Preventive Services

A health intervention is cost-saving when the

intervention is 1) effective and 2) costs less in the

long run than the cost of not intervening. For

example, the cost of vaccinating all children in a

given population against measles is less than the cost of treating the children who would

contract measles without the population-wide protection of immunization. 

Cost-Effective Clinical Preventive Services

A medical intervention is considered cost-effective when the intervention provides a health

benefit at an acceptable cost. The term “acceptable cost” is not precisely defined and

involves important ethical considerations such as the value of a life. The answer to this

question boils down to a concept called “willingness-to-pay”: for example, how much is an

individual, an employer, or a society willing to pay to extend the life of one individual for

one year? Some conditions produce life- and work-altering disability, but not premature

death. Economists can use willingness-to-pay methods to assess the cost-effectiveness of

methods to prevent or modify disabilities as well. In the United States, there is no

universally accepted answer to the “willingness-to-pay” question and, thus, no universally

accepted threshold that distinguishes a cost-effective health intervention from an

intervention that is not cost-effective. 

In order to compare and rank various preventive interventions, economists use costeffectiveness (CE) ratios. A CE ratio is calculated as the ratio of differences in costs and

outcomes of the status quo and the proposed intervention according to the following

formula:

A CE ratio can be interpreted as the “price” of accepting a new intervention. The lower the

price, the more cost-effective the new intervention.

For more information on defining 

the value of preventive services and

prioritizing services for inclusion in a

medical benefit plan, please refer to

Part IV: The Prioritization and

Strategic Implementation of Clinical

Preventive Service Benefits.

29

Cost-effectiveness ratio =

(Outcome with intervention – Outcome without intervention)

(Cost with intervention – Cost without intervention)

Health economists use several terms to explain the cost, benefit, and overall value of a

clinical preventive service. The following terms are used throughout the Purchaser’s

Guide to describe the economic benefits of clinical preventive services.

Cost-saving: The reduction in healthcare costs resulting from the intervention or 

program exceeds the money required to develop, implement, and maintain the 

respective intervention or program.

Cost-effective: The net cost per unit of health generated is favorable relative to other

health services.

High-value: An intervention that prevents a substantial amount of morbidity and/or

mortality and is cost-effective.

Definition Box 1.3: Health Economics Terms
Quality Adjusted Life Years (QALY)

Outcomes in cost-effectiveness analysis (CEA) are usually measured in terms of number of

life years saved as a result of implementation of a new intervention. For interventions with

multiple health endpoints (e.g., hospitalization, treatment, death, etc) an outcome measure

needs to combine information on both morbidity (a measure of clinical illness) and

mortality (the number of deaths in the population under consideration). The best known of

these is the quality-adjusted life year or QALY. In principle, QALYs are based on the

preferences or “utilities” of respondents reflecting tradeoffs among different health states

(e.g., total cure, partial cure, disability, death). A preference or utility weight or score of 1.0

represents perfect health and 0 represents death. The number of QALYs is calculated as the

sum of the duration spent in each health state times the utility weight for that health state.

For example, if the utility weight for a chronic condition is 0.6, and an individual remains

in that health state for 1 year and then dies, the number of QALYs is 0.6. QALYs provide a

common currency that permits comparisons among different people and across different

kinds of conditions. QALYs permit comparisons of diseases that are rapidly fatal with those

that do not produce death but instead produce years of severe disability.

The results of a CEA may be interpreted to determine whether an intervention yields good

value for the investment. An intervention can be considered more or less cost-effective

relative to either another intervention or to a benchmark value. Cost-effectiveness (CE)

ratios are usually expressed in dollars per QALY. The lower the number, the more costeffective the intervention.

It is commonly said that an intervention that costs more than $50,000 or $100,000 per

QALY is not cost-effective, but a substantial number of healthcare interventions generally

accepted in the United States have higher CE ratios.18 The use of a fixed cost-effectiveness

threshold to define cost effectiveness ignores other determinants of social value such as

perceptions of risk. Further, the Partnership for Prevention has estimated ranges of CE ratios

using standardized methods for 25 clinical preventive services recommended for the general

population by the U.S. Preventive Services Task Force (USPSTF).19 The investigators used a

utility weight of 0.7 for chronic conditions, along with other simplifying assumptions that

make the results difficult to compare with the published CE ratios from studies that are

reported in the Purchaser’s Guide. The investigators found that one-fifth of all recommended

clinical preventive services had CE ratios between $165,000 and $450,000 per QALY in

year 2000 dollars.

30

1 The Role of Clinical Preventive Services in Disease Prevention and Early Detection

High-Value Clinical Preventive Services

Many preventive services are considered to be of high-value, meaning they are both costeffective (they cost a “reasonable” amount of money for the added quality of life or life years

gained) and prevent a substantial proportion of disease or injury when delivered appropriately.

The National Commission on Prevention Priorities (NCPP), a blue-ribbon panel of thoughtleaders on prevention chaired by former Surgeon General Dr. David Satcher and staffed by

Partnership for Prevention, recently ranked the health impact and cost-effectiveness of 25

preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) and the

Advisory Committee on Immunization Practices (ACIP). Please refer to Part IV: The Prioritization 

of Clinical Preventive Services in a Strategic Implementation Plan for more information.
31

HIGH-VALUE CLINICAL AS NOTED IN THE DESCRIPTION

PREVENTIVE SERVICE PURCHASER’S GUIDE

CE RATIO  $0/QALY (Defined as Cost-Saving)

Aspirin Chemoprophylaxis

Tobacco Use Screening and 

Brief Intervention

Colorectal Cancer Screening

Influenza Immunization

Problem Drinking Screening 

and Brief Counseling

Hypertension Screening

Cervical Cancer Screening

Calcium Chemoprophylaxis

Cholesterol Screening

Breast Cancer Screening

Aspirin Therapy for the Prevention of

Cardiovascular Disease, Counseling

Tobacco Use Treatment, Screening,

counseling, and treatment

Colorectal Cancer, Screening

Immunizations (Child, Adolescent, Adult)

Alcohol Misuse, Screening and counseling

Hypertension, Screening, counseling, 

and treatment

Cervical Cancer, Screening

Not included in the Purchaser’s Guide

Lipid Disorders, Screening, counseling, 

and treatment

Breast Cancer, Screening

Discuss the benefits/harms of daily

aspirin use for the prevention of

cardiovascular events with men 40,

women 50, and others at increased

risk.

Screen adults for tobacco use, provide

brief counseling, and offer

pharmacotherapy.

Screen adults aged 50 years routinely

with FOBT, sigmoidoscopy, or

colonoscopy.

Immunize adults aged 50 against

influenza annually. 

Screen adults routinely to identify

those whose alcohol use places them at

increased risk and provide brief

counseling with follow-up.

Measure blood pressure routinely in all

adults and treat with antihypertensive

medication to prevent incidence of

cardiovascular disease.

Screen women who have been sexually

active and have a cervix within 3 years

of onset of sexual activity or age 21

routinely with cervical cytology (Pap

smears).

Counsel adolescent and adult women

to use calcium supplements to prevent

fractures.

Routinely screen for lipid disorders

among men aged 35 and women

aged 45 and treat with lipidlowering drugs to prevent the incidence

of cardiovascular disease.

Screen women aged 50 routinely

with mammography alone or with

clinical breast examination, and discuss

screening with women aged 40 to 49 to

choose an age to initiate screening.

Table 1.4: Cost-Effectiveness Gradient Based on Partnership for Prevention’s Ranking of

Clinical Preventive Services Targeted to Working Age Adults19

$0/QALY  CE RATIO  $14,000/QALY

$14,000/QALY  CE RATIO  $35,000/QALY

$35,000/QALY  CE RATIO  $165,000/QALY
Relevance to Business

While economic analyses of cost-effectiveness focus on the overall costs and benefits to

society and the healthcare system, business case analyses of the value of clinical preventive

services estimate the financial return-on-investment (ROI) to individual employers,

healthcare plans, or providers. Those who pay for services are not necessarily the ones who

obtain the full financial return, however. Interventions that are cost-effective or even costsaving at the societal level do not necessarily yield a positive ROI from the business

perspective, although they may provide a better value than other services.20

The “Value of Prevention” in the Purchaser’s Guide

Each evidence-statement contains a “Value of Prevention” section that provides detailed

information on the economic burden, including the workplace burden, of the condition/

disease and information on the estimated cost of implementing the recommended preventive

intervention. Select chapters also include information on the cost of treatment. A sample

section is provided on the following page. 

32

1 The Role of Clinical Preventive Services in Disease Prevention and Early Detection

Obesity Screening

Depression Screening

Diabetes Screening

Diet Counseling

Tetanus-Diphtheria Booster

Obesity, Screening, counseling, and treatment

Depression, Screening

Diabetes (type 2), Screening

Healthy Diet, Counseling

Immunizations (Child, Adolescent, Adult)

Screen all adult patients routinely for

obesity and offer obese patients highintensity counseling about diet, exercise,

or both together with behavioral

interventions for at least 1 year.

Screen adults for depression in clinical

practices that have systems in place to

assure accurate diagnosis, treatment,

and follow-up.

Screen for diabetes in adults with high

cholesterol or hypertension, and treat

with a goal of lowering levels below

conventional target values.

Offer intensive behavioral dietary

counseling to adult patients with

hyperlipidemia and other known risk

factors for cardiovascular and dietrelated chronic disease.

Immunize adults every 10 years.

$165,000/QALY  CE RATIO  $450,000/QALY

Table 1.4: (Continued)

Source: Maciosek MV, Coffield AB, et al. Priorities among effective clinical preventive services: results of a

systematic review and analysis. Am J Prev Med 2006;31(1): 55-6.

HIGH-VALUE CLINICAL AS NOTED IN THE DESCRIPTION

PREVENTIVE SERVICE PURCHASER’S GUIDE
Promoting Effective and Appropriate Clinical Preventive

Services

The Underutilization of Preventive Care

Despite the documented benefits of timely preventive care, in 2002, only half of insured

adults (52%) received preventive care and screening tests according to guidelines for their

age and sex.30 The underutilization of clinical preventive services has a negative impact on

beneficiaries’ health status and on employers’ overall healthcare costs. For example, in 2004

the National Committee for Quality Assurance (NCQA) identified 7,600 excess cases of

late-stage breast cancer, 20,000 excess cases of late-stage colorectal cancer, and 21,000 excess

osteoporosis-related fractures that could have been averted if individuals received appropriate

and timely preventive care.6 Had these conditions been effectively prevented, $485.2 million

in excess medical expenses could have been avoided.6 

Reasons for the underutilization of preventive care are complex. In the past, preventive

services were poorly covered by health insurance policies in comparison to care for acute

services and medications. Differential coverage created perceived and real access barriers for

beneficiaries. Other barriers to preventive care include patient and provider attitudes about

33

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Value of Prevention

Obesity contributes significantly to medical costs in the United States. In 1998,

9.1% of total annual medical expenditures could be attributed to obesity.21

Between 1987 and 2001, 27% of the growth in inflation-adjusted per-capita

healthcare spending was associated with obesity.22 The annual cost of obesity is

estimated to range from $69 billion to $117 billion (including $61 billion for

direct medical expenses and $56 billion for indirect expenses such as lost

productivity [in year 2000 dollars]).23

The expected lifetime costs of cardiovascular disease (including coronary heart

disease, heart attack, and stroke) increase by 20% with mild obesity (class I: BMI

of 30 to 34.9), 50% with moderate obesity (class II: BMI of 35 to 39.9), and

nearly 200% with severe obesity (class III: BMI of 40 or higher).24 One large

health plan found that its yearly total medical claims were 18% higher for

overweight individuals and 32% higher for obese than for healthy-weight

individuals.25

A 2001 study found obese adults had, on average, about 37% higher healthcare

expenses per person than normal-weight adults. This excess expense increased

private healthcare spending by nearly 12% (more than $36 billion).22

The cost to employers of obesity-related health problems in 1994 was estimated

to be $13 billion per year, including $8 billion in medical claims, $2.4 billion in

paid sick leave, $1.8 billion in life insurance, and almost $1 billion in disability

insurance.24

Obesity and related illnesses are also a major cause of disability. Each year, an

estimated 39 million work days are lost to obesity-related illnesses.22

Nutrition education, diet, and exercise counseling are effective interventions for

obesity prevention and have the potential to significantly reduce the direct and

indirect costs of obesity-related illnesses. Researchers have estimated that even a

modest reduction of 10% in body weight in an obese individual might reduce

the expected lifetime healthcare costs of major obesity-related diseases for the

individual by $2,200 to $5,300, depending on age, sex, and initial BMI.26

The cost of BMI screening is negligible when height and weight measurements

are already recorded as part of a routine physical exam. In 2004, the privatesector cost of obesity counseling averaged $39 per session; approximately 95% of

all paid claims fell within the range of $0 to $129 per session.27

In the United States, the costs associated with treating obesity vary by location,

provider type, and treatment modality. For example, in 2006 the average wholesale

price of a 1-month supply of pharmacological therapy for obesity was $207.04 for

orlistat (Xenical“) (120 mg three times daily) and $423.60 for a 3-month supply of

sibutramine (Meridia“) (15 mg daily).28 In contrast, the average price of a surgical

procedure for obesity in 2004 ranged from $20,000 to $35,000.29

Obesity Sample
the value of prevention and the healthcare system’s

lack of capacity to effectively track, promote, and

deliver clinical preventive services. Even today, too

little time and too few resources are devoted to

prevention. In order to increase the utilization of

clinical preventive services, all stakeholders will

need to increase their investments in prevention.

Emphasizing Effective and Appropriate

Clinical Preventive Services

Not only is the underutilization of effective

preventive services a concern to employers, but so

too is the overutilization of ineffective or

unproven clinical preventive services. Providers

and patients have a limited amount of time and

purchasers have a limited amount of money to

spend on healthcare interventions. It is therefore

imperative for purchasers to cover and promote

high-impact clinical preventive services that have

proven benefit. Employers expanding their

medical benefit plan to include preventive services

should be careful to first select services with strong evidence of effectiveness. For more

information on effective clinical preventive services and the prioritization of clinical

preventive service benefits, please refer to Part IV: The Prioritization and Strategic

Implementation of Clinical Preventive Service Benefits. 

Employer Action Steps

Employers can reduce their total healthcare costs and improve the health of their beneficiaries

through the implementation and promotion of clinical preventive service benefits. For this

purpose, employers should: 

• Offer a structured set of clinical preventive service benefits through their health plan(s).

• Inform employees, dependents, and retirees about the availability of clinical preventive

service benefits and promote the consistent and appropriate use of recommended

clinical preventive services. 

• Educate employees, dependents, and retirees about the importance of preventive

services and healthy lifestyles.

• Implement programs that promote healthy lifestyles and provide opportunities for

employees to engage in disease prevention and health promotion outside of the clinical

setting (e.g., health promotion or wellness programs, disease prevention programs,

employee assistance programs).

• Support community-based and worksite-based preventive service interventions.

For more information on promoting the delivery and use of clinical preventive services,

please refer to Part VI: Leveraging Benefits: Opportunities to Promote the Delivery and Use of

Preventive Services.

34

1 The Role of Clinical Preventive Services in Disease Prevention and Early Detection

A recent study conducted by

Milliman, C-Change, and the

American Cancer Society, found that 

3 to 5 lives (per 50,000 employees)

could be saved each year if employers

fully adopted select USPSTF cancer

screening and tobacco treatment

recommendations.31 The cost to

employers of achieving 100%

compliance with USPSTF guidelines for

tobacco use treatment as well as breast,

cervical, and colorectal cancer was

estimated to be $7.50 per member/per

month (PMPM). Because most employers

already provide some type of cancer

prevention and early detection benefit,

the average incremental cost of moving

to 100% compliance would equal just

$2.95 PMPM.31
References: 

1 Gordis L. Epidemiology. 2nd Ed. Philadelphia, PA: WB Saunders Company; 2000.

2. U.S. Department of Health and Human Services. U.S. Surgeon General. The Power of Prevention, Steps 

to a Healthier US: A Program and Policy Perspective. Washington, DC: U.S. Department of Health and 

Human Services; 2003 [cited 2005 Aug 8]. Available from: 

http://www.healthierus.gov/steps/summit/prevportfolio/power/index.html. 

3. Centers for Disease Control and Prevention. The Community Guide to Preventive Services: Systematic 

Reviews and Evidence-Based Recommendations. [cited 2005 Sept 22]. Available from: 

http://www.thecommunityguide.org/. 

4. Engelgau MM, Venkat Narayan KM, Herman WH. Screening for type 2 diabetes. Diabetes Care 2000; 

23:1563-1580.

5. U.S. Department of Health and Humans Services. Prevention Makes Common “Cents”. Washington, 

DC: U.S. Department of Health and Humans Services; 2003 [cited Dec 21 2005]. Available from: 

http://aspe.hhs.gov/health/prevention/. 

6 National Committee for Quality Assurance. Executive Summary. In: The State of Health Care Quality

2004. Washington, DC; National Committee for Quality Assurance; 2005.

7. Center for Medicare & Medicaid Services. National Health Expenditures and Selected Economic

Indicators, Levels and Average Annual Percent Change: Selected Calendar Years 1990-2013. Washington,

DC: Center for Medicare & Medicaid Services, Office of the Actuary; 2004.

8. Institute of Medicine. The Future of the Public’s Health in the 21st Century. Washington, DC: National

Academy Press; 2002.

9. American Diabetes Association. Economic costs of diabetes in the U.S. in 2002. Diabetes Care 2003;

26:917-932.

10. Thom T, Haase N, Rosamond W, Howard VJ, Rumsfeld J, Manolio T, et al. Heart Disease and Stroke

Statistics--2006 Update: A Report From the American Heart Association Statistics Committee and Stroke

Statistics Subcommittee. Circulation 2006;113(6):e85-151.

11. Thorpe KE, Florence CS, Howard DH, Joski P. The impact of obesity on rising medical spending. Health

Aff 2004;W4:480-6.

12. Centers for Disease Control and Prevention. Annual smoking-attributable mortality, years of potential life

lost, and economic costs—United States, 1997–2001. MMWR 2005; 54(25);625-628.

13. Mokdad A, Marks JS, Stroup DE, Gerberding JL. Actual causes of death in the United States. JAMA 2004;

291(10): 1238-1245. Corrected and republished from: JAMA 2005; 293(3): 293-294.

14. Finch RA. Preventive services: improving the bottom line for employers. Compensation and Benefits

Review 2005 [cited 2006 Oct 1]; 18-22. Available from: http://cbr.sagepub.com/cgi/reprint/37/2/18.pdf. 

15. Fleming MF, Mundt MP, French MT, Manwell LB, Stauffacher EA, Barry KL. Brief physician advice for

problem alcohol drinkers: long-term efficacy and benefit-cost analysis. A randomized controlled trial in

community-based primary care settings. Alcohol Clin Exp Res 2002;26:36-43.

16. Gentilello LM, Ebel BE, Wickizer TM, Salkever DS, Rivara FP. Alcohol interventions for trauma patients

treated in emergency departments and hospitals: a cost benefit analysis. Ann Surg 2005;241:541-50.

17. National Committee for Quality Assurance. The State of Health Care Quality 2005: Industry Trends and

Analysis. Washington, DC; National Committee for Quality Assurance; 2006.

18. Grosse SD, Teutsch SM, Haddix AC. Lessons from cost-effectiveness research for United States public

health policy. Ann Rev Public Health 2007;28. In press.

19. Maciosek MV, Coffield AB, Edwards NM, Goodman MJ, Flottemesch TJ, Solberg LI. Priorities among

effective clinical preventive services: results of a systematic review and analysis. Am J Prev Med 2006;

31(1):52-61. Table reprinted from Am J Prev Med 2006; 31(1):52-61 with permission from the American

Journal of Preventive Medicine.

35
20. Grosse SD, Sotnikov SV, Leatherman S, Curtis M. The business case for preconception care: methods and

issues. Matern Child Health J. 2006. 10 Suppl 7: 93-9

21. Finkelstein EA, Fiebelkorn IC, Wang G. National medical spending attributable to overweight and obesity:

How much, and who’s paying? Health Aff 2003;W3; 219-26.

22. Thorpe KE, Florence CS, Howard DH, Joski P. The impact of obesity on rising medical spending. Health

Aff 2004;W4:480-6.

23. U.S. Department of Health and Human Services. Estimated economic costs of obesity to U.S. businesses.

In: Prevention Makes Common ‘Cents’ Washington, DC: Department of Health and Human Services;

2004.

24. Thompson D, Edelsberg J, Kinsay KL, Oster G. Estimated economic costs of obesity to U.S. business. Am

J Health Promot 1998;13:120-7. 

25. Kaiser Network. Blue Cross and Blue Shield of North Carolina introduces benefits package featuring

obesity treatments. Kaiser Daily Health Policy Report, 2004. Available from:

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=3&DR_ID=26217. 

26. Oster G, Thompson D, Edelsberg J, Bird AP, Colditz GA. Lifetime health and economic benefits of weight

loss among obese persons. Am J Public Health 1999;89:1536-42.

27. Thomson Medstat. Marketscan. 2004.

28. Fleming T. 2006 Redbook: Pharmacy’s Fundamental Reference. Thomson PDR; Rev Ed edition. May

2006.

29. National Institute of Diabetes and Digestive and Kidney Disease Weight-control Information Network.

Gastrointestinal Surgery for Severe Obesity. NIH Publication No. 04-4006. 

30. The Commonwealth Fund Commission on a High Performance Health System, Why Not the Best?

Results from a National Scorecard on U.S. Health System Performance.The Commonwealth Fund.

September 2006. Available from:

http://www.cmwf.org/publications/publications_show.htm?doc_id=401577 

31. Pyenson B, Zenner PA. Milliman, Inc. Cancer Screening: Payer Cost / Benefit thru Employee Benefits

Programs. Commissioned by C-Change and the American Cancer Society; 2005.

32. Thom T, Haase N, Rosamond W, Howard VJ, Rumsfeld J, Manolio T, et al. Heart Disease and Stroke 

Statistics—2006 Update: A Report From the American Heart Association Statistics Committee and Stroke 

Statistics Subcommittee. Circulation 2006;113(6):e85-151.

36

1 The Role of Clinical Preventive Services in Disease Prevention and Early Detection
2

Overview: 

46 clinical preventive service

Summary Plan Description (SPD)

language statements designed to

assist benefits staff as they design,

discuss, negotiate, and set benefit

structures and coverage guidelines

with a health plan, union, or 

consumer group. Sections include:

• The Purpose of Comprehensive

and Structured Clinical

Preventive Service Benefits

• An Overview of EmployerSponsored ERISA Healthcare

Benefits

• Communicating Health 

Benefits to Beneficiaries 

• Federal Regulation and

Preventive Services

• Clinical Preventive Services 

and High-Deductible Health

Plans: A Unique Opportunity 

to Promote Use

• Clinical Preventive Service

Summary Plan Description 

(SPD) Language

• Current Procedural 

Terminology (CPT) Codes

Summary Plan Description (SPD) 

Language Statements for 

Recommended Clinical Preventive 

Service Benefits

Summary Plan Description (SPD)

Language Statements

37

This section presents information on 1) the purpose of structured clinical preventive service

benefits; 2) information on the federal rules and regulations surrounding the provision of

clinical preventive services and preventive medications within employer-sponsored medical

benefits; and 3) summary plan description (SPD) language for each clinical preventive

service recommended in the Purchaser’s Guide. A condition/disease-specific evidencestatement, supporting the information contained in each SPD language example, is

provided in Part III: Evidence-Statements for Recommended Clinical Preventive Service Benefits.

The Purpose of Comprehensive and Structured Clinical

Preventive Service Benefits

Many of the clinical preventive services recommended in

the Purchaser’s Guide are covered by typical medical

benefit plans and are well-used by beneficiaries (e.g.,

cervical cancer screening). Other preventive services have

proven efficacy but are neither widely covered by

employers nor widely used by beneficiaries (e.g., tobacco

use treatment counseling).

Some types of clinical preventive services can be delivered

in the course of routine medical care, such as an annual

physical. For example, a patient who presents with

shortness of breath may be screened for obesity and

advised to lose weight. An informal screening service such as this would usually be covered

by a health plan as part of routine care, not as a unique preventive service. Informal

screening and counseling sessions serve an important function, but they are inadequate to

address some preventable conditions that

require more prevention resources. To

encourage beneficiaries to consistently and

appropriately use effective clinical preventive

services and to incentivize providers to actively

offer preventive services to their patients, it is

imperative for employers to provide a

structured and defined set of clinical

preventive service benefits within their medical

benefit plan(s) and to assure that health plans,

providers, and beneficiaries know that these

benefits exist and should be used.

Summary Plan Description

(SPD) Language Statements

for Recommended Clinical

Preventive Service Benefits

2

To encourage beneficiaries to 

consistently and appropriately use 

clinical preventive services and to

encourage providers to actively offer

clinical preventive services to their

patients, it is imperative for employers

to provide structured clinical 

preventive service benefits within 

their medical benefit plan(s) and to

assure that health plans, providers,

and beneficiaries know that these 

benefits exist and should be used.

As a nation, increasing our 

investment in high-impact,

cost-effective preventive services

will not only save valuable 

healthcare dollars but, more 

important, will significantly improve

the health status of the U.S.

population.1

—Sam Nussbaum, WellPoint Inc.
38

2 Summary Plan Description (SPD) Language Statements for 

Recommended Clinical Preventive Service Benefits

An Overview of Employer-Sponsored ERISA Healthcare

Benefits

Group health plans are employee healthcare benefit plans established and maintained by

employers. These plans provide coverage for eligible employees and dependents and, often,

for retirees as well. The vast majority of employer-sponsored health plans are subject to the

provisions of the Employee Retirement Income Security Act (ERISA) of 1974.2 This Act

provides protections and assurance to plan participants, defines the information that must

be provided to beneficiaries, and defines the fiduciary responsibilities of plan administrators. 

Summary Plan Descriptions (SPDs): Communicating Health Benefits to

Beneficiaries 

ERISA requires health plan administrators to give plan participants specific information

about the benefits to which they are entitled, including covered benefits, plan rules,

financial information, and documents about the plan’s operation and management. This

information must be provided on a regular basis, either in writing or on request. 

One important document that participants are legally entitled to receive automatically is a

plan summary or summary plan description (SPD). Generally, SPDs:

• Outline healthcare services covered in the plan.

• Describe how services are provided and how the plan(s) operate.

• Describe how benefits are calculated.

• Explain the portion of costs for which the plan is responsible and the portion of 

costs for which the participant (i.e., the beneficiary) is responsible (e.g., copays,

coinsurance). 

• Include information about how participants and providers should file claims.

ERISA specifically requires that SPDs include the following types of information:

1. Annual or lifetime caps or other limits on covered benefits. 

2. Cost-sharing provisions, including premiums, deductibles, and 

coinsurance/copayment amounts for which the participant (i.e., the beneficiary) is 

responsible. 

3. The extent to which preventive services are covered under the plan.

4. Whether, and under what circumstances, existing and new drugs are covered under 

the plan.

5. Whether, and under what circumstances, coverage is provided for medical tests, 

devices, and procedures. 

6. Provisions governing the use of network providers, the composition of provider 

networks and whether, and under what circumstances, coverage is provided for outof-network services. 

7. Conditions or limits on the selection of primary care providers or providers of 

specialty medical care. 

The Department of Labor requires that all SPDs be written in a way that can be understood by

the average plan participant.3 Even though plan services may be complex, the use of technical

language and long, complex sentences should be avoided. Detailed technical descriptions of

clinical preventive services must be made available to beneficiaries upon request.
The ERISA Act has been amended several times; the latest revisions were released on

January 1, 2005 and reinforced previous requirements stating that SPDs must provide a

detailed schedule of benefits, including a listing of covered preventive service benefits.4

Federal Regulation and Preventive Services

Federal rules and regulations govern employer-sponsored preventive services. The

Department of Labor provides regulatory oversight of employer-sponsored healthcare

benefits. The Internal Revenue Service (IRS) offers

guidance relative to plan services and related

payments. Recently, the IRS has provided rules

regarding how preventive services may be structured

in high-deductible health plans (HDHPs) that are

used in conjunction with health savings accounts

(HSAs). 

High-Deductible Health Plans (HDHPs)

Health Savings Accounts (HSAs)

Over the past few years, employers have introduced consumer-directed healthcare (CDH)

plans as an alternative to traditional health benefit plans. The purpose of these plans is to

control cost increases by requiring beneficiaries to take responsibility for their healthcare

spending. The most common CDH plan design involves a high-deductible health plan

(HDHP) with or without an accompanying health savings account (HSA). 

Health savings accounts (HSAs) are tax-advantaged, funded accounts established to support

saving for future medical expenses. HSAs are funded by tax-free dollars and, if ultimately

used for eligible medical expenses, these dollars remain non-taxed.5

To access the tax advantages of an HSA, an individual must be covered by an IRS-defined

HDHP. These are health plans with deductibles of at least $1,100 for individual coverage

($2,200 for family coverage) and caps on allowable out-of-pocket spending ($5,500 for

individual coverage/$11,000 for family coverage). These amounts are applicable for 2007,

and are updated annually to adjust for inflation. 

Clinical Preventive Services and High-Deductible 

Health Plans: A Unique Opportunity to Promote Use

Generally, a HDHP cannot provide benefits prior to fulfillment of the required deductible.

However, the IRS has provided an exception for preventive medical care to encourage the

use of preventive services. Employers have at least four options in structuring HDHP

benefits to promote prevention:

1. Waive the plan deductible and eliminate copayment/coinsurance requirements 

(100% first-dollar coverage).

2. Waive the plan deductible and reduce required copayment /coinsurance amounts.

3. Waive the plan deductible and require the usual copayment/coinsurance amounts.

39

Due to tax implications, the IRS 

has become involved in outlining

preventive services in the context of

consumer directed health care plans,

including HSA-qualified high-deductible

health plans (HDHPs), health savings

accounts (HSAs), and health reimbursement arrangements (HRAs).
4. Apply the plan deductible and provide a 

separate financial benefit for preventive 

care ($500 per prevention per year, for 

example). 

Notices 2004-236 and 2004-507 from the

Department of Treasury outline a preventive care

deductible safe-harbor for HDHPs under section

223(c)(2)(C) of the IRS code. The preventive care

safe-harbor includes deductible exemptions for

clinical preventive services, preventive

medications, and treatment incidental to

preventive care. 

Clinical Preventive Services and Preventive

Medications: Notice 2004-23

I. Preventive care benefits are allowed to be

provided by a high-deductible health plan

(HDHP) without satisfying the minimum

deductible. Preventive care includes, but is not

limited to, the following6: 

• Immunizations 

• Obesity weight-loss programs

• Periodic health evaluations, including tests

and diagnostic procedures ordered in

connection with routine examinations, such as annual physicals. 

• Prenatal care

• Screening services for 

> Cancer 

> Heart and vascular diseases 

> Infectious diseases 

> Mental health conditions and substance abuse 

> Metabolic, nutritional, and endocrine conditions 

> Musculoskeletal disorders 

> Obstetric and gynecologic conditions 

> Pediatric conditions 

> Vision and hearing disorders 

• Tobacco cessation programs

• Well-child care 

II. Drugs prescribed to prevent diseases or conditions that have not yet manifested

themselves or to prevent reoccurrence of diseases or conditions [are considered

preventive] and may be covered outside of the deductible.6

40

2 Summary Plan Description (SPD) Language Statements for 

Recommended Clinical Preventive Service Benefits

Preventive care benefits such as

annual physicals, immunizations,

and screening services are

exempt from HDHP deductible

requirements. Therefore,

employers can offer HDHPs that 

provide 100% first-dollar coverage

for clinical preventive services.

This type of exemption is known 

as “safe-harbor” coverage.

Clinical preventive services and

preventive medications can be

exempted from the deductible in

HSA-qualified HDHPs. Employers

who offer traditional health plan

types (e.g., HMOs, PPOs, POS) or

CDH plans that are not HSA-qualified

may wish to consider waiving

deductibles or lowering copay or

coinsurance amounts for preventive

medical care in order to promote 

the use of preventive services by

beneficiaries in these plan types.
Notice 2004-23 recognized clinical preventive services such as screening, counseling, and

immunizations as “preventive medical care” and provided an exemption from deductible

requirements. It also deemed drugs/medications to be “preventive medications” (and

therefore excludable from deductible requirements) when taken by a person who has

developed risk factors for a disease that has not yet manifested itself or not yet become

clinically apparent (this is known as primary prevention) or to prevent the reoccurrence of a

disease from which a person has recovered. For example, the treatment of high cholesterol

with cholesterol-lowering medications (e.g., statins) to prevent heart disease may be

considered preventive. Similarly, treating an initial heart attack with angiotensin-converting

enzyme (ACE) inhibitors to prevent a reoccurrence may be considered preventive. In

addition, drugs or medications used as part of procedures providing preventive care services,

such as weight-loss programs and tobacco use treatment programs, may be considered

preventive. 

Treatment Incidental to Preventive Care: Notice 2004-50 

Treatment that is performed along with preventive care services or screening may be

provided without meeting the deductible requirements as long as it is ancillary or incidental

to preventive care.7

Notice 2004-50 extended safe-harbor coverage to treatments that are ancillary to prevention

or when a separate procedure/visit for treatment would be impractical or unreasonable. For

example, the removal of polyps is an allowable preventive treatment benefit when provided

as a part of a screening colonoscopy.7

Guidance on the Definition of “Preventive Medical Care”

Prior to the 2004 guidance and clarification notices, employers and plan administrators

requested that the Department of Labor clearly define preventive medical care. The

Department of Labor responded that services and medications may vary from plan to plan

and are best described in the context of total plan provisions and not by regulation.8 Rather

than developing a schedule of allowable services and medications, the Department of

Treasury gave employers the discretion to define them relative to need and cost within the

limits set forth in Notices 2004-23 and 2004-50. Employers interested in exempting

preventive services and medications from the deductibles of HSA-qualified and HDHP

plans must therefore decide for themselves which services and medications qualify as

preventive and which do not. 

Defining Clinical Preventive Services

The Purchaser’s Guide recommends 46 clinical preventive

services for inclusion in medical benefit plans. All of the

recommended services qualify as preventive medical care

and could be exempted from the deductible in HSAqualified HDHP plans and other plan types. Employers

who offer preventive service benefits should evaluate these

benefits and exempt them from the deductible on a caseby-case basis. 

41

It is especially important for 

employers who offer HDHPs to 

clearly define clinical preventive 

service benefits and to inform 

beneficiaries about safe-harbor 

coverage so that the services will be

optimally used.
42

Defining Preventive Medications

The National Business Group on Health recognizes that the decisions employers must make

regarding the definition of medications as preventive are not always clear-cut particularly

because:

• Many drugs have both preventive and curative applications. For example, beta

blockers can be used to prevent stroke or treat hyperthyroidism.

• Several types of prevention exist (e.g., primary, secondary, tertiary).

A comprehensive listing of recommendations regarding preventive medication was beyond

the scope of the Purchaser’s Guide. Figure 2.0 was developed in order to provide employers

with some idea of the type of medications that may be defined as preventive. It presents

options employers have when selecting medications to consider preventive within a

pharmacy benefit. The listing draws upon evidence from regulators (such as the Food and

Drug Administration), authoritative expert groups that convene to review clinical evidence

(such as the U.S. Preventive Services Task Force), or the results of systematic literature

reviews (such as those produced by the Cochrane Collaboration, a reliable source of evidence

in health care). In the absence of such information, the sources cited are either consensus

expert opinion or important studies. The listing is intended to be a tool for benefit design

and communications; it is not a comprehensive list and is not endorsed in its entirety by any

of the referenced sources. In order to ensure compliance with IRS regulations, benefit

managers should consult with other knowledgeable sources such as health plans, consultants,

pharmacy benefit managers, and especially their internal legal departments. 

2 Summary Plan Description (SPD) Language Statements for 

Recommended Clinical Preventive Service Benefits

Important Note on the Difference Between the Use of the Term “Preventive

Medication” as a Category of Prevention and as a Pharmacy Benefit Definition

Several clinical preventive services recommended in the Purchaser’s Guide include the 

prescription/use of a preventive medication. Preventive medications, as recommended in

the Purchaser’s Guide, are limited to those medications that can be used to prevent a 

specific condition or disease (e.g., folic acid supplementation to prevent neural tube

defects). The prescription/use of these medications is thus a type of preventive 

intervention, in the same way that an immunization or counseling session is a type of 

preventive intervention.

There are many other types of medications that can be used to prevent the escalation of a

condition into another type of disease or disability (e.g., asthma medications to prevent

permanent damage to the airways) or to prevent a comorbidity from occurring as a result

of untreated disease (e.g., anti-diabetic agents to prevent cardiovascular disease).

Medications such as these can also be considered preventive and, according to the most

recent Department of Treasury guidance, qualify for safe-harbor coverage in HSA-qualified

HDHPs.
43

COVERED DRUG RATIONALE SOURCES OF DRUGS OR THERAPEUTIC 

CATEGORY EVIDENCE CLASSES 

(* = Generic Available)

Alcohol cessation agents

Antiasthmatic agents

Anticoagulant agents

Antidepressant agents

Antidiabetic agents

Antihypertensive agents

Bone density promoters

(Medications to prevent)

breast cancer 

Contraceptive agents

Drug abuse cessation

agents

Emergency adrenaline

shots

Erythroid stimulants

Flouride supplements

Prevents liver cancer and

cirrhosis of the liver

Prevents airway

remodeling and its

sequelae in asthmatics

Prevents strokes and other

poor cardiovascular

outcomes

Prevents the reoccurrence

of clinically apparent

depressive episodes

Prevents cardiovascular

disease, retinopathy,

neuropathy and

nephropathy

Prevents strokes, heart

attacks, kidney failure and

other poor cardiovascular

outcomes

Prevents osteoporosis and

bone fractures

Prevents breast cancer

Prevents pregnancy

Prevents liver disease

Prevents anaphylaxic

shock induced by severe

allergic reactions

Prevents chemotherapyinduced anemia and postsurgical anemia

Prevents dental caries

SAMHSA9

Standard use10

Standard use10

Meta analysis11

Standard use10

JNC 712

Standard use10

USPSTF13

Peer-reviewed research14

FDA15

CDC16

American Academy of

Allergy, Asthma and

Immunology17

NIH18

USPSTF19

Naltrexone*, disulfiram

Theophyllines*, oral beta-2

agonists*, mast cell stabilizers*,

inhaled beta-2 agonists*

leukotriene modifiers,

inhaled corticosteroids,

omalizumab

Anticoagulants*, thrombin

inhibitors*, antiplatelet agents

Tricyclics*, SSRIs*, bupropion*,

lithium*, maprotiline*,

mirtazapine*, nefazodone*,

trazodone*, SNRIs, MAOIs,

venlafaxine, duloxetine

Biguanides*, sulfonylureas*,

meglitinides, thiazolidinediones

and alpha-glucosidase inhibitors,

injectable or inhaled insulin

Thiazide diuretics*, loop

diuretics*, potassium sparing

diuretics*, ß-blockers*, CCBs*,

ACEIs*, ARBs

Calcium*, ergocalciferol*,

biphosponates*, bone formation

agents, parathyroid hormones,

selective receptor modulators

Tamoxifen

Oral contraceptives*,

contraceptive patch

Methadone*

Epinephrine auto-injector

Epoetin alfa, darbepoetin 

alfa-albumin

Sodium fluoride*, pediatric

combination vitamins with

fluoride*

Figure 2.0: Preventive Medications that Employers May Select to Include 

in Pharmacy Benefits
44

2 Summary Plan Description (SPD) Language Statements for 

Recommended Clinical Preventive Service Benefits

Folic acid supplements

Immunizations (for

children, adolescents,

and adults)

Lipid/cholesterol

lowering agents

Medical nutrition

therapy

Myeloid stimulants

Prenatal supplements 

that include folic acid

Proton pump inhibitors

Tobacco use cessation

agents

Weight-loss agents

Prevents some

cardiovascular conditions

Prevents neural tube defects

Prevents transmission of

infectious diseases

Prevents AMIs and other

poor cardiovascular

outcomes

Prevents mental

retardation in persons

with PKU and poor

outcomes in persons with

other inherited metabolic

diseases

Prevents chemotherapyinduced febrile

neutropenia

Prevents neural tube

defects, vitamin

deficiencies, and 

preeclampsia

Prevents esophageal

damage caused by GERD

Prevents emphysema and

lung cancer

Prevents poor

cardiovascular outcomes

Standard use10, CDC,

U.S. Public Health

Service20, 24

ACIP29

ATP III21 ATP III

update22, ICSI23

AAP25-26

CDC27

Cochrane

Collaboration

Reviews24, 28

IRS30

Peer-reviewed research31

CDC, U.S. Public

Health Service32

USPSTF33

Folate*

All AClP Recommend vaccines

Statins*, niacin*

Variable

Filgrastim, pegfilgrastim,

sargramostim

Prenatal combination vitamins*

Proton pump inhibitors*,

histamine-2 receptor blockers*,

antacids*, promotility agents*

Bupropion*, nicotine patch,

nicotine inhaler, varenicline

Sibutramine, orlistat,

phentermine, diethylpropion

COVERED DRUG RATIONALE SOURCES OF DRUGS OR THERAPEUTIC 

CATEGORY EVIDENCE CLASSES 

(* = Generic Available)

Figure 2.0: Preventive Medications that Employers May Select to Include 

in Pharmacy Benefits (Continued)
Abdominal Aortic Aneurysm ✔

Alcohol Misuse ✔ ✔

Aspirin Therapy for the 

Prevention of Cardiovascular ✔

Disease

Breast Cancer

Breast Cancer ✔

Breast Cancer Genetic 

Risk Assessment and ✔✔ ✔

BRCA Mutation Testing

Breast Cancer ✔ ✔

Cervical Cancer ✔

Childhood Health Promotion

Child Development ✔

Child Immunizations ✔

Dental Caries Prevention ✔

Lead, Elevated Blood Level ✔

Newborn Screening for 

Genetic and Endocrine ✔ ✔* ✔

Disorders

Newborn Hearing ✔

Vision ✔

Colorectal Cancer ✔

Contraceptive Use ✔ ✔

Depression ✔

Diabetes (type 2) ✔

Healthy Diet ✔

Healthy Pregnancy

Alcohol Misuse ✔ ✔

Asymptomatic Bacteriuria ✔

Breastfeeding ✔

Folic Acid Supplementation ✔ ✔

Group B Streptococcal ✔ ✔

Screening Testing Counseling Immunization Preventive (Preventive)

Medication/ Treatment

Intervention

45

Figure 2.1: Intervention Chart 
46

2 Summary Plan Description (SPD) Language Statements for Recommended 

Clinical Preventive Service Benefits

Disease (GBS)

Hepatitis B Virus (HBV) ✔ ✔✔

Human Immunodeficiency ✔✔ ✔

Virus (HIV)

Influenza ✔

Preeclampsia ✔

Prenatal Diagnosis of 

Chromosomal Abnormalities ✔ ✔

and Neural Tube Defects 

(NTDs)

Rh (D) Incompatibility ✔ ✔

Rubella ✔

Syphilis ✔

Tetanus ✔

Tobacco Use Treatment ✔ ✔

Hypertension ✔✔ ✔

Immunizations ✔

(Child, Adolescent, Adult)

Lipid Disorders ✔✔ ✔

Motor Vehicle-Related ✔

Injury Prevention

Obesity ✔✔ ✔

Osteoporosis ✔ ✔

Sexually Transmitted 

Infections (STIs)

Counseling to prevent STIs ✔

Chlamydia ✔

Gonorrhea ✔

Human Immunodeficiency ✔ ✔

Virus (HIV)

Syphilis ✔

Tobacco Use Treatment ✔✔ ✔

Tuberculosis ✔

*Includes medical foods in addition to medications

Screening Testing Counseling Immunization Preventive (Preventive)

Medication/ Treatment

Intervention

Figure 2.1: Intervention Chart (Continued)
Sample Summary Plan Description

(SPD) Language Statements for

Recommended Clinical Preventive 

Service Benefits

Summary Plan Description (SPD) Language 

The following pages contain condition, disease or

injury specific SPD language statements for each

clinical preventive service recommended in the Purchaser’s Guide. The SPD language

statements clearly outline the recommended benefits for each service.

The recommended benefits (and hence the SPDs), are a translation of the clinical guidelines

featured in the corresponding evidence-statements, which outline the medical evidence for

each intervention.The process of translating clinical guidelines into benefit language is

difficult. The National Business Group on Health (Business Group) has made every effort to

align benefits recommended in the Purchaser’s Guide with the most current clinical

guidelines and recommendations. However, because recommendation-making bodies (e.g.,

USPSTF, professional organizations, etc) sometimes disagree on the specifics of a particular

clinical preventive service, for example, how often a service should be provided, the Business

Group combined multiple recommendations to construct the detailed benefits described in

the SPDs. For an exact listing of the recommendations and guidelines, please refer to the

corresponding evidence-statements provided in Part III: Evidence-Statements for

Recommended Clinical Preventive Service Benefits.

Current Procedural Terminology (CPT®) Codes

Applicable current procedural terminology (CPT) codes are provided for each recommended

benefit. CPT codes are listed in alphabetical order as an appendix to the SPD language

statements. 

CPT codes are provided for employers and health plans to facilitate the implementation and

reimbursement of clinical preventive service benefits. Employers who adopt the

recommendations set forth in the Purchaser’s Guide should ensure that their health plan

administrators approve the listed CPT codes for provider reimbursement. 

CPT codes are developed by the American Medical Association (AMA) for the purpose of

providing a uniform language that accurately describes medical, surgical, and diagnostic services

provided by physicians and other clinicians. The list of codes is updated annually. For more

information on CPT codes and to view updates, please contact the CPT Information and

Education Service at 1-800-634-6922 or visit: www.ama-assn.org/ama/pub/category/3113.html

47

A Note on SPDs 

Summary plan description language does not typically include the names of covered tests

or procedures. SPD language provided in the Purchaser’s Guide includes specific

information on covered tests, procedures, and medications. This information is included for

educational purposes. Some employers may wish to include this information in their SPDs;

other employers may wish to delete this information from their SPDs, and share it only

with their health plan administrators for contracting purposes.

The clinical preventive services 

benefits recommended in the

Purchaser’s Guide address a range 

of health conditions that affect people

of all ages. For a brief summary of 

clinical preventive services appropriate for

different age groups and genders, please

refer to the Life Course Charts featured in

Part VII: Resources & Tools.
48

2 Summary Plan Description (SPD) Language Statements for Recommended 

Clinical Preventive Service Benefits

Alphabetical Listing of SPDs Page Number (CPT Codes)

Abdominal Aortic Aneurysm, Screening................................Pg. 51...............................Pg. 73

Alcohol Misuse, Screening and counseling ............................Pg. 51...............................Pg. 73

Aspirin Therapy for the Prevention of

Cardiovascular Disease, Counseling ................................Pg. 51...............................Pg. 73

Breast Cancer

Breast Cancer, Screening....................................................Pg. 52 ............................. Pg. 73

Breast Cancer Genetic Risk Assessment and 

BRCA Mutation Testing, Counseling, testing,

and preventive treatment ................................................Pg. 52 ............................. Pg. 74

Breast Cancer, Counseling and preventive medication.......Pg. 52 ............................. Pg. 75

Cervical Cancer, Screening ....................................................Pg. 53 ............................. Pg. 76

Childhood Health Promotion 

Child Development, Screening ............................................Pg. 54 ............................. Pg. 77

Dental Caries, Preventive medication..................................Pg. 54 ............................. Pg. 77

Immunizations.....................................................................Pg. 54 ............................. Pg. 88

Lead, Elevated Blood Level, Screening ...............................Pg. 54 ............................. Pg. 78

Newborn Screening for Genetic and Endocrine

Disorders, Screening, medical foods, and treatment.......Pg. 55 ............................. Pg. 78

Newborn Hearing, Screening ..............................................Pg. 55 ............................. Pg. 78

Vision, Screening.................................................................Pg. 56 ............................. Pg. 78

Colorectal Cancer, Screening..................................................Pg. 57 ............................. Pg. 79

Contraceptive Use, Counseling and 

preventive intervention........................................................Pg. 57 ............................. Pg. 79

Depression, Screening.............................................................Pg. 57 ............................. Pg. 80

Diabetes (type 2), Screening...................................................Pg. 58 ............................. Pg. 80

Healthy Diet, Counseling..........................................................Pg. 58 ............................. Pg. 81

Healthy Pregnancy

Alcohol Misuse, Screening and counseling.........................Pg. 58 ............................. Pg. 81

Asymptomatic Bacteriuria, Screening.................................Pg. 59 ............................. Pg. 81

Breastfeeding, Counseling...................................................Pg. 59 ............................. Pg. 81

Folic Acid Supplementation, Counseling and 

preventive medication .....................................................Pg. 60 ............................. Pg. 82

Group B Streptococcal Disease (GBS),

Screening and preventive medication ............................Pg. 60 ............................. Pg. 82

Hepatitis B Virus (HBV), Screening, immunization,

and treatment..................................................................Pg. 61 ............................. Pg. 82

Human Immunodeficiency Virus (HIV), Screening,

counseling, and preventive medication ...........................Pg. 62 ............................. Pg. 83

Influenza, Immunization ......................................................Pg. 63 ............................. Pg. 83

Preeclampsia, Screening.....................................................Pg. 63 ............................. Pg. 84
49

Alphabetical Listing of SPDs Page Number (CPT Codes)

Prenatal Diagnosis of Chromosomal Abnormalities

Screening and testing ...............................................Pg. 63...............................Pg. 86

Rh (D) Incompatibility,

Screening and preventive medication .......................Pg. 64.............................. Pg. 87

Rubella, Screening .........................................................Pg. 64.............................. Pg. 88

Syphilis, Screening.........................................................Pg. 64.............................. Pg. 88

Tetanus, Immunization...................................................Pg. 65.............................. Pg. 88

Tobacco Use Treatment, Screening and counseling ......Pg. 65.............................. Pg. 88

Hypertension, Screening, counseling, and treatment.........Pg. 65.............................. Pg. 89

Immunizations (Child, Adolescent, Adult).......................Pg. 66.............................. Pg. 89

Lipid Disorders, Screening, counseling, and treatment .....Pg. 66.............................. Pg. 92

Motor Vehicle-Related Injury Prevention, Counseling.....Pg. 67.............................. Pg. 93

Obesity, Screening, counseling, and treatment...................Pg. 67.............................. Pg. 94

Osteoporosis, Screening and treatment.............................Pg. 68.............................. Pg. 94

Sexually Transmitted Infections (STIs)

Counseling to Prevent STIs, Counseling.........................Pg. 69.............................. Pg. 95

Chlamydia, Screening....................................................Pg. 69.............................. Pg. 95

Gonorrhea, Screening ....................................................Pg. 69.............................. Pg. 96

Human Immunodeficiency Virus (HIV),

Screening and counseling ..........................................Pg. 70.............................. Pg. 96

Syphilis, Screening.........................................................Pg. 70.............................. Pg. 97

Tobacco Use Treatment,

Screening, counseling, and treatment ...........................Pg. 71.............................. Pg. 97

Tuberculosis, Screening.....................................................Pg. 71 ............................. Pg. 97
50
51

SUMMARY PLAN

DESCRIPTION LANGUAGE

Covered Screening

Initiation, Cessation,

and Interval 

Covered Screening

Initiation, Cessation,

and Interval

Covered Counseling 

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Abdominal Aortic Aneurysm (Screening)

Ultrasonography of the abdomen.

One-time screening ultrasound to look for abdominal aortic aneurysm in men

aged 65 to 75 who have smoked at any time in their lives. The exact timing of

the screen is left to the discretion of the clinician.

Summary Plan Description Language: 

Alcohol Misuse (Screening) 

Screening for alcohol misuse is a covered benefit. Coverage includes the use of

validated screening tools such as:

• Single-question alcohol screens 

• Alcohol Use Disorders Identification Test (AUDIT) or AUDIT-C

• CAGE

Screening is a covered benefit beginning at age 18. Coverage is provided for

younger populations depending on risk and need. For average-risk populations,

one screen is covered annually. More frequent screening is covered for individuals

at risk for alcohol misuse, including people with a history of alcohol misuse or

alcohol-related health and social problems. 

Summary Plan Description Language: 

Alcohol Misuse (Counseling)

Counseling is a covered benefit for patients who meet criteria for alcohol misuse.

Three levels of counseling are covered:

• “Very brief” interventions that last up to 5 minutes and have no follow-up.

• “Brief” counseling interventions that last 15 minutes and have no follow-up.

• “Multi-contact” interventions that include one initial session lasting at least 15

minutes that is followed by several additional contacts. 

Eight (8) counseling sessions are covered per calendar year. Intervals between

counseling sessions are at the discretion of the provider. 

Summary Plan Description Language: 

Aspirin for the Primary Prevention of Cardiovascular Events

(Counseling)

Counseling to discuss the benefits and harms of aspirin therapy is a covered

benefit. 

All beneficiaries aged 30 and older are eligible for one counseling session every 5

years or whenever a cardiovascular risk factor is detected.
52

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Screening

Initiation, Cessation,

and Interval

Covered Counseling 

Initiation, Cessation,

and Interval

Covered Testing

Initiation, Cessation,

and Interval

Covered Counseling 

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Breast Cancer (Screening)

Breast cancer screening is a covered benefit and may include mammography and,

as an adjunct, a clinical breast exam (CBE).

Breast cancer screening is a covered benefit for average-risk women aged 40 to

80. Average-risk women are eligible for one mammography per calendar year.

Women at high risk of breast cancer may qualify for screening at a younger age,

if screening is deemed medically indicated. 

Summary Plan Description Language: 

Breast Cancer Genetic Risk Assessment and BRCA Mutation

Testing (Counseling)

Beneficiaries determined to be at high risk for breast cancer based on the results

of a clinician’s risk assessment are eligible for genetic counseling.

Counseling is provided as medically indicated, and should be conducted at least

once before and after genetic testing.

Summary Plan Description Language: 

Breast Cancer Genetic Risk Assessment and BRCA Mutation

Testing (Testing)

Beneficiaries determined to be at high risk for breast cancer based on the results

of a clinician’s risk assessment are eligible for BRCA mutation testing. 

BRCA mutation testing is covered once per lifetime.

Summary Plan Description Language: 

Breast Cancer (Counseling on Preventive Medication and

Preventive Treatment)

Beneficiaries determined to be at high-risk for breast cancer based on the results

of the clinician’s risk assessment or the results of BRCA mutation testing are

eligible for counseling on the use of preventive medication or preventive

treatments.

Counseling is provided as medically indicated.
53

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Preventive

Medications

Initiation, Cessation,

and Interval

Covered Preventive

Treatment

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Breast Cancer (Preventive Medication)

Beneficiaries determined to be at high risk for breast cancer based on the results

of a clinician’s risk assessment are eligible for preventive medication. Coverage is

provided for all FDA-approved breast cancer preventive medications (e.g.,

tamoxifen).

Coverage is provided for 5 years. Preventive treatment may be extended, if

continued treatment is determined to be medically necessary. 

Summary Plan Description Language: 

Breast Cancer Genetic Risk Assessment and BRCA Mutation

Testing (Preventive Treatment)

Beneficiaries determined to be at high risk for breast cancer based on the results

of a clinician’s risk assessment or the results of BRCA mutation testing are eligible

for preventive treatment, which may include any of the following:

• Surgical removal of the breast(s) with or without reconstructive surgery

• Surgical removal of the ovaries

Treatment coverage includes counseling-based office visits for treatment

education, decision-making, and monitoring.

Preventive treatment is provided, as medically indicated. 

Summary Plan Description Language: 

Cervical Cancer Screening (Screening)

Conventional Pap test.

***Health plans have the discretion to provide coverage for newer screening

methods, such as liquid-based, thin-layer preparations (e.g., ThinPrep®) or

computer-assisted screening (e.g., AutoCyte®), and human papillomavirus (HPV)

tests, such as Hybrid Capture II®.

Cervical cancer screening is a covered benefit for women age 21 (or women of

any age 3 years within the onset of sexual activity) through age 65. Coverage

beyond the age of 65 is provided for women with known risk factors, recent

abnormal pap smears, inadequate previous screening, or when information about

previous screening is unavailable or when screening is unlikely to have occurred

in the past.

Coverage allows Pap tests to be performed at least once every three years, but not

more than once per calendar year.
54

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Screening

Initiation, Cessation,

and Interval

Covered Preventive

Medication(s)

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Childhood Health Promotion (Screening, Immunization,

Medical Foods, and Preventive Medication)

Summary Plan Description Language: 

Child Development (Screening)

Coverage is provided for developmental screening including the use of

standardized instruments. 

Developmental screening services are covered for all children as a component of

the 9, 18, and 30-month well-child care visits.

Summary Plan Description (SPD) Language: 

Dental Caries Prevention through Oral Fluoride

Supplementation (Preventive Medication)

Oral fluoride 

Oral fluoride is covered as prescribed by the clinician according to age and need. 

Coverage for supplementation is provided from 6 months to 5 years of age and

may be extended through 16 years of age, if medically indicated. 

Summary Plan Description (SPD) Language: 

Child Immunizations (Immunization)

Please refer to the general Immunizations SPD language.

Summary Plan Description Language: 

Elevated Blood Lead Levels (Screening)

Covered screening tests for lead exposure include blood lead concentration

measured from capillary or venous samples. 

Screening is a covered benefit for children at risk for lead exposure at the

following ages: 12 months, 24 months, and 36–72 months, or at any age when

deemed medically necessary by a risk assessment, clinical signs or symptoms

consistent with elevated BLL, or when other evidence indicates possible lead

exposure. Secondary venous blood lead concentration tests, taken for

confirmation, are covered for all children identified as having an elevated BLL

through a capillary blood lead concentration screen.
55

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Screening

Initiation, Cessation,

and Interval

Covered Screening

Methods

Initiation, Cessation,

and Interval

Covered Medical

Foods

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Newborn Hearing (Screening)

Hospital-based hearing screening is a covered benefit for all newborns. Newborns

who are not screened in the hospital, or who require further screening, may be

tested in a clinician’s office. Screening may include the use of the following tests:

• Automated or semiautomated audiologic screening

• Auditory Brainstem Response (ABR) 

• Otoacoustic Emissions (OAE) 

Diagnostic audiological evaluation is a covered benefit for all infants and children

who do not pass initial screening tests.

Screening is covered for all newborns during the first 3 months of life. Additional

screening is provided for at-risk children, as determined medically necessary,

through age 3 years. Diagnostic audiological evaluation is covered, as medically

necessary.

Summary Plan Description Language: 

Newborn Screening for Genetic and Endocrine Disorders

(Screening)

Newborn blood spot screening is a covered benefit. Screening is provided for the

following conditions: phenylketonuria (PKU), congenital hypothyroidism (CH),

galactosemia, sickle cell disease (SCD) and other hemoglobin disorders,

congenital adrenal hyperplasia (CAH), biotinidase deficiency, and medium chain

acyl-coA dehydrogenase (MCAD) deficiency. Screening for other conditions is

covered, as medically indicated.

Newborn screening is covered from birth through 4 months of age. Follow-up

testing is covered, as medically indicated.

Summary Plan Description Language: 

Newborn Screening for Genetic and Endocrine Disorders

(Medical Foods)

Medical formulas and foods are covered for the purpose of preventing illness,

disability, or death among beneficiaries with genetic or endocrine disorders. 

Medical formulas and foods are covered, as medically necessary.
56

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Treatment

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Newborn Screening for Genetic and Endocrine 

Disorders (Treatment)

Medications and other forms of treatment used to prevent illness or disability

among beneficiaries with genetic or endocrine disorders are covered. Case

management is a covered benefit and is provided, as medically necessary, for

beneficiaries with complex disorders. 

Medications and other forms of treatment are covered, as medically indicated.

Summary Plan Description Language: 

Vision (Screening) (Child)

Vision screening is a covered benefit for all children and may include use of the

following screening tests: 

• Cover test

• External inspection of the eyes and lids

• Hirschberg light reflex test

• Ocular history

• Ocular motility assessment

• Photo-screening 

• Pupil examination

• Random Dot E test

• Red reflex examination

• Titmus Fly test

• Vision assessment

• Visual acuity tests including the Snellen Acuity Chart, the Tumbling E, the

HOTV Test, Allen Cards, and LH Symbols 

Vision screening is covered in the newborn period and at all subsequent wellchild visits.

The following vision screenings are covered for children birth to 3 years of age:

ocular history, vision assessment, external inspection of the eyes and lids, ocular

motility assessment, pupil examination, and red reflex examination.

The following vision screenings are covered for children ages 3 to 5 years: age

appropriate visual acuity measurements using the Snellen Chart, Tumbling E, the

HOTV Test, Allen Cards, or LH Symbols) and ophthalmoscopy.
57

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Screening

Initiation, Cessation,

and Interval

Covered Counseling

Initiation, Cessation,

and Interval

Covered Preventive

Medications/

Devices

Initiation, Cessation,

and Interva

Covered Screening

l

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Colorectal Cancer (Screening)

• Colonoscopy • Double-contrast barium enema. 

• Fecal occult blood testing (FOBT) (alone or combined with flexible sigmoidoscopy)

• Flexible sigmoidoscopy (alone or combined with FOBT)

Colorectal cancer screening is a covered benefit for men and women aged 50 and

older. Screening may be initiated at an earlier age if the beneficiary has certain risk

factors and a clinician determines that the individual requires early screening. 

Colorectal cancer screening intervals are based on the method of screening used: 

Screening Method Approved Interval for Coverage

Colonoscopy Every 10 years 

Flexible sigmoidoscopy Every five years 

Double-contrast barium enema Every five years 

Fecal occult blood tests (FOBT) Every year 

Combination of flexible Every five years for the flexible

sigmoidoscopy and FOBT sigmoidoscopy and annually for the FOBT

Summary Plan Description Language: 

Contraceptive Use (Counseling) 

Counseling on contraceptive use is a covered benefit.

Counseling is a covered benefit for all beneficiaries aged 13 to 55 years, whenever

it is deemed medically indicated. Counseling should be conducted at least once a

year and whenever emergency contraception is prescribed. 

Summary Plan Description Language: 

Contraceptive Use (Preventive Intervention) 

The full range of Food and Drug Administration (FDA) approved contraceptives

are covered including:

• All hormonal medications (e.g., pills and patches) including emergency contraceptives

• All contraceptive devices (e.g., IUD, diaphragm, vaginal ring)

• Voluntary sterilization (e.g., vasectomy, tubal ligation)

Hormonal medications (e.g., pills and patches) — including emergency contraceptives

— and contraceptive devices are covered as medically necessary for the prevention of

pregnancy. Voluntary sterilization (e.g., vasectomy, tubal ligation) is covered once per

lifetime. Coverage may be extended if the procedure fails. 

Summary Plan Description Language: 

Depression (Screening)

Depression screening, including the use of standardized depression screening or

informal instruments, is a covered benefit. 

Depression screening is a covered benefit for all adults age 18 and older, when deemed

medically indicated. Depression screening is covered for adolescents, as medically indicated. 
58

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Screening

Initiation, Cessation,

and Interval

Covered Counseling

Initiation, Cessation,

and Interval

Covered Screening

Summary Plan Description Language: 

Diabetes (Screening)

• Fasting plasma glucose test (FBG)

• 2-hour post-load plasma glucose

• Oral glucose tolerance test (OGTT)

Diabetes screening is a covered benefit for beneficiaries of any age with

hypertension or hyperlipidemia (lipid disorders). Screening should be initiated

whenever these conditions are diagnosed. Screening should be conducted,

depending on risk, at least once every 3 years, but not more than once during

any calendar year. 

Coverage for diabetes screening among those at high risk for the disease is

provided beginning at age 30, if medically indicated. Screening should be

conducted at least once every 2 years, but not more than once during any

calendar year. 

Coverage for diabetes screening among individuals at normal risk for the disease

is provided beginning at age 45, or earlier if medically indicated. Screening may

be conducted once every 3 years.

Individuals with impaired glucose function diagnosed by any test listed in

“covered screening methods” qualify for a second screen to verify disease status.

The secondary screening should be conducted on another day in the same

calendar month.

Summary Plan Description Language: 

Healthy Diet (Counseling)

Intensive behavioral dietary counseling is covered for adult beneficiaries with

hyperlipidemia (lipid disorders) and other known risk factors for cardiovascular

and diet-related chronic diseases.

Beneficiaries who meet the criteria for counseling are eligible for 3 intensive (30-

45 minute) counseling sessions per calendar year. 

Summary Plan Description Language: 

Healthy Pregnancy (Screening, Testing, Counseling,

Preventive Medication, and Treatment)

Summary Plan Description Language: 

Alcohol Misuse (Screening)

Screening for alcohol misuse is a covered benefit. Coverage includes the use of

validated screening tools such as the:

• AUDIT
59

SUMMARY PLAN DESCRIPTION LANGUAGE

Initiation, Cessation,

and Interval

\

Covered Counseling

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Covered Counseling

Initiation, Cessation,

and Interval

• AUDIT-C 

• TWEAK

• T-ACE 

Screening is a covered benefit during pregnancy. Normal-risk women may be

screened once per pregnancy. Patients at greater risk for alcohol problems, either

because they have a history of past alcohol misuse or report other risky behaviors,

qualify for multiple screenings during pregnancy.

Summary Plan Description Language: 

Alcohol Misuse (Counseling)

Counseling for alcohol misuse during pregnancy is a covered benefit. Three levels

of counseling are covered:

• “Very brief” interventions that last up to 5 minutes and have no follow-up.

• “Brief” counseling interventions that last 15 minutes and have no follow-up.

• “Multi-contact” interventions that include one initial session lasting at least 15

minutes that is followed by several additional contacts.

Eight (8) counseling sessions are covered per calendar year. Intervals between

counseling sessions are at the discretion of the provider. These covered visits are

not intended to supplant mental health or addiction treatment coverage.

Summary Plan Description Language: 

Asymptomatic Bacteriuria (Screening)

Urine culture

Screening for asymptomatic bacteriuria is a covered benefit between 12 and 16

weeks’ gestation for all pregnant women. Subsequent screenings are covered, as

medically indicated.

Summary Plan Description Language: 

Breastfeeding (Counseling)

Structured breastfeeding education and behavioral counseling is a covered benefit

for all pregnant and lactating women. Counseling may be provided in an office

setting, during hospitalization for labor/delivery, or in the patient’s home after

the birth of their child.

Counseling to promote breastfeeding initiation and continuation is a covered

benefit for all pregnant women and all lactating women. There is no maximum

number of sessions, provided that the care is medically necessary.
60

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Counseling

Initiation, Cessation,

and Interval

Covered Preventive

Medications

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Covered Preventive

Medications

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Folic Acid Supplementation (Counseling)

Counseling to promote the use of folic acid supplements (for the prevention of

neural tube defects) is a covered benefit.

Counseling on folic acid supplementation is a covered benefit for all women

considering pregnancy and all pregnant women through the first trimester of

pregnancy. 

Summary Plan Description Language: 

Folic Acid Supplementation (Preventive Medication)

• Prescription strength folic acid

• Prenatal vitamins containing folic acid

Folic acid medications of any type are covered, when used to reduce the risk of

having a pregnancy affected by a neural tube defect. 

Summary Plan Description Language: 

Group B Streptococcal Disease (Screening)

All methods of GBS isolation and identification are covered.

Screening for vaginal and rectal group B streptococcal (GBS) colonization is a

covered benefit for all pregnant women between 35 and 37 weeks gestation, or as

medically indicated.

Summary Plan Description Language: 

Group B Streptococcal Disease (Preventive Medication)

Intrapartum antibiotic prophylaxis is a covered benefit for all pregnant women. 

Intrapartum antibiotic prophylaxis to prevent GBS disease is a covered benefit

for:

• All pregnant women whose screening status is unknown at the time of labor if

they present with any of the following risk factors: delivery at < 37 weeks

gestation, membrane rupture ≥ 18 hours, or intrapartum fever ≥ 38C.

• Women who have had GBS isolated from their urine at any time during their

current pregnancy.

• All women who have previously given birth to an infant with invasive GBS

disease.

• Women who are expected to deliver preterm (< 37 weeks) and found to be at

risk for perinatal GBS disease. 
61

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Screening

Initiation, Cessation,

and Interval

Covered

Immunizations

Initiation, Cessation,

and Interval

Covered Treatment

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Hepatitis B Virus (HBV) (Screening)

Hepatitis B screening is a covered benefit for all pregnant women. Coverage

includes the use of all validated screening tools, including the HBsAg

Immunoassay and the “rapid test.”

Average-risk women should be screened once, ideally at the first prenatal care

visits. Additional screenings are covered for women at increased risk of acquiring

HBV. 

Summary Plan Description Language: 

Hepatitis B Virus (HBV) (Immunization)

All types and brands of hepatitis B immunization are covered.

Immunizations may be given at any time during pregnancy, as deemed

appropriate by the clinician. 

Summary Plan Description Language: 

Hepatitis B Virus (HBV) (Treatment)

Treatment for infants born to hepatitis B (HBV)-positive women includes:

• Postexposure hepatitis B immune globulin 

• HBV vaccination

Treatment for infants born to women with unknown HbsAg status includes:

• Single-antigen hepatitis B vaccine (without HBIG) 

Note: The hepatitis B vaccine (without HBIG) is a covered benefit for all infants,

regardless of their mother’s hepatitis status.

Immune globulin and HBV immunizations are covered, as medically indicated. 
62

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Screening

Initiation, Cessation,

and Interval

Covered Counseling

Initiation, Cessation,

and Interval

Covered Preventive

Medications

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Human Immunodeficiency Virus (HIV) (Screening)

All FDA-licensed screens and tests, including:

• Enzyme immunoassay (EIA)

• Western blot test

• Abbott Murex Single Use Diagnostic System HIV-1 test

• Rapid assay test

All pregnant women are eligible for HIV screening. One-time screening is

covered for normal-risk women and should be conducted as early as possible

during the pregnancy. All pregnant women with a positive screen are eligible for

confirmatory testing. Women at high risk of HIV infection are eligible for

additional screening/confirmatory testing during the third trimester, or as

medically indicated. 

Summary Plan Description Language: 

Human Immunodeficiency Virus (HIV) (Counseling)

Counseling regarding HIV screening and HIV test results, risk reduction, and

transmission reduction is a covered benefit for all pregnant women.

All pregnant women are eligible to receive counseling and educational

information on HIV and HIV screening before they are screened. 

All pregnant women who are screed for HIV are eligible for post-test counseling

on their result and risk reduction. 

Pregnant women who have behaviors that place them at high risk for acquiring

HIV infection (e.g., multiple sex partners, history of STDs, substance abuse, etc)

are eligible for a referral to an HIV risk-reduction service (e.g., HIV centers with

personnel trained in HIV counseling, drug treatment centers, etc).

Summary Plan Description Language: 

Human Immunodeficiency Virus (HIV) (Preventive Medication)

Antiretroviral chemoprophylaxis is a covered benefit for all infant beneficiaries

who are born to women who are HIV positive or whose HIV status is unknown

at the time of labor and delivery. 

All FDA-approved medications used for the prevention of perinatal HIV

transmission are covered, as prescribed by a clinician, for exposed infants during

the first 6 weeks of life (or as medically indicated).
63

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered

Immunizations

Initiation, Cessation,

and Interval

Covered Screening

Methods

Initiation, Cessation,

and Interval

Covered Screening

Methods

Initiation, Cessation,

and Interval

Covered Screening 

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Influenza (Immunization)

All brands and types of influenza immunization are covered, as medically

indicated.

Influenza immunization is a covered benefit for all women who will be pregnant

during the influenza season (October to mid-May). One influenza immunization

is covered per influenza season and women should be immunized with each

pregnancy, as indicated.

Summary Plan Description Language: 

Preeclampsia (Screening)

Conventional measure using an arm cuff and an appropriately validated aneroid

(containing no liquid) or digital sphygmomanometer (blood pressure meter). 

Blood pressure screening is covered for all pregnant women, as medically

indicated. 

Summary Plan Description Language: 

Prenatal Diagnosis of Chromosomal Abnormalities and 

Neural Tube Defects (NTDs) (Screening)

All screening tests used to detect risk for chromosomal abnormalities and neural

tube defects are covered.

The timing and frequency is determined by the screening method used. 

Summary Plan Description Language: 

Prenatal Diagnosis of Chromosomal Abnormalities and 

Neural Tube Defects (NTDs) (Testing)

Testing for chromosomal abnormalities and neural tube defects is a covered

benefit. Coverage includes the use of all validated testing tools, including, but

not limited to:

• Amniocentesis 

• Chorionic villus sampling (CVS) 

• Ultrasound

Testing for chromosomal abnormalities is covered for all pregnant women age 35

or older (and those who have equivalent risk) in place of, or in addition to,

screening services. 

Testing for neural tube defects is covered for all pregnant women at elevated risk

of neural tube defects based on a positive screen or other documented risk factor. 

Genetic counseling, when medically indicated and provided in association with

testing, is also covered.
64

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Screening 

Initiation, Cessation,

and Interval

Covered Preventive

Medications

Initiation, Cessation,

and Interval

Covered Screening 

Initiation, Cessation,

and Interval

Covered Screening 

Summary Plan Description Language: 

Rh (D) Incompatibility (Screening)

Rh (D) blood typing and antibody testing is a covered benefit for all pregnant

women. 

All pregnant women are eligible for Rh (D) blood typing and antibody testing at

their first prenatal visit. Women known to be Rh (D)-negative and unsensitized

are eligible for repeat Rh (D) antibody test at 24 to 28 weeks’ gestation to

determine their degree of sensitivity. 

Summary Plan Description Language: 

Rh (D) Incompatibility (Preventive Medication)

Immune globulin 

Immune globulin is covered as a preventive medication for the following

populations (as medically indicated): 

• All unsensitized Rh (D)-negative women after their repeated antibody screen at

24-28 weeks’ gestation.

• Rh (D)-negative mothers within 72 hours of delivering a Rh (D)-positive

infant.

• Rh (D)-negative mothers following amniocentesis or either induced or

spontaneous abortion.

Summary Plan Description Language: 

Rubella (Screening)

Screening for rubella susceptibility is a covered benefit of all women of

reproductive age. Screening may include:

• Ascertaining an individual’s risk for rubella by way of immunization history

• Serologic test for antibodies

All women of childbearing age, including pregnant women, are eligible for

screening.

Summary Plan Description Language: 

Syphilis (Screening)

• Venereal disease research laboratory (VDRL) or the rapid plasma regain (RPR)

on serum specimens followed by a fluorescent treponemal antibody absorbed

(FTA-ABS) or T. palladium particle agglutination (TP-PA) for confirmation.

• Enzyme-linked Immunosorbent Assay (ELISA) for treponemal antibody in

serum specimens. 

• RPR point-of-care test for nontreponemal antibody in serum specimens. 

• Dark field microscope examination of lesion specimens.
65

SUMMARY PLAN DESCRIPTION LANGUAGE

Initiation, Cessation,

and Interval

Covered

Immunizations

Initiation, Cessation,

and Interval

Covered Screening 

Initiation, Cessation,

and Interval

Covered Counseling

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Syphilis screening is a covered benefit for all pregnant women at their first

prenatal care visit. Women with a positive screen are eligible for a confirmatory

test. Women who are at high risk for syphilis, are previously untested, or have a

positive serology in the first trimester are eligible for re-screening and

confirmatory testing during the third trimester and at delivery, or as medically

indicated.

Summary Plan Description Language: 

Tetanus (Immunization)

All brands and types of tetanus immunization are covered as medically indicated.

Coverage for tetanus vaccines is provided for all pregnant women without

adequate documentation of a completed primary tetanus series and those without

a tetanus vaccination within the past ten years. 

Summary Plan Description Language: 

Tobacco Use Treatment (Screening)

Screening for tobacco use is a covered benefit for all pregnant women.

There is no maximum limit on screening during pregnancy, provided that the

care is medically indicated.

Summary Plan Description Language: 

Tobacco Use Treatment (Counseling)

Smoking cessation counseling (5 to 15 minute sessions) is a covered benefit for

all pregnant women who smoke. Counseling may be conducted during

individual face-to-face office visits, in a group setting, or by telephone.

Pregnant women who screen positive for tobacco use should be advised to quit at

every medical encounter. There is no maximum number of counseling sessions

for eligible pregnant women.

Summary Plan Description Language:

Hypertension (Screening)

Conventional measure using an arm cuff and an appropriately validated aneroid

(containing no liquid) or digital sphygmomanometer (blood pressure meter). 

Screening is a covered benefit for all children, adolescents, and adults, and may

be conducted as medically indicated. 
66

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Counseling

and Treatments

Initiation, Cessation,

and Interval

Covered Screening/

Evaluation for

Susceptibility and

Immunization

Methods

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Hypertension (Counseling and Treatment) 

Covered treatment for hypertension includes:

• Counseling to promote therapeutic lifestyle changes

• Office visits to monitor hypertension and treatment efforts

• Medications used to treat hypertension

Six (6) counseling, treatment, and monitoring sessions are covered per calendar

year. Additional counseling sessions are covered, as medically indicated.

Beneficiaries undergoing treatment with hypertension-lowering medications

qualify for additional medication management visits, as medically indicated. 

Summary Plan Description Language: 

Child, Adolescent, Adult Immunizations (Immunization)

Screening/risk assessment for vaccine-preventable disease (VPD) is a covered

benefit for all beneficiaries. Screening may include counseling by the provider.

Screening can be accomplished by a review of vaccination history, preferably

documented history, or (when appropriate) serologic testing for antibodies to

VPD using accepted laboratory tests. 

Covered immunizations (children/adolescents): Single-antigen or combination

vaccines as consistent with the most current ACIP recommendations. Currently

included vaccines are: hepatitis B, diphtheria, tetanus, pertussis, Haemophilus

influenzae type b, polio, measles, mumps, rubella, varicella, pneumococcal

disease, influenza, meningococcal disease, hepatitis A, rotavirus, human

papillomavirus. 

Covered immunizations (adults): Single-antigen or combination vaccines as

consistent with the most current ACIP recommendations. Currently included

vaccines are: diphtheria, tetanus, influenza, human papillomavirus, pneumococcal

disease. Also covered as necessary are: hepatitis A, hepatitis B, pertussis, measles,

mumps, rubella, varicella, meningococcal disease, polio.

Screening/risk assessment and immunizations are covered whenever indicated by

medical conditions or other risk factors. There are no age or frequency

limitations.

Summary Plan Description Language: 

Lipid Disorders (Screening)

9–12-hour fasting lipoprotein profile of total cholesterol, low-density lipoprotein

cholesterol, high-density lipoprotein cholesterol, and triglycerides. 

Screening is a covered benefit for all adults aged 20 and older and may be

conducted once every 5 years, or as medically indicated. 
67

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Counseling

and Treatments

Initiation, Cessation,

and Interval

Covered Counseling 

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Lipids Disorders (Counseling and Treatment)

Covered treatment for a lipid disorder includes:

• Counseling to promote therapeutic lifestyle changes

• Office visits to monitor lipid disorders and treatment efforts 

• Medications used to treat lipid disorders 

Six (6) counseling, treatment, and monitoring sessions are covered per calendar

year. Additional counseling sessions are covered, as medically indicated.

Beneficiaries undergoing treatment with lipid-lowering medications qualify for

additional medication management visits, as medically indicated. 

Summary Plan Description Language:

Motor Vehicle-Related Injury Prevention (Counseling)

Counseling to reduce motor vehicle related injuries is a covered benefit. Both

brief clinician counseling (3 minutes or less) and intensive counseling are

covered.

Counseling to prevent motor vehicle-related injuries is a covered benefit for

beneficiaries of driving age. Counseling should be conducted: 1) when

beneficiaries first begin to drive (age 15, 16, or older depending on state law), 2)

when beneficiaries first become parents, 3) when beneficiaries seek other

preventive services for young children, 4) when beneficiaries present with alcohol

or other drug dependencies, and 5) when beneficiaries receive trauma care for

alcohol-related injuries.

One counseling session is covered per year. Individuals at high risk for a motor

vehicle-related injury (beneficiaries aged 18 to 33 years, parents of small children

or adolescents, and substance and alcohol abusers) may be counseled more

frequently, if medically indicated.

Summary Plan Description Language: 

Obesity (Screening)

Screening for obesity is a covered benefit and may include measurements and

calculations relating to body mass index (BMI) and waist circumference. 

Screening is covered for all beneficiaries aged 2 and above once per calendar year.

More frequent screening is covered, if medically indicated.
68

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Counseling 

Initiation, Cessation,

and Interval

Covered Treatment

Medications

Procedures 

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Obesity (Counseling)

Intensive counseling (2 or more person-to-person individual or group sessions per

month, for at least 3 months) is a covered benefit for beneficiaries aged 18 and

older who meet criteria for obesity (BMI > 30). 

Six (6) counseling sessions are covered per calendar year. Additional sessions are

covered, if medically indicated. 

Summary Plan Description Language: 

Obesity (Treatment)

All FDA-approved medications for the treatment of obesity or weight loss are are

covered. Coverage is reserved for beneficiaries with a BMI higher than 30 and

beneficiaries with a BMI of 27 to 29 who also have at least one additional major

risk factor for cardiovascular disease. Coverage for medication is contingent on

physician monitoring and participation in an individual or group counseling

program.

Surgical treatment procedures are covered. Coverage is reserved for beneficiaries

aged 18 and older with class III obesity (BMI exceeding 40) and beneficiaries

with class II obesity (BMI of 35 or higher) who also have at least one obesityrelated illness. All obesity-related surgical procedures are subject to preauthorization requirements. 

The duration of treatment is determined by the type of medication used and its

dosage. Coverage is provided for medications and surgery, as prescribed by a

clinician.

Summary Plan Description Language: 

Osteoporosis (Screening)

Screening for osteoporosis is a covered benefit. Screening may include the use of

standardized instruments such as the Osteoporosis Risk Assessment Instrument

(ORAI) and the Simple Calculated Osteoporosis Risk Estimation tool (SCORE)

and/or use of the following:

• Dual-energy x ray absorptiometry (DXA) 

• Peripheral dual-energy x-ray absorptiometry, 

• Peripheral quantitative computed tomography

• Radiographic absorptiometry

• Single-energy absorptiometry

• Ultrasound

Screening is provided for normal-risk women beginning at age 65. Screening is a

covered benefit for all men beginning at age 70. High-risk women and men are

eligible for screening beginning at age 60, or as otherwise medically indicated.

Screening may not be conducted more frequently than once every 2 calendar years. 
69

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Treatment

Initiation, Cessation,

and Interval

Covered Counseling 

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Osteoporosis (Treatment)

All FDA-approved medications for the treatment of osteoporosis are covered for

beneficiaries aged 60 and older who meet medical necessity criteria for the

treatment of osteoporosis. 

The duration of treatment is determined by the type of medication used and its

dosage. Coverage is provided for medications, as prescribed by a clinician.

Summary Plan Description Language: 

Sexually Transmitted Infections (Screening and Counseling)

Counseling to Prevent Sexually Transmitted Infections

(Counseling)

Counseling to prevent sexually transmitted infections (STIs) is a covered benefit.

Counseling is a covered benefit for all adolescent and adult beneficiaries. One

counseling session is covered per calendar year.

Summary Plan Description Language: 

Chlamydia (Screening)

Chlamydia screening is a covered benefit. The following tests are covered:

• Antigen detection tests 

• Culture analysis of a endocervical or urethral swab

• Culture of swab specimens from exposed sites

• Non-amplified nucleic acid hybridization tests

• Nucleic acid amplification assays

• Point-of-care antigen detection tests on genital swab specimens and leukocyte

esterase on urine.

Annual screening is a covered benefit for all women aged 25 years and younger.

Coverage is provided for women over age 25, if medically indicated.

Summary Plan Description Language: 

Gonorrhea (Screening)

Gonorrhea screening is a covered benefit. The following tests are covered:

• Culture of swab specimens from exposed sites 

• Microscopic examination of Gram-stained urethral or cervical specimen

• Non-amplified nucleic acid hybridization tests on genital swab specimens

• Nucleic acid amplification assays 

• Point-of-care antigen detection tests on genital swab specimens and urine

dipstick for leukocyte esterase (LE)

Annual screening is a covered benefit for all women aged 25 years and younger.

Coverage is provided for women over age 25, if medically indicated.
SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Screening

Initiation, Cessation,

and Interval

Covered Counseling

Initiation, Cessation,

and Interval

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Human Immunodeficiency Virus (HIV) (Screening)

HIV screening is a covered benefit. The following tests are covered:

• All FDA-approved home collection kits using dried blood spots

• Laboratory-based options on serum, plasma, or whole blood. 

• Rapid HIV tests (Uni-Gold Recombigen & Oraquick Advance) 

• Repeatedly reactive enzyme immunoassay 

• Western blot or immunoflourescent assay on serum or plasma

Screening is a covered benefit for all persons aged 13 to 64. The frequency of

screening should be determined by the beneficiary’s risk factors, but should be

conducted no more than once per calendar year. 

Summary Plan Description Language: 

Human Immunodeficiency Virus (HIV) (Counseling)

HIV counseling is a covered benefit. 

Counseling is a covered benefit for all beneficiaries aged 13 to 64 considering

HIV testing. Beneficiaries are eligible for pre- and post-test counseling for a total

of 3 sessions per test cycle.

Summary Plan Description Language: 

Syphilis (Screening)

Syphilis screening is a covered benefit. The following tests are covered:

• Nontreponemal tests venereal disease research laboratory (VDRL) or the rapid

plasma regain (RPR) on serum specimens followed by a fluorescent treponemal

antibody absorbed (FTA-ABS) or T. palladium particle agglutination (TP-PA)

for confirmation.

• Immunochromatographic Strip (ICS) point-of-care test on blood specimen,

when FDA approved.

• Line Immunoassay (LIA) point-of-care test on blood specimen, when FDA

approved.

• Enzyme-linked Immunosorbent Assay (ELISA) for treponemal antibody in

serum specimens. 

• RPR point-of-care test for nontreponemal antibody in serum specimens. 

• Dark field microscope examination of lesion specimens.

Annual screening is a covered benefit for all beneficiaries at risk of infection.

More frequent screening is provided, if medically indicated.

70
71

SUMMARY PLAN DESCRIPTION LANGUAGE

Covered Screening

Initiation, Cessation,

and Interval

Covered Counseling

Initiation, Cessation,

and Interval

Covered Treatment

Initiation, Cessation,

and Interval

Treatment Services

Not Covered

Covered Screening

Initiation, Cessation,

and Interval

Summary Plan Description Language: 

Tobacco Use Treatment (Screening)

Screening for tobacco use is a covered benefit beginning at age 18. Coverage is

provided for younger populations depending on risk and need. 

Screening may be conducted at every clinical encounter.

Summary Plan Description Language:

Tobacco Use Treatment (Counseling)

Brief counseling (in-person) and intensive counseling (in-person or over the

telephone) are covered benefits for tobacco use treatment.

Beneficiaries who meet criteria are eligible for 2 courses of 6 counseling sessions

per calendar year, for a total of 12 sessions per calendar year. 

Summary Plan Description Language:

Tobacco Use Treatment (Treatment)

All FDA-approved nicotine replacement products and tobacco cessation

medications are covered.

Medications are covered as prescribed by a clinician. 

Neither hypnosis nor acupuncture has been demonstrated to be effective for

tobacco cessation and these services are therefore not covered.

Summary Plan Description Language: 

Tuberculosis (Screening)

Screening for tuberculosis is a covered benefit and may include the use of the

following:

• Chest radiography

• Intracutaneous administration of purified protein derivative {PPD} tuberculin

using the Mantoux method, called the tuberculin skin test (TST) 

• Mycobacteriology services for smears, cultures

• QuantiFERON®-TB Gold (QFT-G) 

• Sputum induction

Screening is a covered benefit for all persons at high risk of tuberculosis and may

be conducted as medically indicated. Follow up re-testing is covered as medically

indicated. Note: Routine testing for TB or LTBI is not recommended for persons

who are not at high risk of TB.
72
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

73

Current Procedural Terminology Codes (CPT© Codes)

Current Procedural Terminology © 2005 American Medical Association. 

Abdominal Aortic Aneurysm (Screening)

76700 Abdominal ultrasound, complete

76705 Abdominal ultrasound, limited

Alcohol Misuse (Screening) 

99420 Administration and interpretation of health risk assessment instrument

H0001* Alcohol and/or drug assessment

H0049* Alcohol and other drug screening

Alcohol Misuse (Counseling) 

96150-5 Health and behavior assessment and intervention

98960-2 Education and training for patient self-management

90804-8 Psychotherapy, including medical management for some codes

99201-5 Evaluation and management, new patient

99212-5 Evaluation and management, established patient

99381-97 Preventive services

99401-5 Preventive counseling

H0050* Brief counseling intervention

H0004* Behavioral health counseling

Aspirin for the Primary Prevention of Cardiovascular Events (Counseling)

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

Breast Cancer (Screening)

76092 Screening mammography, bilateral

76083 Computer aided detection with further physician review for interpretation, with 

or without digitization of film radiographic images; diagnostic mammography

0060T Electrical impedance scan of the breast, bilateral (risk assessment device for 

breast cancer)
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

74

99386 Initial preventive medicine evaluation and management, 40 to 64 years, new

patient 

99387 Initial preventive medicine evaluation and management, 65 years and older

99396 Periodic preventive medicine evaluation and management, 40 to 64 years,

established patient 

99397 Periodic preventive medicine evaluation and management, 65 years and older

S8075* Computer analysis of full-field digital mammogram and further physician 

review and interpretation, mammography 

Breast Cancer Genetic Risk Assessment and BRCA Mutation Testing (Counseling)

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

Breast Cancer Genetic Risk Assessment and BRCA Mutation Testing (Testing)

83890 Molecular diagnostics; molecular isolation or extraction

83891 Molecular diagnostics; isolation or extraction of highly purified nucleic acid

83892 Molecular diagnostics; enzymatic digestion 

83893 Molecular diagnostics; dot/slot blot production 

83894 Molecular diagnostics; separation by gel electrophoresis

83896 Molecular diagnostics; nucleic acid probe, each 

83897 Molecular diagnostics; nucleic acid transfer

83898 Molecular diagnostics; amplification of patient nucleic acid, each nucleic acid

sequence

83900 Molecular diagnostics; amplification of patient nucleic acid, multiplex, first two

nucleic acid sequences

83901 Molecular diagnostics; amplification of patient nucleic acid, multiplex, each

additional nucleic acid

83902 Molecular diagnostics; reverse transcription

83903 Molecular diagnostics; mutation scanning by physical properties, single 

segment, each

83904 Molecular diagnostics; mutation identification by sequencing, single segment,

each segment

83905 Molecular diagnostics; mutation identification by allele specific transcription, 

single segment, each segment
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

75

83906 Molecular diagnostics; mutation identification by allele specific translation,

single segment, each segment

83907 Molecular diagnostics; lysis of cells prior to nucleic acid extraction

83908 Molecular diagnostics; signal amplification of patient nucleic acid, each nucleic

acid sequence

83909 Molecular diagnostics; separation and identification by high resolution technique

83912 Molecular diagnostics; interpretation and report 

88271 Molecular cytogenetics; DNA probe, each

88272* Molecular cytogenetics; chromosomal in situ hybridization, analyze 3 – 5 cells

S3818* Complete gene sequence analysis; BRCA1 gene

S3819* Complete gene sequence analysis; BRCA2 gene

S3820* Complete BRCA1 and BRCA2 gene sequence analysis for susceptibility to 

breast and ovarian cancer

S3822* Single mutation analysis (in individual with a known BRCA1 or BRCA2

mutation in the family) for susceptibility to breast and ovarian cancer

S3823* Three-mutation BRCA1 and BRCA2 analysis for susceptibility to breast and

ovarian cancer in Ashkenazi individuals

Breast Cancer Preventive Medication and Preventive Treatment (Counseling)

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

Breast Cancer (Preventive Medication)

S0187* Tamoxifen citrate, oral 10 mg

Breast Cancer Genetic Risk Assessment and BRCA Mutation Testing (Preventive Treatment)

19160 Mastectomy, partial

19162 Mastectomy, partial; with axillary lymphadenectomy

19180 Mastectomy, simple, complete

19182 Mastectomy, subcutaneous

19200 Mastectomy, radical, including pectoral muscles, axillary lymph nodes

19220 Mastectomy, radical, including pectoral muscles, axillary and internal mammary

lymph nodes 

19240 Mastectomy, modified radical
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

76

19340 Immediate insertion of breast prosthesis following mastectomy

19342 Delayed insertion of breast prosthesis following mastectomy

19357 Breast reconstruction, immediate or delayed, with tissue expander, including

subsequent expansion 

19361 Breast reconstruction with latissimus dorsi flap, with or without prosthetic

implant

19364 Breast reconstruction with free flap

19366 Breast reconstruction with other technique

19367 Breast reconstruction with transverse rectus abdmoninis myocutaneous flap,

single pedicle, including closure of donor site

19369 Breast reconstruction with transverse rectus abdmoninis myocutaneous flap,

double pedicle, including closure of donor site

58661 Laparoscopy, surgical; with removal of adnexal structures

58720 Salpingo-oophorectomy, complete or partial, unilateral or bilateral 

58940 Oophorectomy, partial or total, unilateral or bilateral 

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

Cervical Cancer (Screening)

88141 Cytopathology, cervical or vaginal, requiring interpretation by physician

88142 Cytopathology, cervical or vaginal, automated thin layer prep, manual screening

under physician supervision

88143 Cytopathology, cervical or vaginal, automated thin layer prep, manual screening

and rescreening under physician supervision 

88147 Cytopathology smears, cervical or vaginal, screening by automated system, 

under physician supervision

88148 Cytopathology smears, cervical or vaginal, screening by automated system with

manual rescreening under physician supervision

88150 Cytopathology slides, cervical or vaginal, manual screening under physician

supervision

88152 Cytopathology slides, cervical or vaginal, manual screening and computerassisted rescreening under physician supervision

88153 Cytopathology slides, cervical or vaginal, manual screening and rescreening

under physician supervision
88154 Cytopathology slides, cervical or vaginal, manual screening and computerassisted rescreening using cell selection and review under physician supervision 

88155 Cytopathology slides, cervical or vaginal, definitive hormonal evaluation 

88164 Cytopathology slides, cervical or vaginal (Bethesda), manual screening under

physician supervision 

88165 Cytopathology slides, cervical or vaginal (Bethesda), manual screening and

rescreening under physician supervision 

88166 Cytopathology slides, cervical or vaginal (Bethesda), manual screening and

computer-assisted rescreening under physician supervision 

88167 Cytopathology slides, cervical or vaginal (Bethesda), manual screening and

computer-assisted rescreening using cell selection and review under physician

supervision 

88174 Cytopathology, cervical or vaginal, collected in preservation fluid, automated

thin layer prep, screening by automated system under physician supervision 

88175 Cytopathology, cervical or vaginal, collected in preservation fluid, automated

thin layer prep, screening by automated system and manual rescreening or review

under physician supervision

Childhood Health Promotion (Screening, Counseling, Immunization, Preventive

Medication and Treatment)

Child Development (Screening)

96110 Developmental screening; limited with interpretation and report

96111 Developmental testing; extended with interpretation and report

99381 Initial comprehensive preventive medicine evaluation and management, infant

(under 1 year), new patient 

99382 Initial comprehensive preventive medicine evaluation and management, early

childhood (ages 1 to 4), new patient 

99391 Periodic comprehensive preventive medicine evaluation and management, infant

(under 1 year), established patient 

99392 Periodic comprehensive preventive medicine evaluation and management, early

childhood (ages 1 to 4 ), established patient 

99201– Office or outpatient visit, new patient

99205

99211– Office or outpatient visit, established patient 

99215

Dental Caries Prevention through Oral Fluoride Supplementation (Preventive Medication)

D1201 Topical application of fluoride, including prophylaxis, child 

D1203 Topical application of fluoride, excluding prophylaxis, child

CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

77
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

78

Elevated Blood Lead Levels (Screening) 

83655 Lead 

36415 Venipuncture

Childhood Immunizations

See Immunizations 

Newborn Hearing (Screening)

92585 Auditory evoked potentials for evoked response audiometry and/or testing of 

the central nervous system; comprehensive

92586 Auditory evoked potentials for evoked response audiometry and/or testing of the

central nervous system; limited

92587 Evoked otoacoustic emissions; limited (single stimulus level, either transient or

distortion products) 

92588 Evoked otoacoustic emissions; comprehensive or diagnostic evaluation

(comparison of transient and/or distortion product otoacoustic emissions at

multiple levels and frequencies) 

Newborn Screening for Genetic and Endocrine Disorders (Screening)

Screening for genetic and endocrine disorders is a covered benefit. Purchasers

should refer to their health plan administrators for a current list of applicable

CPT codes.

Newborn Screening for Genetic and Endocrine Disorders (Medical Foods)

CPT code not applicable

Newborn Screening for Genetic and Endocrine Disorders (Treatment)

Medications and other forms of treatment used to prevent illness or disability 

among beneficiaries with genetic or endocrine disorders are covered. Case 

management is a covered benefit and is provided, as medically necessary, for 

beneficiaries with complex disorders. Purchasers should refer to their health 

plan administrators for a list of applicable CPT codes.

Vision (Screening) (Child)

92081 Visual field exam, unilateral or bilateral, limited exam 

92082 Visual field exam, unilateral or bilateral, intermediate exam 

92083 Visual field exam, unilateral or bilateral, extended exam 

99172 Visual function screening, automated or semi-automated bilateral, quantitative 

99173 Visual acuity screening, quantitative, bilateral 

92002 Ophthalmological medical exam and evaluation, intermediate, new patient 
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

79

92004 Ophthalmological medical exam and evaluation, comprehensive, one or more

visits, new patient

92012 Ophthalmological medical exam and evaluation, intermediate, established

patient 

92014 Ophthalmological medical exam and evaluation, comprehensive, one or more

visits, established patient 

0065T Ocular photoscreening, interpretation and report, bilateral

Colorectal Cancer (Screening)

45378 Colonoscopy 

45330 Sigmoidoscopy, flexible 

74270 Barium enema, with/without KUB

74280 Radiological exam, colon, air contrast with specific high-density barium,

with/without glucagon 

82270 Fecal occult blood for colorectal neoplasm screening, by peroxidase activity,

consecutive collected specimens with single determination

Contraceptive Use (Counseling)

99384 Initial preventive medicine evaluation and management, adolescent (12 to 17

years), new patient

99385 Initial preventive medicine evaluation and management, 18 to 39 years, new

patient 

99386 Initial preventive medicine evaluation and management, 40 to 64 years, new

patient 

99394 Periodic preventive medicine evaluation and management, adolescent (12 to 17

years), established patient 

99395 Periodic preventive medicine evaluation and management, 18 to 39 years,

established patient 

99396 Periodic preventive medicine evaluation and management, 40 to 64 years,

established patient

Contraceptive Use (Preventive Intervention)

11975 Insertion implantable contraceptive capsules

58300 IUD insertion

58565 Hysteroscopy; with bilateral fallopian tube cannulation to induce occlusion by 

placement of permanent implants

58600 Ligation or transection of fallopian tube(s), abdominal or vaginal approach, 

unilateral or bilateral
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

80

58605 Ligation or transection of fallopian tube(s), abdominal or vaginal approach, 

postpartum, unilateral or bilateral, during same hospitalization 

(separate procedure)

58611 Ligation or transection of fallopian tube(s) when done at the time of cesarean 

delivery or intra-abdominal surgery (not a separate procedure) (List separately in 

addition to code for primary procedure)

58615 Occlusion of fallopian tube(s) by device (e.g, band, clip, Falope ring) vaginal or 

suprapubic approach

58661 Laparoscopy; with removal of adnexal structures (partial or total oophorectomy 

and/or salpingectomy)

58671 Laparoscopy, surgical; with occlusion of oviducts by device (e.g., band, clip, or 

Falope ring)

58700 Salpingectomy, complete or partial, unilateral or bilateral (separate procedure)

55250 Vasectomy, unilateral or bilateral (separate procedure), including postoperative 

semen examination(s)

S4993 Contraceptive pills for birth control

Depression (Screening)

99420 Administration and interpretation of health risk assessment instrument

Diabetes (Screening)

82947 Glucose, blood (except reagent stript)

82948 Glucose, blood, reagent strip 

82950 Glucose, post glucose dose

82951 Glucose tolerance test, 3 specimens

82952 Glucose tolerance test, each additional specimen beyond 3 

82962 Glucose, blood, by monitoring device FDA-approved for home use

36415 Venipuncture

99385 Initial preventive medicine evaluation and management, 18 to 39 years, new

patient 

99386 Initial preventive medicine evaluation and management, 40 to 64 years, new

patient 

99394 Periodic preventive medicine evaluation and management, adolescent (12 to 17

years), established patient 

99395 Periodic preventive medicine evaluation and management, 18 to 39 years,

established patient 

99396 Periodic preventive medicine evaluation and management, 40 to 64 years,

established patient
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

81

Healthy Diet (Counseling)

99402 Preventive medicine counseling/risk factor reduction, individual, 30 minutes 

99412 Preventive medicine counseling/risk factor reduction, group, 60 minutes

99403 Preventive medicine counseling/risk factor reduction, individual, 45 minutes

99411 Preventive medicine counseling/risk factor reduction, group, 30 minutes

98960 Education and training for patient self-management by a qualified, nonphysician

healthcare professional using a standardized curriculum, face-to-face with the 

patient (could include caregiver/family) each 30 minutes; individual patient

S9470* Nutritional counseling, dietician visit

Healthy Pregnancy (Screening, Testing, Counseling, Preventive Medication, and Treatment)

Alcohol Misuse (Screening)

99420 Administration/interpretation health risk assessment instrument

Alcohol Misuse (Counseling)

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

Asymptomatic Bacteriuria (Screening)

87077 Culture, bacterial; aerobic isolate, additional methods required for definitive

identification, each isolate

87086 Culture, bacterial; quantitative colony count, urine

87088 Culture, bacterial; with isolation and presumptive identification of isolates, urine

87187 Susceptibility studies, antimicrobial agent; microdilution or agar dilution,

minimum lethal concentration (MLC), each plate 

Breastfeeding (Counseling)

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

82

98960 Education and training for patient self-management by a qualified, non-physician

health care professional using a standardized curriculum, face-to-face with the patient

(could include caregiver/family) each 30 minutes; individual patient

Folic Acid Supplementation (Counseling)

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

Folic Acid Supplementation (Preventive Medication)

CPT code not applicable 

Group B Streptococcal Disease (Screening)

87081 Culture, presumptive, pathogenic organisms, screening only

Group B Streptococcal Disease (Preventive Medication)

CPT code not applicable

Hepatitis B Virus (HBV) (Screening)

36415 Venipuncture

87340 Hepatitis B surface antigen (HBsAg) 

Hepatitis B Virus (HBV) (Immunization)

90471 Immunization administration (includes percutaneous, intradermal, 

subcutaneous, or intramuscular injections); one vaccine (single or combination 

vaccine/toxoid)

90740 Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (3 dose

schedule), for intramuscular use

90743 Hepatitis B vaccine, adolescent (2 dose schedule), for intramuscular use

90744 Hepatitis B vaccine, pediatric/adolescent dosage (3 dose schedule), for

intramuscular use

90746 Hepatitis B vaccine, adult dosage, for intramuscular use

90747 Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (4 dose

schedule), for intramuscular use

Hepatitis B Virus (HBV) (Treatment)

90471 Immunization administration (includes percutaneous, intradermal, 

subcutaneous, or intramuscular injections); one vaccine (single or combination 

vaccine/toxoid)
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

83

90740 Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (3 dose

schedule), for intramuscular use

90743 Hepatitis B vaccine, adolescent (2 dose schedule), for intramuscular use

90744 Hepatitis B vaccine, pediatric/adolescent dosage (3 dose schedule), for

intramuscular use 

90746 Hepatitis B vaccine, adult dosage, for intramuscular use

90747 Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (4 dose

schedule), for intramuscular use 

90371 Hepatitis B immune globulin (HBIg), human, for intramuscular use

90772 Therapeutic, prophylactic or diagnostic injection (specify substance or drug);

subcutaneous or intramuscular

Human Immunodeficiency Virus (HIV) (Screening)

36415 Venipuncture 

86689 HTLV or HIV antibody, confirmatory test

86701 HIV-1 antibody

86702 HIV-2 antibody

86703 HIV-1 and HIV-2 antibody, single assay 

87390 Infectious agent antigen detection, HIV-1

87391 Infectious agent antigen detection, HIV-2

S3645* HIV antibody testing of oral mucosal transudate 

Human Immunodeficiency Virus (HIV) (Counseling)

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

Human Immunodeficiency Virus (HIV) (Preventive Medication)

J3485 Zidovudine, injection, 10 mg 

S0104* Zidovudine, oral, 100 mg 

Influenza (Immunization)

90471 Immunization administration (includes percutaneous, intradermal, 

subcutaneous, or intramuscular injections); one vaccine (single or combination 

vaccine/toxoid)
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

84

90656 Influenza virus vaccine, split virus, preservative free, for use in individuals 

3 years and above, for intramuscular use

90658 Influenza virus vaccine, split virus, for use in individuals 3 years of age and

above, for intramuscular use

Preeclampsia (Screening)

CPT code not applicable 

Prenatal Diagnosis of Chromosomal Abnormalities and Neural Tube Defects (NTDs) (Screening)

36415 Venipuncture

82105 Alpha-fetoprotein; serum

82106 Amniotic fluid

84702 Gonadotropin, chorionic (hCG); quantitative

84703 Qualitative

86336 Inhibin A

83632 Lactogen, human placental (HPL) human chorionic somatomammotropin

59000 Amniocentesis

76946 Ultrasound guidance for amniocentesis

59015 Chorionic villus sampling

76945 Ultrasound guidance for chorionic villus sampling 

59012 Cordocentesis

76941 Ultrasonic guidance for cordocentesis

89290 Biopsy, oocyte polar body or embryo blastomere, microtechnique (for preimplantation genetic diagnosis); less than or equal to 5 embryos

89291 Greater than 5 embryos

11100– Skin Biopsy

11107 

82012 ACHE 

82677 Quantitative Estriol 

83020 Hemoglobin Electrophoresis 

83896 Nucleic Acid Probe (each) 

83898 Nucleic Acid Probe w/Amplication (PCR) 

83912 DNA Interpretation and Report 

86316 Cancer Antigen Immunoassay 
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

85

88230 Cell Culture, Lymphocytes 

88233 Cell Culture, Tissue 

88235 Cell Culture, Amnio/CVS 

88237 Cell Culture, Bone Marrow 

88239 Cell Culture, Other Tissue 

88245 Blood Chromosomes, Bloom syndrome

88248 Blood Chromosomes, Fanconi syndrome 

88250 Blood Chromosomes, Fra(X) 

88261 Chromosome Analysis, 5 Cell, Karyotype 

88262 Chromosome Analysis, Routine 

88262 Chromosome Analysis, Post BMT 

88262 Additional Tissue 

88267 Chromosome Analysis, Mosaic 

88267 Chromosome Analysis/Karyotype (Amnio) 

88267 Chromosome Analysis/Karyotype (CVS) 

88269 Chromosomal Analysis/Karyotype (In situ) 

88280 Additional Karyotype 

88283 Additional Banding 

88285 Additional Cells Counted 

88289 Additional High Resolution 

88271 X 5 Molecular cytogenetics, DNA probe, each (code applied 5 times, once for

each probe in the assay)

88275 Interphase in situ hybridization, count 100 to 300 cells

88291 Molecular cytogenetics, interpretation and report 

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

S3828* Complete gene sequence analysis; MLH1 gene

S3830* Complete mlh1 and mlh2 gene sequence analysis for hereditary nonpolyposis

colorectal cancer (HNPCC) genetic testing
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

86

S3831* Single-mutation analysis (in individual with a known MLH1 and MLH2

mutation in the family) for hereditary nonpolyposis colorectal cancer (HNPCC)

genetic testing

S3833* Complete APC gene sequence analysis for susceptibility to familial adenomatous

polyposis (FAP) and attenuated FAP

S3834* Single-mutation analysis (in individual with a known APC mutation in the family)

for susceptibility to familial adenomatous polyposis (FAP) and attenuated FAP 

S3835* Complete gene sequence analysis for cystic fibrosis genetic testing

S3837* Complete gene sequence analysis for hemochromatosis genetic testing

S3840* DNA analysis for germline mutations of the ret proto-oncogene for

susceptibility to multiple endocrine neoplasia type 2 

S3841* Genetic testing for retinoblastoma

S3842* Genetic testing for von Hippel-Lindau disease

S3843* DNA analysis of the F5 gene for susceptibility to Factor V Leiden thrombophilia 

S3844* DNA analysis of the connexin 26 gene (GJB2) for susceptibility to congenital,

profound deafness 

S3845* Genetic testing for alpha-thalassemia 

S3846* Genetic testing for hemoglobin E beta-thalassemia 

S3847* Genetic testing for Tay-Sachs disease 

S3848* Genetic testing for Gaucher disease

S3849* Genetic testing for Niemann-Pick disease 

S3850* Genetic testing for sickle cell anemia 

S3851* Genetic testing for Canavan disease 

S3853* Genetic testing for myotonic muscular dystrophy

Prenatal Diagnosis of Chromosomal Abnormalities and Neural Tube Defects (NTDs) (Testing)

9000 Amniocentesis

76946 Ultrasound guidance for amniocentesis

59015 Chorionic villus sampling

76945 Ultrasound guidance for chorionic villus sampling 

76801 Ultrasound, pregnant uterus, real time with image documentation, fetal and

maternal evaluation, first trimester (14 weeks 0 days), transabdominal approach;

single or first gestation
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

87

76802 Ultrasound, pregnant uterus, real time with image documentation, fetal and

maternal evaluation, first trimester (14 weeks 0 days), transabdominal approach;

each additional gestation (List separately in addition to code for primary

procedure)

76805 Ultrasound, pregnant uterus, real time with image documentation, fetal and

maternal evaluation, after first trimester ( or = 14 weeks 0 days),

transabdominal approach; single or first gestation

76810 Ultrasound, pregnant uterus, real time with image documentation, fetal and

maternal evaluation, after first trimester ( or = 14 weeks 0 days),

transabdominal approach; each additional gestation

76811 Ultrasound, pregnant uterus, real time with image documentation, fetal and

maternal evaluation plus detailed fetal anatomic examination, transabdominal

approach; single or first gestation

76812 Ultrasound, pregnant uterus, real time with image documentation, fetal and

maternal evaluation plus detailed fetal anatomic examination, transabdominal

approach; each additional gestation

76815 Ultrasound, pregnant uterus, real time with image documentation, limited (eg,

fetal heart beat, placental location, fetal position, and/or qualitative amniotic

fluid volume), one or more fetuses

76816 Ultrasound, pregnant uterus, real time with image documentation, follow-up

(e.g., re-evaluation of fetal size by measuring standard growth parameters and

amniotic fluid volume, re-evaluation of organ system(s) suspected or confirmed

to be abnormal on a previous scan), transabdominal approach, per fetus

76817 Ultrasound, pregnant uterus, real time image documentation, transvaginal

76818 Fetal biophysical profile; with non-stress testing

76819 Fetal biophysical profile; without non-stress testing

Rh(D) Incompatibility (Screening)

36415 Venipuncture 

86901 Blood typing, Rh(D)

Rh(D) Incompatibility (Preventive Medication)

90384 Rho(D) immune globulin (RhIg), human, full-dose, for intramuscular use

90385 Rho(D) immune globulin (RhIg), human, mini-dose, for intramuscular use

90386 Rho(D) immune globulin (RhIgIV), human, for intravenous use

90772 Injection, intramuscular 

90774 Injection, IV push
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

88

90765 Intravenous infusion, up 1 hour 

90766 Intravenous infusion, each additional hour

Rubella (Screening)

36415 Venipuncture

86762 Rubella antibody

Syphilis (Screening)

36415 Venipuncture

86592 Syphilis, qualitative

86593 Syphilis, quantitative 

86781 Treponema pallidum, confirmatory test (e.g., FTA-abs)

86403 Particle agglutination; screen, each antibody

86406 Particle agglutination; titer, each antibody\

Tetanus (Immunization)

90471 Immunization administration (includes percutaneous, intradermal, 

subcutaneous, or intramuscular injections); one vaccine (single or 

combination vaccine/toxoid)

90703 Tetanus toxoid adsorbed, for intramuscular use

90714 Tetanus and diphtheria toxoids (Td) adsorbed, preservation free, for use in 

individuals sever years or older, intramuscular use

90718 Tetanus and diphtheria toxoids (Td) adsorbed for use in individuals 7 years or

older, for intramuscular use

Tobacco Use Treatment (Screening)

99420 Administration/interpretation health risk assessment instrument

Tobacco Use Treatment (Counseling)

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

S9075* Tobacco use treatment
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

89

Hypertension (Screening)

CPT code not applicable

Hypertension (Counseling, Treatment)

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

99201 Office/outpatient evaluation and management visit, new patient, level 1

99202 Office/outpatient evaluation and management visit, new patient, level 2

99203 Office/outpatient evaluation and management visit, new patient, level 3

99204 Office/outpatient evaluation and management visit, new patient, level 4

99205 Office/outpatient evaluation and management visit, new patient, level 5

99211 Office/outpatient evaluation and management visit, established patient, level 1

99212 Office/outpatient evaluation and management visit, established patient, level 2

99213 Office/outpatient evaluation and management visit, established patient, level 3

99214 Office/outpatient evaluation and management visit, established patient, level 4

99215 Office/outpatient evaluation and management visit, established patient, level 5

Immunizations (Child, Adolescent, Adults) 

This list is complete and up-to-date as of July 11, 2006. Please refer to your 

appropriate state or local agency, providers, or partner organizations (e.g., 

Medicaid, AAP, AAFP, etc.) regarding use of these codes. Please refer to 

AMA/CPT publications as the current, authoritative source. AMA/CPT 

publication information can be found online at (www.ama-assn.org/ama/pub/ 

category/3113.html). Errata for the most recent CPT print edition can also be 

found online (www.ama-assn.org/ama/pub/category/3896.html). Please refer 

to (www.ama-assn.org/ama/pub/category/10902.html) for additional “early 

release” codes.

Vaccines (Toxoids)

90281 Immune globulin (Ig), human, intramuscular use

90283 Immune globulin (IgIV), human, intravenous use

90296 Diphtheria antitoxin, equine, any route

90371 Hepatitis B immune globulin (HBIg), human, intramuscular use

90389 Tetanus immune globulin (TIg), human, intramuscular use
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

90

90396 Varicella-zoster immune globulin, human, intramuscular use

90399 Unlisted immune globulin

90632 Hepatitis A vaccine, adult dosage, intramuscular use

90633 Hepatitis A vaccine, pediatric/adolescent dosage-2 dose schedule, intramuscular

use

90634 Hepatitis A vaccine, pediatric/adolescent dosage-3 dose schedule, intramuscular

use

90636 Hepatitis A and hepatitis B (HepA-HepB), adult dosage, intramuscular use

90645 Hemophilus influenza b vaccine (Hib), HbOC conjugate (4 dose schedule),

intramuscular use

90646 Hemophilus influenza b vaccine (Hib), PRP-D conjugate, for booster use only, 

intramuscular use

90647 Hemophilus influenza b vaccine (Hib), PRP-OMP conjugate (3 dose schedule), 

intramuscular use

90648 Hemophilus influenza b vaccine (Hib), PRP-T conjugate (4 dose schedule),

intramuscular use

90649 Human papilloma virus (HPV) vaccine, types 6, 11, 16, 18 (quadrivalent) 

3 dose schedule, intramuscular use.

90655 Influenza virus vaccine, split virus, preservative free, for children 6-35 months 

of age, intramuscular use

90656 Influenza virus vaccine, split virus, preservative free, for use in individuals 

3 years of age and above, intramuscular use

90657 Influenza virus vaccine, split virus, for children 6-35 months of age,

intramuscular use

90658 Influenza virus vaccine, split virus, for use in individuals 3 years of age and

above, intramuscular use

90660 Influenza virus vaccine, live, intranasal use

90669 Pneumococcal conjugate vaccine, polyvalent, for children under five years,

intramuscular use

90680 Rotavirus vaccine, pentavalent, 3 dose schedule, live, oral use.

90698 Diphtheria, tetanus toxoids, and acellular pertussis vaccine, haemophilus

influenza Type B, and poliovirus vaccine, inactivated (DTaP - Hib - IPV),

intramuscular use

90700 Diphtheria, tetanus toxoids, and acellular pertussis vaccine (DTaP), for use in

individuals younger than seven years, intramuscular use

90701 Diphtheria, tetanus toxoids, and whole cell pertussis vaccine (DTP),

intramuscular use
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

91

90702 Diphtheria and tetanus toxoids (DT) adsorbed for use in individuals younger

than seven years, intramuscular use

90703 Tetanus toxoid adsorbed, intramuscular use

90704 Mumps virus vaccine, live, subcutaneous use

90705 Measles virus vaccine, live, subcutaneous use

90706 Rubella virus vaccine, live, subcutaneous use

90707 Measles, mumps and rubella virus vaccine (MMR), live, subcutaneous use

90708 Measles and rubella virus vaccine, live, subcutaneous use

90710 Measles, mumps, rubella, and varicella vaccine (MMRV), live, subcutaneous use

90712 Poliovirus vaccine, (any type(s)) (OPV), live, oral use

90713 Poliovirus vaccine, inactivated, (IPV), subcutaneous or intramuscular use

90714 Tetanus and diphtheria toxoids (Td) adsorbed, preservative free, for use in

individuals seven years or older, intramuscular use

90715 Tetanus, diphtheria toxoids and acellular pertussis vaccine (Tdap), for use in

individuals 7 years or older, intramuscular use

90716 Varicella virus vaccine, live, subcutaneous use

90718 Tetanus and diphtheria toxoids (Td) adsorbed for use in individuals seven years

or older, intramuscular use

90719 Diphtheria toxoid, intramuscular use

90720 Diphtheria, tetanus toxoids, and whole cell pertussis vaccine and Hemophilus

influenza B vaccine (DTP-Hib), intramuscular use

90721 Diphtheria, tetanus toxoids, and acellular pertussis vaccine and Hemophilus

influenza B vaccine (DTaP-Hib), intramuscular use

90723 Diphtheria, tetanus toxoids, acellular pertussis vaccine, Hepatitis B, and

poliovirus vaccine, inactivated (DTaP-HepB-IPV), intramuscular use

90732 Pneumococcal polysaccharide vaccine, 23-valent, adult or immunosuppressed

patient dosage, subcutaneous or intramuscular use

90733 Meningococcal polysaccharide vaccine (any group(s)), subcutaneous use

90734 Meningococcal conjugate vaccine, serogroups A, C, Y and W-135 (tetravalent),

intramuscular use

90740 Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (3 dose

schedule), intramuscular use

90743 Hepatitis B vaccine, adolescent (2 dose schedule), intramuscular use

90744 Hepatitis B vaccine, pediatric/adolescent dosage (3 dose schedule), 

intramuscular use
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

92

90746 Hepatitis B vaccine, adult dosage, intramuscular use

90747 Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (4 dose

schedule), intramuscular use

90748 Hepatitis B and Hemophilus influenza b vaccine (HepB-Hib), intramuscular use

90749 Unlisted vaccine/toxoid

Vaccines (Administration and Counseling)

90465 Immunization administration under 8 years of age (includes percutaneous,

intradermal, subcutaneous, or intramuscular injections) when the physician

counsels the patient/family; first injection (single or combination

vaccine/toxoid), per day

90466 Each additional injection (single or combination vaccine/toxoid), per day (List

separately in addition to code for primary procedure)

90467 Immunization administration under 8 years of age (includes intranasal or oral

routes of administration) when the physician counsels the patient/family; first

administration (single or combination vaccine/toxoid), per day

90468 Each additional administration (single or combination vaccine/toxoid), per day

(List separately in addition to code for primary procedure)

90471 Immunization administration (includes percutaneous, intradermal, 

subcutaneous, or intramuscular injections); one vaccine (single or combination 

vaccine/toxoid)

90472 Each additional vaccine (single or combination vaccine/toxoid) (List separately 

in addition to code for primary procedure)

90473 Immunization administration by intranasal or oral route; one vaccine (single or

combination vaccine/toxoid)

90474 Each additional vaccine (single or combination vaccine/toxoid) (List separately 

in addition to code for primary procedure)

Lipid Disorders (Screening)

82465 Cholesterol, serum or whole blood, total

83721 Lipoprotein, direct measurement, LDL cholesterol

83719 Lipoprotein, direct measurement, VLDL cholesterol 

83718 Lipoprotein, direct measurement, high density cholesterol 

84478 Triglycerides
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

93

Lipid Disorders (Counseling and Treatment)

99401 Preventive medicine counseling/risk factor reduction, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, 60 minutes

99201 Office/outpatient evaluation and management visit, new patient, level 1

99202 Office/outpatient evaluation and management visit, new patient, level 2

99203 Office/outpatient evaluation and management visit, new patient, level 3

99204 Office/outpatient evaluation and management visit, new patient, level 4

99205 Office/outpatient evaluation and management visit, new patient, level 5

99211 Office/outpatient evaluation and management visit, established patient, level 1

99212 Office/outpatient evaluation and management visit, established patient, level 2

99213 Office/outpatient evaluation and management visit, established patient, level 3

99214 Office/outpatient evaluation and management visit, established patient, level 4

99215 Office/outpatient evaluation and management visit, established patient, level 5

Motor Vehicle-Related Injury Prevention (Counseling)

99401 Preventive medicine counseling and/or risk factor reduction, 15 minutes

99402 Preventive medicine counseling and/or risk factor reduction, 30 minutes

99403 Preventive medicine counseling and/or risk factor reduction, 45 minutes 

99404 Preventive medicine counseling and/or risk factor reduction, 60 minutes 

Obesity (Screening)

99420 Administration and interpretation of health risk assessment instrument

Obesity (Counseling)

99401 Preventive medicine counseling/risk factor reduction, individual, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, individual, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, individual, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, individual, 60 minutes

99411 Preventive medicine counseling/risk factor reduction, group, 30 minutes

99412 Preventive medicine counseling/risk factor reduction, group, 60 minutes
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

94

Obesity (Treatment)

43842 Gastric restrictive procedure, without gastric bypass, for morbid obesity; 

vertical-banded gastroplasty

43843 Gastric restrictive procedure, without gastric bypass, for morbid obesity; other

than vertical-banded gastroplasty

43845 Gastric restrictive procedure with partial gastrectomy, pylorus-preserving

duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit

absorption

43846 Gastric restrictive procedure, with gastric bypass for morbid obesity; with short

limb (150 cm or less) Roux-en-Y gastroenterostomy

43847 Gastric restrictive procedure, with gastric bypass for morbid obesity;With small

intestine reconstruction to limit absorption

43848 Revision, open, of gastric restrictive procedure for morbid obesity, other than

adjustable gastric band

43886 Gastric restrictive procedure, open; revision of subcutaneous port component

only

43887 Gastric restrictive procedure, open; removal of subcutaneous port component

only

43888 Gastric restrictive procedure, open removal and replacement of subcutaneous

port component only

43770 Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable

gastric band 

43771 Laparoscopy, surgical, gastric restrictive procedure; revision of adjustable gastric

band component only

43772 Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric

band component only

43773 Laparoscopy, surgical, gastric restrictive procedure; removal and replacement of

adjustable gastric band component only

43774 Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric

band and subcutaneous port components

43644 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and 

Roux-en-Y gastroenterostomy 

43645 Laparoscopy, surgical, gastric restrictive procedure with gastric bypass and small

intestine reconstruction to limit absorption

Osteoporosis (Screening)

99420 Administration and interpretation of health risk assessment instrument

76071 Computerized tomography, bone mineral density study, one or more sites;

appendicular skeleton 
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

95

76076 Dual energy x-ray absorptiometry (DXA), bone density study, one or more sites;

appendicular skeleton 

76077 Dual energy x-ray absorptiometry (DXA), bone density study, one or more sites;

vertebral fracture assessment 

76078 Radiographic absorptiometry (e.g., photodensitometry, radiogrammetry), one or

more sites

76977 Ultrasound bone density measurement and interpretation, peripheral site(s), any

method

78350 Bone density (bone mineral content) study, one or more sites; single photon

absorptiometry

78351 Bone density (bone mineral content) study, one or more sites; dual photon

absorptiometry, one or more sites 

Osteoporosis (Treatment)

CPT code not applicable

Sexually Transmitted Infections (Screening and Counseling)

Counseling to Prevent Sexually Transmitted Infections (STI)

99401 Preventive medicine counseling/risk factor reduction, individual, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, individual, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, individual, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, individual, 60 minutes

Chlamydia (Screening)

87270 Infectious agent antigen detection by immunofluorescent technique, Chlamydia

trachomatis 

87320 Infectious agent antigen detection by enzyme immunoassay technique,

qualitative or semi-quantitative, Chlamydia trachomatis 

87320 Chlamydia, culture, any source

87810 Infectious agent detection by immunoassay with direct optical observation,

Chlamydia trachomatis 

87490 Infectious agent detection by nucleic acid; Chlamydia trachomatis, direct probe

technique

87491 Infectious agent detection by nucleic acid; Chlamydia trachomatis, amplified

probe technique

87800 Infectious agent detection by nucleic acid, multiple organisms; direct probe

technique
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

96

87801 Infectious agent detection by nucleic acid, multiple organisms; amplified probe

technique

81000 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin,

ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any

number of these constituents; non-automated, with microscopy

81001 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin,

ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any

number of these constituents; automated, with microscopy

81002 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin,

ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any

number of these constituents; non-automated, without microscopy

81003 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin,

ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any

number of these constituents; automated without microscopy 

Gonorrhea (Screening)

87081 Culture, presumptive, pathogenic organisms, screening only

87205 Smear, primary source with interpretation; Gram or Giemsa stain for bacteria,

fungi, or cell types

87800 Infectious agent detection by nucleic acid, multiple organisms; direct probe

technique

87801 Infectious agent detection by nucleic acid, multiple organisms; amplified probe

technique

87590 Infectious agent detection by nucleic acid (DNA or RNA); Neisseria 

gonorrhoeae, direct probe technique

87591 Infectious agent detection by nucleic acid (DNA or RNA); Neisseria 

gonorrhoeae, amplified probe technique

81003 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin,

ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any

number of these constituents; automated without microscopy

Human Immunodeficiency Virus (HIV) (Screening)

36415 Venipuncture 

86689 HTLV or HIV antibody, confirmatory test

86701 HIV-1 antibody

86702 HIV-2 antibody

86703 HIV-1 and HIV-2 antibody, single assay 

87390 Infectious agent antigen detection, HIV-1
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

97

87391 Infectious agent antigen detection, HIV-2

S3645* HIV antibody testing of oral mucosal transudate 

Human Immunodeficiency Virus (HIV) (Counseling)

99401 Preventive medicine counseling/risk factor reduction, individual, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, individual, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, individual, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, individual, 60 minutes

Syphilis (Screening)

36415 Venipuncture

86592 Syphillis test, qualitative 

86781 Antibody, treponemal pallidum, confirmatory test 

87164 Dark field examination, any source, includes specimen collection 

87166 Dark field examination, any source, without collection

Tobacco Use (Screening)

99420 Administration/interpretation health risk assessment instrument

Tobacco Use (Counseling)

99401 Preventive medicine counseling/risk factor reduction, individual, 15 minutes

99402 Preventive medicine counseling/risk factor reduction, individual, 30 minutes 

99403 Preventive medicine counseling/risk factor reduction, individual, 45 minutes

99404 Preventive medicine counseling/risk factor reduction, individual, 60 minutes

S9075* Smoking cessation treatment 

Tobacco Use (Treatment)

CPT code not applicable

Tuberculosis (Screening)

71010 Chest xray, single view 

71020 Chest xray, two views, frontal and lateral 

71030 Chest xray, complete, minimum of four views 

86580 Skin test, tuberculosis, intradermal
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

98

86480 Tuberculosis test, cell mediated immunity measurement of gamma interferon

antigen response

94640 Sputum induction for diagnostic purposes 

87116 Culture, tubercle or other acid-fast bacilli (eg, TB, AFB, mycobacteria) any

source, with isolation and presumptive identification of isolates

36415 Venipuncture 

Source:

CPT codes, descriptions, and numeric modifiers only are copyrighted 2006 American Medical Association.

All Rights Reserved. 

This publication contains CPT codes to offer information regarding coding of medical services using the CPT

coding system. The CPT codes presented are based on the experience and interpretations of the publisher.

The material in this manual is to assist in obtaining correct and appropriate coverage and reimbursement for

healthcare goods and services. To the best of our knowledge, the information contained in the manual was

correct as of the date of publication. However, there can be no assurances that it will not become outdated

without notice or that the government or other payers may differ with the guidance contained in the manual.

The responsibility for coding correctly lies with the healthcare provider, and we urge you to consult with your

coding advisors to resolve any billing questions that you might have. Though all of the information has been

carefully researched and checked for accuracy and completeness, the publisher does not accept any

responsibility or liability with regard to errors, omissions, misuse or misinterpretation. Please note that CPT

codes change annually, the most current CPT is available from the American Medical Association.

No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no

liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.

Notes:

*“S” codes are national Permanent Level II HCPCS Codes that are maintained by the HCPCS National

Panel, a group comprised of representatives from the Blue Cross/Blue Shield Association (BCBSA), the

Health Insurance Association of America (HIAA), and the Centers for Medicare and Medicaid Services

(CMS). Permanent Level II HCPCS Codes provide a standardized coding system that is managed jointly by

public and private insurers, thus providing a stable system for claims processing. These codes can be used by

all private and public insurers.

*“H” codes are used by Medicaid and other plans in order to identify mental health services such as alcohol

and drug screening.

References:

1. Nussbaum SR. Prevention: The cornerstone of quality health care. Am J Prev Med 2006; 31(1): 107-108. 

2. U.S. Department of Labor, Health and Benefits, Employee Retirement Income Security Act—ERISA. 

[cited 2006 Mar 22]. Available from: http://www.dol.gov/dol/topic/health-plans/planinformation.htm. 

3. U.S. Department of Labor, Pension and Welfare Benefits Administration, Part 2520, Subpart B, Nov. 21,

2000.

4. U.S. Department of Labor. Pension and Welfare Benefit Administration; January 1, 2005.

5. Internal Revenue Service. Internal Revenue Code Instructions. Form 8889. [cited 2006 Mar 22]. Available 

from: http://www.irs.gov/instructions/i8889/ch01.html. 

6. Internal Revenue Service. Bulletin 2004-15; Notice 2004-23. April 24, 2004 [cited 2006 Apr 13]. 

Available from: http://www.irs.gov/irb/2004-15_IRB/ar10.html. 

7. U.S. Department of the Treasury. Health Savings Accounts Q & A. Notice 2004-50. Washington, DC: 

U.S. Department of the Treasury; 2004 [cited 2006 Mar 22]. Available from: 

http://www.Treas.gov/press/releases/reports/hsanotice200450072304.pdf. 

8. U.S. Department of Labor, Pension and Welfare Benefits Administration, Federal Register. 2000 Nov 21; 

25(225): 70228.
CURRENT PROCEDURAL TERMINOLOGY CODES (CPT© CODES)

99

9. U.S. Department of Health and Human Services. Substance Abuse and Mental Health Services 

Administration. Naltrexone and alcoholism treatment. Treatment improvement protocol (TIP) series 28. 

[cited 2006 Oct 17]. Available from: http://ncadi.samhsa.gov/govpubs/BKD268/28c.aspx. 

10. Aetna. List of Preventive Medications. [cited 2006 Oct 17]. Available from: 

http://www.aetna.com/data/preventive_medication_list.pdf. 

11. Geddes JR, Carney SM, Davies C, Furukawa TA, Kupfer DJ, Frank E, et al. Relapse prevention with 

antidepressant drug treatment in depressive disorders: A systematic review. Lancet 2003; 361(9358): 653-661. 

12. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, et al. Seventh report of the 

joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. 

Hypertension 2002; 42(6):1206-1252. 

13. Kinsinger LS, Harris R, Woolf SH, Sox HC, Lohr KN. Chemoprevention of breast cancer: A summary of 

the evidence for the U.S. preventive services task force. Ann Intern Med 2002; 137(1): 59-69. 

14. Westhoff C. Emergency contraception. N Engl J Med 2003; 346: 1830-5.

15. Food and Drug Administration. Birth control guide. Washington, DC: U.S. Food and Drug

Administration; 197. Updated December 2003 [cited 2006 Oct 17]. Available from:

http://www.fda.gov/fdac/features/1997/babytabl.html. 

16. U.S. Department of Health and Human Services. Centers for Disease Control and Prevention. Methadone

maintenance treatment. IDU HIV Prevention February 2002. 

17. Nish A. Causes of anaphylaxis and epinephrine options. Allergy and Asthma Advocate; Spring 2006. 

18. National Institutes of Health. U.S. National Library of Medicine. MedlinePlus. Drugs & Supplements:

Epoetin (Systemic). [cited 2006 Oct 17]. Available from:

http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/202214.html. 

19. Bader JD, Rozier RG, Lohr KN, Frame PS. U.S. Preventive Services Task Force. Physicians’ roles in

preventive dental caries in preschool children. Summary of the evidence. Rockville, MD: Agency for

Healthcare Research and Quality; 2004 [cited 2006 Sep 24]. Available from:

http://www.ahrq.gov/clinic/3rduspstf/dentalchild/dentchsum.htm. 

20. Centers for Disease Control and Prevention. Recommendations for the use of folic acid to reduce the

number of cases of spina bifida and other neural tube defects. MMWR 1992; 41(RR14): 001.

21. Executive summary of the third report of the national cholesterol education program (NCEP) expert panel

on detection, evaluation, and treatment of high blood cholesterol in adults (adult treatment panel III).

JAMA 2001; 285(19): 2486-2497.

22. Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, et al. Implications of

recent clinical trials for the national cholesterol education program adult treatment panel III guidelines.

Circulation 2004; 110(2): 227-239. 

23. Institute for Clinical Systems Improvement. Lipid Management in Adults. 2006 [cited 2006 Sep 24].

Available from: http://www.icsi.org/knowledge/detail.asp?catID=29&itemID=197. 

24. Lumley J, Watson L, Watson M, Bower C. Periconceptional supplementation with folate and/or

multivitamins for preventing neural tube defects. Cochrane Database of Systematic Reviews (Online :

Update Software); Cochrane Database of Systematic Reviews (Online), (3)(3), CD001056; 2001.

25. Levy, HL.Levy, HLLevey HL. Historical background for the maternal PKU syndrome. Pediatrics. 2003

Dec;112(6 Pt 2):15168.

26. American Academy of Pediatrics; Committee on Nutrition. Reimbursement for foods for special dietary

use. Policy Statement. Pediatrics 2003; 11(5): 1117-1119.

27. U.S. Department of Health and Human Services. Centers for Disease Control and Prevention. Emergency

Preparedness and Response. Facts about Neupogen®. [Cited 2006 Oct 17]. Available from:

http://www.bt.cdc.gov/radiation/neupogenfacts.asp. 

28. Rumbold A, Middleton P, Crowther CA. Vitamin supplementation for preventing miscarriage. Cochrane

Database of Systematic Reviews (Online : Update Software); Cochrane Database of Systematic Reviews

(Online), (2)(2), CD004073; 2005.

29. Centers for Disease Control and Prevention. General recommendations on immunization:

recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American

Academy of Family Physicians (AAFP). MMWR 2002; 51(No. RR-02):1-36.
100

30. Internal Revenue Service. Internal Revenue Bulletin: 2004-33. Notice 2004-50. Health Savings Accounts –

Additional Qs&As. August 16, 2004 [cited 2006 Oct 17]. Available from: http://www.irs.gov/irb/2004-

33_IRB/ar08.html#d0e1823. 

31. Hopkins DP, Briss PA, Ricard CJ, Husten CG, Carande-Kulis VG, Fielding JE, et al. Task Force on

Community Preventive Services. Am J Prev Med 2001; 20(2 Suppl):16-66.

32. Fiore MC, Bailey WC, Cohen SJ, Dorfman SF, Goldstein MG, Gritz ER et al. A Clinical Practice

Guideline for Treating Tobacco Use and Dependence. Rockville, Maryland. U.S. Department of Health and

Human Services, Public Health Service, June 2000.

33. Berg AO. U.S. Preventive Services Task Force. Screening for obesity in adults: Recommendations and

Rationale. Ann Intern Med 2003;139: 930-932. 
3

Overview: 

The scientific evidence behind each of the 46 screening, testing, counseling, immunization,

preventive medication, and (preventive) treatment benefit recommendations.

Evidence-Statements for Recommended

Clinical Preventive Service Benefits

Abdominal Aortic Aneurysm, Screening

Alcohol Misuse, Screening and counseling

Aspirin Therapy for the Prevention of Cardiovascular Disease, Counseling

Breast Cancer

Breast Cancer, Screening

Breast Cancer Genetic Risk Assessment and BRCA Mutation Testing, Counseling, testing,

and preventive treatment

Breast Cancer, Counseling and preventive medication

Cervical Cancer, Screening

Childhood Health Promotion

Child Development, Screening

Dental Caries, Preventive medication

Immunizations 

Lead, Elevated Blood Level, Screening

Newborn Hearing, Screening

Newborn Screening for Genetic and Endocrine Disorders, Screening, medical foods, and treatment

Vision, Screening

Colorectal Cancer, Screening

Contraceptive Use, Counseling and preventive intervention

Depression, Screening

Diabetes (type 2), Screening

Healthy Diet, Counseling

Healthy Pregnancy

Alcohol Misuse, Screening and counseling

Asymptomatic Bacteriuria, Screening

Breastfeeding, Counseling

Folic Acid Supplementation, Counseling and preventive medication

Group B Streptococcal Disease (GBS), Screening and preventive medication

Hepatitis B Virus (HBV), Screening, immunization, and treatment

Human Immunodeficiency Virus (HIV), Screening, counseling, and preventive medication

Influenza, Immunization

Preeclampsia, Screening

Prenatal Diagnosis of Chromosomal Abnormalities and Neural Tube Defects (NTDs), Screening 

and testing

Rh (D) Incompatibility, Screening and preventive medication

Rubella, Screening

Syphilis, Screening

Tetanus, Immunization

Tobacco Use Treatment, Screening and counseling

Hypertension, Screening and treatment

Immunizations (Child, Adolescent, Adult)

Lipid Disorders, Screening, counseling, and treatment

Motor Vehicle-Related Injury Prevention, Counseling

Obesity, Screening, counseling, and treatment

Osteoporosis, Screening and treatment

Sexually Transmitted Infections (STIs)

Counseling to Prevent STIs, Counseling

Chlamydia, Screening

Gonorrhea, Screening

Human Immunodeficiency Virus (HIV), Screening and counseling

Syphilis, Screening

Tobacco Use Treatment, Screening, counseling, and treatment

Tuberculosis, Screening

Evidence-Statements

101

Evidence Statements for Recommended Clinical

Preventive Service Benefits

The following is a complete list of clinical preventive services covered in the Purchaser’s

Guide. These recommended clinical preventive services address a range of health conditions

that affect people of all ages. For a brief summary of clinical preventive services appropriate

for different age groups and genders, please refer to the Life Course Charts featured in Part

VII: Resources & Tools.

Evidence-statements are organized in alphabetical order. Each evidence-statement has an

accompanying SPD language statement. Please refer to Part II: Summary Plan Description

(SPD) Language Statements for Recommended Clinical Preventive Service Benefits, for

additional information.

Estimating the Cost of Preventive Interventions 

The information provided in the “Cost of Preventive Intervention” subsection of the “Value

of Prevention” section of each evidence-statement was adapted from the 2004 Medstat

Marketscan health insurance claims database. The analysis used claims paid by preferred

provider organizations (PPOs) to calculate average reimbursement rates and 95% confidence

intervals for preventive screenings and procedures. The Medstat Marketscan database is

compiled from health insurance claims of 40 self-insured employers. All 50 states are

represented in the database, which captured 6 million covered life-years during 2004.

Information in the “Cost of Treatment” subsection of the “Value of Prevention” section of

each evidence-statement was adapted from peer-reviewed journal articles and other sources.

This information may not be exclusive to commercially-insured beneficiaries. 

It is important to note that the Medstat Marketscan database is a compilation of data from a

commercially-insured population and does not reflect the costs or charges of patients in

other populations (e.g., Medicare, Medicaid, self-insured). Medstat Marketscan data is

valuable because it reflects what purchasers actually pay for healthcare and not what

providers bill for their services. Paid claims data can help purchasers estimate the cost of

implementing coverage for a preventive service. In some instances a billed service is not

reimbursed by a payer; in these instances the Medstat Marketscan database contains a $0

value for the paid claim. 

Evidence-Statements for

Recommended Clinical

Preventive Service Benefits

3
102

3

3 Evidence-Statements for Recommended Clinical Preventive Service Benefits

Updating Cost Estimates in the “Value of Prevention” Section to Current

Year Dollars

The dollar figures presented in the “Value of Prevention” section of each evidence-statement

are not directly comparable because the figures were taken from sources that were developed

in different years. A proper updating of information related to the value of prevention for

each disease/condition should take into account the changes in both real and monetary

factors over time. For example, to update the costs of alcohol abuse from 1992 to 1998,

researchers adjusted for both changes in incidence/prevalence of alcohol abuse and changes

in the population over the time interval and used the consumer price index (CPI), medical

care price index (MCPI), and wage compensation index to respectively update 1992 nonmedical care costs, medical care costs, and productivity loss estimates to year 1998 dollars.1

Because earnings do not increase or decrease at the same rates as the prices of goods and

services, productivity losses associated with lost workdays should not be updated by CPI.

Instead, the employment cost index (ECI) should be used as it is able to accurately measure

relative changes in wages, benefits, and bonuses of workers over time and thus can be used

to update productivity loss estimates to current dollars.

Table 3.1 lists annual values of CPI, MCPI, and ECI for civilian workers for the period

1985 to 2005. The table can be used to quickly update past dollar values without

undertaking a detailed analysis based on changes in both real and monetary factors. For

example, the total cost of obesity is estimated to be $117 billion in year 2000 U.S. dollars

including $61 billion in medical care expenses and $56 billion in indirect costs (i.e., lost

productivity). To get the updated value of direct medical care costs in 2005, $61 billion of

direct medical care costs should be multiplied by 1.24, the ratio of 2005 MCPI and 2000

MCPI (323.2/260.8) to yield $75.6 billion. Similarly, assuming that the total number of

lost work hours due to obesity stayed the same between 2000 and 2005, the $56 billion of

productivity loss in 2000 would translate to approximately $67.2 billion in 2005 ($56

billion multiplied by a factor of 1.2, the ratio of 2005 ECI and 2000 ECI [100/83.6]).

Thus, the total cost of obesity would sum to $142.8 billion in year 2005 dollars. For many

diseases/conditions, there may be significant non-health related outcomes. The costs of these

outcomes need to be updated by the general CPI. For example, the cost of crime and

property damage due to alcohol abuse should be updated by general CPI. Depending on the

information available, it is possible to improve the updates by using appropriate categories

of CPI, MCPI, and ECI. For example, within the medical care category, separate price

indices are available for medical care goods and medical care services. Similarly, separate

ECIs can readily be obtained for workers in different occupations. 

Updated Direct Cost

Figure 3.0: Current Year Value Equations

Current Year Value of 

Direct Medical Care Cost

Data Year

Direct Medical Care Cost = X

Updated Indirect Cost

Current Year Value of 

Indirect Cost Due to

Productivity Lost

Data Year Indirect Cost

Current Year ECI _______________

Data Year ECI

= X

Current Year MCPI

_______________

Data Year MCPI
103

Year Consumer 

Price Index 

All Items2

Medical Care

Price Index3

Employment Cost Index

(Compensation) for

Civilian Workers4

Quarter Ending in

December

Table 3.1: Consumer Price Index (CPI), Medical Care Price Index (MCPI), and Employment

Cost Index (ECI)

Base Period 1982-84=100 1982-84=100 December 2005=100

1985 107.6 113.5 48.2

1986 109.6 122.0 49.9

1987 113.6 130.1 51.7

1988 118.3 138.6 54.2

1989 124.0 149.3 56.9

1990 130.7 162.8 59.7

1991 136.2 177.0 62.3

1992 140.3 190.1 64.4

1993 144.5 201.4 66.7

1994 148.2 211.0 68.7

1995 152.4 220.5 70.6

1996 156.9 228.2 72.6

1997 160.5 234.6 75.0

1998 163.0 242.1 77.6

1999 166.6 250.6 80.2

2000 172.2 260.8 83.6

2001 177.1 272.8 87.0

2002 179.9 285.6 90.0

2003 184.0 297.1 93.5

2004 188.9 310.1 96.9

2005 195.3 323.2 100.0
References: 

1. Harwood, H. Updating Estimates of the Economic Costs of Alcohol Abuse in the United States: Estimates,

Update Methods, and Data. Report prepared by The Lewin Group for the National Institute on Drug 

Abuse and the National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 

Department of Health and Human Services. NIH Publication No. 98-4327. Rockville, MD: National 

Institutes of Health, 1998.

2. Series Id: CUUR0000SA0, Not Seasonally Adjusted, Area: U.S. City Average. Bureau of Labor Statistics. 

[cited 2006 Sep 27]. Available from: http://data.bls.gov/cgi-bin/surveymost?cu. 

3. Series Id: CUUR0000SAM, Not Seasonally Adjusted, Area: U.S. City Average. Bureau of Labor Statistics. 

[cited 2006 Sep 27]. Available from: http://data.bls.gov/cgi-bin/surveymost?cu. 

4. Employment Cost Index: Historical Listing: Current-dollar 1975-2005. Not Seasonally Adjusted. Bureau 

of Labor Statistics. [cited 2006 Sep 27]. Available from: http://www.bls.gov/web/echistry.pdf. 

Note: civilian workers include private industry and State and local government workers and excludes farm, 

household, and Federal government workers.

104

3

3 Evidence-Statements for Recommended Clinical Preventive Service Benefits
105

Abdominal Aortic Aneurysm, Screening .........................................................................Pg. 107

Alcohol Misuse, Screening and counseling......................................................................Pg. 113

Aspirin Therapy for the Prevention of Cardiovascular Disease, Counseling ...............Pg. 125

Breast Cancer

Breast Cancer, Screening................................................................................................Pg. 131

Breast Cancer Genetic Risk Assessment and BRCA Mutation Testing,

Counseling, testing, and preventive treatment ...........................................................Pg. 132

Breast Cancer, Counseling and preventive medication...................................................Pg. 133

Cervical Cancer, Screening...............................................................................................Pg. 145

Childhood Health Promotion

Child Development, Screening ........................................................................................Pg. 154

Dental Caries, Preventive medication..............................................................................Pg. 160

Immunizations ................................................................................................................Pg. 337

Lead, Elevated Blood Level, Screening ...........................................................................Pg. 164

Newborn Hearing, Screening ..........................................................................................Pg. 169

Newborn Screening for Genetic and Endocrine Disorders, Screening,

medical foods, and treatment.....................................................................................Pg. 175

Vision, Screening.............................................................................................................Pg. 181

Colorectal Cancer, Screening ...........................................................................................Pg. 195

Contraceptive Use, Counseling and preventive intervention ............................................Pg. 201

Depression, Screening ......................................................................................................Pg. 211

Diabetes (type 2), Screening ............................................................................................Pg. 217

Healthy Diet, Counseling...................................................................................................Pg. 227

Healthy Pregnancy

Alcohol Misuse, Screening and counseling.........................................................................Pg. 243

Asymptomatic Bacteriuria, Screening .............................................................................Pg. 248

Breastfeeding, Counseling...............................................................................................Pg. 252

Folic Acid Supplementation, Counseling and preventive medication ..............................Pg. 257

Group B Streptococcal Disease (GBS), Screening and preventive medication................Pg. 262

Alphabetical Listing of Evidence-Statements
106

3 Evidence-Statements for Recommended Clinical Preventive Service Benefits

Hepatitis B Virus (HBV), Screening, immunization, and treatment ....................................Pg. 266

Human Immunodeficiency Virus (HIV),

Screening, counseling, and preventive medication ......................................................Pg. 272

Influenza, Immunization....................................................................................................Pg. 277

Preeclampsia, Screening ..................................................................................................Pg. 281

Prenatal Diagnosis of Chromosomal Abnormalities and Neural 

Tube Defects (NTDs), Screening and testing................................................................Pg. 284

Rh (D) Incompatibility, Screening and preventive medication...........................................Pg. 290

Rubella, Screening ............................................................................................................Pg. 294

Syphilis, Screening............................................................................................................Pg. 298

Tetanus, Immunization......................................................................................................Pg. 302

Tobacco Use Treatment, Screening and counseling .........................................................Pg. 305

Hypertension, Screening, counseling, and treatment.........................................................Pg. 323

Immunizations (Child, Adolescent, Adult) ......................................................................Pg. 337

Lipid Disorders, Screening, counseling, and treatment......................................................Pg. 349

Motor Vehicle-Related Injury Prevention, Counseling .....................................................Pg. 363

Obesity, Screening, counseling, and treatment ...................................................................Pg. 373

Osteoporosis, Screening and treatment .............................................................................Pg. 383

Sexually Transmitted Infections (STIs)

Counseling to Prevent STIs, Counseling............................................................................Pg. 394

Chlamydia, Screening .......................................................................................................Pg. 395

Gonorrhea, Screening .......................................................................................................Pg. 398

Human Immunodeficiency Virus (HIV),

Screening and counseling............................................................................................Pg. 401

Syphilis, Screening............................................................................................................Pg. 407

Tobacco Use Treatment, Screening, counseling, and treatment........................................Pg. 415

Tuberculosis, Screening......................................................................................................Pg. 427

Alphabetical Listing of Evidence-Statements
107

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/

At Least Fair

Evidence)

Information Sources

• An abdominal aortic aneurysm (AAA) is a potentially fatal abnormal swelling

(often balloon-like) of a segment of the body’s largest artery, the aorta. The

wall of the artery bulges out rather than remaining straight.1

• Abdominal aortic aneurysms affect 4% to 8% of older men and 0.5% to 1.5%

of older women.2-6

• Older age, smoking, male sex, and family history are the most significant AAA

risk factors.2-6

• Approximately 69% of men in the United States age 65 to 74 years have a

history of smoking (defined as lifetime consumption of more than 100

cigarettes) and are therefore at risk for AAA.7

• Although AAAs may be asymptomatic for years, as many as 1 in 3 eventually

rupture if left untreated.8

• Voluntary AAA screening may reduce AAA-related mortality by 43% in men

age 65 to 75 years.9 Therefore, it is particularly important that employers who

provide retiree health care coverage or who have active employees over the age

of 65 provide coverage for AAA screening. 

• In 2003, AAA (without rupture) was responsible for $2.7 billion in hospital

charges and AAA rupture was responsible for an additional $639.71 million.

Each patient treated for AAA (without rupture) costs more than $59,000; each

hospital-treated patient with an AAA rupture costs more than $93,000.10

• The average cost of elective surgery following AAA screening is $25,000; the

average cost of emergency AAA surgery following a rupture is approximately

$50,000.11

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends one-time

screening for abdominal aortic aneurysm (AAA) by ultrasonography in men aged

65 to 75 who have ever smoked.12

The USPSTF found good evidence that screening for AAA and surgical repair of

large AAAs (5.5 cm or more) in men aged 65 to 75 who have ever smoked

(current and former smokers) leads to decreased AAA-specific mortality. There is

good evidence that abdominal ultrasonography, performed in a setting with

adequate quality assurance (i.e., in an accredited facility with credentialed

technologists), is an accurate screening test for AAA. There is also good evidence

of important harms of screening and early treatment, including an increased

number of surgeries with associated clinically-significant morbidity and mortality,

and short-term psychological harms. Based on the moderate magnitude of net

benefit, the USPSTF concluded that the benefits of screening for AAA in men

aged 65 to 75 who have ever smoked outweigh the harms.12

The recommendations and supporting information contained in this document

came from several sources, including the:

• Agency for Healthcare Research and Quality (AHRQ)

EVIDENCE-STATEMENT:

ABDOMINAL AORTIC ANEURYSM (Screening)
108

EVIDENCE-STATEMENT: Abdominal Aortic Aneurysm (Screening)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

• American College of Cardiology

• Harvard Medical School

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

An abdominal aortic aneurysm (AAA) is a potentially fatal abnormal swelling

(often balloon-like) of a segment of the body’s largest artery, the aorta. The wall

of the artery bulges out rather than remaining straight.1

Abdominal aortic aneurysms are found in 4% to 8% of older men and 0.5% to

1.5% of older women.2-6 Aortic aneurysms account for approximately 15,000

deaths in the United States annually; of these, 9,000 are AAA-related and the

remainder are due to thoracic aortic aneurysms.13-14

Once an aortic aneurysm develops, it is a lifelong condition. Most abdominal

aortic aneurysms grow larger with time, expanding at an average rate of .33

centimeters to .5 centimeters each year. As many as 1 in 3 AAAs eventually

rupture if left untreated.8 In about 20% of cases, an undiscovered abdominal

aneurysm ruptures without warning and the patient collapses and dies from

massive bleeding inside the abdomen. Most AAAs do not cause any symptoms,

however when present, symptoms may include:

• Pain in the abdomen, back, or the fleshy part of sides between the bottom ribs

and the hips.

• A feeling of fullness after eating a small meal.

• Nausea and vomiting.

• A pulsating mass in the abdomen.

Older age, smoking, male sex, and family history are the most significant AAA

risk factors.2 Other risk factors include high blood pressure, high blood

cholesterol levels, and obesity.15 Approximately 69% of men in the United States

age 65 to 74 years are current or former smokers and are therefore at risk for

AAA.7 A former smoker, also called an “ever smoker” is defined as anyone with a

lifetime consumption of more than 100 cigarettes.7
109

EVIDENCE-STATEMENT: Abdominal Aortic Aneurysm (Screening)

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention:

Purpose of Screening

Value of Prevention

An estimate of the total societal economic burden of AAA is not available.

However, hospital discharge data from Health Cost and Utilization Project

(HCUP) show that, in 2003, 45,986 patients were discharged with AAA

(without rupture) with a mean length of stay of 6.7 days and aggregate charges of

$2.7 billion.10 Therefore, the average AAA patient staying in the hospital cost

more than $59,000. Hospital discharge data also show that in 2003, 6,815

patients were discharged with a ruptured AAA with a mean length of stay of 10.7

days and total charges of $639.71 million. The average cost per discharge for a

ruptured AAA exceeded $93,000. Men accounted for 75% of all discharges and

80% of aggregate charges.10

The economic burden of AAA would be much larger if lost productivity,

premature mortality, and morbidity costs were accounted for.

Detailed data on the workplace burden of AAA is not available. The workplace

burden of AAA is likely to increase due to the rapidly aging workforce.

Early detection and appropriate management of AAA through screening can

prevent costs resulting from rupture or leakage. The average cost of emergency

surgery for AAA is approximately $50,000, while elective surgery (following AAA

screening) is only $25,000.11

In 2004, the private-sector cost of screening for AAA averaged $115;

approximately 95% of all paid claims fell within the range of $35 to $336.16

The average cost of surgery for AAA is between $25,000 and $50,000 (in year

2004 dollars).11

The Oregon Evidence-Based Practice Center (EPC) conducted an evidence

synthesis of AAA screening studies.17-20 Their principal findings point to a costeffectiveness ratio for population-based AAA screening (compared with no

screening) that lies in the range of $14,000 to $20,000 per quality-adjusted life

year (QALY).15 In comparison to other preventive interventions and to

commonly accepted cost-effectiveness benchmarks, screening for AAA is costeffective. 

Preventive Intervention Information

Screening for AAA allows clinicians to identify affected patients and those who

require preventive surgery and can thereby prevent rupture or leakage of the

aneurysm. 
Early intervention reduces AAA-specific mortality9 and is more cost-effective than

emergency surgery.11 

Ultrasonography of the abdomen is accurate21-22 and reliable23 in detecting AAAs

and it does not expose patients to radiation. One-time AAA ultrasound screening

and the surgical repair of large AAAs (5.5 centimeters or more) in men aged 65

to 75 who have ever smoked reduces AAA-related mortality by as much as 43%.9

The USPSTF found good evidence of important harms associated with screening

and early treatment, including an increased number of surgeries with clinicallysignificant morbidity and mortality, and short-term psychological harms. Based

on the moderate magnitude of net benefit, the USPSTF concluded that the

benefits of screening for AAA in men aged 65 to 75 who have ever smoked

outweigh the harms.12

The USPSTF recommends a one-time screening ultrasound to look for

abdominal aortic aneurysm in men aged 65 to 75 who have smoked at any time

in their lives. The exact timing of the screen is left to the discretion of the

clinician.12

Ultrasonography of the abdomen is used to screen for AAA. Ultrasonography

should be performed in an accredited facility with credentialed technologists.

Treatment depends on the size of the aneurysm. The larger the aneurysm, the

more likely it is to burst (rupture). Death rates for ruptured aneurysms and

emergency surgery are higher than rates for scheduled repair of unruptured

aneurysms. Surgery is almost always recommended for an aneurysm that is

leaking. Surgery is generally recommended for people with aneurysms larger than

5.5 centimeters in diameter unless another illness makes surgery unusually risky.

Even with no symptoms, a person with an aneurysm larger than 6.5 centimeters

would almost always have urgent surgery to repair the problem. People with

smaller aneurysms may be monitored with ultrasound tests (every 12 months for

anyone with an aneurysm smaller than 3.5 centimeters and every six months for

those with aneurysms larger than 3.5 centimeters) to determine if the aneurysm

is growing larger.1 

Health benefits should include provisions for follow-up and treatment.

110

EVIDENCE-STATEMENT: Abdominal Aortic Aneurysm (Screening)

Benefits and Risks of

Intervention

Initiation, Cessation,

and Interval of

Screening

Intervention Process

Treatment

Information
Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this

chapter is described below.

Evidence-Based Research:

U.S. Preventive Service Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

• The USPSTF recommends one-time screening for abdominal aortic

aneurysm (AAA) by ultrasonography in men aged 65 to 75 who have ever

smoked.12

EVIDENCE-STATEMENT: Abdominal Aortic Aneurysm (Screening)

111

Authored by: 

Vandiver KP, Lanza A, Sotnikov S. Abdominal aortic aneurysm evidence-statement: screening. In:

Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to

Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on

Health; 2006.

References:

1. Harvard Medical School. Aetna. Abdominal aortic aneurysm. Updated 2005 Nov 25 [cited 2006 Aug 8]. Available from:

http://www.intelihealth.com/IH/ihtIH/WSIHW000/9339/31040.html. 

2. Lederle FA, Johnson GR, Wilson SE, Chute EP, Hye RJ, Makaroun MS, et al. The aneurysm detection and management

study screening program: validation cohort and final results. Aneurysm Detection and Management Veterans Affairs

Cooperative Study Investigators. Arch Intern Med 2000;160:1425–30. 

3. Lederle FA, Johnson GR, Wilson SE. Abdominal aortic aneurysm in women. J Vasc Surg 2001;34:122–6.

4. Lindholt JS, Henneberg EW, Fasting H, Juul S. Hospital based screening of 65–73 year old men for abdominal aortic

aneurysms in the county of Viborg, Denmark. J Med Screen 1996;3:43–6. 

5. Norman PE, Jamrozik K, Lawrence-Brown MM, Dickinson JA. Western Australian randomized controlled trial of screening

for abdominal aortic aneurysm [Abstract]. Br J Surg 2003;90:492. 

6. Vardulaki KA, Walker NM, Couto E, Day NE, Thompson SG, Ashton HA, et al. Late results concerning feasibility and

compliance from a randomized trial of ultrasonographic screening for abdominal aortic aneurysm. Br J Surg 2002;89:861–4. 

7. Schoenborn CA, Adams PF, Barnes PM, Vickerie JL, Schiller JS. Health behaviors of adults: United States, 1999–2001.

National Center for Health Statistics. Companion Table 4.1. Vital Health Statistics. 2004 [cited 2004 Nov 15];10(219).

Available from: http://www.cdc.gov/nchs/data/series/sr_10/sr10_219companion.pdf

8. Darling RC, Messina CR, Brewster DC, Ottinger LW. Autopsy study of unoperated abdominal aortic aneurysms. 

The case for early resection. Circulation 1977;56:II161–4. 

9. Fleming C, Whitlock EP, Beil TL, Lederle FA. Screening for Abdominal Aortic Aneurysm: A Best-Evidence Systematic

Review for the U.S. Preventive Services Task Force (Conducted by the Oregon Evidence-based Practice Center under

Contract No. 290-02-0024, Task Order Number 2, Rockville, Agency for Healthcare Research and Quality. 2005 Feb.

Available from: www.preventiveservices.ahrq.gov.

10. Agency for Healthcare Research and Quality. Nationwide inpatient sample data set. Hospital Cost and Utilization Project.

Rockville, MD: Agency for Healthcare Research and Quality. 2006 [cited 2006 Aug 8] Available from:

http://hcup.ahrq.gov/HCUPnet.asp.
112

11. Silverstein MD, Pitts SR, Chaikof EL, Ballard DJ. Abdominal aortic aneurysm: Cost-effectiveness of screening, surveillance

of intermediate sized AAA, and management of symptomatic AAA. Proc (Barl Univ Med Centr) 2005 Oct; 18(4):345-67.

12. U.S. Preventive Services Task Force. Screening for abdominal aortic aneurysm. Recommendation statement. AHRQ

Publication No. 05-0569-A. Rockville, MD: Agency for Healthcare Research and Quality; Feb 2005. Available from:

http://www.ahrq.gov/clinic/uspstf05/aaascr/aaars.htm.

13. Table 1. Deaths, percent of total deaths, and death rates for the 10 leading causes of death in selected age groups, by race and

sex: United States, 2000. National Center for Health Statistics. National Vital Statistics Report. 2002 [cited 2004 November

15]. Available from: www.cdc.gov/nchs/fastats/pdf/nvsr50_16t1.pdf. 

14. Gillum RF. Epidemiology of aortic aneurysm in the United States. J Clin Epidemiol 1995;48:1289–98.

15. Meenan RT, Fleming C, Whitlock EP, Beil TL, Smith P. Cost-effectiveness analyses of population-based screening for

abdominal aortic aneurysm: Evidence synthesis. AHRQ Electronic Newsletter Issue No. 159. Rockville, MD: Agency for

Healthcare Research and Quality; February 4, 2005. Available from: http://ahrq.gov/news/enews/enews159.htm.

16. Thompson Medstat. Marketscan. 2004.

17. Fleming C, Whitlock EP, Beil T, Lederle F. Primary care screening for abdominal aortic aneurysm. Evidence synthesis No. 35

(Prepared by the Oregon Evidence-based Practice Center under Contract No. 290-02-0024.) Rockville, MD: Agency for

Healthcare Research and Quality. February 2005. Available from: www.ahrq.gov/clinic/serfiles.htm.

18. Multicentre Aneurysm Screening Study Group. Multicentre aneurysm screening study (MASS): cost effectiveness analysis of

screening for abdominal aortic aneurysms based on four year results from a randomised controlled trial. BMJ 2002;325:1135-8.

19. Soisalon-Soininen S, Rissanen P, Pentikäinen T, Mattila T, Salo JA. Cost-effectiveness of screening for familial abdominal

aortic aneurysms. VASA 2001;30:262-70.

20. Lee TY, Korn P, Heller JA, et al. The cost-effectiveness of a “quick-screen” program for abdominal aortic aneurysms. Surgery

2002;132(2):399-407.

21. Nusbaum JW, Freimanis AK, Thomford NR Echography in the diagnosis of abdominal aortic aneurysm. Arch Surg

1971;102:385–8. 

22. Wilmink AB, Forshaw M, Quick CR, Hubbard CS, Day NE. Accuracy of serial screening for abdominal aortic aneurysms by

ultrasound. J Med Screen 2002;9:125–7.

23. Wilmink AB, Hubbard CS, Quick CR. Quality of the measurement of the infrarenal aortic diameter by ultrasound. J Med

Screen 1997;4:49–53. 

EVIDENCE-STATEMENT: Abdominal Aortic Aneurysm (Screening)
113

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/

At Least Fair

Evidence)

• Alcohol misuse contributes to illnesses and injuries and is the third most

common behavior-related cause of death in the United States. Alcohol misuse

was associated with 75,000 deaths and 2.3 million years of potential life lost

(30 years per premature death) in 2001.1

• Alcohol misuse results in a variety of adverse health and social outcomes. These

include increased risk of unintentional injuries, violence, liver disease,

hypertension, certain cancers, and diseases of the central nervous system.

Individuals who misuse alcohol are also at increased risk of a variety of adverse

reproductive health outcomes.1-7

• Alcohol misuse is associated with high costs to employers in the form of

increased absenteeism, decreased productivity and lost productivity, and

increased employer-sponsored healthcare expenditures. Overall, 15.3% of U.S.

workers report using or being impaired by alcohol at work at least one time

during the previous year, including 9% of workers who report being hung over

at work.8 Lost productivity accounted for 73% of the total costs resulting from

alcohol misuse in 1998.9 

• Alcohol misuse is costly for health insurers and society. The cost of alcohol

misuse in the United States was estimated to be $185 billion in 1998.9 About

$16 billion of this amount was spent on medical care for alcohol-related

complications (not including fetal alcohol syndrome [FAS]), $7.5 billion was

spent on specialty alcohol treatment services, and $2.9 billion was spent on

FAS treatment. The remaining costs ($134) billion were due to lost

productivity. 

• Randomized trials demonstrate that brief counseling leads to reduced alcohol

consumption among excessive drinkers and to reductions in adverse alcoholrelated health outcomes, including excess mortality.10-13

• Screening and counseling for alcohol misuse reduces both societal and

healthcare costs. Each $1 invested in screening and brief counseling

interventions saves approximately $4 in healthcare costs.12,14 

• Coverage for screening and brief counseling is currently offered by only 20%

of employer-sponsored health plans, despite the fact that such services are

among the most cost-effective clinical preventive services and have a proven

impact on health outcomes.10,15

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends screening and

behavioral counseling interventions to reduce alcohol misuse by adults, including

pregnant women, in primary care settings.16

The USPSTF found good evidence that screening in primary care settings can

accurately identify patients whose levels or patterns of alcohol consumption do

not meet criteria for alcohol dependence but place them at risk for increased

morbidity or mortality. The USPSTF also found good evidence that brief

behavioral counseling interventions with follow-up produce small-to-moderate

EVIDENCE-STATEMENT:

ALCOHOL MISUSE (Screening and Counseling)
114

EVIDENCE-STATEMENT: Alcohol Misuse (Screening and Counseling)

Other Recommended

Guidance

National Institute on

Alcohol Abuse and

Alcoholism (NIAAA)

Evidence Rating:

American Academy

of Pediatrics (AAP)

Evidence Rating:

American Medical

Association (AMA)

Evidence Rating:

American College of

Surgeons (ACS)

Evidence Rating: 

American College of

Emergency

Physicians (ACEP)

Evidence Rating:

American Society of

Addiction Medicine

(ASAM)

Evidence Rating:

Information Sources

reductions in alcohol consumption that are sustained over 6 to 12 month periods

or longer.16

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) recommends

incorporating screening for alcohol misuse and counseling into routine medical

practice.17

Expert Consensus

The American Academy of Pediatrics (AAP) encourages clinicians to ask

adolescents about their alcohol use and refer adolescents with suspected drinking

problems for age-appropriate treatment.18 It also encourages including substance

abuse prevention counseling in routine and episodic office visits.19

Expert Consensus (Committee on Substance Abuse)

The American Medical Association (AMA) recommends that primary care

physicians establish routine alcohol screening and be trained to conduct brief

intervention counseling and motivational interviewing.20

Expert Consensus (Office of Alcohol, Tobacco and Other Drug Abuse

Prevention)

The American College of Surgeons (ACS) recommends alcohol screening with

brief counseling or referral, as appropriate, for all injured patients.21

Expert Consensus (Committee on Trauma)

The American College of Emergency Physicians (ACEP) recommends that

physicians mitigate the consequences of alcohol abuse through screening, brief

interventions, and appropriate referral.22

Expert Consensus (Board of Directors)

The American Society of Addiction Medicine (ASAM) recommends routine

screening for alcohol misuse in primary care settings, with appropriate counseling

and referral.

Not Specified

The recommendations and supporting information contained in this document

came from several sources, including the:

• Agency for Healthcare Research and Quality (AHRQ)

• American Academy of Family Physicians (AAFP)

• American Academy of Pediatrics (AAP) 

• American College of Emergency Physicians (ACEP)
115

EVIDENCE-STATEMENT: Alcohol Misuse (Screening and Counseling)

Epidemiology of

Condition/Disease

• American College of Surgeons (ACS)

• American Medical Association (AMA) 

• American Society of Addiction Medicine (ASAM)

• Center for Medicare and Medicaid Services (CMS)

• National Business Group on Health 

• National Institute on Alcohol Abuse and Alcoholism (NIAAA) 

• Peer-reviewed research 

• Substance Abuse and Mental Health Services Administration (SAMHSA)

• U.S. Preventive Services Task Force (USPSTF)

The information contained in this document is based on a compilation of

research findings. Information presented in this document should be attributed

to its referenced source and should not be considered a reflection of the opinions

of other organizations cited in the text. 

Condition/Disease-Specific Information

The term “alcohol misuse” is used to describe alcohol consumption that puts

individuals at increased risk for adverse health and social consequences. The

NIAAA defines alcohol misuse (which the Institute calls “at-risk drinking”) as

either excessive daily consumption (more than four drinks for men or more than

three drinks for women), excessive total consumption (more than 14 drinks per

week for men or more than 7 drinks per week for women), or both.17 Alcohol

abuse, which is a subset of alcohol misuse, is defined on the basis of having

suffered negative consequences from drinking (e.g., legal problems, job loss, or

family problems). Alcohol dependence (i.e., alcoholism) is also a subset of alcohol

misuse and is defined on the basis of having suffered negative consequences from

drinking and some combination of experiencing withdrawal symptoms, loss of

control, or alcohol tolerance. Other types of alcohol misuse include alcohol

consumption among high-risk populations (e.g., pregnant women, youth) and

drinking prior to or during certain activities (e.g., driving a motor vehicle,

operating heavy equipment). 

Among adults in the United States, approximately 30% of current drinkers

exceed NIAAA’s daily or weekly alcohol consumption limits. Of these excessive

drinkers, more than 90% report past-month binge drinking (consuming 5 or

more drinks during one or more occasions),23 approximately 15% abuse alcohol,

and approximately 10% are dependent on alcohol.24

Alcohol misuse contributes to illnesses and injuries and is the third most

common behavior-related cause of death in the United States. Alcohol misuse

was associated with 75,000 deaths and 2.3 million years of potential life lost

(30 years per premature death) in 2001.1 Alcohol misuse is a risk factor for:

unintentional injuries (e.g., motor vehicle crashes, falls); violence (e.g.,
116

EVIDENCE-STATEMENT: Alcohol Misuse (Screening and Counseling)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

homicide, suicide); liver disease; diseases of the central nervous system (e.g.,

stroke, dementia); hypertension; and various cancers (e.g., breast, neck,

stomach, colon, and liver). Alcohol misuse is also associated with a variety of

adverse reproductive health outcomes (e.g., unintended pregnancy, sexual

assault, sexually transmitted infections), fetal alcohol spectrum disorders (e.g.,

fetal alcohol syndrome), low birth weight, and sudden infant death syndrome

(SIDS). Finally, alcohol misuse often coexists with mental health problems as

well as other substance abuse problems.1-7

There are multiple risk factors for alcohol misuse.2 These include environmental

and regulatory factors such as the price and availability of alcohol, marketing

exposure, and the provision of alcohol in public facilities. Social factors include

familial country of origin, peer group norms, religious affiliation, and other

socio-cultural factors. Intrinsic (internal or personal) risk factors for alcohol

misuse include personality characteristics and genetic factors. 

Value of Prevention

The direct and indirect costs of alcohol misuse in the United States were

estimated to at $185 billion in 1998.9 About $16 billion of this amount was

spent directly on medical care for alcohol-related complications (excluding FAS),

$7.5 billion was spent on specialty alcohol treatment services, and $2.9 billion

was spent on the treatment of FAS. The remaining costs (73% of all costs) were

due to lost productivity and costs incurred by law enforcement agencies and the

criminal justice system.9

Lost productivity due to alcohol-related deaths and disabilities impose a greater

economic burden than do healthcare costs. Lost productivity is due to 1)

absenteeism and 2) to poor job performance among those who come to work

drunk, hungover, or who drink on the job. Over 15% of workers in the United

States report drinking on the job or being hungover at work at least once during

the previous year.8

The economic benefits of screening and treatment of alcohol misuse are

measured in terms of savings from future reductions in medical costs and future

reductions in productivity losses. These costs are considerable. For example, in

1998, the estimated cost of the medical consequences of alcohol misuse was $18

billion, lost future earnings due to premature deaths from alcohol-related causes

totaled $36.5 billion, lost earnings due to alcohol-related illness totaled $86.4

billion, lost earnings due to FAS totaled $1.3 billion, and lost earnings due to

alcohol-related crimes and lost productivity of incarcerated persons totaled $10

billion.9

Implementing screening and brief counseling programs for alcohol misuse is

relatively inexpensive compared with other clinical preventive services. Costs

depend on the number of sessions, the mode of delivery (in office or by

telephone), and the type of provider that delivers the counseling. 

Screening for alcohol misuse using standard questions is a brief clinical activity
117

EVIDENCE-STATEMENT: Alcohol Misuse (Screening and Counseling)

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention:

Purpose of Screening

and Counseling

Benefits and Risks of

Intervention

that is not typically reimbursable. Approximately 10% of patients in primary care

settings can be expected to screen positive for alcohol misuse and accept brief

counseling. In 2004, the private-sector cost of alcohol misuse counseling averaged

$22 per session when counseling was provided in a separate visit and a preventive

service code was used; approximately 95% of paid claims fell within the range of

$0 to $81.25 Brief counseling bundled in a primary care visit would cost less.

The vast majority of people with alcohol misuse are not alcohol dependent. For

those who are alcohol dependent, referral for specialty treatment might be

appropriate. Costs of treatment for alcohol dependence are beyond the scope of

this document, but treatment is generally cost-saving.

In economic evaluation studies of screening and counseling for alcohol misuse,

outcomes are commonly converted from natural units (e.g., reduced

hospitalizations) to dollars to enable direct comparison of benefits and costs. Several

cost-benefit analyses of screening and brief counseling have been conducted, all of

which demonstrated cost-savings. One of these studies, the Trial for Early Alcohol

Treatment (Project TrEAT), was a randomized clinical trial of screening and brief

counseling conducted in 64 primary care clinics in Wisconsin; study participants

had non-dependent alcohol misuse. Over the study’s 48-month follow-up period,

each $1.00 invested in the intervention saved $4.30 by reducing future health care

costs.12 Another study assessed the cost-effectiveness of alcohol screening and

counseling for injured patients treated in U.S. emergency department settings or

admitted to the hospital. The cost analysis, which was restricted to medical costs,

identified $3.81 in savings for each $1 spent on the intervention.14

Treatment of alcohol dependence also saves money when downstream medical

care costs associated with non-treatment are considered. For example, a 14-year

longitudinal follow-up study found that healthcare costs for alcoholics who

underwent treatment declined substantially over time, while costs rose among

untreated alcoholics.26 After adjusting for the pre-treatment status of the two

groups, those whose alcoholism that had been treated experienced a 25% decline

in medical care costs compared to those whose alcoholism had not been treated.

Preventive Intervention Information

The purpose of screening and counseling for alcohol misuse is to identify patients

who drink excessively and to assist them in reducing their consumption to safer

levels. Screening and counseling can also identify patients with more severe

alcohol problems who may require intensive substance abuse treatment. However,

most individuals with positive screening results do not meet the criteria for

alcohol dependence and are thus eligible for brief counseling interventions that

can be delivered in primary care settings and by telephone.

Most recommended screening instruments reliably identify alcohol misuse. A

majority of these instruments have a sensitivity of 70% to 90% for detecting alcohol

dependence, and single-question screens can detect milder forms of alcohol misuse

with similar sensitivity levels. In primary care settings, 10% to 25% of patients screen

positive for alcohol misuse, depending on the setting and patient population.16,27-28
Brief counseling with appropriate follow-up results in moderate reductions

(approximately 13% to 34%) in alcohol consumption lasting 6 to 12 months or

longer.16,29 Studies also show that the extent of reductions in alcohol-related health

problems may exceed the extent of reductions in alcohol consumption itself. For

example, one randomized study that assessed long-term effects (48-month followup) of screening and brief counseling found that the intervention group had 20%

fewer emergency department visits, 33% fewer nonfatal injuries, 37% fewer

hospitalizations, 46% fewer arrests, and 50% fewer motor vehicle crashes than

the controls.12 These reductions exceeded the reductions experienced by these

participants in alcohol consumption; the intervention group experienced a 20%

reduction in binge drinking episodes, a 10% reduction in drinks per week, and a

4% increase in reporting no binge drinking episodes relative to controls. A metaanalysis found that counseling interventions also reduced mortality.13

The USPSTF identified two theoretical harms from regular screening and

counseling for alcohol misuse: those who drink moderate amounts of alcohol

might abstain from drinking alcohol altogether, thus losing any of the potential

health benefits of light or moderate drinking, and those who abuse alcohol or are

dependent on alcohol might under-treat their condition by drinking moderately

rather than quitting. However, the USPSTF found no data showing that

screening and counseling for alcohol misuse are likely to produce either of these

theoretical harms. Furthermore, it should be noted that no randomized trial has

demonstrated that moderate alcohol consumption reduces mortality of any type.

Although the benefits of screening for alcohol misuse (including early

identification of misuse and treatment with behavioral counseling) outweigh the

potential harms associated with screening,16 fewer than half of patients in primary

care settings are screened for alcohol misuse,30 making it one of the least

commonly performed of the clinical preventive services recommended by the

USPSTF.31 In the absence of screening, clinicians cannot reliably identify patients

with alcohol misuse.32

The USPSTF recommends that screening begin in adulthood (i.e., at age 18).

The USPSTF found insufficient evidence to recommend for or against screening

in younger populations. However, alcohol misuse is frequent among adolescents,

has severe consequences in this population, and is an important predictor of

adult alcohol misuse. The AAP encourages clinicians to ask adolescents about

their alcohol use and refer adolescents with suspected drinking problems for ageappropriate treatment.18

Alcohol misuse among all women of childbearing age, whether pregnant or not,

should be appropriately assessed, counseled, and treated. Furthermore, women of

childbearing age should be advised to use an effective form of contraception until

alcohol intake can be reduced or eliminated because pregnancy is often not

recognized until a woman has been pregnant for at least a month (particularly

among women who have unintended pregnancies) and fetal damage can occur

during the pre-recognition period.33 Finally, pregnant women should be screened

118

EVIDENCE-STATEMENT: Alcohol Misuse (Screening and Counseling)

Initiation, Cessation,

and Interval 

Screening
for alcohol use and should be advised to refrain from drinking alcohol altogether

during their pregnancies.34

The optimal frequency of screening is unknown. The NIAAA recommends

annual screening, with more frequent screening and counseling for high-risk

individuals such as those with a history of previous alcohol misuse.17

Those who screen positive on an alcohol screen should be counseled as medically

indicated. Eight (8) counseling sessions are covered per calendar year. 

The NIAAA and USPSTF recommend that clinicians use the screening strategy

most appropriate to their own patient population, clinical practice style, or

general setting. Examples of effective screening tools include:

• Single-question screens, which address alcohol consumption that exceeds

recommended daily limits. The question typically asks patients to identify the

last occasion, if any, when they consumed five or more drinks (or four or more

drinks for a woman). Drinking at such levels within a specified time period

(e.g., three months) constitutes a positive screening result. Single-question

screens are recommended by the NIAAA because of their high sensitivity for

detecting both severe and less severe forms of alcohol misuse, and because

having fewer questions streamlines the screening process, thereby improving its

acceptability in busy practices.17,35-37

• The Alcohol Use Disorders Identification Test (AUDIT), which is a 10-item

questionnaire that is designed to detect alcohol misuse by asking about

frequency, quantity, and consequences of drinking. The AUDIT is sensitive

and specific for detecting all forms of alcohol misuse. The first three questions

(referred to as the AUDIT-C) comprise a validated screening approach that is

less time consuming than the full AUDIT; it too has a high sensitivity for

detecting all forms of alcohol misuse. The third AUDIT question can also be

used as a single-question screen, although it uses a threshold of 6 or more

drinks that is slightly higher than the threshold used by some other singlequestion screens.28,36,38-39

• The CAGE (feeling the need to Cut down, Annoyed by criticism, Guilty

about drinking, and need for Eye opener in the morning), which is a four-item

risk assessment instrument. The CAGE is reasonably sensitive and specific for

detecting alcohol abuse and dependence. However, it is relatively insensitive for

detecting less severe forms of alcohol misuse.28,36,39

Clinicians should provide counseling interventions for patients who meet the

criteria for alcohol misuse (i.e., patients who drink in excess of NIAAA

guidelines). The USPSTF identifies three levels of counseling intervention,

differentiated by level of intensity, for these patients. Multi-contact counseling is

more effective than single-contact counseling interventions, but providers should

tailor counseling intensity to address individual patient needs. Intensity is

determined by the duration of the initial contact and whether any follow-up

occurs. “Very brief” interventions last up to 5 minutes and have no follow-up.

“Brief” counseling interventions last 15 minutes and have no follow-up. “Multi119

EVIDENCE-STATEMENT: Alcohol Misuse (Screening and Counseling)

Counseling

Intervention Process
120

EVIDENCE-STATEMENT: Alcohol Misuse (Screening and Counseling)

Treatment

Information

contact” interventions include one initial session lasting at least 15 minutes and

several follow-up contacts.16

Effective counseling for alcohol misuse in the primary care setting includes

feedback, advice, goal setting, and follow-up. Alcohol misuse counseling should

follow the counseling framework known as the “5 As”17: 

• Providers should assess the degree of a patient’s drinking, including any

problems caused by alcohol and whether the person is alcohol dependent or

not. 

• Providers should advise patients to reduce their alcohol consumption to safer

levels or to abstain altogether from drinking. 

• Providers should agree with patients on their goals for reducing alcohol

consumption. 

• Providers should assist patients in acquiring personal motivation, self-help

skills, or outside resources necessary to achieve behavior change. 

• Finally, providers should arrange for patients to receive appropriate follow-up

support services and counseling, depending on the nature of their alcohol

misuse.

Interventions for those with alcohol dependence are more intense and time

consuming. Addiction treatment was not discussed in the USPSTF document.16

Counseling interventions for non-dependent alcohol misuse are described above.

A detailed description of treatment for alcohol dependence is beyond the scope

of this chapter but such treatment is accepted medical practice. The benefits of

alcohol dependence treatment include a 50% reduction in alcohol consumption

compared with those who do not undergo treatment. 

Health benefits should include provisions for diagnostic follow-up and treatment

services.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/ At Least Fair Evidence)

• The USPSTF found good evidence to support screening and behavioral

counseling interventions to reduce alcohol misuse by adults, including

pregnant women, in primary care settings.16
121

EVIDENCE-STATEMENT: Alcohol Misuse (Screening and Counseling)

Recommended Guidance:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Strength of Evidence: Expert Recommendation

• The NIAAA recommends incorporating screening for alcohol misuse and

counseling into routine medical practice.17

American Academy of Pediatrics (AAP)

Strength of Evidence: Expert Consensus (Committee on Substance Abuse)

• The AAP encourages clinicians to ask adolescents about their alcohol use and

refer adolescents with suspected drinking problems for age-appropriate

treatment.18 It also encourages including substance abuse prevention in routine

and episodic office visits.19

American Medical Association (AMA)

Strength of Evidence: Expert Consensus (Office of Alcohol, Tobacco, and Other

Drug Abuse Prevention)

• The AMA recommends that primary care physicians establish routine alcohol

screening and be trained to conduct brief intervention counseling and

motivational interviewing.20

American College of Surgeons (ACS)

Strength of Evidence: Expert Consensus (Committee on Trauma)

• The ACS recommends alcohol screening with brief counseling or referral, as

appropriate, for all injured patients.21

American College of Emergency Physicians (ACEP)

Strength of Evidence: Expert Consensus (Board of Directors)

• The ACEP recommends that physicians mitigate the consequences of alcohol

abuse through screening, brief interventions, and appropriate referral.22

American Society of Addiction Medicine (ASAM)

Strength of Evidence: Not Specified

• The ASAM recommends routine screening for alcohol misuse in primary care

settings, with appropriate counseling and referral.

Authored by: 

Naimi T, Brewer RD, Campbell KP, Chattopadhyay S. Alcohol misuse evidence-statement: screening 

and counseling. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors.

A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC:

National Business Group on Health; 2006.
122

EVIDENCE-STATEMENT: Alcohol Misuse (Screening and Counseling)

References:

1. Centers for Disease Control and Prevention. Alcohol-attributable deaths and years of potential life lost—United States, 2001.

MMWR 2004;53:866-70.

2. National Institute of Alcohol Abuse and Alcoholism. Tenth Special Report to the U.S. Congress on Alcohol and Health. Bethesda

(MD): National Institutes of Health; 2000.

3. Corrao G, Bagnardi B, Zambon A, LaVecchia C. A meta-analysis of alcohol consumption and the risk of 15 diseases. Prev

Med 2004;38:613-9.

4. Thun MJ, Peto R, Lopez AD, Monaco JH, Henley SJ, Heath CW Jr, et al. Alcohol consumption and mortality among

middle-aged men and elderly U.S. adults. N Eng J Med 1997;337:1705-14.

5. Naimi TS, Lipscomb LE, Brewer RD, Gilbert BC. Binge drinking in the preconception period and the risk of unintended

pregnancy: implications for women and their children. Pediatrics 2003;111:1136-41.

6. Gladstone J, Nulman I, Koren G. Reproductive risks of binge drinking during pregnancy. Reprod Toxicol 1996;10:3-13.

7. Iyasu S, Randall LL, Welty TK, Hsia J, Kinney HC, Mandell F, et al. Risk factors for sudden infant death syndrome among

Northern Plains Indians. JAMA 2002;288:2717-23.

8. Frone MR. Prevalence and distribution of alcohol use in the workplace: a U.S. national survey. J Stud Alcohol 2006;67:147-56.

9. Harwood H. Updating Estimates of Economic Costs of Alcohol Abuse in the United States: Estimates, Update Methods, and Data.

Rockville (MD): National Institute of Alcohol Abuse and Alcoholism; 2000. NIH Publication No. 98-4327.

10. Maciosek MV, Coffield AB, Edwards NM, Flottemesch TJ, Goodman MJ, Solberg LI. Priorities among effective clinical

preventive services. Am J Prev Med 2006;31:90-6.

11. Bertholet N, Daeppen J-B, Fleming M, Burnand B. Reduction of alcohol consumption by brief alcohol intervention in

primary care: systematic review and meta-analysis. Arch Intern Med 2005;165:986-95.

12. Fleming MF, Mundt MP, French MT, Manwell LB, Stauffacher EA, Barry KL. Brief physician advice for problem alcohol

drinkers: long-term efficacy and benefit-cost analysis. A randomized controlled trial in community-based primary care

settings. Alcohol Clin Exp Res 2002;26:36-43.

13. Cuijpers P, Riper H, Lemmers L. The effects on mortality of brief interventions for problem drinking: a meta-analysis.

Addiction 2004;99:839-45.

14. Gentilello LM, Ebel BE, Wickizer TM, Salkever DS, Rivara FP. Alcohol interventions for trauma patients treated in

emergency departments and hospitals: a cost benefit analysis. Ann Surg 2005;241:541-50.

15. Bondi MA, Harris JR, Atkins D, French ME, Umland B. Employer coverage of clinical preventive services in the United

States. Am J Health Promot 2006;20:214-22.

16. U.S. Preventive Services Task Force. Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol

Misuse. Available from: http://www.ahrq.gov/clinic/3rduspstf/alcohol/alcomisrs.htm. 

17. National Institute of Alcohol Abuse and Alcoholism. Helping Patients Who Drink Too Much, a Clinician’s Guide. [Cited 2006

Aug 21]. Available from:

http://pubs.niaaa.nih.gov/publications/Practitioner/CliniciansGuide2005/guide.pdf#search=%22NIAAA%20clinician's%20g

uide%22. 

18. American Academy of Pediatrics. Alcohol use and abuse: a pediatric concern. Pediatrics 2001;108:185-9.

19. Kulig JW. Tobacco, alcohol, and other drugs: the role of the pediatrician in prevention, identification, and management of

substance abuse. Pediatrics 2005;115:816-21.

20. American Medical Association. Screening and Brief Interventions for Alcohol Problems 1999, 2001. AMA House of Delegates

resolution H30.942.

21. American College of Surgeons Committee on Trauma. Resources for optimal care of the injured patient. Chicago, IL:

American College of Surgeons; 2006.

22. American College of Emergency Physicians (ACEP). Alcohol screening in the emergency departments. Policy #400346.

Dallas (TX): ACEP; 2005.
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23. Naimi TS, Brewer RD, Mokdad AH, Denny C, Serdula M, Marks JS. Binge drinking among U.S. adults. JAMA

2003;289:70-5.

24. Dawson DA, Grant BF, Li T-K. Quantifying the risks associated with exceeding recommended drinking limits. Alcohol Clin

Exp Res 2005;29:902-8.

25. Thomson Medstat. Marketscan. 2004.

26. Holder HD, Blose JO. The reduction of health care costs associated with alcoholism treatment: a 14-year longitudinal study.

J Stud Alcohol 1992;53:293-302.

27. Town M, Naimi TS, Mokdad A, Brewer RD. Health care access among U.S. adults who consume alcohol excessively: missed

opportunities for prevention. Prev Chronic Dis 2006;3:A53.

28. Fiellin DA, Reid MC, O'Connor PG. Screening for alcohol problems in primary care—a systematic review. Arch Intern Med

2000;160:1977-989.

29. Fleming M. Screening and brief intervention in primary care settings. Alcohol Res Health 2004/5;28:57-62.

30. Denny CH, Serdula MK, Holtzman D, Nelson DE. Physician advice about smoking and drinking: are U.S. adults being

informed? Am J Prev Med 2003;24:1-4.

31. Coffield AB, Maciosek MV, McGinnis MJ, Harris JR, Caldwell MB, Teutsch SM, et al. Priorities among recommended

clinical preventive services. Am J Prev Med 2001;21:1-9.

32. Saitz R, Mulvey KP, Plough A, Samet JH. Physician unawareness of serious substance abuse. Am J Drug Alcohol Abuse

1997;23:343-54.

33. Floyd RL, Decoufle P, Hungerford DW. Alcohol use prior to pregnancy recognition. Am J Prev Med 1999;17:101-7.

34. National Institute of Alcohol Abuse and Alcoholism. Fetal Alcohol Exposure and the Brain. Available from:

http://pubs.niaaa.nih.gov/publications/aa50.htm. 

35. Williams R, Vinson DC. Validation of a single screening question for problem drinking. J Fam Pract 2001;50:307-12.

36. Fleming MF. In search of the Holy Grail for the detection of hazardous drinking. J Fam Pract 2001;50:321-2.

37. Canagasaby A, Vinson DC. Screening for hazardous or harmful drinking using one or two quantity-frequency questions.

Alcohol 2005;40:208-13.

38. Dawson DA, Grant BF, Stinson FS, Zhou Y. Effectiveness of the derived Alcohol Use Disorders Identification Test (AUDITC) in screening for alcohol use disorders and risk drinking in the U.S. general population. Alcohol Clin Exp Res

2005;29:844-54.

39. Fiellin DA, Saitz R. Alcohol problems: screening and management in the primary care setting. Primary Care Case Review

1999;2:133-44.
124
Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/ 

Good Evidence)

Other Recommended

Guidance

American Diabetes

Association (ADA)

Evidence Rating: E

American Diabetes

Association (ADA)

• Heart disease is the leading cause of death in the United States.1

• Each year, over 1 million Americans experience new or recurrent myocardial

infarction (heart attack) or fatal coronary heart disease (CHD). Most events

occur in older people and those with recognized risk factors for cardiovascular

disease, including high blood cholesterol levels, hypertension, diabetes, or a

history of smoking.2

• Coronary heart disease (CHD), which is the most common type of heart

disease in the United States, is a leading cause of death and disability in the

working population.

• Heart disease and stroke are expected to cost more than $403 billion in 2006.3

• Aspirin therapy may decrease the risk of CHD in adults who are at increased

risk for heart disease, although aspirin is contraindicated for some individuals.2

• Adults who are at increased risk for heart disease may wish to consider aspirin

therapy, but only after consultation with their medical providers.2

• Aspirin, when used as a preventive medication by men at average risk for

cardiovascular events (men whose 10-year risk of CHD is 7.5% or higher), is

both cost-saving and life-saving. A recent study found that average risk men

who took therapeutic aspirin gained 15 quality-adjusted days of life at a cost

that was $215 less than no therapy at all.4

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) strongly recommends that

clinicians discuss aspirin chemoprevention with adults who are at increased risk

for coronary heart disease (CHD). Discussions with patients should address both

the potential benefits and harms of aspirin therapy.2

The USPSTF found good evidence that aspirin decreases the incidence of

coronary heart disease in adults who are at increased risk for heart disease. They

also found good evidence that aspirin increases the incidence of gastrointestinal

bleeding and fair evidence that aspirin increases the incidence of hemorrhagic

strokes. The USPSTF concluded that the balance of benefits and harms is most

favorable in patients at high risk of CHD (5-year risk of greater than or equal to

3%) but is also influenced by patient preferences.2

The American Diabetes Association (ADA) recommends that physicians consider

aspirin therapy in diabetic patients between that ages of 30 and 40 years,

particularly when there is the presence of other cardiovascular risk factors.5

The ADA has designated an “E” rating as a standard of care based on expert

opinion.

The ADA recommends that use of aspirin therapy (75-162mg/day) as a primary

prevention strategy in those with either type 2 diabetes (A rating) or type 1

diabetes (B rating) who are over 40 years of age or have additional risk factors

(family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria.).5

EVIDENCE-STATEMENT:

ASPIRIN THERAPY FOR THE PRIMARY PREVENTION OF

CARDIOVASCULAR DISEASE (Counseling)

125
126

EVIDENCE-STATEMENT: Aspirin Therapy for the Primary Prevention of 

Cardiovascular Disease (Counseling)

Evidence Rating: A/B

The American Heart

Association (AHA)

Evidence Rating: 

Information Sources

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

An “A” rating is based upon clear evidence from randomized control trials.

A “B” rating is based upon supportive evidence from well-controlled cohort studies.

The American Heart Association (AHA) recommends aspirin use, if not

contraindicated, for patients who have had a myocardial infarction (heart attack),

unstable angina, ischemic stroke (caused by blood clot), or transient ischemic

attacks (TIAs or “little strokes”). This recommendation is based on sound

evidence from clinical trials showing that aspirin helps prevent the recurrence of

such events. Studies show aspirin also helps prevent these events from occurring

in people at high risk.6

The AHA also concluded that aspirin may be warranted for patients at high risk

for myocardial infarction but that health care providers must consider a patient’s

particular cardiovascular risk profile, the demonstrated benefits of aspirin on

reducing risk for a first myocardial infarction, and known as well as unknown

side effects of aspirin.7

Evidence from clinical trials.

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Diabetes Association (ADA)

• American Heart Association (AHA)

• Peer reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Heart disease and stroke are the most common types of cardiovascular disease

and are the first and third leading causes of death for both men and women in

the United States.8 In 2002, the age-adjusted death rate was 241 per 100,000

people, equating to almost 700,000 deaths per year.9

Each year, over 1 million Americans experience new or recurrent myocardial

infarction (heart attack) or fatal coronary heart disease. Most events occur in

older people and those with recognized risk factors for cardiovascular disease. In

2003, approximately 37% of adults reported having at least 2 of 6 risk factors for

heart disease and stroke (high blood pressure, high cholesterol, diabetes, current

smoking, physical inactivity, and obesity).10

Decisions about aspirin therapy should take into account the overall risk for

coronary heart disease. Risk assessment should include asking about the presence

and severity of the following risk factors: age, sex, diabetes, elevated blood
127

EVIDENCE-STATEMENT: Aspirin Therapy for the Primary Prevention of 

Cardiovascular Disease (Counseling)

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

pressure, family history (in younger adults), smoking,2 elevated total cholesterol

levels, low levels of high density lipoprotein (HDL-C) cholesterol, and high levels

of low density lipoprotein (LDL-C) cholesterol.3

Value of Prevention

In 2006, cardiovascular disease is expected to cost more than $403 billion,

including expenses related to healthcare services, medications, and lost

productivity.3 The total (direct and indirect) cost of coronary heart disease was

estimated at $142 billion in 2006.3

The workplace burden of heart diseases and stroke in 2006 included $35.6

billion in lost productivity due to morbidity and an additional $109.9 billion

dollars in lost future earnings due to premature mortality.3 Already a leading

cause of death and disability in the United States working population, the

workplace burden of cardiovascular diseases is expected to grow as a result of the

aging workforce.3

The economic benefit of counseling primarily results from the improved quality

of life and the averted cost of illness with successful aspirin therapy. Most trials

demonstrate a 15% to 40% reduction in cardiovascular events with chronic

aspirin use.11

The annual cost of an aspirin regimen is $18 and ranges from $3 to $55 per year

in 2004 dollars.12

In 2004, the private-sector cost of prevention counseling averaged $39 per

session; approximately 95% of paid claims fell within the range of $0 to $129

per session.13

In 2004, the cost of treatment for all conditions with myocardial infarction as the

principal diagnosis was $45,076 per discharge.14 

Aspirin, when used as a preventive medication by men at average risk for

cardiovascular events (men whose 10-year risk of CHD is 7.5% or higher), is

both cost-saving and life-saving. A recent study found that average risk men who

took therapeutic aspirin gained 15 quality-adjusted days of life at a cost that was

$215 less than no therapy at all.4

According to one study, increasing the use of aspirin therapy (so that all eligible

patients with coronary heart disease over 35 years of age take aspirin for 25 years)

would have an estimated cost-effectiveness ratio of about $11,000 per qualityadjusted year of life gained.15 In comparison to other preventive interventions and

to commonly accepted cost-effectiveness benchmarks, the increased prescription

of aspirin for secondary prevention of CHD is cost-effective.
128

EVIDENCE-STATEMENT: Aspirin Therapy for the Primary Prevention of 

Cardiovascular Disease (Counseling)

Preventive

Intervention: 

Purpose of

Counseling

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Counseling

Intervention Process

Treatment

Information

Preventive Intervention Information

There is good evidence that aspirin decreases the incidence of coronary

heart disease in adults who are at increased risk for heart disease.

Therefore, clinician discussion of the benefits and harms with their

patients who are at increased risk for heart disease is indicated.2

Aspirin can prevent myocardial infarctions but adds to the risk of

gastrointestinal bleeding and increases the risk of hemorrhagic stroke,

especially among older people and people with hypertension. The net

benefit of aspirin increases with growing cardiovascular risk.16 Although

older patients may derive greater benefits because they are at higher risk

for CHD and stroke, their risk of bleeding may also be higher.

Uncontrolled hypertension may attenuate the benefits of aspirin in

reducing CHD,2 and, uncontrolled hypertension and concomitant use of

non-steroidal anti-inflammatory agents or anticoagulants increase risk for

serious bleeding.16

Here is an illustration of the relationship between the benefits and risks

of the preventive intervention: For 1,000 patients with a 5% risk of

CHD event(s) over 5 years, aspirin would prevent 14 myocardial

infarctions (range 6 to 20), but would cause one hemorrhagic stroke

(range 0 to 2), and 3 major gastrointestinal bleeds (range 2 to 4). In

contrast, for patients with CHD risk of only 1% over 5 years, aspirin

would prevent 3 myocardial infarctions (range 1 to 4), but would cause 1

hemorrhagic stroke (range 0 to 2) and 3 major gastrointestinal bleeding

events (range 2 to 4).7

According to the USPSTF, physicians should inform adults who are at

increased risk for CHD of the benefits and risks of aspirin therapy.2 The

AHA’s recommendation is primarily based on physician discretion. 

Although the optimal timing and frequency of discussions related to

aspirin therapy are unknown, reasonable options include every 5 years in

middle-aged and older people or whenever cardiovascular risk factors are

detected.16

Counseling and discussion methods are left to the discretion of the

clinician. Discussions about aspirin therapy should focus on potential

CHD benefits, such as prevention of myocardial infarction, and potential

harms, such as gastrointestinal and intracranial bleeding. Discussions

should take into account individual attitudes and risk preferences about

myocardial infarction, stroke, and gastrointestinal bleeding.2

When it is determined that the benefits of intervention outweigh the

risks of intervention, physicians should encourage patients to take aspirin

for the prevention of cardiovascular disease events. The optimum dose of

aspirin for prevention is not known. Primary and secondary prevention

trials have demonstrated benefits with a variety of regimens, including 75
EVIDENCE-STATEMENT: Aspirin Therapy for the Primary Prevention of 

Cardiovascular Disease (Counseling)

129

mg per day, 100 mg per day and 325 mg every other day. Doses of approximately

75 mg per day appear as effective as higher doses17 whether doses below 75 mg

per day are effective has not been established. Enteric-coated or buffered

preparations do not clearly reduce adverse gastrointestinal effects of aspirin.16

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The USPSTF strongly recommends that clinicians discuss aspirin

chemoprevention with adults who are at increased risk for coronary heart disease

(CHD).2

Recommended Guidance:

American Diabetes Association (ADA)

Strength of Evidence: A, B, E 

E (Based on Expert Opinion)

• The ADA recommends that physicians consider aspirin therapy in patients

between that ages of 30 to 40 years, particularly when there is the presence of

other cardio-vascular risk factors.5

A (Based upon clear evidence from randomized control trials)

B (Based upon supportive evidence from well-controlled cohort studies)

• The ADA recommends the use of aspirin therapy (75-162 mg/day) as a

primary prevention strategy in those with either type 2 diabetes (A rating) or

type 1 diabetes (B rating) who are over 40 years of age or have additional risk

factors (family history of CVD, hypertension, smoking, dyslipidemia, or

albuminuria).5

American Heart Association (AHA)

Strength of Evidence: Evidence from clinical trials

• The AHA recommends aspirin use for patients who have had a myocardial

infarction (heart attack), unstable angina, ischemic stroke (caused by blood

clot) or transient ischemic attacks (TIAs or “little strokes”), if not

contraindicated. This recommendation is based on sound evidence from

clinical trials showing that aspirin helps prevent the recurrence of such events.

Studies show aspirin also helps prevent these events from occurring in people

at high risk.6
130

EVIDENCE-STATEMENT: Aspirin Therapy for the Primary Prevention of 

Cardiovascular Disease (Counseling)

Authored by: 

Lanza A, Campbell KP, Sotnikov S. Aspirin therapy for the prevention of cardiovascular disease 

evidence-statement: counseling. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N,

Finch RA, editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage.

Washington, DC: National Business Group on Health; 2006.

References:

1. Hoyert DL, Kochanek KD, Murphy SL. Deaths: Final Data from 1997. National Vital Statistics Report. Hyattsville, MD:

National Center for Health Statistics; 1999. 

2. U.S. Preventive Services Task Force. Aspirin for the primary prevention of cardiovascular events. recommendations and

rationale. Rockville, MD: Agency for Healthcare Research and Quality; 2002 [cited 2006 May 12]. Available from:

http://www.ahrq.gov/clinic/3rduspstf/aspirin/asprr.htm. 

3. American Heart Association. Heart Disease and Stroke Statistics—2006 Update: A Report from the American Heart

Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2006 Feb 14; 113: e85-151e.

4. Pignone M, Earnshaw S, Tice JA, Pletcher MJ. Aspirin, statins, or both drugs for the primary prevention of coronary heart

disease events in men: a cost-utility analysis. Ann Intern Med 2006 Mar 7;144(5):326-36.

5. American Diabetes Association. Standards of Medical Care in Diabetes-2006. Diabetes Care 2006;29(suppl_1):S4-42. [cited

2006 Aug 22] Available from: http://care.diabetesjournals.org/cgi/content/full/29/suppl_1s4#sec14.

6. The American Heart Association. Aspirin in heart attack and stroke prevention. [cited 2006 Aug 16]. Available from:

http://www.americanheart.org/presenter.jhtml?identifier=4456. 

7. Hennekens CH, Dyken ML, Fuster V. Aspirin as a therapeutic agent in cardiovascular disease: a statement for healthcare

professionals from the American Heart Association. Circulation 1997; 96:2751-3.

8. National Center for Health Statistics. Health, United States 2005 [cited 2006 Sep 6]. Available from:

http://www.cdc.gov/nchs/products/pub/pubd/hus/state.htm.

9. Anderson RN, Smith BL. Deaths: leading causes for 2002. Centers for Disease Control and Prevention. National Vital

Statistics Reports 2005;53(17).

10. Hayes DK, Greenlund KJ, Denny CH, Keenan NL, Croft JB. Disparities in multiple risk factors for heart disease and stroke,

2003. MMWR 2005;54: 113-116.

11. Stafford RS, Monti V, Ma J. Underutilization of aspirin persists in U.S. ambulatory care for secondary and primary

prevention of cardiovascular disease. PLoS Med 2005; 2(12):e353.

12. CDC communication. 2006.

13. Thomson Medstat. Marketscan. 2004.

14. HealthCare Cost and Utilization Project, the National Inpatient Sample. Rockville, MD: Agency for Healthcare Research and

Quality. [Cited 2006 Aug 31]. Available from: http://www.ahrq.gov?HCUPnet.asp.

15. JM Gaspoz, PG Coxson, PA Goldman, LW Williams, KM Kuntz, MGM Hunink, L Goldman Cost Effectiveness of Aspirin,

Clopidogrel, or Both for Secondary Prevention of Coronary Heart Disease N Engl J Med 2003;348(6):560.

16. U.S. Preventive Services Task Force. The Pocket Guide to Clinical Preventive Services 2005, Recommendations of the U.S.

Preventive Services Task Force. AHRQ Publication No. 05-0570. Rockville, MD: Agency for Healthcare Research and Quality,

Rockville, MD; 2005. Available from: http://www.ahrq.gov/clinic/pocketgd.htm.

17. Prevention of coronary heart disease in clinical practice. Recommendations of the Second Joint Task Force of European and

other Societies in coronary prevention. Eur Heart J 1998;19(10): 1434-1503.
131

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/

At Least Fair

Evidence)

• Breast cancer is the most commonly diagnosed non-skin cancer and the second

leading cause of cancer death among women in the United States.1

• In 2005, 211,000 women are expected to be diagnosed with breast cancer and

40,000 women are expected to die as a result of breast cancer.1

• Women aged 40 to 64 years accounted for 61% of in situ cases, 54% of

invasive breast cancer cases, and 40% of breast cancer deaths in 2005.1 The

direct medical care costs for breast cancer treatment were estimated to exceed

$6 billion in 1996.2

• Breast cancer accounts for up to one-quarter of all cancer-related costs.3

• The risk of breast cancer increases with age.4 Population aging in the next three

decades is expected to increase the number of breast cancer cases and the

economic burden of the disease.

• Mammography screening is a valuable early detection tool because it can

identify breast cancer at an early stage, usually before physical symptoms or

complications develop, when treatment is more effective and less expensive.

• Women with certain specific family history patterns have an increased risk for

developing breast or ovarian cancer associated with mutations in genes known

as BRCA1 and BRCA2. Although these mutations are uncommon, public

interest in testing is growing.5 Further, for women who are positive for a

BRCA1 or BRCA2 genetic mutation, prophylactic surgery at a young age

significantly improves survival and is cost-effective in comparison to other

interventions.6

• For the minority of women with a clear, high risk for breast cancer, preventive

medication can reduce the risk of certain types of breast cancer although such

treatment can also produce serious side effects.7 For women at low or average

risk for breast cancer, the potential harms of preventive medication may

outweigh the potential benefits.

Breast Cancer (Screening)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends screening

mammography, with or without clinical breast examination (CBE), every 1 to 2

years for women aged 40 and older.8

The USPSTF found fair evidence that screening for breast cancer every 12 to 33

months significantly reduces mortality from breast cancer and that the benefits of

screening outweigh the associated risks, for women aged 40 and older.8

EVIDENCE-STATEMENT:

BREAST CANCER (Screening, Counseling, Testing,

Preventive Medication, and Treatment)
132

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/

At Least Fair

Evidence)

Guidance

Other Recommended

Guidance

American College of

Medical Genetics

(ACMG)

Evidence Rating:

American Society of

Clinical Oncology

(ASCO)

Evidence Rating:

National

Comprehensive

Cancer Network

Breast Cancer: Genetic Risk Assessment and

BRCA MutationTesting (Counseling, Testing, and

Preventive Treatment)

The U.S. Preventive Services Task Force (USPSTF) recommends that women

whose family history is associated with an increased risk of deleterious mutations

in BRCA1 or BRCA2 genes be referred for genetic counseling and evaluation for

BRCA testing.9

The USPSTF found fair evidence that women with certain specific family history

patterns (increased-risk family history) have an increased risk for developing

breast or ovarian cancer associated with BRCA1 or BRCA2 mutations. The

USPSTF determined that these women would benefit from genetic counseling

that allows informed decision making about testing and further prophylactic

treatment. This counseling should be done by suitably trained healthcare

providers. There is fair evidence that prophylactic surgery significantly decreases

breast and ovarian cancer incidence in women who test positive for deleterious

BRCA1 or BRCA2 mutations, although there is insufficient evidence to

determine other health-outcome benefits from intensive screening or preventive

medication in such women.9

Note: The U.S. Preventive Services Task Force (USPSTF) recommends against

routine referral for genetic counseling or routine breast cancer susceptibility gene

(BRCA) testing for women whose family history is not associated with an

increased risk for deleterious mutations in breast cancer susceptibility. The

USPSTF concluded that the potential harms of routine referral for genetic

counseling or BRCA testing in these women outweigh the benefits.9

The American College of Medical Genetics (ACMG) recommends risk

assessment and genetic counseling before testing for BRCA1/BRCA2 mutations

in individuals at increased risk, based on a personal or family history of breast

cancer, ovarian cancer or both.10 In a previous guideline published in 1996, the

ACMG recommended testing for BRCA1 mutations in high-risk families and

population screening of Ashkenazi Jews after discussion of test limitations and

appropriate informed consent.11

Expert Opinion

The American Society of Clinical Oncology (ASCO) recommends that genetic

testing be offered when an individual has a personal or family history that

suggests a genetic cancer susceptibility, the test can be adequately interpreted, and

its results will influence diagnosis or management of the patient or family

members at risk for hereditary cancer.12

Not Specified

The National Comprehensive Cancer Network recommends offering genetic

susceptibility testing (after risk assessment and counseling) to individuals who

meet the criteria for hereditary breast or ovarian cancer or both.13
133

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

Evidence Rating: 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/ At

Least Fair Evidence)

Other Recommended

Guidance

American Society of

Clinical Oncology

(ASCO)

Evidence Rating:

Information Sources

Not Specified

Breast Cancer: (Counseling and Preventive

Medication)

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians

discuss preventive medication with women at high risk for breast cancer and at

low risk for adverse effects of preventive medication use. Clinicians should

inform patients of the potential benefits and harms of preventive medication.14

The USPSTF found fair evidence that treatment with tamoxifen can significantly

reduce the risk of invasive estrogen-receptor-positive breast cancer in women at

high risk for breast cancer and that the likelihood of benefit increases as the risk

for breast cancer increases. Although raloxifene is not now FDA-approved for this

use, the USPSTF found consistent, but less abundant, evidence for its benefit as

well. The USPSTF found good evidence that estrogen antagonists (e.g.,

tamoxifen) increase the risk for thromboembolic events (for example, stroke,

pulmonary embolism, and deep vein thrombosis) and symptomatic side effects

(for example, hot flashes) and that tamoxifen increases the risk of endometrial

cancer.14

The USPSTF concluded that the balance of benefits and harms may be favorable

for some high-risk women but will depend on breast cancer risk, risk from

potential harms and individual patient preferences.14

Note: The U.S. Preventive Services Task Force (USPSTF) recommends against

routine use of tamoxifen or raloxifene for the primary prevention of breast cancer

in women at low or average risk for breast cancer.14

The American Society of Clinical Oncology (ASCO) suggests that women with

sufficient risk, based on the Gail Index, be offered tamoxifen to reduce their risk

of breast cancer.15 The Gail Index is a breast cancer risk tool developed by the

National Cancer Institute, and is available online (http://cancer.gov/bcrisktool/)

or by telephone (800-4-CANCER).

Expert Opinion

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Cancer Society (ACS)

• American College of Medical Genetics (ACMG)

• American Society of Clinical Oncology (ASCO)

• Centers for Disease Control and Prevention (CDC)

• International Agency for Research on Cancer (IARC)

• National Cancer Institute (NCI)

• National Committee for Quality Assurance (NCQA)

• National Comprehensive Cancer Network
134

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

• National Heart, Lung, and Blood Institute (NHLBI)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Breast cancer is the most commonly diagnosed non-skin cancer and the

second leading cause of cancer death among women in the United States.1 In

2005, 211,000 women are expected to be diagnosed with breast cancer and

40,000 women are expected to die as a result of breast cancer.1

Risk factors for breast cancer (reported by the USPSTF) include16:

• A family history of breast cancer (especially a mother or sister with breast

cancer)

• Atypical hyperplasia

• Having a first child after the age of 30

• Increasing age 

Risk factors reported by other organizations include17-19: 

• Early age at menarche

• Late age at menopause

• Overweight/obesity

• Physical inactivity

• Hormone replacement therapy

• Exposure to radiation

Another risk factor for breast cancer is the presence of genetic markers for the

BRCA1 or BRCA2 genes.19 However, only a small proportion of breast cancer

cases are attributable to genetic susceptibility. Approximately 2% of adult

women in the United States have a family history indicating they are at

increased risk of a deleterious mutation in the BRCA1 or BRCA2 gene, and

about1 in 10 women with these histories (2 to 3 per 1,000 adult US women)

actually have a mutation.5 Among women with a deleterious BRCA1 or

BRCA2 mutation, 35% to 84% may develop breast cancer by age 70.5
Value of Prevention

The direct medical care costs for breast cancer treatment were estimated to exceed

$6 billion in 1996.2 The total economic burden of breast cancer would be much

higher if breast cancer related mortality and morbidity costs were included in this

figure. In 2004, for example, the overall cost of cancer (including direct and

indirect cots) was estimated to be almost $190 billion20, and breast cancer could

account for up to one-quarter of this total.3 A small proportion of the economic

burden of breast cancer is attributable to genetically-related breast cancers.

The risk of breast cancer increases with age.4 Population aging in the coming

decades is expected to increase the number of breast cancer cases and the

economic burden of the disease. 

Women aged 40 to 64 years accounted for 61% of in situ cases, 54% of invasive

breast cancer cases, and 40% of breast cancer deaths in 2005.1 The breast cancer

medical care costs, productivity losses, and mortality costs among working

women in this group is substantial. 

Screening may reduce breast cancer treatment costs by identifying tumors in their

earliest stages when treatment is more successful and less expensive. For example,

a study that examined the cancer-care costs among members of a health

maintenance organization (HMO) found that the net cost of initial care for

breast cancer was $7,093 when the cancer was identified at the carcinoma in situ

stage and to $10,900 when it was identified at the regional stage (both figures in

year 1992 dollars).21

The recognition of BRCA mutations through testing allows for early intervention

and treatment. This is important because women who receive early treatment

generally have better outcomes. For example, in one research model, a 30-yearold BRCA1 and 2 positive woman could prolong her life by about 1 year by

having bilateral oophorectomy, 3.4 years by having bilateral mastectomy, and 4.3

years by having both procedures instead of surveillance alone.7

The use of preventive medication in carefully-selected, high-risk women can

reduce their risk of breast cancer or delay the onset of breast and ovarian cancers.

It is estimated that for every 100 women treated with tamoxifen for 5 years,

1.665 expected cancers are delayed or prevented. If breast cancer death is fully

prevented by this strategy, then the use of preventive medication (compared to no

intervention) would cost $8,479 per year of life gained.22

In 2004, the private-sector cost of a screening mammography averaged $51

(range $0 to $122).23 A diagnosis of breast cancer is more costly ($451 to $2,520

in year 2002 dollars) as it requires additional tests, interpretations, and office

visits.4

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit of

Preventive

Intervention

Screening

Counseling, Testing,

and Preventive

Treatment

Preventive

Medication

Estimated Cost of

Preventive

Intervention

Screening

135
136

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

Counseling, Testing,

and Preventive

Treatment

Preventive

Medication

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of 

Preventive

Intervention

Screening 

Counseling, Testing,

and Preventive

Treatment

Preventive

Medication

Preventive

Intervention: 

Purpose of Screening

In 2004, the private-sector cost of BRCA mutation testing averaged $53 per test;

approximately 95% of all paid claims fell within the range of $12 to $201 per

test.23 The cost of genetic counseling averaged $39 per session; approximately 95%

of all paid claims fell within the range of $0 to $129 per session.23 The cost of a

preventive mastectomy or oophorectomy varies by location and facility type. 

The average wholesale price (AWP) of a 1-month supply of tamoxifen citrate is

between $58.38 (generic) and $128.62 (brand — Nolvadex®).24

The cost of breast cancer treatment depends on the stage of disease at diagnosis

and the procedures or treatments selected. Treatment costs have been reported to

range from $21,287 to $45,220 per patient. However, terminal care costs for

Medicare patients were reported to be as high as $63,455 (all figures in year 2002

dollars).4

The cost-effectiveness of breast cancer screening depends on the age of the

population screened. Many cost-effectiveness analyses have shown that screening

for breast cancer in women 65 years of age and younger reduces mortality at a

reasonable cost.1 A systematic review of cost-effectiveness analyses performed for

the USPSTF noted that biennial screening after the age of 65 also reduces

mortality at a reasonable cost. However, screening becomes more costly in

women with significant comorbidities, such as dementia, or comorbidities that

limit life expectancy. For example, the incremental costs per life-year saved for

screening beyond age 65 were found to range from $34,000 to $88,000 in year

2002 dollars4, which compare favorably with most other preventive interventions

and to commonly accepted cost-effectiveness benchmarks.1

One study, using modeling techniques, concluded that BRCA1 and BRCA2

testing is cost-effective only if women who screen positive proceed with

prophylactic surgery.25 The model further suggested that, per life-year saved,

combined surgery cost $20,717, mastectomy cost $29,970, and oophorectomy

cost $72,780 (all figures in year 1995 dollars).25 Another study, which also used

modeling techniques, concluded that for women who are positive for a BRCA1

or BRCA2 genetic mutation, prophylactic surgery at a young age significantly

improves survival and is cost-effective in comparison to other interventions.8

Tamoxifen is cost-effective for women aged 40 to 50 years who are at significant

risk for breast cancer.26 Tamoxifen costs $46,619 per life-year saved for women

who begin taking the medication at age 35. For women over the age of 50, the

intervention costs more than $50,000 per life-year saved.27

Preventive Intervention Information

Mammography screening is a valuable early detection tool because it can identify

breast cancer at an early stage, usually before physical symptoms or complications

develop, and when treatment is more effective and less expensive.
The purpose of family history assessment, counseling, and BRCA mutationtesting is to identify women with certain specific family history patterns that are

associated with an increased risk for deleterious mutations in the BRCA1 or

BRCA2 gene and an increased risk of breast or ovarian cancer. With the

assistance of genetic counseling, women at risk can make an informed decision

on testing and treatment options. 

The purpose of preventive medication counseling is to educate women at high

risk of breast cancer on the benefits and risks associated with tamoxifen. 

Screening allows for the early detection of breast cancer. Screening is estimated to

reduce breast cancer mortality by 20% to 25% during the 10-year period

following screening.8 The risk of breast cancer increases with age. Therefore, the

absolute benefit of screening also increases as a woman ages, at least from age 40

through age 70.16 Because the risk of breast cancer is higher after age 70,

mammography may offer important benefits to older women. However, these

benefits may be offset by the fact that many older women, especially the very old

and those with other illnesses, will die from other causes before they experience

the benefits of early cancer detection.16 Risks associated with screening include

false-positive test results, which may cause undue anxiety, and the inconvenience,

occasional complications, and costs associated with biopsies. False-positive test

results are common among all types of cancer screening, including

mammography; 80% to 90% of abnormal mammogram or clinical breast exam

results are false-positive.16

The USPSTF determined that women with certain specific family history

patterns benefit from genetic counseling that allows informed decision making

about testing and preventive treatment (e.g., removal of the breasts and/or

ovaries).9 The USPSTF found fair evidence that prophylactic surgery significantly

decreases the incidence of breast and ovarian cancer among women with a BRCA

mutation. Thus, the potential benefits of referral and discussion of testing and

prophylactic treatment for these women may be substantial. The inherent risk

associated with preventive treatment and surgery, such as patient anxiety and

medical errors, may be substantial for some individuals.

The USPSTF concluded that for women whose family history is not associated

with an increased risk of deleterious mutations, the harms of routine referral for

counseling and testing outweigh the benefits.9

Among women at high risk for breast cancer, an estrogen antagonist (i.e.,

tamoxifen) has been found to reduce the incidence of invasive breast cancer by

approximately one-half.14, 28 Estrogen antagonists increased survival by 1.6 years

(range 1.0 to 2.1 years) and 2.2 years (range 1.3 to 2.8 years), respectively.

Research shows that preventive medication yields more quality-adjusted life years

than does prophylactic surgery, even when treatment is delayed to age 40 or 50

years.9

137

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

Purpose of

Counseling, Testing,

and Preventive

Treatment

Purpose of

Counseling and

Preventive

Medication

Benefits and Risks 

of Intervention

Screening

Counseling, Testing,

and Preventive

Treatment

Counseling and

Preventive

Medication
Estrogen antagonists are associated with an increased risk of venous

thromboembolic disease (deep vein thrombosis and pulmonary embolism);

tamoxifen is also associated with an increased risk of endometrial cancer.14, 28

The balance between benefits and harms varies among subgroups of women,

depending on age, predicted risk of breast cancer, and hysterectomy status. In

general, the balance of benefits and harms of preventive medication is more

favorable for women in their 40s who are at increased risk for breast cancer and

have no predisposition to thromboembolic events or women in their 50s who are

at increased risk for breast cancer, have no predisposition to thromboembolic

events, and do not have a uterus. Women are at lower risk for adverse effects

from preventive medication if they are younger; have no predisposition to

thromboembolic events such as stroke, pulmonary embolism, or deep venous

thrombosis; or do not have a uterus.

The USPSTF concluded that routine use of estrogen antagonists for the primary

prevention of breast cancer in women at low or average risk for breast cancer

would cause more harm than benefit.14

According to the USPSTF women aged 40 and above should be screened for

breast cancer with mammography, with or without CBE (clinical breast

examination), every 1 to 2 years.16 The USPSTF notes that the precise age is not

known when the benefits of breast cancer screening first outweigh the associated

risks and costs; thus, the specific ages at which screening should begin and cease

should consider patient preferences.16

Patients identified as high-risk through a clinician risk assessment should be

referred for genetic counseling and, if appropriate, follow-up genetic mutation

testing. The initiation, cessation, and frequency of counseling is left to the

discretion of the clinician. A onetime BRCA test should be administered to atrisk patients who request testing. Preventive treatment including mastectomy

and/or ophorectomy should be conducted, as medically necessary, at the

discretion of the clinician. 

Note: The USPSTF realizes that clinical decisions about patients involve more

complex considerations that the evidence alone; clinicians should always

understand the evidence but individualize decision making to the specific patient

and situation.

The initiation and cessation of preventive medication therapy with an estrogen

antagonist is left to the discretion of the clinician (in discussion with the patient).

In general, preventive medication is more favorable for women in their 40s who

are at increased risk for breast cancer and have no predisposition to

thromboembolic events or women in their 50s who are at increased risk for

breast cancer, have no predisposition to thromboembolic events, and do not have

a uterus.14 Women younger than 40 years of age have a lower risk for breast

cancer, and thus will not experience as large an absolute benefit from beast cancer

preventive medication as older women.14 Women 60 years of age and older, who

have the highest risk for breast cancer also have the highest risk for complications

138

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

Initiation, Cessation,

and Interval

Screening

Counseling, Testing,

and Preventive

Treatment

Counseling and

Preventive

Medication
139

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

Intervention Process

Screening

Counseling, Testing,

and Preventive

Treatment 

Preventive

Medication

Treatment

Information

from preventive medication/chemoprevention with a less favorable balance of

benefits and harms.14

The standard course of preventive medication with tamoxifen in clinical trials is

5 years.29

Approved screening methods for breast cancer include mammography and, as an

adjunct, a clinical breast exam. CBE is a low-cost screening method that provides

an opportunity for health professionals to discuss breast health with women.30

Although CBE is not explicitly recommended by the USPSTF, many experts

encourage routine CBE.30 However, clinicians who perform routine CBE should

understand that there is currently insufficient evidence to determine whether CBE

affects breast cancer mortality and that they are likely to increase the incidence of

clinical assessments and biopsies.16 Coverage should also include diagnostic followup. Coverage should also include diagnostic follow-up (e.g., biopsies).

The clinician should assess the patient's family history of breast cancer to

determine the likelihood that the patient has a deleterious BRCA mutation.9 If

the assessment is positive, the woman should be referred for genetic counseling to

help determine if she wishes to have genetic testing. Women may require further

counseling after test results are received. A positive test for a deleterious mutation

may result in a decision to have the surgical removal of her breasts and/or ovaries.

Coverage should include clinician time to evaluate family history for possible

referral to a genetic counselor, counseling on the harms and benefits of genetic

testing by a qualified practitioner, and preventive treatment (e.g., complete

mastectomy with or without reconstructive surgery, ophorectomy).

Clinicians should assess a patient’s risk for breast cancer and the risk for adverse

preventive medication effects when identifying women who may be candidates

for preventive medication therapy. Clinicians can assess a patient’s risk of

developing breast cancer within the next 5 years using risk-factor information

from the National Cancer Institute Breast Cancer Risk Tool (the “Gail Index”).

Clinicians should discuss the results of the risk assessment, inform the patient of

the risks associated with breast cancer, and counsel about the benefits and risks

associated with the use of preventive treatment. Clinicians should counsel on the

harms and benefits of preventive medication use and prescribe an FDA-approved

preventive medication to eligible women who choose to use preventive

medication. Coverage should include clinician time to monitor the potential

harms/adverse effects associated with preventive medication use and the cost of

the preventive medication approved for use by the FDA.

Health benefits should include provisions for diagnostic and treatment services. 
140

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

Strength of Evidence for the Clinical Preventive Service

Breast Cancer (Screening)

The level of evidence supporting the recommendations contained in this section

is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence) 

• The USPSTF found fair evidence to recommend screening mammography,

with or without clinical breast examination (CBE), every 1 to 2 years for

women aged 40 and older.8

Strength of Evidence for the Clinical Preventive Service 

Breast Cancer Genetic Risk Assessment and BRCA Mutation

Testing (Counseling, Testing and Preventive Treatment)

The level of evidence supporting the recommendations contained in this section

is described below.

Evidence-Based Research:

The U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

• The USPSTF found fair evidence that women with certain specific family

history patterns (increased risk family history) have an increased risk for

developing breast or ovarian cancer associated with BRCA1 or BRCA2

mutations.9

Note: The USPSTF recommended against routine referral for genetic counseling

or gene testing for women whose family history is not associated with an

increased risk of deleterious mutations as the USPSTF concluded that the

potential harms of routine referral for genetic counseling or BRCA testing in

these women outweigh the benefits.9

Recommended Guidance: 

The American College of Medical Genetics (ACMG) 

Strength of Evidence: Expert Opinion

• The ACMG recommends risk assessment and genetic counseling before testing

for BRCA1/BRCA2 mutations in individuals at increased risk, based on a

personal or family history of breast cancer, ovarian cancer or both.10 In a

previous guideline published in 1996, the ACMG recommended testing for

BRCA1 mutations in high risk families and population screening of Ashkenazi

Jewish individuals after discussion of test limitations and appropriate informed

consent.11

The American Society of Clinical Oncology (ASCO)

Strength of Evidence: Not Specified

• The American Society of Clinical Oncology recommends that genetic testing

be offered when: an individual has a personal or family history that suggests a

genetic cancer susceptibility and the test can be adequately interpreted and its
141

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

results will influence diagnosis or management of the patient or family

members at risk for hereditary cancer.12

The National Comprehensive Cancer Network 

Strength of Evidence: Not Specified

• The National Comprehensive Cancer Network recommends offering genetic

susceptibility testing (after risk assessment and counseling) to individuals who

meet the criteria for hereditary breast or ovarian cancer or both.13

Strength of Evidence for the Clinical Preventive Service

Breast Cancer (Counseling and Preventive Medication)

The level of evidence supporting the recommendations contained in this section

is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

B (Recommended/At Least Fair Evidence);

• The USPSTF recommends that clinicians discuss preventive medication with

women at high risk for breast cancer and at low risk for adverse effects of

chemoprevention. Clinicians should inform patients of the potential benefits

and harms of chemoprevention.14

Note: The USPSTF recommends against routine use of tamoxifen for the

primary prevention of breast cancer in women at low or average risk for breast

cancer.14

Recommended Guidance: 

American Society of Clinical Oncology (ASCO)

Strength of Evidence: Expert Opinion

• The American Society of Clinical Oncology suggests that women with

sufficient risk, based on the Gail Index, be offered tamoxifen to reduce their

risk of breast cancer.16

Authored by: 

Campbell KP, Coates RJ, Lanza A, Chattopadhyay S. Breast cancer evidence-statement: screening,

counseling, testing, preventive medication, and preventive treatment. In: Campbell KP, Lanza A,

Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive

Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.
142

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

References:

1. American Cancer Society. Breast cancer facts & figures 2005-2006. Atlanta, GA: American Cancer Society, Inc. Note: data

are computed from Table 2 in this document.

2. Brown ML, Lipscomb J, Snyder C. The burden of illness of cancer: economic cost and quality of life Annu Rev Public

Health. 2001; 22:91-113

3. Radice D, Redaelli A. Breast cancer management: quality of life and cost considerations. Pharmacoeconomics 2003;

21:383–96

4. Mandelblatt J, Saha S, Teutsch S, Hoerger T, Siu AL, Atkins S, et al. The cost effectiveness of screening mammography

beyond the age 65: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med 2003;139:835–42.

5. Nelson HD, Hoyt Huffman L, Fu R, Harris EL. Genetic risk assessment and BRCA mutation testing for breast and ovarian

cancer susceptibility: systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med 2005;143:362-

79

6. Grann VR, Panageas KS, Whang W, Antman KH, Neugut AI. Decision analysis or prophylactic mastectomy and

oophorectomy in BRCA-1 positive or BRCA2-positive patients. J Clin Oncol 1998;16(3):979-85.

7. Grann VR, Jacobson JS, Whang W, Hershman D, Heitjan DF, Antman KH, Neugut AI. Prevention with tamoxifen or other

hormones versus prophylactic surgery in BRCA1/2-positive women: a decision analysis. Cancer J Sci Am 2000;6(1):13-20.

8. U.S. Preventive Services Task Force. Screening for breast cancer. AHRQ Publication No. APPIP02-0016. Rockville (MD):

Agency for Health Care Research and Quality; 2002.

9. U.S. Preventive Services Task Force. Genetic risk assessment and BRCA mutation testing for breast and ovarian cancer

susceptibility. Summary of Recommendation. Agency for Healthcare Research and Quality; September 2005 [cited 2006 Oct

18]. Available from: http://www.ahrq.gov/clinic/uspstf/uspsbrgen.htm. 

10. American College of Medical Genetics Foundation. Genetic Susceptibility to Breast and Ovarian Cancer: Assessment,

Counseling and Testing Guidelines. June 1998 [cited 2005 Mar 4]. Available from:

www.health.state.ny.us/nysdoh/cancer/obcancer/contents,htm. 

11. American College of Medical Genetics. Statement on population screening for BRCA 1 mutation in Ashkenazi Jewish

women. 1996 [cited 2005 Mar 25]. Available from: www.acmg.net/resources/policies/pol-002.asp. 

12. American Society of Clinical Oncology Policy Statement Update: Genetic testing for cancer susceptibility. J Clin Oncol 11

April 2003 [cited 2005 Mar 4]. Available from: www.asco.org/asco/downloads/GeneticTesting.pdf. 

13. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Genetic/Familial High Risk Assessment:

Breast and Ovarian Cancer. 2005 [cited 2005 Mar 4]. Available from:

www.nccn.org/professionals/physician_gls/PDF/genetics_screening.pdf. 

14. U.S. Preventive Services Task Force. Chemoprevention of breast cancer: Recommendations and rationale. July 2002. Agency

for Healthcare Research and Quality, Rockville, MD 

15. Chiebowski RT, Collyar DE. Somerfield MR, Pfister DG. American Society of Clinical Oncology technology assessment on

breast cancer reduction strategies: tamoxifen and raloxifen. J Clin Oncol 1999;17:1939-54

16. Berg AO, Atkins D. Screening for breast cancer: recommendation and rationale. Ann Intern Med 2002; 137(5 Part 1): 344-6. 

17. International Agency for Research on Cancer. Weight control and physical activity. IARC Handbooks of cancer prevention.

Vol. 6. Lyon: IARC Press; 2002

18. Curry SJ, Byers T, Hewitt M, editors. Fulfilling the Potential of Cancer Prevention and Carly Detection. Washington, DC:

National Academies Press; 2003.

19. National Cancer Institute. Breast cancer PDQ treatment. General information about breast cancer. [cited 2006 Feb 24].

Available from: http://www.nci.nih.gov/cancertopics/pdq/treatment/breast/patient/. 

20. American Cancer Society. Cancer facts & figures 2005. Atlanta: American Cancer Society: 2005.

21. Taplin SH, Barlow W, Urban N, et al. Stage, age, comorbidity, and direct costs of colon, prostate, and breast cancer care. J

Natl Cancer Inst 1995; 87(6):417-26. 

22. Smith TJ, Hillner BE. Tamoxifen should be cost-effective in reducing breast cancer risk in high-risk women. (Comment). J

Clin Oncol 2000; 18(2):284-6
143

EVIDENCE-STATEMENT: Breast Cancer (Screening, Counseling, Testing, 

Preventive Medication, and Treatment)

143

23. Thompson MedStat. Marketscan 2004.

24. Fleming T. 2006 Redbook: Pharmacy’s Fundamental Reference. Thomson PDR; Rev Ed edition. May 2006.

25. Grann VR, Whang W, Jacobson JS, Heitjan DF, Antman KH, Neugut AI. Benefits and cost of screening Ashkenazi Jewish

women for BRCA1 and BRCA2. J Clin Oncol 1999;17(2)494-500.

26. Cykert S, Phifer N, Hansen C. Tamoxifen for breast cancer prevention: a framework for clinical decisions. (Comment) Am J

Obstet Gynecol 2004; 104(3):431-2.

27. Grann VR, Sundararajan V, Jacobson JS, Whang W, Heitjan DF, Antman KH, Neugut AI. Decision analysis of tamoxifen for

the prevention of invasive breast cancer. Cancer Journal 2000;6(3):169-78.

28. Kinsinger LA, Harris R, Lewis C, Woddell M. Chemoprevention of breast cancer systematic evidence review No.8 (Prepared

by the RTI-UNC Evidence-based Center under Contract No. 290-97-0011).

29. Fisher B, Costantino JP, Wickerham L, Redmond CK, Kavanak M et al. Tamoxifen for prevention of breast cancer: report of

the National Surgical Adjuvant Breast and Bowl Project P-1 study. J Natl Cancer Inst 1998; 90:1371-88

30. Saslow D, Hannan J, Osuch J, Alciati MH, Baines C, Barton M, et al. Clinical breast examination: practical

recommendations for optimizing performance and reporting. CA Cancer J Clin 2004;54:327–44.
144
Why This Chapter is

Important for

Employers:

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/ 

Good Evidence)

Information Sources

Epidemiology of

Condition/Disease

• Cervical cancer was once the most common cause of cancer death among

women in the United States. Screening, earlier detection, and more effective

treatment methods reduced the death rate from cervical cancer 74% between

1955 and 1992.1

• Nevertheless, cervical cancer remains a concern. In 2005, it was estimated that

10,370 women would be diagnosed with cervical cancer and 3,710 women

would die as a result of the disease.1

• The direct medical care costs associated with cervical cancer were estimated to

equal $1.7 billion in year 1996 dollars.2

• Screening can prevent cervical cancer by allowing clinicians to identify and

remove precancerous lesions before they develop into cancer. Screening can

also identify cancer early in the course of the disease when treatment is more

effective and the chance of recovery is high.3

• The cost of screening is typically less than the cost of treating cancer and,

when screening identifies a lesion in its early stages, the cost of treatment is

often much less expensive than if the lesion was identified at a later stage.

Clinical Preventive Service Recommendations for Screening

The U.S. Preventive Services Task Force (USPSTF) strongly recommends cervical

cancer screening for all women who have been sexually active and have a cervix.3

The USPSTF found good evidence that the benefits of screening for cervical

cancer substantially outweigh the risks associated with screening.3

The recommendations and supporting information contained in this document

came from several sources, including the:

• Advisory Committee on Immunization Practices (ACIP)

• Alliance for Cervical Cancer Prevention; Program for the Appropriate use of

Technology in Health (PATH)

• American Cancer Society (ACS)

• National Cancer Institute (NCI)

• Peer-reviewed research

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Cervical cancer was once the most common cause of cancer death among women

in the United States, but the death rate from cervical cancer dropped 74%

EVIDENCE-STATEMENT:

CERVICAL CANCER (Screening)

145
146

EVIDENCE-STATEMENT: Cervical Cancer (Screening)

Condition/Disease

Risk Factors

between 1955 and 1992, due to screening, earlier detection and treatment, and

more effective treatment methods.1 Despite this progress, cervical cancer remains

a major cause of premature morbidity and mortality among women in the

United States.

In 2005, it was estimated that 10,370 women would be diagnosed with cervical

cancer and 3,710 women would die as a result of the disease.1 Cervical cancer is

most common among women in their 40s to 60s, although some women develop

cancer in their 30s.4

Cervical cancer screening has been conducted using the conventional Pap test

screening method since 1940; the Pap test has proven to be one of the most

successful methods of cancer prevention and early detection available.5 More than

50% of women who develop cervical cancer have never been screened for cervical

cancer and 60% of women who develop cervical cancer have not been screened

in the previous 5 years.5-6 The dose-response relationship between the number of

times a woman is screened during her lifetime and her likelihood of developing

cervical cancer is illustrated in the following table: 

Source: Alliance for Cervical Cancer Prevention. Cervical cancer prevention fact sheet. Seattle,

WA: Program for the Appropriate use of Technology in Health (PATH); 2003.

The major risk factor for cervical cancer is infection with the human

papillomavirus (HPV), a common sexually transmitted infection (STI). Clinical

research shows that 95% to 100% of all squamous cell cervical cancers and 75%

to 95% of all cervical intraepithelial neoplasia (CIN) lesions (a precursor to

cervical cancer) can be linked to infection with HPV.7

HPV is the most common sexually transmitted disease in the United States; over

50% of adults contract an HPV infection during their lifetime.8 In most women

infected with HPV, the virus remains asymptomatic and does not progress to

precancerous lesions (CIN or dysplasia) or cervical cancer.9-10 However,

approximately 5% to 10% of women with persistent HPV infection develop

cervical cancer during their lifetimes if they do not have a Pap test to detect

precancerous lesions and do not receive appropriate follow-up care.10

In 2006, the Food and Drug Administration (FDA) licensed a vaccine to reduce

the risk of cervical cancer. The Advisory Committee on Immunization Practices

(ACIP) has issued provisional recommendations for use of this vaccine.11 The

Frequency of Screening Reduction in Cancer Rate

At least every three years

*Screening interval recommended by the USPSTF 75%-88%

Five times per lifetime 61%-75%

Three times per lifetime 35%-55%

Twice per lifetime 29%-42%

Once per lifetime 17%-32%
147

EVIDENCE-STATEMENT: Cervical Cancer (Screening)

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention 

Estimated Cost of

Treatment

vaccine is not a substitute for recommended screening services: screening is still

the primary method of cervical cancer prevention.11 Additional information on

the HPV vaccine is provided in the Immunization Evidence-Statement.

Although cervical cancer precursor lesions only develop after HPV infection, other

factors—such as age, being a smoker, starting sexual intercourse at an early age,

having a large number of sexual partners, using oral contraceptives, and having

seven or more live births—increase a woman’s risk of cervical cancer.9 Some

research suggests that diet; a woman’s immune status and genetic predisposition;

and co-infection with chlamydia, HIV/AIDS, or other sexually transmitted

infections (STIs) may also influence risk of developing cervical cancer.9, 12

Value of Prevention

The direct medical care costs associated with cervical cancer were estimated to

equal $1.7 billion in year 1996 dollars based on SEER (Surveillance,

Epidemiology, and End Results) and Medicare-linked data.2

The cost of cervical cancer ($1.7 billion) would be significantly higher if work

loss and premature deaths were included in the analysis. For example, 25.9 years

of life are lost, on average, by each woman who dies of cervical cancer. These lost

years of life—which often occur during the prime working years—translate into

lost earnings for women and their families, worker-replacement costs for

businesses, and are a significant cost to society.13

As with most preventive services, screening for and treating cervical cancer in its

early stages is much less expensive than intervening at later stages in the disease

process. For example, the cost of treating a single case of localized (early-stage)

cervical cancer averages $20,255, while the cost of treating a single case of distant

(late-stage) disease averages $36,912 (both figures in year 2000 dollars).14 In

addition to reduced medical care costs, the years of life gained from early

detection and treatment are valuable to families, businesses, and the community

at large.13

The cost of a conventional Pap smear test will vary depending on location, type

of provider, and the patient’s age. In 2004, the private-sector cost of screening for

cervical cancer among women under age 65 averaged $31 including specimen

collection, laboratory processing, and interpretation; approximately 95% of all

paid claims fell within the range of $9 to $64.15 For Medicare eligible women,

cervical cancer screening cost an average of $28 and approximately 95% of all

paid claims fell within the range of $0 to $62.15

Costs of vaccination are in addition to the costs for recommended screening

services. 

The costs associated with an abnormal Pap test as a result of HPV infection,

including the cost of physician visits, laboratory tests, colposcopies, and

treatment of cervical neoplasia if present, were estimated to be $1,281 per patient

in year 2000 dollars.14
148

EVIDENCE-STATEMENT: Cervical Cancer (Screening)

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening

The cost of treating established cervical cancer varies. Localized (early-stage)

cervical cancer costs and average of $20,255 to treat and distant (late-stage)

disease costs an average $36,912 to treat (both figures in year 2000 dollars).14

The relative costs and benefits of screening will vary depending on the age of

patients screened and the screening interval. A recent study (that included

patient-time costs) estimated that the cost-effectiveness ratio of a conventional

Pap test repeated every three years up to the age of 75 was $11,830 per qualityadjusted life year (QALY) saved (in year 2000 dollars).7 In comparison to other

preventive interventions and to commonly accepted cost-effectiveness

benchmarks, cervical cancer screening is highly cost-effective.16

Preventive Intervention Information 

The purpose of screening for cervical cancer is twofold. First, screening reduces

the risk of cervical cancer by identifying women with precancerous conditions

that can be treated before the conditions progress to cancer. The primary

precursor lesions of cervical cancer, CIN III and carcinoma in situ, progress

slowly, often over more than 8 to 9 years. Pap test screening detects these lesions

before they develop into invasive cancers and, with appropriate and timely

treatment, a full recovery is likely. Second, screening can identify women with

cervical cancer before symptoms appear. Early detection, which allows for early

treatment, improves outcomes.3

The benefits of cervical cancer screening are substantial. Screening reduces

cervical cancer incidence and mortality. When Pap test screening programs are

introduced into populations for the first time, the risk of developing cervical

cancer is typically reduced by 60% to 90% within 3 years.12 Mathematical

models suggest that population-wide screening with the Pap test every 3 years

reduces the rate of invasive cervical cancer by 91%; screening with the Pap test

every 5 years reduces the rate by 84%.6, 12 In North America and Europe, the

introduction of screening programs was associated with reductions in cervical

cancer mortality of between 20% and 60%.12

The harms of screening for cervical cancer are small compared to the benefits.

False-positive screening results may lead to unnecessary treatment of low-grade

lesions, unnecessary evaluations and biopsies, and psychological stress.12

Screening is of little or no value among women who have undergone a

hysterectomy for benign disease. The USPSTF suggests that clinicians obtain a

full and accurate surgical history to confirm indication for hysterectomy and that

a total hysterectomy has been performed before deciding against screening.12

The USPSTF recommends that screening begin within 3 years of the onset of

sexual activity or the age of 21, whichever occurs first, and continue until the age

of 65 for adult women of normal risk. Some professional organizations

recommend more frequent Pap tests, but the USPSTF found no direct evidence

that annual screening achieves better outcomes than screening every 3 years.

Further, although screening women who are not sexually active has little value,
EVIDENCE-STATEMENT: Cervical Cancer (Screening)

Intervention Process

Treatment

Information

149

many professional organizations recommend that clinicians screen all women

over the age of 21 for cervical cancer because women may not always accurately

report their history of sexual activity.12

Because the risk of cervical cancer decreases after the age of 65 in women who

have a history of normal Pap test results, the risks associated with screening,

including false-positive results and inconvenience, outweigh the benefits of

screening for older women.3 Screening is recommended in older women who

have not been previously screened, when information about previous screening is

unavailable, or when screening is unlikely to have occurred in the past (e.g.,

among women from countries without screening programs).3 Evidence is limited

to define “adequate recent screening.” The American Cancer Society (ACS)

guidelines recommend that older women who have had three or more

documented, consecutive, technically satisfactory normal/negative cervical

cytology tests, and who have had no abnormal/positive cytology tests within the

last 10 years, can safely stop screening.1

Note: In addition to screening, coverage should be provided for immunization

with the HPV vaccine in accordance with recommendations by the Advisory

Committee on Immunization Practices (ACIP). For more information on the

HPV vaccine, please refer to the Immunization Evidence-Statement.

The approved screening method for cervical cancer is the conventional Pap test.

Newer screening methods, such as liquid-based, thin-layer preparations (e.g.,

ThinPrep®), computer-assisted screening (e.g., AutoCyte®), and human

papillomavirus (HPV) tests, such as Hybrid Capture II®, are available. Purchasers

may choose to cover these screening tests in addition to the conventional Pap

test.5

Health coverage should include provisions for diagnostic and treatment services.

Strength of Evidence for the Clinical Preventive Service

(Screening)

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research:

U.S. Preventive Service Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The USPSTF found good evidence to recommend cervical cancer screening for

all women who have been sexually active and have a cervix.3
150

EVIDENCE-STATEMENT: Cervical Cancer (Screening)

Authored by: 

Campbell KP, Coates RJ, Chattopadhyay S. Cervical cancer evidence-statement: screening.

In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s 

Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National 

Business Group on Health; 2006.

References:

1. American Cancer Society Cervical Cancer Screening. What are the key statistics for cervical cancer? Updated, 2004 [cited

2005 Mar 24]. Available from:

http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_cervical_cancer_8.asp?rnav=cri). 

2. Brown ML, Riley GF, Schussler N, Etzioni RD. Estimating health care costs related to cancer treatment from SEERMedicare data. Med Care. 2002;40(8 Suppl):IV-104-17.

3. U.S. Preventive Services Task Force Screening for cervical cancer. Summary of recommendations / supporting documents.

Guide to Clinical Preventive Services. Rockville, MD: Agency for Health Care Research and Quality; 2003.

4. Ries LAG, Eisner MP, Kosary CL, Hankey BF, Miller BA, Clegg L, Mariotto A, Feuer EJ, Edwards BK (eds). SEER Cancer

Statistics Review, 1975-2002. Bethesda, MD: National Cancer Institute; 2005 [cited 2005 Sep 25]. Available from:

http://seer.cancer.gov/csr/1975_2002/.

5. Nuovo J. Melinkow J. Howell LP. New tests for cervical cancer screening. Am Fam Physician. 2001; 64(5): 780-786.

6. McMeekin SD. McGonigle KF. Vasilev SA Cervical cancer prevention: toward cost-effective screening. MedGenMed. 1999;

1(2):1-14.

7. Mandelblatt JS, Lawrence WF, Womack SM, Jacobson D, Bin YI, Yi-Ting H. et al. Benefits and costs of using HPV testing

to screen for cervical cancer. JAMA 2002; 287(18):2372-2381.

8. Valdiserri, RO. Deputy Director, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and

Prevention , U.S. Department of Health and Human Services. Testimony on cervical cancer before the House Committee on

Commerce, Subcommittee on Health and Environment. March 16, 1999. 

9. National Cancer Institute. Cervical Cancer Prevention PDQ. [Cited 2005 Sep 21]. Available from:

http://www.cancer.gov/cancertopics/pdq/prevention/cervical/Patient/page2. 

10. Alliance for Cervical Cancer Prevention. Cervical cancer prevention fact sheet. Seattle, WA; Program for the Appropriate use

of Technology in Health: 2003.

11. Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices. 2006

[cited 2006 Oct 6]. Available from: http://www.cdc.gov/nip/recs/provisional_recs/hpv.pdf. 

12. Berg AO. Atkins D. Screening for cervical cancer. Recommendations and rationale. Guide to Clinical Preventive Services.

2nd Ed. US Preventive Services Task Force. Rockville, MD: Agency for Health Care Research and Quality; 2004.

13. Brown ML, Lipscomb J, Snyder C. The burden of illness of cancer: Economic cost and quality of life. Annu Rev Public

Health. 2001; 22:91-113.

14. Chesson HW, Blanford JM, Gift TL, Tao G, Irwin KL. The estimated direct medical cost of sexually transmitted diseases

among American youth, 2000. Perspect Sex Reprod Health. 2004; 36(1):11-19.

15. Thompson Medstat. Marketscan. 2004

16. Eichler H, Kong SX, Gerth WC, Mavros P, J?nsson B. Use of cost-effectiveness analysis in health-care resource allocation

decision-making: how are cost-effectiveness threshold expected to emerge? Value Health 2004; 7(5): 518-528.
151

Why This Chapter is

Important for

Employers: 

An Overview

Child Developmental (Screening):

• Approximately 17% of children age 17 years and younger in the United States

have at least one developmental disability, and 30% of children with a

developmental disability have comorbid or multiple developmental disorders.1

• Children with developmental delays and disabilities are at increased risk for

poor health and social outcomes and added medical and education costs. 

• The lifetime direct and indirect costs for persons born in 2000 with

developmental disabilities were estimated to equal $51.2 billion for persons

with mental retardation, $11.5 billion for persons with cerebral palsy, $2.1

billion for persons with hearing loss, and $2.5 billion for persons with vision

impairment (all figures in year 2003 dollars).2

• The added time and stress associated with caring for a child with a

developmental disability may result in employees experiencing higher medical

claims (due to increased health problems or depression), lower productivity,

increased absenteeism, or an early exit from the workforce. The mothers of

children with disabling conditions are estimated to lose an average of

approximately 5 hours of work per week equaling 250 hours per year.3

Assuming an hourly cost of $12 to $20 (including fringe benefits), that implies

a lost productivity cost of $3,000 to $5,000 per child, per year.3

• Children with developmental delays and disabilities who are identified and

treated early have better long-term outcomes.

Dental Caries Prevention Through Oral Fluoride Supplementation 

(Preventive Medication):

• Dental caries (tooth decay) is an infectious, transmissible disease in which

bacterial by-products (i.e., acids) dissolve the hard surfaces of teeth. It is the

most common chronic disease of childhood; up to 27% of children aged 2 to

5 years and 49% of children aged 6 to 11 years have experienced dental caries.4

• Dental caries can result in pain and loss of tooth structure or teeth and can

progress to acute systemic infection.

• Dental disease is particularly prevalent among young children of lower

socioeconomic status.

• Fluoride supplementation prevents 32% to 81% of caries lesions in primary

teeth or tooth surfaces.5

• Expenditures for dental services in the United States in 2004 totaled $81.5

billion, which was slightly more than 4% of the amount spent on health care

that year. Private health insurance paid for $40.5 billion, or about half, of this

amount.6

• Preventing tooth decay can reduce school absenteeism7 and therefore reduce

lost productivity among adult caregivers.

• Many preschool-aged children never visit a dentist. Primary care physicians are

often the first and only health care professionals that children visit and are

therefore in a unique position to address dental disease in this population.8

EVIDENCE-STATEMENT:

CHILD HEALTH PROMOTION (Screening, Counseling,

Immunization, Preventive Medication, and Treatment)
152

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Immunizations for Children and Adolescents (Immunization):

• Approximately 11,000 babies born each day in the United States will need

vaccination against fourteen diseases before age two.

• All vaccines are cost-effective, and most child and adolescent vaccines are costsaving. The routine childhood vaccination program saves nearly $10 billion in

direct medical costs and $43 billion in societal costs for every birth cohort (all

children born in one year).9

• Approximately 24% of toddlers may be vulnerable to serious illnesses,

including polio, measles, mumps, rubella, diphtheria, tetanus, pertussis,

invasive Haemophilus influenzae type b infection, hepatitis B, and varicella

because they have not completed the recommended vaccination series.10

Lead, Elevated Blood Lead Levels (Screening):

• The dangers of lead are well documented for all age groups, and high levels of

lead exposure produce serious neurologic complications that can result in

permanent disability or death. Lead affects multiple organ systems such as the

cardiovascular, renal, and hepatic systems.11-12 Lead can also reduce growth,

resulting in restricted height.13-14 Among children, elevated BLLs are associated

with behavioral and reaction (attention) deficits15-19 and intellectual

impairments (lowered IQ).20-25

• Approximately 310,000 children between the ages of 1 and 5 years have

elevated blood lead levels.26

• An estimated 24 million housing units have significant lead-based paint hazards

and pose a serious threat to children’s health. These units include 1.2 million

homes occupied by low-income families with children under the age of 6 years.26

• Between 1988 and 1992, childhood lead poisoning was estimated to result in

53,400 hospitalization days and $41 million in inpatient treatment costs.27

• Screening for elevated blood lead levels helps identify children who are exposed

to lead and need interventions to reduce their blood lead levels. The higher a

child's BLL and the longer it persists, the greater the chance that the child will

experience serious adverse neurologic effects or other problems. 

• Only 33% of children ages 1 to 5 years in the United States receive

recommended screening.28

• In most states, case identification and treatment is the responsibility of health

care providers and is therefore dependent on private insurance coverage.

Environmental management and education of affected families remains the

responsibility of local public health departments.

Newborn Hearing (Screening):

• Congenital hearing loss affects approximately 3 per 1,000 children.29 Hearing

loss, even loss that is mild in magnitude or unilateral (only one ear affected),

can affect a child’s potential to develop speech, language, and social skills, and

school performance.30

• The average lifetime cost for one person with early childhood-onset hearing

loss is estimated to be $417,000 (in year 2003 dollars).31 It is estimated that

the lifetime cost for all people born with congenital hearing loss in the year

2000 will total $2.1 billion (in year 2003 dollars).31
153

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

• Screening newborn infants for hearing loss identifies most children with

congenital hearing loss prior to the onset of language development, allowing

their parents to access support services much earlier than otherwise.

Newborn Screening for Genetic and Endocrine Disorders 

(Screening, Medical Foods, and Treatment):

• Newborn screening using dried blood spot specimens collected from newborn

infants’ heels can detect a number of disorders such as phenylketonuria (PKU),

congenital hypothyroidism (CH), galactosemia, and sickle cell disease (SCD).

All states require newborn screening for at least some genetic and endocrine

disorders, but the required tests differ among various jurisdictions.

• At least 4 million babies in the United States undergo newborn blood spot

screening each year. Severe disorders are detected in about 3,000 newborns.

Accurate screening: 

– Identifies affected babies quickly.

– Ensures that cases are not missed. 

– Helps start treatment early to reduce negative and irreversible health

problems for affected newborns. 

• Disorders identified by newborn screening programs require treatment in order

to prevent serious and sometimes fatal complications. Lifelong medical

management (including specialized medical foods or access to specialty clinics)

is required to prevent serious medical complications associated with newborn

metabolic disorders.

• The economic value of the prevention of mental retardation due to just two

metabolic conditions (PKU and CH) exceeds $400 million per year, more than

twice the amount of money spent on all newborn screening.32-33

• Sickle cell disease is a major cause of hospitalizations. During 1989 to 1993,

hospitalization costs for children and adults with SCD averaged $475 million

per year (in year 1996 dollars).34

Vision (Child) (Screening):

• Visual impairment is a common condition that affects 7% to 8% of children.35

The most common forms of visual impairment in children are refractive errors

(nearsightedness, farsightedness, anisometropia, and astigmatism), amblyopia

(reduced visual acuity without a detectable organic lesion of the eye), and

strabismus (ocular misalignment). 

• Uncorrected amblyopia may be a risk factor for future blindness in later

childhood and adulthood36 and may harm school performance, ability to learn,

and later, adult self-image.37 Further, the lack of binocular vision disqualifies

individuals with amblyopia from many occupations. 

• The estimated lifetime cost (in year 2003 dollars) for persons born in 2000

with vision impairment is $2.5 billion.38

• Early detection and treatment is essential for amblyopia, as treatment is highly

effective in early childhood.

• Because visual impairment in children is common and believed to have an

early sensitive period when interventions lead to better outcomes, much

interest has focused on primary care vision screening tools for early detection,

referral, and treatment.
Child Development (Screening)

Clinical Preventive Service Recommendations

In 2006, the U.S. Preventive Services Task Force (USPSTF) found that

evidence was “insufficient” to recommend for or against routine use of

brief, formal screening instruments in primary care to detect speech and

language delay in children up to 5 years of age.1

The USPSTF was unable to find studies that addressed the overarching

question of whether screening for speech and language delay with brief,

formal instruments improves long-term speech, language, and other nonspeech-and-language outcomes. However, the USPSTF did find fair

evidence to suggest that interventions can improve the results of shortterm assessments of speech and language skills. The USPSTF could not

find studies that addressed the potential harms of screening or

interventions for speech and language delays. The USPSTF could not

determine the balance of benefits and harms of screening with brief,

formal screening instruments.1

The USPSTF did not examine other aspects of developmental screening. 

The American Academy of Pediatrics (AAP) recommends regular,

universal developmental screening of infants and young children by

primary pediatric healthcare providers at 9, 18, and 30 months, using

standardized screening tools with high specificity and sensitivity, to

identify children in need of further assessment and diagnosis, and

appropriate referral for early intervention and education services as

indicated.2

Not Specified

Other professional organization such as the National Association of

Pediatric Nurse Practitioners (NAPNAP)3 and the American Academy of

Neurology4 recommend screening for developmental disorders. 

The recommendations and supporting information contained in this

document came from several sources, including the:

• American Academy of Child and Adolescent Psychiatry

• American Academy of Neurology

• American Academy of Pediatrics (AAP)

• American Psychological Association (APA)

• Centers for Disease Control and Prevention (CDC)

• Committee on Educational Interventions for Children with Autism,

National Research Council, National Academies of Science

• Maternal Child Health Bureau (MCHB)

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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: I

(Insufficient

Evidence)

Other Recommended

Guidance

American Academy

of Pediatrics (AAP)

Evidence Rating:

Information Sources
• National Association of Pediatric Nurse Practitioners (NAPNAP)

• National Research Council, Committee on Educational Interventions for

Children with Autism, Division of Behavioral and Social Sciences and

Education

• Peer-reviewed research

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

A developmental delay, disorder, or disability refers to the presence of one or

more of a diverse group of chronic conditions that hinders a child from

developing age-appropriate cognitive, emotional, social, behavioral, psychological,

or motor skills such as learning, communicating with adults, playing with other

children, or walking. Developmental disabilities can begin at any time during

childhood and, depending on the severity of the condition, can result in delayed

learning (such as a speech impediment that can be overcome with speech

therapy), a physical or mental impairment (such as dyslexia), or a permanent

disability (such as cerebral palsy or mental retardation). 

Examples of developmental disabilities include: 

• Attention deficit/Hyperactivity disorder (ADD/ADHD)

• Autism spectrum disorders 

• Cerebral palsy

• Depressive or anxiety disorders

• Epilepsy

• Hearing loss

• Learning disorders such as dyslexia

• Mental retardation

• Muscular dystrophy

• Speech disorder

• Tourette syndrome and other tic disorders

• Vision impairment

Approximately 6.6% of children (aged 5 to 17 years) in the United States have

ADD, 3.6% have a developmental delay (DD), 8.2% have a learning disability

(LD), and 13.6% have a mental health problem.5

Children with developmental disabilities have poorer health outcomes, a lower

level of education attainment, and higher rates of delinquency and incarceration

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Epidemiology of

Condition/Disease

155
than do children without disabilities. Poor outcomes associated with

developmental delays and disabilities include: 

Reduced educational attainment

• Poor school performance

• Reduced school attendance

Poor overall health status

• Increased rate of injuries

• Increased rate of emergency room visits, doctor visits, and hospitalizations

• Longer hospital stays

• Higher rates of mental illness and behavioral problems

Social problems

• Poor peer relationships

• Increased risk of substance abuse

• Increased risk of delinquency and violence in adolescence and adulthood

There are multiple risk-factors for developmental delays, disabilities, and

disorders.6-8

Value of Prevention

The economic and social burden of developmental disabilities is great. The poor

health and social outcomes of children with developmental disabilities result in

excess medical, education, and criminal justice system costs for families,

employers, and communities. The lifetime direct and indirect costs for persons

born in 2000 with developmental disabilities were estimated to equal $51.2

billion for persons with mental retardation, $11.5 billion for persons with

cerebral palsy, $2.1 billion for persons with hearing loss, and $2.5 billion for

persons with vision impairment (all figures in year 2003 dollars).9 Indirect costs

for the developmentally disabled person include the value of productivity losses

in the workplace and household because of premature death, inability to work, or

limitation in the amount and type of work that can be performed. 

The excess medical costs associated with developmental disabilities are welldocumented. For example, children with ADHD have higher health-related

expenses than do children without developmental delays and disabilities. In fact,

compared to children who develop normally, children with ADHD have 2.6

times as many medical claims and average nearly $1,000 per year in added

medical costs (the average annual per patient cost for a child with ADHD in

1998 was $1,574 compared to $541 for a child without ADHD).10 Further,

family members of children with ADHD have per-capita annual direct and

indirect costs nearly twice that of the family members of children without

ADHD ($2,728 compared to $1,440).10

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Preventive Medication, and Treatment)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease
Similarly, results from Washington State Medicaid claims data show that,

compared to children who develop normally, children with developmental delays:

• Are at least 5 times more likely to have chronic health conditions such as

gastrointestinal disorders, central nervous system disorders, and conditions of

the ear, nose, and throat;

• Have 1.5 times as many physician visits during their first 5 years of life;

• Have more hospitalizations during their first 5 years of life, even when factors

such as health status are controlled; and

• Have more than 10 times the number of visits to specialty practitioners such as

physical and occupational therapists, speech therapists, and audiologists.11

This additional need for healthcare translates into added costs for employers. 

While employers are not directly impacted by the societal costs of

developmentally disabled children, the added cost to the healthcare system

should be of major concern to employers. Further, children with developmental

delays and disabilities are a source of indirect costs to employers due to the fact

that affected children experience more health problems and therefore require

more substantial parental caregiving than do children without developmental

problems. The added time and stress associated with intensive caregiving may

result in employees experiencing higher medical claims themselves (due to

increased health problems or depression), and lower productivity, increased

absenteeism, or an early exit from the workforce. For example, the mothers of

children with disabling conditions are estimated to lose an average of

approximately 5 hours of work per week equaling 250 hours per year.12 Assuming

an hourly cost of $12 to $20 (including fringe benefits), that implies a lost

productivity cost of $3,000 to $5,000 per child, per year.12

Screening and early intervention services may reduce long-term societal costs.

However, there is no direct evidence to support cost-savings associated with

screening or early detection.13

In 2004, the private-sector cost of a well-child visit that included developmental

screening averaged $83; approximately 95% of all paid claims fell within the range

of $30 to $127 dollars. The private-sector cost of a limited developmental screen

(e.g., Developmental Screening Test II, Early Language Milestone Test) averaged $27

and 95% of all paid claims fell within the range of $0 to $95. The private-sector cost

of an extended developmental test (i.e., assessment of motor, language, social,

adaptive, and/or cognitive functioning by standardized assessment instruments)

averaged $144 and 95% of all paid claims fell within the range of $0 to $466.13

The cost of treatment will vary widely depending on the type and severity of the

condition. 

Screening and early intervention services may reduce long-term societal costs.

However, there is no direct evidence to support cost-savings associated with

screening or early detection.13

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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Workplace Burden of

Condition/Disease

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention
Preventive Intervention Information

Screening tools are designed to identify children who may have a delay or

disability and thus need more intensive diagnostic assessment and possible

intervention or treatment. The purpose of screening is to identify children

affected by developmental delays and disabilities when they are still

developmentally receptive and malleable and therefore most responsive to

interventions.

Research has shown substantial benefits to early recognition and intervention,

especially for certain conditions. For example, children with autism who are

identified early in life and receive specialized interventions have significantly

improved cognitive, language, and motor skills and attain a higher level of

education than do autistic children who are identified later in life.14-15 Early

intervention can also improve the cognitive developmental trajectories of children

with developmental disabilities and decrease conduct problems at home and in

the classroom (resulting in an increased rate of high school graduation and

decreased juvenile and adult arrests).16-17

The risks of screening for developmental delays and disabilities include the

possibility of a negative influence on the parent’s perception of their child, the

added time and costs associated with screening and—as with all screenings—the

risk of false-positives which can produce anxiety and subject the child and parent

to unneeded tests and evaluations. Research has found that false-positive rates can

reach 15% to 30% for developmental screening.13 False-positive results can place

an extraordinary burden on the healthcare system, erode trust in the system, and

potentially influence parents’ perception of their child.18 However, some research

has found children with false-positives perform substantially lower than do

children with true-negative scores on measures of intelligence, language, and

academic achievement indicating that while these children do not have a

developmental disability they may nonetheless benefit from further assessment

and referral to services such as Head Start and specialized day care.18-19

The benefits of early recognition and the opportunity for early intervention are

expected to outweigh the risks and costs associated with screening.

Research is insufficient to determine the most efficacious age at which to screen

for, diagnose, and treat specific developmental disorders. The AAP recommends

screening all infants and young children due to the availability and importance of

1) early intervention services for children birth to 3 years of age, and 2) early

childhood education services for children age 3 to 5 years. 

Developmental concerns should be addressed among other health topics at each

preventive care visit during the first 5 years of life. Developmental surveillance,

asking for example, “Do you have any concern about your child’s development,

learning, or behavior?” is important at each visit. 

Structured screening should occur at the 9, 18, and 30-month visits.2

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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Preventive

Intervention: 

Purpose of 

Screening

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening
159

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Intervention Process

Treatment

Information

Authored by: 

Campbell KP, Lollar D, Chattopadhyay S. Child development evidence-statement: screening. In:

Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to

Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group

on Health; 2006.

Developmental screening consists of a brief assessment conducted by a parent

and/or health care provider that can include direct observation, patient (child)

elicitation (i.e., asking the child to name three colors), interviewing parents of a

child expressing usual behavior, and physical testing (e.g., measuring a child’s

ability to visually track objects). Screening tools help a clinician assess a child’s

attainment of developmental milestones—the physical, cognitive, and behavioral

skills that are necessary components of a child’s development. Developmental

screening is best conducted by a primary care provider who has knowledge of the

child’s health and consistent contact with the child. 

Providers should refer children with development disabilities to Early

Intervention (EI) services and other developmentally appropriate services, as

medically indicated. Health benefits should include provisions for diagnostic

follow-up and treatment services. 

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this section

is described below.

Recommended Guidance:

American Academy of Pediatrics (AAP)

Strength of Evidence: Not Specified

• The AAP recommends regular, universal developmental screening of infants

and young children by primary pediatric healthcare providers at 9, 18, and 30

months, using standardized screening tools with high specificity and

sensitivity,to identify children in need of further assessment and diagnosis, and

appropriate referral for early intervention and education services, as indicated.2

Note: In 2006, the U.S. Preventive Services Task Force (USPSTF) found that

evidence was “insufficient” to recommend for or against routine use of brief,

formal screening instruments in primary care to detect speech and language delay

in children up to 5 years of age.1 The USPSTF did not examine other aspects of

developmental screening.20
160

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

U.S. Preventive

Services Task Force

(USPSTF)

Recommendation

Evidence Rating: B

(Recommended/

At Least Fair

Evidence

Centers for Disease

Control and

Prevention (CDC)

Recommendation

Other Recommended

Guidance

Information Sources

Dental Caries Prevention Through Oral

Fluoride Supplementation 

(Preventive Medication)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends that primary

care clinicians prescribe oral fluoride supplementation at currently recommended

doses to preschool children older than 6 months of age whose primary water

source is deficient in fluoride.1

The USPSTF found fair evidence that the service improves important health

outcomes and concluded that the benefits of oral fluoride supplementation

outweigh the harms. The USPSTF found fair evidence that, in preschool children

with low fluoride exposure, prescriptions of oral fluoride supplements by primary

care clinicians lead to reduced dental caries. The USPSTF concluded that the

benefits of caries prevention using oral fluoride supplementation outweigh the

potential harms of dental fluorosis, which in the United States are primarily in

the form of mild discoloration of the teeth.1

The Centers for Disease Control and Prevention (CDC) has developed

recommendations for preventing tooth decay while reducing the risk of enamel

fluorosis, or the hypo-mineralization of the tooth’s enamel surface that results

from ingesting fluoride during tooth formation. The CDC recommends the

judicious prescription of fluoride supplements in preschool-aged children, and for

those at risk, supplementation may continue through 16 years of age. Fluoride

supplements may be prescribed for children who are at high risk for tooth decay

and whose primary source of drinking water has low fluoride concentration,

based on the child’s risk of developing decay without fluoride supplements; the

benefit of decay prevention; the potential for enamel fluorosis; and the child's

sources of fluoride, especially drinking water. Parents and caregivers should be

informed of both the benefits and the risks associated with fluoride

supplementation. The dosage of prescribed fluoride supplements should be

consistent with the schedule established by American Dental Association (ADA),

American Academy of Pediatric Dentistry (AAPD), and American Academy of

Pediatrics (AAP) which is available online (www.cdc.gov/fluoridation/other/

spplmnt_schdl.htm). Fluoride supplements may be prescribed for specific

children (as appropriate) or they may be given through school-based programs.

When practical, supplements should be prescribed as chewable tablets or lozenges

to maximize the topical effects that aid with enamel remineralization.2

The American Dental Association (ADA), American Academy of Pediatrics

(AAP), and American Academy of Pediatric Dentistry (AAPD) concur with the

USPSTF and CDC recommendations described above.

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Pediatric Dentistry (AAPD)
161

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

• American Academy of Pediatrics (AAP)

• American Dental Association (ADA)

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information in this document is based on

research findings. All information presented in this document should be

attributed to its referenced source and should not be considered a reflection of

the opinions of other organizations cited in the text. 

Condition/Disease-Specific Information

Dental caries (tooth decay) is an infectious, transmissible disease in which bacterial

by-products (i.e., acids) dissolve the hard surfaces of teeth.3 It is the most common

chronic disease of childhood and is five times more common than asthma and

seven times more common than hay fever.4 Dental caries can result in pain and loss

of tooth structure or teeth, and can progress to acute systemic infection. 

Populations believed to be at increased risk of dental caries are those with low

socioeconomic status or low levels of parental education, those that do not obtain

regular dental care, and those without dental insurance or access to dental

services.5-7 Persons can be at high risk of dental caries even if they do not have

any recognized risk factors. Individual factors that might increase risk include

active dental caries; a history of high levels of caries in older siblings or caregivers;

high levels of infection with cariogenic bacteria; impaired ability to maintain oral

hygiene; malformed enamel or dentin; reduced salivary flow because of

medications, radiation treatment, or disease; low salivary buffering capacity (i.e.,

decreased ability of saliva to neutralize acids); and the wearing of space

maintainers or dental prostheses. Risk can increase if any of these factors are

combined with dietary practices conducive to dental caries, such as frequent

consumption of refined carbohydrates, while risk decreases with adequate

exposure to fluoride.5,8 An individual’s risk of developing caries can vary over time

as his or her risk factors change.

Value of Prevention

Expenditures for dental services in the United States in 2004 totaled $81.5 billion,

which was slightly more than 4% of the amount spent on healthcare that year.

Private health insurance paid for $40.5 billion, or about half, of this amount.9

In 1996, 3.7 days of restricted activity per 100 employed people aged 18 years

and older were reported to be associated with an acute dental conditions and over

2.4 million work days (1.9 days per person) were lost because of an acute dental

conditions.10 These statistics do not include days that parents were absent from

work to care for children with dental conditions. Parental caregiving

requirements associated with child dental problems can be extensive as children
162

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Preventive

Medication

Benefits and Risks of

Intervention

miss a significant number of school days due to dental problems. In 1996, U.S.

schoolchildren missed 1.6 million days of school as a result of acute dental

conditions. Preventing tooth decay can reduce school absenteeism10 and therefore

reduce lost productivity among adult caregivers. 

Fluoride modalities are most cost-effective for persons at high risk of dental

caries. Limited benefit is gained by providing additional caries-preventive

modalities to persons consuming fluoridated water. 

In 2004, the private-sector cost of fluoride supplementation averaged $33;

approximately 95% of all paid claims fell within the range of $0 to $42).11 This

cost does not include the cost of physician time for counseling and risk

assessment.

The ADA has estimated per-capita dental care expenditures (in year 1995 dollars)

at $174 per person, per year.12 The Health Care Financing Administration (now

called the Centers for Medicare and Medicaid Services) came up with a similar

estimate of $164 per person, per year.13

The USPSTF found consistent evidence showing that fluoride supplementation

prevents 32% to 81% of caries lesions in primary teeth or tooth surfaces.14 No

long-term cost-benefit analyses are available. 

Preventive Intervention Information

Appropriate fluoride supplementation can prevent dental caries, infections, and

other complications, thereby improving overall oral and physical health.

Preventing tooth decay in preschool children can have a positive impact on oral

health and quality of life in later years. 

Fluoride controls early dental caries by both preventing caries from occurring and

controlling caries when they do occur. Fluoride has a pre-eruptive effect on

developing tooth enamel and a post-eruptive topical effect. Although community

water fluoridation is recommended as the ideal way to provide fluoride’s benefits

to both children and adults, fluoride supplements are an effective alternative for

children who lack access to fluoridated drinking water.2

However, fluoride ingested during tooth development can result in a range of

changes in the appearance of teeth, broadly known as enamel fluorosis. Certain

extremes of enamel fluorosis are cosmetically unacceptable. Severe forms of this

condition occur only when young children ingest excess fluoride, from any

source, during critical periods of tooth development. The use of dietary

supplements in areas with fluoridated drinking water, which is inconsistent with

the recommended supplement schedule, might increase the risk of enamel

fluorosis.15 Although the studies assessing the appropriateness of primary care

clinicians’ prescription of fluoride supplements have uncertain external and

internal validity, they indicate that the majority of physicians in the United
163

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Initiation, Cessation,

and Interval of

Preventive

Medication

Intervention Process

Treatment

Information

States, especially pediatricians, prescribe oral fluoride supplements for at least

some of their patients.2 Research shows that many physicians do not know the

fluoride status of their patients or the fluoridation level of their patients’ water

supplies, raising the possibility of inappropriate fluoride supplement prescriptions

that may lead to excessive fluoride intake.1

When healthcare providers identify preschool children who live in nonfluoridated areas as being at high risk of dental caries, they should consider

prescribing dietary fluoride supplements for these children. These supplements

are normally taken once per day and are not recommended for children younger

than 6 months of age. Depending on the child’s level of risk, supplementation

may continue from age 6 months to 16 years.2 Fluoride supplements should not

be initiated or should be discontinued if the assessed risk of dental caries

decreases to a low level or if the child obtains access to fluoride through other

sources, especially drinking water. 

When prescribing any pharmaceutical agent, primary care providers should

attempt to maximize benefit and minimize harm.16 Although fluoride's

posteruptive action can benefit the primary (i.e., “baby”) teeth of children aged 1

to 6 years and provide some protection for developing permanent teeth, fluoride

supplements can also increase the risk of enamel fluorosis.17-18 Before prescribing

fluoride supplements, clinicians should verify that the patient is not obtaining

fluoride from any source of drinking water, medications, or swallowed

toothpaste.2

Dietary fluoride supplements in the form of tablets, lozenges, or liquids

(including fluoride-vitamin preparations) have been used throughout the world

since the 1940s. Sodium fluoride is the active ingredient in most supplements.

Tablets and lozenges typically contain 1.0, 0.5, or 0.25 mg of fluoride. To

maximize the topical effect of the fluoride, tablets and lozenges should be chewed

or sucked for 1 to 2 minutes before being swallowed. For infants, supplements

are available in liquid form and are dispensed with a dropper.

Health benefits should include provisions for routine dental care and the

treatment of dental caries and other forms of dental disease.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this section

is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

• The USPSTF found at least fair evidence to recommend oral fluoride

supplementation for preschool children older than 6 months of age whose

primary water source is deficient in fluoride.1
164

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

U.S. Preventive

Services Task Force

(USPSTF)

Recommendation

CDC

Recommendation

Authored by: 

Bailey W, Maas W, Lanza A. Dental caries evidence-statement: preventive medication. In: Campbell KP,

Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical

Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on 

Health; 2006.

Recommended Guidance:

Centers for Disease Control and Prevention (CDC)

Strength of Evidence: Expert Panel

• The CDC recommends the judicious prescription of fluoride supplements in

preschool-aged children, and for those at risk, supplementation may continue

through 16 years of age. Fluoride supplements may be prescribed for children

who are at high risk for tooth decay and whose primary source of drinking

water has low fluoride concentration, based on the child’s risk of developing

decay without fluoride supplements; the benefit of decay prevention; the

potential for enamel fluorosis; and the child's sources of fluoride, especially

drinking water. Parents and caregivers should be informed of both the benefits

and the risks associated with fluoride supplementation. The dosage of

prescribed fluoride supplements should be consistent with the schedule

established by American Dental Association (ADA), American Academy of

Pediatric Dentistry (AAPD), and American Academy of Pediatrics (AAP).2

Immunizations for Children and Adolescents

(Immunization)

Please refer to the Immunizations Evidence-Statement on page 337.

Lead, Elevated Blood Lead Levels

(Screening)

Clinical Preventive Service Recommendations

In 1996, the U.S Preventive Services Task Force recommended that clinicians

screen children at risk for lead exposure for elevated blood lead levels. Given the

availability of new evidence, the USPSTF has decided to update its 1996

recommendation. This work is currently in progress. 

The Centers for Disease Control and Prevention (CDC) recommends blood lead

testing for children at high risk for exposure from lead paint, from house dust

and soils contaminated by lead paint, from industrial sources of lead (e.g.,

smelters), and from imported cosmetics, traditional remedies, and cultural items

that contain lead.1 
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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Other Recommended

Guidance

Centers for Medicare

and Medicaid

Services (CMS)

Evidence Rating:

Information Sources

Epidemiology of

Condition/Disease

The Centers for Medicare and Medicaid Services (CMS) requires blood lead

testing of all Medicaid enrolled children at 1 and 2 years of age or at 3 years of

age if not previously tested.2

CMS Mandate

The recommendations and supporting information contained in this document

came from several sources, including the:

• Advisory Committee on Childhood Lead Poisoning Prevention (ACCLP)

• Agency for Toxic Substances and Disease Registry (ATSDR)

• Center for Medicare and Medicaid Services (CMS)

• Centers for Disease Control and Prevention (CDC)

• National Health and Nutrition Examination Survey (NHANES)

• Peer-reviewed research

• U.S. Department of Health and Human Services (USDHHS)

• U.S. Environmental Protection Agency (EPA)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

The dangers of lead are well-documented for all age groups. High levels of lead

exposure produce serious neurologic complications that can result in permanent

disability or death. Lead affects multiple organ systems such as the cardiovascular,

renal, and hepatic systems.3-4 Lead can also reduce growth, resulting in restricted

height.5-6 Among children, elevated blood lead levels (BLLs) are associated with

behavioral and reaction (attention) deficits7-11 and intellectual impairments

(lowered IQ).12-17 Neurologic complications associated with lead exposure and

lead poisoning are irreversible, even with treatment. The association between

elevated BLLs and reduced intellectual capacity is strong and has a dose-response

relation, meaning that the more lead present in the blood, the more severe the

impairments become.18-19 For example, a rise in blood lead from 10 to 20 μg/dL

reduces a child’s score on an IQ test by an average of 2 points.18 No “safe” BLL in

children has been specified.15-16,19

It is estimated that 310,000 children between the ages of 1 and 5 years have

elevated BLLs.20 An estimated 24 million housing units have significant leadbased paint hazards, including 1.2 million homes occupied by low-income

families with children under the age of 6 years. These units pose a serious threat

to children’s health.20
166

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit of

Preventive

Intervention

The prevalence of elevated BLLs among young children in the United States has

declined 98% since 1976-1980.20 A critical factor in reducing children’s BLLs has

been the reduction in the number of homes with lead-based paint, which fell

from 64 million in 1990 to approximately 38 million in 2000.20 Despite the

dramatic reduction in elevated BLLs, lead exposure and lead poisoning remain

serious public health problems in the United States, especially for young children,

who are most susceptible to the harmful effects of lead. 

Reducing BLLs and eliminating BLLs higher than 10 μg/dL in children are two

of the nation’s Healthy People 2010 objectives.21

Racial and ethnic minorities (particularly African-Americans), individuals with

low incomes, children living in housing built before 1950, and those living in

urban centers and in the Northeast bear the highest rates of lead exposure.22-23

Major sources of lead exposure include dilapidated housing with lead-based paint

(commonly used until 1950) and paint dust, lead-soldered pipes, and lead found

in dust or soil from peeling paint, leaded gasoline, or industrial emissions. Other

sources of lead exposure include lead waste brought into the home from

industry,24 ethnic remedies,25–27 or from lead in consumer products.28–31

Value of Prevention

The costs of providing medical care and public health services to treat adverse

health outcomes constitute the immediate direct costs of lead exposure and lead

poisoning. Between 1988 and 1992, childhood lead poisoning was estimated to

result in 53,400 hospitalization days and $41 million in inpatient treatment

costs.32 The longer term burden to taxpayers includes the costs of special

education and lost tax revenues from the lower wages of workers with intellectual

deficits due to childhood lead exposure or lead poisoning. The total economic

burden would be much higher if lifetime productivity losses due to cognitive

impairment and premature mortality were included in cost analyses.

Lead poisoning results in dose-related reductions in IQ which, in turn,

contributes to lower wages and diminished lifetime earning power. The present

value of economic losses attributable to lead exposure in the birth cohort of

current 5-year-olds was estimated to be $43.4 billion in 1997.33 

Reducing lead exposure yields economic benefits by avoiding healthcare and

special education costs and by preventing reductions in children's intelligence,

academic achievement, and future productivity. A recent study quantified

economic benefits from projected improvements in worker productivity that

resulted from the reduction in children's exposure to lead in the United States

since 1976. It was estimated that, because of falling BLLs in the United States,

preschool-aged children in the late 1990s had IQs that were, on average, 2.2 to

4.7 points higher than they would have been if they had the blood lead

distribution observed among United States preschool-aged children in the late

1970s. It was also estimated that each IQ point raises worker productivity 1.76%

to 2.38%. With discounted lifetime earnings of $723,300 for each 2-year-old in
167

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks of

Intervention

Initiation, Cessation,

and Interval of

Screening

2000 dollars, the estimated economic benefit for each year's cohort of 3.8 million

2-year-old children ranges from $110 billion to $319 billion.34

In 2004, the private-sector cost of blood lead screening (venous sample test)

averaged $22 per specimen for shipping, handling, and laboratory analysis;

approximately 95% of all paid claims fell within the range of $8 to $55.35

Including the blood draw, which costs an average of $9, the total cost for blood

lead level screening averaged $31. Approximately 95% of all paid medical claims

fell within the range of $10 to $69.35

Chelation therapy, the standard treatment, which leeches lead from the body,

costs an estimated $2,046 (in year 2001 dollars) for each child treated.36

A study based on mathematical simulations of a blood lead screening program,

estimated that, compared with no screening, universal screening of all 1-year old

children for elevated BLLs would produce economic benefits exceeding program

costs in communities where at least 11% to 17% of children had elevated BLLs.37

Preventive Intervention Information

Identifying children with elevated BLLs allows parents to make necessary

environmental changes to limit the child’s exposure to lead and allows clinicians

to begin medical treatment with chelating agents (if necessary), before lead

poisoning and its serious complications occur. Environmental changes, such as

lead-paint abatement and removal of lead-soldered pipes, can have beneficial

effects on both exposed children and other children who live in the home.

Risks associated with BLL screening include increased anxiety among parents,

discomfort to the child of repeated blood draws, and the inconvenience

associated with office visits. As with all screening tests, a false-positive test result

can lead to unnecessary treatment. However, the benefits of screening, including

early identification of lead exposure and the prevention of lead poisoning,

outweigh the costs and risks associated with screening.

Chelating agents can cause adverse effects, which may be severe. Thus, the benefits

and risks associated with lead poisoning treatment should be carefully weighed. 

Children at risk for lead exposure should be screened at or before age 12 months.

Clinicians should note that, on average, blood levels peak in exposed children

between 18 and 24 months of age. Screening for elevated BLLs should cease

when the clinician determines the child is no longer at risk for exposure based on

age or environmental risk profile.

At a minimum, blood lead testing for at-risk populations should be conducted at

the following ages: 

• 12 months

• 24 months 

• 36–72 months
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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Intervention Process

Treatment

Information

Children of any age should be screening when deemed medically necessary by a

clinician’s risk assessment, when clinical signs or symptoms consistent with

elevated BLL are present, or when other evidence indicates possible exposure. 

Children with symptoms consistent with increased intracranial pressure should

also be considered for screening.

Recently resettled refugee, immigrant, and internationally adopted children 6

months to 16 years of age should be tested upon arrival and again 3 to 6 months

after resettlement if local conditions warrant.38

State screening plans can be found on the CDC Childhood Lead Poisoning

Prevention Branch website (www.cdc.gov/nceh/lead).

Screening for lead exposure is conducted by measuring the amount of lead

circulating in the blood through either a capillary or venous blood sample.

Venous samples are more accurate and are thus the preferred method of testing.

However, because of the added discomfort and cost of venous samples, clinicians

often screen low-risk populations by taking a capillary blood sample and by

performing a confirmatory venous blood lead concentration test on samples that

show elevated BLLs. 

The main treatment for lead exposure is to stop the exposure by removing

environmental or dietary sources of lead. Lead exposure reduction may include

full lead abatement in the home, special cleaning techniques, the removal of

contaminated objects, or the removal of the child from the home.40 Treatment for

lead poisoning (a BLL of 45 μg/dL or higher) requires pharmacologic

intervention. Chelation therapy is the most common form of lead poisoning

treatment and may prevent further damage by reducing the amount of lead

circulating in the blood. Clinicians may choose to begin chelation therapy for

children with BLLs lower than 45 μg/dL if the children have persistently elevated

BLLs that do not respond to environmental risk reduction.39

Health benefits should include provisions for diagnostic, surveillance, and

treatment services.

Strength of Evidence for the Clinical Preventive Service

The evidence supporting the recommendations contained in this section is

described below.

Recommended Guidance:

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on

Childhood Lead Poisoning Prevention

Strength of Evidence: Not Specified

• The CDC supports routine blood lead testing for children at high risk for

exposure from lead paint, from house dust and soils contaminated by lead

paint, from industrial sources of lead (e.g., smelters), and from imported

cosmetics, traditional remedies, and cultural items that contain lead.1
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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: I

(Insufficient

Evidence)

CDC

Recommendation

Evidence Rating:

Observational

Studies, Expert

Opinion

Other Recommended

Guidance

Joint Committee on

Infant Hearing (JCIH)

Authored by: 

Brown MJ, Chattopadhyay S. Lead, elevated blood lead level evidence-statement: screening. In:

Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to

Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on

Health; 2006.

Center for Medicare and Medicaid Services (CMS)

Strength of Evidence: CMS Mandate

• The Centers for Medicare/Medicaid Services (CMS) requires blood lead testing

of all Medicaid enrolled children at 1 and 2 years of age or at 3 years of age if

not previously tested.2

Newborn Hearing (Screening)

Clinical Preventive Service Recommendations

In 2001, the U.S. Preventive Services Task Force (USPSTF) issued an “I”-rating

for “insufficient” evidence to recommend for or against routine newborn hearing

screening. The USPSTF found inconclusive evidence to determine whether

earlier treatment resulting from screening leads to clinically important

improvement in speech and language skills at 3 years of age.1 However, the

USPSTF did note that there is evidence that the average age of diagnosis is

significantly reduced with newborn hearing screening.

The CDC recommends screening all children for hearing loss at birth.

The CDC recommendation for screening at birth is based on evidence from

observational studies that children who receive intervention services for hearing

loss before the age of 6 months develop significantly better language skills.2-4 This

is supported by expert opinion of those who care for children with hearing loss

and parents of children with hearing loss, who report that children with hearing

loss detected as infants have better language skills than older siblings with laterdiagnosed hearing loss.

The Joint Committee on Infant Hearing (JCIH) endorses early detection of and

intervention for infants with hearing loss (early hearing detection and

intervention, EHDI) through integrated, interdisciplinary state and national

systems of universal newborn hearing screening, evaluation, and family-centered

intervention. Thus, all infants’ hearing should be screened using objective,

physiologic measures in order to identify those with congenital or neonatal onset

hearing loss. Audiologic evaluation and medical evaluations should be in progress

before 3 months of age. Infants with confirmed hearing loss should receive

intervention before 6 months of age from health care and education professionals

with expertise in hearing loss and deafness in infants and young children.5
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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Evidence Rating:

National Institutes of

Health (NIH)

Evidence Rating: 

State Legislation

Information Sources

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Expert Opinion

A 1993 National Institutes of Health (NIH) Consensus Development

Conference Statement on Early Identification of Hearing Impairment in Infants

and Young Children recommended that universal newborn hearing screening be

implemented.6

Expert Consensus

At present, 38 states and territories have enacted legislation on universal

screening of all infants for hearing loss, and all states have programs to promote

newborn hearing screening.7

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Audiology

• American Academy of Pediatrics (AAP)

• American Speech, Language, and Hearing Association

• Centers for Disease Control and Prevention (CDC)

• Directors of Speech and Hearing Programs in State Health and Welfare

Agencies

• Joint Committee on Infant Hearing (JCIH)

• Health Resources and Services Administration (HRSA)

• National Center for Hearing Assessment and Management (NCHAM) 

• National Institutes on Health (NIH)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Congenital hearing loss affects approximately 3 per 1,000 children.8 About 30%

of children with hearing loss have another condition at birth. Hearing loss, even

loss that is mild in magnitude or unilateral (only one ear affected), can affect a

child’s potential to develop speech, language, social skills, and school performance,

including grade retention.9 Hearing loss may be present at birth or may occur

later.

About 40% to 60% of hearing loss is due to genetic or gene-environment factors.

The causes of hearing loss for many children are poorly defined, and infants may

have no identifiable risk factors to prompt targeted screening. But assorted risk

factors are known. Some cases occur in families with a history of permanent

childhood hearing loss. Infections such as bacterial meningitis or in utero

cytomegalovirus (CMV), herpes, toxoplasmosis, and rubella are associated with

hearing loss. Anatomical anomalies, caused either by birth defects or trauma or
171

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

other factors are also associated with hearing loss. Finally, a variety of other

predispositions such as severe neonatal hyperbilirubinemia (jaundice) requiring

exchange transfusion or persistent otitis media are associated with hearing loss.10

Value of Prevention

Many people with hearing loss need long-term services. The average lifetime cost

for one person with early-childhood-onset hearing loss is estimated to be

$417,000 (in year 2003 dollars).11 It is estimated that the lifetime cost for all

people with congenital hearing loss who were born in 2000 will total $2.1 billion

(in year 2003 dollars).11 These costs include both direct and indirect costs. Direct

medical costs, such as doctor visits, prescription drugs, and inpatient hospital

stays, make up 6% of these costs. Non-medical expenses, such as home

modifications and special education, make up 30% of the costs. These estimates

do not include other expenses, such as hospital outpatient visits, sign language

interpreters, and family out-of-pocket expenses. 

Indirect costs of hearing loss, which include the value of lost wages when a

person either cannot work or is limited in the amount or type of work possible,

make up 63% of total costs.11

The economic benefits of newborn hearing screening include reduced special

education costs associated with improved hearing and language and also lower

social and community services. A new study from England has reported that

average education costs among 7 to 9 year-old children with bilateral hearing loss

were lower by 22% among children born in districts with universal newborn

hearing screening.12

The cost of screening for hearing loss depends on the location (inpatient or

outpatient setting), provider type, and the screening instrument used. In 2004,

the private-sector cost of screening for hearing loss in the hospital (recommended

setting) averaged $84 if billed and paid separate from the labor and delivery

charge; approximately 95% of paid claims fell within the range of $0 to $200.13

If the screening was missed before discharge or needed to be repeated on an

outpatient basis, the average private-sector cost was $98 (in this scenario 95% of

paid claims fell within the range of $0 to $235).13 Both figures include the cost of

staff time, consumables, and the cost of the equipment. When screening is billed

as a part of labor and delivery charges the incremental cost is lower.

The cost of treatment will vary widely depending on the type and severity of the

hearing loss and the kinds of interventions chosen.

Screening programs detect approximately 3 children with hearing loss for every

1,000 infants screened. Assuming an average cost of $30, the cost per infant

detected may be as low as $10,000. In comparison to other preventive

interventions and to commonly accepted cost-effectiveness benchmarks, newborn

hearing screening is cost-effective. 
172

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Preventive

Intervention:

Purpose of Screening

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening

The cost-effectiveness of early detection depends on long-term outcomes. To the

extent that improved language leads to lower special education costs and to

improved learning potential, the monetary benefits of screening are likely to

exceed the costs.14-15 The savings in special education costs are likely to exceed the

costs of screening within 5 years.12

Preventive Intervention Information

Screening newborn infants for hearing loss identifies most children with

congenital hearing loss prior to the onset of language development, allowing their

parents to access services much earlier than otherwise. In the absence of

screening, the majority of children with congenital hearing loss do not receive a

diagnosis until 2 to 3 years of age, by which point language development is

usually seriously delayed.16 The average deaf or hard-of-hearing adult reads at

only a 4th grade level.17 The average language development score of children who

are deaf or hard of hearing in the absence of early identification is two standard

deviations below the mean.2

Certain children have later-onset or progressive hearing loss that cannot be

detected during the newborn period. Clinicians and parents should be alert to

hearing, speech, language, or developmental delay and should have children

tested for hearing function if they are concerned about delays regardless of

previous hearing screenings. 

With screening, most cases of hearing loss can be detected prior to 3 to 4 months

of age. With early identification, parents have the opportunity to communicate

with their child beginning early in infancy. This aids language development for

the child and strengthens the parent-child bonding. Research suggests that most

preschool-age children with hearing loss will have language development within

the normal range if intervention beginnings by 6 to12 months of age.2-4 It is

widely believed that this will lead to improved school performance and

occupational success.12,14-15

The main risk of screening is that false-positive results can lead to additional

screening or evaluation, incurring unnecessary costs and inconvenience for

families and providers. The expected number of newborns who do not pass the

hearing screen is 40 per 1,000 births, of which 3 will have hearing loss.

Following and re-testing the remaining 37 incur costs and challenge follow-up

systems. On the other hand, a number of surveys of families whose children

screened positive for hearing loss found that most parents support hearing

screening and consider the inconvenience to be minor compared to the benefits

of early recognition.18

Hearing screening for newborn infants is mandated in many jurisdictions, and

CDC recommends it for all infants. 

Since hearing loss may develop or first become apparent later, infants and

children and should also be screened when a clinician suspects that language or

developmental delay may be related to hearing loss. Physicians should be
encouraged to see that patients at high-risk for late-onset or progressive hearing

loss be screened in accordance with recommendations set forth by the Joint

Committee on Infant Hearing (JCIH).5

It is recommended by the JCIH that infants with risk indicators for progressive

or delayed-onset hearing loss should receive audiologic monitoring before age 3

years.5 In addition, an infant who does not pass a newborn screening should get a

diagnostic audiological evaluation before 3 months age at the latest. 

Hospital-based screening programs should use automated audiologic screening

instruments approved for use with newborn infants. This type of instrumentation

is also appropriate for use in pediatrician and other provider offices, but very few

of these offices provide this type of screening. Those offices that do not have the

appropriate instrumentation and training should refer to audiological practices

that do provide this service. Infants who are suspected to have hearing loss on the

basis of the initial screening test should be referred for comprehensive audiologic

assessment and specialty medical evaluations to confirm the presence of hearing

loss and to determine type, nature, options for treatment, and (whenever

possible) etiology of the hearing loss.5 Audiological diagnosis requires a testbattery approach to cross-check results of multiple physiologic and

developmentally-appropriate behavioral measures. Early audiologic assessments

rely on physiologic measures of auditory function including: Auditory Brainstem

Response (ABR), Otoacoustic Emissions (OAE), acoustic immittance measures,

and acoustic reflexes.19

Auditory Brainstem Response (ABR) is a test that checks the brain's response to

sound and is measured by placing electrodes on the head to record the brain’s

response to sound. Older babies, as well as those who do not routinely sleep well

after eating, frequently require sedation to attain accurate ABR test results.19

Otoacoustic Emissions (OAE) is a test that checks the inner ear response to

sound and is measured by placing a very sensitive microphone in the ear canal to

measure the ear’s response to sound. Either type of instrument can be used alone

or in sequence. Evidence is mixed as to what instrument or method is most

effective in accurately identifying children with hearing loss, but most

instruments seem to have an adequate level of sensitivity and specificity.19

Health benefits should include provisions for diagnostic, surveillance, and

treatment services. 

Infants with a diagnosed hearing loss should receive appropriate services before 6

months of age, including medical services, early intervention services (i.e., Part C

services or other state approved intervention services), and audiologic services.5,20

Every infant with confirmed hearing loss should be referred for an otolaryngology

medical evaluation to determine the etiology of hearing loss, to identify related

physical conditions, and to provide recommendations for treatment as well as

referral for other services, including genetics evaluation and counseling. The

clinician should refer families to a source of information about qualified early

intervention service providers and the state Universal Newborn Hearing

173

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Intervention Process

Treatment

Information
174

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Screening (UNHS)/Early Hearing Detection and Intervention (EHDI) program.

In many states, clinicians are required to report children with hearing loss to the

state program. 

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Recommended Guidance:

Centers for Disease Control and Prevention (CDC)

Strength of Evidence: Observational Studies, Expert Opinion

• The CDC found evidence to support universal newborn hearing screening at

birth. The CDC recommendation is based on evidence from observational

studies that children who receive intervention services for hearing loss before

the age of 6 months develop significantly better language skills. This is

supported by expert opinion of those who care for children with hearing loss

and parents of children with hearing loss, who report that children with

hearing loss detected as infants have better language skills than older siblings

with later-diagnosed hearing loss.2-4

The Joint Committee on Infant Hearing (JCIH) 

Strength of Evidence: Expert Opinion

• JCIH endorses early detection of and intervention for infants with hearing loss

(early hearing detection and intervention, EHDI) through integrated,

interdisciplinary state and national systems of universal newborn hearing

screening, evaluation, and family-centered intervention. Thus, all infants’

hearing should be screened using objective, physiologic measures in order to

identify those with congenital or neonatal onset hearing loss. Audiologic

evaluation and medical evaluations should be in progress before 3 months of

age. Infants with confirmed hearing loss should receive intervention before 6

months of age from health care and education professionals with expertise in

hearing loss and deafness in infants and young children.5

National Institutes of Health (NIH)

Strength of Evidence: Expert Consensus

• A NIH Consensus Development Conference Statement on Early Identification

of Hearing Impairment in Infants and Young Children recommended that

universal newborn hearing screening be implemented.6

State Legislation

Strength of Evidence: Not Specified

• At present, 38 states and territories have enacted legislation on universal

screening of all infants for hearing loss, and all states have programs to

promote newborn hearing screening.7
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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

U.S. Preventive

Services Task Force

Recommendation

Other Recommended

Guidance

American Academy

of Pediatrics (AAP)

Authored by: 

Grosse S. Newborn hearing evidence-statement: screening. In: Campbell KP, Lanza A, Dixon R,

Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive Services:

Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.

Note: In 2001, the U.S. Preventive Services Task Force (USPSTF) issued an “I”-

rating for “insufficient” evidence for newborn hearing screening, as a result of a

lack of randomized controlled trials evaluating outcomes from newborn hearing

screening.1 However, the USPSTF did note that there is evidence that the average

age of diagnosis is significantly reduced with newborn hearing screening. 

Newborn Screening for Genetic and

Endocrine Disorders

(Screening, Medical Foods, and Treatment)

Clinical Preventive Service Recommendations

In 1996, the U.S. Preventive Services Task Force recommended screening

newborns for phenylketonuria (PKU), congenital hypothyroidism (CH), and

hemoglobin disorders.1 It did not considered other disorders included in state

newborn screening panels. 

Given the availability of new evidence, the USPSTF has decided to update its

1996 recommendation on phenylketonuria (PKU). This review is currently

underway. Please refer the USPSTF website for further information

(www.ahrq.gov/clinic/uspstf/uspsspku.htm).

The American Academy of Pediatrics (AAP) recommends that all food for special

dietary use with accepted benefit for treatment of a medical condition be

reimbursed [covered] as a medical expense, provided that the costs are over and

above usual foods. All expenses for medical equipment and medical supplies

necessary for the delivery of foods for special dietary use should be reimbursed

[covered]. Reimbursement [coverage] for foods for special dietary use should be

mandatory for the following2

: 

1. Any medical condition for which specific dietary components or the

restriction of specific dietary components is necessary to treat a physical,

physiologic, or pathologic condition resulting in inadequate nutrition.

2. An inherited metabolic disorder, including but not limited to disorders of

carbohydrate metabolism, lipid metabolism, vitamin metabolism, mineral

metabolism, or amino acid and nitrogen metabolism.

3. A condition resulting in impairment of oral intake that affects normal

development and growth. 
Expert Consensus (Committee on Nutrition)

An expert group convened by the American College of Medical Genetics

(ACMG) with support from the Health Resources and Services Administration

(HRSA) recently recommended a core panel of 29 disorders to be screened for in

newborn blood spot specimens.3 This screening panel has been endorsed by a

Department of Health and Human Services (DHHS) Secretary’s Advisory

Committee on Heritable Disorders and Genetic Diseases in Newborns and

Children4 and by professional organizations, including the American Academy of

Pediatrics (AAP).5

PKU Management

Screening newborns is just a first step. In 2000, a NIH Consensus Statement on

Phenylketonuria Screening and Management stated that a “multidisciplinary

approach to lifelong care...for the treatment of PKU with....continuity of care

from infancy through adulthood is considered medically necessary for optimal

outcomes for individuals with PKU.” Treatment includes access to appropriate

medical services at specialized multidisciplinary treatment centers and provision

of medical formula and foods.6

SCD Management

NIH guidelines on the management of SCD, last revised in 2002, call for

comprehensive management by a team that includes physicians, nurses, health

educators, and medical social workers, as well as access to a number of specialists.

NIH recommends that a mid-level practitioner coordinate preventive and

primary care, pain management, transfusion and chelation therapy compliance,

and education of patients and other health care providers.7

The recommendations and supporting information contained in this document

came from several sources, including the: 

• American Academy of Pediatrics (AAP)

• American College of Medical Genetics (ACMG) 

• DHHS Secretary’s Advisory Committee on Heritable Disorders and Genetic

Diseases in Newborns and Children

• Government Accountability Office (GAO)

• National Institutes of Health (NIH)

• National Newborn Screening and Genetics Resource Center, funded by the

Health Resources and Services Administration (HRSA)

• Peer-reviewed research

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text.

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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Evidence Rating:

American College of

Medical Genetics

(ACMG)

Information Sources
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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Condition/Disease Specific Information

All states require that providers collect dried blood spot specimens from infants

soon after birth and send them to be tested at an approved screening laboratory

for a panel of disorders specified by the state. All states require screening for a

minimum of four disorders: phenylketonuria (PKU), congenital hypothyroidism

(CH), galactosemia, and sickle cell disease (SCD) and other hemoglobin

disorders. Other disorders that are mandated by the majority of states include

congenital adrenal hyperplasia (CAH), biotinidase deficiency, and medium chain

acyl-CoA dehydrogenase (MCAD) deficiency.8-9 Most states are moving to adopt

the core panel of disorders recommended by the ACMG. 

The most common newborn genetic disorders are congenital hypothyroidism

(CH), with a prevalence at birth of 1 in 2,500 newborns, and sickle cell disease

(SCD), which is diagnosed in 1 in 2,600 newborns.9 The birth prevalence of

phenylketonuria (PKU) in the United States is 1 in 20,000 newborns. 

If untreated, phenylketonuria (PKU) results in severe mental retardation in most

children. Congenital hypothyroidism (CH) results in mental retardation as well

as other forms of cognitive impairment and physical and behavioral problems in

many untreated infants. Sickle cell disease (SCD) results in repeated bouts of

severe pain, disability, and can increase susceptibility to blood-borne infections

that can cause sepsis, meningitis, and death. SCD also results in frequent, painful

crises. In addition, children with SCD are at risk of stroke, which can cause brain

damage and cognitive impairment. 

Most disorders detected by newborn blood spot screening are genetic disorders,

except for congenital hypothyroidism, an endocrine disorder which is primarily

non-genetic.

Value of Prevention

In the absence of screening and treatment, almost all children with

phenylketonuria (PKU) (about 200 births per year) would develop mental

retardation. The average lifetime direct and indirect cost per child born with

mental retardation is $1 million (in year 2003 dollars).10 This indicates a lifetime

burden of at least $200 million for each birth cohort. Prior to screening, at least

1 in every 20,000 children developed mental retardation due to congenital

hypothyroidism (CH).11 This indicates that CH and PKU have similar economic

burdens and, when combined, cost at least $400 million per year.

Sickle cell disease is a major cause of hospitalizations. During 1989 to 1993,

hospitalization costs for children and adults with SCD averaged $475 million per

year (in year) 1996 dollars.12

Family caregivers for children with disabling sequelae such as mental retardation

or painful sickle cell crises are liable to miss days of work, cut back hours, or

leave the workforce altogether. Mothers of children with disabling conditions are
estimated to lose an average of approximately 5 hours of work per week, or 250

hours per year.13 Assuming an hourly cost between $12 and $20 (including fringe

benefits), that implies an economic cost from $3,000 to $5,000 per child, per year.13

Screening for two disorders, phenylketonuria (PKU) and congenital

hypothyroidism (CH), has been demonstrated to be cost-saving to public payers,

with the averted costs of care exceeding the costs of providing screening and

diagnostic services and treatment.14

The cost of newborn screening for genetic and endocrine disorders depends on

the conditions tested for, the screening instruments used, the number of

specimens tested, and the type of follow-up conducted.15

A study by the General Accountability Office (GAO) concluded that, in 2001,

state newborn screening programs spent over $120 million, or an average of

$29.44 per infant.16 All except 5 states charge a fee to birthing centers or other

providers to cover the cost of providing laboratory screening and, to a varying

extent, follow-up services. Some states also use the fee to subsidize the costs of

providing specialist services and/or medical foods. These fees vary from $10 to

over $100 per infant.17

Children with phenylketonuria (PKU) require treatment from specialized

metabolic disease clinics. Dietary treatment for PKU, which is recommended for

life, entails special phenylalanine-free formula that is supplemented with tyrosine

and medical foods. The cost for one year of formula and medical foods can reach

$10,000.18 In contrast, congenital hypothyroidism (CH) can be treated by

primary care providers using inexpensive thyroid hormone medications. 

Children with sickle cell disease (SCD) may be prescribed antibiotics as

prophylaxis against infections, and vaccination against selected bacterial

infections may also be needed. Although many children with SCD are treated by

primary care providers, outcomes such as survival are improved among children

who receive care from a comprehensive SCD center.19 Federally-insured children

with SCD in 1992-1993 had mean expenditures 9 times higher than other

similarly insured children.20 Most of the costs were associated with hospital and

emergency department admissions, although optimal pain management has been

shown to reduce those costs substantially.21 New interventions such as

hydroxyurea, transfusions, and bone marrow transplantation offer promise in the

prevention of painful crises, morbidity, disability, and mortality but, those

treatments require significant expertise and specialized clinical experience to be

utilized appropriately.22

The cost-effectiveness of newborn screening is well established. In particular,

screening for phenylketonuria (PKU) and congenital hypothyroidism (CH) is

cost-saving, with the averted costs of care exceeding the costs of providing

screening, diagnostic services, and treatment.14 Screening for other disorders is

generally cost-effective, if not cost-saving. For example, one analysis of screening

for sickle cell disease (SCD) concluded that screening all newborns for SCD

results in a cost of $10,000 per discounted life year saved.23 Another analysis of

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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention
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Preventive Medication, and Treatment)

Preventive

Intervention:

Purpose of

Screening, Medical

Foods, and Treatment

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening, Medical

Foods, and Treatment

newborn screening for medium chain acyl-CoA dehydrogenase (MCAD)

deficiency found that the cost per quality-adjusted life year (QALY) is likely less

than $30,000.24

Preventive Intervention Information

Newborn screening allows treatment to be initiated within the first few weeks of

life thereby preventing some of the complications associated with genetic and

endocrine disorders. 

Newborn screening for phenylketonuria (PKU) and congenital hypothyroidism

(CH) has been a major public health success in preventing numerous cases of

intellectual disability and assuring normal development of thousands of children.

Newborn screening for other disorders has saved the lives of many children who

would otherwise have died in early childhood.

Studies have shown that treatment for phenylketonuria (PKU) and congenital

hypothyroidism (CH), if begun in the first 3 weeks and adhered to subsequently,

can prevent mental retardation and assure normal cognitive functioning.25-26 Risks

resulting from discontinuation or lack of adherence to treatment vary with the

age of the individual and the severity of the disorder. Newborn screening for

sickle cell disease (SCD), in association with parent and provider education,

clinical management, and vaccine and antibiotic prophylaxis, has been shown to

prevent most deaths associated with SCD in the first 3 to 4 years of life. Early

identification of SCD does not prevent pain crises and strokes, and long-term

outcomes are less clear.27 Treatments for other disorders that are included in some

state screening panels also have benefits and risks. For example, a recent CDC report

evaluated benefits and risks of screening and early treatment for cystic fibrosis.28

The effectiveness of newborn screening is dependent on access to appropriate

medical services and treatments, including medical foods for disorders such as

PKU. Failure of payers to cover medical foods can result in serious adverse

consequences, including, for example, severe intellectual disability and

devastating birth defects among children born to mothers with inadequately

treated PKU.29 Similarly, access to specialized, multidisciplinary treatment centers

may be needed in order to minimize mortality and medical complications. 

The main risk of screening is false-positive results, which can lead to unnecessary

testing and unneeded treatment. False-negative screening results, as well as missed

cases, may lead to delays in diagnosis and treatment. 

Screening should be initiated upon birth, or as soon thereafter as possible, because

initiation of treatment within the first few months of life may be required to

prevent adverse outcomes. Some states require or recommend the collection of

another blood spot specimen between 1 and 4 weeks of age. Families adopting

children from other countries should consult their child’s healthcare provider. 

Medical foods and preventive treatment should be provided as medically necessary.
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Preventive Medication, and Treatment)

Intervention Process

Treatment

Information

A variety of types of equipment, reagents, and protocols are used to screen

newborns. All newborn screening laboratories are CLIA-certified, use approved

technologies, and participate in a rigorous proficiency testing and quality

assurance program maintained by CDC in collaboration with the Association of

Public Health Laboratories.

Children with positive screening test results need to be followed up with further

testing. For disorders for which early treatment is urgent, treatment may be

initiated based on presumptive positive results pending final confirmation.

Children with genetic and endocrine disorders may require one or more of the

following:

• Medical formula or medical foods 

• Medications 

• Treatment from specialized metabolic clinics 

Health benefits should include provisions for case management services, access to

specialty clinics, medical formulas/foods, and medications — as medically

indicated — for the purpose of preventing illness or disability among

beneficiaries with genetic or endocrine disorders. 

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Recommended Guidance:

Medical Foods

The American Academy of Pediatrics (AAP) 

Strength of Evidence: Expert Consensus

• AAP recommends that all food for special dietary use with accepted benefit for

treatment of a medical condition be reimbursed [covered] as a medical

expense, provided that the costs are over and above usual foods. All expenses

for medical equipment and medical supplies necessary for the delivery of foods

for special dietary use should be reimbursed [covered].2

Screening

American College of Medical Genetics (ACMG) 

Strength of Evidence: Expert Opinion

• An expert group convened by the American College of Medical Genetics

(ACMG) recently recommended a core panel of 29 disorders to be screened

for in newborn blood spot specimens.3
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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/At

Least Fair Evidence)

Other Recommended

Guidance

American Academy

of Pediatrics

Authored by: 

Grosse S. Newborn screening for genetic and endocrine disorders evidence-statement: screening,

medical foods, and treatment. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA,

editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington,

DC: National Business Group on Health; 2006.

Management and Preventive Medication

National Institutes on Health (NIH)

Strength of Evidence: Not Specified

• NIH PKU treatment guidelines stipulate that treatment should include access

to appropriate medical services at specialized multidisciplinary treatment

centers and provision of medical formula and foods.6

• NIH guidelines on the management of SCD call for comprehensive

management by a team that comprises doctors, nurses, health educators, and

medical social workers, as well as access to a number of specialties. The NIH

recommends coordination of care by a mid-level practitioner, including

preventive and primary care, pain management, transfusion and chelation

therapy compliance, and education of patients and other health care providers.7

Vision (Child) (Screening)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends screening to

detect amblyopia, strabismus, and defects in visual acuity in children younger

than age 5 years.1-2

The USPSTF found at least fair evidence that the service improves important

health outcomes and concludes that benefits outweigh harms. The USPSTF

found no direct evidence that screening for visual impairment in children leads to

improved visual acuity. However, studies from Sweden and Israel suggest that

early screening for visual impairment may reduce the prevalence of amblyopia in

children.1 Also, the USPSTF found fair evidence that screening tests have

reasonable accuracy in identifying strabismus, amblyopia, and refractive error in

children with these conditions; that more intensive screening compared with

usual screening leads to improved visual acuity; and that treatment of strabismus

and amblyopia can improve visual acuity and reduce long-term amblyopia.1-2

The American Academy of Pediatrics (AAP) recommends the following vision

screening be performed at all well-child visits for children starting in the newborn

period to 3 years: ocular history, vision assessment, external inspection of the eyes

and lids, ocular motility assessment, pupil examination, and red reflex examination.

For children ages 3 to 5 years, the AAP recommends the aforementioned screening
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Preventive Medication, and Treatment)

Evidence Rating:

Center for Medicare

and Medicaid

Services (CMS)

Evidence Rating:

Information Sources

Epidemiology of

Condition/Disease

in addition to age-appropriate visual acuity measurement and ophthalmoscopy. All

children who fail the vision assessment or who have an ocular abnormality should

be referred to a pediatric ophthalmologist or an eye care specialist appropriately

trained to treat pediatric patients.3

Expert Opinion

The Center for Medicare and Medicaid Services (CMS) requires that Early and

Periodic Screening, Diagnostic, and Treatment (EPSDT) services be provided to

all individuals under age 21 enrolled in Medicaid. The EPSDT benefit, at a

minimum, must include diagnosis and treatment of defects in vision, including

eyeglasses. Vision services must be provided according to a distinct periodicity

schedule developed by the state and at other intervals as medically necessary.4

CMS Mandate

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Pediatrics (AAP)

• Centers for Disease Control and Prevention (CDC)

• Center for Medicare and Medicaid Services (CMS)

• National Institutes of Health (NIH)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Visual impairment is a common condition that affects 7% to 8% of children.1

Relatively severe bilateral visual impairment with a best corrected visual acuity in

the better eye of 20/70 or worse occurs in about 1 per 1,000 children ages 6 to

10 years, and blindness (visual acuity worse than 20/400) occurs in about 4 per

10,000 children.5

Causes of visual impairment in children include amblyopia, refractive error not

associated with amblyopia, and strabismus. Significant refractive errors are the

most common and easily corrected vision disorder, affecting up to 20% of young

children.6 Refractive errors are eye disorders in which the shape of the eye does

not allow the light that enters the eye to be focused properly, resulting in blurred

vision. Types of refractive errors include myopia (nearsightedness), hyperopia

(farsightedness), anisometropia (a difference in refractive error between eyes), and

astigmatism (an unequal curvature of the cornea that prevents light rays from

focusing clearly at one point on the retina). Refractive errors are strong risk

factors for amblyopia.
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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Amblyopia refers to reduced visual acuity in one or both eyes that is not due to

ocular structure anomalies and that is not eliminated when refractive error is

corrected. The disorder is most frequently caused by uncorrected anisometropia

or strabismus and can also be caused by cataracts.1 The best estimate of the

prevalence of ambylopia is 3% to 4%.1 An untreated amblyopic eye does not

develop normal vision, and the individual has impaired binocular function

(ability to use the eyes together, such as in depth perception). In addition,

uncorrected amblyopia may be a risk factor for future blindness in later

childhood and adulthood and may harm school performance, ability to learn,

and later, adult self-image. 

Strabismus is present in 3% to 4% of the population.1 It is a deviation or

misalignment of the eyes resulting from the failure of the eye muscles to work

together. Most strabismus develops in early childhood and some types may not

be cosmetically obvious. Strabismus results in poor to absent binocular function

(ability of the eyes to work together) and can result in amblyopia.1

Prematurity and low birth weight are risk factors for amblyopia and strabismus.7-8

Risk factors for other visual impairment disorders are not well understood. 

Value of Prevention

The estimated lifetime cost (in year 2003 dollars) for persons born in 2000 with

vision impairment is $2.5 billion. This is a conservative estimate because it

applies only to the 1 in 1,000 children with corrected visual acuity of 20/70 or

worse. The cost estimate includes both direct and indirect costs and refers to all

excess costs for individuals with vision impairment. 

An estimate of the excess costs attributable specifically to vision impairment in

children in the United States is not available.

The workplace burden of visual impairment in children has not been effectively

measured. Indirect costs of visual impairment, which include the value of lost

wages when a person either cannot work or is limited in the amount or type of

work he or she can do, may be substantial.

No economic evaluation of vision screening in preschool-age children has been

published. A primary benefit of screening is the early detection of amblyopia,

which allows for earlier treatment and improvement of visual acuity in the

affected eye. 

The cost of conducting vision screening in young children varies depending on

the methods used, the setting, and the type of staff performing the screening. In

2004, the private-sector cost of vision screening averaged $71; approximately

95% of paid claims fell within the range of $5 to $133.9

Treatment for visual impairment varies depending on the type, cause, and

severity of impairment. For amblyopia, treatment and associated costs (in year

2001 dollars) are10: 
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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Purpose of

Preventive

Intervention

Benefits and Risks of

Intervention

Initiation, Cessation,

and Interval of

Screening

Intervention Process

• Nonsurgical amblyopia therapy – $1,452

• Nonsurgical amblyopia therapy and ocular alignment – $2,190

• Nonsurgical amblyopia therapy and cataract extraction – $2,628

• Nonsurgical amblyopia therapy and ptosis repair – $1,853

The weighted average cost of surgical and nonsurgical treatment was $1,623 in

year 2001 dollars.10

One cost-effectiveness analysis of treatment for amblyopia in preschool-age

children has been published.6 That study reported that treatment was associated

with a mean improvement in visual acuity from 20/80 to 20/32, and an

associated improvement of health-related quality of life. The estimated cost per

QALY (a measure of health impact) gained from treatment was $2,281 in year

2001 dollars.6 In comparison to other preventive interventions and to commonly

accepted cost-effectiveness benchmarks, vision screening is highly cost-effective. 

Preventive Intervention Information

Visual impairment in children is believed to have an early sensitive period when

interventions lead to better outcomes. Screening for visual impairment allows

clinicians to identify affected patients early and initiate treatment.

The USPSTF found no evidence of harms associated with screening, judged the

potential for harms to be small, and concluded that the benefits of screening are

likely to outweigh any potential harms.2

Based on their review of current evidence, the USPSTF was unable to determine

the optimal periodicity of screening. They recommend screening beginning in

infancy with the methods of screening depending on the child. 

Based on expert opinion, the American Academy of Pediatrics (AAP)

recommends the following vision screening be performed at well-child visits for

children starting in the newborn period to 3 years: ocular history, vision

assessment, external inspection of the eyes and lids, ocular motility assessment,

pupil examination, and red reflex examination. Between the ages of 3 and 5

years, visual acuity can be screened using simple recognition charts.3 After age 5,

standard visual acuity charts such as the Snellen Acuity Chart can generally be

added to the screening.11

Various tests are used widely in the United States to identify visual defects in

children, and the choice of tests is influenced by the child’s age. Beginning in the

first year of life, strabismus can be screened for by using the cover test, the

Hirschberg light reflex test, and the red reflex test. Screening children younger

than age 3 years for visual acuity is more challenging than screening older

children and typically requires testing by specially trained personnel. Newer

automated techniques can be used to screen these children. Photo-screening and

autorefractors can detect amblyogenic risk factors such as significant refractive

error and media opacities; however, these techniques do not provide acuity
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EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)

Treatment

Information

information on the children screened. In children older than 3 years, stereopsis

(ability of both eyes to function together) can be assessed with the Random Dot

E test or Titmus Fly. Some of these tests have better test characteristics than others. 

Recent results from a large, rigorous evaluation of commonly used preschool

vision screening tests supported by the National Institutes of Health (NIH)

indicate that some tests outperform others. The Vision in Preschoolers Study

(VIP) found that the best tests were able to detect two-thirds of children with

vision disorders and that select objective and subjective screening tests can be

effective.11-12

Health benefits should include provisions for follow-up and treatment services. 

Significant refractive errors are easily corrected with eyeglasses and some

amblyopia and strabismus may be prevented by early detection and correction of

significant refractive errors.

Most amblyopia can be treated nonsurgically. Treatment strategies include

covering the sound eye with patching or using pharmacologic agents such as eye

drops. Amblyopia associated with refractive errors may also be treated with

eyeglasses. Select types of amblyopia do require surgical treatments, such as ocular

alignment and cataract extraction, in addition to nonsurgical therapy. 

Treatment of strabismus largely consists of correction with eyeglasses, surgical

correction, and orthoptics (optometric vision therapy). Large constant deviations

present in the first few years usually require surgical intervention, while

intermittent or accommodative esotropia, which most commonly develops at 2

to 3 years of age, can almost always be corrected with eyeglasses.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this section

is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

• The USPSTF found at least fair evidence to recommend screening to detect

amblyopia, strabismus, and defects in visual acuity in children younger than

age 5 years.2

Recommended Guidance:

American Academy of Pediatrics (AAP)

Strength of Evidence: Expert Opinion

• The American Academy of Pediatrics (AAP) found good evidence to support

the following components of vision screening at all well-child visits for
children starting in the newborn period to 3 years: ocular history, vision

assessment, external inspection of the eyes and lids, ocular motility assessment,

pupil examination, and red reflex examination. For children ages 3 to 5 years,

the AAP recommends the aforementioned screening in addition to age

appropriate visual acuity measurement and ophthalmoscopy.3

Center for Medicare and Medicaid Services (CMS)

Strength of Evidence: CMS Mandate

• The Center for Medicare and Medicaid Services (CMS) requires that Early and

Periodic Screening, Diagnostic, and Treatment (EPSDT) services be provided

to all individuals under age 21 enrolled in Medicaid. The EPSDT benefit, at a

minimum, must include diagnosis and treatment of defects in vision, including

eyeglasses. Vision services must be provided according to a distinct periodicity

schedule developed by the state and at other intervals as medically necessary.4

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Preventive Medication, and Treatment)

Authored by: 

Grosse S, Biernath K. Vision evidence-statement: screening. In: Campbell KP, Lanza A, Dixon R,

Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive Services:

Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.

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Preventive Medication, and Treatment)
34. Hilliard LM, Maddox MH, Teng S, Howard TH. Development of a regionalized, comprehensive care network for pediatric

sickle cell disease to improve access to care in a rural state. Dis Manage Health Outcomes 2004;12:393-8.

35. Kemper A, Harris R, Lieu TA, Homer CJ, Whitener BL. Screening for vision impairment in children younger than age 5

years: a systematic evidence review for the U.S. Preventive Services Task Force Systematic Evidence Review Number 27.

Research Triangle Institute, Research Triangle Park, NC. Available from:

http://www.ahrq.gov/downloads/pub/prevent/pdfser/visualser.pdf. 

36. Agency for Healthcare Research and Quality. Guide to Clinical Preventive Services. 3rd ed. Rockville, MD: U.S. Preventive

Services Task Force, Agency for Healthcare Research and Quality; 2001.

37. Packwood EA, Cruz OA, Rychwalski PJ, Keech RI. The psychological effects of amblyopia study. J AAPOS 1999;3:15-7.

38. Centers for Disease Control and Prevention. Economic costs associated with mental retardation, cerebral palsy, hearing loss,

and vision impairment—United States, 2003. MMWR. 2004;53(3):57-9. 

Child Development (Screening)

1. U.S. Preventive Services Task Force. Screening for speech and language delay in preschool ahildren: Recommendation

statement. Pediatrics 2006;117(2):497-501.

2. American Academy of Pediatrics. Identifying infants and young children with developmental disorders in the medical home:

an algorithm for developmental surveillance and screening. Pediatrics 2006;118(1):405-420.

3. Cole L. National Association of Pediatric Nurse Practioners input for Congressman Waxman regarding how to improve

screening and treatment services for children with autistic spectrum disorders in the U.S. August, 2003. 

4. Filipek PA, Accardo PJ, Ashwal S, Baranek GT, Cook EH, et al. Practice paramenter: Screening and diagnosis of autism.

Report of the Quality Standards Subcommittee of the American Academy of Neurology and the Child Neurology Society.

Neurology 2000;55: 468-474.

5. Center for Mental Health Services. Mental Health, United States, 2002. Manderscheid RW, Henderson MJ, eds. DHHS

Publication No. (SMA) 3938. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2004. Chapter 9

pp109-119. 

6. Cordero JF. A new look at behavioral outcomes and teratogens: A commentary. Birth Defects Res. Part A. Clin Mol Teratol

2003; 67:900-902.

7. Koger SM, Schettler T, and Weiss B. Environmental toxicants and developmental disabilities. Am Psychol. 2005; 60(3): 243-255.

8. Cordero JF, Lollar DJ. Environmental factors affecting learning and behavior performance: a commentary. School Psychology

Quarterly 2006 (special issue: In press). 

9. Honeycutt A, Dunlap L, Chen H, et al. Economic costs associated with mental retardation, cerebral palsy, hearing loss, and

vision impairment — United States. MMWR 2004; 53(03):57-59.

10. Swensen AR, Birnbaum HG, Secnik K, Marynchenko M, Greenberg P, Claxton A. Attention-Deficit/Hyperactivity Disorder:

increased costs for patients and their families. J Am Acad Child Adolesc Psychiatry 2003; 42(12):1415-23.

11. Gallaher MM. Christakis DA. Connell FA. Healthcare use by children diagnosed as having developmental delay. Arch Pediatr

Adolesc Med 2002; 156(3): 246-251.

12. Powers ET. Children’s health and maternal work activity: Estimates under alternative disability definitions. J Hum Resour

2003; 38(3):522-556.

13. Thomson Medstat. Marketscan. 2004.

14. National Research Council, Committee on Educational Interventions for Children with Autism, Division of Behavioral and

Social Sciences and Education. Educating Children with Autism. Washington, DC: National Academy Press; 2001.

15. Rogers SJ. Brief report: intervention in Autism. J Autism Dev Disord 1996;26(2):243-246.

16. Reynolds AH, Ou S-R, Topitzes JW. Paths of effects of early childhood intervention on educational attainment and

delinquency: a confirmatory analysis of the Chicago Child-Parent Centers. Child Dev 2004;75(5):1299-1328.

17. Webster-Stratton C and Taylor T. Nipping early risk factors in the bud: preventing substance abuse, delinquency, and violence

in adolescence through interventions targeted at young children (0-8 years). Prev Sci 2001;2(3):165-192.

188

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Preventive Medication, and Treatment)
18. Kwon C and Farrell PM. The magnitude and challenge of false-positive newborn screening test results. Archives of Pediatric

& Adolescent Medicine 2000;154:714-718.

19. Glascoe FP. Are overreferrals on developmental screening tests really a problem? Archives of Pediatrics & Adolescent Medicine

2001;155(1):54-59.

20. U.S. Preventive Services Task Force. Screening for Speech and Language Delay in Preschool Children: Recommendation

Statement. Pediatrics 2006:117(2):497-501.

Dental Caries Prevention Through Oral Fluoride Supplementation (Preventive Medication)

1. Agency for Healthcare Research and Quality. Guide to Clinical Preventive Services. 3rd ed. Rockville, MD: U.S. Preventive

Services Task Force, Agency for Healthcare Research and Quality; 2001.

2. Centers for Disease Control and Prevention. Recommendations for using fluoride to prevent and control dental caries in the

United States. MMWR 2001;50 (RR 21):1-42.

3. Centers for Disease Control and Prevention. Surveillance for dental caries, dental sealants, tooth retention, edentulism, and

enamel fluorosis. MMWR 2005; 54,SS-3:1-44.

4. U.S. Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General. Rockville, MD:

National Institute of Dental and Craniofacial Research, National Institutes of Health; 2000.

5. Pitts NB. Risk assessment and caries prediction. J Dent Educ 1998;62:762-70.

6. Vargas CM, Crall JJ, Schneider DA. Sociodemographic distribution of pediatric dental caries: NHANES III, 1988-1994. J

Am Dent Assoc 1998;129:1229-38.

7. Edelstein BL. The medical management of dental caries. J Am Dent Assoc 1994;125 (suppl):31-9.

8. Meskin LH, editor. Caries diagnosis and risk assessment: a review of preventive strategies and management. J Am Dent Assoc

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9. Palmer, C. Dental spending up 6.1 percent in 2004 to $81.5 billion. ADA News. American Dental Association; 2006.

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11. Thomson Medstat. Marketscan. 2004. 

12. American Dental Association. Key dental facts. Chicago (IL): American Dental Association; 1997.

13. U.S. Census Bureau. The official statistics, statistical abstract of the United States, estimates for dental expenditures. Available

from: http://www.census.gov/prod/2004pubs/03statab/health.pdf.

14. Bader JD, Rozier G, Harris R, Lohr KN. Dental caries prevention: the physician’s role in child oral health. Systematic

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15. Pendrys DG, Katz RV, Morse DR. Risk factors for enamel fluorosis in a fluoridated population. Am J Epidemiol

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16. Lasagna L. Balancing risks versus benefits in drug therapy decisions. Clin Ther 1998;20 (suppl C):72-9. 

17. Levy SM. Review of fluoride exposures and ingestion. Community Det Oral Epidemiology 1994;22:173-80.

18. Margolis FJ, Burt BA, Schork A, Bashshur RL, Whittaker BA, Burns TL. Fluoride supplements for children: a survey of

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Lead, Elevated Blood Lead Levels (Screening)

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2. Centers for Medicare and Medicaid Services. Medicaid Early & Periodic Screening & Diagnostic Treatment Benefit. Updated

189

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December 2005. [cited 2006 Oct 17]. Available from: http://www.cms.hhs.gov/MedicaidEarlyPeriodicScrn/02_Benefits.asp.

3. Agency for Toxic Substances and Disease Registry. The nature and extent of lead poisoning in children in the United States: a

report to Congress. Atlanta, GA: Agency for Toxic Substances and Disease Registry; 1988.

4. Lidsky TI, Schneider JS. Lead neurotoxicity in children: basic mechanisms and clinical correlates. Brain 2003;126:5-19.

5. Schwartz J, Angle C, Pitcher H. Relationship between childhood blood lead levels and stature. Pediatrics 1986;77:281-8.

6. Shukla R, Bornschein RL, Dietrich KN, Buncher CR, Berger OG, Hammond PB, Succcop PA. Fetal and infant lead

exposure: effects on growth in stature. Pediatrics 1989;84:604-12.

7. Bellinger D, Leviton A, Allred E, Rabinowitz M. Pre- and postnatal lead exposure and behavior problems in school-aged

children Environ Res 1994;66:12-30.

8. Wasserman GA, Staghezza-Jaramillo B, Shrout P, Popovac D, Graziano J. The effect of lead exposure on behavior problems in

preschool children. Am J Public Health 1998;88:481-6.

9. Burns JM, Baghurst PA, Sawyer MG, McMichael AJ, Tong SL. Lifetime low-level exposure to environmental lead and

children’s emotional and behavioral development at ages 11-13 years. The Port Pirie Cohort Study. Am J Epidemiol

1999;149:740-9.

10. Kahn C, Kelly P, Walker W. Lead screening in children with attention deficit hyperactivity disorder and developmental delay.

Clin Pediatr 1995;34:498-501.

11. Bellinger D, Hu H, Titlebaum L Needleman HL. Attentional correlates of dentin and bone lead levels in adolescents. Arch

Environ Health 1994;49:98-105.

12. Bellinger D, Leviton A, Waternaux C, Needleman H, Rabinowitz M. Longitudinal analyses of prenatal and postnatal lead

exposure and early cognitive development. N Engl J Med 1987;316:1037-43.

13. Needleman H, Gatsonis C. Low-level lead exposure and the IQ of children. JAMA 1990;263:673-8.

14. Wasserman GA, Liu X, Lolacono NJ, Factor-Litvak kP, Kline JK, Popovac D, et al. Lead exposure and intelligence in 7 year

old children: the Yugoslavia Prospective Study. Environ Health Perspect 1997;105:956-62.

15. Lanphear BP, Dietrich K, Auinger P, Cox C. Cognitive deficits associated with blood lead concentrations <10 μg/dL in U.S.

children and adolescents. Public Health Rep 2000;115:521-9.

16. Canfield RL, Henderson CR, Cory-Slechta DA, Cox C, Jusko TA, Lanphear BP. Intellectual impairment in children with

blood lead concentrations below 10 _g/dL. N Engl J Med 2003;348:1517–26.

17. Chen A, Dietrich KN, Ware JH, Radcliffe J, Rogan WJ. IQ and blood lead from 2 to 7 years of age: Are the effects in older

children the residual of high blood lead concentrations in 2-year olds? Environ Health Perspect 2005;113:597-601.

18. National Research Council. Measuring Lead Exposure in Infants, Children and Other Sensitive Populations. Washington, DC:

National Academy Press: 1993.

19. Schwartz J. Low-level lead exposure and children’s IQ: A meta-analysis and search for a threshold. Environ Res. 1994;65:42-55.

20. Blood lead levels—United States 1999–2002. MMWR 2005;54:513–6.

21. Jacobs DE, Clickner RP, Zhou JY, Viet SM, Marker DA, Rogers JW, et al. The prevalence of lead-based paint hazards in U.S.

Housing. Environ Health Perspect 2002;110:A599-A606.

22. Brody DJ, Pirkle JL, Kramer RA, Flegal KM, Matte TD, Gunter EW, Paschal DC. Blood lead levels in the US Population:

Phase 1 of the Third National Health and Nutrition Examination Survey (NHANES III, 1988-1991). JAMA 1994;272:277-

283.

23. Pirkle JL, Kaufmann RB, Brody DJ, Hickman T, Gunter EW, Paschal DC. Exposure of the U.S. population to lead, 1991-

1994. Environ Health Perspect 1998;106:745-750.

24. Roscoe RJ, Gittleman JL, Deddens JA, Petersen MR, Halperin WE. Blood lead levels among children of lead-exposed

workers. A meta-analysis. Am J Ind Med 1999;36:475-81.

25. Centers for Disease Control and Prevention. Folk remedy-associated lead poisoning in Hmong children- Minnesota. MMWR

1983;32:555-6.

26. Centers for Disease Control and Prevention. Lead poisoning associated with use of traditional ethnic remedies-California

1991-1992. MMWR 1993; 42:531-4.

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Preventive Medication, and Treatment)
27. Centers for Disease Control and Prevention. Lead poisoning from Mexican folk remedies-California. MMWR 1983;32:554-5.

28. Centers for Disease Control and Prevention. Childhood lead poisoning from commercially manufactured French ceramic

dinnerware --- New York City, 2003. 2004;53:584.

29. Centers for Disease Control and Prevention. Brief report: Lead poisoning from ingestion of a toy necklace --- Oregon, 2003.

MMWR 2004;53;509.

30. Norman EH, Hertz-Picciotto I, Salmen DA Ward TH. Childhood lead poisoning and vinyl miniblind exposure. Arch Pediatr

Adolesc Med 1997;151:1033-7.

31. Centers for Disease Control and Prevention. Death of a child after ingestion of a metallic charm. MMWR Dispatch 2006;55.

32. Vergara AE, Pertowski CA, Rosenblum LS. Lead poisoning: costs of care in the United States, 1988-1992. JAMA

1996;276(15):1221.

33. Landrigan PJ, Schechter CB, Lipton JM, Fahs MC, Schwartz J. Environmental pollutants and disease in American children:

estimates of morbidity, mortality, and costs for lead poisoning, asthma, cancer and developmental disabilities. Environ Health

Perspect 2002;110(7):721-728.

34. Grosse SD, Matte TD, Schwartz J, Jackson RJ. Economic gains resulting from the reduction in children’s exposure to lead in

the United States. Environ Health Perspect 2002;110:563-9.

35. Thomson Medstat. Marketscan. 2004. 

36. Brown MJ. Costs and benefits of enforcing housing policies to prevent childhood lead poisoning. Med Dec Making

2002;22:482–92.

37. Briss PA, Matte TD, Schwartz J, Rosenblum LS, Binder S. Costs and benefits of a universal screening program for elevated

blood lead levels in 1-year-old children. In: Centers for Disease Control and Prevention. Screening young children for lead

poisoning; guidance for state and local health officials. Atlanta. GA: US DHHS. CDC, National Center for Environmental

Health; 1997.

38. Centers for Disease Control and Prevention. Elevated blood lead levels in refugee children--New Hampshire, 2003—2004.

MMWR January 21, 2005.

39. Lane WG, Kemper AR. American College of Preventive Medicine Practice Policy Statement. Screening for elevated blood

lead levels in children. Am J Prev Med 2001;20(1):78–82. As cited by the National Guidelines Clearinghouse. Agency for

Healthcare Research and Quality. Available form:

http://www.guideline.gov/summary/summary.aspx?doc_id=3155&nbr=2381&string=lead+AND+poisoning.

40. Centers for Disease Control and Prevention. Managing elevated blood lead levels among young children: recommendations

from the Advisory Committee on Childhood Lead Poisoning Prevention. Atlanta, GA: US Department of Health and

Human Services, Public Health Service, CDC; 1997. Available from: www.cdc.gov/nceh/lead.

Newborn Hearing (Screening)

1. U.S. Preventive Services Task Force. Screening for Newborn Hearing. Summary of Recommendations. Rockville, MD:

Agency for Healthcare Research and Quality; 2001 Available from: http://www.ahrq.gov/clinic/uspstf/uspsnbhr.htm.

2. Moeller M. Early intervention and language development in children who are deaf and hard of hearing. Pediatrics 2000

Sep;106(3):1-9.

3. Yoshinaga Itano C, Sedey A, Coulter B, Mehl A. Language of Early- and later-identified children with hearing loss. Pediatrics

1998;102:1161-71.

4. Yoshinaga-Itano C, Gravel JS. The evidence for universal newborn hearing screening. Am J Audiol 2001;10:62-4.

5. Joint Committee on Infant Hearing. Year 2000 position statement: principles and guidelines for early hearing detection and

intervention programs. Pediatrics 2000 Oct;106(4): 198-817. Available from: http://www.jcih.org/jcih2000.pdf.

6. Early identification of hearing impairment in infants and young children. NIH Consensus Statement 1993 Mar 1-3;11(1):1-

24. Available from: http://consensus.nih.gov/1993/1993HearingInfantsChildren092html.htm. 

7. National Center for Hearing Assessment and Management. Legislative activities. Available from:

http://www.infanthearing.org/legislative/index.html.

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Preventive Medication, and Treatment)
192

8. Centers for Disease Control and Prevention. Frequently Asked Questions (FAQs) on General Information on Hearing Loss.

Available from: http://www.cdc.gov/ncbddd/ehdi/FAQ/questionsgeneralHL.htm#prev.

9. Bess F, Dodd-Murphy J, Parker R. Children with minimal sensorineural hearing loss: Prevalence, educational performance,

and functional status. Ear Hear 1998;19:339-354.

10. Cone-Wesson B, Vohr B, Sininger Y, Widen J, Folsom R, Gorga M, et al. Identification of Neonatal Hearing Impairment:

Infants with Hearing Loss. Ear Hear 2000;21:488-507. Notes: Filed under “Norton Study Articles”.

11. Centers for Disease Control and Prevention. Economic costs associated with mental retardation, cerebral palsy, hearing loss,

and vision impairment — United States, 2003. MMWR 2004;53:57 59. 

12. Schroeder L, Petros S, Kennedy C, McCann D, Law C, Watkin PM, et al. The economic costs of congenital bilateral

permanent childhood hearing impairment. Pediatrics 2006;117:1101-12.

13. Thomson Medstat. Marketscan. 2004.

14. Mehl AL, Thomson V. Newborn hearing screening: the great omission. Pediatrics 1998 Jan;101(1):E4.

15. Keren R, Helfand M, Homer C, McPhillips H, Lieu TA. Projected cost-effectiveness of statewide universal newborn hearing

screening. Pediatrics 2002;110:855-64.

16. Van Naarden K, Decoufle P, Caldwell K. Prevalence and characteristics of children with serious hearing impairment in

metropolitan Atlanta, 1991-1993. Pediatrics 1999;103:570-5.

17. Traxler CB. Measuring up to performance standards in reading and mathematics: Achievement of selected deaf and hard-ofhearing students in the national norming of the 9th Edition Stanford Achievement Test. J Deaf Stud Deaf Educ 2000;5:337-

348.

18. Clemens CJ, Davis SA, Bailey AR. The false-positives in Universal Newborn Hearing Screening. Pediatrics 2000;106(1):e7 

(5 pages).

19. Reich DS, Wiatrak BJ. Methods of sedation for auditory brainstem response testing. Int J Pediatr Otorhinolaryngol

1996;38:131-41.

20. Centers for Disease Control and Prevention. National EHDI goals. Available from:

http://www.cdc.gov/ncbddd/ehdi/nationalgoals.htm.

Newborn Screening for Genetic and Endocrine Disorders (Screening, Medical Foods, and Treatment)

1. Agency for Healthcare Research and Quality. Guide to Clinical Preventive Services. 2nd ed. Baltimore, MD: U.S. Preventive

Services Task Force, Agency for Healthcare Research and Quality; 1996.

2. American Academy of Pediatrics; Committee on Nutrition. Reimbursement for foods for special dietary use. Policy

Statement. Pediatrics 2003;11(5):1117-1119.

3. American College of Medical Genetics. HRSA Commissioned Report: Newborn Screening: Toward a Uniform Screening

Panel and System. [cited 2005 Mar 10]. Available from: http://mchb.hrsa.gov/screening/.

4. Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children. Minutes of Second Meeting,

Washington, DC, September 22–23, 2004. [cited 2003 Jul 13]. Available from:

http://mchb.hrsa.gov/programs/genetics/committee/2ndmeeting.htm. 

5. American Academy of Pediatrics. AAP endorses newborn screening report from the American College of Medical Genetics.

Released May 12, 2005. [cited 2005 Jul 15]. Available from: http://www.aap.org/advocacy/releases/mayscreening.htm. 

6. National Institutes of Health. Phenylketonuria: Screening and management. Consensus development conference statement.

Bethesda, MD: National Institutes on Health; Oct 2000. [cited 2005 Jul 15]. Available from:

http://www.nichd.nih.gov/publications/pubs/pku/sub3.htm. 

7. National Institutes of Health. The Management of Sickle Cell Disease. 4th edition. NIH Publication 02-2117. Bethesda, MD;

2002. [cited 2006 May 5]. Available from: http://www.nhlbi.nih.gov/health/prof/blood/sickle/sc_mngt.pdf. 

8. National Newborn Screening and Genetics Resource Center. National Newborn Screening Status Report. San Antonio, TX:

National Newborn Screening and Genetics Resource Center, updated 7/12/ 2005. [cited 2005 July 12]. Available from URL:

http://genes-r-us.uthscsa.edu/nbsdisorders.pdf.

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)
9. National Newborn Screening and Genetics Resource Center. National Newborn Screening Report 2000. San Antonio, TX:

National Newborn Screening and Genetics Resource Center, 2003. Available from: 

http://genes-r-us.uthscsa.edu/resources/newborn/00chapters.html.

10. Centers for Disease Control and Prevention. Economic costs associated with mental retardation, cerebral palsy, hearing loss,

and vision impairment — United States, 2003. MMWR 2004;53:57–9.

11. Alm J. Hagenfeldt L. Larsson A. Lundberg K. Incidence of congenital hypothyroidism: retrospective study of neonatal

laboratory screening versus clinical symptoms as indicators leading to diagnosis. BMJ 1984;289:1171–5.

12. Hilliard LM. Maddox MH, Teng S. Howard TH. Development of a regionalized, comprehensive care network for pediatric

sickle cell disease to improve access to care in a rural state. Dis Manage Health Outcomes 2004;12:393-8.

13. Powers ET. Children's health and maternal work activity: Estimates under alternative disability definitions. J Hum Resour

2003;38(3):522-556.

14. U.S. Congress, Office of Technology Assessment. Healthy Children: Investing in the Future. Washington, DC: U.S.

Government Printing Office; 1988.

15. Thompson Medstat. Marketscan. 2004. 

16. General Accounting Office. Newborn Screening: Characteristics of State Programs, 2002. [cited 2005 July 17]. Available from:

www.gao.gov/new.items/d03449.pdf.

17. National Newborn Screening and Genetics Resource Center. Newborn Screening Program Fees. Austin, Texas: August 30, 2004.

18. Foundation for Blood Research. Available from: http://www.fbr.org/publications/cc/cc-scene1-main.html.

19. Davis H, Moore RM Jr, Gergen PJ. Cost of hospitalizations associated with sickle cell disease in the United States. Public

Health Rep 1997;112:40-3.

20. Bilenker JH, Weller WE, Shaffer TJ, Dover GJ, Anderson GF. The costs of children with sickle cell anemia: preparing for

managed care. J Pediatr Hematol Oncol 1998;20:528-33.

21. Jamison C, Brown HN. A special treatment program for patients with sickle cell crisis. Nurs Econ 2002;20:126-32. 

22. Nietert PJ, Silverstein MD, Abboud MR. Sickle cell anemia: epidemiology and cost of illness. Pharmacoeconomics

2002;20:357-66.

23. Panepinto JA, Magid D, Rewers MJ, et al. Universal versus targeted screening of infants for sickle cell disease: A costeffectiveness analysis. J Pediatrics 2000;136:201-208.

24. Insinga RP, Laessig RH, Hoffman GL. Newborn screening with tandem mass spectrometry: examining its cost-effectiveness

in the Wisconsin Newborn Screening Panel. J Pediatr 2003 Jan;142(1):56.

25. American Academy of Pediatrics. Committee on Genetics. Newborn screening fact sheets. Pediatrics 2006 Sep;118(3):e934-63. 

26. American Academy of Pediatrics; Rose SR; Section on Endocrinology and Committee on Genetics, American Thyroid

Association; Brown RS; Public Health Committee, Lawson Wilkins Pediatric Endocrine Society; Foley T, Kaplowitz PB, Kaye

CI, Sundararajan S, Varma SK.Update of newborn screening and therapy for congenital hypothyroidism. Pediatrics 2006

Jun;117(6):2290-303. 

27. Quinn CT, Rogers ZR, Buchanan GR. Survival of children with sickle cell disease. Blood. 2004;103:4023-7.

28. Grosse SD, Boyle CA, Botkin JR, Comeau AM, Kharrazi M, Rosenfeld M, et al; CDC. Newborn screening for cystic fibrosis:

evaluation of benefits and risks and recommendations for state newborn screening programs. MMWR 2004 Oct 15;53(RR13):1-36.

29. Levy, HL. Historical background for the maternal PKU syndrome. Pediatrics 2003 Dec;112 (6 part 2): 15168. 

193

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Preventive Medication, and Treatment)
194

Vision (Child) (Screening)

1. Kemper A, Harris R, Lieu TA, Homer CJ, Whitener BL. Screening for vision impairment in children younger than age 5

years: a systematic evidence review for the U.S. Preventive Services Task Force Systematic Evidence Review Number 27.

Research Triangle Institute, Research Triangle Park, NC. Available from:

http://www.ahrq.gov/downloads/pub/prevent/pdfser/visualser.pdf. 

2. U.S. Preventive Services Task Force. Guide to Clinical Preventive Services, 3rd ed. Rockville (MD): Agency for Healthcare

Research and Quality; 2003.

3. American Academy of Pediatrics Committee on Practice and Ambulatory Medicine, Section on Ophthalmology. Eye

examination in infants, children, and young adults by pediatricians. Pediatrics 2003;111(4):902-7. 

4. Centers for Medicare and Medicaid Services. Medicaid Early & Periodic Screening and Treatment Benefit. Available from:

http://www.cms.hhs.gov/MedicaidEarlyPeriodicScrn/02_Benefits.asp. Accessed October 23, 2006.

5. Center for Preventive Ophthalmology and Biostatistics. University of Pennsylvania School of Medicine. Vision in

Preschoolers Study. Available from: http://www.med.upenn.edu/cpob/studies/studies_vip.shtml. 

6. Robaei D, Kifley A, Gole GA, Mitchell P. The impact of modest prematurity on visual function at age 6 years: findings from

a population-based study. Arch Ophthalmol 2006;124(6):871-7.

7. Centers for Disease Control and Prevention. Economic costs associated with mental retardation, cerebral palsy, hearing loss,

and vision impairment—United States, 2003. MMWR 2004;53(3):57-9.

8. Rudanko SL, Fellman V, Laatikainen L. Visual impairment in children born prematurely from 1972 through 1989.

Ophthalmology 2003;110(8):1639-45.

9. Thomson Medstat. Marketscan. 2004.

10. Membreno JH, Brown MM, Brown GC, Sharma S, Beauchamp GR. A cost-utility analysis of therapy for amblyopia.

Ophthalmol 2002;109:2265-71.

11. The Vision in Preschoolers Study Group. Comparison of preschool vision screening tests as administered by licensed eye care

professionals in the Vision in Preschoolers Study. Ophthalmology 2004;111:637-650.

12. The Vision in Preschoolers Study Group. Preschool vision screening tests administered by nurse screeners compared with lay

screeners in the Vision in Preschoolers Study. Invest Ophthalmol Vis Sci 2005;46(8):2639-2648. 

EVIDENCE-STATEMENT: Child Health Promotion (Screening, Counseling, Immunization, 

Preventive Medication, and Treatment)
195

Why This Chapter is

Important for

Employers:

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/ 

Good Evidence)

Information Sources

• Colorectal cancer is the second leading cause of cancer death.1

• Routine screening can reduce the number of people who die of colorectal

cancer. While estimates of mortality reduction due to screening vary by type of

screening test, the range is approximately 15% to 60%.2-3

• The estimated annual national expenditure for colorectal cancer treatment is

$5.5-$6.5 billion; inpatient hospital care accounts for 80% of this cost.4

• Because colorectal cancer is a disease of middle and old age, the costs related to

colorectal cancer treatment are likely to increase as the population ages. For

example, hospital admissions for colorectal cancer are expected to double by

2050.4

• Screening can prevent colorectal cancer by allowing clinicians to identify and

remove precancerous polyps before they develop into cancer. Screening can

also identify cancer early in the course of the disease when treatment is more

effective and the chance of recovery is high.2-5

• The cost of screening is typically less than the cost of treating cancer. When

screening identifies a colorectal tumor in its early stages, the cost of treatment

is often much less expensive than if the tumor is detected later in the course of

disease.4

Clinical Preventive Service Recommendations

The USPSTF strongly recommends that clinicians screen men and women 50

years of age or older for colorectal cancer.2

The USPSTF found fair to good evidence that several screening methods are

effective in reducing mortality from colorectal cancer. The USPSTF concluded

that the benefits from screening substantially outweigh potential harms, but the

quality of evidence, magnitude of benefit, and potential harms vary with each

method.2

The recommendations and supporting information contained in this document

came from several sources, including the:

• Agency for Healthcare Research and Quality (AHRQ)

• American Cancer Society (ACS)

• International Agency for Research on Cancer (IARC)

• National Academy of Sciences (NAS)

• Peer-reviewed research

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

EVIDENCE-STATEMENT:

COLORECTAL CANCER (Screening)
196

EVIDENCE-STATEMENT: Colorectal Cancer (Screening)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Condition/Disease Specific Information

Colorectal cancer is the second leading cause of cancer death in the United

States. It is also a major cause of premature mortality; patients who die of

colorectal cancer lose 13 years of life, on average.1 The American Cancer Society

(ACS) estimated that there would be 104,950 colon and 40,340 rectal cancer

cases in the United States in 2005. Although mortality rates have continued to

decline over the past 15 years, an estimated 56,290 deaths from colorectal cancer

were predicted to occur in 2005, comprising about 10% of all cancer deaths.1

Risk factors for colorectal cancer include being male, being older, having a family

history of colorectal cancer, having a personal history of inflammatory bowel

disease, being overweight or obese, being physically inactive, having certain

genetic conditions3, and (possibly) consuming inadequate amounts of fruits and

vegetables.6

Value of Prevention

The annual expenditure for colorectal cancer was conservatively estimated to

equal $5.3 billion in 2000.5 However, other investigators estimated that inpatient

costs alone exceeded $5 billion in 1994 and their analysis also indicated that

colon cancer-related admissions were twice as long and twice as expensive as the

average hospital admission in the United States.4

Because colorectal cancer is a disease of middle and old age, the costs related to

colorectal cancer treatment are likely to increase as the population ages. Based on

census projections, the annual number of colon cancer-related hospital

admissions among persons aged 50 years is expected to increase from 215,000 in

1992 to 471,000 in 2050. Similarly, among persons aged 60 years and older

hospital admissions for colorectal cancer are expected to increase from 192,000 in

1992 to 448,000 in 2050.4

Besides the health, disability, and life insurance costs for employees affected by

colorectal cancer, lost productivity associated with morbidity and premature

mortality contributes to significant additional costs. During 1998, colorectal patients

were hospitalized for 2.3 million days — a work loss equivalent of $70.9 million in

lost wages among the working-age population. This figure would increase to $106.1

million if time away from work due to care in all settings was considered.5

Screening can prevent colorectal cancer by allowing clinicians to identify and remove

precancerous polyps before they develop into cancer. Screening can also identify

cancer early in the course of the disease when treatment is more effective and the

chance of recovery is high. The cost of screening is typically less than the cost of

treating cancer and, when screening identifies a colorectal tumor in its early stages,

the cost of treatment is often much less expensive. For example, one study, which

looked at the cancer care costs among members of a health maintenance organization

(HMO), found that the net costs of initial care for colon cancer were $7,002 at the

carcinoma in situ stage and $11,624 at the local stage compared to $13,367 at the

regional stage, and $15,276 at the distant stage (all figures in year 1992 dollars).7
197

EVIDENCE-STATEMENT: Colorectal Cancer (Screening)

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

The average cost of colorectal cancer screening varies by location and provider.

The 5 recommended methods of screening for colorectal cancer have very

different initial costs, with FOBT and colonoscopy being the least and most

expensive methods respectively. However, because they are typically used at

different time intervals and because colonoscopy is required to confirm results of

the other methods, the 10-year overall cost for screening methods that include

diagnostic colonoscopy are similar. Table 1 lists the average price of colorectal

cancer screening, by type. Cost estimates are based on 2004 data from privatelyinsured beneficiaries.8

Table 1: Average Private-Sector Cost of Colorectal

Cancer Screening Methods (in year 2004 dollars)8

Screening Technique Average Price Recommended Average Price 

per Procedure Number of Over Over a 10-year 

a 10-Year Period Interval

Colonoscopy $557 1 $557

(range $150 to (range $150 to 

$1,112)* $1,112)*

Flexible sigmoidoscopy; $174 2 $348

requires a follow-up (range $54 (range $108 to 

colonoscopy if polyps to $392)* $784)*

are found

Double-contrast barium $126 2 $252

enema; may require follow-up (range $38 (range $76

colonoscopy to $399)* to $798)*

Fecal occult blood test $7 10 $70 

(FOBT); may require (range $2 (range $20

follow-up colonoscopy to $16)* to $160)*

Combination of flexible $181 2/10 $418

sigmoidoscopy and FOBT (range $56 (range $128

to $408)* to $944)*

Source: Thompson Medstat. Marketscan. 2004.*Approximately 95% of paid claims fell within

the stated range.

Not Provided

A systematic review of cost-effectiveness analyses for different colorectal cancer

screening methods found that most common screening strategies for adults aged

50 years or more would result in an average cost-effectiveness ratio ranging from

$10,000 to $30,000 per life-year saved (year 2000 dollars) compared to no

screening.9 In comparison to other preventive interventions and to commonly

accepted cost-effectiveness benchmarks, screening for colorectal cancer is costeffective.
198

EVIDENCE-STATEMENT: Colorectal Cancer (Screening)

Preventive

Intervention: 

Purpose of 

Screening

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening

Preventive Intervention Information

The purpose of screening for colorectal cancer is to find precancerous

polyps so that they can be removed before they turn cancerous, thus

preventing the development of a tumor. Screening can also identify

cancer early in the course of the disease when treatment is more effective

and the chance of recovery is high. 

Unfortunately, screening rates for colorectal cancer are low; fewer than

half of men and women over age 50 are screened at the recommended

intervals.10

The benefits of screening are substantial. Routine screening can reduce

the number of people who die of colorectal cancer by preventing cancer

or identifying it in its earliest stages when treatment is most effective.

While estimates of mortality reduction due to screening vary by type of

screening test, the range is approximately 15% to 60%.2 

The risks associated with screening depend on the type of screening

method used. All of the recommended tests can produce false-positive

results, which may lead to unnecessary procedures with resultant harms.

Flexible sigmoidoscopy, colonoscopy, and double-contrast barium enema

may cause perforation and bleeding. However, the benefits of colorectal

cancer prevention and early detection outweigh the risks of every

screening method.2

Screening for colorectal cancer should be initiated at age 50 for both men

and women. For individuals who are determined by their physicians to be

at higher risk of the disease, screening may be initiated at an earlier age.11

Screening has been found to be effective for people up to age 80.

However, randomized trials suggest that life expectancy of at least 5 years

may be required to realize the benefits of screening, so the risks and costs

of screening may outweigh the benefits for people with reduced life

expectancy because of age or illness.5

The optimal interval between screenings depends on the screening

method used and is illustrated in Table 2.

Table 2: Colorectal Cancer Screening Methods and 

Recommended Intervals5

Screening Method Recommended Interval

Colonoscopy 10 years

Flexible sigmoidoscopy 5 years

Double-contrast barium enema 5 years

Fecal occult blood tests (FOBT) 1 year

Combination of flexible 5 years for the flexible 

sigmoidoscopy and FOBT sigmoidoscopy and one year for 

the FOBT
EVIDENCE-STATEMENT: Colorectal Cancer (Screening)

Intervention Process

Treatment

Information

199

Approved methods of screening for colorectal cancer include colonoscopy, flexible

sigmoidoscopy, fecal occult blood testing (FOBT), and double-contrast barium

enema. FOBT may be combined with flexible sigmoidoscopy to improve the

sensitivity of the tests. The approved FOBT test uses specimens collected in the

patient’s home.2-3

Health benefits should include provisions for diagnostic and treatment services.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research: 

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence) 

• The USPSTF found fair to good evidence that several screening methods are

effective in reducing mortality from colorectal cancer. The USPSTF concluded

that the benefits from screening substantially outweigh potential harms, but

the quality of evidence, magnitude of benefit, and potential harms vary with

each method.2

Authored by: 

Campbell KP, Coates RJ, Chattopadhyay S. Colorectal cancer evidence-statement: screening. In:

Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to

Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on

Health; 2006.

References:

1. American Cancer Society. Cancer Facts & Figures 2005. Atlanta, GA: American Cancer Society; 2005.

2. U.S. Preventive Services Task Force. Screening for colorectal cancer. Summary of recommendations. Rockville, MD: Agency

for Healthcare Research and Quality; 2002; [cited 2006 Sep 15]. Available from:

http://www.ahrq.gov/clinic/uspstf/uspscolo.htm. 

3. U.S. Preventive Services Task Force. Colorectal cancer screening. Summary, evidence report: Number 1. AHCPR Publication

No. 97-0302. Rockville, MD: Agency for Health Care Research and Quality; 1998.

4. Seifeldin R, Hantsch JJ. The economic burden associated with colon cancer in the United States. Clinical Therapeutics. 1999;

21(8): 1370-1379.

5. The American Gastroenterological Association. The Burden of Gastrointestinal Diseases. Bethesda, MD: American

Gastroenterological Association; 2001. Available from: http://www.gastro.org/user-assets/Documents/burden-report.pdf.

6. International Agency for Research on Cancer. Weight control and physical activity. IARC handbooks of cancer prevention,

vol. 6. Lyon (France): IARC Press; 2002.

7. Taplin SH, Barlow W, Urban N, Mandelson MT, Timlin DJ, Ichikawa L, et al. Stage, Age, Comorbidity, and Direct Costs of

Colon, Prostate, and Breast cancer Care. Journal of the National Cancer Institute 1995;87(6):417-426. 
200

EVIDENCE-STATEMENT: Colorectal Cancer (Screening)

8. Thomson Medstat. Marketscan. 2004.

9. Pignone M, Saha S, Heorgem T, Mandelblatt J. Cost-effectiveness analyses of colorectal cancer screening: a systematic review.

Ann Internal Med 2002;137:96-104.

10. Seeff LC, Nadel MR, Klabunde CN, Thompson T, Shapiro JA, Vernon SW, et al. Patterns and predictors of colorectal cancer

test use in the adult U.S. population. Cancer 2004;100: 2093-103.

11. Berg AO, Atkins D. Screening for colorectal cancer: recommendations and rationale. Rockville, MD: Agency for Health Care

Research and Quality; 2002.

12. Pignone M, Saha S, Heorgem T, Mandelblatt J. Cost-effectiveness analyses of colorectal cancer screening: a systematic review.

Ann Internal Med 2002;137:96-104.
201

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence-Based

Recommendations

American Academy

of Family Physicians

(AAFP)

Evidence Rating: R

(Recommended)

• Unintended pregnancy is a significant problem in the United States.

Approximately 3 million unintended pregnancies occur each year1 and roughly

half of all pregnancies and 31% of all live births are unintended.2

• During the course of a singe menstrual cycle (28 days) a fertile couple has a

25% chance of pregnancy with repeated unprotected sexual intercourse.1

Among women ages 19 to 26 (when fertility is at its peak) the chance of

pregnancy following a single act of unprotected intercourse around the time of

ovulation is approximately 50%.1

• Contraceptives, when consistently and appropriately used, effectively prevent

pregnancy.

• Approximately 50% of all unintended pregnancies occur among women who

do not use contraception.3

• Contraception counseling increases the consistent and correct use of

contraceptives, which in turn leads to lower rates of unintended pregnancy,

fewer induced abortions, and better pregnancy outcomes.4-5 In fact, it is

estimated that halving the number of women not using contraception would

reduce the number of unintended pregnancies (per year) by one-third. The

reduction in unintended pregnancies would in turn reduce the number of

abortions by 500,000 per year.6

• Comprehensive contraceptive coverage is relatively inexpensive. The average

cost of adding coverage for all reversible methods of contraception is $25.31

per employee, per year.7

• Researchers estimate that over a 5-year period, employers can save $9,000 to

$14,000 (in year 1993 dollars) by providing comprehensive contraceptive

coverage.8 Experts suggest that employers may begin to see some savings in the

first year of coverage.8

Clinical Preventive Service Recommendations

In 1996, the U.S. Preventive Services Task Force (USPSTF) recommended that

clinicians counsel all men and women at risk for unintended pregnancy on

effective contraceptive methods. This recommendation is archived and is no

longer active. 

The American Academy of Family Physicians (AAFP) recommends that primary

care providers obtain a history of sexual practices and provide counseling on the

prevention of unintended pregnancy and contraceptive options to all sexually

active women who do not want to become pregnant and men who do not want

to have a child.9

Although evidence exists which demonstrates the net benefit of counseling to

prevent unintended pregnancy, either the benefit is only moderate in magnitude

or the evidence supporting a substantial benefit is only fair. The intervention is

perceived to be cost-effective and acceptable to most patients.9

EVIDENCE-STATEMENT:

CONTRACEPTIVE USE (Counseling and 

Preventive Interventions)
202

EVIDENCE-STATEMENT: Contraceptive Use (Counseling and Preventive Interventions)

American College of

Obstetricians and

Gynecologists (ACOG)

Evidence Rating: A

(Recommended/

Good Evidence)

Other Recommended

Guidance

American Academy

of Pediatrics (AAP)

Evidence Rating:

American College of

Obstetricians and

Gynecologists (ACOG)

Evidence Rating: C

(Recommended/

Evidence from Expert

Opinion)

American Medical

Association (AMA)

Evidence Rating: 

Jacobs Institute of

Women’s Health

The American College of Obstetricians and Gynecologists (ACOG) strongly

recommends that combination or progestin-only oral contraceptives for

emergency contraception should be offered to women who have had unprotected

sexual intercourse within 72 hours of intercourse.10

ACOG found good and consistent scientific evidence to support their

recommendation of emergency contraception following unprotected

intercourse.10

The American Academy of Pediatrics (AAP) notes that the comprehensive health

care of adolescents should include counseling on the prevention of sexually

transmitted infections (STIs), education on contraceptive methods, and family

planning services for the sexually active patient.11 Specifically:

1. Adolescents should be strongly encouraged to postpone the initiation of sexual

intercourse.

2. For patients already engaged in sexual intercourse or who are contemplating

having sexual intercourse, a discussion of contraceptive methods and

prevention of sexually transmitted infections (STIs) (including HIV) is

essential. 

3. The pediatrician should support compliance, manage side effects, change the

method of contraception as circumstances require, and provide referrals and

frequent follow-up with periodic screening for STIs. 

Not Specified

ACOG recommends that when a woman is prescribed emergency contraception,

she should be counseled about effective contraceptive methods, sexually

transmitted infections, and safe-sex practices.10

ACOG’s recommendation that women receive contraceptive counseling post

emergency contraception use is based on consensus and expert opinion.10

The American Medical Association (AMA) recommends that healthcare

professionals12:

1. Help women plan for pregnancy.

2. Support age-appropriate education in esteem building, decision-making and

family life, ultimately introducing the concept of planning for childbearing

into the educational process. 

Not Specified

Due to the side-effect profile of some medications and devices, the difference in

permanence and reversibility of contraceptives, and women’s personal preferences,

employers/health plans should [cover] the full range of Food and Drug
203

EVIDENCE-STATEMENT: Contraceptive Use (Counseling and Preventive Interventions)

Evidence Rating:

Information Sources

Epidemiology of

Condition/Disease

Administration (FDA) approved contraceptive methods including, but not

limited to7:

• Hormonal medications (e.g., pills and patches) including emergency

contraceptives

• Contraceptive devices (e.g., IUD, diaphragms, vaginal rings)

• Sterilization (e.g., vasectomy, tubal ligation)

Not Specified

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Family Physicians (AAFP)

• American Academy of Pediatrics (AAP)

• American College of Obstetricians and Gynecologists (ACOG)

• American Medical Association (AMA)

• Centers for Disease Control and Prevention (CDC)

• Employee Benefits Institute 

• Food and Drug Administration (FDA)

• Healthy People 2010, U.S. Department of Health and Human Services

• Institute of Medicine (IOM)

• Internal Revenue Service (IRS), Department of Treasury

• Jacobs Institute of Women’s Health

• March of Dimes

• Peer-reviewed research

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Unintended pregnancy is a significant problem in the United States.

Approximately 3 million unintended pregnancies occur each year1 and roughly

half of all pregnancies and 31% of all live births are unintended.2

The risk of pregnancy (unintended or intended) is high. Women in the United

States, on average, are fertile from ages 15 to 44.13 During the course of a singe

menstrual cycle (28 days) a fertile couple has a 25% chance of pregnancy with

repeated unprotected intercourse.1 Among women ages 19-26 (when fertility is at

its peak) the chance of pregnancy following a single act of unprotected

intercourse around the time of ovulation is 50%.1 Approximately 50% of all

unintended pregnancies occur among women who do not use contraception. It is

estimated that the overall rate of unintended pregnancy could be cut in half if

these women were to use a highly effective method of contraception.3
204

EVIDENCE-STATEMENT: Contraceptive Use (Counseling and Preventive Interventions)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

A wide range of effective contraceptives are available. They include reversible

methods (e.g., hormonal pills and patches, IUDs, condoms, etc.) and irreversible

methods (e.g., vasectomy, tubal ligation). Nearly all women (98%) who have had

sexual intercourse have, at some point, used contraception to either avoid or

delay pregnancy. Approximately 82% of women have used the oral contraceptive

pill and about 90% have had a partner use the male condom.4 The birth control

pill, which is used by 11.6 million women, is the most common form of birth

control in the United States.14

Despite the availability and effectiveness of contraception, women continue to

experience unintended pregnancies. Most unintended pregnancies occur as a

result of contraceptive nonuse, misuse, or a noticeable contraceptive failure (i.e.,

condom breaks).1 In 2001, 5% of women of reproductive age experienced an

unintended pregnancy.15 Contrary to popular belief, unintended pregnancy is not

only a problem of adolescence: women of all ages experience unintended

pregnancies.8

Healthy People 2010, the national health agenda, has set the following goals for

reducing the rate of unintended pregnancy is the United States6:

1. To increase the proportion of pregnancies that are intended to 70%.

2. To reduce the proportion of births occurring within 24 months of a previous

birth to 6%.

3. To increase to 100% the proportion of females at risk of unintended

pregnancy (and their partners) who use contraception.

4. To reduce the proportion of females that get pregnant despite using a reversible

contraceptive method.

5. To increase male involvement in pregnancy prevention and family planning

efforts.

All women who are aged 13 to 44, are sexually active and fertile, and who are not

trying to become pregnant are at risk of an unintended pregnancy.2

Approximately 10.7% of women in the United States who are at risk for an

unintended pregnancy do not use contraception.2 Certain groups are at an

elevated risk for unintended pregnancy, they include: teenagers and young

women age 20 to 24, women age 40 years and older, black women, women with

lower levels of education, unmarried women, and women with low incomes.2

Value of Prevention

The economic burden of unintended pregnancy is substantial, both to employers

and the society at large. The economic cost of an unintended pregnancy to an

employer includes either A) the cost of termination or B) the cost of prenatal,

delivery, and postpartum care for the woman and the cost of continuing medical

care for the infant as long as s/he remains a beneficiary. 

Unplanned pregnancies, compared to planned pregnancies, often result in higher

total medical claims costs and lost productivity costs because women whose
pregnancies are unintended are less likely to have proper folic acid intake, are less

likely to breastfeed, and are more likely to continue smoking during pregnancy.16

The adverse health outcomes associated with these behaviors lead to higher

obstetric medical claims.14

Unintended pregnancies result in substantial excess direct medical claims costs17

and indirect costs such as disability, employee replacement costs, lost

productivity, and presenteeism.14

Providing coverage for contraceptive counseling and contraceptive medications

and devices improves access and use, thereby avoiding the substantial direct and

indirect costs associated with unintended pregnancies, abortions, and unwanted

births. The average cost of a 1-year supply of prescription birth control pills is

$240 to $300 (in year 2005 dollars) and the cost of a single prescription of

emergency contraception is $20 to $150. These costs are lower than the

“treatment” costs for an unintended pregnancy.7 For example, the average cost to

employers of: 

• A first term abortion is approximately $468 (in year 2003 dollars).7

• A normal vaginal delivery (without complications) is $7,340 (in year 2005

dollars).7

• A cesarean delivery (without complications) is $12,257 (in year 2005 dollars).7

• The delivery and first year care of a premature infant is $41,610 (in year 2001

dollars).18

Comprehensive contraceptive coverage is relatively inexpensive. The average total

cost (including administrative costs) of adding coverage for all reversible methods

of contraception is $25.31 per employee, per year.7 The added cost to employers

of providing contraception coverage (assuming 20% employee cost sharing) is

$1.69 per employee, per month (all figures from 1998, adjusted to year 2005

dollars using the NASA Inflation Calculator).7

In 2004, the private-sector cost of preventive medicine evaluation and

management averaged $107 per session; approximately 95% of paid claims fell

within the range of $45 to $165 per session.19

Treatment costs of an unintended pregnancy include the cost of termination

($428)7 or the cost of prenatal, delivery, and postpartum care and the ongoing

cost of care for the infant. The cost of labor and delivery alone ranges from

$7,3406 to $41,610 (figures in year 2003, 2005, 2001 dollars, respectively).18 The

cost of prenatal care and ongoing infant/child care varies substantially, but it can

be assumed to be significant if the child remains a beneficiary until 18 to 25

years of age.

Researchers estimate that over a 5-year period, employers can save $9,000 to

$14,000 (in year 1993 dollars) by providing comprehensive contraceptive

coverage.8 Experts suggest that employers may begin to see some savings in the

first year of coverage.8

205

EVIDENCE-STATEMENT: Contraceptive Use (Counseling and Preventive Interventions)

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost 

of Preventive

Intervention

Estimated Cost 

of Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention
206

EVIDENCE-STATEMENT: Contraceptive Use (Counseling and Preventive Interventions)

Preventive

Intervention: 

Purpose of

Counseling 

Purpose of

Preventive

Intervention

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Counseling

Preventive Intervention Information

Contraceptive counseling is a key component of family planning. The purpose of

contraceptive counseling is to educate at-risk men and women about ways of

effectively preventing an unintended pregnancy. 

Contraceptive medications and devices reduce the occurrence of pregnancy. This

allows women and their partners to avoid, limit, or delay pregnancy. 

There are several documented benefits of contraceptive use. First, women/couples

who use contraceptives and engage in family planning have lower rates of

induced abortion. It is estimated that halving the number of women not using

contraception would reduce the number of unintended pregnancies (per year) by

one-third. The reduction in unintended pregnancies would in turn reduce the

number of abortions by 500,000 per year.6 Second, planned and properly spaced

pregnancies are associated with improved maternal and infant health outcomes:

women who wait 18 to 23 months between delivery and subsequent conception

lower their risk of adverse perinatal outcomes, including low birth weight,

preterm birth, and small for size gestational age.4-5 Finally, women who are able to

limit their fertility have improved opportunities to seek education and thus

higher earning employment. This improves individual, family, and societal

economic status.4

Contraceptives are effective and safe when used as directed (see discussion of side

effects below). Immediate use of an emergency contraceptive following

unprotected sex or a contraceptive failure can reduce the risk of unintended

pregnancy to 1% to 2%.1

Risks associated with family planning counseling have not been well

documented, but may include partner discord. There are a number of side effects

associated with contraceptives. Vaginal irritation is the most common side effect

associated with cervical condoms, caps, diaphragms, shields, spermicides, and

sponges. Other rare side effects may include urinary tract infections, vaginal

infections, and toxic shock syndrome (with prolonged use). Side effects associated

with birth control pills include headaches, breast tenderness, nausea, vomiting,

bloating, decreased sex drive (libido), and depression. Women who take birth

control pills, especially those who smoke, are also at an increased risk of heart

disease, high blood pressure, and blood clots. The major side effects of

intrauterine devices (IUDs) are abnormal vaginal bleeding and pelvic infection.20

According to the American Academy of Family Physicians (AAFP) and the

American College of Obstetricians and Gynecologists (ACOG):

• Clinicians should regularly ask all patients of reproductive age (men and

women) about contraception needs, even at office visits initiated for other

reasons.9-10 

• Clinicians should offer emergency contraception to all women who have had
unprotected sexual intercourse within 72 hours of intercourse or as otherwise

indicated.9-10 Emergency contraception should be offered in advance of need (as

a back-up method) to all women, particularly those using barrier methods of

contraception.10

Counseling should target both men and women and be inclusive of natural and

artificial, permanent and reversible techniques. Contraceptive methods

recommended by a clinician should be suited to the needs and lifestyle of

patients. 

Specific counseling methods are left to the discretion of the clinician. 

The American Academy of Family Physicians (AAFP) recommends that

clinicians9:

• Use a patient-centered strategy to help patients choose a contraceptive method,

acknowledging concerns that can interfere with adherence. 

• Inform patients about efficacy rates for different methods and recommend use

of high-efficacy options. 

• Encourage patients to call or return to the office if they experience problems

with the method chosen. 

The American Academy of Pediatrics (AAP) notes that the comprehensive health

care of adolescents should include counseling on the prevention of sexually

transmitted infections (STIs), education on contraceptive methods, and family

planning services for the sexually active patient.11 Adolescents should be strongly

encouraged to postpone the initiation of sexual intercourse. For patients already

engaged in sexual intercourse or who are contemplating having sexual

intercourse, a discussion of contraceptive methods and prevention of sexually

transmitted infections (STIs) (including HIV) is essential. For these patients the

pediatrician should support compliance, manage side effects, change the method

of contraception as circumstances require, and provide referrals and frequent

follow-up with periodic screening for STIs.11

Clinicians should prescribe contraceptive medications (e.g., birth control pill) or

devices (e.g., IUDs) or provide the appropriate surgery or intervention (e.g.,

vasectomy) to men and women who wish to limit their fertility. Because research

indicates that women and couples are more likely to use contraception

successfully if given their contraceptive method of choice,21-22 coverage of a wide

range of contraceptive options is optimal. Employers are therefore encouraged to

provide coverage for the full range of Food and Drug Administration (FDA)

approved methods of contraception including, but not limited to7:

• Hormonal medications (e.g., pills and patches) including emergency

contraceptives

• Contraceptive devices (e.g., IUD, diaphragms, vaginal rings)

• Sterilization (e.g., vasectomy, tubal ligation)

Note: Condoms play an important role in unintended pregnancy prevention and

STI prevention. Because condoms do not require a prescription they are not

207

EVIDENCE-STATEMENT: Contraceptive Use (Counseling and Preventive Interventions)

Intervention Process

Counseling

Preventive

Interventions 
208

EVIDENCE-STATEMENT: Contraceptive Use (Counseling and Preventive Interventions)

Treatment

Information

typically covered in employer-sponsored health insurance plans. While condoms

are not addressed in the 2005 IRS23 statement of qualified medical expenses for

flexible spending arrangements (FSAs), some flexible spending administrators do

consider condoms a qualified medical expense.24 Birth control pills and

sterilization are designated as qualified medical expenses by the IRS.23 Employers

who offer FSAs should alert beneficiaries to their administrator’s rules and

regulations regarding birth control, condoms, and sterilization.

Treatment for an unintended pregnancy may include either prenatal, delivery,

and postpartum care or abortion.

Strength of Evidence for the Clinical Preventive Service 

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research:

The American Academy of Family Physicians (AAFP)

Strength of Evidence: R (Recommended)

• AAFP recommends that primary care providers obtain a history of sexual

practices and provide counseling on the prevention of unintended pregnancy

and contraceptive options to all sexually active women who do not want to

become pregnant and men who do not want to have a child. Counseling

should also be provided regarding high-risk sexual behavior and the prevention

of sexually transmitted diseases and human immunodeficiency virus (HIV)

infection.9 Although evidence exists which demonstrates the net benefit of

counseling to prevent unintended pregnancy, either the benefit is only

moderate in magnitude or the evidence supporting a substantial benefit is only

fair. The intervention is perceived to be cost-effective and acceptable to most

patients.9

The American College of Obstetricians and Gynecologists (ACOG) 

Strength of Evidence: A (Recommended/Good Evidence)

• ACOG found good and consistent scientific evidence to support the provision

of emergency contraception following unprotected intercourse.10

Recommended Guidance:

The American Academy of Pediatrics (AAP)

Strength of Evidence: Not Specified

• The American Academy of Pediatrics (AAP) notes that the comprehensive

health care of adolescents should include counseling on the prevention of

sexually transmitted infections (STIs), education on contraceptive methods, and

family planning services for the sexually active patient.11 Adolescents should be

strongly encouraged to postpone the initiation of sexual intercourse. For

patients already engaged in sexual intercourse or who are contemplating having

sexual intercourse, a discussion of contraceptive methods and prevention of

sexually transmitted infections (STIs) (including HIV) is essential. For these
209

EVIDENCE-STATEMENT: Contraceptive Use (Counseling and Preventive Interventions)

Authored by: 

Campbell KP. Contraceptive use evidence-statement: counseling and preventive intervention.

In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s 

Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National 

Business Group on Health; 2006.

patients the pediatrician should support compliance, manage side effects,

change the method of contraception as circumstances require, and provide

referrals and frequent follow-up with periodic screening for STIs.11

American College of Obstetricians and Gynecologists (ACOG)

Strength of Evidence: C (Evidence Based on Expert Opinion)

• ACOG recommends that when a woman is prescribed emergency

contraception, she should be counseled about effective contraceptive methods,

sexually transmitted diseases, and safe-sex practices.10

American Medical Association (AMA)

Strength of Evidence: Not Specified

• The AMA recommends that healthcare professionals:

1. Help women plan for pregnancy.

2. Support age-appropriate education in esteem building, decision-making

and family life, ultimately introducing the concept of planning for

childbearing into the educational process.12

Jacobs Institute of Women’s Health

Strength of Evidence: Not Specified

• Due to the side effect profile of some medications and devices, the difference

in permanence and reversibility of contraceptives, and women’s personal

preferences, employers/health plans should [cover] the full range of Food and

Drug Administration (FDA) approved contraceptive methods including, but

not limited to7:

– Hormonal medications (e.g., pills and patches)

– Contraceptive devices (e.g., IUD, diaphragms, vaginal rings, condoms)

– Sterilization (e.g., vasectomy, tubal ligation)

References: 

1. Westhoff C. Emergency contraception. N Engl J Med 2003; 346: 1830-5.

2. Williams L, Morrow B, Shulman H, Stephens R, D’Angelo D, Fowler CI. PRAMS 2002 Surveillance Report. Atlanta, GA:

Division of Reproductive Health, National Center for Disease Prevention and Health Promotion, Centers for Disease

Control and Prevention; 2006 [cited 2006 Sep 8]. Available from: http://www.cdc.gov/PRAMS/UP.htm. 

3. Burnhill M. Contraceptive use: the U.S. perspective. Int J Gynaecol Obstet 1998;62[Suppl 1]:S17–S23.

4. Mosher WD, Martinez GM, Chandra A, Abma JC, Willson SJ. Use of Contraception and Use of Family Planning Services in

the United States: 1982-2002. Advance Data from Vital and Health Statistics. No 350. Atlanta. GA: Centers for Disease

Control; 2004.

5. The American College of Obstetricians and Gynecologists. Birth Control: A Woman’s Choice. Washington, DC: ACOG; 2003.
6. Planned Parenthood Federation of America. Facts about birth control. 2004 [cited 2005 Dec 29]. Available from:

http://www.plannedparenthood.org/pp2/portal/medicalinfo/birthcontrol/pub-birth-control-01.xml. 

7. Jacobs Institute of Women’s Health. Frequently asked questions for employee benefit managers. Covering contraceptives: an

online guide for employers. [cited 2006 Sep 4]. Available from: http://www.contraceptivecoverage.org.

8. Trussell J, Leveque JA, Koenig JD, London R, Borden S, Henneberry J, et al. The economic value of contraception: a

comparison of 15 methods. Am J Public Health 1995; 85(4):494-503.

9. Lesnewski R. Preventing unintended pregnancy: implications for physicians. Am Fam Phys 2004 [cited 2004 Jun 15];

69(12).

10. American College of Obstetricians and Gynecologists. Emergency Oral Contraception. Mar 8 ACOG practice bulletin; no.

25. Washington, DC: American College of Obstetricians and Gynecologists; 2001.

11. American Academy of Pediatrics, Committee on Adolescence. Adolescents and contraception. Pediatrics 1999; 104(5):1161-

1166.

12. American Medical Association. Resolution. 512, A-97. Chicago, IL: American Medical Association. Available from:

www.ama-assn.org. 

13. U.S. Bureau of the Census, Annual estimates of the population by sex and five-year age groups for the United States: April 1,

2000 to July 1, 2003. [Cited 2004 Dec 15]. Available from: http://www.census.gov/popest/national/asrh/NC-EST2003/NCEST2003-01.xls.

14. Brown SS, Eisenberg L, eds. Committee on Unintended Pregnancy, Institute of Medicine. The Best Intentions: Unintended

Pregnancy and the Well-being of Children and Families. Washington, DC: National Academy Press; 1995.

15. Finer LB, Henshaw SK. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex

Reprod Health, 2006;38(2):90–96.

16. Kost K, Landry DJ, Darroch JE. Predicting maternal behaviors during pregnancy: does intention status matter? Fam Plan

Perspect 1998;30(2):79-88

17. March of Dimes. Prematurity: the answers can’t come soon enough. The cost of premature birth. [cited 2004 Oct 18].

Available from: http://www.marchofdimes.com/prematurity/5415_10719.asp.sed.

18. March of Dimes. The cost of prematurity. Impact on business [cited 2006 Sep 4] Available from:

http://www.marchofdimes.com/prematurity/15341_15349.asp.

19. Thomson Medstat. Marketscan. 2004.

20. Birth Control Decision Guide. Mayo Foundation for Medical Education and Research (MFMER). 2006 Aug 1 [cited 2006

Sep 5]. Available from: http://www.mayoclinic.com/health/birth-control/BI99999/PAGE=BI00015.

21. Noone J. Finding the Best Fit: A Grounded Theory of Contraceptive Decision Making in Women. Nursing Forum Oct-Dec

2004; 39(4).

22. Henshaw SK. Unintended pregnancy in the United States. Fam Plan Perspect 1998;30:24-29.

23. Internal Revenue Service. Medical and Dental Expenses. IRS Publication 502. Cat. No. 15002Q. Washington, DC:

Department of the Treasury; 2005 [cited 2006 Sep 6]. Available from: http://www.irs.gov/pub/irs-pdf/p502.pdf. 

24. FlexAmerica.com. Eligible expenses. Health care expenses table. Employee Benefits Institute interpretation of the IRS and

Treasury Department rules and regulations surrounding qualified medical expenses. [Updated 2006 Aug 24; cited 2006 Sep 5]. 

210

EVIDENCE-STATEMENT: Contraceptive Use (Counseling and Preventive Interventions)
211

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/

At Least Fair

Evidence)

Other Recommended

Guidance

Information Sources

Epidemiology of

Condition/Disease

EVIDENCE-STATEMENT:

DEPRESSION (Screening)

• In a given year, 18.8 million American adults (9.5% of the adult population)

will suffer from a depressive illness.1

• Routine, systematic screening can successfully identify patients who are

depressed, allowing them to access care earlier in the course of their illnesses.2

• Depression is a major cause of disability, absenteeism, and productivity loss

among working-age adults.1 Depression is estimated to cause 200 million lost

workdays each year at a cost to employers of $17 to $44 billion.3

• Research suggests that 80% of patients with depression will improve with

treatment.4

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends screening all

adults for depression in clinical practices that have systems in place to assure

accurate diagnosis, effective treatment, and adequate follow-up.5 Although not

explicitly stated in the USPSTF recommendation statement, screening adults for

depression should be part of an overall system to improve depression recognition

and outcomes. Important system aspects include feedback, treatment advice,

education, case management, access to mental health care, telephone follow-up,

and an institutional commitment to quality improvement.5

The USPSTF found good evidence that screening 1) improves the accurate

identification of depressed patients in primary care settings and 2) that treating

depressed adults identified in primary care settings reduces clinical morbidity.

The USPSTF concluded the benefits of screening are likely to outweigh any

potential harms.5

The American Academy of Family Physicians (AAFP) concurs with the U.S.

Preventive Services Task Force recommendation.6

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Family Physicians (AAFP)

• National Institutes of Mental Health (NIMH)

• U.S. Preventive Services Task Force (USPSTF)

• Peer-reviewed research

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Depression is a serious condition that affects 5% to 9% of adult patients

presenting at primary care in the United States.2 In a given year, 18.8 million

American adults (9.5% of the adult population) will suffer from a depressive
212

EVIDENCE-STATEMENT: Depression (Screening)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

illness. Approximately 5% to 12% of men and 10% to 25% of women will

experience a major depressive episode at some point during their lives.1

Depression is a major cause of morbidity in the United States, and it is projected

to become the leading cause of disability worldwide by 2020.3

Risk factors for depression include a family history of depression, female sex,

unemployment, and chronic disease.2

Value of Prevention

In 2000, over $83.1 billion dollars were spent on depression in the United States;

$26.1 billion dollars (31%) for direct medical costs, $5.4 billion dollars (7%) for

suicide-related mortality costs, and $51.5 billion dollars (62%) for workplace

costs.7

Depression is a major cause of disability, absenteeism, and productivity loss

among working-age adults. In a 3-month period, patients with depression miss

an average of 4.8 workdays and suffer 11.5 days of reduced productivity.1 In

total, depression is estimated to cause 200 million lost workdays each year at a

cost to employers of $17 to $44 billion.3

In addition to its direct medical and workplace costs, depression also increases

healthcare costs and lost productivity indirectly by contributing to the severity of

other costly conditions such as heart disease, diabetes, and stroke.

The economic benefits of screening mainly result from averting the lost

productivity costs associated with the disease.8 Some studies suggest that

treatment of depression may lead to decreased general medical costs, however,

conclusive evidence is not available. 

The cost of screening for depression depends on the location, provider type, and

the screening instrument used. In 2004, the private-sector cost of depression

screening averaged $23; approximately 95% of paid claims fell within the range

of $0 to $81.9

Treatment of depression in the primary care setting (based on one initial physician

visit and one follow-up visit within 3 months) costs an average of $99.68 (in year

2001 dollars). The cost of medication to treat depression varies substantially based

on the type of medication chosen. Average wholesale price (AWP) figures are noted

below for a 1-month supply of a few varieties of the FDA-approved selectiveserotonin-reuptake-inhibitors (SSRIs) commonly used to treat depression.10

Drug Name 2006 Average Wholesale Price (AWP)

Generic Brand

fluoxetine/Prozac® $74.35 (20 mg) $138.91 to $277.82

paroxetine/Paxil® $92.50 to $105.02 $72.90 to $81.00

sertraline/Zoloft® $7.17 (50 mg) $86.89 (25mg–100mg)
213

EVIDENCE-STATEMENT: Depression (Screening)

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of 

Screening

Benefits and Risks of

Intervention

Initiation, Cessation,

and Interval of

Screening

The total cost of treatment should consider treatment-related cost-offsets due to

the reduction of lost productivity, absenteeism, and other factors. For example,

the indirect cost associated with an employee who is treated for depression

(extrapolated from lost work days/time for medical appointments, etc) over a 3

month period averages $400, whereas the indirect cost associated with a

depressed employee who does not receive treatment (extrapolated from sick days,

etc) averages $840 over a 3 month period.1 If benefits of treatment on work

impairment are taken into account, the estimated cost-savings would exceed the

average treatment cost of depression.8

The cost-effectiveness of screening is sensitive to screening costs and achievable

depression remission rates. Based on an economic modeling approach, one study

found that one-time depression screening had a relatively low cost per qualityadjusted life year gained compared to no screening. However, neither annual nor

periodic screening for depression were found to be cost-effective in comparison

to preventive service benchmarks.1

Preventive Intervention Information

Screening for depression identifies patients suffering from depression, allowing

them to access care earlier in the course of their illness. Research suggests that

80% of patients with depression will improve with treatment.4 The USPSTF

found evidence that patient outcomes improve significantly when depression

recognition and management are integrated.2 Yet despite the value of screening, it

is infrequently conducted, and hence, primary care physicians fail to identify

30% to 50% of patients suffering from depression.5

Risks of screening include false-positive results, which can lead to additional

testing, incurring further costs and inconvenience. Patients may also suffer some

negative effects after being labeled as depressed. However, the USPSTF felt that

these potential risks were likely outweighed by the benefits of screening.11

There is insufficient evidence to determine the optimal ages at which to begin

and cease depression screening. Thus, experts agree that depression screening

should be initiated and stopped when deemed appropriate by the clinician. 

Evidence is also insufficient to determine the optimal interval of screening. Thus,

clinicians are encouraged to use their judgment in deciding how frequently to

screen patients for depression. The USPSTF notes that recurrent screening is

most likely to benefit patients with a history of depression, unexplained somatic

symptoms, chronic pain or other comorbid psychological conditions such as

anxiety, panic attack, or substance abuse.11

The USPSTF found insufficient evidence to recommend for or against

depression screening among children or adolescents in primary care settings.

However, the USPSTF encourages physicians to remain alert for signs of

depression in these populations and to treat or refer to specialty care as

appropriate.2
While the USPSTF did not recommend screening adolescents for depression,

new evidence shows that the benefits of screening in the adolescent population

may outweigh the risks involved. A recent randomized controlled trial of highschool students showed that screening adolescents for depression with a

standardized screening instrument did not increase suicidal ideation (thoughts or

fantasies about committing suicide) or increase feelings of discomfort.

Surprisingly, depressed students reported less distress at being asked questions

about suicidal ideation than did non-depressed students. Identifying adolescents

with suicidal ideation is an important part of youth suicide prevention.12

Providers need to be aware that the signs and symptoms of depression in

adolescents are different from those in adult populations.

Several depression screening tools, called instruments, are currently available for

use in the primary care setting. These instruments are composed of standardized

questions that assess the number and severity of a patient’s depression symptoms.

Clinicians can then interpret the results to make a diagnosis of depression and to

develop a treatment plan. Evidence is mixed as to what instrument or method is

most effective in accurately identifying patients with depression, but most

instruments seem to have an adequate level of sensitivity and specificity.

Commonly used instruments, such as the Patient Health Questionnaire-9, are

simple to administer and take less than 5 to 10 minutes for a patient or provider

to complete.5

The USPTF recommends that physicians choose their preferred method of

screening based on their patient population and practice setting.2 Clinicians who

do not use a standardized instrument to screen for depression may want to ask

their patients the two questions below to assess their mental health status. These

may be as effective as using longer screening tools.2

1. Over the past two weeks, have you ever felt down, depressed, or hopeless? 

2. Over the past two weeks, have you felt little interest or pleasure in doing

things?

Positive responses to these questions or positive responses to questions on a short

standardized screening test should trigger a full diagnostic interview by the

clinician so that they may identify the specific depressive symptoms experienced

by the patient and make an accurate diagnosis.2 The USPSTF recommends that

clinicians use standard diagnostic criteria, such as those featured in the

Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).11

The process used in screening patients for depression is important. Screening

adults for depression in clinical practices that have well functioning systems in

place to assure accurate diagnosis, effective treatment, and careful follow-up, are

more likely to produce benefits.2 The USPSTF found several other clinically

relevant factors pertinent to successful depression screening processes. For

information on these factors please refer the USPSTF website

(www.ahrq.gov/clinic/uspstf/uspsdepr.htm).

Implementing a systematic depression screening program in a clinical practice

will increase the number of patients diagnosed with depression and the number 214

EVIDENCE-STATEMENT: Depression (Screening)

Intervention Process
of patients treated for depression. It is important to remember that not all of the

patients who screen positive for depression will be diagnosed with depression. 

Considering the prevalence of depression in the primary care setting, it can be

expected that 25% to 40% of patients who screen positive for depression will

actually have depression.2

• Many screened patients will have screened false-positive, meaning that

although they screened positive for depression, they are not actually depressed.

These patients do not require treatment. 

• Some patients who screen positive for depression may suffer from depressive

illnesses other than major depression, such as adjustment reactions with

depression or grief reactions, and these patients may benefit from monitoring. 

• Some of the patients who screen positive for depression may have, in addition

to or in place of depression, another psychological disorder such as anxiety

disorder, panic attack, post-traumatic stress disorder (PTSD), obsessivecompulsive disorder (OCD), a substance abuse disorder, or another type of

mental health condition. Physicians should refer these patients to a mental

health specialist. 

Because of the complexities involved in screening for depression, the USPSTF

recommends that clinicians follow-up all positive screens with further diagnostic

work, including a full diagnostic interview such as that featured in the DSM-IV.11

Health benefits should include provisions for diagnostic and treatment services.

Most patients with depression present and are treated in the primary care setting.

While depression is one of the most common disorders seen by primary care

providers, research shows that the standard of care delivered is poor. In the

primary care setting, 35% to 70% of patients with depression do not receive an

appropriate diagnosis or adequate treatment.1

Patients who screen positive for depression and are diagnosed with depression as

confirmed by the DSM-IV diagnostic interview should 1) begin treatment in the

primary care or specialty mental healthcare setting or 2) be referred for treatment

to a mental health professional. A primary care treatment plan can include

pharmacological therapy (tricyclic anti depressants and selective-serotoninreuptake-inhibitors [SSRIs], are proven to be effective in the treatment of major

depression) psychotherapy, or a combination of the two.11

Current research points to a number of successful identification and diseasemanagement techniques for addressing depression in primary care. Experts note

that routine, systematic screening can successfully identify patients who are

depressed. Patients who are identified in primary care settings as suffering from

depression or other mental health conditions, can often benefit from referral to a

mental health specialist. Depressed patients may also benefit from collaborative

care; an approach to care that pairs a mental health specialist with a primary care

provider to provide evidence-based treatment services.12

215

EVIDENCE-STATEMENT: Depression (Screening)

Treatment

Information
References:

1. Valenstein M, Vijan S, Zeber JE, Boehm K, Buttar A. The cost-utility of screening for depression in primary care. Ann Intern

Med 2001; 134: 345-360.

2. Screening for depression. What’s new from the U.S. Preventive Services Task Force: A summary of recommendations

Publication No. APPIP02-0019. Rockville, MD; Agency for Health Care Research and Quality; 2003.

3. Leopold RS. A Year in the Life of a Million American Workers. New York, New York: MetLife Disability Group; 2001

4. National Institutes of Mental Health. The invisible disease: Depression. Rockville, MD: National Institutes of Health; 2001

[cited 2006 Mar 23]. Available from: http://www.nimh.nih.gov/publicat/invisible.cfm

5. U.S. Preventive Services Task Force. Screening for depression. Summary of Recommendations / Supporting Documents.

Guide to Clinical Preventive Services. Rockville, MD: Agency for Health Care Research and Quality; 2003

6. American Academy of Family Physicians. Policy Action November 1996; Revision 5.4 August 2003. Order No. 968. Kansas

City, MO; American Academy of Family Physicians; 2003.

7. Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, Corey-Lisle PK. The economic burden of

depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry 2003; 64(12): 1465-75

8. Wang PS, Simon G, Kessler RC. The economic burden of depression and the cost-effectiveness of treatment. Int J Methods

Psychiatr Res 2003; 12(1):22-33.

9. Thomson Medstat. Marketscan. 2004.

10. Fleming T. 2006 Redbook: Pharmacy’s Fundamental Reference. Thomson PDR; Rev Ed edition. May 2006.

11. Berg AO. Atkins D. Screening for depression: recommendation and rationale of the U.S. Preventive Service Task Force. Ann

Intern Med 2002; 136(10):760-764

12. Gould MS, Marrocoo FA, Kleinman M, Thomas JG, Mostkoff K, Cote J, et al. Evaluating iatrogenic risk of youth suicide

screening programs: A randomized controlled trial. JAMA 2005; 239(13): 1635-1642

216

EVIDENCE-STATEMENT: Depression (Screening)

Strength of Evidence for the Clinical Preventive Service 

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

• The USPSTF found good evidence to support screening all adults for

depression in clinical practices that have systems in place (such as a referral

system, on-site mental health provider, or other mental health resources) to

assure accurate diagnosis, effective treatment, and adequate follow-up.5 

Authored by: 

Campbell KP, Lollar D. Depression evidence-statement: screening. In: Campbell KP, Lanza A, Dixon R,

Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive Services:

Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.
217

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/At

Least Fair Evidence)

Other Recommended

Guidance

American Diabetes

Association (ADA)

Evidence Rating:

American Association

of Clinical

Endocrinologists

(AACE)

• Diabetes affects over 21 million Americans, 7% of the United States

population.1 In addition, 41 million adults aged 40 to 74 have prediabetes, a

condition that increases the risk of diabetes, heart disease, and stroke.1-2

• Alarmingly, the prevalence of type 2 diabetes and gestational diabetes has

increased 61% in United States since 1990.3

• Diabetes is a major cause of premature morbidity, disability, and death. In

addition to being a direct cause of death, uncontrolled diabetes can cause heart

disease, stroke, blindness, kidney failure, pregnancy complications, and

amputations of toes, feet, or legs.

• The total annual economic burden of diabetes in the United States exceeds

$132 billion dollars.4

• Diabetes is among the top 10 most costly physical health conditions for

employers in various industries in terms of direct medical expenditures,

absenteeism, short-term disability, and presentism.5

• In 2002, the average annual healthcare cost for a person with diabetes was

$13,243 as opposed to $2,560 for a person without diabetes.4

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends screening for

type 2 diabetes in adults with hypertension (high blood pressure) or

hyperlipidemia (high cholesterol).6

The USPSTF found good evidence that, in adults who have hypertension and

clinically detected diabetes, lowering blood pressure below conventional target

blood pressure values reduces the incidence of cardiovascular events and

cardiovascular mortality; this evidence is considered fair when extrapolated to

cases of diabetes detected by screening. Among patients with hyperlipidemia,

there is good evidence that detecting diabetes substantially improves estimates of

individual risk for coronary heart disease, which is an integral part of decisions

about lipid-lowering therapy.6

Note: the USPSTF found insufficient evidence to support a recommendation for

or against universal screening of adults for diabetes. 

The American Diabetes Association (ADA) recommends that adults at normal

risk for diabetes be screened at 3-year intervals for prediabetes and diabetes

beginning at age 45. Adults at high risk (based on a family history of the disease,

overweight or obesity, or other factors; see condition/disease risk factor section

below) should be screened at a younger age or screened more frequently (1 to 2

year intervals).7

Expert Opinion 

The American Association of Clinical Endocrinologists (AACE) recommends

targeted screening beginning at age 30 for people at high risk for diabetes.8

EVIDENCE-STATEMENT:

DIABETES (Screening)
218

EVIDENCE-STATEMENT: Diabetes (Screening)

Evidence Rating:

Information Sources

Epidemiology of

Condition/Disease

Expert Opinion 

The recommendations and supporting information contained in this document

came from several sources, including the:

• Agency for Healthcare Research and Quality (AHRQ)

• American Association of Clinical Endocrinologists (AACE)

• American Diabetes Association (ADA)

• Centers for Disease Control and Prevention (CDC)

• Center for Medicare & Medicaid Services (CMS)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Diabetes is divided into 3 types: type 1 diabetes (previously referred to as

“juvenile” diabetes), type 2 diabetes (previously referred to as “adult-onset”

diabetes), and gestational diabetes (a form of diabetes that occurs only during

pregnancy). 

In the past, type 1 diabetes typically affected young people who had few

symptoms or signs of the disease before experiencing an abrupt onset, type 2

diabetes primarily affected adults, and gestational diabetes affected pregnant

women and indicated a higher-than-average risk for type 2 diabetes. While the

epidemiological profiles of type 1 diabetes and gestational diabetes have remained

constant, the profile of type 2 diabetes has changed dramatically in recent years.

Type 2 diabetes used to be an adult-onset disorder; now type 2 diabetes affects

children, adolescents, and young adults as well.

Since the onset of type 1 diabetes is usually relatively sudden and associated with

symptoms that require care, screening for type 1 diabetes has not been considered

useful. 

Type 2 diabetes, on the other hand, has a longer asymptomatic phase. Early

recognition and intervention can forestall its onset and may even prevent its

emergence. For reasons not completely understood, but seemingly related (at

least in part) to obesity, changing dietary habits, and levels of physical activity,

the incidence of type 2 diabetes is increasing. It is also being identified at

younger and younger ages.

Type 2 diabetes (hereafter referred to as diabetes) affects over 21 million Americans

(7% of the United States population) and more than 6 million Americans with

diabetes are undiagnosed. In addition, 41 million adults age 40 to 74 have
219

EVIDENCE-STATEMENT: Diabetes (Screening)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

prediabetes, a condition that increases the risk of diabetes, heart disease, and

stroke.1-2 People with prediabetes have a high blood sugar level but not high

enough to be classified as diabetes. Many people with prediabetes will develop

clinical diabetes. Alarmingly, the prevalence of type 2 diabetes (including

gestational diabetes) in the United States has increased 61% since 1990.3

Diabetes is a major cause of premature morbidity and disability, and

uncontrolled diabetes can cause death. Diabetes is the sixth leading cause of

death in the United States — each year 200,000 Americans die of complications

resulting from the disease.1

Death rates are about 2 to 4 times higher for adults with diabetes than for those

without the disease.2 Heart disease and stroke are leading causes of diabetesrelated deaths. Uncontrolled diabetes can also cause blindness, neurologic

problems, kidney failure, pregnancy complications, and amputations of toes, feet,

or legs. Persons with diabetes are at higher risk of acquiring influenza and

pneumonia, which are additional causes of disproportionate death among

diabetics. Each year, 12,000 to 24,000 people become blind, 42,813 have kidney

failure, and 82,000 have leg, foot, or toe amputations.2

Diabetes disproportionately affects women, older adults, and certain racial and

ethnic groups, such as African-Americans, Hispanics, and American Indians/

Alaska Natives. One in five adults older than 65 has diabetes.

The risk of developing type 2 diabetes increases with8:

• Cardiovascular disease, high cholesterol levels, or both

• Hypertension

• High levels of triglycerides

• Low concentrations of high-density lipoprotein

• Family history of diabetes

• Impaired glucose tolerance or impaired fasting glucose

• Hispanic, African-American, Asian American, Native American, or Pacific

Islander race or ethnicity

• BMI over 25kg/m2 and/or central obesity

• History of gestational diabetes

• Delivery of a baby weighing more than 9 pounds (4 kg)

• Polycystic ovary syndrome

• Sedentary lifestyle

Value of Prevention*

The estimated direct and indirect costs for diabetes care in 2002 totaled $132

billion4, 11% of the national health care expenditures for 2002. Diabetes is among

the costliest physical health conditions in terms of total medical costs9-11 and

productivity losses.4,9,12 In 2002, the average annual healthcare cost for a person

with diabetes was $13,243 as opposed to $2,560 for a person without diabetes.4
Diabetes is among the top 10 most costly physical health conditions for

employers in various industries in terms of direct medical expenditures,

absenteeism, short-term disability, and presentism.5 If pharmaceutical

expenditures, costs related to absenteeism, and claims for short-term disability are

combined with medical expenditures, diabetes ranks as the third most costly

physical health condition for employers.13 In addition, diabetes-related

prescriptions rank in the top 2 treatment expenses for employers based on 1997-

1999 claims data for inpatient and outpatient costs.13

Employees with diabetes who reduce their glycemic levels (the way your body’s

sugar level responds to certain foods) demonstrate short-term (4 to 5 months)

health outcomes (quality of life improvements), work-related outcomes (reduced

absenteeism and increased productivity), and cost-savings through reduced

hospital visits.14 Sustaining reduced glycemic levels for 1 year reduces primary and

specialty care visits and is associated with (longer-term) cost-savings within 1 to 2

years of improvement.15 Therefore, reduced glycemic levels in persons with

diabetes has short- and long-term direct and indirect economic benefits. 

More than 30% of employer costs associated with employees who have diabetes

are attributable to medically related absences or disability.16 Diabetes may affect

the number of disability claims and the length of disability claims.16-18 When

stratified by age, total medical and productivity costs for beneficiaries with

diabetes range from $2,589 for those younger than 18 years to $8,568 for those

aged 56 through 64 years (in year 1998 dollars).16

People with diabetes lose income as a result of missing work and disability. The

average annual earnings loss (in year 1994 dollars) for a person with diabetes is

estimated at $4,306 for men and $1,865 for women.12 In 1998 dollars, medically

related work loss cost employees with diabetes an estimated $1,121 for those

aged 18 through 35 years, $1,448 for those aged 36 through 45 years, $1,467 for

those aged 46 through 55 years, and $1,095 for those aged 56 through 64 years.16

The Diabetes Prevention Program (DPP) showed that lifestyle interventions

delayed the development of diabetes by 11 years and reduced the absolute

incidence by 20%.19 Metformin, an oral medication, delayed the development of

diabetes by 3 years and reduced the absolute incidence by 8% (compared to a

placebo). The cost was $1,100 per quality-adjusted life year (QALY) for the lifestyle

intervention and $31,300 for the metformin intervention. The lifestyle

intervention included a weight reduction goal of at least 7% of initial body weight

through a healthy, low-fat, lower calorie diet; and physical activity of moderate

intensity (brisk walking) for at least 150 minutes/week. A 16 lesson curriculum was

developed and group and individual sessions were designed to reinforce changes.19

The cost of screening for type 2 diabetes varies by location and provider. In

2004, the private-sector cost of diabetes screening averaged $15 (range $0 to

$40).20 However, this is a rough average: one or two follow-up visits may be

necessary (depending on test results), and if so, would increase the cost of each

complete screening cycle.

220

EVIDENCE-STATEMENT: Diabetes (Screening)

Workplace Burden of

Condition/Disease

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention
221

EVIDENCE-STATEMENT: Diabetes (Screening)

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks 

of Intervention

From the health system perspective, the cost of a metformin intervention

(compared to placebo) is $2,191/participant over 3 years; the cost of a lifestyle

intervention (compared to placebo) is $2,269/participant over 3 years.19 It is

significant to note that although the lifestyle intervention costs about 37% more

than the metformin in year 1, the lifestyle intervention costs about 12% and 7%

less than metformin intervention in years 2 and 3. Therefore, the cost of lifestyle

intervention relative to metformin intervention would decrease with follow-up

beyond 3 years.19

It is cost-effective to screen people with hypertension in all age groups for type 2

diabetes. It is even more cost-effective to screen people with hypertension aged

55 to 75 years.21 In year 1997 dollars, the cost per quality-adjusted life year

(QALY) for targeted screening (compared to no screening) at age 55 was

estimated to be $34,375. In comparison to other preventive interventions and to

commonly accepted cost-effectiveness benchmarks, diabetes screening is costeffective.22 In general, opportunistic screening (i.e., screening patients during

routine healthcare encounters) is more cost-effective than universal or population

screening, and targeted screening (i.e., screening people with particular health

risk factors, such as hypertension) is the most cost-effective.21

Preventive Intervention Information

Screening is meant to identify individuals with diabetes and individuals at high

risk of diabetes. Intervention may delay the onset of diabetes and its

complications among individuals at high-risk.1 Early detection by screening

allows clinicians to suggest a variety of interventions during the preclinical

period, including tight glycemic control; intensive use of antihypertensive agents;

aggressive use of lipid treatment and aspirin; foot care programs; and

improvements in diet, increases in physical activity, and cessation of tobacco use.

The efficacy of early interventions is affected by numerous variables, such as the

relationship between the intervention and the timing of the specific

complication: some complications typically occur early in the disease process

(e.g., cardiovascular disease) and some occur late in the process (e.g., blindness).23

The USPSTF found that people at risk for cardiovascular disease benefit most from

diabetes screening. Screening people with hypertension or hyperlipidemia for type

2 diabetes allows the disease to be diagnosed and treated before it causes certain

complications. Evidence shows that people with hypertension and type 2 diabetes

can reduce their risk of cardiovascular disease by reducing their blood pressure to a

level below that recommended for people with hypertension but without diabetes.

People with hyperlipidemia and type 2 diabetes can lower their risk of cardiovascular

disease by beginning lipid-lowering therapy in combination with diabetes treatment.24

Few studies have examined the harmful effects of screening asymptomatic people

for diabetes. As with all screening tests, there is a risk of false-positive results.

False-positive results have the potential to cause harmful effects including a

negative change in self-perception, undue stress and anxiety, risk of loss of

insurability (life insurance or health insurance), and the risk of beginning

unneeded treatment for diabetes.23
222

EVIDENCE-STATEMENT: Diabetes (Screening)

USPSTF

The USPSTF found insufficient evidence in order to determine whether adults

without hypertension or hyperlipidemia should be screened for diabetes.

Therefore, when to screen individual patients is a matter of clinical judgment and

patient preference. 

Patients at increased risk for cardiovascular disease may benefit the most from

screening for type 2 diabetes, since effective management of cardiovascular risk

factors leads to reductions in major adverse cardiovascular events. For adult

patients with diagnosed hypertension or hyperlipidemia, diabetes screening

should be part of an integrated approach to reduce cardiovascular risk.24

American Diabetes Association

While acknowledging the insufficiency of evidence regarding the benefits of

screening, the ADA recommends (on the basis of expert opinion) that adults at

normal risk for diabetes should be screened at 3-year intervals for prediabetes and

diabetes beginning at age 45. Adults at high risk (based on a family history of

the disease, overweight or obesity, or other factors) should be screened at a

younger age or screened more frequently (1 to 2 year intervals).7

There is no universally accepted interval for type 2 diabetes screening of healthy

adults or adults with hypertension or hyperlipidemia. The ADA recommends

that adults at normal risk for diabetes undergo screening every 3 years and adults

at high-risk of diabetes undergo screening every 1 to 2 years.7

CMS Coverage 

As of September 2006, the Centers for Medicare and Medicaid Services (CMS)

covers screening tests for diabetes. This is significant because CMS’s decisions

frequently influence other managed care policies. Some employers also provide

healthcare insurance to retirees eligible for Medicare. The CMS policy covers the

following25:

• Two screening tests per year for individuals with diagnosed prediabetes (not

less than 6 months apart).

• For those who are not diabetic or have not previously been diagnosed as prediabetic, Medicare covers one diabetes screening test within a 12-month period

(or that at least 11 months have passed following the month in which the last

Medicare covered diabetes screening test was performed).

Covered tests are the fasting blood glucose (FBG) test and the Oral Glucose

Tolerance Test (OGTT). 

Individuals who have any one of the following risk factors for diabetes are eligible

for the CMS benefit:

• Hypertension (high blood pressure)

• Dyslipidemia (high cholesterol)

222

Initiation, Cessation,

and Interval of

Screening
223

EVIDENCE-STATEMENT: Diabetes (Screening)

Intervention Process

Treatment

Information

• Obesity (a body mass index equal to or greater than 30 kg/m2)

• Elevated impaired fasting glucose intolerance

Also eligible for the CMS benefit are individuals who have at least two of the

following characteristics: 

• Overweight (a body mass index >25 but <30 kg/m2

• A family history of diabetes

• Age 65 or older

• A history of gestational diabetes

• Delivery of a baby weighing more than 9 lbs

Screening requires a blood glucose test. Several tests are appropriate and should

be used at the discretion of the physician, they include the fasting plasma glucose

test (FPG), the 2-hour post-load plasma glucose test, and the oral glucose

tolerance test (OGTT). 

Health benefits should include provisions for diagnostic, follow-up, and

treatment services. 

Strength of Evidence for the Clinical Preventive Service 

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

• The USPSTF found at least fair evidence that the benefits of screening adults

with hypertension or hyperlipidemia for diabetes outweigh the associated risks

and costs. 

Recommended Guidance:

The American Diabetes Association (ADA) 

Strength of Evidence: Expert Opinion

• The ADA recommends that adults at normal risk for diabetes be screened at 

3-year intervals for prediabetes and diabetes beginning at age 45. Adults at

high risk (based on a family history of the disease, overweight or obesity, or

other factors) should be screened at a younger age or screened more frequently

(1-2 year intervals).7

The American Association of Clinical Endocrinologists (AACE) 

Strength of Evidence: Expert Opinion

• The AACE recommends targeted screening, beginning at age 30, for people at

high risk for diabetes.8
224

EVIDENCE-STATEMENT: Diabetes (Screening)

Authored by: 

Cooksey C, Allweiss P, Campbell KP. Diabetes evidence-statement: screening. In: Campbell KP, Lanza A,

Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive

Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.

References:

1. Centers for Disease Control and Prevention. National diabetes fact sheet, 2003. Updated 2006 [cited 2006 May 11].

Available from: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf. 

2. Centers for Disease Control and Prevention. Diabetes: disabling, deadly, and on the rise, 2005 [cited 2006 Jul 25]. Available

from: http://www.cdc.gov/nccdphp/aag/pdf/aag_ddt2005.pdf.

3. Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor R, Bales V, et al. Prevalence of obesity, diabetes, and obesity-related

health factors. JAMA 2003; 289:76-79.

4. American Diabetes Association. Economic costs of diabetes in the U.S. in 2002. Diabetes Care 2003; 26:917-932.

5. Goetzel RZ, Long SR, Ozminkowski RJ, Hawking K, Wang S, Lynch W. Health, absence, disability, and presenteeism cost

estimates of certain physical and mental health conditions affecting U.S. employers. J Occup Environ Med 2004; 46:398.

6. U.S. Preventive Services Task Force. Diabetes screening. Summary of recommendations. Rockville, MD: Agency for

Healthcare Research and Quality; 2003 [cited 2006 Sep 30] Available from: http://www.ahrq.gov/clinic/uspstf/uspsdiab.htm.

7. American Diabetes Association. Screening for type 2 diabetes. Diabetes Care 2004; 27:S11-S14.

8. American Association of Clinical Endocrinologists. AACE diabetes guidelines. Endocr Pract 2002; 8(Suppl 1):40-82. 

9. Druss BG, Marcus SC, Olfson M, Pincus HA. The most expensive conditions in America. Health Aff 2002; 2:105-111.

10. Thorpe KE, Florence CS, Joski P. Which medical conditions account for the rise in health care spending? Health Aff Web

Exclusive 2004; Aug 25: 437-445. [cited 2006 Jul 18] Available from:

http://content.healthaffairs.org/cgi/content/full/hlthaff.w4.437/DC1?maxtoshow=&HITS=10&hits=10&RESULTFORMAT

=&author1=Thorpe&fulltext=conditions&andorexactfulltext=and&searchid=1133354631117_304&stored_search=&FIRSTI

NDEX=0&resourcetype=1&journalcode=healthaff. 

11. Ettaro I, Songer TJ, Zhang P, Engelgau MM. The economic burden of diabetes. Pharmacoeconomics 2004; 22:149-164. 

12. Yassin AS, Beckles GL, Messonier ML. Disability and its economic impact among adults with diabetes. J Occup Environ

Med 2002; 44:136-142.

13. Goetzel RZ, Hawkins K, Ozminkowski RJ, Wang S. The health and productivity cost burden of the “top 10” physical and

mental health conditions affecting six large U.S. employers in 1999. J Occup Environ Med 2003; 45:5-14.

14. Testa MA, Simonson DC. Health economic benefits and quality of life during improved glycemic control in patients with

type 2 diabetes mellitus: a randomized, controlled, double-blind trial. JAMA 1998; 280:1490-1496.

15. Wagner EH, Sandhu N, Newton KM, McCulloch DK, Ramsey SD, Grothaus LC. Effect of improved glycemic control on

health care costs and utilization. JAMA 2001; 285:182-189.

16. Ramsey S, Summers KH, Leong SA, Birnbaum HG, Kemner JE, Greenberg P. Productivity and medical costs of diabetes in

a large employer population. Diabetes Care 2002; 25:23-29.

17. Mayfield J, Deb P, Whitecotton L. Work disability and diabetes. Diabetes Care 1999; 22:1105-1109.

18. Burton WN, Conti DJ, Chen C, Schultz AB, Edington DW. The role of health risk factors and disease on worker

productivity. J Occup Environ Med 1999; 41:863-877.

19. Diabetes Prevention Research Group, Costs associated with the primary prevention of type 2 diabetes mellitus in the Diabetes

Prevention Program. Diabetes Care 2003; 26:36-37.
20. Thomson Medstat. Marketscan. 2004.

21. Hoerger TJ, Harris R, Hicks KA, Donahue K, Sorenson S. Screening for type 2 diabetes mellitus: A cost-effective analysis.

Ann Intern Med 2004; 140:689-710.

22. Eichler H, Kong SX, Gerth WC, Mavros P, Jönsson B. Use of cost-effectiveness analysis in health-care resource allocation

decision-making: how are cost-effectiveness thresholds expected to emerge. Value Health 2004; 7:518-528.

23. Harris R, Donahue K, Rathore SS, Frame P, Woolf SH, Lohr KN. Screening adults for type 2 diabetes: a review of the

evidence for the U.S. Preventive Services Task Force. Ann Intern Med 2003; 138:215-229. 

24. Agency for Healthcare Research and Quality (AHRQ). Screening for type 2 diabetes mellitus in adults: recommendations of

the U.S. Preventive Services Task Force, 2005. Washington, DC: AHRQ; 2005 [cited 2005 Jul 25]. Available from:

http://www.ahrq.gov/clinic/pocektgd.pdf.

25. Center for Medicare & Medicaid Services (CMS). Diabetes screening tests., Washington, DC: CMS; 2005 [2006 Sept 14].

Available from: http://www.cms.hhs.gov/DiabetesScreening/.

Notes:

* The preceding are direct and indirect economic data on diabetes for employers to consider in the design of employee

healthcare benefits, including conducting annual negotiations on contracts for healthcare. Some studies cited compared

employers’ diabetes-related costs with costs for other conditions. Because no standard method can account for the nuances

associated with each disease, differing study methods, designs, and data sets create challenges for 1) researchers who compare

the cost of different disease conditions and 2) executives and senior managers who may use the cost data to inform their

decisions for covering specific preventive services. The study researchers acknowledged the limitations and scientifically

accounted for these limitations as well as possible. In addition, the lack of standard metrics for indirect cost, such as disability

and productivity, create challenges. Yet, it is for this reason that some researchers (Goetzel, et. al.) conducted their studies—

to advance 1) the scientific knowledge and collection methods related to such complex data and 2) the usefulness of such data

to the real world (i.e., its usefulness to employers who must make decisions related to employee health and wellness).

225

EVIDENCE-STATEMENT: Diabetes (Screening)
226
227

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/

At Least Fair

Evidence)

Other Recommended

Guidance

• Four of the 10 leading causes of death in the United States — coronary heart

disease, some types of cancer, stroke, and type 2 diabetes — are associated with

an unhealthy diet.1 More than half of all deaths in 1994 were attributable to

these four diseases.

• Diet also contributes significantly to the development of high cholesterol, high

blood pressure, and overweight. These health conditions are associated with

considerable medical expenses, disability, and premature deaths.2

• The total cost attributable to diet-associated coronary heart disease, cancer,

stroke, and diabetes is estimated to be $70.9 billion (in year 1995 dollars).2-3

Direct medical costs account for nearly half (47%) of this total; premature

deaths account for 39% and lost productivity accounts for 13% of the

remainder.2-3 Diet-related osteoporosis and hip fractures cost an additional $5.1

to $10.6 billion each year (in year 1995 dollars).4

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force recommends intensive behavioral dietary

counseling for adults with hyperlipidemia (lipid disorders) and other known risk

factors for cardiovascular and diet-related chronic diseases. Intensive counseling

can be delivered by primary care clinicians or specialists such as nutritionists and

dieticians.3

The USPSTF found good evidence that medium- to high-intensity counseling

interventions can produce medium to large changes in average daily intake of the

core components of a healthy diet (including reduced consumption of saturated

fat and increased consumption of fiber, fruits, and vegetables) in adult patients at

increased risk of diet-related chronic diseases.3

Controlled clinical trials have assessed intensive counseling interventions for atrisk adult patients. The trials involved combined nutrition education with

behavioral dietary counseling provided by a nutritionist, dietician, or specially

trained primary care clinician. The USPSTF concluded that such counseling is

likely to improve important health outcomes and that its benefits outweigh its

potential harms. No controlled trials of intensive counseling in children or

adolescents were identified that measure effective dietary counseling in the

primary care setting.3

Dietary guidelines for the general population have been issued by the U.S.

Department of Agriculture and the Department of Health and Human Services5

and specific dietary objectives for the nation are outlined in Healthy People 2010.

6

Guidelines from the American Heart Association7 address diets that lower the

risks for heart disease, and the American Cancer Association8 has issued

guidelines on diet and cancer. All of these agencies and organizations recommend

a diet that includes a variety of fruits, vegetables, and grains; is low in saturated

fat and cholesterol and moderate in total fat; and balances calories with physical

activity to maintain a healthy weight.

Several groups have recommended nutritional counseling or dietary advice for

EVIDENCE-STATEMENT:

HEALTHY DIET (Counseling)
228

EVIDENCE-STATEMENT: Healthy Diet (Counseling)

Information Sources

patients at average risk of chronic disease, including the American College of

Preventive Medicine (ACPM), American Academy of Family Physicians (AAFP),

American Academy of Pediatrics (AAP), and American College of Obstetricians

and Gynecologists (ACOG).9-12 These recommendations are based primarily on

the benefits of a healthy diet rather than on evaluations of counseling efficacy.13

Recommendations on nutritional counseling for patients at risk of diet-related

chronic diseases (e.g., persons with hypertension or hyperlipidemia) have been

issued by the American Dietetic Association and two panels sponsored by the

National Heart, Lung and Blood Institute (NHLBI). The American Dietetic

Association recommends that primary care providers screen all patients for

nutrition-related illnesses and, for patients with positive screening results,

prescribe diets, provide preliminary counseling on specific nutritional needs,

follow up with the patients, and refer them to appropriate dietetic professionals

when necessary.14 Similarly, the Joint National Committee on Prevention,

Detection, Evaluation and Treatment of High Blood Pressure recommends that

dietary assessments be included in routine medical histories and that patients at

risk of diet-related chronic diseases should be counseled about lifestyle

modifications to prevent and treat high blood pressure; the lifestyle changes

emphasize weight loss for those overweight, limiting alcohol intake, reducing

sodium consumption, and reducing intake of saturated fat and cholesterol.15

The National Cholesterol Education Program (NCEP) recommends that 

persons with elevated levels of low-density lipoprotein limit their intake of fats,

particularly saturated fats and cholesterol, and increase their intake of dietary

fiber.16

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Family Physicians (AAFP)

• American Academy of Pediatrics (AAP)

• American College of Obstetricians and Gynecologists (ACOG)

• American College of Preventive Medicine (ACPM)

• American Dietetic Association 

• American Heart Association (AHA)

• Healthy People 2010

• Joint National Committee on Prevention, Detection, Evaluation, and

Treatment of High Blood Pressure 

• National Cancer Institute (NCI)

• National Cholesterol Education Program (NCEP)

• National Institutes of Health (NIH)

• National Heart, Lung, and Blood Institute (NHLBI)

• Peer-reviewed Research

• U.S. Department of Agriculture (USDA)

• U.S. Department of Health and Human Services (USDHHS)

• U.S. Preventive Services Task Force (USPSTF)
229

EVIDENCE-STATEMENT: Healthy Diet (Counseling)

Epidemiology of

Condition/Disease

Epidemiology of

Condition/Disease

The background and supporting information in this document is based on a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of the opinions of other organizations cited in the text. 

Condition/Disease-Specific Information

The relationship between dietary patterns and health outcomes has been examined

in a wide range of observational studies and randomized trials with patients at risk

of diet-related chronic disease. The majority of these studies have shown that

people who consume diets that are low in fat, saturated fat, trans-fatty acids, and

cholesterol and high in fruits, vegetables, and whole-grain products containing

fiber have lower rates of morbidity and mortality from coronary heart disease and,

possibly, several forms of cancer than those who consume unhealthy diets.17 In

fact, 4 of the 10 leading causes of death — coronary heart disease, some types of

cancer, stroke, and type 2 diabetes — are associated with unhealthy diets.1

Lipid Disorders 

Nearly 107 million American adults (50.7% of the adult population) have a total

blood cholesterol value of 200 mg/dl or above, and 37.7 million of these adults

(18.3%) have a total blood cholesterol level of 240 mg/dl or above.18 A reading of

less than 200 mg/dl is considered desirable and a reading of 240 mg/dl or more is

considered high.

Obesity

Obesity is epidemic in the United States. Between 1976 to 1980 and 1999 to

2002, the proportion of obese adults doubled, the proportion of overweight

children (aged 6 to 11) doubled, and the proportion of overweight adolescents

(aged 12 to 19) tripled.19 Approximately half to two-thirds of obese adults have

diabetes, high blood pressure, coronary artery disease, high cholesterol, or a

combination of these conditions.20

Both lipid disorders and obesity are risk factors for cardiovascular diseases,

including coronary heart disease and coronary artery disease.

Cardiovascular Disease

Coronary heart disease, a cardiovascular disease, is caused by arteriosclerosis (a

thickening or hardening of the arteries) and can lead to angina pectoris (heart pain),

heart attack, or both. An estimated 1.5 million adults have a heart attack each year

in the United States. The American Heart Association estimates that 13.9 million

adults have a history of coronary heart disease and about every minute, someone

dies from a heart attack.18 Arteriosclerosis is particularly sensitive to lipid levels. 

Alcohol and caffeine use and insufficient calcium or vitamin D intake are also

risk factors for osteoporosis. Please refer to the Osteoporosis Screening and

Treatment Evidence-Statement for additional information. 
230

EVIDENCE-STATEMENT: Healthy Diet (Counseling)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Cancer

The American Cancer Society estimates that almost 1.4 million new cases of

cancer will develop in 2006.8 About one-third of the 564,830 deaths expected to

result from cancer in 2006 are related to diet, physical inactivity, and overweight

or obesity and are thus preventable.8

To reduce the risk of morbidity and mortality from coronary heart disease and to

maintain a healthy weight, it is necessary to eat a healthy diet and to balance

calories consumed with physical activity.3 A healthy eating plan is one that

emphasizes fruits, vegetables, whole grains, and fat-free or low-fat milk and milk

products; includes lean meats, poultry, fish, beans, eggs, and nuts; is low in

saturated fats, trans-fats, cholesterol, salt (sodium), and added sugars; and balances

caloric intake with caloric needs. The Federal publication, Nutrition and Your

Health: Dietary Guidelines for Americans provides a good source of dietary advice21:

• Consume a variety of nutrient-dense foods and beverages within and among

the basic food groups while choosing foods that limit the intake of saturated

and trans-fats, cholesterol, added sugars, salt, and alcohol. 

• Meet recommended intake of calories within energy needs by adopting a

balanced eating pattern, such as the U.S. Department of Agriculture’s Food

Guide or the Dietary Approaches to Stop Hypertension (DASH) eating plan.

• Maintain a diet with less than 10% of calories from saturated fat, no more than

30% of calories from total fat, and limited consumption of trans-fatty acids.

Consuming a healthy diet is associated with a reduced risk of chronic disease

morbidity and mortality. 

Value of Prevention

Unhealthy diets contribute to several diseases that impose a heavy economic

burden on employers and employees. 

The total cost attributable to diet-associated coronary heart disease, cancer,

stroke, and diabetes is estimated to be $70.9 billion (in year 1995 dollars).2-3

Direct medical costs account for nearly half (47%) of this total; premature deaths

account for 39% and lost productivity accounts for 13% of the remainder.2-3

Diet-related osteoporosis and hip fractures cost an additional $5.1 to $10.6

billion each year (in year 1995 dollars).4

Productivity losses due to unhealthy diet-associated morbidity from coronary

heart disease, cancer, stroke, and diabetes cost $9.3 billion (in 1995 dollars) per

year.2-3

The cost to employers of obesity-related health problems in 1994 was $13 billion

per year, including $8 billion in medical claims, $2.4 billion in paid sick leave,

$1.8 billion in life insurance, and almost $1 billion in disability insurance.22 In

addition, an estimated 39 million workdays are lost to obesity-related illnesses

each year.23
231

EVIDENCE-STATEMENT: Healthy Diet (Counseling)

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks 

of Intervention

A randomized controlled trial of a low-cost healthy nutrition education program

in the California Public Employee’s Retirement System found a cost savings of

20% over 12 months.24

The Massachusetts Dietetic Association found that diet modification and

counseling for hypercholesterolemia by a registered dietitian saved an estimated

$1,300 per patient, per year.25

In 2004, the private-sector cost of preventive medicine counseling by a physician

averaged $39 per session; approximately 95% of all paid claims fell within the

rage of $0 to $129 per session.26 Nutritional counseling by a dietician averaged

$61 per session and approximately 95% of all paid claims fell within the range of

$0 to $150 per session.26

Nutrition education from the expanded Food and Nutrition Education Program,

administered by the U.S. Department of Agriculture, helps limited-resource

populations acquire the knowledge, skills, and attitudes, and make the behavior

changes necessary for nutritionally sound diets. The benefit-to-cost ratio of

$10.64/$1.00 for a Food and Nutrition Education Program in Virginia27 and

$10.75/$1.00 in Iowa28 shows that nutrition counseling can produce a significant

return-on-investment (ROI).

Another study found that an intensive nutrition intervention in patients with

type 2 diabetes had a cost-effectiveness ratio of $4.20, while the cost-effectiveness

ratio of usual nutrition care was $5.32.29-30

Some evidence indicates that lifestyle interventions may be more cost-effective

than drug treatments for some diet-related chronic illnesses.31

Preventive Intervention Information

Behavioral counseling can help persons at high risk of cardiovascular disease and

other diet-related chronic diseases improve their diets and thereby reduce their

risk of the poor outcomes and complications associated with obesity, lipid

disorders, and coronary heart disease.3

Medium- to high-intensity behavioral interventions appear to produce consistent,

sustained, and clinically important changes in dietary intake of total fat, saturated

fat, fruits, vegetables, and fiber.3 It is important to note that the studies

supporting these benefits were conducted in patients with known risk factors for

diet-related chronic disease or in special clinics with select patients and specially

trained providers. The most effective interventions generally combined education,

behavior-oriented counseling, patient reinforcement, and follow-up. More

intensive interventions and those of longer duration were associated with greater

benefits and more sustained changes in diet.3 The largest effects of dietary

counseling in asymptomatic adults with hyperlipidemia or hypertension and

those at increased risk of diet-related chronic disease have been observed with

more intensive interventions (multiple sessions lasting 30 minutes or longer).3
232

EVIDENCE-STATEMENT: Healthy Diet (Counseling)

Two other approaches appear promising for adult patients in primary care

settings3: 

1. Medium-intensity face-to-face dietary counseling (two to three group or

individual sessions) delivered by a dietitian or nutritionist or by a specially

trained primary care physician or nurse practitioner. 

2. Lower intensity interventions that involve 5 minutes or less of counseling by a

primary care provider and are supplemented by patient self-help materials,

telephone counseling, or other interactive health communications.

However, more research is needed to assess the long-term efficacy of these

treatments and to balance the benefits and harms.3

Possible harms of dietary counseling have not been well-defined or measured.

Some researchers have suggested that a focus on reducing total fat intake but not

reducing caloric intake might lead to an increased intake of carbohydrates (in the

form of reduced-fat or low-fat food products), which could result in weight gain,

elevated triglyceride levels, or insulin resistance.3

Little is known about effective dietary counseling for children or adolescents in

the primary care setting. Most studies of nutritional interventions in these

populations have focused on non-clinical settings, such as schools, or have used

physiologic outcomes, such as cholesterol level or weight reduction, rather than

indicators of a healthy diet, such as intakes of total and saturated fats.32-33

The USPSTF was not able to determine the ideal frequency of counseling. Other

research has indicated that intensive counseling (30 to 45 minutes in duration)

can reasonably be conducted at baseline, 3 months after the initial intervention,

and every 6 months thereafter, as medically indicated. Thus, in any given

calendar year, 3 counseling sessions could be provided.34

Decisions about behavioral counseling should take into account the overall risk

for coronary heart disease. Risk assessment should consider age, sex, and the

presence and severity of the following risk factors: diabetes, elevated total

cholesterol levels, low levels of high density lipoprotein cholesterol, elevated

blood pressure, family history (in younger adults), and smoking.3

Effective interventions include individual or group counseling, which can be

delivered by nutritionists, dietitians, specially trained primary care practitioners

and health educators in the primary care setting, or in other clinical settings by

referral.3

Effective interventions combine nutrition education with behavior-oriented

counseling to help patients acquire the skills, motivation, and support needed to

alter their daily eating and food preparation practices. Examples of behaviororiented counseling interventions include teaching self-monitoring, training

patients to overcome common barriers to selecting a healthy diet, helping

patients set their own goals, providing guidance in shopping and food

preparation, engaging in role playing with patients, and arranging for social

support during treatment. In general, these interventions align with the “5 As”

Initiation, Cessation,

and Interval of

Counseling

Intervention Process
233

EVIDENCE-STATEMENT: Healthy Diet (Counseling)

Treatment

Information

behavioral counseling framework35:

• Assess dietary practices and related risk factors.

• Advise patients to change dietary practices.

• Agree on individual diet change goals.

• Assist patients in changing their dietary practices or addressing motivational

barriers.

• Arrange regular follow-up and support or refer patients to more intensive

behavioral nutritional counseling (e.g., medical nutrition therapy) if needed.5,20

Systems supports (prompts, reminders, and counseling algorithms) for primary

care clinicians have been found to significantly improve their delivery of

appropriate dietary counseling.36-38

Initial assessments and follow-up monitoring can be conducted using any of

several brief dietary assessment questionnaires, which have been validated for use

in the primary care setting.39 These instruments identify dietary counseling needs,

guide interventions, and monitor changes in patients’ dietary patterns. Since

patients enrolled in diet-change programs may exaggerate their adherence the

programs, clinicians may not wish to rely on brief dietary assessment

questionnaires but may find them useful to verify self-reported information.21, 40-42

Not Applicable

Strength of Evidence for the Clinical Preventive Service 

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research: 

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/ At Least Fair Evidence)

• The U.S. Preventive Services Task Force found good evidence to recommend

intensive behavioral dietary counseling for adult patients with hyperlipidemia

(lipid disorders) and other known risk factors for cardiovascular and dietrelated chronic disease. Intensive counseling may be delivered by primary care

clinicians or by referral to other specialists, such as nutritionists or dieticians.3

Recommended Guidance:

American Dietetic Association

Strength of Evidence: Not Specified

• The American Dietetic Association recommends that primary care providers

screen all patients for nutrition-related illnesses and, for patients with positive

screening results, prescribe diets, provide preliminary counseling on specific

nutritional needs, follow up with the patients, and refer them to appropriate

dietetic professionals when necessary.14
Joint National Committee on Prevention, Detection, Evaluation and Treatment

of High Blood Pressure

Strength of Evidence: Not Specified

• The Joint National Committee on Prevention, Detection, Evaluation and

Treatment of High Blood Pressure recommends that dietary assessments be

included as part of a routine medical history and that physicians counsel

patients on lifestyle modifications for the prevention and treatment of high

blood pressure (lose weight if overweight, limit alcohol intake, reduce sodium

intake, reduce saturated fat and cholesterol intake).15

The National Cholesterol Education Program (NCEP)

Strength of Evidence: Not Specified

• The National Cholesterol Education Program recommends that persons with

elevated levels of low-density lipoprotein limit their intake of fats, particularly

saturated fats, and cholesterol and increase their intake of dietary fiber.16

234

EVIDENCE-STATEMENT: Healthy Diet (Counseling)

Authored by: 

Lanza A, Tohill BC, Campbell KP. Healthy diet evidence-statement: counseling. In: Campbell KP, Lanza A,

Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive

Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.

References:

1. Ammerman A, Pignone M, Fernandez L, Lohr K, Jacobs AD, Nester C, et al. Counseling to promote a healthy diet.

Systematic Evidence Review No. 18. Rockville (MD): Agency for Healthcare Research and Quality; 2002. Available from:

www.ahrq.gov/clinic/serfiles.htm.

2. Frazao, E. The high costs of poor eating patterns in the United States. In: E. Frazao, editor. America’s eating habits: changes

and consequences. Washington (DC): U.S. Department of Agriculture, Economic Research Service; 1999. 

3. U.S. Preventive Services Task Force. Behavioral counseling in primary care to promote a healthy diet. Recommendations and

rationale, Available from http://www.guideline.gov/summary/summary.aspx?doc_id=3494&nbr=2720.

4. Barefield E. Osteoporosis-related hip fractures cost 13 billion to 18 billion yearly. Food Review 1996;19:31-36.

5. U.S. Department of Health and Human Services. Nutrition and your health: dietary guidelines for Americans. 2005 edition.

Available from: http://www.health.gov/dietaryguidelines/. 

6. U.S. Department of Health and Human Services. Healthy People 2010: Understanding and Improving Health. 2nd ed.

Washington (DC): U.S. Government Printing Office; 2000. Available from: http://www.health.gov/healthypeople/.

7. Wylie-Rosett J. Fat substitutes and health: an advisory from the Nutrition Committee of the American Heart Association.

Circulation 2002;105:2800-4.

8. American Cancer Society. Cancer facts and figures 2006. Available from:

http://www.cancer.org/docroot/STT/content/STT_1x_Cancer_Facts__Figures_2006.asp. 

9. Nawaz H, Katz DL. American College of Preventive Medicine policy statement: weight management counseling of

overweight adults. Am J Prev Med 2001:21:73-8.

10. American Academy of Family Physicians. Summary of policy recommendations for periodic health examinations, revision

5.1, April 2006. Available from: http://www.aafp.org/exam.xml. 
11. American Academy of Pediatrics, Committee on Nutrition. Policy statement: cholesterol in childhood. Pediatrics

1998;101:141-7. Available from: http://www.aap.org/policy/re9805.html. 

12. American College of Obstetricians and Gynecologists. Guidelines for Women’s Health Care. 2nd ed. Washington (DC):

American College of Obstetricians and Gynecologists; 2002.

13. Canadian Task Force on the Periodic Health Examination. Canadian guide to clinical preventive health care. Ottawa: Health

Canada; 1994. Available from: http://www.phac-aspc.gc.ca/publicat/clinic-clinique/index.html. 

14. Maillet JO, Young EA. Nutrition education for healthcare professionals: Position of the ADA. J Am Diet Assoc 1998;98:343-6.

15. Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure.

Bethesda (MD): National Heart Lung and Blood Institute; 1997. Available from:

http://www.nhlbi.nih.gov/guidelines/hypertension/jncintro.htm. 

16. Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation and Treatment of

High Blood Cholesterol in Adults (Adult Treatment Panel III). Bethesda (MD): National Heart Lung and Blood Institute; 2001.

Available from: http://www.nhlbi.nih.gov/guidelines/cholesterol/index.htm. 

17. Clifford C, Ballard-Barbash R, Lanza E, Block G. Diet and cancer risk. Risk factors. National Cancer Institute, National

Institutes on Health. Available from: http://rex.nci.nih.gov/NCI_Pub_Interface/raterisk/risks73.html. 

18. American Heart Association. Heart disease and stroke statistics: 2005 update. Dallas (TX): American Heart Association;

2005.

19. Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among U.S.

children, adolescents and adults. 1999-2002. JAMA 2004; 291:2847-50.

20. Must A, Spandano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and

obesity. JAMA 1999;282:1523-29. 

21. U.S. Department of Health and Human Services. Nutrition and Your Health: Dietary Guidelines for Americans. Fifth Edition;

2000. Available from: http://www.health.gov/dietaryguidelines/.

22. Thompson D, Edelsberg J, Kinsay KL, Oster G. Estimated economic costs of obesity to U.S. business. Am J Health Promot

1998;13:120-7.

23. Thorpe KE, Florence CS, Howard DH, Joski P. The impact of obesity on rising medical spending. Health Aff 2004;W4:480-

6.

24. Fries JF, Harrington H, Edwards R, Kent L, Richardson N. Randomized controlled trial of cost savings from a low-cost

health education program: the California Public Employee’s Retirement System (PERS). Am J Health Promot 1994;8:216-

23.

25. National Cholesterol Education Program. Second report of the Expert Panel on Detection, Evaluation, and Treatment of High

Blood Cholesterol in Adults. Washington (DC): National Institutes of Health; 1993.

26. Thomson Medstat. Marketscan. 2004.

27. Lambur M, Rajgopal R, Lewis E, Cox RH, Ellerbrock M. Applying cost benefit analysis to nutrition education programs:

focus on the Virginia Expanded Food and Nutrition Education Program. Washington (DC): U.S. Department of Agriculture;

1999. 

28. Wessman C, Betterley C, Jensen H. Evaluation of the costs and benefits of Iowa’s Expanded Food and Nutrition Education

Program (EFNEP): final report. Available from: http://ideas.repec.org/p/ias/cpaper/01-sr93.html. 

29. Franz MJ, Splett PL, Monk A, Barry B, McClain K, Weaver T, et al. Cost-effectiveness of medical nutrition therapy provided

by dieticians for persons with non-insulin-depended diabetes mellitus. J Am Diet Assoc 1995;95:1018-24. 

30. Obarzanek E, Hunsberger SA, Van Horn L, Hartmuller VV, Barton BA, Stevens VJ, et al. Safety of a fat-reduced diet: the

Dietary Intervention Study in Children (DISC). Pediatrics 1997;100:51-9. 

31. Herman WH, Hoerger TJ, Brandle M, Hicks K, Sorensen S, Zhang P, et al. The cost-effectiveness of lifestyle modification or

Metformin in preventing type 2 diabetes in adults with impaired glucose tolerance. Ann Intern Med 2005;142:323-32.

32. Obarzanek E, Kimm SY, Barton BA, Van Horn LL, Kwiterovich PO Jr, Simons-Morton DG, et al. Long-term safety and

efficacy of a cholesterol-lowering diet in children with elevated low-density lipoprotein cholesterol: seven-year results of the

Dietary Intervention Study in Children (DISC). Pediatrics 2001;107:256-64.

235
236

33. Maskarinec G, Chan CL, Meng L, Franke AA, Cooney RV. Exploring the feasibility and effects of a high-fruit and -vegetable

diet in healthy women. Cancer Epidemiol Biomarkers Prev 1999;8:919-24.

34. Hjerkinn EM, Seljeflot I, Ellingsen I, Berstad P, Hjermann I, Sandvik L, Arnesen H. Influence of long-term intervention

with dietary counseling, long-chain n–3 fatty acid supplements, or both on circulating markers of endothelial activation in

men with long-standing hyperlipidemia. Am J Clin Nutr 2005; 81(3): 583-589.

35. Beresford SA, Curry SJ, Kristal AR, Lazovich D, Feng Z, Wagner EH. A dietary intervention in primary care practice: the

Eating Patterns Study. Am J Public Health 1997;87:610-6. 

36. Ockene IS, Hebert JR, Ockene JK, Saperia GM, Stanek E, Nicolosi R, et al. Effect of physician-delivered nutrition counseling

training and an office-support program on saturated fat intake, weight, and serum lipid measurements in a hyperlipidemic

population: Worcester Area Trial for Counseling in Hyperlipidemia (WATCH). Arch Int Med 1999;159:725-31.

37. Ockene IS, Hebert JR, Ockene JK, Merriam PA, Hurley TG, Saperia GM. Effect of training and a structured office practice

on physician-delivered nutrition counseling: the Worcester-Area Trial for Counseling in Hyperlipidemia (WATCH). Am J

Prev Med 1996;12:252-8.

38. Calfas KJ, Zabinski MF, Rupp J. Practical nutrition assessment in primary care settings: a review. Am J Prev Med

2000;18:289-299.

39. Beresford SA, Farmer EM, Feingold L, Graves KL, Sumner SK, Baker RM. Evaluation of a self-help dietary intervention in a

primary care setting. Am J Public Health 1992;82:79-84. 

40. Coates RJ, Bowen DJ, Kristal AR, Feng Z, Oberman A, Hall WD, et al. The Women's Health Trial Feasibility Study in

Minority Populations: changes in dietary intakes. Am J Epidemiol 1999;149:1104-12.

41. Kristal AR, Curry SJ, Shattuck AL, Feng Z, Li S. A randomized trial of a tailored, self-help dietary intervention: the Puget

Sound Eating Patterns study. Prev Med 2000;31:380-9.

42. Little P, Barnett J, Margetts B, Kinmonth AL, Gabbay J, Thompson R, et al. The validity of dietary assessment in general

practice. J Epidemiol Comm Health 1999;53:165-72.

EVIDENCE-STATEMENT: Healthy Diet (Counseling)
237

Why This Chapter is

Important for

Employers: 

An Overview

Alcohol Misuse (Screening and Counseling): 

• Fetal exposure to alcohol during pregnancy is one of the leading causes of

preventable birth defects, mental retardation, and developmental disorders in

the United States.1

• In 2003, 10% of pregnant women reported alcohol use, including 4% who

reported binge drinking.2 Approximately 55% of women of childbearing-age

age drink alcohol and 12% report binge drinking on one or more occasions in

the past month.2 Because half of all pregnancies in the United States are

unintended, many women of childbearing-age who use or abuse alcohol are at

risk of an alcohol-exposed pregnancy. 

• The direct and indirect costs of alcohol misuse in the United States were

estimated to equal nearly $185 billion in 1998. Medical consequences of fetal

alcohol syndrome (FAS) accounted for approximately $2.9 billion of this

amount.3

• Researchers estimate that the excess medical costs for a child with fetal alcohol

syndrome (FAS) are $2,342 per year (in year 1997 dollars).4

• Randomized trials demonstrate that brief counseling leads to reduced alcohol

consumption among excessive drinkers and to reductions in adverse alcoholrelated health outcomes, including excess mortality.5-7

• It is estimated that each $1 invested in screening and brief counseling

interventions saves approximately $4 in healthcare costs.6,8

Asymptomatic Bacteriuria (Screening):

• Urinary tract infections (UTIs) are the most common bacterial infections

among pregnant and non pregnant women; each year 8 million women visit a

physician for evaluation of a UTI.9

• Physiologic changes that occur during pregnancy make pregnant women more

susceptible to UTIs, including asymptomatic bacteriuria (infection in the

urine), cystitis (infection in the bladder), and pyelonephritis (infection in the

kidneys).9

• Asymptomatic bacteriuria occurs in approximately 2% to 14% of pregnant

women and 80,000 to 400,000 cases occur each year in the United States.9

• Bacteriuria increases the risk for preterm delivery twofold.9 It also increases the

risk of low birth weight and fetal and perinatal mortality.9-10 

• Without treatment, asymptomatic bacteriuria can progress to pyelonephritis, a

serious kidney infection. Pyelonephritis complicates 1% to 2% of all

pregnancies and affects 100,000 women each year.9

• Early identification and treatment of asymptomatic bacteriuria improves

pregnancy outcomes as it reduces the incidence of pyelonephritis and

premature births.

Breastfeeding (Counseling):

• Human milk is universally recognized to be the optimal food for infants and is

nutritionally superior to formula: breast milk confers immunity and protects

infants from infections and allergens. 

EVIDENCE-STATEMENT:

HEALTHY PREGNANCY (Screening, Testing, Counseling,

Immunization, and Preventive Medication)
238

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

• Research shows that children who were breastfed are at significantly lower risk

for childhood obesity as well as type 1 and type 2 diabetes compared to their

non-breastfed peers.11

• Breastfeeding also has important short- and long-term health benefits for the

mother. A woman’s risk of breast cancer is decreased 4.3% for every 12-month

increment of breastfeeding over her lifetime. Her risk of ovarian and

endometrial cancer is decreased through breastfeeding as well.12

• Data from 2005 show that 72.9% of all new mothers initiated breastfeeding;

but only 39.1% continued to breastfeed for 6 months and only 20.1%

continued to breastfeed for the recommended 12-month period.13

• A 2001 U.S. Department of Agriculture (USDA) study estimated that at least

$500 million (in year 1998 dollars) could be saved in healthcare costs if

breastfeeding rates were increased to match those recommended by the

Surgeon General/Healthy People 2010 goals.14

• Research indicates that working outside the home reduces the initiation and

duration of breastfeeding.15 Therefore, employers should support women

returning to work by offering lactation benefits (such as counseling) and

programs. 

Folic Acid Supplementation (Counseling and Preventive Medication):

• Neural tube defects (NTD), such as spina bifida and anencephaly, result from

a failure of the neural cord to properly fuse. 

• Each year, approximately 3,000 pregnancies are affected by neural tube defects

(NTDs) and approximately 2,200 infants are born with NTDs.16

• Folic acid, a B vitamin, helps prevent NTD. Consuming the recommended

daily amount of folic acid (0.4mg) can reduce a woman’s chance of having a

NTD-affected pregnancy by 40% to 80%.17

• Despite the benefits of supplementation, only 33% of women of childbearing

age report taking vitamins that contain folic acid.18

• NTD rates are highest among the Hispanic population. Efforts to ensure

supplementation among this population are important for eliminating health

disparities.19

• The economic impact of NTDs is substantial. The average lifetime cost for a

child born with spina bifida is estimated to be $636,000 (in year 2002

dollars).20 Costs associated with NTDs are shared by parents, employers, and

communities.

Group B Streptococcal Disease (Screening and Preventive Medication): 

• Group B streptococcus (GBS), a bacterium, has been a leading cause of

infection-related infant deaths in the United States since the 1970s. 

• GBS disease is a serious infection that causes sepsis (blood poisoning),

pneumonia, and meningitis in newborns. 

• Each year in the United States between 1,300 and 1,600 infants contract earlyonset GBS and 65 to 80 infants die from it.21 Those who survive are often left
239

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

with lifelong disabilities such as hearing loss, vision impairments, and/or

learning disabilities. 

• While most women colonized with GBS are asymptomatic (meaning that they

can pass the disease to their children, but are not affected by it themselves),

some women become infected with GBS and are at risk of womb infections,

bladder infections, and stillbirth.21

• By identifying women who carry group B streptococcal bacteria, clinicians can

administer antibiotic prophylaxis during labor, thus preventing transmission of

bacteria to the infant. 

• The average neonatal intensive care cost of a GBS-infected infant was

estimated to be $30,100 in 2001.22 The cost of treating an infant with earlyonset group B streptococcal sepsis (a severe form of the disease) is estimated to

exceed $123,000 (in year 1993 dollars).23

• In 1993, researchers estimated that treating high-risk women identified

through screening with intrapartum antibiotic prophylaxis could prevent 3,300

cases of GBS annually; saving approximately $16 million in direct medical

costs.24

Hepatitis B Virus (HBV) (Screening, Immunization, and Treatment): 

• Over 1 million people in the United States are chronic HBV carriers.25

• In 2003, 73,000 new HBV infections were reported.25

• Screening pregnant women for HBV, and treating the infants of HBV-positive

women with post-exposure hepatitis B immune globulin prophylaxis and HBV

vaccination can dramatically reduce the incidence of perinatal HBV

transmission and thus the number of infants who become chronically infected

with hepatitis B.26

• The economic burden of hepatitis B infection can be substantial depending on

whether the infection is acute or chronic and what treatment is required.

• From a societal perspective, prevention of perinatal HBV infection was estimated

to save $41.8 million (in year 1993 dollars) in medical and work-loss costs.27

Human Immunodeficiency Virus (HIV) (Screening, Counseling, and

Preventive Medication)

• Approximately 120,000 to 160,000 HIV-infected women live in the United

States, 80% of whom are of childbearing age. Each year between 1985 and

1995, approximately 6,000 to 7,000 HIV-infected women gave birth.28

• Mother-to-infant HIV transmission, called perinatal transmission, can occur

during pregnancy, during labor and delivery, or through breastfeeding.

Perinatal HIV transmission is almost entirely preventable.

• Despite screening and treatment advances, perinatal HIV transmission

continues to occur; CDC estimates that 280 to 370 infants are born with HIV

each year in the United States.28

• In 2000, there were 4,107 hospitalizations among HIV-infected children in the

United States, which accounted for approximately $100 million in hospital

charges and more than 30,000 hospital days.29
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Immunization, and Preventive Medication)

• The estimated average lifetime healthcare-related cost of a perinatal

HIV infection is estimated to range between $100,000 and $117,000.30

Influenza (Immunization):

• Pregnant women are considered to be at increased risk for

complications from influenza infections. 

• Influenza immunization has many benefits. Foremost, when a pregnant

woman is immunized during pregnancy, antibodies can be passed to

her fetus and can also be passed in breast milk.31

• Researchers estimate that an average of 1 to 2 hospitalizations can be

prevented for every 1,000 pregnant women vaccinated.32

• Despite the seriousness of influenza infection and the fact that the

inactivated influenza vaccine is safe and effective, only 12% to 13% of

pregnant woman are inoculated against influenza.31,33

• Immunization of healthy working adults is cost-effective and may

result in cost-savings in some years.34 Economic results are likely to be

as favorable for pregnant women since they are at high risk for

influenza-related complications.

Preeclampsia (Screening):

• Preeclampsia (pregnancy-related high blood pressure) affects 5% to 7%

of all pregnancies.35 If preeclampsia is not effectively treated it can lead

to eclampsia, a severe condition that is characterized by maternal

seizure activity, coma, and death. 

• Preeclampsia/eclampsia is the third leading cause of maternal death

worldwide36 and is responsible for 18% of all maternal deaths in the

United States.37

• Spending on pregnancy-related hypertension totaled nearly $2.3 billion

in the United States in 2003.38

• In 2003, approximately 204,868 pregnant women were admitted to

the hospital for hypertension, staying on average 3.5 days. The average

per-person charge for such hospital admissions totaled $11,208.38

• Screening, which involves minimal cost, and early treatment can

minimize and prevent otherwise costly medical conditions.

Prenatal Diagnosis of Chromosomal Abnormalities and Neural Tube

Defects (NTDs) (Screening and Testing): 

• Down syndrome (trisomy 21) is the most common chromosomal

abnormality in the United States, affecting 1 in every 800 to 1,000

live-born babies.39

• Spina bifida and anencephaly are common, permanent, and potentially

fatal birth defects. Both are neural tube defects (NTD) resulting in

failure of the neural cord to properly fuse. Each year in the United

States, approximately 3,000 pregnancies are affected by NTDs and

approximately 2,200 infants are born with neural tube defects.16

• The purpose of screening and testing is to identify affected
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

pregnancies. Early identification of an affected pregnancy allows parents and

providers to prepare for the birth of a special needs infant or to terminate the

pregnancy.40

• Chromosomal abnormalities and NTDs have a substantial economic impact.

For example, the average lifetime cost for a child born with spina bifida is

estimated to be $636,000 (in year 2002 dollars).41

• Employers also face productivity losses associated with workdays lost by

employees who must care for affected infants and children.42

Rh(D) Incompatibility (Screening and Preventive Medication): 

• Rh(D) incompatibility occurs in 9% to 10% of all pregnancies, depending on

the race of the pregnant woman and fetus, and may cause severe destruction of

an affected fetus’s red blood cells.43

• Without treatment, 25% to 30% of affected fetuses will experience hemolytic

anemia and hyperbilirubinemia (jaundice) and an additional 20% to 25% will

be hydropic and will either die in the womb or shortly after birth.43

• Early identification of Rh(D) incompatibility allows clinicians to begin

treatment before damage is done to the fetus. This prevents otherwise

expensive medical treatment, lifelong disability, and even death.

Rubella (Screening):

• When contracted during early pregnancy, rubella can cause serious

complications including miscarriage, stillbirth, and congenital rubella

syndrome (CRS) – a constellation of birth defects that includes hearing

impairment, growth retardation, developmental delays, and heart and eye

defects.44

• CRS and its complications have substantial health consequences and economic

costs. A large rubella outbreak in 1964-65 cost an estimated $840 million.45 In

2006, the estimated lifetime cost of treating a child born with CRS exceeded

$200,000.45

• Screening allows clinicians to identify childbearing-age women who are at risk

for rubella and to immunize them before they become pregnant. Screening

pregnant women allows clinicians to identify at-risk women and to encourage

them to be immunized immediately after delivery, thereby offering protection

during subsequent pregnancies. 

Syphilis (Screening):

• In addition to sexual transmission, syphilis can be passed from an infected

pregnant woman to her infant during pregnancy and delivery.

• Congenital syphilis is particularly severe and results in fetal or infant death in

40% of cases.46

• In 2002, 451 cases of congenital syphilis were reported in the United States.47

• The average annual national cost of treating infants with congenital syphilis is

approximately $18.4 million (in year 1995 dollars).48

• Screening for syphilis allows clinicians to identify affected patients and begin
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

treatment earlier in the course of disease, thereby improving outcomes and

avoiding the health and economic consequences of latent disease. Further,

ensuring that all women receive prenatal care and are screened for syphilis

during pregnancy will reduce the incidence of congenital syphilis.47

Tetanus (Immunization): 

• Neonatal tetanus is a severe and often fatal disease; it accounted for an

estimated 200,000 deaths worldwide in 200049 but is extremely rare in the

United States.50

• Nearly all neonatal tetanus occurs in infants born to women who are not

adequately immunized against tetanus. Therefore, it is important for all

pregnant women to be vaccinated against tetanus.51

• There are few economic data on the burden of tetanus disease and no data

about the costs of neonatal tetanus in the United States. A recent economic

evaluation of the 7-vaccine routine childhood immunization schedule in the

United States estimated that, if there had not been a tetanus vaccination

program in the U.S., 153 cases of tetanus and 23 deaths from tetanus would

have occurred in each birth cohort (all children born in one year) at a total

cost of $29 million (direct and indirect costs in year 2001 dollars).52

• Tetanus immunization offers long-term protection against tetanus for the

vaccinated woman, and maternal vaccination confers significant protection to

the fetus.53

Tobacco Use Treatment (Screening and Counseling):

• Twenty-five percent (25%) of all childbearing-age women in the United States

smoke. Depending on demographic factors, between 11% and 20% of all

pregnant women in the United States smoke.54

• Women who smoke during their pregnancies are 83% more likely to deliver a

low-birth-weight infant, 129% more likely to deliver an infant that will die of

SIDS, 30% more likely to deliver an infant with respiratory distress syndrome,

and 41% more likely to deliver an infant with a perinatal respiratory condition

than are women who do not smoke during pregnancy.

• Each pregnant smoker incurs an additional $704 in healthcare costs (in year

1996 dollars)55 and, annually, smoking-attributable neonatal costs (defined as

all costs related to labor/delivery and the care of infants within the first few

months of life) are estimated to meet or exceed $367 million in the United

States.56-57

• Tobacco use treatment is considered to be one of the most cost-effective

preventive services.54 Clinical trials have shown that $6 are saved in healthcare

costs for every $1 invested in smoking cessation programs for pregnant

women.58

• A smoking cessation program that could achieve an annual drop of 1 percentage

point in smoking prevalence has been estimated to produce an economic

benefit of $21 million in direct medical costs solely by reducing the number of

low-birth-weight live births. In 7 years, the cumulative undiscounted saving in

direct medical costs would become $572 million through the prevention of

57,200 low-birth-weight infants (all figures in year 1995 dollars).59
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Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/At

Least Fair Evidence)

Recommended

Guidance

U.S. Surgeon General

Evidence Rating:

Information Sources

Epidemiology of

Condition/Disease

Alcohol Misuse (Screening and Counseling)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends screening and

behavioral counseling interventions to reduce alcohol misuse by adults, including

pregnant women, in primary care settings.1

The evidence on the effectiveness of counseling to reduce alcohol consumption

during pregnancy is limited; however, studies in the general adult population show

that behavioral counseling interventions are effective among women of childbearing

age. The USPSTF concluded that the benefits of behavioral counseling

interventions to reduce alcohol misuse by adults outweigh any potential harms.1

The USPSTF recommendation is supported by the American Academy of Family

Physicians (AAFP).2

The Surgeon General of the United States recommends that clinicians 1) screen

pregnant women for alcohol use, 2) inform them of the risks of alcohol

consumption, and 3) advise them not to drink alcohol during their pregnancy.3

Not Specified

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Family Physicians (AAFP)

• Centers for Disease Control and Prevention (CDC)

• National Institute of Alcohol Abuse and Alcoholism (NIAAA)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

• U.S. Surgeon General

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

No amount of alcohol can be considered safe during pregnancy: alcohol

consumed during any stage of pregnancy increases the risk of alcohol-related

birth defects.3 Fetal exposure to alcohol during pregnancy is one of the leading

causes of preventable birth defects, mental retardation, and developmental

disorders in the United States.4

Despite the documented risks associated with fetal alcohol exposure 10% of

pregnant women reported consuming alcohol in 2003.5 Annually, 55% of
244

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden 

of Condition/Disease

Economic Benefit of

Preventive

Intervention

women of childbearing age report alcohol use, and 12% report binge drinking.5

This statistic is of particular concern because half of all pregnancies in the United

States are unplanned and are at particular risk of unintentional prenatal alcohol

exposure. Therefore, experts recommend that women of childbearing age consult

their physicians and take steps to reduce the possibility of an alcohol-exposed

pregnancy by either 1) using an effective form of contraception or 2) reducing or

eliminating alcohol use.5 

Prenatal alcohol use can lead to one or more fetal alcohol spectrum disorders

(FASD). FASD is characterized by permanent disabilities of varying degrees of

severity. FASD may result in subtle defects, such as learning disabilities or mild

physical abnormalities, or it may result in fetal alcohol syndrome (FAS), the most

severe form of FASD, which is characterized by mental retardation, abnormal

facial features, growth retardation, and central nervous system complications.3

FASD is identified in 2 of every 1,000 live births, and FAS is identified in

between 0.5 to 2 of every 1,000 live births.3 Because many alcohol-related deficits

are not identified at the time of birth, the actual prevalence of alcohol-related

disorders is much higher. In fact, researchers estimate that, for every case of FAS

documented at birth, there are 3 additional cases that are not identified until

later in life.3

Alcohol misuse (in the form of binge drinking, heavy drinking, alcohol abuse, or

alcohol dependence) before pregnancy is highly predictive of continued use.4

Value of Prevention

The direct and indirect costs of alcohol misuse in the United States were

estimated to equal nearly $185 billion in 1998. Medical consequences of fetal

alcohol syndrome (FAS) accounted for about $2.9 billion of this amount and

approximately $1.3 billion were attributed to lost earnings due to FAS.6

Data are limited about presenteeism and absenteeism stemming from parental

caregiving requirements for FASD/FAS-affected children, but parents are likely to

take time off from work to attend to special needs children. 

The economic benefits of screening and counseling mainly result from:

• The averted costs of medical care for FAS and related disorders.

• Cost-savings in neonatal care and the management of developmental delays

and birth defects.

• Cost-savings associated with special education, the criminal justice system,

alcohol and/or drug abuse treatment, and mental health services. 

Interventions directed toward alcohol misuse that occur during pregnancy may

also improve a pregnant woman’s long-term drinking behavior. A permanent or

long-term reduction/elimination of alcohol use would generate additional costsavings due to averted long-term healthcare costs.
245

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

and Counseling

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening

Screening patients for alcohol misuse in primary care settings is relatively

inexpensive. The cost of follow-up counseling sessions depends on the number of

sessions, their mode of delivery (in-office or by telephone), and on the type of

provider who delivers the counseling. In 2004, the private-sector cost of the

initial health risk assessment and counseling averaged $23; approximately 95% of

all paid claims fell within the range of $0 to $81.7

Treatment costs for pregnant women who misuse alcohol should not differ from

general alcohol treatment costs unless there are other pregnancy-related

complications.

Screening and counseling for alcohol misuse have a greater impact and are more

cost-effective than most clinical preventive services.8 Screening and counseling for

alcohol misuse among all adults (not just pregnant women) reduce both societal

and healthcare costs. It is estimated that each $1 invested in screening and brief

counseling interventions saves approximately $4 in healthcare costs.9-10

Furthermore, researchers estimated that the excess medical costs for a child with

fetal alcohol syndrome (FAS) are $2,342 per year (based on North Dakota

Health Claims data for 1996 and 1997). This suggests that a alcohol-reduction

program that costs $50,000 and is able to prevent one case of FAS each

year would have paid for itself in 6 years by generating healthcare savings. The

benefits are returned even faster if the prevention of alcohol-related conditions

other than FAS are included in the analysis.11

Preventive Intervention Information

Screening for alcohol misuse allows clinicians to identify women who misuse

alcohol early in the course of pregnancy (or during the pre- or interconception

periods). Pregnant women who misuse alcohol can be counseled to reduce or

eliminate their use and referred to treatment services as needed. 

The benefits of screening and intervention include the prevention of FASD and

FAS in addition to the maternal benefits accrued from identifying and

intervening with their alcohol misuse. Randomized trials demonstrate that brief

counseling leads to reduced alcohol consumption among excessive drinkers and

to reductions in adverse alcohol-related health outcomes, including excess

mortality.9, 12-13 The USPSTF found little direct evidence regarding harms of

screening for alcohol misuse or behavioral counseling interventions to reduce or

eliminate alcohol use in general populations.14

All women should be screened for alcohol use with each pregnancy. Because the

optimal frequency of screening is unknown, screening is left to the discretion of

the clinician. Patients at greater risk for alcohol problems, either because they

have a history of past alcohol misuse or may report other risky behaviors, may

benefit from re-screening during pregnancy.14 Counseling should be conducted as

medically indicated. A total of 8 counseling sessions are covered each calendar

year.
246

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Intervention Process

Screening

Counseling

There are several effective screening tools currently available for assessing alcohol

use in primary care settings. Non-pregnant women of childbearing age seen in

primary care settings should be screened with general tools such as a single

questions screen (e.g., AUDIT or AUDIT-C).15 Pregnant women seen in primary

care settings should be screened with a pregnancy-specific tool such as the

TWEAK or T-ACE. The TWEAK, a 5-question tool, and the T-ACE, a 4-

question tool, were specifically designed to screen pregnant women for “risky

drinking”, “harmful drinking”, and alcohol abuse disorders. The T-ACE is very

sensitive and has been shown to outperform unaided clinicians in identifying

pregnant women who use alcohol.

All pregnant women and women considering pregnancy should be advised of the

harmful effects of alcohol on the fetus. Because safe levels of alcohol

consumption during pregnancy are unknown, pregnant women should be

advised to refrain from drinking alcohol altogether.5,14 Non pregnant women

should also be advised to use contraception until their drinking can be reduced

or eliminated.

Clinicians should provide counseling interventions for patients who meet the

criteria for alcohol misuse. The USPSTF identifies 3 levels of counseling

intervention, differentiated by level of intensity, for these patients. Multi-contact

counseling is more effective than single-contact counseling interventions, but

providers should tailor counseling intensity to address individual patient needs.

Intensity is determined by the duration of the initial contact and whether any

follow-up occurs. “Very brief” interventions last up to 5 minutes and have no

follow-up. “Brief” counseling interventions last 15 minutes and have no followup. “Multi-contact” interventions include one initial session lasting at least 15

minutes and several follow-up contacts.1 More intensive interventions are

typically recommended for those meeting criteria for alcohol dependence.

Effective counseling for alcohol misuse in the primary care setting includes

feedback, advice, goal setting, and follow-up. Alcohol misuse counseling should

follow the counseling framework known as the “5 As”15: 

• Providers should assess the degree of a patient’s drinking, including any

problems caused by alcohol and whether the person is alcohol dependent or

not. 

• Providers should advise patients to reduce their alcohol consumption to safer

levels or to abstain altogether from drinking. 

• Providers should agree with patients on their goals for reducing alcohol

consumption. 

• Providers should assist patients in acquiring personal motivation, self-help

skills, or outside resources necessary to achieve behavior change. 

• Finally, providers should arrange for patients to receive appropriate follow-up

support services and counseling, depending on the nature of their alcohol

misuse. 
247

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Treatment

Information

Health benefits should include provisions for diagnostic assessment, follow-up,

and treatment services.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Evidence-Based Research: 

The U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

• The USPSTF found at least fair evidence to support screening and behavioral

counseling all adults, including pregnant women, for alcohol misuse.1

This recommendation is supported by the:

• American Academy of Family Physicians (AAFP)2

Recommended Guidance:

The U.S. Surgeon General

Strength of Evidence: Not Specified

• The U.S. Surgeon General recommends that clinicians should routinely 1)

screen pregnant women for alcohol use, 2) inform them of the risks of alcohol

consumption, and 3) advise them not to drink alcohol during their pregnancy.3

Authored by: 

Campbell KP, Naimi T, Chattopadhyay S. Alcohol misuse during pregnancy evidence-statement:

screening and counseling. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA,

editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington,

DC: National Business Group on Health; 2006.
248

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/ 

Good Evidence) 

Evidence-Based

Recommendation

American Academy

of Family Physicians

(AAFP)

Evidence Rating: SR

(Strongly

Recommends) 

Recommended

Guidance

American College of

Obstetricians and

Gynecologists (ACOG)

Evidence Rating:

Information Sources

Asymptomatic Bacteriuria (Screening)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) strongly recommends

screening for asymptomatic bacteriuria with urine culture for pregnant women at

12 to 16 weeks’ gestation.1

The USPSTF found good evidence that screening pregnant women for

asymptomatic bacteriuria with urine culture significantly reduces symptomatic

urinary tract infections, low birth weight, and preterm delivery. The benefits of

screening and treatment substantially outweigh any potential harm.1

The American Academy of Family Physicians (AAFP) strongly recommends that

all pregnant women be screened for asymptomatic bacteriuria using urine culture

at 12 to 16 weeks’ gestation or at the first prenatal visit if after that time.2

Good quality evidence exists which demonstrates the substantial net benefit of

screening for asymptomatic bacteriuria over harm; the intervention is perceived

to be cost-effective and acceptable to nearly all patients.2

The American College of Obstetricians and Gynecologists (ACOG) recommends

that clinicians screen all pregnant women for asymptomatic bacteriuria by taking

a urine culture at the first prenatal visit. They further recommend that a repeat

urine culture be obtained during the third trimester.3

Not Specified

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Family Physicians (AAFP)

• American College of Obstetricians and Gynecologists (ACOG)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 
249

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden 

of Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Condition/Disease Specific Information

Asymptomatic bacteriuria in pregnancy is defined at the presence of a significant

amount of bacterial growth in a urine culture taken from a urine sample4 and the

absence of symptoms of a urinary infection such as pain or urgency.5

Asymptomatic bacteriuria occurs in approximately 2% to 14% of pregnant

women and 80,000 to 400,000 cases occur each year in the United States.6

Without treatment, 20% to 40% of asymptomatic bacteriuria cases among

pregnant women progress to pyelonephritis, a serious kidney infection.

Pyelonephritis complicates 1% to 2% of all pregnancies and affects 100,000

women each year.6 It is also a leading cause of antepartum hospitalization.1 With

appropriate screening and treatment, only 3% of bacteriuria cases will progress to

pyelonephritis.6

Bacteriuria increases the risk for preterm delivery and low birth weight and may

also increase the risk of fetal and perinatal mortality.1,6 If fact, the risk of preterm

delivery is twice as high among women who had asymptomatic bacteriuria at

some point during pregnancy compared to those who did not.6

Risk factors for asymptomatic bacteriuria during pregnancy include low

socioeconomic urinary tract infections (UTIs) in childhood. Other risk factors

include preexisting medical conditions such as diabetes, sickle cell disease,

immunosuppression (e.g., HIV/AIDS), urinary tract anatomic anomalies, and

spinal cord injuries. UTIs experienced before pregnancy are predictive of the

diagnosis of asymptomatic bacteriuria at the first prenatal visit.6

Value of Prevention

Specific data about the economic burden of UTIs among pregnant women are

not available. The annual cost of all community-acquired urinary tract infections

in 1995 was estimated to be approximately $1.6 billion, including $659 million

in direct costs and $936 million in indirect costs.7 The direct and indirect costs of

acute pyelonephritis were estimated to be $2.14 billion (in year 2000 dollars).8

Lost productivity due to absenteeism associated with pregnancy-related

complications of UTIs among working women (in addition to the increased

medical care costs of such complications) has important financial ramifications

for employers. Specific data on the workplace burden of pregnancy-related UTIs

are not available. 

The preventive treatment of asymptomatic bacteriuria during pregnancy

produces economic benefits such as preventing cases of cystitis, pyelonephritis,

and premature births. In addition, preventing cases of mild and serious

pyelonephritis produce significant improvements in quality of life.9
250

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Estimated Cost of

Preventive

Intervention

Estimated Cost 

of Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval

Intervention Process

Treatment

Information

In 2004, the private-sector cost of screening for bacteriuria averaged $17 per screen;

approximately 95% of all paid claims fell within the range of $1 to $45 per screen.10

One cost-effectiveness study estimated the cost of antibiotic treatment to be $11,

based on a 7-day course of the generic form of commonly used antibiotics for the

treatment of asymptomatic bacteriuria (in year 1994 dollars).7

Research shows that screening for asymptomatic bacteriuria using urine culture,

when compared with use of dipstick analysis, is cost-effective among populations

where the prevalence of asymptomatic bacteriuria is at least 9%.6

Preventive Intervention Information

The purpose of screening for and treating asymptomatic bacteriuria in pregnancy

is the prevention of poor maternal and infant outcomes associated with infection

including pyelonephritis and prematurity. 

Good evidence exists that screening pregnant women for asymptomatic

bacteriuria with urine culture (rather than urinalysis) — and treating those with

the infection — significantly reduces symptomatic urinary tract infections, low

birth weight, and preterm delivery. A urine specimen obtained at 12 to 16 weeks’

gestation will detect approximately 80% of patients with asymptomatic

bacteriuria.6,11

The USPSTF did not identify any information on the potential harms of

screening for asymptomatic bacteriuria.11

All pregnant women should be screened for asymptomatic bacteriuria at 12 to 16

weeks’ gestation.1,3 The optimal frequency of subsequent urine testing during

pregnancy is uncertain and is thus left to the discretion of the clinician. The

American College of Obstetricians and Gynecologists (ACOG) recommends that

clinicians re-screen all pregnant women for asymptomatic bacteriuria by

performing a urine culture during the third trimester.3

Urine culture is the gold standard for detecting asymptomatic bacteriuria.1 Other

types of screening tests commonly used in the primary care setting (such as

dipstick analysis and direct microscopy) are not as accurate for detecting

bacteriuria in asymptomatic persons.1

Asymptomatic bacteriuria can be treated with a range of antibiotics. A Cochrane

Collaboration review of 14 randomized trials of asymptomatic bacteriuria in

pregnant women showed that antibiotic treatment was significantly associated

with decreased incidence of pyelonephritis. The review also determined that

antibiotic treatment reduced the rate of preterm delivery and low birth weight.12

Health benefits should include provisions for diagnostic and treatment services.
251

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Authored by: 

Campbell KP, Chattopadhyay S. Asymptomatic bacteriuria evidence-statement: screening.

In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s 

Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business

Group on Health; 2006.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The U.S. Preventive Services Task Force (USPSTF) strongly recommends

screening for asymptomatic bacteriuria with urine culture for pregnant women

at 12 to 16 weeks’ gestation.1 The USPSTF found good evidence that

screening pregnant women for asymptomatic bacteriuria with urine culture

significantly reduces symptomatic urinary tract infections, low birth weight,

and preterm delivery. The benefits of screening and treatment substantially

outweigh any potential harm.1

The American Academy of Family Physicians (AAFP) 

Strength of Evidence: SR (Strongly Recommended)

• AAFP strongly recommends that all pregnant women be screened for

asymptomatic bacteriuria using urine culture at 12 to16 weeks’ gestation or at

the first prenatal visit if after that time. Good quality evidence exists which

demonstrates the substantial net benefit of screening for asymptomatic

bacteriuria over harm; the intervention is perceived to be cost-effective and

acceptable to nearly all patients.2

Recommended Guidance:

American College of Obstetricians and Gynecologists (ACOG)

Strength of Evidence: Not Specified

• The American College of Obstetricians and Gynecologists (ACOG)

recommends that clinicians screen all pregnant women for asymptomatic

bacteriuria by taking a urine culture at the first prenatal visit. They further

recommend that a repeat urine culture be obtained during the third trimester.3
252

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force 

Recommendation

Evidence Rating: B

(Recommended/

At Least Fair

Evidence)

CDC

Recommendation

Evidence Rating:

Other Evidence Based

Recommendations

American Academy

of Family Physicians

(AAFP)

Evidence Rating: R

(Recommends)

Information Sources

Breastfeeding (Counseling)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians

provide structured breastfeeding education and behavioral counseling to all

pregnant and postpartum women to promote the initiation and continuation of

breastfeeding.1

The USPSTF found fair evidence that programs which combine breastfeeding

education with behaviorally-oriented counseling increase the rates of the

initiation and continuation of breastfeeding for up to 3 months. The USPSTF

notes that effective programs involve at least one in-person session; are usually 

30 to 90 minutes in duration; follow structured protocols; and include practical

behavioral skills training, problem-solving, and didactic instruction.1

The USPSTF also found fair evidence to suggest that continued support via 

in-person visits or telephone contact with a clinician or counselor increases the

proportion of women who continue breastfeeding their infants for 6 months.1

The CDC Guide to Breastfeeding Interventions recognizes the critical role

returning to work plays in women’s infant feeding decisions, and identifies a

strong need to establish lactation support in the workplace.2

Not Specified

The American Academy of Family Physicians (AAFP) recommends structured

breastfeeding education and behavioral counseling programs to promote

breastfeeding.3

Although evidence exists which demonstrates the net benefit of counseling to

promote breastfeeding, either the benefit is only moderate in magnitude or the

evidence supporting a substantial benefit is only fair. The intervention is

perceived to be cost-effective and acceptable to most patients.3

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Family Physicians (AAFP)

• Centers for Disease Control and Prevention (CDC)

• Healthy People 2010, U.S. Department of Health and Human Services

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document
253

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Breastfeeding provides protective immune globulins from the mother to the

infant, completing the development of the infant’s immune system after birth

and thereby reducing the risk that the infant will acquire some serious infections.

This immunologic protection is impossible to replicate with infant formula.

Infants who are breastfed are thus better prepared to fight off infections and

allergens than their non-breastfed counterparts. Additionally, human breast milk

is universally recognized to be the optimal food for infants and is nutritionally

superior to formula. Evidence suggests that breastfed infants are less likely to

develop obesity, and type 1 and type 2 diabetes than bottle-fed infants.2 Further,

children who were breastfed have lower rates of otitis media (ear infections),

respiratory infections, gastroenteritis, and eczema (a skin disorder).2

Despite the benefits of breastfeeding for both women and infants, breastfeeding

rates in the United States remain suboptimal, especially among certain

subpopulations. Data from 2005 show that 72.9% of all new mothers initiated

breastfeeding and 39.1% continued to breastfeed for 6 months.4 However, only

63.5% of low income mothers and 55.4% of African-American mothers initiated

breastfeeding. Further, only 29.7% of low income mothers and 24.8% of

African-American mothers continued to breastfeed their infants for the

recommend 6-month period.4

The Healthy People 2010 goals for breastfeeding aim to increase breastfeeding

rates so that 75% of all new mothers initiate breastfeeding, 50% continue

breastfeeding for at least 6 months postpartum, and 25% continue to breastfeed

at least 1 year postpartum.5

Breastfeeding rates should be of paramount importance to employers as working

outside the home negatively affects initiation and duration of breastfeeding.6

Furthermore, one-third of working mothers return to work within 3 months of

the birth of their child, and two-thirds return within 6 months, the exact time

period when breastfeeding is most critical.6

The mothers at highest risk for not breastfeeding are first-time mothers, those

who have less formal education, those who are non-white, and those who are ill

postpartum.7

Value of Prevention

Healthcare costs of treating respiratory tract infections, ear infections, and

gastrointestinal illnesses represent the majority of healthcare expenses for children

less than one year of age.8 Because all of these illnesses are significantly more

common among formula-fed infants than breastfed infants, support of

breastfeeding initiation and continuation saves healthcare dollars.8 Indirect costs

include time and income lost from work to take care of a sick child.
254

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of

Counseling

Benefits and Risks 

of Intervention

Children who are not breastfed contribute to huge additional healthcare

expenditures for the employers of their parents. Their parents are also responsible

for significant productivity losses in the workplace associated with absenteeism

and presenteeism. A study that compared infant feeding among employed

mothers found that 75% of all 1-day maternal absences were among formulafeeding mothers.9 The study also found that infants who were formula fed were

much more likely to fall ill. In fact, only 14% of infants with no illnesses were

formula-fed (comparatively 86% of infants with no illnesses were breastfed).9

Breastfeeding offers important economic benefits to families, employers, and

society at large. Breastfeeding allows the family to save the money that otherwise

would be spent on infant formula, other human milk substitutes, and feeding

equipment. 

Further, a 2001 U.S. Department of Agriculture (USDA) study estimated that at

least $3.6 billion (in year 1998 dollars) would be saved if breastfeeding rates

were increased from the current rates to those recommended by the U.S. Surgeon

General (75% in-hospital and 50% at 6 months). This estimate includes $3.1

billion is savings from prevented premature deaths, $500 million in savings from

reduced healthcare costs (e.g., hospital visits, etc), and savings from averted

indirect costs such as forgone earnings of parents.8

In 2004, the private-sector cost of counseling to promote breastfeeding initiation

and continuation averaged $23 per session; approximately 95% of all paid claims

fell within the range of $0 to $81 per session.10

Not Applicable

A study based on 1993-1994 data from the Special Supplemental Nutrition

Program for Women, Infants, and Children (WIC) in Colorado found that

compared with formula-feeding, breastfeeding each infant enrolled in WIC saved

$478 in WIC costs and Medicaid expenditures during the first 6 months of the

infant’s life, or $161 after consideration of the formula manufacturers’ rebate.11

The cost saving was realized by the averted WIC costs for formula and foods for

infants and mothers as well as reduced administrative expenses and lower

Medicaid health care costs including costs for pharmacy reimbursement for the

breastfed infants.11

Preventive Intervention Information

The purpose of counseling is to educate women on the benefits of breastfeeding

and to provide support and skills-training for women who choose to breastfeed,

thereby increasing the number of women who initiate and maintain breastfeeding

for the minimum recommended period of 12 months.

Breastfeeding has important short- and long-term health outcomes for children.

Research shows that children who were breastfed are at significantly lower risk for

childhood obesity as well as type 1 and type 2 diabetes than their non-breastfed
255

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Initiation, Cessation,

and Interval of

Counseling

Intervention Process

Counseling

Treatment Information

peers. Breastfed infants and children also have lower rates of otitis media (ear

infections), respiratory infections, gastroenteritis, and eczema (a skin disorder).12

Breastfeeding also has important short- and long-term health benefits for the

mother. A woman’s risk of breast cancer is decreased 4.3% for every 12-month

increment of breastfeeding over her lifetime.12 Her risk of ovarian and

endometrial cancer is decreased by breastfeeding as well. Breastfeeding improves

uterine tone, helps to stop post-birth bleeding, assists postpartum weight loss,

and temporarily suppresses ovulation to aid in child-spacing.2

Educational programs have been shown to increase the proportion of women

who initiate breastfeeding immediately after birth by 23% and the number of

women who continue to breastfeed for 1 to 3 months by 39%. The efficacy of

education programs is enhanced by ongoing support for breastfeeding initiation

and continuation.13

There are no known risks of counseling to promote breastfeeding. In the United

States, only women with the following conditions should be advised to avoid

breastfeeding: women who are HIV positive; are taking antiretroviral

medications; have untreated, active tuberculosis; are infected with human T-cell

lymphotropic virus type I or type II; are using illicit drugs; are taking prescribed

cancer chemotherapy agents that interfere with DNA replication; and whose

infants who are diagnosed with galactosemia. Women undergoing radiation

therapies need to temporarily interrupt breastfeeding but do not need to

discontinue breastfeeding permanently.14

Counseling to promote breastfeeding should be offered to all women of

childbearing age. It should begin during prenatal care and continue throughout

the intrapartum hospital stay and into the postpartum period. Counseling should

be given, according to need, throughout the course of lactation.

Counseling should include breastfeeding initiation advice as well as skills and

referrals to support breastfeeding continuation. The most effective breastfeeding

education and counseling interventions last approximately 30 to 90 minutes and

feature directive health education combined with behaviorally-oriented skills

training and problem-solving.1

Effective breastfeeding education and behavioral counseling programs1: 

• Begin during the prenatal period.

• Use face-to-face individual or group sessions. 

• Are led by specially trained nurses, midwives, or lactation specialists.

• Sessions last 30 to 90 minutes.

• Include education on the benefits of breastfeeding for mother and infant, basic

physiology, technical training on positioning and latch-on techniques, skills on

how to overcome common barriers, skills to garner social support, how to use

basic lactation support equipment such as breast pumps, etc.

Not Applicable
256

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

• The USPSTF found at least fair evidence to support the provision of

structured breastfeeding education and behavioral counseling to all pregnant

and postpartum women to promote the initiation and continuation of

breastfeeding.1

• The USPSTF also found at least fair evidence to suggest that continued

support via in-person visits or telephone contact with a clinician or counselor

increases the proportion of women who continue breastfeeding their infants

for 6 months.1

The American Academy of Family Physicians (AAFP)

Strength of Evidence: R (Recommended)

• AAPF recommends structured breastfeeding education and behavioral

counseling programs to promote breastfeeding. Although evidence exists which

demonstrates the net benefit of counseling to promote breastfeeding, either the

benefit is only moderate in magnitude or the evidence supporting a substantial

benefit is only fair. The intervention is perceived to be cost-effective and

acceptable to most patients.3

Authored by: 

Campbell KP, Chattopadhyay S. Breastfeeding evidence-statement: counseling. In: Campbell KP, Lanza A,

Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive

Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.
257

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force

Recommendation

CDC

Recommendation

Evidence-Based

Recommendation

American Academy

of Family Physicians

(AAFP)

Evidence Rating: SR

(Strongly

Recommends)

American Academy

of Family Physicians

(AAFP)

Evidence Rating: R

(Recommended)

American Academy

of Family Physicians

(AAFP)

Evidence Rating: SR

(Strongly

Recommended)

Folic Acid Supplementation (Counseling 

and Preventive Medication)

Clinical Preventive Service Recommendations

In 1996, the U.S. Preventive Services Task Force (USPSTF) recommended that

all women of childbearing age who are capable of becoming pregnant (even those

currently using contraception) consume 0.4 micrograms of folic acid per day to

reduce the risk of a pregnancy affected by either spina bifida, anencephaly, or

another neural tube defect. 

This recommendation is archived and considered out of date. 

The CDC concurs with the U.S. Public Health Service (see description below). 

The American Academy of Family Physicians (AAFP) recommends that clinicians

prescribe 0.4-0.8 mg/day of folic acid supplementation from at least 1 month

prior to conception through the first trimester of the pregnancy to women who

have not had a previous pregnancy affected by a neural tube defect.1

Good quality evidence exists which demonstrates the substantial net benefit of

folic acid supplementation over harm; the intervention is perceived to be costeffective and acceptable to nearly all patients.1

The American Academy of Family Physicians (AAFP) recommends that clinicians

prescribe 0.4 mg folic acid supplementation to women not planning a pregnancy

but of childbearing potential who have not had a previous pregnancy affected by

a neural tube defect.1

Although evidence exists which demonstrates the net benefit of folic acid

supplementation, either the benefit is only moderate in magnitude or the

evidence supporting a substantial benefit is only fair. The intervention is

perceived to be cost-effective and acceptable to most patients.1

The American Academy of Family Physicians (AAFP) recommends that clinicians

prescribe 4 mg/day of folic acid supplementation from 1 to 3 months prior to

conception through the first trimester of pregnancy to women who are planning

a pregnancy and have had a previous pregnancy affected by a neural tube defect.1

Good quality evidence exists which demonstrates the substantial net benefit 

of folic acid supplementation over harm; the intervention is perceived to be 

cost-effective and acceptable to nearly all patients.1
258

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Other Recommended

Guidance

U.S. Public Health

Service

Evidence Rating:

Information Sources

Epidemiology of

Condition/Disease

The U.S. Public Health Service recommends that2-3:

• All women of childbearing age in the United States who are capable of

becoming pregnant should consume 0.4 mg of folic acid per day for the

purpose of reducing their risk of having a pregnancy affected with spina bifida

or other neural tube defects.

• Women who have had a prior NTD-affected pregnancy are at high risk of

having a subsequent affected pregnancy and should consult their physicians

when planning to become pregnant again. 

Not Specified

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Family Physicians (AAFP)

• American College of Obstetricians and Gynecologists (ACOG)

• Centers for Disease Control and Prevention (CDC)

• National March of Dimes Birth Defects Foundation

• Peer-reviewed research

• U.S. Public Health Service (USPHS)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Spina bifida and anencephaly are severe, potentially fatal birth defects. Both are

neural tube defects (NTD) resulting in failure of the neural tube to fuse correctly.

Approximately 3,000 pregnancies are affected by NTDs, and approximately

2,200 infants are born with neural tube defects each year.4 Many NTD-affected

pregnancies do not result in a live birth because they are electively or

spontaneously aborted (commonly referred to as a miscarriage) or result in fetal

death or stillbirth.4

Anencephaly is always fatal and affected infants die shortly after birth. The

majority of infants born with spina bifida grow into adulthood, but have severe

medical complications such as paralysis and varying degrees of bowel and bladder

incontinence.2

Folic acid, a B vitamin, prevents NTDs. Evidence (from populations not

consuming foods fortified with folic acid) shows that consuming the

recommended daily amount of synthetic folic acid (0.4 mg) through folic acid

supplements can reduce a woman’s chance of having a NTD-affected pregnancy

by 40% to 80%.5 
259

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost 

of Preventive

Intervention

Estimated Cost 

of Treatment

Synthetic folic acid can be consumed via folic acid supplements, folic acidcontaining multivitamins, cereals that have been fortified with folic acid, and

fortified grains. The natural form of this vitamin, folate, can be found in foods

such as green leafy vegetables, orange juice, and beans. Synthetic folic acid

vitamin supplementation is recommended because it is easier for the body to

absorb than folate found in food and because up to 50% of naturally occurring

folate is lost during cooking.6

Despite the known benefit of folic acid, only 33% of women of childbearing age

report taking vitamins that contain folic acid and certain subpopulations have

even lower rates of vitamin supplementation.7

NTD rates are highest among the Hispanic population. Efforts to ensure

supplementation among this population are important for eliminating health

disparities.8

Value of Prevention

The economic burden of NTDs is substantial. The total lifetime cost for a child

born with spina bifida is estimated to be $636,000 (in year 2002 dollars).9

Applying the prevalence rate for spina bifida from the National Birth Defect

Prevention Network data10 to the 4 million live births each year, that amounts to

$814 million in lifetime costs for each one-year cohort of births (all children

born in one year).9 Costs associated with NTDs are shared by parents, employers,

and communities.

Apart from the excess medical costs for affected children, employers face

productivity loss costs associated with employees’ absences to care for children

with spina bifida. The present value of the cost of such caregiver time was

estimated to be $252,000 per child (in year 1993 dollars).11

The economic benefit of folic acid supplementation is based on the cost savings

that result from averted direct and indirect costs of each NTD that is prevented

with supplementation. 

In 2004, the private-sector cost of counseling to promote folic acid

supplementation averaged $23 per session; approximately 95% of all paid claims

fell within the range of $0 to $81 per session.12

The cost of supplementation is highly variable, depending on the type of vitamin

supplement that is taken and for how long. The cost of over-the-counter vitamins

is relatively cheap and is an out-of-pocket cost for beneficiaries. Prescription

strength folic acid (recommended for women who have had a previous pregnancy

affected by a NTD) costs approximately $100 per year.13

Not Provided
260

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of

Counseling and

Preventive

Medication

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Counseling and

Preventive

Medication

Intervention Process,

Counseling, and

Preventive

Medication

Treatment

Information

At present there is no evidence on the incremental cost-effectiveness of folic acid

supplementation. A study undertaken before the implementation of the folic acid

fortification program, examined a public and provider education program as a

possible strategy to increase folic acid consumption through consumption of

vitamin supplements and estimated that, compared to no program, the costeffectiveness of supplementation was approximately $5,000 per quality-adjusted

life year (QALY).11 

Preventive Intervention Information

Encouraging a woman to increase her folic acid intake prior to pregnancy via

support, counseling, and/or prescription vitamins can lead to improved nutrition,

thereby improving her chance of a healthy pregnancy and reducing her risk of an

NTD-affected pregnancy. 

A double-blind, placebo-controlled, randomized trial showed that folic acid

supplementation before and during pregnancy decreased the risk of a first

occurrence of a neural tube defect.14-15 The efficacy of such folic acid

supplementation has since been confirmed by many other studies. 

The South Carolina NTD prevention program has reported great success in

preventing the recurrence of isolated NTDs by providing counseling and

vitamins to women who have had a previous NTD-affected pregnancy.16

Folic acid supplementation is believed to have minimal risks. Folic acid is

considered nontoxic even at very high doses and is rapidly excreted in the urine.

Folic acid supplementation information should be provided during routine

healthcare visits and throughout the first trimester of pregnancy. Folic acid

supplements should be prescribed/recommended, as medically indicated.

Clinicians should 1) advise all women of child-bearing age who are capable of

becoming pregnant about the importance of folic acid supplementation and 2)

provide them with guidance on folic acid supplementation and, if needed, a

prescription for folic acid supplements.

Not Applicable

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Evidence-Based Research:

The American Academy of Family Physicians (AAFP) 

Strength of Evidence: SR (Strongly Recommended ), R (Recommended)

SR (Strongly Recommended)
261

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Authored by: 

Campbell KP, Grosse S, Chattopadhyay S. Folic acid supplementation evidence-statement: counseling and

preventive medication. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors.

A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC:

National Business Group on Health; 2006.

• AAFP recommends that clinicians prescribe 0.4-0.8 mg/day of folic acid

supplementation from at least 1 month prior to conception through the first

trimester of the pregnancy to women planning to become pregnant who have

not had a previous pregnancy affected by a neural tube defect. Good quality

evidence exists which demonstrates the substantial net benefit of folic acid

supplementation over harm; the intervention is perceived to be cost-effective

and acceptable to nearly all patients.1

R (Recommended)

• AAFP recommends that clinicians prescribe 0.4 mg folic acid supplementation

to women not planning a pregnancy but of childbearing potential who have

not previously had a baby with a neural tube defect. Although evidence exists

which demonstrates the net benefit of folic acid supplementation, either the

benefit is only moderate in magnitude or the evidence supporting a substantial

benefit is only fair. The intervention is perceived to be cost-effective and

acceptable to most patients.1

• AAFP recommends that clinicians prescribe 4 mg/day of folic acid

supplementation from 1-3 months prior to conception through the first

trimester of pregnancy to women who are planning a pregnancy and had a

previous pregnancy affected by a neural tube defect.1 Good quality evidence

exists which demonstrates the substantial net benefit of folic acid

supplementation over harm; the intervention is perceived to be cost-effective

and acceptable to nearly all patients.1

Recommended Guidance:

U.S. Public Health Service (USPHS)

Strength of Evidence: Not Specified

• The U.S. Public Health Services recommends that all women of childbearing

age in the United States who are capable of becoming pregnant should

consume 0.4 mg of folic acid per day for the purpose of reducing their risk of

having a pregnancy affected with spina bifida or other neural tube defects.

Women who have had a prior NTD-affected pregnancy are at high risk of

having a subsequent affected pregnancy, and should consult their physicians

when planning to become pregnant again.2-3
262

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force

Recommendation

CDC

Recommendation

Evidence Rating:

Information Sources

Group B Streptococcal Disease (GBS)

(Screening and Preventive Medication)

Clinical Preventive Service Recommendations

Not Applicable

The Centers for Disease Control and Prevention (CDC) recommends that

clinicians screen all pregnant women for vaginal and rectal group B streptococcal

(GBS) colonization at 35 to 37 weeks’ gestation.1

• Women should be tested for GBS at each pregnancy as colonization at a prior

pregnancy is not an indication for antibiotic prophylaxis in subsequent

pregnancies. 

• Women who are identified through screening as GBS carriers should be given

intrapartum antibiotic prophylaxis. 

• Women whose screening status is unknown at the time of labor should receive

intrapartum antibiotic prophylaxis if they present with any of the following

risk factors: delivery at less than 37 weeks’ gestation, membrane rupture >18

hours, or intrapartum fever 38C.

• Women with GBS isolated from the urine at any time in the current

pregnancy should also be given intrapartum antibiotic prophylaxis.

• Women who have previously given birth to an infant with invasive GBS

disease should receive intrapartum antibiotic prophylaxis. 

• Women who are expected to deliver preterm (less than 37 weeks’ gestation)

should be assessed for their need for intrapartum antibiotic prophylaxis to

prevent perinatal GBS disease. 

• GBS colonized women who have a planned cesarean before rupture of the

membranes are at a low risk for delivering an infant with early-onset GBS

disease and should thus not routinely receive intrapartum antibiotic

prophylaxis.

Not Specified

The recommendations and supporting information contained in this document

came from several sources, including the:

• Centers for Disease Control and Prevention (CDC)

• Royal College of Obstetricians and Gynecologists 

• Peer-reviewed research

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 
263

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost 

of Preventive

Intervention

Condition/Disease Specific Information

Group B streptococcus (GBS), a bacterium, has been a leading cause of infectionrelated infant death in the United States since the 1970s.1 GBS disease is a

serious infection that causes sepsis (blood poisoning), pneumonia, and meningitis

in newborns. GBS can be lethal: 1 in every 20 babies born with GBS dies. Each

year in the United States between 1,300 and 1,600 infants contract early-onset

GBS and 65 to 80 infants die from it.1 Those who survive are often left with

lifelong disabilities such as hearing loss, vision impairments, and/or learning

disabilities.1

In the 1980s, scientists discovered that administering antibiotics during labor to

women who carry GBS could prevent early-onset GBS disease from developing

in newborns. One in every 4 to 5 pregnant women carries GBS in her vagina or

rectum.1 While most women colonized with GBS are asymptomatic (meaning

that they can pass the disease to their child, but are not affected by it themselves),

some women become infected with GBS and are at risk of womb infections,

bladder infections, and stillbirth.1

Pregnant women are at a higher risk of delivering an infant with GBS disease if

they have GBS in their urine, are colonized with GBS at the time of labor, have a

fever during labor, rupture their membranes 18 hours or more before delivery, or

if they have previously had a baby with GBS disease.1

Value of Prevention

While the rate of neonatal GBS infections has declined since the 1990s due to

widespread screening and treatment, GBS continues to have an economic toll in

the United States.2 The average neonatal intensive care cost of a GBS-infected

infant was estimated to be $30,100 in 2001.3 The excess average discounted

lifetime healthcare cost for an infant disabled by an early-onset GBS (over that

for a healthy infant) was estimated to equal $261,000 (in year 2001 dollars).4

Productivity losses associated with absenteeism and presenteeism for parents of

GBS-affected children have not been quantified. 

Preventing a case of infant disability due to GBS can reduce the discounted

lifetime healthcare costs for an infant by $261,000, on average (year 2001

dollars).4 In 1993, researchers estimated that treating high-risk women identified

through screening with intrapartum antibiotic prophylaxis could prevent 3,300

cases of GBS annually; saving approximately $16 million in direct medical costs.2

In 2004, the private-sector cost of screening for GBS averaged $13 per screen;

approximately 95% of all paid claims fell within the range of $4 to $33 per

screen.6 When women with a positive test result are treated with antibiotic

therapy during labor (an initial dose of 2g of ampicillin intravenously, followed

by 1g every 4 hours) the preventive mediation costs are estimated to equal $63

per course of therapy.4
264

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Estimated Cost 

of Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening and

Preventive

Medication

Intervention Process 

Screening

Preventive

Medication

The cost of treating an infant with early-onset group B streptococcal sepsis (a

severe form of the disease) was estimated to exceed $123,000 (in year 1993

dollars).4

Screening to prevent early-onset GBS is estimated to cost less than $12,000 (in

year 1997 dollars) per prevented case. Preventive intervention may also generate

net cost-savings if the high cost of managing a case of early-onset GBS is

considered.3

In comparison to other preventive interventions and to commonly accepted costeffectiveness benchmarks, screening for GBS is cost-effective. 

Preventive Intervention Information

Identifying women who carry group B streptococcal bacteria allows clinicians to

administer antibiotic prophylaxis during labor, thus preventing transmission of

the bacteria to the infant. Vaccines to prevent GBS disease are under

development but are not currently available. Thus, universal prenatal GBS

culture-based screening is the best available prevention strategy.1

The risks of screening for GBS colonization are minimal. However, there are risks

associated with intrapartum antibiotic prophylaxis. Severe anaphylaxis is

associated with the use of penicillin in some women. Anaphylaxis occurs in 1 out

of every 10,000 treatments and can be fatal. Also, the widespread use of

antibiotics, particularly broad-spectrum antibiotics such as ampicillin, contributes

to the development of resistant organisms.1

Despite the risks associated with prevention, screening for group B streptococcal

colonization and intrapartum antibiotic prophylaxis can reduce the rate of

neonatal infection death and prevent infants from significant disability. These

significant benefits outweigh the risks and costs associated with screening. 

All pregnant women should be screened for vaginal and rectal group B

streptococcal (GBS) colonization between 35 and 37 weeks’ gestation. Preventive

medication should be given to colonized women, as medically indicated. 

All women should be screened for vaginal and rectal group B streptococcal

colonization using recommended laboratory methods for GBS isolation and

identification. Women should be screened for GBS with each pregnancy as

colonization at a prior pregnancy is not an indication for antibiotic prophylaxis

in subsequent pregnancies.

Intrapartum antibiotic prophylaxis should be given, as medically indicated, to: 

• Women who are identified as GBS carriers. 

• Women whose screening status is unknown at the time of labor if they present

with any of the following risk factors: delivery at less than 37 weeks’ gestation,

membrane rupture 18 hours, or intrapartum fever 38C. 
265

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Treatment

Information

U.S.

• Women with GBS isolated from the urine at any time in the current

pregnancy. 

• Women who have previously given birth to an infant with invasive GBS

disease.

Women who are expected to deliver preterm (less than 37 weeks gestation)

should be assessed for their need for intrapartum antibiotic prophylaxis to

prevent perinatal GBS disease. 

GBS colonized women who have a planned cesarean before rupture of the

membranes are at a low risk for delivering an infant with early-onset GBS disease

and should thus not routinely receive intrapartum antibiotic prophylaxis.1

Health benefits should include provisions for treatment services for affected

women and infants. 

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Recommended Guidance:

The Centers for Disease Control and Prevention (CDC)

Strength of Evidence: Not Specified

• The CDC recommends screening all pregnant women for vaginal and rectal

group B streptococcal (GBS) colonization between 35 and 37 weeks’

gestation.1

Authored by: 

Campbell KP, Chattopadhyay S. Group B streptococcal disease evidence-statement: screening and 

preventive medication. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA,

editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington,

DC: National Business Group on Health; 2006.
266

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Preventive Services

Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/ 

Good Evidence)

CDC

Recommendation

Advisory Committee

on Immunization

Practices (ACIP)

Hepatitis B Virus (HBV) (Screening,

Immunization, and Treatment)

Clinical Preventive Service Recommendations

Screening

The U.S. Preventive Services Task Force (USPSTF) strongly recommends screening

for hepatitis B virus (HBV) infection in pregnant women at their first prenatal visit.1

The USPSTF found good evidence that universal prenatal screening for HBV

infection using HBsAg substantially reduces prenatal transmission of HBV and

the subsequent development of chronic HBV infection. The current practice of

vaccinating all infants against HBV infection and post-exposure prophylaxis with

hepatitis B immune globulin administered at birth to infants of HBV-infected

women substantially reduces the risk for acquiring HBV infection.1

Immunization

The U.S. Preventive Services Task Force (USPSTF) defers to the Advisory

Committee on Immunization Practices (ACIP) and the Centers for Disease

Control and Prevention (CDC) on recommendations surrounding immunization.

Screening

The Advisory Committee on Immunization Practices (ACIP) recommends that all

pregnant women be tested routinely for hepatitis B surface antigen (HBsAg) during

an early prenatal visit (i.e., first trimester) in each pregnancy, even if they have been

previously vaccinated or tested. Women who were not screened prenatally, those

who engage in behaviors that put them at high risk for infection (e.g., injectiondrug use, having had more than one sex partner in the previous 6 months or an

HBsAg-positive sex partner, evaluation or treatment for a sexually transmitted

infection [STI], or recent or current injection-drug use) and those with clinical

hepatitis should be tested at the time of admission to the hospital for delivery.2,3

Immunization

The ACIP further recommends the hepatitis B vaccine for pregnant women at risk

for hepatitis B virus infection. Pregnant women who are identified as being at risk

for HBV infection during pregnancy (see list of risk factors in preceding paragraph)

should be vaccinated. Pregnant women at risk for HBV infection during pregnancy

should be counseled concerning other methods to prevent HBV infection.2,3

Management of Exposed or Potentially Exposed Infants/Treatment

The ACIP recommends that all infants born to HBsAg-positive women should

receive single-antigen hepatitis B vaccine and hepatitis B immune globulin

prophylaxis (HBIG) (0.5 mL) within the first 12 hours following the birth,

administered at different injection sites.2,3
267

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Evidence Rating:

Other Evidence-Based

Recommendations

American Academy

of Family Physicians

(AAFP)

Evidence Rating: SR

(Strongly

Recommended)

Information Sources

Epidemiology of

Condition/Disease

Women admitted for delivery without documentation of HBsAg test results

should have blood drawn and tested as soon as possible after admission. While

test results are pending, all infants born to women without documentation of

HBsAg test results should receive the first dose of single-antigen hepatitis B

vaccine (without HBIG) within 12 hours following the birth.2-3

A summary of guidelines for the immunization of pregnant women can be found

online (www.cdc.gov/nip/publications/preg_guide.htm).

Expert Consensus

The American Academy of Family Physicians (AAFP) strongly recommends

screening for hepatitis B virus (HBV) infection in pregnant women at their first

prenatal visit.5

Good quality evidence exists which demonstrates the substantial net benefit of

screening for HBV over harm; the intervention is perceived to be cost-effective

and acceptable to nearly all patients.5

The recommendations and supporting information contained in this document

came from several sources, including the:

• Advisory Committee on Immunization Practices (ACIP)

• American Academy of Family Physicians (AAFP)

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Over 1 million people in the United States are chronic carriers of HBV.4 In 2003,

an estimated 73,000 new HBV infections were reported in the United States.4

Hepatitis infection can lead to liver disease, including liver cancer, which without

treatment can result in death. Between 4,000 and 5,000 chronic carriers of HBV

die each year in the United States.4 Hepatitis B can be treated with medications if

diagnosed early, but some individuals do not respond to treatment and require

liver transplants to survive. 

The severity of hepatitis B infection depends on the age at which an individual

becomes infected and the presence of other comorbid conditions such as alcohol

abuse, HIV/AIDS, or other types of liver disease.6 Most adolescents and adults

with acute HBV infections recover fully, but 30% of children aged 1 to 5 years
268

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Condition/Disease

Risk Factors

Economic Burden 

of Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

and 2% to 6% of adults become chronically infected with hepatitis B.7

Immunization against HBV is the single most effective way of preventing

hepatitis B infection and its consequences.2

The risk factors for hepatitis B include intravenous drug use, concurrent

infection with a sexually transmitted infection (STI), multiple sexual partners,

household contact with an infected person, and being a healthcare worker with

exposure to bodily fluids. However, 30% to 40% of infected individuals have no

identified risk factors.6

Infants can contract hepatitis B from an infected woman during labor and

delivery and as many as 90% of infants infected through perinatal transmission

become chronic carriers of HBV.2

Value of Prevention

The economic burden of hepatitis B infection depends on whether the infection

is acute or chronic and what treatment is required. The direct medical cost of

outpatient treatment for symptomatic acute hepatitis B has been estimated at

$272 per occurrence, while the cost of hospitalization for symptomatic hepatitis

B infection is $8,080 per occurrence (both in year 2000 dollars).8 If a patient

develops liver disease as a result of chronic HBV infection, the direct medical cost

of treatment is estimated to be $59,308 (before discounting)8 and patients who

require a liver transplant can have first-year billed charges of up to $244,600 (in

year 1999 dollars).9

HBV is also responsible for disability costs, costs associated with work-loss and

absenteeism, and other indirect costs.

Screening pregnant women for HBV, and treating the infants of HBV-positive

women with post-exposure hepatitis B immune globulin prophylaxis and HBV

vaccination can dramatically reduce the incidence of perinatal HBV transmission

and thus the number of infants who become chronically infected with hepatitis

B.2 The additional recommended step of vaccinating all infants with HBV at

birth also serves as a safety net to prevent perinatal hepatitis B transmission.2 The

averted direct and indirect costs of illness from each case of HBV prevented

constitute the predominant economic benefit of the preventive intervention.

From a societal perspective, prevention of perinatal HBV infection was estimated

to save $41.8 million (in year 1993 dollars) in medical and work-loss costs.10

In 2004, the private-sector cost of11:

• Screening for HBV via the hepatitis B surface antigen test averaged $22;

approximately 95% of all paid claims fell within the range of $0 to $64 per

test.

• An adult HBV vaccine averaged $35; approximately 95% of all paid claims fell

within the range of $0 to $77.

• Vaccine administration averaged $10; approximately 95% of all paid claims fell

within the range of $0 to $20 (3 doses are usually needed for full protection).
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

and Immunization

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval

Screening

Immunization

Treatment

In 2004, the private-sector cost of post-exposure hepatitis B immune globulin

prophylaxis (for infants born to HBV-positive women) averaged $178 and

approximately 95% of all paid claims fell within the range of $0 to $514.11

The cost of therapeutic treatment of chronic hepatitis B varies according to the

medication required; a single course of interferon therapy costs $5,570 including

provider visits and laboratory costs (in year 1995 dollars).12

The estimated cost of preventing a perinatal HBV infection is $164 per year of

life saved, (in year 1993 dollars).10 In comparison to other preventive

interventions and to commonly accepted cost-effectiveness benchmarks, hepatitis

B screening is highly cost-effective. 

Preventive Intervention Information

Screening pregnant women for HBV, immunizing women at high-risk of HBV,

and treating the infants of HBV-positive women with post-exposure hepatitis B

immune globulin prophylaxis and HBV vaccination, can dramatically reduce

perinatal HBV transmission and, thus, the number of infants who become

chronically infected with hepatitis B.2

The benefits of screening, immunization, and treatment are substantial; an

untreated maternal hepatitis B viral infection may result in severe disease for the

woman and chronic infection for the newborn.2

There is no apparent risk of adverse effects for developing fetuses when a

hepatitis B vaccine is administered to a pregnant woman.3

Screening for hepatitis B should be conducted at the first prenatal visit in each

pregnancy. Women at increased risk of acquiring HBV may be screened again

during the third trimester and/or during labor and delivery and should be offered

the hepatitis B vaccine. Household contacts of women with a positive HBsAg test

should also be screened for HBV infection. Women admitted for delivery

without documentation of HBsAg test results should have blood drawn and

tested as soon as possible after admission.2

HBV immunization should be given to high-risk pregnant women as deemed

appropriate by the clinician.2 

All infants should receive their first hepatitis B immunizations at the time of

birth. Infants born to HBV-infected women should be immunized and given

immune globulin within 12 hours of birth. Infants born to women with

unknown HBsAg status should receive one dose of single-antigen hepatitis B

vaccine (without HBIG) within 12 hours of birth, while awaiting the woman’s

test results.2

Post-exposure hepatitis B immune globulin prophylaxis should be given, as

medically indicated.2
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Intervention Process

Screening

Immunization

Treatment

Treatment

Information

The principal screening test for detecting an HBV infection (acute or chronic) is

the identification of HBsAg in the blood. Testing methods include the HBsAg

Immunoassay and the “rapid test,” an assay that detects HBsAg and the hepatitis

B e-antigen HBeAg simultaneously.

HBV immunizations are administered via injection. 

Post-exposure hepatitis B immune globulin prophylaxis.

Please refer to the “Intervention Process” section for information on preventive

treatment. 

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Evidence-Based Research:

The U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The USPSTF found good evidence that universal prenatal screening for HBV

infection using HBsAg substantially reduces prenatal transmission of HBV and

the subsequent development of chronic HBV infection. The current practice of

vaccinating all infants against HBV infection and post-exposure prophylaxis

with hepatitis B immune globulin administered at birth to infants of HBVinfected women substantially reduces the risk for acquiring HBV infection.1

The American Academy of Family Physicians (AAFP) 

Strength of Evidence: SR (Strongly Recommended)

• AAFP strongly recommends screening for hepatitis B virus (HBV) infection in

pregnant women at their first prenatal visit.5 Good quality evidence exists

which demonstrates the substantial net benefit of screening for HBV over

harm; the intervention is perceived to be cost-effective and acceptable to nearly

all patients.5

Recommended Guidance:

The Advisory Committee on Immunization Practices (ACIP)

Strength of Evidence: Expert Consensus

Screening

The ACIP recommends that all pregnant women be tested routinely for HBsAg

during an early prenatal visit (e.g., first trimester) in each pregnancy, even if they

have been previously vaccinated or tested. Women who were not screened

prenatally, those who engage in behaviors that put them at high risk for infection

(e.g., injection-drug use, having had more than one sex partner in the previous 6

months or an HBsAg-positive sex partner, evaluation or treatment for a sexually

transmitted infection [STI], or recent or current injection-drug use) and those
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

with clinical hepatitis should be tested at the time of admission to the hospital

for delivery.2,3 

Immunization

The ACIP recommends the hepatitis B vaccine for pregnant women at risk for

hepatitis B virus infection. 

This recommendation is supported by:

The U.S. Preventive Services Task Force (USPSTF) 

Management of Exposed Infants/Treatment

The ACIP recommends that all infants born to HBsAg-positive women should

receive single-antigen hepatitis B vaccine and HBIG (0.5 mL) within 12 hours of

birth, administered at different injection sites.2

The ACIP recommends that all infants born to women without documentation

of HBsAg test results should receive the first dose of single-antigen hepatitis B

vaccine (without HBIG) within 12 hours of birth, while the woman’s test results

are pending.2

Authored by: 

Campbell KP, Lindley MC, Lentine D, Bhatt A. Hepatitis B virus evidence-statement: screening,

immunization, and treatment. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA,

editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington,

DC: National Business Group on Health; 2006.
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommend/Good

Evidence)

CDC

Recommendation

Human Immunodeficiency Virus (HIV) 

(Screening, Counseling, and Preventive

Medication)

Clinical Preventive Service Recommendations (Screening)

The U.S. Preventive Services Task Force recommends that clinicians screen all

pregnant women for HIV.1

The USPSTF found good evidence that both standard and FDA-approved rapid

screening tests accurately detect HIV infection in pregnant women and fair

evidence that introduction of universal prenatal counseling and voluntary testing

increases the proportion of HIV-infected women who are diagnosed and are

treated before delivery. There is good evidence that recommended regimens of

highly active antiretroviral therapy (HAART) are acceptable to pregnant women

and lead to significantly reduced rates of mother-to-child transmission. Early

detection of maternal HIV infection also allows for discussion of elective cesarean

section and avoidance of breastfeeding, both of which are associated with lower

HIV transmission rates. There is no evidence of an increase in fetal anomalies or

other fetal harm associated with currently recommended antiretroviral regimens

(with the exception of efavirenz). Serious or fatal maternal events are rare using

currently recommended combination therapies. The USPSTF concluded that the

benefits of screening all pregnant women substantially outweigh potential harms.1

The Centers for Disease Control and Prevention (CDC) recommends that

clinicians screen all pregnant women for HIV.2

• HIV screening should be a routine part of prenatal care for all women.

Providers should inform all of their obstetric patients of the substantial benefit

that knowledge of HIV status has for the health of a woman and her infant. 

• HIV screening should occur as early as possible during pregnancy so that

informed therapeutic decisions can be made and treatment can begin early. For

women at high-risk of HIV infection (e.g., women who have a history of

sexually transmitted infections [STIs], women who exchange sex for money or

drugs, women who have multiple sex partners during pregnancy, and women

who use illicit drugs during pregnancy) should be re-tested during the third

trimester (at or before 36 weeks’ gestation). 

• Women who are admitted for labor and delivery who have not been screened

for HIV or whose HIV status is unknown should be tested immediately so

that timely prophylactic treatment can be initiated if appropriate. In such

cases, rapid testing or the expedited return of standard testing results is

recommended. After delivery, the standard confirmatory testing should be

completed. 

• HIV screening should be voluntary and free of coercion. Women should not

be tested without their knowledge, and a woman’s decision to decline testing

must not have detrimental consequences for the quality of prenatal care or

labor and delivery care she receives.
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Other Recommended

Guidance

Important Screening

Information

Information Sources

Epidemiology of

Condition/Disease

CDC recommends that all pregnant women receive counseling and educational

information on HIV and HIV screening before they are screened/tested.2

• Information regarding HIV and the risks of HIV infection should be given to

all pregnant women as a part of routine prenatal care health education. 

• Pregnant women who have behaviors that place them at high risk for acquiring

HIV infection (e.g., multiple sex partners, history of STIs, substance abuse,

etc) should be referred to an HIV risk-reduction service (e.g., HIV centers

with personnel trained in HIV counseling, drug treatment centers, etc).

The U.S. Public Health Service concurs with the CDC recommendations

regarding screening and counseling. 

Regulations, laws, and policies regarding HIV screening of pregnant women and

infants differ throughout the United States and its territories. Healthcare providers

should adhere to local laws and regulations concerning maternal HIV screening.3

The recommendations and supporting information contained in this document

came from several sources, including the:

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research

• U.S. Public Health Service (USPHS)

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Approximately 120,000 to 160,000 HIV infected women live in the Unites States,

80% of whom are of childbearing age.3 Each year between 1985 and 1995,

approximately 6,000 to 7,000 HIV infected women gave birth. Infected women

can pass on HIV to their infants (called perinatal HIV transmission) during

pregnancy, during labor and delivery, or after delivery through breastfeeding.3

During the early 1990s, before preventive medication was available to prevent

HIV transmission from an infected pregnant woman to her infant, an estimated

1,000 to 2,000 infants were born with HIV infection each year and the risk for

mother-to-child transmission ranged from 16% to 25%.3 Widespread universal

screening and perinatal use of combination antenatal antiretroviral drugs and/or

zidovudine combined with cesarean section sharply reduced transmission risk and

thus the number of perinatally acquired HIV infections.3 By 2001, the perinatal

transmission rate was reduced to less than 2%.3

However, despite important screening and treatment advances, perinatal HIV

transmission continues to occur; the CDC estimates that each year in the United
274

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

States 280 to 370 infants are born with HIV.3 Most exposed infants are born to

women who were not tested for HIV prenatally or whose test results were

unknown at the time of delivery.3

Risk factors for perinatal HIV transmission include immunologically or clinically

advanced HIV disease in the woman, a high plasma viral load, preterm delivery,

injection drug use during pregnancy, and breastfeeding. The risk of perinatal

transmission also increases with protracted labor after the rupture of membranes,

maternal infection with a secondary STI, and the use of certain obstetrical

procedures.3

Value of Prevention

Analysis of the KIDS Inpatient Database of the Healthcare Cost and Utilization

Project (HCUP) estimated that there were 4,107 hospitalizations among HIVinfected children in the United States in 2000, which accounted for approximately

$100 million in hospital charges and more than 30,000 hospital days.4

The estimated lifetime health care related cost of a pediatric HIV infection is

estimated to range between $100,000 and $117,000 (in year 1994 dollars). The

total costs depends on how rapidly an infant’s HIV progresses to AIDS and the

length of his or her life.5

Not Provided

The economic benefit of the preventive intervention includes the value of life

years saved plus savings that accrue by avoiding the lifetime cost of managing an

HIV infection. 

The cost of screening, testing, and treating HIV varies significantly, depending

on where the test is administered, whether counseling is also provided, and what

treatment protocol is followed. In 2004, the private-sector cost of HIV screening

averaged $29 (range $4 to $90); the cost of counseling averaged $39 (range $0-to

$129).6

The average wholesale price (AWP) for a 1-month supply of oral zidovudine

(ZDV) tablets is $219.02 (generic) or $410.54 (brand – Retrovir®).7 The AWP

for 6 weeks worth of zidovudine syrup — the recommended treatment for

exposed infants — is $48.13 (generic) or $54.73 (brand – Retrovir®). Retrovir®

treatment for HIV-positive women during labor/delivery is $246.71 (cost varies

depending on dose, which is based on the woman’s weight).7

Researchers studied the costs associated with screening and treating HIV/AIDS

in pregnant women and found that universal screening can be cost-saving in this

population. For example, compared to no screening, a universal screening

program targeting pregnant women would save an estimated $3.69 million

dollars and prevent 64.6 cases of pediatric HIV infection for every 100,000

pregnant women screened.8
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Preventive

Intervention: 

Purpose of

Screening,

Counseling, and

Preventive

Medication

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening

Counseling

Preventive

Medication

Intervention Process:

Screening

Preventive Intervention Information

The purpose of screening is to identify infected women early in the course of

pregnancy. Early identification and the administration of preventive medication

can reduce perinatal transmission rates to less than 2%.3 Counseling services are

required to educate women on the benefits and risks of screening, risk reduction

strategies, and, for those who screen positive, treatment options.

The risks associated with screening for HIV include the potential negative

consequences of HIV infection such as discrimination and stigmatization, loss of

relationships, domestic violence, and adverse psychological reactions such as

depression or anxiety. The benefit of identification and early treatment — both

necessary to prevent perinatal HIV transmission — outweigh the risks and costs

associated with screening. Further, many of the aforementioned risks can be

reduced through appropriate education and counseling.3

HIV screening should occur as early as possible during pregnancy so that

informed therapeutic decisions can be made and treatment can begin early. For

women at high risk of HIV infection (e.g., women who have a history of STIs,

women who exchange sex for money or drugs, women who have multiple sex

partners during pregnancy, and women who use illicit drugs during pregnancy)

should be re-tested during the third trimester (at or before 36 weeks’ gestation). 

Women who are admitted for labor and delivery who have not been screened for

HIV or whose HIV status is unknown should be tested immediately so that

timely prophylactic treatment can be initiated if appropriate. In such cases, rapid

testing or the expedited return of standard testing results is recommended. After

delivery, the standard confirmatory testing should be completed.2

Counseling should be provided before and after screening, as medically indicated.

Preventive medication should be provided, as medically indicated, to prevent

perinatal transmission.

Screening for HIV should be conducted with an Food and Drug Administration

(FDA)-licensed enzyme immunoassay (EIA). If positive, the EIA should be

followed by a confirmatory test with an FDA-licensed supplemental test such as

the Western blot test. If a woman is being screened for the first-time during labor

and delivery, a rapid assay test should be used in place of the EIA. A rapid test

can provide a definitive negative result and a preliminary positive result, thus

identifying women who could benefit from antiretroviral treatment and a

cesarean delivery, and identifying infants who could benefit from antiretroviral

prophylactic treatment. Rapid tests should be confirmed by a supplemental test,

but, due to time constraints, suspected HIV positive women may be offered

treatment before the results of the supplemental test are received. Only one FDAapproved rapid HIV test is currently available in the United States, the Abbott
276

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Counseling

Preventive

Medication

Treatment

Information

Murex Single Use Diagnostic System HIV-1 test. Other tests are pending

approval.2

All pregnant women should receive counseling and educational information on

HIV and HIV screening before they are screened.2 Pregnant women who have

behaviors that place them at high risk for acquiring HIV infection (e.g., multiple

sex partners, history of STIs, substance abuse, etc) should be referred to an HIV

risk-reduction service (e.g., HIV centers with personnel trained in HIV

counseling, drug treatment centers, etc).1 HIV-infected pregnant women should

receive HIV prevention counseling. This counseling should include discussion of

the risk for perinatal HIV transmission, ways to reduce this risk, and the

prognosis for infants who become infected. HIV-infected pregnant women

should be counseled regarding antiretroviral therapy during pregnancy to

improve their health and prevent perinatal transmission.3

The primary strategy to prevent perinatal transmission (in addition to avoidance

of breastfeeding) is antiretroviral chemoprophylaxis using zidovudine (ZDV),

now often part of a combined antiretroviral therapy regimen that reduces viral

load as low as possible near the time of delivery. ZDV should be administered

orally to the mother during the second and third trimesters of pregnancy;

intravenous administration of ZDV should be given to the woman during labor

and delivery. Infants born to HIV-positive women should be given ZDV during

the first 6 weeks of life.3

Health benefits should include provisions for ongoing treatment for HIV-positive

women and their infants.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence) 

• The USPSTF found good evidence to recommend that clinicians screen all

pregnant women for HIV.1

Recommended Guidance:

The Centers for Disease Control and Prevention (CDC)

Strength of Evidence: Not Specified

• The CDC recommends that clinicians screen all pregnant women for HIV.2

• The CDC recommends that all pregnant women receive counseling and

educational information on HIV and HIV screening before they are

screened/tested.2

• The CDC recommends that zidovudine be administered orally to HIV-positive

pregnant women during the second and third trimesters of pregnancy and
277

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force

Recommendation

CDC

Recommendation

Evidence Rating:

Other Recommended

Guidance 

intravenously during labor and delivery. The CDC also recommends that oral

ZDV be administered to exposed infant during the first 6 weeks of life.2

These recommendations are supported by the:

• U.S. Public Health Service

Influenza (Immunization)

Clinical Preventive Service Recommendations

Not Applicable – The U.S. Preventive Services Task Force defers to the Advisory

Committee on Immunization Practices and the CDC on recommendations

surrounding immunization.

The Advisory Committee on Immunization Practices (ACIP) recommends that

all women who are pregnant during the influenza season (October to mid-May)

be vaccinated with trivalent inactivated influenza vaccine.1 Because this

population is considered at risk for influenza-related complications, it should be

given priority access to the vaccine in case of shortage.2

Note: Live attenuated influenza vaccine (LAIV) is contraindicated during

pregnancy. Because the intranasal vaccine spray contains live virus, it should not

be administered to pregnant women.1

A summary of guidelines for the immunization of pregnant women can be found

online (www.cdc.gov/nip/publications/preg_guide.htm).

Expert Consensus

The American Academy of Family Physicians (AAFP) and the American College

of Obstetricians and Gynecologists (ACOG) concur with the ACIP

recommendations. 

Authored by: 

Lentine D, Campbell KP. Human immunodeficiency virus evidence-statement: screening, counseling, and

preventive medication. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors.

A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC:

National Business Group on Health; 2006.
278

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Information Sources

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of 

Condition/Disease

The recommendations and supporting information contained in this document

came from several sources, including the:

• Advisory Committee on Immunization Practices (ACIP)

• American Academy of Family Physicians (AAFP)

• American College of Obstetricians and Gynecologists (ACOG)

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research 

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Influenza is a viral respiratory tract infection that occurs during the winter

months in temperate climates. Uncomplicated cases of the illness usually resolve

within several days to weeks and include fever, cough, sore throat, headache,

muscle aches, and tiredness. 

Influenza infection can exacerbate other underlying medical conditions and can

lead to hospitalization or even death.1 Throughout the 1990s in the United

States, influenza infection was associated with an average of 36,000 deaths and

over 200,000 hospitalizations per year.3-4

Pregnant women are considered to be at increased risk for complications from

influenza infection. Healthy pregnant women in their third trimester are

hospitalized for influenza at rates as high as 250 per 100,000 reported cases.1

Rates are higher among pregnant women with other underlying medical

conditions. Researchers estimate that an average of 1 to 2 hospitalizations can be

prevented for every 1,000 pregnant women vaccinated.5

Despite the seriousness of influenza infection and the fact that the inactivated

influenza vaccine is safe and effective, only 12% to 13% of pregnant woman are

inoculated against influenza.1,6

All pregnant women who are not immunized against influenza are at risk of

infection.

Value of Prevention

The overall national economic burden of influenza-attributable illness for adults

aged 18 to 64 years is $4.6 billion in direct medical costs and an additional $5.6

billion in lost productivity resulting from 17 million missed workdays.7

Furthermore, adult hospitalizations from influenza-attributable illness result in

3.1 billion dollars per year in direct hospitalization costs (in year 2003 dollars).7
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of

Immunization

Benefits and Risks 

of Intervention

Influenza-related complications during pregnancy increase medical care costs and

productivity losses triggered by lost work days. An infected employee may also

spread infection to other employees or family members.

Although no study specifically examined the case for pregnant women, studies of

the economic benefit of immunization in working adults commonly include

reduced hospitalizations, physician visits, and lost workdays; and an increase in

quality-adjusted days due to symptom relief from influenza-like illness.8-9

In 2004, the private-sector cost of an adult influenza vaccine averaged $13 and

approximately 95% of all paid claims fell within the range of $3 to $24 per

vaccine.10 Vaccine administration averaged $10 per dose and approximately 95%

of all paid claims fell within range of $0 to $20 per dose.10

Zanamivir and oseltamivir, the antiviral medications recommended for treatment

of influenza, have not been studied in pregnant women. Because of the unknown

effects of these drugs, they should only be used during pregnancy if the potential

benefit justifies the potential risk to the embryo or fetus.1

A review of several economic studies shows that vaccination of healthy working

adults is cost-effective and may result in cost-savings in some years.11 Though no

specific study was conducted with reference to pregnant women, economic

results are likely to be at least as favorable for this group since pregnant women

are at high risk for influenza-related complications.

Preventive Intervention Information

Immunization against influenza reduces the chance that a pregnant woman will

contract influenza thereby reducing her chance of experiencing influenza-related

illness, hospitalization, and associated costs.

There are many benefits to influenza vaccination. First, when a pregnant woman

is immunized during pregnancy, antibodies can be passed to her fetus and can

also be passed in breast milk.6 Because children under 6 months are at high risk

of complications from influenza, but cannot be vaccinated themselves, the

vaccination of persons who may transmit influenza to infants is recommended.1

That includes parents, siblings, and other caregivers. Second, healthy, working

adults who receive influenza shots (in a year when the vaccine is well matched to

the circulating influenza viruses) experience significantly fewer days of influenzalike illness (ILI), make fewer doctor visits for such illnesses, and take fewer days

off from work due to ILIs, compared to unvaccinated workers.8-9

Influenza vaccination with inactivated virus is considered to be safe for both

pregnant women and their fetuses. Two studies with a total of over 2,250

pregnant women found no adverse events after vaccination, regardless of when

during pregnancy the vaccine is given.6,12

No studies have been conducted on the safety of LAIV in pregnant women.
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Initiation, Cessation,

and Interval of

Immunization

Intervention Process

Treatment

Information

Authored by: 

Lindley MC, Bhatt A. Influenza evidence-statement: immunization. In: Campbell KP, Lanza A, Dixon R,

Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive Services:

Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.

All women who will be pregnant during the influenza season (October to midMay) should be given the inactivated influenza vaccine at some point during

pregnancy. This single-dose vaccine may be administered during any trimester.1

The ideal time to vaccinate is October and November, although vaccination in

December or even later can still be beneficial since influenza activity peaks in

February or later in most years.1

It is important to note that a woman should receive an influenza vaccination with

each pregnancy to protect herself and her fetus. Immunity gained from the influenza

vaccine does not carry from year to year. Influenza vaccination is also recommended

for all household contacts of children less than 5 years of age and particularly for

households with children less than 6 months of age since infants are at very high risk

of influenza complications but are too young to receive the influenza vaccine.1

Inactivated influenza vaccine is administered via intra-muscular injection.

Injections can be administered in various settings including doctor office visits or

at the worksite. 

Influenza-specific antiviral medications are available, but no safety studies have

been conducted in pregnant women. Because of the unknown effects of these

drugs on fetuses, they should be used during pregnancy only if the potential

benefit justifies the potential risk to the embryo or fetus.1

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Recommended Guidance:

Advisory Committee on Immunization Practices (ACIP)

Strength of Evidence: Expert Consensus

• The ACIP recommends vaccinating all women who are/will be pregnant

during the influenza season (October to mid-May) with trivalent inactivated

influenza vaccine.1

This recommendation is supported by the:

• American Academy of Family Physicians (AAFP) 

• American College of Obstetricians and Gynecologists (ACOG) 

• U.S. Preventive Services Task Force (USPSTF)
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EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force

Recommendation

Other Recommended

Guidance

American College of

Obstetricians and

Gynecologists (ACOG)

Information Sources

Epidemiology of

Condition/Disease 

Preeclampsia (Screening)

Clinical Preventive Service Recommendations

In 1996, the U.S. Preventive Services Task Force (USPSTF) recommended that

clinicians screen all pregnant women for preeclampsia by taking a blood pressure

measurement at the first prenatal visit and periodically throughout the

pregnancy.1

Given the availability of new evidence, the USPSTF decided to update its 1996

recommendation. This work is in a queue to be scheduled for review. 

The American College of Obstetricians and Gynecologists (ACOG) recommends

that clinicians monitor blood pressure at the first prenatal visit, every 4 weeks

until 28 weeks’ gestation, every 2 to 3 weeks until 36 weeks’ gestation, and

weekly thereafter.2

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Pediatrics (AAP)

• American College of Obstetricians and Gynecologists (ACOG) 

• Agency for Healthcare Quality and Research (AHRQ)

• National Vital Statistics

• Peer-reviewed research

• Preeclampsia Foundation

• World Health Organization (WHO)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Preeclampsia occurs when a woman with normal blood pressure experiences acute

hypertension (140 mm Hg or higher systolic or 90 mm Hg or higher diastolic)

or an increase blood pressure (an increase of 30 mm Hg in systolic blood

pressure or 15 mm Hg in diastolic blood pressure) after 20 weeks’ of

gestation.3 While more common towards the end of pregnancy, preeclampsia can

appear as early as 20 weeks’ gestation. Symptoms of the condition include the

presence of protein in the urine, swollen extremities, sudden weight gain,

headaches, and changes in vision. However, many women report no symptoms.4

Preeclampsia affects 5% to 7% of all pregnancies.5 Women with preeclampsia are

at an increased risk for placental abruption, acute renal failure, cerebral

hemorrhage, disseminated intravascular coagulation, pulmonary edema,
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Immunization, and Preventive Medication)

circulatory collapse, and progression to full-blown eclampsia, an extremely

serious condition characterized by maternal seizure activity, coma, and death.

Preeclampsia can also cause severe problems for the fetus such as delayed growth,

low birth weight, and the risk of premature birth.6

Preeclampsia/eclampsia is the third leading cause of maternal death worldwide1

and is responsible for 18% of all maternal deaths in the United States.7 In the

United States during 2002, preeclampsia/eclampsia caused:

• Maternal death in 56 out of every 100,000 live birth.8

• Neonatal death in 71 out of every 100,000 live births.9

Research indicates that women that are pregnant for the first time, women with

multiple gestations, molar pregnancy or fetal hydrops, chronic hypertension or

diabetes, and those with a personal or family history of eclampsia or preeclampsia

are at increased risk for preeclampsia and eclampsia. Overweight and obese

women are also at increased risk of preeclampsia.10

Value of Prevention

According to the Hospital Cost Utilization Project (HCUP) Nationwide Inpatient

Survey (NIS), spending on hypertension during pregnancy totaled nearly $2.3

billion in the United States in 2003.11 During that year, approximately 204,868

pregnant women were admitted to the hospital for hypertension, staying an

average of 3.5 days. The average per-person charge for such hospital admissions

totaled $11,208.11 Few data are available about the incremental costs for infants

because of preeclampsia or the value of years of life lost due to preeclampsia and

its complications, including maternal or neonatal deaths. 

The medical care costs of maternal and neonatal complications due to

preeclampsia impose an additional financial burden on employer-sponsored

health insurance plans. 

Pregnancy-related complications affecting their own health or the health of their

children may also require working mothers to take significant time off from

work, resulting in additional productivity losses at the workplace.

Screening, which involves minimal cost, and early treatment can minimize and

prevent otherwise costly medical conditions. For example, although there is a lack

of recent research, there is acceptance of the finding that women with

preeclampsia or eclampsia stay in the hospital substantially longer than do

normotensive women (i.e., women having blood pressure typical of the group to

which they belong), regardless of their method of delivery. The longer hospital

stays and higher rates of cesarean section delivery among women with

preeclampsia and eclampsia lead to more costly obstetric medical claims. For

example, 217,700 excess hospital days for delivery admissions were attributable to

preeclampsia and eclampsia in 1986.10

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention
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Immunization, and Preventive Medication)

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening

Intervention Process

Treatment

Information

Blood pressure screening is a standard procedure at each office visit and involves

minimal cost. Screening for preeclampsia is conducted as a part of routine

prenatal care and does not require a separate visit. 

Not Provided

Complete cost-effectiveness analyses are not available. 

Preventive Intervention Information

Screening allows clinicians to identify affected women early in the course of their

pregnancies and begin treatment, thereby reducing the risk of complications for

affected women and their infants. 

Regular blood pressure screening during pregnancy is used to detect

preeclampsia. Early detection of hypertension permits continuous monitoring

and early intervention (e.g., bed rest, medications, early delivery). Although

studies have not shown that early identification of hypertension and preeclampsia

is associated with better outcomes, clinical experience suggests that to be the case.

As such, the medical community considers regular blood pressure screening to be

in the best interest of both mother and fetus. At the same time, blood pressure

screening is simple, inexpensive, and acceptable to patients.

ACOG recommends that clinicians monitor blood pressure at the first prenatal

visit, every 4 weeks until 28 weeks’ gestation, every 2 to 3 weeks until 36 weeks’

gestation, and weekly thereafter.

Screening for preeclampsia can be conducted via conventional measures (arm 

cuff and a mercury calibrated aneroid or digital sphygmomanometer) or

ambulatory blood pressure monitoring. Before a diagnosis of preeclampsia can 

be made, the patient must have two elevated blood pressure readings (defined 

as 140/90 mmHg) taken at least 6 hours apart. Preeclampsia may also be

diagnosed if a woman has undergone an increase of 30 mmHg or more in

systolic pressure or 15 mmHg or more in diastolic pressure since becoming

pregnant. Clinicians should be aware that overweight and obese patients may

need to be monitored more closely, especially if they have preexisting

hypertension, due to their increased risk of preeclampsia.2

Treatment methods for preeclampsia include bed rest, medication, and delivery.

Health benefits should include provisions for follow-up and treatment services.
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U.S. Preventive

Services Task Force

Recommendations

Recommended

Guidance

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Recommended Guidance: 

The American College of Obstetricians and Gynecologists (ACOG)

Strength of Evidence: Not Specified

• The American College of Obstetricians and Gynecologists recommends

screening pregnant women for preeclampsia by monitoring blood pressure at

the first prenatal visit, every 4 weeks until 28 weeks’ gestation, every 2 to 3

weeks until 36 weeks’ gestation, and weekly thereafter.2

Prenatal Diagnosis of Chromosomal

Abnormalities and Neural Tube Defects

(Screening and Testing)

Clinical Preventive Service Recommendations

In 1996, the U.S. Preventive Services Task Force (USPSTF) recommended that

clinicians offer serum multiple marker screening to all pregnant women at low

risk for Down syndrome and amniocentesis or chorionic villus sampling (CVS)

testing to all pregnant women at high risk for Down syndrome. 

This recommendation is considered out of date and has been archived. 

In 1996, the U.S. Preventive Services Task Force recommended that clinicians

offer neural tube defect screening to all pregnant women who have access to

adequate prenatal care, counseling, and follow-up services. 

Screening for neural tube defects during pregnancy is currently considered part of

standard prenatal care. The USPSTF knows of no reason at the present time to

update its 1996 recommendation.

Offering pregnant women screening and testing (prenatal diagnosis) to detect

chromosomal abnormalities is standard clinical practice. All pregnant women are

candidates for screening services. Most clinical guidelines recommend that

women age 35 and older (and those who have equivalent risk) be offered testing

in place of, or in addition to, screening.1

Authored by: 

Campbell KP, Chattopadhyay S. Preeclampsia evidence-statement: screening. In: Campbell KP, Lanza A,

Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive

Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.
285

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Immunization, and Preventive Medication)

Information Sources

Epidemiology of

Condition/Disease

Offering all pregnant women (irrespective of age) screening services to detect

neural tube defects (NTDs) and offering testing services (prenatal diagnosis) to

women at elevated risk is standard clinical practice.2

There are several screening and prenatal diagnosis methods available. There is no

single current authoritative source on which of the various methods provides the

best outcome. Therefore, it is recommended that employers provide healthcare

coverage for all screening and testing methods, including — but not limited to

— the following:

• All types of maternal serum screening tests

• Amniocentesis 

• Chorionic villus sampling (CVS) 

• Ultrasound

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Obstetricians and Gynecologists (ACOG)

• Centers for Disease Control and Prevention (CDC)

• March of Dimes

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

• U.S. Public Health Service

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Chromosomal Abnormalities

Down syndrome (trisomy 21) is the most common chromosomal abnormality in

the United States, affecting 1 in every 800 to 1,000 live-born babies.3 Children

with Down syndrome have physical abnormalities including heart defects, short

stature, characteristic facial abnormalities, and varying degrees of mental

retardation. Although Down syndrome and its complications cannot be cured,

early intervention programs that begin in infancy may help those living with

Down syndrome achieve certain developmental milestones in a more timely

fashion.

Life expectancy among individuals with Down syndrome has increased

substantially over the past three decades. In 1983, the average life expectancy for

an individual with Down syndrome was 25 years; by 1997, life expectancy had

risen to 49 years.4 However, life expectancy gains have not been equal among

individuals with Down syndrome, and large survival disparities have been noted

between white and black infants.4
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Other chromosomal abnormalities include trisomy 13, trisomy 18, and sexchromosome abnormalities. Trisomy 13 and 18 are very severe and usually cause

fetal or infant death.5 Sex-chromosome abnormalities are the most mild form or

chromosomal abnormality and occur in approximately 1 in every 2,000 to 2,500

female infants and 1 in every 600 to 800 male infants.5 These abnormalities lead

to sexual development problems (including infertility) and, sometimes,

behavioral or learning problems.5

Neural Tube Defects (NTDs)

Spina bifida and anencephaly are common and permanent neural tube defects

(NTDs) which result from the failure of the neural cord to properly fuse. Each

year in the United States, approximately 3,000 pregnancies are affected by NTDs

and approximately 2,200 infants are born with neural tube defects.6 Many 

NTD-affected pregnancies do not result in a live birth since they are electively or

spontaneously aborted (commonly referred to as a miscarriage) or result in fetal

death or stillbirth.

Anencephaly is fatal; all affected infants die shortly after birth. Approximately

92% of infants born with spina bifida survive with varying degrees of disability.

Debilitating medical complications associated with spina bifida include paralysis

and bowel and bladder incontinence.7

Chromosomal Abnormalities

The risk of Down syndrome increases dramatically with advancing maternal age.

For example, the risk of delivering a baby with Down syndrome is about 1 in

1,250 for a 25-year-old woman, 1 in 1,000 for a 30-year-old woman, 1 in 400

for a 35-year-old woman, and 1 in 100 for a 40-year-old woman.8 Risk factors

other than age are poorly understood, and 97% of Down syndrome pregnancies

occur in families with no previous history of the syndrome.1

As with Down syndrome, the risk of trisomy 13 and trisomy 18 increases with

advancing maternal age; women age 35 or older are most at risk for these

conditions.5

Neural Tube Defects (NTDs)

Inadequate folic acid consumption is the major risk factor for NTDs.

Consuming the recommended daily amount of folic acid (0.4-0.8mg) can reduce

a woman’s chance of having a NTD-affected pregnancy by 40% to 80%.9

However, only 33% of childbearing-age women report taking vitamins that

contain folic acid.9

Spina bifida, the most common type of NTD, occurs most frequently among

Hispanics and European whites and least frequently among African-Americans

and Asians. Low socioeconomic status has been reported to be a risk factor for

NTDs.10

Condition/Disease

Risk Factors
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Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Value of Prevention

The economic impact of chromosomal abnormalities and NTDs is substantial. 

The lifetime cost of live-born infants with Down syndrome includes the

incremental medical, developmental, and special education costs as well as lost

productivity and earnings due to death and disability. The total lifetime cost for

all cases of Down syndrome (based on 1988 cross-sectional data) was estimated

to exceed $1.8 billion in year 1992 dollars.11

The total lifetime cost for a child born with spina bifida is estimated at $636,000

(in year 2002 dollars).12 Applying that cost to the prevalence rate for spina bifida

from National Birth Defect Prevention Network data13 (4 million live births each

year) yields an estimated $814 million in lifetime costs for each cohort.12 Costs

associated with NTDs are shared by parents, employers, and communities.

Lost productivity attributable to premature morbidity and mortality due to

Down syndrome was estimated to total $1.18 billion in 1992 dollars, comprising

nearly 64% of total lifetime cost for all cases of Down syndrome.11

Apart from the incremental excess cost of medical care for affected children,

employers face productivity losses of employees who must care for affected

children. The present value of lost workdays for a typical caregiver was estimated

to be $252,000 in year 1993 dollars.14

The economic benefit of prenatal screening is defined as the averted cost from

preventing the birth of a child with a chromosomal abnormality or NTD. These

averted costs include savings from the direct costs of medical, developmental, and

special education services as well as the indirect costs associated with lost

productivity due to morbidity and mortality.12

In 2004, the private-sector cost of15:

• Screening for NTDs via ultrasound averaged $155; approximately 95% of all

paid claims fell within the range of $41 to $352 per ultrasound.

• Screening for chromosomal abnormalities averaged $56; approximately 95% of

all paid claims fell within the range of $0 to $158 per test. The full range of

tests totaled, on average, $8,255.

• Genetic testing (including complete gene sequence analysis) averaged $408 per

test; approximately 95% of all paid claims fell within the range of $0 to

$1,852. The full range of tests totaled, on average, $5,013. 

• Genetic counseling averaged $39; approximately 95% of all paid claims fell

within the range of $1 to $129.

• An amniocentesis averaged $296.

• Chorionic villus sampling averaged $355. 

When birth defects are detected, the cost of treatment may include costs

associated with genetic counseling and termination.
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Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

and Testing

Benefits and Risks 

of Intervention

California is one of two states with a public prenatal screening program, which is

supported by fees paid by prenatal care providers and insurers. In 1998, the fee

paid by payers was $105, which covered the cost of the State’s expanded

screening program for chromosomal abnormalities and NTDs. The fee covered

both the initial screening and reimbursements for genetic counseling, ultrasound,

amniocentesis, and genetic testing.16 The California prenatal screening program

estimated a benefit-to-cost ratio of 2.7, meaning that, on average, each $1 spent

on the program would be offset by $2.70 in economic benefits calculated using a

discount rate of 5% per year.16

Preventive Intervention Information

The major benefit of screening for and diagnosing chromosomal abnormalities

and NTDs is the opportunity to inform women and their partners of the

likelihood that they are carrying an affected fetus. The usefulness of this

information depends on the values and preferences of the parents. With

appropriate information and counseling, parents can decide whether to terminate

or continue a pregnancy. Parents who decide to continue the pregnancy have an

opportunity to prepare emotionally and financially for the birth of their child. 

The knowledge gained by screening can help women and their families make an

informed decision as to whether or not to undergo prenatal diagnosis (testing). In

turn, prenatal diagnosis can help women and their families make an informed

decision about whether to continue or terminate the pregnancy. Prenatal

diagnosis of a chromosomal abnormality or NTD may preclude trauma

associated with the unexpected delivery of an affected infant.1 Furthermore,

information gained from prenatal diagnosis may help providers better prepare for

the delivery of an affected infant.1,17 For example, some studies show reduced

severity of paralysis in infants with spina bifida delivered by cesarean section

compared with those having vaginal delivery.17

The risks of screening and prenatal diagnosis depend on the method used. The

major risk associated with screening is the chance of a false-positive result, which

can lead to unnecessary anxiety.16 Thus, confirmatory testing (prenatal diagnosis)

is considered to be essential. Risks of prenatal diagnosis include the risks

associated with amniocentesis or CVS (in very rare cases the fetus can be injured,

suffer an infection, or miscarry), the psychological effects for the woman and her

partner of a positive result, and the risks associated with abortion.

Many women who test positive for an NTD-affected pregnancy choose to

terminate their pregnancy. Screening thus leads to the prevention of the births of

affected infants. In fact, some studies have shown that the availability of

screening, testing, and the opportunity for termination reduces the number of

infants born with NTDs by up to 70%.16 However, termination rates vary

depending on the ethnic and religious backgrounds of the families and many

other factors. In one study of an ethnically diverse population in California,

termination rates for spina bifida averaged 67%.16 It is important to remember

that many women who choose to carry the pregnancy to term will have either a

stillborn fetus or an infant who will die in the first few hours or days after birth.
289

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The screening and testing process is defined by several factors: the type of test

utilized, whether there is need for follow-up testing, and the risk-status of the

pregnant woman. Timing is left to the discretion of the physician and should be

determined by the pregnant woman’s needs and the stage of pregnancy when she

began prenatal care. 

Several screening methods are used to determine risk for chromosomal

abnormalities and NTDs. Most methods examine biological markers in maternal

blood samples. 

Down syndrome can be diagnosed prenatally by identifying an extra

chromosome 21 through a cell sample. Fetal cell samples can be obtained

through an amniocentesis, chorionic villus sampling (CVS), or cordocentesis.1

Health benefits should include provisions for follow-up services such as:

• Genetic counseling

• Termination or continuing prenatal care and labor and delivery. 

Cures for chromosomal abnormalities and NTDs are not available, but various

interventions can be used to improve the functioning or quality of life of those

who are affected. 

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Recommended Guidance: 

Offering pregnant women screening and testing (prenatal diagnosis) to detect

chromosomal abnormalities is standard clinical practice. All pregnant women are

candidates for screening services. Most clinical guidelines recommend that

women age 35 and older, (and those who have equivalent risk) be offered testing

in place of, or in addition to, screening.2-3 

Offering all pregnant women (irrespective of age) screening to detect neural tube

defects (NTDs) and offering testing (prenatal diagnosis) to women at elevated

risk is standard clinical practice.2-3 

There are several screening and prenatal diagnosis methods available. There is no

single current authoritative source on which of the various methods provides the

best outcome. Therefore, it is recommended that employers provide healthcare

coverage for all screening and testing methods, including — but not limited to

— the following:

• All types of maternal serum screening tests

• Amniocentesis 

• Chorionic villus sampling (CVS) 

• Ultrasound

Initiation, Cessation,

and Interval of

Screening and

Testing

Intervention Process

Treatment

Information
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U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommend/Good

Evidence) 

B (Recommend/At

Least Fair Evidence

Other Recommended

Guidance

American College of

Obstetricians and

Gynecologists (ACOG)

Evidence Rating:

Rh (D) (Screening and Preventive

Medication)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) strongly recommends Rh (D)

blood typing and antibody testing for all pregnant women during their first visit

for pregnancy-related care.1

The USPSTF also recommends repeated Rh (D) antibody testing for all

unsensitized Rh (D)-negative women between 24 and 28 weeks’ gestation, unless

the biological father is known to be Rh (D)-negative.1

The USPSTF found good evidence that Rh (D) blood typing, anti-Rh (D)

antibody testing, and intervention with Rh (D) immunoglobulin, as appropriate,

prevents maternal sensitization and improves outcomes for newborns. The

benefits substantially outweigh any potential harms.1

The USPSTF found fair evidence that repeated antibody testing for unsensitized

Rh (D)-negative women (unless the father is also known to be Rh [D]-negative)

and intervention with Rh (D) immunoglobulin, as appropriate, provides

additional benefit over a single test at the first prenatal visit in preventing

maternal sensitization and improving outcomes for newborns. The benefits of

repeated testing substantially outweigh any potential harms.1

The American Academy of Family Physicians (AAFP) concurs with the USPSTF.

The American College of Obstetricians and Gynecologists (ACOG) concurs with

the U.S. Preventive Service Task Force (USPSTF) recommendations, with the

exception that ACOG strongly recommends that clinicians administer

immunoglobulin to Rh (D)-negative pregnant women after undergoing invasive

procedures such as chronic villus sampling or fetal blood sampling.2

ACOG further recommends that immunoglobulin be administered following a

possible spontaneous or elective abortion, second or third trimester bleeding,

external cephalic version, or abdominal trauma.2

Expert Consensus

Authored by: 

Campbell KP, Grosse S, Chattopadhyay S. Prenatal diagnosis of chromosomal abnormalities and neural

tube defects evidence-statement: screening and testing. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay

S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into

Coverage. Washington, DC: National Business Group on Health; 2006.
291

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Information Sources

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Family Physicians (AAFP)

• American Academy of Pediatricians (AAP)

• The American College of Obstetricians and Gynecologists (ACOG)

• National Institutes of Health (NIH)

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Rh (D) incompatibility refers to a condition that develops when a pregnant

women with Rh-negative blood type carries a fetus with an Rh-positive blood

type. In reaction to what is perceived to be a foreign substance, the woman’s body

makes antibodies that attack fetal red blood cells (isoimmunization). Since it

takes time to build up antibodies, first pregnancies are typically not affected by

Rh incompatibility. However, in subsequent pregnancies, Rh incompatibility may

cause destruction of fetal red blood cells (hemolysis), which leads to anemia and

an accumulation of bilirubin in the fetus’s bloodstream (hyperbilirubinemia) that

produces jaundice. Extreme jaundice leads to kernicterus, a form of brain damage

associated with cerebral palsy and mental retardation. The hemolytic destruction

of red blood cells can also lead to hydrops fetalis, a severe anemia resulting in

fetal heart failure, total body swelling, respiratory distress or total circulatory

collapse, and often death.3

Rh incompatibility occurs in approximately 10% of all pregnancies, depending

on the race of the pregnant woman and her fetus. Without treatment, 25% to

30% of these fetuses will show various degrees of hemolytic anemia and

hyperbilirubinemia. An additional 20% to 25% will be hydropic and will either

die in utero (resulting in a stillbirth) or shortly after birth. Hemolytic disease of

the fetus accounts for 4 to 5 deaths per 100,000 births in the United States.3

Only Rh-negative women are at risk of having a baby with Rh disease. If an Rhnegative woman and Rh-positive man conceive an Rh-positive fetus, there is a

chance that some of the fetus’s Rh-positive red blood cells may enter the woman’s

blood stream, which stimulates the woman’s immune system to produce

antibodies against the fetus’s Rh-positive cells. The risk of Rh disease becomes

greater with each subsequent pregnancy.4

Value of Prevention

No data exist that estimate the total direct or indirect costs of Rh (D)

incompatibility in the United States.
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Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

and Preventive

Medication

Benefits and Risks of

Intervention

Initiation, Cessation,

and Interval

The value of life years lost due to fetal loss, stillbirth, neonatal and post-neonatal

deaths, and productivity loss associated with disability constitute the major

components of the economic burden of Rh (D) incompatibility. Costs would be

even higher if the additional medical care costs and productivity losses of

working pregnant women are considered. 

In addition to the incremental medical care utilization costs due to complications

from Rh (D) incompatibility, there can be significant productivity losses at the

workplace when working parents need to take time off from work to care for

short- or long-term health problems of their children. 

Early identification of Rh (D) incompatibility allows clinicians to begin

treatment before damage is done to the fetus. This prevents otherwise expensive

medical treatment, lifelong disability, and even death.

In 2004, the private-sector cost of screening for Rh (D) incompatibility averaged

$15 per screen; approximately 95% of all paid claims fell within the range of $0

to $38. The cost of immune globulin averaged $111 and approximately 95% of

all paid claims fell within the range of $0 to $178.5

Not Provided

A review undertaken on behalf of the National Institute of Clinical Excellence in

the United Kingdom, the governmental unit responsible for producing evidencebased recommendations for the UK, found that routine antenatal anti-D

preventive medication (immunoglobulin) provides a cost-effective intervention

for preventing the incidence of hemolytic disease of the newborn in pregnancies

of Rh (D)-negative women.6

Preventive Intervention Information

Early identification of Rh (D) incompatibility allows clinicians to begin

treatment before damage is done to the fetus. This prevents otherwise expensive

medical treatment, lifelong disability, and even death.

Early detection of Rh (D)-negative blood type in a pregnant woman is of

substantial benefit (when the woman is not yet isoimmunized and the father of

the fetus is not known to be Rh (D)-negative) because it makes prevention of

isoimmunization possible. Clinicians can administer anti-D immune globulin to

Rh (D)-negative pregnant women, thereby preventing the maternal

isoimmunization that would adversely affect subsequent pregnancies. This course

of treatment prevents isoimmunization in 96% of women at risk.4 Screening and

treatment with immunoglobulins have few adverse affects.4

The USPSTF strongly recommends that all pregnant women undergo Rh (D)

blood typing and antibody testing at their first prenatal visit. Furthermore, the
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Intervention Process

Treatment

Information

USPSTF recommends that women known to be Rh (D)-negative and

unsensitized undergo a repeat Rh (D) antibody test between 24 and 28 weeks’

gestation to determine their degree of sensitivity. This second step is unnecessary

if the fetus’s father is known to be Rh (D)-negative. 

A full dose (300mg) of immunoglobulin should be administered to1-2:

• All unsensitized Rh (D)-negative women after their repeated antibody screen

between 24 and 28 weeks’ gestation.

• D-negative women within 72 hours of delivering a Rh (D)-positive infant.

• D-negative women following amniocentesis or either induced or spontaneous

abortion (a 50 mg dose should be administered when abortion occurs prior to

13 weeks).

Clinicians have discretion regarding the provision of immunoglobulin to 

Rh (D)-negative pregnant women after undergoing invasive procedures such as

chorionic villus sampling or fetal blood sampling and/or following a possible

spontaneous or elective abortion, second or third trimester bleeding, external

cephalic version, or abdominal trauma.2

Rh (D) blood typing and antibody testing is conducted via an analysis of the

blood. Immunoglobulin is administered to those at risk of Rh disease through an

injection.

Health benefit coverage should include provisions for follow-up and treatment

services. 

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Evidence-Based Research:

The U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence), 

B (Recommended/At Least Fair Evidence)

A (Strongly Recommended/Good Evidence)

• The USPSTF found good evidence to support Rh (D) blood typing and

antibody testing for all pregnant women during their first visit for pregnancyrelated care.1

B (Recommended/At Least Fair Evidence)

• The USPSTF found fair evidence to support Rh (D) antibody testing for all

unsensitized Rh (D)-negative women between 24 and 28 weeks’ gestation,

unless the biological father is known to be Rh (D)-negative.1

This recommendation is supported by the:

• American Academy of Family Physicians (AAFP)
294

U.S. Preventive

Services Task Force

Recommendation

CDC

Recommendation

Evidence Rating:

Recommended Guidance: 

The American College of Obstetricians and Gynecologists (ACOG)

Strength of Evidence: Expert Consensus 

• The ACOG concurs with the USPSTF recommendations, with the exception

that ACOG strongly recommends that clinicians 1) administer

immunoglobulin to Rh (D)-negative pregnant women after undergoing

invasive procedures such as chorionic villus sampling or fetal blood sampling,

and 2) administer immunoglobulin following a possible spontaneous or

elective abortion, second or third trimester bleeding, external cephalic version,

or abdominal trauma.2

Rubella (Screening)

Clinical Preventive Service Recommendations

Not Applicable – The U.S. Preventive Services Task Force defers to the Advisory

Committee on Immunization Practices and the CDC on recommendations

surrounding immunization. 

Rubella vaccine is contraindicated during pregnancy. Because the vaccine

contains live virus, it should not be administered to pregnant women.1

The Advisory Committee on Immunization Practices (ACIP) recommends that

clinicians screen all women of childbearing age, including pregnant women, for

rubella susceptibility during their first clinical encounter. A history of vaccination

(proved by written documentation of receipt of 1 dose of a rubella-containing

vaccine after the age of 1 year) or a serologic test for antibodies (offering

laboratory evidence of immunity) can be used to document immunity against

rubella. Susceptible, nonpregnant women should be vaccinated, and susceptible

pregnant women should be vaccinated immediately after delivery or at the end of

their pregnancies (such as following miscarriage). Nonpregnant women may be

offered vaccination without serologic screening.1

A summary of guidelines for the immunization of pregnant women can be found

online (www.cdc.gov/nip/publications/preg_guide.htm). 

Expert Consensus

Authored by: 

Campbell KP, Chattopadhyay S. Rh (D) incompatibility evidence-statement: screening and preventive

medication. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors.

A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC:

National Business Group on Health; 2006.

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)
295

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Other Recommended

Guidance

Information Sources

Epidemiology of

Condition/Disease

The American Academy of Family Physicians (AAFP) concurs with the ACIP

recommendations.

The recommendations and supporting information contained in this document

came from several sources, including the:

• Advisory Committee on Immunization Practices (ACIP)

• American Academy of Family Physicians (AAFP)

• Centers of Disease Control and Prevention (CDC)

• Peer-reviewed research

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

For most people, rubella is a mild illness. However, when contracted during early

pregnancy, particularly during the first trimester, rubella can cause serious

complications including miscarriage, stillbirth, and congenital rubella syndrome

(CRS) – a constellation of birth defects that include hearing impairment, growth

retardation, developmental delays, and heart and eye defects.2 Because rubella

infection can affect all the organs of a developing fetus, the earlier a woman is

infected with rubella during her pregnancy, the more severe the complications are

for the developing fetus. Approximately 90% of infants born to women who

contracted rubella during the first 11 weeks of pregnancy develop CRS and about

20% of infants born to women who contracted rubella during the first 20 weeks

of pregnancy develop CRS.2

In 1964-1965, an epidemic of rubella hit the United States: over 12 million

individuals were infected resulting in 11,000 fetal losses (as a result of miscarriage

or abortion) and 20,000 cases of CRS.3

In 1969, rubella vaccines were licensed in the United States to protect individuals

from rubella. Widespread vaccine use led to a 99% reduction in the number of

rubella cases over 3 decades; this reduced the rubella caseload from a high of

57,686 cases in 1969 to only 271 cases in 1999.2

Since universal childhood immunization was initiated in 1969, there has not

been another rubella epidemic, although isolated outbreaks do occur. The United

States experienced a resurgence of rubella in the early 1990s with 1,124 cases

reported in 1990 and 1,412 in 1991. During this time period 66 infants were

born with CRS.4

In 2004, an expert panel convened by CDC concluded that rubella and CRS

have been eliminated from the United States; however, continued vaccination of

susceptible women and children is necessary to maintain this success.3
296

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost 

of Preventive

Intervention

Estimated Cost 

of Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Because pregnant women are most susceptible to the complications of rubella,

experts recommend the targeted screening and vaccination of childbearing-aged

women. Such a practice would reach those individuals who were not vaccinated

in childhood. The rubella vaccine is contraindicated for use during pregnancy

due to the theoretical possibility that the live virus rubella vaccine could cause

fetal infection and CRS; however, there have been no documented cases of CRS

related to use of the rubella vaccine.1

Since the mid-1990s, rubella and CRS has disproportionately affected foreignborn ethnic minorities. In 1999, 73% of all rubella cases in the United States

occurred among Hispanics, most of whom were from Mexico and Central

America (CDC, unpublished data). Between 1998 and 2000, over 90% of all

CRS cases occurred among infants of Hispanic women 96% of whom were

foreign-born.3

Value of Prevention

CRS and its complications have substantial health consequences and economic

costs. A large rubella outbreak in 1964-1965 cost an estimated $840 million.5 In

2006, the estimated lifetime cost of treating a child born with CRS exceeded

$200,000.5

Rubella and CRS result in excess direct medical costs. Indirect costs constitute

the major workplace burden of rubella, however. Indirect costs include

permanent disability caused by CRS as well as productivity losses associated with

the missed work time of employed caregivers attending to their sick children. 

The economic benefits of immunization result from reducing hospitalizations

and outpatient visits and by avoiding productivity losses caused by rubella or

CRS-related disabilities.

In 2004, the private-sector cost of screening for rubella antibodies averaged $21;

approximately 95% of paid claims fell within the range of $0 to $50.6 The cost of

the rubella vaccine averaged $20 and approximately 95% of all paid claims fell

within the range of $0 to $40 per dose (1 to 2 doses are required for protection

against rubella).6

In 2006, the lifetime cost of treating a child born with CRS exceeded $200,000.5

Although there is a lack of economic evidence about the cost-effectiveness of

screening pregnant women, one study that investigated the current 2-dose MMR

vaccination program for children through a decision-tree-based analysis

demonstrated that the program resulted in substantial cost-savings and high

benefit-to-cost ratios. The estimated total cost savings to society of $7.6 billion

(in year 2001 dollars) included a savings of $549 million from rubella and CRS

prevention.7
297

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening

Intervention Process

Screening

Immunization

Treatment

Information 

Preventive Intervention Information

Screening allows clinicians to identify childbearing-age women who are at risk for

rubella and to immunize them before they become pregnant. Screening pregnant

women allows clinicians to identify at-risk women and to encourage them to be

immunized immediately after delivery, thereby offering protection during

subsequent pregnancies. 

Screening for rubella susceptibility involves minimal risk, although false-positive

test results may lead to unnecessary treatment. The rubella vaccine is very

effective; more than 90% of individuals vaccinated show long-term protection

from the illness.1 Adverse reactions to the rubella vaccine may include pain at the

injection site or temporary rash, which are usually mild in both children and

adults, although adults — particularly women — commonly complain of

temporary joint pain after vaccination.

All women of childbearing age, including pregnant women, should be screened

for rubella susceptibility during their first clinical encounter. All women of

childbearing age who are not pregnant should be vaccinated at their first clinical

encounter if not immune to rubella. A susceptible pregnant woman should be

vaccinated immediately after delivery or at the end of her pregnancy (e.g.,

miscarriage).

Screening is conducted by ascertaining an individual’s risk for rubella. Immunity

to rubella can be documented by 1) a history of immunization (proved by

written documentation of receipt of 1 dose of a rubella-containing

immunization after the age of 1 year), or 2) a serologic test for antibodies

(offering laboratory evidence of immunity). Individuals who cannot document

immunity are considered at risk for rubella. 

Rubella immunization is administered via an injection. 

Health benefits should include provisions for treatment services.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Recommended Guidance:

Advisory Committee on Immunization Practices (ACIP)

Strength of Evidence: Expert Consensus

The ACIP recommends that clinicians screen all women of childbearing age,

including pregnant women, for rubella susceptibility during their first clinical

encounter. Susceptible non-pregnant women should be vaccinated and

susceptible pregnant women should be vaccinated immediately after delivery or

at the end of their pregnancy (e.g., miscarriage).1
298

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/

Good Evidence)

CDC

Recommendation

Evidence Rating:

Information Sources

This recommendation is supported by the:

• U.S. Preventive Services Task Force (USPSTF) 

Syphilis (Screening)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) strongly recommends that

clinicians screen all pregnant women for syphilis infection.1

The USPSTF found good evidence that screening pregnant women decreases the

proportion of infants with clinical manifestations of syphilis infection and those

with positive serologies. The USPSTF concludes that the benefits of screening

substantially outweigh the potential harms.1

The Centers for Disease Control and Prevention (CDC) recommends a serologic

test for syphilis for all pregnant women at the first prenatal visit. Women who are

at high risk for syphilis morbidity, are previously untested, or have a positive

serology in the first trimester should be screened again early in the third trimester

(28 weeks gestation) and at delivery. Infants should not be discharged from the

hospital unless the syphilis serologic status of the mother has been determined at

least one time during pregnancy and preferably again at delivery.2

Not Specified

The recommendations and supporting information contained in this document

came from several sources, including the:

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Authored by: 

Campbell KP, Lindley MC, Bhatt A, Chattopadhyay S. Rubella evidence-statement: screening. In: Campbell

KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical

Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on Health;

2006.
299

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention 

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Condition/Disease Specific Information

Syphilis is a serious sexually transmitted infection (STI) that, if left untreated,

may result in cardiovascular and neurological complications leading to disability

and ultimately death.1

In addition to sexual transmission, syphilis can be passed from an infected

mother to her infant during pregnancy and delivery. Congenital syphilis is

particularly severe and results in fetal or infant death in 40% of cases.1 In 2002,

451 cases of congenital syphilis were reported in the United States.3 Of these

cases, 333 (73.8%) occurred because the mother had no documented treatment

or received inadequate treatment of syphilis before or during pregnancy.3 Infected

infants who survive may suffer serious central nervous system abnormalities,

deafness, bone and joint deformities, skin abnormalities, blood disorders, and

other problems.3

Populations at increased risk for syphilis infection (as determined by incidence

rates) include commercial sex workers, persons who exchange sex for drugs, and

those in adult correctional facilities. 

The prevalence of syphilis infection varies widely among communities and

patient populations.1 Some populations have a particularly high risk of infection,

specifically African-Americans and people living in the Southeastern United States.4

Value of Prevention

The average annual national cost of treating infants with congenital syphilis is

approximately $18.4 million (in year 1995 dollars).5

The health, disability, and life insurance costs of syphilis-infected employees

impose a significant economic burden on employers. Affected women may also

lose work time in order to seek treatment for themselves or for their affected

infants. 

Screening and early detection are key to averting costs associated with disease

progression, long-term complications, and neonatal transmission. For example,

treatment for early stage syphilis ($41.26) is much less expensive than treatment

for later stage disease ($2,062) (both figures in year 2001 dollars).6

In 2004, the private-sector cost of screening for syphilis averaged $12;

approximately 95% of all paid claims fell within the range of $0 to $32.7

The cost of treating syphilis will vary depending on the medication used and

other factors. For azithromycin therapy, the 2001 public-sector price of the 1-g

sachet formulation was $11.50 and the wholesale price for a 1-g dose ranged

from $17.32 for the sachet formulation to $27.89 for tablets. The public sector

cost of standard IM benzathine penicillin therapy ranged from $18.64 to $22.22

(in year 2001 dollars).6
300

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of 

Screening

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening

Intervention Process

Serological screening of pregnant women is cost-effective even when there is a

very low prevalence of maternal infection because screening is inexpensive but

treating congenital syphilis is costly.8

Preventive Intervention Information

Screening for syphilis allows clinicians to identify affected patients and begin

treatment early in the course of disease. Early intervention improves outcomes

and avoids the health and economic consequences of latent disease in the mother

and the occurrence of congenital syphilis.2 Treatment also reduces the risk of

transmission between the affected woman and her sexual partner(s). 

No studies have documented harms associated with screening for syphilis.

Theoretical harms include partner discord, stigma, unnecessary anxiety, treatment

in the case of a false-positive result, and opportunity costs (in terms of time and

resources) to both the clinician and patient. Harms of treatment include allergic

reactions to penicillin and other side effects of treatment medications such as the

Jarisch-Herxheimer reaction (fever, headache, and pain that occurs during the 24

hours after initiating antibiotic treatment for syphilis and is caused by the release

of fragments of the dead, infective microorganism into the bloodstream).1

The benefits associated with screening are substantial. Screening allows for early

detection and treatment, prevention of complications that may occur in later

stages of the disease, and prevention of neonatal transmission. Antibiotic

treatment for syphilis is effective, and inexpensive. Therefore, the USPSTF

concluded that the benefits of screening pregnant women for syphilis infection

substantially outweigh the potential harms.1

All pregnant women should be screened for syphilis at their first prenatal care

visit. For women in high-risk groups, repeat serologic testing may be necessary in

the third trimester (28 weeks) and again at delivery.1-2 Follow-up serologic tests

should be obtained to document successful treatment.1

A variety of syphilis tests are available and in development. Screening for syphilis

typically involves the use of 2 different tests, a nontreponemal test and a

treponemal-specific test, for screening and confirmation. For example, a

nontreponemal blood test such as the venereal disease research laboratory

(VDRL) or the rapid plasma reagin (RPR) may be performed. A second,

different kind of test, such as the fluorescent treponemal antibody absorbed

(FTA-ABS) or the T. palladium particle agglutination (TP-PA) may then be used

to confirm the results of the nontreponemal test.1,4 

Syphilis screening tests that are approved by the Food and Drug Administration

(FDA) or are pending FDA approval include1,4:

• Nontreponemal test such as the venereal disease research laboratory (VDRL) or

the rapid plasma regain (RPR) on serum specimens followed by a fluorescent

treponemal antibody absorbed (FTA-ABS) or T. palladium particle
301

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Treatment

Information

agglutination (TP-PA) for confirmation.

• Immunochromatographic Strip (ICS) point-of-care test on blood specimen,

when FDA approved.

• Line Immunoassay (LIA) point-of-care test on blood specimen, when FDA

approved.

• Enzyme-linked Immunosorbent Assay (ELISA) for treponemal antibody in

serum specimens. 

• RPR point-of-care test for nontreponemal antibody in serum specimens. 

• Dark field microscope examination of lesion specimens.

Follow-up tests should be performed using the same nontreponemal test initially

used to document infection (e.g., VDRL or RPR) to ensure comparability.1

Syphilis should be treated with an antibiotic regimen appropriate for the woman’s

stage of disease. Some experts recommend additional therapy (e.g., a second dose

of benzathine penicillin 2.4 million units IM) one week after the initial dose,

particularly for those women in the third trimester of pregnancy and for women

who have secondary syphilis during pregnancy.9

Infants should be treated for presumed congenital syphilis if they were born to

mothers who, at delivery:

• Had untreated syphilis; 

• Were treated with a non-recommended antibiotic regimen; 

• Were treated less than one month prior to delivery; or 

• Had evidence of relapse or reinfection after treatment. 

Recommended treatment regimens for infants include aqueous crystalline

penicillin G (administered every 12 hours during the first 7 days of life and every

8 hours thereafter) for 10 to14 days or procaine penicillin G (administered daily

in a single dose for 10 to 14 days). If more than one day of therapy is missed, the

entire course should be restarted.10

Health benefits should include provisions for treatment services.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence) 

• The USPSTF found good evidence that screening pregnant women decreases

the proportion of infants with clinical manifestations of syphilis infection and

those with positive serologies. The USPSTF concludes that the benefits of

screening substantially outweigh the potential harms.1
302

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force

Recommendation

CDC

Recommendation

Evidence Rating:

Other Recommended

Guidance

American Academy

of Family Physicians

(AAFP)

Recommended Guidance:

Centers for Disease Control and Prevention (CDC)

Strength of Evidence: Not Specified

• The CDC recommends a serologic test for syphilis on all pregnant women at

the first prenatal visit. Women who are at high risk for syphilis morbidity, are

previously untested, or have a positive serology in the first trimester should be

screened again early in the third trimester (28 weeks gestation) and at delivery.

Infants should not be discharged from the hospital unless the syphilis serologic

status of the mother has been determined at least one time during pregnancy

and preferably again at delivery.2

Tetanus (Immunization)

Clinical Preventive Service Recommendations

Not Applicable – The U.S. Preventive Services Task Force defers to the Advisory

Committee on Immunization Practices and the CDC on recommendations

surrounding immunization.

The Advisory Committee on Immunization Practices (ACIP) recommends that

all previously vaccinated pregnant women who have not been vaccinated against

tetanus in the past 10 years receive a booster vaccination against tetanus.1-2

Pregnant women who have not completed a three-dose primary vaccination series

against tetanus should complete the series.1-2 Pending guidance from ACIP,

pregnant women should receive the Td vaccine in preference to the Tdap

vaccine.3

A summary of guidelines for the immunization of pregnant women can be found

online (www.cdc.gov/nip/publications/preg_guide.htm). 

Expert Consensus

The American Academy of Family Physicians (AAFP) supports the ACIP

recommendation.1

Authored by: 

Choucair J, Lentine D, Campbell KP, Chattopadhyay S. Syphilis evidence-statement: screening.

In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide 

to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group 

on Health; 2006.
303

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Information Sources

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost 

of Preventive

Intervention

Estimated Cost 

of Treatment

The recommendations and supporting information contained in this document

came from several sources, including the:

• Advisory Committee on Immunizations (ACIP)

• American Academy of Family Physicians (AAFP)

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Tetanus is generally characterized by painful muscle rigidity and uncontrollable

spasms. Between 1998 and 2000, 18% of persons in the United States who

contracted tetanus died as a result of the disease.4 Neonatal tetanus is a severe and

often fatal disease; it accounted for an estimated 200,000 deaths worldwide in

2000 but is extremely rare in the United States.5 Because nearly all neonatal

tetanus occurs in infants born to mothers who are not adequately immunized

against tetanus, it is important that all pregnant women be vaccinated against tetanus.4

All pregnant women who are not fully immunized are at risk of infection.

Value of Prevention

There are few economic data on the burden of tetanus disease and no data about the

costs of neonatal tetanus in the United States. A recent economic evaluation of the

7-vaccine routine childhood immunization schedule in the United States estimated

that, if there had not been a tetanus vaccination program in the United States, 153

cases of tetanus and 23 deaths from tetanus would have occurred at a total cost of

$29 million (direct and indirect costs in year 2001 dollars) based on a hypothetical

2001 birth cohort of 3.8 million infants that was followed from birth to death.6

Not Provided

The averted mortality and morbidity costs due to prevented tetanus cases

constitute the major economic benefit of immunization. 

In 2004, the private-sector cost of an adult tetanus vaccine (usually given as Td)

averaged $15; approximately 95% of all paid claims fell within the range of $0 to

$28.7 The additional cost of vaccine administration averaged $10 and 95% of

paid claims fell within the range of $0 to $20.7

Not Provided
304

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of

Immunization

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Immunization

Intervention Process

Risk Assessment

Immunization

Treatment

Information

In one analysis, it was estimated that administering tetanus booster

immunizations every 10 years (‘decennial’ boosters) is associated with a cost of

$143,138 per year of life saved. Although decennial boosters are more

expensive than once-in-a-lifetime booster immunizations, they also prevent

more than twice the number of tetanus cases that would be prevented by a

single lifetime booster.8

Preventive Intervention Information

Tetanus immunization offers long-term protection against tetanus for the

vaccinated woman, and maternal vaccination confers significant protection to the

fetus. In fact, field assessments have reported 70% to 100% effectiveness of the

vaccine in preventing neonatal tetanus among the children of women receiving at

least two doses of tetanus vaccine.9 Notably, in all three cases of neonatal tetanus

that have occurred in the United States since 1989, the infant’s mother was not

fully immunized against tetanus.4

The benefits of tetanus immunization are substantial. Adverse reactions to

tetanus vaccination can include local swelling or pain; extensive swelling and

systemic reactions are rare, however.10 Although no evidence exists that tetanus

immunization during pregnancy causes harm to the fetus, delaying needed

tetanus immunizations to the second or third trimester is a reasonable precaution

to minimize any concerns about the theoretical possibility of such adverse

effects.11

Women should be assessed for risk of tetanus at their first prenatal care visit.

Pregnant women without adequate documentation of a completed primary

tetanus series and a tetanus vaccination within the past ten years should be

immunized against tetanus in the second or third trimester.

Clinicians should assess all pregnant women for susceptibility to tetanus.

Pregnant women are considered susceptible to tetanus if they have an uncertain

immunization history (i.e., they cannot provide written proof of immunization)

or if they have not had a tetanus booster in the previous 10 years. 

Susceptible women who have not completed a primary series of immunizations

against tetanus should complete a three-dose series; women who have completed

the primary series but have not been vaccinated against tetanus in the past ten

years should receive a booster dose.1-2

In 2005, two new tetanus toxoid, reduced diphtheria toxoid, and acellular

pertussis (Tdap) vaccines were licensed for use in the United States. Pending

guidance from ACIP on the use of Tdap during pregnancy, pregnant women

should receive Td vaccine in preference to the Tdap vaccine.3

Tetanus vaccinations are given via injection.

Health benefits should include provisions for treatment services.
305

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/

Good Evidence

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Recommended Guidance:

Advisory Council on Immunization Practices (ACIP)

Strength of Evidence: Expert Consensus

• The ACIP recommends that all adults with an uncertain history of a complete

tetanus vaccination series receive a three-dose primary tetanus series, and that

all adults receive periodic tetanus boosters every 10 years.1-2

This recommendation is supported by the:

• American Academy of Family Physicians (AAFP)

• U.S. Preventive Services Task Force (USPSTF)

Tobacco Use Treatment (Screening and

Counseling)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians

screen all pregnant women for tobacco use and provide augmented pregnancytailored counseling to those who smoke.1

The USPSTF found good evidence that extended or augmented smoking

cessation counseling (5 to15 minutes) using messages and self-help materials

tailored for pregnant smokers, compared with brief generic counseling

interventions alone, substantially increases abstinence rates during pregnancy, and

leads to increased birth weights. Although relapse rates are high in the

postpartum period, the USPSTF concluded that reducing smoking during

pregnancy is likely to have substantial health benefits for both the baby and the

expectant mother. The USPSTF concluded that the benefits of smoking cessation

counseling outweigh any potential harms.1

The American Academy of Family Physicians (AAFP)2, the American College of

Preventive Medicine (ACPM)3, and the U.S. Surgeon General concur with the

USPSTF recommendations.4

Authored by: 

Lindley MC, Bhatt A, Campbell KP, Chattopadhyay S. Tetanus immunization evidence-statement. In: Campbell KP,

Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive

Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006.
306

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Other Evidence-Based

Recommendations

American Academy

of Family Physicians

(AAFP)

Evidence Rating: SR

(Strongly

Recommended)

Information Sources

Epidemiology of

Condition/Disease

The American Academy of Family Physicians (AAFP) strongly recommends that

clinicians counsel smoking parents with children in the house regarding the

harmful effect of smoking and children’s health.2

Good quality evidence exists which demonstrates the substantial net benefit

(compared with harm) of counseling to prevent exposure to secondhand smoke; the

intervention is perceived to be cost-effective and acceptable to nearly all patients.2

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Family Physicians (AAFP)

• American College of Preventive Medicine (ACPM)

• Centers for Disease Control and Prevention (CDC)

• National Institutes of Health (NIH)

• Peer-reviewed research

• Smoke Free Families

• U.S. Public Health Service (USPHS)

• U.S. Surgeon General

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Twenty-one percent (21%) of all childbearing-aged women in the United States

smoke.4 Depending on demographic factors, between 11% and 20% of all

pregnant women in the United States smoke.4

Tobacco use during pregnancy causes significant damage to the developing fetus,

putting the future infant at risk for an array of severe short- and long-term health

problems. Compared to non-smokers, women who smoke during their

pregnancy are 83% more likely to deliver a low-birth-weight infant, 129% more

likely to deliver an infant that will die of SIDS, 30% more likely to deliver an

infant with respiratory distress syndrome, and 41% more likely to deliver an

infant with a perinatal respiratory condition.5 And children whose mothers

smoked during pregnancy and/or smoke in the home shortly after birth are at

increased risk of asthma, impaired lung function, stunted growth, ear infections,

and upper respiratory problems.6-7

Prenatal tobacco use is a known risk factor for low birth weight, which itself is a

significant risk factor for neonatal morbidity and mortality. In 2003, 12.4% of all

women, 13% of Hispanic women, and 20.2% of black women who smoked

during pregnancy delivered a low-birth-weight infant.8
307

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Table 1.0 Infant Deaths Resulting from Tobacco Use 

Source: Centers for Disease Control and Prevention. National Center for Chronic Disease

Prevention and Health Promotion: Division of Reproductive Health. MCH health outcomes

report. Maternal and Child Health Smoking-Attributable Mortality, Morbidity, and Economic

Costs. Atlanta, GA: Centers for Disease Control and Prevention; 2005.

* March of Dimes. Perinatal statistics. [cited 2005 Jul 8]. Available from:

http://www.marchofdimes.com/aboutus/680_2203.asp. 

**Discovery labs (distributors of surfactant, a medicine used to treat RDS in infants. [cited 2005

Jul 8]. Available from: http://www.discoverylabs.com/2002pr/071802-PR.pdf. 

Women who smoke during pregnancy are likely to be young (18 to 24 years of

age), have low levels of education, and be from racial or ethnic minorities. Level

of education is highly correlated with prenatal smoking. For example, while only

2% of college-educated non-Hispanic white women smoke during pregnancy,

42.7% of non-Hispanic white women with only 9 to 11 years of education

smoke during one or more of their pregnancies.9

Value of Prevention

The economic burden of prenatal tobacco use is substantial. In 1996, maternal

smoking accounted for 2.3% of all neonatal medical expenditures.10 Each

pregnant smoker incurs an additional $704 in healthcare costs (in year 1996

dollars)5 and, annually, smoking-attributable neonatal costs (defined as all costs

related to labor /delivery and the care of infants within the first few months of

life) are estimated to meet or exceed $367 million in the United States.10-11

The direct costs of care for mothers and their children exposed to environmental

tobacco smoke (ETS) (also known as secondhand smoke) also add to the overall

cost of smoking, although exact cost figures are not known. 

Smoking-attributable neonatal costs impose a heavy burden on employersponsored health insurance spending. Moreover, working parents are required to

Health Problem Percent of Cases

Caused by

Smoking

No. of Infants

who Died as a

Result of a

Smoking Induced

Health Problem

(2001)

Years of Potential

Life Lost due to

Smoking Induced

Health Problem

Estimated Cost

per Case

Low birth weight

(LBW)

9.1% 400 20,732 $32,000-

$90,000*

Sudden infant

death syndrome

(SIDS)

13.4% 299 22,909

Respiratory

distress syndrome

3.5% 35 2,686 $8,500 per day of

intensive care**

Other respiratory

problem

4.7% 71 5,444
308

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

and Counseling

Benefits and Risks 

of Intervention

take additional time off from work to attend to the health care needs of children

affected by neonatal smoke exposure. This results in productivity losses in the

workplace. 

A smoking cessation program that could achieve an annual drop of 1 percentage

point in smoking prevalence has been estimated to produce an economic benefit

of $21 million in (in year 1995 dollars) direct medical costs solely by reducing

the number of low-birth-weight live births. In 7 years, the cumulative

undiscounted saving in direct medical costs would become $572 million through

the prevention of 57,200 low-birth-weight infants.12

In 2004, the private-sector cost of tobacco risk assessment and prevention

counseling averaged $62; approximately 95% of all paid claims fell within the

range of $0 to $139.13 In 2004, the private-sector cost (per pregnant smoker) for

tobacco use treatment averaged $39 and approximately 95% of all paid claims

fell within the range of $0 to $134.13

Tobacco cessation treatment for pregnant women is considered one of the most

cost-saving preventive services.4,14 Clinical trials have shown that $6 are saved in

healthcare costs for every $1 invested in smoking cessation programs for pregnant

women.15

Preventive Intervention Information

Screening allows clinicians to identify smokers and offer them cessation services

in order to improve their chances of quitting. Quitting smoking reduces the risk

of serious smoking-related health problems for the individual and — with regards

to pregnant smokers — reduces the fetus’s risk of smoking-related health

problems such as pre-term birth, low birth weight, and SIDS. 

The benefits of tobacco use screening and counseling are substantial. Tailored

tobacco cessation programs that feature patient education and support have been

proven to be effective in reducing the number of women who smoke during

pregnancy. For example, one health plan’s tobacco cessation program saw a

massive reduction in smoking among participants; 81% of participants reported

that they stopped smoking altogether or cut the number of cigarettes they

smoked each day in half. Women in the program who stopped smoking

completely had fewer preterm deliveries and fewer low-birth-weight babies

compared to the pregnant smokers who did not participate in the program.16

Counseling interventions (as compared to printed self-help materials) are

especially effective for smokers at high risk of complications from smoking, such

as pregnant women. Notably, 21% of pregnant women who receive physician

counseling successfully quit, which is double the quit rate of their nonpregnant

counterparts.3

There are no documented risks to screening pregnant women for tobacco use.

Risks of tobacco cessation counseling are few but include the possibility of a
309

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

negative self-perception and perceived feelings of discrimination. 

The benefits of screening and counseling, including early identification and early

treatment, far outweigh the risks associated with screening and counseling. 

All adults, including pregnant women, should be screened for tobacco use at

every preventive care visit or as deemed appropriate by the clinician.1,3 Pregnant

women who screen positive for tobacco use should be advised to quit at every

medical encounter and referred to 1-800-Quit-Now, the national portal number

that refers callers to their state’s quitline service. All pregnant women who screen

positive for tobacco use should be counseled.

The USPSTF recommends the use of the “5-A” behavioral counseling framework

for tobacco screening and counseling. This framework is composed of 5 steps

aimed at engaging the patient in a discussion about their tobacco use and their

intention to quit:

• Ask about tobacco use

• Advise to quit through clear and personalized messages

• Assess the patient’s willingness to quit

• Assist to quit

• Arrange for follow-up and support services

The USPSTF further recommends that clinicians provide problem-solving

guidance for smokers to develop a quit plan and to overcome common barriers to

quitting. Practices that complement the “5-A” framework include motivational

interviewing or other methods of intensive counseling, referral for quitters that

may need extra help, and referral to quitlines for adjunct counseling.1,5

Effective counseling interventions for pregnant smokers include individual faceto-face, group, and telephone counseling.17 The most effective type of smoking

cessation interventions for pregnant women are multi-component programs that

feature: 1) healthcare provider reinforcement, 2) printed self-help materials, and

3) follow-up in-person or telephone counseling.11 Physician counseling has been

shown to increase quit rates among patients in primary care. The more intensive

the counseling is (as measured by length of counseling session) the higher the

quit rate. For example, 10.5% of patients who receive less than 3 minutes of

physician counseling quit smoking, 12.1% of patients who receive 3 to 10

minutes quit, and 18.7% of patients who receive over 10 minutes of counseling

quit.3

Pharmacologic therapy can enhance the effectiveness of tobacco-cessation

interventions and can be used when the physician and patient concur that

medication use would be beneficial. Because there have not been adequate studies

to ensure the safety of tobacco cessation medications among pregnant women,

patient education and provider counseling remain the primary methods of

tobacco use treatment. Postpartum women who are not breastfeeding may want

to consider using medication to enhance their likelihood of a successful quit

attempt.17

Initiation, Cessation,

and Interval of

Screening and

Counseling

Intervention Process

Screening

Counseling
310

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Treatment

Information

Please refer to the “Intervention Process” section.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this 

section is described below.

Evidence-Based Research:

The U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The USPSTF found good evidence that extended or augmented smoking

cessation counseling (5 to 15 minutes) using messages and self-help materials

tailored for pregnant smokers, compared with brief generic counseling

interventions alone, substantially increases abstinence rates during pregnancy,

and leads to increased birth weights.1

This recommendation is supported by the:

• American Academy of Family Physicians (AAFP)

• American College of Preventive Medicine (ACPM)

• U.S. Public Health Service (USPHS)

The American Academy of Family Physicians (AAFP) 

Strength of Evidence: SR (Strongly Recommended)

• AAFP strongly recommends that clinicians counsel smoking parents with

children in the house regarding the harmful effect of smoking and children’s

health.2 Good quality evidence exists which demonstrates the substantial net

benefit of counseling to prevent exposure to secondhand smoke; the

intervention is perceived to be cost-effective and acceptable to nearly all

patients.2

Authored by: 

Campbell KP, Rosenthal AC, Chattopadhyay S. Tobacco use treatment during pregnancy evidence-statement:

screening and counseling. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors.

A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National

Business Group on Health; 2006.
311

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

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Alcohol Misuse (Screening and Counseling)

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MMWR 2005; 54(09): 229.

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9. Fleming MF, Mundt MP, French MT, Manwell LB, Stauffacher EA, Barry KL. Brief physician advice for problem alcohol

drinkers: long-term efficacy and benefit-cost analysis. A randomized controlled trial in community-based primary care

settings. Alcohol Clin Exp Res 2002;26:36-43.

10. Gentilello LM, Ebel BE, Wickizer TM, Salkever DS, Rivara FP. Alcohol interventions for trauma patients treated in

emergency departments and hospitals: A cost benefit analysis. Ann Surg 2005;241:541-50.

11. Klug MG. Burd L. Fetal alcohol syndrome prevention: Annual and cumulative cost savings. Neurotoxicol Teratol 2003;

25(6): 763-765. 

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Asymptomatic Bacteriuria (Screening)

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associated risk factors in pregnant women. Philippines Journal of Microbial Disease 2003; 32(2): 63-69. 

6. Mittal P, Wing DA. Urinary tract infections in pregnancy. Clin Perinatol 2005; 32: 749-764.

7. Rouse DJ, Andrews WW, Goldenberg RL, Owen J. Screening and treatment of asymptomatic bacteriuria in pregnancy to

prevent pyelonephritis: a cost-effectiveness and cost benefit analysis. Obstet Gynecol 1995; 86:119-123.

8. Brown P, Ki M, Foxman B. Acute pyelonephritis among adults: cost of illness and considerations for the economic evaluation

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9. Yen Zui-Shen, davis MA, Chen Shyr-Chyr, Chen Wen-Jone. A cost-effectiveness analysis of treatment strategies for acute

uncomplicated pyelonephritis in women. Acad Emerg Med 2003; 10: 309-314.

10. Thomson Medstat. Marketscan. 2004. 

11. U.S. Preventive Services Task Force. Screening for asymptomatic bacteriuria: Recommendation statement. Guide to Clinical

Preventive Services. 3rd ed. Rockville, MD; Agency for Healthcare Research and Quality; 2001 [cited 2006 Mar 22].

Available from: http://www.ahrq.gov/clinic/3rduspstf/asymbac/asymbacrs.htm. 

12. U.S. Preventive Services Task Force. Screening for asymptomatic bacteriuria: A brief evidence update for the U.S. Preventive

Services Task Force. AHRQ Publication No. 05-551-B. Rockville, MD: Agency for Healthcare Research and Quality; 2004.
315

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Breastfeeding (Counseling)

1. Berg AO. Behavioral interventions to promote breastfeeding: Recommendations and rationale. U.S. Preventive Services Task

Force. Ann Fam Med 2003; 1(2): 79-80.

2. Shealy KR, Li R, Benton-Davis S, Grummer-Strawn LM. The CDC Guide to Breastfeeding Interventions. Atlanta: U.S.

Department of Health and Human Services, Centers for Disease Control and Prevention, 2005.

3. American Academy of Family Physicians. Summary of Policy Recommendations for Periodic Health Examinations. AAFP

Policy Action. Revision 6.0; August 2005.

4. Centers for Disease Control and Prevention. National Immunization Survey. [cited 2006 Aug 31]. Available from:

http://www.cdc.gov/breastfeeding/data/NIS_data/data_2005.htm. 

5. U.S. Department of Health and Human Services. Healthy People 2010. 2nd ed. 2 vols. Washington, DC: U.S. Government

Printing Office, November 2000 [cited 2006 Aug 21]. Available from: http://www.healthypeople.gov/Publications. 

6. United States Breastfeeding Committee. Workplace breastfeeding support. Issue paper. Raleigh, NC: United States

Breastfeeding Committee; 2002.

7. Donnelly A, Snowden HM, Renfew MJ, Woolridge MW. Commercial hospital discharge packs for breastfeeding women

(Cochrane review). In: The Cochrane Library, Issue 2, 2004. Chichester, UK: John Wiley & Sons, Ltd.

8. Weimer J. The economical cost of breastfeeding: A review and an analysis. ERS Food Assistance and Nutrition Research

Report No. 13, Washington, DC: Economic Research Services, U.S. Department of Agriculture; 2001.

9. Cohen R, Mrtek MB, Mrtek RG. Comparison of maternal absenteeism and infant illness rates among breast-feeding and

formula-feeding women in two corporations. Am J Health Promot 1995:10(2):148-53.

10. Donnelly A, Snowden HM, Renfew MJ, Woolridge MW. Commercial hospital discharge packs for breastfeeding women

(Cochrane review). In: The Cochrane Library, Issue 2, 2004. Chichester, UK: John Wiley & Sons, Ltd.

11. Montgomery DL, Splett PL. Economic benefit of breast-feeding infants enrolled in WIC. J Am Diet Assoc 1997:97:379-385.

12. Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and breastfeeding: collaborative reanalysis of

individual data from 47 epidemiological studies in 30 countries, including 50,302 women with breast cancer and 96,973

without the disease. Lancet 2002; 360: 187-95.

13. Guise JM, Palda V, Westhoff C, Chan BKS, Helfand M, Lieu TA. The effectiveness of primary care-based interventions to

promote breastfeeding. U.S. Preventive Services Task Force. Ann Fam Med 2003; 1(2): 70-78. 

14. Centers for Disease Control and Prevention. Breastfeeding: Infectious diseases and specific conditions affecting human milk:

When should a mother avoid breastfeeding. [cited 2005 Dec 21]. Available from: http://www.cdc.gov/breastfeeding/disease/

contraindicators.htm. 

Folic Acid Supplementation (NTD) (Preventive Medication)

1. American Academy of Family Physicians. Summary of Policy Recommendations for Periodic Health Examinations. AAFP

Policy Action. Revision 6.0; August 2005.

2. Centers for Disease Control and Prevention. Recommendation s for the use of folic acid to reduce the number of cases of

spina bifida and other neural tube defects. MMWR 1992; 41(RR14): 001.

3. Centers for Disease Control and Prevention. Folic Acid. Centers for Disease Control and Prevention; 2006. Available from:

http://www.cdc.gov/ncbddd/folicacid/health_recomm.htm.

4. Centers for Disease Control and Prevention. Spina bifida and anencephaly before and after folic acid mandate – United

States, 1995-1996 and 1999-2000. MMWR 2004; 53(17): 362-365.

5. Berry RJ, Li Z, Erickson JD, Li S, Moore CA, Wang H et al. Prevention of neural-tube defects with folic acid in China.

China-US. Collaborative Project for Neural Tube Defect Prevention. N Engl J Med 1999; 341:1485–1490.

6. March of Dimes. Spina bifida. Quick Facts and Reference Sheets. Updated 2005 [cited 2005 Jul 6]. Available from:

http://www.marchofdimes.com. 
316

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

7. Centers for Disease Control and Prevention. Use of dietary supplements containing folic acid among women of childbearing

age – United States, 2005. MMWR 54(38); 955-958. Available from:

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5438a4.htm.

8. Williams LJ, Rasmussen SA, Flores A, Kirby RS, Edmonds LD. Decline in the prevalence of spina bifida and anencephaly by

race/ethnicity: 1995-2002. Pediatrics 2005;116(3):580-586.

9. Grosse SD, Waitzman NJ, Romano PS, Mulinare J. Re-evaluating the benefits of folic acid fortification in the United States:

Economic analysis, regulation, and public health. Am J Public Health 2005;95:1917–1922.

10. Canfield MA, Collins JS, Botto LD, Williams LJ, Mai CT, Kirby RS, et al. Changes in the birth prevalence of selected birth

defects after grain fortification with folic acid in the United States: findings from a multi-state population-based study. Birth

Defects Res A Clin Mol Teratol 2005;73:679-689.

11. Kelly AE, Haddix AC, Scanlon KS, Helmick CG, Mulinare J. Cost-effectiveness of strategies to prevent neural tube defects.

In: Gold MR, Siegel JE, Russell LB, Weinstein MC, eds. Cost-Effectiveness in Health and Medicine. New York, Oxford:

Oxford University Press; 1996:312–349.

12. Thomson Medstat. Marketscan 2004. 

13. Pricegrabber.com cost estimate for a one-year supple of prescription strength (1 mg) folic acid. [cited 2006 Aug 31]. Available

from: http://www.pricegrabber.com/search_attrib.php?form_keyword=folic+acid&topcat_id=&page_id=1776&lo_p=0&hi_p=0. 

14. Medical Research Council Vitamin Study Research Group. Prevention of neural tube defects: results of the Medical Research

Council Vitamin Study. Lancet 1991;338:131–137. 

15. Czeizel AE, Dudas I. Prevention of the first occurrence of neural-tube defects by periconceptional vitamin supplementation.

N Engl J Med 1992;327:1832–1835.

16. Stevenson RE, Allen WP, Pai GS, Best R, Seaver LH, Dean J, Thompson S. Decline in prevalence of neural tube defects in a

high-risk region of the United States. Pediatrics 2000;106:677-683.

Group B Streptococcal Disease (Screening and Preventive Medication)

1. Schrag S, Gorwitz R, Fultz-Butts K, Schuchat A. Centers for Disease Control and Prevention. Prevention of perinatal Group

B streptococcal disease: Revised guidelines from the CDC. MMWR 2002; 51(RR11); 1-22. 

2. Keenan C. Prevention of neonatal group B streptococcal infection. Am Fam Physician 1998: 57(1). 

3. Mohle-Boetani JC, Schuchat A, Plikaytis D, Smith JD, Broome CV. Comparison of prevention strategies for neonatal group

B streptococcal infection. A population-based analysis. JAMA 1993; 270(12):1442-1448.

4. Haberland CA, Benitz WE, Sanders GD, Pietzsch JB, Yamada S,Nguyen L, et al. Perinatal screening for Group B

Streptococci: Cost-Benefit analysis of rapid polymerase chain reaction. Pediatrics 2002;110(3):471-480. 

5. Benitz WE, Gould JB, Druzin ML. Preventing early-onset Group B streptococcal sepsis: Strategy development using decision

analysis. Pediatrics 1999;103(6):76-91.

6. Thomson Medstat. Marketscan. 2004.

Hepatitis B Virus (Screening and Immunization)

1. U.S. Preventive Services Task Force. Screening for hepatitis B virus infection. Rockville, MD; Agency for Healthcare Research

and Quality; February 2004 [cited 2006 Sep 11]. Available from: http://www.ahrq.gov/clinic/uspstf/uspshepb.htm. 

2. Mast EE, Margolis HS, Fiore AE, Brink EW, Goldstein ST, Wang SA, Moyer LA, Bell BP, Alter MJ. A comprehensive

immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. MMWR 2005 [cited

2006 Aug 22]; 54(RR-16): 1-23. Available from: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5416a1.htm?s_cid=

rr5416a1_e. 

3. Centers for Disease Control and Prevention. Guidelines for vaccinating pregnant women: From recommendations of the

Advisory Committee on Immunization Practices (ACIP). October 1998; [updated July 2005; cited 2006 Aug 28]. Available

from: http://www.cdc.gov/nip/publications/preg_guide.htm. 
317

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

4. Centers for Disease Control and Prevention. Disease burden from hepatitis A, B, and C in the United States, 1980-2004.

National Center for HIV, STD and TB Prevention, Division of Viral Hepatitis. [cited 2005 Aug 25]. Available from:

http://www.cdc.gov/ncidod/diseases/hepatitis/resource/PDFs/disease_burden2004.pdf

5. American Academy of Family Physicians. Summary of policy recommendations for periodic health examinations. AAFP

Policy Action. Revision 6.0; August 2005.

6. U.S. Preventive Services Task Force. Screening for hepatitis B infection: Recommendation statement. Rockville, MD: Agency

for Healthcare Research and Quality; February 2004 [cited 2006 Sep 15]. Available from: http://www.ahrq.gov/clinic/

3rduspstf/hepbscr/hepbrs.htm.

7. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR 2006; 55

(RR-11): 1-94.

8. Chesson HW, Blandford JM, Gift TL, Tao G, Irwin KL. The estimated direct medical cost of sexually transmitted diseases

among American youth, 2000. Perspect Sex Reprod Health 2004; 36(1):11-19. 

9. Hauboldt RH. Cost Implications of Human Organ and Tissue Transplantations, An Update. Seattle, WA: Milliman &

Robertson, INC; 1999.

10. Margolis HS, Coleman PJ, Brown RE, Mast EE, Sheingold SH, Arevalo JA. Prevention of hepatitis B virus transmission by

immunization: An economic analysis of current recommendations. JAMA 1995; 274(15):1201-8.

11. Thomson Medstat. Marketscan. 2004.

12. Wong J, Koff R, Tine F, Pauker S. Cost-effectiveness of interferon-alpha2b treatment for hepatitis B e antigen-positive

chronic hepatitis B. Ann Intern Med 1995; 122:664-675.

Human Immunodeficiency Virus (HIV) (Screening) 

1. U.S. Preventive Services Task Force. Screening for Human Immunodeficiency Virus Infection. Rockville, MD: Agency for

Healthcare Research and Quality; July 2005. Available from: http://www.ahrq.gov/clinic/uspstf/uspshivi.htm.

2. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant

women in health care settings. MMWR. 2006;55(RR14):1-17.

3. Centers for Disease Control and Prevention. Revised recommendations for HIV screening of pregnant women. MMWR

2001; 50(RR19): 59-86.

4. Kourtis AP, Paramsothy P, Posner SF, Meikle SF, Jamieson DJ. National estimates of hospital use by children with HIV

infection in the United States: analysis of data from the 2000 KIDS Inpatient database. Pediatrics 2006; 118:167-173.

5. Mauskopf JA, Paul JE, Wichman DS, White AD, Tilson HH. Economic impact of treatment of HIV-positive pregnant

women and their newborns with zidovudine JAMA 1996; 276: 132-138.

6. Thomson Medstat. Marketscan. 2004.

7. Fleming T. 2006 Redbook: Pharmacy’s Fundamental Reference. Thomson PDR; Rev Ed edition. May 2006.

8. Immergluck LC. Cull WL. Schwatrz A, Elstein AS. Cost-effectiveness of universal compared with voluntary screening for

human immunodeficiency virus among pregnant women in Chicago. Pediatrics 2000; 105(4): E54.

Influenza (Immunization)

1. Centers for Disease Control and Prevention. Prevention and control of influenza: Mortality associated with recommendations

of the Advisory Committee on Immunization Practices (ACIP) MMWR 2006; 55(RR-10):1-42.

2. Centers for Disease Control and Prevention. Updated interim influenza vaccination recommendations: 2004-2005 influenza

season. MMWR 2004; 53(50):1183-4.

3. Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, et al. Influenza-associated hospitalizations in the

United States. JAMA 2004; 292(11):1333-40.

4. Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, et al. Mortality associated with respiratory

syncytial virus in the United States. JAMA 2003; 289(2):179-86.
318

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

5. Neuzil KM, Reed GW, Mitchel EF, Simonsen L, Griffin MR. Impact of influenza on acute cardiopulmonary hospitalizations

in pregnant women. Am J Epidemiol 1998;148:1094-102.

6. Munoz FM, Greisinger AJ, Wehmanen OA, Mouzoon ME, Hoyle JC, Smith FA, et al. Safety of influenza vaccination during

pregnancy. Am J Obstet Gynecol 2005; 192:1098-1106.

7. Molinari N, Ortega-Sanchez I, Messonnier M, Thompson W, Wortley P, Weintraub E, et al. National expenditures on

influenza: Estimating medical and indirect costs. Draft manuscript. 

8. Rothberg MB, Rose DN. Vaccination versus treatment of influenza in working adults: a cost-effectiveness analysis. Am J Med

2005;118:68-77.

9. Bridges CB, Thompson WW, Meltzer MI, Reeve GR, Talamonti WJ, Cox NJ, et al. Effectiveness and cost benefit of

influenza vaccination of healthy working adults: A randomized controlled trial. JAMA 2000; 284 (13) 1655-63.

10. Thomson Medstat. Marketscan. 2004.

11. Lee PY, Matchar DB, Clements DA, Huber J, Hamilton JD, Peterson ED, et al. Economic analysis of influenza vaccination

and antiviral treatment for healthy working adults. Ann Intern Med 2002:137:225-231.

12. Heinonen OP, Shapiro S, Monson RR, Hartz SC, Rosenberg L, Slone D, et al. Immunization during pregnancy against

poliomyelitis and influenza in relation to childhood malignancy. Int J Epidemiol 1973;2:229-35.

Preeclampsia (Screening)

1. U.S. Preventive Service Task Force. Prenatal Disorders: Screening for preeclampsia. Guide to Clinical Preventive Services. 2nd

ed. Washington, DC: U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion;

1996.

2. American Academy of Pediatrics and American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care. 3rd

ed. Washington, DC: American College of Obstetricians and Gynecologists.

3. Werner L. Diagnosis and management of pre-eclampsia. Am Fam Physician 2004 Dec 15;70(12):2317-24.

4. Conde-Agudelo A, Villar J, Lindheimer M. World Health Organization Systemic Review of Screening Tests for Preeclampsia.

Obstet Gynecol 104(6)1367-91. 

5. Wagner L. Diagnosis and management of preeclampsia. Am Fam Phys 2004; 70:2317-24.

6. American Academy of Family Physicians. Preeclampsia. Kansas City, MO: American Academy of Family Physicians; 2006.

7. Preeclampsia Foundation. [cited 2006 Feb 28]. Available from: http://www.preeclampsia.org/statistics.asp. 

8. National Vital Statistics 2004; 53(5): 97.

9. American College of Obstetricians & Gynecologists. Committee opinion: Obesity in pregnancy. Obstet Gynecol 2005;

106(3): 671-675.

10. Saftlas AF, Olson DR, Franks AL, Atrash HK, Pokras R. Epidemiology of preeclampsia and eclampsia in the United States,

1979-1986. Am J Obstet Gynecol 1990; 163:460-465.

11. Agency for Healthcare Research and Quality. Health Care Utilization Project Data Source. [cited 2005 Jul 12]. Available

from: http://hcup.ahrq.gov. 

Prenatal Diagnosis of Chromosomal Abnormalities and Neural Tube Defects (Screening)

1. American College of Obstetricians and Gynecologists. Prenatal diagnosis of fetal chromosomal abnormalities. Washington,

DC: American College of Obstetricians and Gynecologists, 2001; 27. 

2. American College of Obstetricians and Gynecologists. Neural tube defects. Clinical management guidelines for obstetriciangynecologist. ACOG Practice Bulletin 2004; 44: 1-11.

3. The March of Dimes. Down syndrome fact sheet. The March of Dimes 2006; Available from:

http://www.marchofdimes.com/professionals/681_1214.asp.
319

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

4. Rasmussen SA, Wong LY, Correa A, Gambrell D, Friedman JM. Survival in infants with Down syndrome, Metropolitan

Atlanta, 1979-1998. J Pediatr 2006;148:806-812.

5. March of Dimes. Chromosomal Abnormalities. Quick reference fact sheet for professionals. [cited 2005 Jul 6]. Available

from: http://www.marchofdimes.com/professionals/681_1209.asp. 

6. Centers for Disease Control and Prevention. Spina bifida and anencephaly before and after folic acid mandate – United

States, 1995-1996 and 1999-2000. MMWR 2004; 53(17): 362-365.

7. Centers for Disease Control and Prevention. Recommendations for the use of folic acid to reduce the number of cases of

spina bifida and other neural tube defects. MMWR 1992; 41(RR14): 001.

8. March of Dimes. Chromosomal abnormalities. [cited 2005 July 6]. Available from:

http://www.marchofdimes.com/professionals/681_1209.asp. 

9. Centers for Disease Control and Prevention. Use of dietary supplements containing folic acid among women of childbearing age –

United States, 2005. MMWR 54(38); 955-958. Available from: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5438a4.htm.

10. Wasserman CR, Shaw GM, Selvin S, Gould JB, Syme SL. Socioeconomic status, neighborhood social conditions, and neural

tube defects. Am J Public Health 1998; 88(11): 1674-1680. 

11. Centers for Disease Control and Prevention. Economic costs of birth defects and cerebral palsy – United States, 1992.

MMWR 1995: 44(37): 694-649.

12. Grosse SD, Waitzman NJ, Romano PS, Mulinare J. Re-evaluating the benefits of folic acid fortification in the United States:

Economic analysis, regulation, and public health. Am J of Public Health 2005; 95(11): 1917 - 1922.

13. Canfield MA, Collins JS, Botto LD, Williams LJ, Mai CT, Kirby RS, Pearson K, et al. Changes in the birth prevalence of

selected birth defects after grain fortification with folic acid in the United States: findings from a multi-state population-based

study. Birth Defects Res A Clin Mol Teratol 2005;73:679-689.

14. Kelly AE, Haddix AC, Scanlon KS, Helmick CG, Mulinare J. Cost-effectiveness of strategies to prevent neural tube defects.

In: Gold MR, Siegel JE, Russell LB, Weinstein MC, eds. Cost-Effectiveness in Health and Medicine. New York, Oxford:

Oxford University Press; 1996:312–349.

15. Thomson Medstat. Marketscan. 2004.

16. Cunningham GC, Tompkinison DG. Cost and effectiveness of the California triple marker prenatal screening program.

Genet Med 1999; 1(5): 199-206.

17. The March of Dimes. Maternal blood screening for Down syndrome and neural tube defects. March of Dimes 2006.

Rh (D) Incompatibility (Screening and Preventive Medication)

1. U.S. Preventive Service Task Force. Screening for Rh (D) incompatibility: Recommendations statement. November 2004.

AHRQ Pub. No. 05-0566-A.

2. American College of Obstetricians and Gynecologists. Prevention of Rh (D) alloimmunization. Washington, DC: American

College of Obstetricians and Gynecologists; 1999 May 8. (ACOG practice bulletin; no 4).

3. Medical Encyclopedia: Rh incompatibility. Available from: http://www.nlm.nih.gov/medlineplus/ency/article/001600.htm.

4. March of Dimes. Quick reference and fact sheets. Rh Disease. [cited 2006 Jul 18]. Available from:

http://www.marchofdimes.com/professionals/681_1220.asp. 

5. Thomson Medstat. Marketscan. 2004.

6. Chilcott J, Lloyd Jones M, Wight J, Forman K, Wray J, Beverley C, et al. A review of the clinical effectiveness and costeffectiveness of routine anti-D antibiotic prophylaxis for pregnant women who are rhesus-negative. Health Technol Assess

2003:7(4).
320

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

Rubella (Screening) 

1. Centers for Disease Control and Prevention. Measles, mumps, and rubella – vaccine use and strategies for elimination of

measles, rubella, and congenital rubella syndrome and control of mumps: Recommendations of the Advisory Committee on

Immunization Practices. MMWR 1998; 47(RR-8):1-57.

2. Centers for Disease Control and Prevention. Control and prevention of rubella: Evaluation and management of suspected

outbreaks, rubella in pregnant women, and surveillance of congenital rubella syndrome. MMWR 2001; 50(RR12):1-23.

3. Centers for Disease Control and Prevention. Achievements in public health: elimination of rubella and congenital rubella

syndrome – United States, 1969-2004. MMWR 2005; 54(11):279-282.

4. Reef SE, Frey TK, Theall K, Abernathy E, Burnett CL, Icenogle J, et al. The changing epidemiology of rubella in the 1990s:

On the verge of elimination and new challenges for control and prevention. JAMA 2002; 287(4):464-72.

5. Centers for Disease Control and Prevention. Rubella. In Atkinson W, Hamborsky J, McIntyre L, Wolfe S, eds. Epidemiology

and Prevention of Vaccine-Preventable Diseases, 9th ed. Washington DC: Public Health Foundation; 2006:155–70.

6. Thomson Medstat. Marketscan. 2004.

7. Zhou F, Reef S, Massoudi M, Papania MJ, Yusuf HR, Bardenheier B, et al. An economic analysis of the current universal 2-

dose measles-mumps-rubella vaccination program in the United States. J Infect Dis 2004;189:S131-S145.

Syphilis (Screening)

1. U.S. Preventive Services Task Force. Screening for syphilis infection. Summary of recommendations / Supporting documents.

Rockville, MD: Agency for Healthcare Research and Quality; 2004.

2. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR 2006

;55(No. RR 11). 

3. Centers for Disease Control and Prevention. Congenital syphilis – United States, 2002. MMWR 2004; 50(No. RR-31): 716-

719.

4. Nelson HD, Glass N, Huffman L, Villemyer K, Hamilton A, Frame A, et al. Screening for syphilis: Brief update for the U.S.

Preventive Services Task Force. AHRQ Publication No. 04-0545-B. Rockville, MD: Agency for Healthcare Research and

Quality; 2004.

5. Bateman DA, Phibbs CS, Joyce T, Heagarty MC. The hospital cost of congenital syphilis. J Pediatr 1997; 130 (5): 752-8.

6. Blandford JM, Gift TL. The cost-effectiveness of single-dose azithromycin for treatment of incubating syphilis. Sex Transm

Dis 2003;30(6):502-8.) 

7. Thomson Medstat. Marketscan. 2004.

8. Schmid G. Economic and programmatic aspects of congenital syphilis prevention. Bull World Health Organ 2004; 82(6)

402-409.

9. New York State Department of Health. New York state addendum for congenital syphilis treatment guidelines. [cited 2006

Aug 22]. Available from: http://www.health.state.ny.us/diseases/communicable/std/addendum.htm. 

10. Centers for Disease Control and Prevention. Congenital syphilis. Sexually transmitted diseases treatment guidelines. MMWR

2002 May 10;51(RR-6):26-8.

Tetanus (Immunization)

1. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory

Committee on Immunization Practices and the American Academy of Family Physicians. MMWR 2002; 51(RR-2):1-36.

2. Centers for Disease Control and Prevention. Diphtheria, tetanus, and pertussis: Recommendations for vaccine use and other

preventive measures. Recommendations of the Immunization Practices Advisory Committee. MMWR 1991; 40(RR-10):1-

28.
321

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

3. Centers for Disease Control and Prevention. Preventing tetanus, diphtheria, and pertussis among adolescents: Use of tetanus

toxoid, reduced diphtheria toxoid and acellular pertussis vaccines. Recommendations of the Advisory Committee on

Immunization Practices (ACIP). MMWR 2006; 55(RR-03):1-34.

4. Centers for Disease Control and Prevention. Tetanus surveillance – United States, 1998-2000. MMWR 2003; 52(SS-3):1-8.

5. Vandelaer J, Birmingham M, Gasse F, Kurian M, Shaw C, Garnier S. Tetanus in developing countries: an update on the

Maternal and Neonatal Tetanus Elimination Initiative. Vaccine 2003; 21:3442-3445.6. Zhou F, Santoli J, Messonnier ML,

Yusuf HR, Shefer A, Chu SY, et al. Economic evaluation of the 7-vaccine routine childhood immunization schedule in the

United States, 2001. Arch Pediatr Adolesc Med 2005;159:1136-1144.

7. Thomson Medstat. Marketscan. 2004.

8. Balestra DJ, Littenberg B. Should adult tetanus immunization be given as a single vaccination at age 65? J Gen Intern Med

1993; 8:405-412.

9. Wassilak SGF, Orenstein WA, Sutter RW. Chapter 18: Tetanus Toxoid. In Plotkin SA, Orenstein WA, eds. Vaccines, ed. 3.

Philadelphia, PA: W.B. Saunders Company; 1999:441-474.

10. Centers for Disease Control and Prevention. Tetanus. In Atkinson W, Hamborsky J, McIntyre L, Wolfe S, eds. Epidemiology

and Prevention of Vaccine-Preventable Diseases, 9th ed. Washington D.C.: Public Health Foundation; 2006:69-78.

11. Centers for Disease Control and Prevention. Update: Vaccine side effects, adverse reactions, contraindications, and

precautions. Recommendations of the Advisory Committee on Immunization Practices. MMWR 1996; 45(RR-12):1-35.

Tobacco Use Treatment (Screening and Counseling)

1. U.S. Preventive Services Task Force. Counseling to prevent tobacco use. Rockville, MD; Agency for Healthcare Research and

Quality: 2003 [cited 2006 Aug 22]. Available from: http://www.ahrq.gov/clinic/uspstf/uspstbac.htm. 

2. American Academy of Family Physicians. Summary of policy recommendations for periodic health examinations. AAFP

Policy Action. Revision 6.0; August 2005.

3. Kattapong VJ, Locher TL, Secker-Walker RH, Bell TA. Tobacco-cessation patient counseling. American College of Preventive

Medicine Practice Policy Statement. Am J Prev Med 1998; 15(2): 160-162.

4. U.S. Public Health Service. Treating tobacco use and dependence: A systems approach. Rockville, MD: Office of the U.S.

Surgeon General; U.S. Public Health Service; U.S. Department of Health and Human Services; 2000.

5. Centers for Disease Control and Prevention. National Center for Chronic Disease Prevention and Health Promotion:

Division of Reproductive Health. Smoking-attributable neonatal expenditures: Maternal and child health smokingattributable mortality, morbidity, and economic costs. Atlanta, GA: Centers for Disease Control and Prevention; 2004.

6. Smoke Free Families: Smoking and pregnancy: The real risks for mothers and their babies. [cited 2005 July 8]. Available

from: www.smokefreefamilies.org. 

7. U.S. Surgeon General. Women and Smoking: A Report of the Surgeon General. Rockville, MD: Office of the U.S. Surgeon

General; U.S. Public Health Service; U.S. Department of Health and Human Services; 2001.

8. National Center for Healthcare Statistics. Final Birth Data, 2003. From Table 32. Percentage low birth weight by smoking

status, age, and race and Hispanic origin of mother: Total of 47 reporting States and the District of Columbia, 2003. Atlanta,

GA: Centers for Disease Control and Prevention; 2004.

9. Smoke Free Families: Cigarette smoking during pregnancy, by age, ethnicity, and education. [cited 2005 July 8]. Available

from: www.smokefreefamilies.org. 

10. Centers for Disease Control and Prevention. Annual smoking-attributable mortality, years of potential life lost, and economic

Costs — United States, 1995–1999. MMWR 2002; 51(14): 300-303. 

11. Adams KE, Miller VP, Ernst C, Nishimura BK, Melvin C, Merritt R. Determinants of health: Neonatal health care costs

related to smoking during pregnancy. Health Econ 2002; 11(3): 193-206.

12. Lightwood JM, Phibbs, CS, and Glantz SA. Short-term health and economic benefits of smoking cessation: Low birth

weight. Pediatrics 1999; 104:1312-1320.
322

EVIDENCE-STATEMENT: Healthy Pregnancy (Screening, Testing, Counseling, 

Immunization, and Preventive Medication)

13. Thomson Medstat. Marketscan. 2004.

14. Maciosek MV, Coffield AB, Edwards NM, Goodman MJ, Flottemesch TJ, Solberg LI. Priorities among effective clinical

preventive services: results of a systematic review and analysis. Am J Prev Med 2006; 31(1):52-61. Table reprinted from Am J

Prev Med 2006; 31(1):52-61 with permission from the American Journal of Preventive Medicine.

15. Marks JS, Koplan JP Hogue CJR, et al. A cost-benefit/cost-effectiveness analysis of smoking cessation for pregnant women.

Am J Prev Med 1990;6:282-291.

16. Smoke Free Families. Helping pregnant smokers quit: Model programs. [cited 2005 July 8]. Available from:

www.smokefreefamilies.org. 

17. Ibrahim JK, Schauffler HH, Barker DC, Orleans CT. Coverage of tobacco dependence treatments for pregnant women and

for children and their parents. Am J Public Health 2002; 92(12): 1940-1942.
323

Why This Chapter is

Important for

Employers:

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/

Good Evidence) 

Centers for Disease

Control and

Prevention (CDC)

Guidance

Other Recommended

Guidance

• Hypertension (high blood pressure) is the most common primary diagnosis in

the United States and is responsible for 35 million office visits each year.1

• Nearly 1 in 3 U.S. adults has high blood pressure.2-3

• Adults with untreated or poorly controlled hypertension are at increased risk of

heart disease and stroke, peripheral artery disease, end-stage renal disease,

retinopathy, and aortic aneurysm.3

• The diagnosis and management of hypertension cost $63.5 billion in 2006,

including $47.5 billion in direct medical expenses and $16 billion in lost

productivity.3

• Hypertension is one of the 10 most expensive health conditions for U.S.

employers. Its complications are a major cause of preventable absenteeism,

reduced productivity, and disability.4

• Screening for hypertension allows clinicians to identify affected patients and

begin treatment early. 

• Controlling blood pressure with medications is one of the most cost-effective

methods of reducing premature cardiovascular morbidity and mortality.1,5 A 12

to 13-point reduction in blood pressure can reduce the number of heart attacks

by 21%, strokes by 37%, and all deaths from cardiovascular disease by 25%.1

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force recommends that clinicians screen all

adults aged 18 years and older for hypertension.6

The U.S. Preventive Services Task Force found good evidence that (1) screening

for high blood pressure can identify adults at increased risk for cardiovascular

disease, (2) treating high blood pressure can significantly decrease the prevalence

of cardiovascular disease, and (3) the benefits of screening outweigh the harms.6

The Centers for Disease Control and Prevention (CDC) supports the Seventh

Report of the Joint National Committee on Prevention, Detection, Evaluation,

and Treatment of High Blood Pressure1 recommendations for blood pressure

screening, prevention, and control (described in the next section).7 More

information on the CDC’s hypertension-related guidance is available online

(www.cdc.gov/dhdsp/library/fs_bloodpressure.htm).

Like the U.S. Preventive Services Task Force, the Joint National Committee on

Prevention, Detection, Evaluation, and Treatment of High Blood Pressure

recommends that clinicians screen all adults aged 18 years and older for

hypertension.1

EVIDENCE-STATEMENT:

HYPERTENSION (Screening, Counseling, and Treatment)
324

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

Joint National

Committee on

Prevention,

Detection, Evaluation,

and Treatment of

High Blood Pressure

(JNC-7)

Evidence Rating:

National High Blood

Pressure Education

Program Working

Group on Children

and Adolescents

Evidence Rating:

Information Sources

Guidance for the prevention and management of hypertension is provided in the

Seventh Report of the Joint National Committee on Prevention, Detection,

Evaluation, and Treatment of High Blood Pressure.1 In this report, the

Committee recommends that clinicians incorporate its recommendations into the

management plans of their patient groups by (1) ensuring that screening and

detection of hypertension is provided in the medical practice and community; (2)

evaluating all patients with hypertension for accompanying risk factors and target

organ damage; (3) promoting lifestyle management to prevent hypertension; (4)

setting a target blood pressure for each patient with hypertension and monitoring

progress toward that goal; (5) recognizing that a blood pressure goal of less than

130/85 mm Hg is appropriate for many patients; (6) monitoring special diseases

and conditions, such as diabetes, congestive heart failure, and renal dysfunction;

(7) considering combination therapy for patients with hypertension; (8)

maximizing staff efforts to enhance patient adherence to hypertension therapy;

and (9) encouraging patient, family, and community activities to promote

healthy lifestyles and blood pressure control. In addition, clinicians should

encourage persons with pre-hypertension, defined as systolic pressure of 120–139

or diastolic pressure of 80–89 mm Hg, to adopt lifestyle modifications to prevent

the development of hypertension.1

The Seventh Report of the Joint National Committee on Prevention, Detection,

Evaluation, and Treatment of High Blood Pressure is based on peer-reviewed

scientific literature, including observational studies and clinical trials (from

January 1997 through April 2003), and on expert opinions from 33 national

hypertension leaders.1

The authors of the Fourth Report from the National High Blood Pressure

Education Program Working Group on Children and Adolescents recommend

that children older than 3 years have their blood pressure measured at least once

during every healthcare visit.8 Although the U.S. Preventive Services Task Force

did not find evidence to support screening children, many professional

organizations such as the American Academy of Pediatrics, the American Heart

Association, and the American Medical Association (AMA) recommend that

children aged 3 years and older who are seen in medical care settings should have

their blood pressure measured at least once during every healthcare episode.9

Not Specified

The recommendations and supporting information in this document came from

several sources, including the:

• American Academy of Family Physicians (AAFP)

• American Academy of Pediatrics (AAP)

• American Dietetic Association

• American Heart Association 

• American Medical Association (AMA)

• Centers for Disease Control and Prevention (CDC)
325

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

Explanation of

Condition

• Joint National Committee on Prevention, Detection, Evaluation, and

Treatment of High Blood Pressure

• National Heart, Lung, and Blood Institute (NHLBI)

• Peer-reviewed research 

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information in this document is based on a

compilation of research findings. All information presented in this document

should be attributed to its referenced sources and should not be considered a

reflection of the opinions of other organizations cited in the text. 

Condition/Disease-Specific Information

Blood pressure is often expressed as two numbers — the top (systolic) number

represents the pressure while the heart is beating, while the bottom (diastolic)

number represents the pressure when the heart is resting between beats. Normal

blood pressure is a systolic blood pressure less than 120 mm Hg and a diastolic

blood pressure less than 80 mm Hg.

A person is considered to have high blood pressure (also called hypertension)

when he or she has a systolic pressure of 140 mm Hg or above, a diastolic blood

pressure of 90 mm Hg or above, or both.3 Once hypertension occurs, it generally

remains a life-long, chronic condition. A person who is being treated for high

blood pressure, even though repeated blood pressure readings are recorded in the

normal range, still has high blood pressure.3 If treatment stops, the hypertension

will almost invariably recur.

Pre-hypertension is defined as systolic pressure of 120–139 mm Hg or diastolic

pressure of 80–89 mm Hg.3 Persons with pre-hypertension are at increased risk of

progressing to hypertension. About 28% of American adults aged 18 and older

have pre-hypertension.3

Information on the classification and management of blood pressure for adults

aged 18 years and older is provided in Table 1. The table lists lifestyle

modification and drug therapy recommendations for adults by risk category. 
326

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

Table 1: Classification and Management of Blood Pressure for Adults 

Aged 18 Years and Older 

Note: Initial treatment should be determined by the patient’s highest blood pressure category

(e.g., a patient with a systolic blood pressure of 110 mm Hg and a diastolic blood pressure of

90 mm Hg should be treated for stage 1 hypertension).

Source: Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation,

and Treatment of High Blood Pressure. JAMA 2003;289:2560-72.

Blood Pressure

Classification

Lifestyle

Modifications

(e.g., Increasing

Physical Activity,

Reducing

Dietary Salt

Intake)

Recommended

Drug Therapy

for Patients

Without a

Compelling

Indication

Recommended Drug Therapy

for Patients With Compelling

Indications (Heart Failure,

Post-Myocardial Infarction,

High Coronary Disease Risk,

Diabetes, Chronic Kidney

Disease, Recurrent Stroke)

Normal:

systolic blood pressure

<120 mm Hg and

diastolic pressure 

<80 mg Hg

Encourage

Pre-hypertension:

systolic blood pressure

120–139 mm Hg or

diastolic pressure

80–89 mm Hg

Yes No antihypertensive

drug indicated

Drug(s) should be given for

the compelling indications.

Patients with chronic kidney

disease or diabetes should be

treated with antihypertensive

drugs to achieve a blood

pressure of less than 

130/80 mm Hg.

Stage 1

hypertension: systolic

blood pressure 140–159

mm Hg or diastolic

pressure 90–99 mm Hg

Yes Thiazide-type diuretics are

appropriate for most

patients with stage 1

hypertension. Clinicians

may consider angiotensinconverting enzyme

inhibitors, angiotensinreceptor blockers, -

blockers, calcium channel

blockers, or a combination

of these drugs.

Drug(s) should be given for

the compelling indications.

Other antihypertensive drugs

(diuretics, angiotensinconverting enzyme

inhibitors, angiotensinreceptor blockers, -

blockers, calcium or channel

blockers) should be given as

needed.

Stage 2

hypertension: systolic

blood pressure 160 mm

Hg or higher, or

diastolic pressure 

100 mm Hg or higher

Yes Two-drug combinations

(usually thiazide-type

diuretics and angiotensinconverting enzyme

inhibitors, angiotensinreceptor blockers, or -

blockers) are

recommended for most

patients with stage 2

hypertension. Initial

combined therapy should

be used cautiously in

those at risk of

orthostatic hypotension.

Drug(s) should be given for

the compelling indications.

Other antihypertensive

drugs (diuretics,

angiotensin-converting

enzyme inhibitors,

angiotensin-receptor

blockers, -blockers,

calcium or channel blockers)

should be given as needed.
327

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Nearly 1 in 3, or 65 million, adults in the United States has high blood pressure.2

High blood pressure affects about 2 in 5 African-Americans, 1 in 5 Hispanics and

Native Americans, and 1 in 6 Asians.3 High blood pressure was the primary or a

contributing cause of death for 277,000 people in the United States in 2002.3

Hypertension is the most common ambulatory care primary diagnosis in the

United States and is responsible for 35 million office visits each year.1 Although

hypertension is the most common chronic medical condition to be treated in

primary care settings, only about 34% of people with hypertension have their

blood pressure controlled to a level of less than 140/90 mm Hg, and another

30% are unaware of their condition.1 As a result, about two-thirds of Americans

with hypertension are at increased risk of heart disease and stroke, which are both

leading causes of death in the United States. They also have an increased risk of

developing peripheral artery disease, end-stage renal disease, retinopathy, and

aortic aneurysm.3

Risk factors for hypertension include increased age, smoking, heavy alcohol use,

family history, obesity, physical inactivity, and moderate salt intake.1,3 The

prevalence of hypertension in African-Americans in the United States, in people

with low levels of education or low socioeconomic status, and in those who live

in the southeastern United States is among the highest in the world.3 The rate of

fatal strokes is 1.8 times higher in blacks than whites, while their rates of death

from heart disease are 1.5 times higher and of kidney disease are 4.2 times

greater. These disparities are caused, in part, by their higher prevalence of

hypertension.10

Value of Prevention

The costs associated with hypertension accounted for $63.5 billion of the total

costs associated with cardiovascular diseases in 2006.3 This figure includes $47.5

billion in direct medical expenses and $16 billion in lost productivity.3 When the

costs of other conditions and diagnoses attributable to hypertension were

included, the direct healthcare expenses associated with hypertension were

$108.8 billion in 1998.11

Hypertension is one of the 10 most expensive health conditions for U.S.

employers. Its complications are a major cause of preventable absenteeism,

reduced productivity, and disability.4

A recent study found that the overall economic burden of illness to employers

was higher for hypertension than for nine other conditions — $392 per eligible

employee per year (based on average impairment and prevalence estimates using

2001 average hourly wages and benefits). On-the-job productivity losses

(employees with uncontrolled hypertension who were less productive at work

than healthy employees) accounted for 63% of this total.12

Screening, detection, and early treatment can significantly reduce the medical

care costs associated with hypertension and the other diseases for which people

with hypertension are at increased risk. Estimates of full economic benefits
should also take into account productivity gains due to better on-the-job

performance and added years of life, as well as to declines in disability,

absenteeism, and employee turnover.

A meta-analysis of four trials involving more than 20,000 patients with hypertension

showed that reducing their blood pressure led to a 15% reduction in major

cardiovascular events, a 20% reduction in strokes, and a 10% reduction in coronary

heart disease events.4 According to another study, reducing blood pressure from less

than 140/90 mm Hg to less than 130/85 mm Hg in high-risk individuals would

increase life expectancy by 16.5–17.4 years and decrease total lifetime medical costs

by $1,450.13 A third study found that total life expectancy was about 5 years longer

for adults with normal blood pressure than those with hypertension.14

These studies suggest that reducing blood pressure in patients with hypertension

saves money and extends life expectancy. They also suggest that the medical,

economic, and human costs of untreated and inadequately controlled high blood

pressure are enormous.13,15-16

The cost of screening for blood pressure in a clinician’s office as part of a routine

physical examination is minimal. 

Lifestyle counseling to promote a healthy diet and physical activity is usually the

first step in preventing or treating hypertension and remains important

throughout all stages of treatment. The cost for these services varies.1 In 2004,

the private-sector cost of preventive medicine counseling averaged $39;

approximately 95% of all paid claims fell within the range of $0 to $129.17

If lifestyle changes do not achieve blood pressure control, antihypertensive

medications are typically used. Many types of antihypertensive medications are

currently available. The Seventh Report of the Joint National Committee on

Prevention, Detection, Evaluation, and Treatment of High Blood Pressure states that

thiazide diuretics are among the most effective drugs for hypertension, are available

in generic form, and are also among the least expensive.1,16 The JNC-7 further

states that more than one antihypertensive medication may be needed in order to

achieve hypertension control, the combination of which should be based on the

physician’s treatment decisions in order to achieve the most optimal results.

The cost of follow-up or treatment-related appointments varies by type of

provider, location, and practice setting.

Disease management programs and centralized blood pressure control clinics

have been judged to be useful to encourage compliance with treatment and to

meet treatment goals. The costs of these services also vary considerably.

328

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Counseling and

Treatment
329

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

Controlling blood pressure with medications is one of the most cost-effective

methods of reducing premature cardiovascular morbidity and mortality.1,5 This is

particularly true for older men and women and those with high pretreatment

blood pressure levels.13,18 The ALLHAT Study concluded that thiazide-type

diuretics are at least as effective as newer drugs in preventing one or more forms

of cardiovascular disease and are less expensive.19

Preventive Intervention Information

Screening for hypertension allows clinicians to identify affected patients and

begin treatment early in the disease course to prevent the serious consequences of

high blood pressure, including stroke, coronary artery disease, heart attack, and

heart and kidney failure.1

High blood pressure is easily detectable and can be controlled by lifestyle

modifications, such as increasing physical activity or reducing dietary salt intake,

and a variety of medications. 

The benefits of screening and detecting high blood pressure are substantial.

Screening identifies patients with hypertension and allows them to begin

treatment for their condition early in the course of the disease. 

Some studies have suggested that screening for hypertension and labeling

individuals as having hypertension could result in adverse psychological effects

and transient increases in absenteeism.20 However, these studies had inconsistent

results and the causes of absenteeism related to screening and diagnosis were not

well established.20 The risk of false-positive classification can be reduced by

multiple measurements.1

The benefit-to-harm ratio of treating hypertension overwhelmingly argues for

treatment. A 12 to 13-point reduction in blood pressure can reduce the number

of heart attacks by 21%, strokes by 37%, and all deaths from cardiovascular

disease by 25%.1 In clinical trials, antihypertensive therapy has been associated

with a 35% to 40% mean reduction in stroke incidence, a 20% to 25%

reduction in myocardial infarction incidence, and a decrease of more than 50%

in heart failure incidence.1,21-22 Providing antihypertensive medications to adults

with severe hypertension reduces their odds of developing congestive heart failure

by 86% and active treatment of isolated systolic hypertension in elderly patients

reduces the incidence of both stroke and coronary heart disease events by 30%,

coronary vascular disease by 18%, and total mortality by 13%.9,23

The side effects of antihypertensive medications (such as dizziness,

lightheadedness, or fainting) can interfere with patient adherence, but side effects

can usually be minimized by patient education and by modifying medications or

their dosages. Serious side effects (such as fever or chills, joint or stomach pain)

are rare and can be reduced or eliminated by switching medications or reducing

drug dosage.20 Clinicians should also discuss with their patients the benefits of

adopting a healthy lifestyle (such as increasing physical activity and reducing

dietary salt intake) to prevent and treat high blood pressure.1

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

and Treatment

Benefits and Risks of

Intervention, Risk

Reduction, and

Treatment
Blood pressure screening should be conducted routinely among all patients aged

18 or older, or as deemed necessary by a physician. Children older than 3 years

who are seen in medical care settings should have their blood pressure measured

at least once during every health care epidsode.8-9 Evidence is insufficient to

determine the optimal interval for screening. Expert opinion captured in the

Seventh Report of the Joint National Committee on Prevention, Detection,

Evaluation, and Treatment of High Blood Pressure indicates that people with a

systolic blood pressure of under 130 mm Hg and a diastolic blood pressure of

under 85 mm Hg should be screened every 2 years, while people with elevated

blood pressure (130/85 mm Hg or above) should be screened more frequently.1

All patients with diagnosed hypertension should be counseled and encouraged to

make therapeutic lifestyle changes in order to lower their blood pressure. Many

patients will also require antihypertensive drug therapy. Once this is initiated,

most patients should return for follow-up and adjustment of medications at

monthly intervals or less until the blood pressure goal is reached. More frequent

visits are necessary for patients with stage 2 hypertension or with complicating

comorbid conditions. Comorbidities such as heart failure, diabetes, and the need

for laboratory tests influence the frequency of visits. Other cardiovascular risk

factors should be monitored and treated to their respective goals. After blood

pressure is at goal and stable, follow-up visits can usually be at 3- to 6-month

intervals, or more often if necessary.1

Blood pressure screening is usually conducted in a clinician’s office using an arm

cuff and a calibrated sphygmomanometer (blood pressure meter). Ambulatory

blood pressure measurement techniques, conducted outside of the clinical setting,

can be particularly helpful in identifying patients who have elevated blood

pressures only in the clinic environment, known as “white-coat hypertension.”24

However, due to its high costs, ambulatory blood pressure monitoring is rarely

used to screen for high blood pressure.24 Due to natural variability in blood

pressure in humans and the possibility of equipment or observer error, the U.S.

Preventive Services Task Force recommends that a diagnosis of high blood

pressure be made only after two or more elevated readings are obtained on two or

more occasions over a period of several weeks.9

Beginning at the initial visit with a patient who has hypertension, the clinician

should counsel and encourage the patient to make therapeutic lifestyle changes

— such as dietary changes, increased physical activity, tobacco avoidance, and

weight control — and monitor the patient’s progress. Therapy begins with

lifestyle modification. If the blood pressure goal is not achieved thiazide-type

diuretics should be used as initial therapy for most patients, either alone or in

combination with one of the other class of medications that have also been

shown in clinical trials to reduce one or more hypertensive complications.1

Persons who are diagnosed with hypertension should start a treatment plan to

lower their blood pressure. Treatment plans usually include non-pharmacological

therapies, pharmacological therapies, or a combination of the two.1

330

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

Initiation, Cessation,

and Interval 

Screening

Counseling and

Treatment

Intervention Process

Screening

Counseling and

Treatment
Lifestyle Interventions (Initial Treatment/“First-Line” Therapy): Healthy

lifestyles are critical in preventing and managing hypertension.1 Lifestyle

interventions decrease blood pressure, enhance antihypertensive drug efficacy,

and decrease cardiovascular risk. The major lifestyle modifications that have been

shown to reduce blood pressure are listed in Table 2. They include weight

reduction in obese or overweight individuals,5 programs to assure adequate

physical activity, and adoption of the “Dietary Approaches to Stop Hypertension

Eating Plan,” which calls for reduced consumption of saturated fat, cholesterol,

and total fat and increased consumption of potassium and calcium,25 reduced

intake of dietary sodium,26 increased physical activity,27 and moderation of

alcohol consumption.28 The Plan has been clinically proven to enhance blood

pressure reduction.1 Information about the “Dietary Approaches to Stop

Hypertension Eating Plan” is available online (www.nhlbi.nih.gov/health/

public/heart/hbp/dash/).

• Lifestyle modification is encouraged for those with a systolic blood

pressure greater than 120 mm Hg or a diastolic blood pressure greater

than 80 mm Hg.

• People with multiple coronary heart disease risk factors that place them at

high risk for coronary heart disease (10-year cardiovascular event risk of

10% to 20%) should be encouraged to change their lifestyles to achieve

their blood pressure goals. If lifestyle changes are unsuccessful, drug

therapy should be considered. 

• People with coronary heart disease (10-year cardiovascular event risk

greater than 20%) need to reduce their blood pressure to the target level

and should consider drug therapy in addition to lifestyle interventions if

their systolic blood pressure exceeds 140 mm Hg or their diastolic blood

pressure is higher than 90 mm Hg.

A risk assessment tool is available online

(http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof).

331

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)
Table 2: Lifestyle Modifications to Prevent and Manage Hypertension*

332

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

Weight reduction

Adopt Dietary

Approaches to Stop

Hypertension eating plan

Dietary sodium

reduction

Physical activity

Moderation of alcohol

consumption

Maintain normal body weight (body-mass

index of 18.5 to 24.9)

Consume a diet is rich in fruits, vegetables,

and low-fat dairy products, with little

saturated and total fat

Reduce dietary sodium intake to no more than

2.4 grams of sodium or 6 grams of sodium

chloride. (6 grams of sodium equals about 1

teaspoon of table salt (sodium chloride)

Engage in regular aerobic physical activity,

such as brisk walking, at least 30 minutes

per day on most days of the week

Limit consumption to no more than two

drinks per day (1 ounce or 30 ml ethanol

[e.g., 24 ounces of beer, 10 ounces of wine, or

3 ounces of 80-proof whiskey]) for most men

and no more than one drink per day for

women and lighter-weight persons.

5–20 mm Hg per 10-kg

weight loss

8–14 mm Hg

2–8 mm Hg

4–9 mm Hg

2–4 mm Hg

Modification Approximate Systolic Blood Recommendation

Pressure Reduction Range

*Note: For overall cardiovascular risk reduction, individuals should stop smoking. The effects of

implementing these modifications depend on dose and duration.

Source: Dietary Approaches to Stop Hypertension. JAMA 2003;289:2560-72.

Pharmacologic Treatment: Lifestyle interventions may not be sufficient to

reduce blood pressure in many patients. In those cases, the addition of

pharmacological therapy to a treatment plan is often beneficial. In fact, most

people with hypertension require two or more antihypertensive medications to

achieve their target blood pressure.29-30 Clinical trial outcome data indicate that

several classes of drugs — including angiotensin-converting enzyme inhibitors,

angiotensin-receptor blockers, -blockers, calcium channel blockers, and

thiazide-type diuretics — can reduce the complications of hypertension. A

detailed list of antihypertensive drugs and recommended dose ranges is provided

in Table 6 of the Seventh Report of the Joint National Committee on

Prevention, Detection, Evaluation, and Treatment of High Blood Pressure

Express (www.nhlbi.nih.gov/guidelines/hypertension/jncintro.htm). The Joint

National Committee on Prevention, Detection, Evaluation, and Treatment of

High Blood Pressure recommends that patients with pre-hypertension or stage 1

hypertension return for follow-up and adjustment of medications approximately

once a month until they reach their blood pressure goal. More frequent visits are

necessary for patients with stage 2 hypertension (160/90 mm Hg or higher) or

who have complicating comorbid conditions.
333

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

Other Important Information

The most effective therapy prescribed by clinicians will control hypertension only if

the patient takes the prescribed medication as instructed and establishes and

maintains a health-promoting lifestyle. Electronic and paper clinician decision

support systems, flow sheets, feedback reminders, and involvement of nurse

clinicians and pharmacists are important program components aimed at controlling

hypertension.31 Furthermore, cost-effective healthcare interventions to prevent and

control hypertension can only be implemented if the capacity of primary health

care system, policy environment, and financing enable delivery of services.32

For more information on medication adherence, please refer to Part VI of the

Purchaser’s Guide, “Leveraging Benefits: Promoting the Delivery and Use of

Preventive Services.”

For more information on healthy diets, refer to the National Heart, Lung, and

Blood Institute (NHLBI) tipsheets which are available online (www.nhlbi.nih.

gov/chd/Tipsheets/daily.htm).

Strength of Evidence for the Clinical Preventive Service

The levels of evidence supporting the recommendations in this chapter is

described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The USPSTF found good evidence to support the routine screening of all

adults, aged 18 and above, for hypertension.6

Recommended Guidance:

Seventh report of Joint National Committee on Prevention, Detection,

Evaluation, and Treatment of High Blood Pressure 

Strength of Evidence: The Seventh Report of the Joint National Committee on

Prevention, Detection, Evaluation, and Treatment of High Blood Pressure is

based on peer-reviewed scientific literature on observational studies and clinical

trials (conducted in January 1997 through April 2003) and on expert opinion

from 33 national hypertension leaders.

Screening

• The Joint National Committee on Prevention, Detection, Evaluation, and

Treatment of High Blood Pressure recommends that all adults aged 18 and

above be routinely screened for hypertension.1

Treatment

• The Joint National Committee on Prevention, Detection, Evaluation, and

Treatment of High Blood Pressure recommends that clinicians provide primary
and secondary prevention services to reduce elevated blood pressure, including

lifestyle consultations and medications.1

National High Blood Pressure Education Program Working Group on Children

and Adolescents 

Strength of Evidence: Not Specified

Screening

• The National High Blood Pressure Education Program Working Group found

evidence to support routine screening for hypertension in children aged 3 and

older and adolescents during routine preventive care visits and at every

episodic healthcare visit in medical care settings.8

This recommendation of the National High Blood Pressure Education Program

Working Group is supported by the:

• American Academy of Pediatrics (AAP)

• American Heart Association (AHA)

• American Medical Association (AMA)

334

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

Authored by: 

Matson Koffman D, Chattopadhyay S. Hypertension evidence-statement: screening and treatment.

In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s 

Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National 

Business Group on Health; 2006.

References:

1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, et al. Seventh report of the Joint National

Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003;42:1206-52.

Available from: http://www.nhlbi.nih.gov/guidelines/hypertension/jncintro.htm.

2. Fields LE, Burt VL, Cutler JA, Hughes J, Roccella EJ, Sorlie P. The burden of adult hypertension in the United States 1999

to 2000: a rising tide. Hypertension 2004;44:398-404.

3. American Heart Association. Heart disease and stroke statistics—2006 update. At-a-glance. Dallas (TX): American Heart

Association; 2006. Available from: http://www.americanheart.org/downloadable/heart/1140534985281Statsupdate06book.pdf.

4. Goetzel RZ, Hawkins K, Ozminkowski RJ, Wang S. Top 10 physical conditions and related medical costs to employers. 

J Occup Environ Med 2003;45:5-14.

5. He J, Whelton PK, Appel LJ, Charleston J, Klag MJ. Long-term effects of weight loss and dietary sodium reduction on

incidence of hypertension. Hypertension 2000;35:544-9.

6. U.S. Preventive Services Task Force. High blood pressure screening. Summary of recommendations/supporting documents.

Clinical Guide to Preventive Services. 2nd Ed. Rockville (MD): Agency for Health Care Research and Quality; 2003.
335

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

7. Centers for Disease Control and Prevention. Division for Heart Disease and Stroke Prevention. Available from:

http://www.cdc.gov/dhdsp. 

8. National High Blood Pressure in Education Program Working Group on High Blood Pressure in Children and Adolescents.

The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics

2004;114:555-576. Available from: http://pediatrics.aappublications.org/cgi/content/extract/114/2/S2/555?maxtoshow. 

9. Berg AO, Atkins D. Screening for high blood pressure: recommendation and rationale. Am J Prev Med 2003;25:159-64. 

10. White JV. Hypertension: nutrition management for older adults. Leawood (KS): The American Dietetic Association; 2002.

11. Hodgson TA, Cai L. Medical care expenditures for hypertension, its complications, and its comorbidities. Med Care

2001;39:599-615.

12. Elliott WJ, Weir DR, Black HR. Cost-effectiveness of the lower treatment goal (of JNC VI) for diabetic hypertensive

patients. Arch Intern Med 2000;160:1277-83.

13. Franco OH, Peeters A, Bonneux L, de Laet C. Blood pressure in adulthood and life expectancy with cardiovascular disease in

men and women: Life course analysis. Hypertension 2005;46:280.

14. Elliott WJ, Maddy R, Toto R, Bakris G. Hypertension in patients with diabetes. Overcoming barriers to effective control.

Postgrad Med 2000;107:29-21, 35-36, 38.

15. Esposti LD, Valpiani G. Pharmaeconomic burden of undertreating hypertension. Pharmaeconomics 2004;22:907-28.

16. Fischer MA, Avorn J. Economic implications of evidence-based prescribing for hypertension: can better care cost less? JAMA

2004;291:1850-6.

17. Thomson Medstat. Marketscan. 2004.

18. Johannesson M, Jonsson B. A review of cost-effectiveness analyses of hypertension treatment. Pharmacoeconomics

1992;1:250-64.

19. The ALLHAT Study Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting

enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent

Heart Attack Trial (ALLHAT). JAMA 2002; 288:2981-2997.

20. Screening for high blood pressure: Recommendations and rationale of the U.S. Preventive Services Task Force. Rockville

(MD): Agency for Healthcare Research and Quality; 2003. Available from:

http://www.ahrq.gov/clinic/3rduspstf/highbloodsc/hibloodrr.htm. 

21. Neil B, MacMahon S, Chapman N. Effects of ACE inhibitors, calcium antagonists, and other blood-pressure-lowering

drugs: results of prospectively designed overview of randomised trials. Lancet 2000;356:1955-64.

22. Gueyffier F, Froment A, Gouton M. New meta-analysis of treatment trials of hypertension: improving the estimate of

therapeutic benefit. J Hum Hypertens 1996;10:1-8.

23. Staessen JA, Gasowski J, Wang JG, Thijs L, Den Hond E, Boissel JP, et al. Risks of untreated and treated isolated systolic

hypertension in the elderly: meta-analysis of outcome trials. Lancet 2000;355:865-72.

24. Sheridan S, Pignone M, Donahue K. Screening for high blood pressure: a review of the evidence of the U.S. Preventive

Services Task Force. Am J Prev Med 2003;25:151-8.

25. Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, et al. Effects on blood pressure of reduced dietary

sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. N Engl J Med 2001;344:3-10.

26. Vollmer WM, Sacks FM, Ard J, Appel LJ, Bray GA, Simons-Morton DG, et al. Effects of diet and sodium intake on blood

pressure. Ann Intern Med 2001;135:1019-28

27. Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood pressure. Ann Intern Med 2002;136:838-43.

28. Xin X, He J, Frontini MG, Ogden LG, Motsamai OI, Whelton PK. Effects of alcohol reduction on blood pressure.

Hypertension 2001;38:1112-7. 

29. Cushman WC, Ford CE, Cutler JA, Margolis KL, Davis BR, Grimm RH, et al. Success and predictors of blood pressure

control in diverse North American settings: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial

(ALLHAT). J Clin Hypertens 2002;4:393-404. 
336

EVIDENCE-STATEMENT: Hypertension (Screening, Counseling and Treatment)

30. Black HR, Elliott WJ, Neaton JD, Grandits G, Grambsch P, Grimm RH Jr, et al. Baseline characteristics and elderly blood

pressure control in the CONVINCE trial. Hypertension 2001;37:12-8. 

31. Balas EA, Weingarten S, Garb CT, Blumenthal D, Boren SA, Brown GD. Improving preventive care by prompting

physicians. Arch Intern Med 2000;160:301-8.

32. Mendis S. Challenges for the management of hypertension in low-resource settings. Ethn Dis 2003;13(2 Suppl):s67-70.
337

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Advisory Committee

on Immunization

Practices (ACIP)

and CDC

Recommendation 

Evidence Rating:

• Prevention of vaccine-preventable diseases is one of 10 great public health

achievements of the 20th century.1

• Approximately 11,000 babies born each day in the United States will need

vaccination against fourteen diseases before age two.

• An average of 36,000 deaths and over 200,000 hospitalizations associated with

influenza occur each year in the United States, the majority among adults aged

65 years and older.2 Influenza vaccination of healthy working adults younger

than 65 years can reduce the rates of influenza-like illness, lost workdays, and

physician visits.3

• Vaccines are cost-effective, and most child and adolescent vaccines are costsaving. The routine childhood vaccination program saves nearly $10 billion in

direct medical costs and $43 billion in societal costs for every birth cohort (all

children born in one year).4

• Among adults, influenza in particular results in extensive direct and indirect

costs. The overall national economic burden of influenza-attributable illness for

adults 18 to 64 years old is $10.2 billion. Each year, 17 million workdays are

lost to influenza-related illness at a cost of $5.6 billion.5

• Approximately 24% of toddlers may be vulnerable to serious illnesses,

including polio, measles, mumps, rubella, diphtheria, tetanus, pertussis,

invasive Haemophilus influenzae type b infection, hepatitis B, and varicella

because they have not completed the recommended vaccination series.6

Clinical Preventive Service Recommendations

Not Applicable — The U.S. Preventive Services Task Force (USPSTF) defers to

the Advisory Committee on Immunization Practices (ACIP) and the Centers for

Disease Control and Prevention (CDC) on recommendations for immunizations.

ACIP and CDC recommend that all children and adolescents with no

contraindications receive all routinely recommended childhood vaccinations.

Children and adolescents who fall into high-risk groups because of health

conditions, behaviors, or membership in certain communities should receive

additional vaccines.

ACIP and CDC recommend that all adults with no contraindications receive

three routinely recommended vaccines (age-dependent). Adults who fall into

high-risk groups because of health conditions, behaviors or exposures, as well as

those without a history of immunization for certain diseases, should receive

additional vaccines.

Please refer to Appendix 1 for specific information on child, adolescent, and

adult immunizations and schedules for their administration. Please note these

schedules are abbreviated and may not reflect the most current ACIP

recommendations. Current ACIP recommendations are provided on the ACIP

website (www.cdc.gov/nip/publications/acip-list.htm).

Expert Consensus

EVIDENCE-STATEMENT:

CHILD, ADOLESCENT, ADULT 

IMMUNIZATIONS (Immunizations)
338

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)

Information Sources

Epidemiology of

Condition/Disease

The recommendations and supporting information contained in this chapter

came from several sources, including the:

• Advisory Committee on Immunization Practices (ACIP)

• American Academy of Family Physicians (AAFP)

• American Academy of Pediatrics (AAP)

• American College of Obstetricians and Gynecologists (ACOG)

• Centers for Disease Control and Prevention (CDC)

• Partnership for Prevention

• Peer-reviewed research

The background and supporting information contained in this chapter is a

compilation of research findings. All information presented in this chapter should

be attributed to its referenced source and should not be considered a reflection of

other organizations cited in the text. 

Condition/Disease Specific Information

Prevention of vaccine-preventable diseases is one of 10 great public health

achievements of the 20th century.1 In 2006, Partnership for Prevention evaluated

25 clinical preventive services based on the clinical burden that could be prevented

by the intervention and the cost-effectiveness of the intervention. Childhood

immunization was one of three services to receive a perfect score, and adult

influenza and pneumococcal vaccinations were also highly ranked.7 Today, most

vaccine-preventable diseases (VPD) occur at record or near-record low levels.

However, high rates of vaccination must be constantly maintained: countries that

have reduced or discontinued use of certain vaccines have experienced large, costly

outbreaks of VPD as a result of waning vaccination coverage.8

Children

Approximately 11,000 babies born each day in the United States will need

vaccination against fourteen diseases before age two. Approximately 24% of

toddlers may be vulnerable to serious illnesses, including polio, measles, mumps,

rubella, diphtheria, tetanus (lockjaw), pertussis (whooping cough), invasive

Haemophilus influenzae type b infection, hepatitis B, and varicella (chickenpox)

because they have not completed the recommended vaccination series.6

Adolescents

Traditionally, vaccines have been associated with protecting young children, but

recently many vaccines targeted toward adolescents have been recommended. In

2005, the meningococcal conjugate vaccine (MCV4) was recommended for 11 to

12 year-olds at the pre-adolescent visit, and for older adolescents and college

freshman in dormitories, as these groups experience higher rates of

meningococcal disease than the general population.9 Invasive meningococcal

disease has a 10% death rate, and up to 19% of survivors can suffer serious

aftereffects like deafness or loss of limbs.10 Also recommended in June 2005 was a
339

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

new tetanus-diphtheria-acellular pertussis vaccine meant to combat waning

immunity to pertussis in adolescents. It is also important for adolescents to receive

certain “catch-up” immunizations if they were not fully vaccinated in childhood

(please refer to www.cdc.gov/nip/recs/child-schedule.htm#catchup for more

information). In June 2006, a vaccine against the human papillomavirus (HPV),

which causes cervical cancer, was recommended by the ACIP for use among

adolescent girls and young women (ages 9 to 26). Clinical trials including

approximately 20,000 adolescent girls and women showed that among those not

previously infected, the vaccine prevented 100% of pre-cancerous lesions from the

two types of HPV that cause the majority of cervical cancer in the United States.11-12 

Adult

The burden of vaccine-preventable disease in adults in the United States is

substantial. Recent estimates indicate that an average of 36,000 deaths and over

200,000 hospitalizations associated with influenza occur each year in the United

States, the majority among adults aged 65 years and older.2 When combined,

pneumonia and influenza were the fifth leading cause of death in 2002 among all

persons aged 65 years and older (estimate based on national mortality data).13

Among all age groups, influenza and pneumonia were the seventh leading cause

of death in the United States in 2002, accounting for over 65,000 deaths (2.7%

of all deaths).13

Risk factors vary for each vaccine-preventable disease.

Value of Prevention

Childhood vaccine-preventable diseases were once extremely costly. For example, a

large outbreak of rubella in 1964-1965 cost an estimated $840 million.14 Today, the

lifetime cost to treat a single case of congenital rubella syndrome (CRS) is

estimated to exceed $200,000.14 Using published studies and hospital discharge

data, an economic analysis of the DTaP (diphtheria, tetanus, and acellular pertussis)

vaccine showed that in the absence of immunizations, over $23 million dollars

would be spent to treat disease among all the children born in a single year.15

Among adults, influenza in particular results in extensive direct and indirect costs.

The overall national economic burden of influenza-attributable illness for adults is

$10.2 billion.5 Direct medical costs for influenza total $4.6 billion including $3.1

billion for adult hospitalizations resulting from influenza-attributable illness.5

Influenza is also responsible for substantial indirect costs, which mainly result

from lost productivity. Each year, among adults age 18 to 64 years, 17 million

workdays are lost to influenza-related illness at a cost of $5.6 billion.5

Children/Adolescents

Vaccines are cost-effective, and most child and adolescent vaccines are costsaving. The routine childhood vaccination program saves nearly $10 billion in
340

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)

direct medical costs and $43 billion in societal costs for every birth cohort (all

children born in one year).4 This cost-savings estimate includes reduced costs from

lost productivity. The introduction of new vaccines has led to a substantial decline

in medical spending for some conditions. For example, in 1995, a vaccine to

protect against varicella (chickenpox) was added to the childhood schedule. In

1994-1995, the total estimated direct medical cost of varicella hospitalizations and

ambulatory visits was almost $85 million; in 2002, after the vaccine was

introduced, the cost declined to $22.1 million.16

Although not cost-saving, the 2005 recommendation for routine adolescent

meningococcal vaccination is expected to prevent an estimated $18 million in direct

costs and $50 million in lost productivity caused by meningococcal disease.17 

Adults

A randomized controlled trial showed that healthy, working adults who received

influenza shots (in a year when the vaccine was well matched to circulating

influenza viruses) experienced significantly fewer days of influenza-like illness

(ILI), made fewer doctor visits for such illnesses, and took fewer days off from

work due to ILIs, compared with workers who were not vaccinated.3 Furthermore,

among persons aged 65 to 79 years who were members of a Medicare managed

care plan, influenza immunization was estimated to save about $80 per year, per

person vaccinated by preventing hospitalizations from influenza-related illnesses.18

This is consistent with other studies showing economic benefits from vaccinating

persons 65 and older against influenza.

Table 1 details the direct and indirect savings (per dollar spent) of many vaccines

routinely administered to children and adolescents. 

Table 1: Direct and Indirect Savings per Dollar Spent on Select Vaccines

* Indirect savings include prevention of work loss, death, and disability

+ Includes second dose of MMR

# Includes recommended doses of DTaP, Td, Hib, IPV, MMR, HepB, varicella vaccines 

(completed series)

Vaccine Direct Medical

Savings

Direct & Indirect*

Savings

Diphtheria-Tetanus-Pertussis (DTaP) $9.00 $27.00

Measles-Mumps-Rubella+(MMR) $14.20 $26.00

Haemophilus influenzae type b (Hib) $3.40 $5.40

Hepatitis B 

Perinatal $1.40 $14.70

Infant $0.90 $5.10

Adolescent $0.50 $3.80

Varicella $1.20 $4.40

Inactivated Polio Virus (IPV) $3.03 $5.45

All Routine# $5.30 $16.50
341

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)

Estimated Cost of

Immunization

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of

Immunizations

Sources: Ekwueme DU, Strebel PM, Hadler SC, Meltzer MI, Allen JW, Livengood JR. Economic

evaluation of use of diphtheria, tetanus, and acellular pertussis vaccine or diphtheria, tetanus, and

whole-cell pertussis vaccine in the United States, 1997. Arch Pediatr Adolesc Med 2000;154:797-

803. (DTaP); Zhou F, Reef S, Massoudi M, Papania MJ, Yusuf HR, Bardenheier B, et al. An

economic analysis of the current universal 2-dose measles-mumps-rubella vaccination program in

the United States. J Infect Dis 2004; 189(Suppl 1):S131-45. (MMR); Zhou F, Bisgard KM, Yusuf

HR, Deuson RR, Bath SK, Murphy TV. Impact of universal Haemophilus influenzae type b

vaccination starting at 2 months of age in the United States: an economic analysis.Pediatrics

2002; 110(4):653-61. (Hib); Zhou F, Santoli J, Messonnier ML, Yusuf HR, Shefer A, Chu SY, et

al. Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United

States, 2001. Arch Pediatr Adolesc Med 2005; 159:1136-44. (all routine); CDC unpublished

data. (hepatitis B, varicella, IPV)

Based on catalog prices current as of 7/10/2006, the average private-sector cost to

vaccinate a healthy child through adolescence with universally recommended

vaccines is approximately $1,600 to $1,700, depending on the brand of vaccine

given.19

Based on catalog prices current as of 7/10/2006, the average private-sector cost to

vaccinate a healthy adult through age 74 with universally recommended vaccines

is approximately $380 to $480, depending on the brand of vaccine given.20

In 2004, the private-sector cost per vaccination averaged $36 per dose and

ranged from $20 for the oral polio vaccine to $270 for the hepatitis B vaccine for

immunocompromised patients. Vaccine administration averaged $10;

approximately 95% of paid claims fell within the range of $0 to $20.21

Not Provided

Please refer to “Economic Benefit of Preventive Intervention” for information on

the cost-effectiveness of immunizations. 

Preventive Intervention Information

The purpose of immunizing children, adolescents, and adults, is to prevent

vaccine-preventable diseases.

All routinely recommended childhood vaccines have been demonstrated to be

efficacious, and noticeable reductions in rates of disease have occurred following

consistent, widespread use of vaccines.22 In each birth cohort (all children born in

one year), the routine childhood immunization program prevents at least 13.6

million cases and 33,000 deaths from vaccine-preventable diseases.4 Influenza

vaccination of healthy working adults younger than 65 years can reduce the rates

of influenza-like illness, lost workdays and physician visits.3
Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Immunization

Intervention Process

Treatment

Information

342

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)

The benefits of vaccination include partial or complete protection against the

consequences of infection for the vaccinated person, as well as overall benefits to

society as a whole through reduced transmission of disease. Individual benefits

include protection from symptomatic illness, improved quality of life and

productivity (fewer lost workdays), and prevention of death. Societal benefits

include creation and maintenance of herd immunity against communicable

diseases (which protects people who themselves are not able to be immunized),

prevention of disease outbreaks, and reduction in healthcare-related costs.22

No vaccine is 100% effective or completely without risk. The risks of screening

for susceptibility to vaccine-preventable diseases are minimal for both

examination of vaccination history and serologic testing, although false-positive

or false-negative results are possible. Immunization risks range from common,

minor, and local adverse effects to rare, severe, and life-threatening conditions.

Thus, recommendations for immunization practices balance scientific evidence of

benefits for each person and to society against the potential costs and risks of

vaccination programs.22

The potential for significant adverse reactions to immunization can be minimized

by adherence to the recommendations and contraindications for immunizations

stipulated by ACIP. Information on vaccine contraindications is available online

(www.cdc.gov/nip/recs/contraindications_guide.pdf). 

Patients of all ages, beginning at birth and throughout the lifespan, can benefit

from screening and appropriate immunization. Screening for susceptibility to

rubella should occur at the first clinical encounter with any woman of

childbearing age.

All indicated vaccines should be offered at every visit. It is important for persons

of all age groups who have not received all recommended vaccines to receive

“catch-up” vaccinations. 

One or more vaccinations may be deferred when medically contraindicated or

when a parent, guardian, or patient refuses on religious, philosophical, or other

grounds. Providers should document deferrals and exemptions in accordance

with state and local requirements.

Most vaccines are administered via injection. There are several approved vaccine

types and brands. Please refer to the accompanying SPD for more information.

Health benefits should include provisions for treatment services.
343

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)

Other Important Information

For children, CDC’s National Center for Immunization and Respiratory Diseases

(NCIRD) provides an automatic scheduler that uses a child’s birth date to

calculate the appropriate dates of administration for each routinely recommended

childhood vaccination. The scheduler is available online

(www.cdc.gov/nip/scheduler_online_child.htm). 

The NCIRD website provides a self-administered questionnaire for adults to

determine which immunizations they may need. It asks questions about age,

work environment and travel plans, and information about certain health

conditions and risk factors (“Do you have asthma?” “Has your spleen been

damaged or removed?”) that may affect which immunizations are indicated. The

quiz is available online (www2.cdc.gov/nip/adultImmSched/). 

Strength of Evidence for the Clinical Preventive Service 

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Recommended Guidance:

Advisory Committee on Immunization Practices (ACIP) 

Centers for Disease Control and Prevention (CDC)

Strength of Evidence: Expert Consensus

• The ACIP and CDC recommend that all children and adolescents with no

contraindications receive all routinely recommended childhood vaccinations.

Children and adolescents who fall into high-risk groups because of health

conditions, behaviors, or membership in certain communities should receive

additional immunizations.

• The ACIP and CDC recommend that all adults with no contraindications

receive three routinely recommended vaccines (age-dependent). Adults who fall

into high-risk groups because of health conditions, behaviors or exposures, as

well as those without a history of immunization for certain diseases, should

receive additional immunizations.

Authored by: 

Lindley MC, Bhatt A. Child, adolescent, and adult immunizations evidence-statement. In: Campbell KP,

Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical

Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on 

Health; 2006.
344

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)

Appendix 1: Abbreviated Child/Adolescent and Adult Schedules

Note: The Recommended Childhood and Adolescent Immunization Schedule below does not include existing ACIP

recommendations for routine immunization with rotavirus and human papillomavirus vaccines, and for a routine second dose of

varicella vaccine. Current ACIP recommendations may be obtained from: www.cdc.gov/nip/publications/acip-list.htm.
345

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)
346

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)
References:

1. Centers for Disease Control and Prevention. Ten great public health achievements — United States, 1900-1999. MMWR

1999; 48(12); 241-3.

2. Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, et al. Influenza-associated hospitalizations in the

United States. JAMA 2004; 292(11):1333-40. 

3. Bridges CB, Thompson WW, Meltzer MI, Reeve GR, Talamonti WJ, Cox NJ, et al. Effectiveness and cost-benefit of

influenza vaccination of healthy working adults: a randomized controlled trial. JAMA 2000; 284 (13) 1655-63.

4. Zhou F, Santoli J, Messonnier ML, Yusuf HR, Shefer A, Chu SY, et al. Economic evaluation of the 7-vaccine routine

childhood immunization schedule in the United States, 2001. Arch Pediatr Adolesc Med 2005; 159:1136-44. 

5. Molinari NA, Ortega-Sanchez I, Messonnier M, Thompson W, Wortley P, Weintraub E, et al. National expenditures on

influenza: estimating medical and indirect costs. Draft manuscript. 

6. Centers for Disease Control and Prevention. National, state, and urban area vaccination coverage among children aged 19—

35 months — United States, 2004. MMWR 2005; 54(29):717-21.

7. Maciosek MV, Coffield AB, Edwards NM, Flottemesch TJ, Goodman MJ, Solber LI. Priorities among effective clinical

preventive services: results of a systematic review and analysis. Am J Prev Med 2006; 31(1):52-61.

8. Kaper J, Rappuoli R, Buckley M. Vaccine Development: Current Status and Future Needs. Washington, DC: American

Academy of Microbiology. October 2005.

9. Centers for Disease Control and Prevention. Prevention and control of meningococcal disease: recommendations of the

Advisory Committee on Immunization Practices (ACIP). MMWR 2005; 54(No. RR-7):1-21

10. Raghunathan PL, Bernhardt SA, Rosenstein NE. Opportunities for control of meningococcal disease in the United States.

Annu Rev Med 2004; 55:333-53.

11. United States Food and Drug Administration. Package insert for Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18)

Recombinant Vaccine. [Cited 2006 Oct 10]. Available from: http://www.fda.gov/cber/label/HPVmer060806LB.pdf. 

12. Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, et al. Prophylactic quadrivalent human papillomavirus

(types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled

multicentre phase II efficacy trial. Lancet Oncol. 2005; 6:271-8.

13. Anderson RN, Smith BL. Deaths: leading causes for 2002. Centers for Disease Control and Prevention. National Vital

Statistics Reports 2005;53(17).

14. Centers for Disease Control and Prevention. Rubella. In Atkinson W, Hamborsky J, McIntyre L, Wolfe S, eds. Epidemiology

and Prevention of Vaccine-Preventable Diseases, 9th ed. Washington DC: Public Health Foundation; 2006:155-170.

15. Ekwueme DU, Strebel PM, Hadler SC, Meltzer MI, Allen JW, Livengood JR. Economic evaluation of use of diphtheria,

tetanus, and acellular pertussis vaccine or diphtheria, tetanus, and whole-cell pertussis vaccine in the United States, 1997.

Arch Pediatr Adolesc Med 2000;154:797-803.

16. Zhou F, Harpaz R, Jumaan AO, Winston CA, Shefer A. Impact of varicella vaccination on health care utilization. JAMA

2005; 294:797-802.

17. Shepard CW, Ortega-Sanchez IR, Scott RD, Rosenstein NE and the ABCs Team. Cost-effectiveness of conjugate

meningococcal vaccination strategies in the United States. Pediatrics 2005; 115:1220-32.

18. Davis JW, Lee E, Taira DA, Chung RS. Influenza vaccination, hospitalizations, and costs among members of a Medicare

managed care plan. Med Care 2001;39:1273-80.

19. CDC unpublished data. Assumptions: 5 doses of DTaP, 3-4 doses Hib, 4 doses IPV, 2 doses MMR, 2-3 doses HepB, 2 doses

varicella, 4 doses PCV, 1 dose Tdap, 6 doses influenza, 1 dose MCV4, 2 doses HepA, 3 doses rotavirus, 3 doses HPV.

Influenza vaccine given between 6 and 59 months. Vaccine cost per dose for private sector (catalog prices) available from:

http://www.cdc.gov/nip/vfc/cdc_vac_price_list.htm (price calculated on 7/11/2006).

20. CDC unpublished data. Assumptions: 6 doses Td, 24 doses influenza, 1 dose PPV. Adults are persons between 19 and 74

years of age. Estimate does not include vaccines for persons with medical conditions or exposure indications that require

specific vaccinations. Vaccine cost per dose for private sector (catalog prices) available from:

http://www.cdc.gov/nip/vfc/cdc_vac_price_list.htm (price calculated on 7/11/2006).

347

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)
348

21. Thomson Medstat. Marketscan. 2004

22. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory

Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;

51(No. RR-02):1-36.

EVIDENCE-STATEMENT: Child, Adolescent, Adult Immunizations (Immunizations)
349

Why This Chapter is

Important for

Employers:

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/Good

Evidence)

Evidence Rating: B

(Recommended /At

Least Fair Evidence)

• Lipid disorders result from abnormal levels of cholesterol in the blood.

• Cardiovascular disease is caused by atherosclerosis, a thickening or hardening

of the arteries, and is particularly sensitive to lipid (including cholesterol)

levels. Coronary heart disease, a type of cardiovascular disease, can lead to

angina pectoris (heart pain), heart attack, or both.1

• The American Heart Association estimates that more than 70 million women

and men in the United States have some form of cardiovascular disease and

927,000 die of the disease every year. Heart disease and stroke, the major

forms of cardiovascular disease, account for nearly 38% of all reported deaths

nationally in the United States.1

• Several large studies have found that patients who take cholesterol-lowering

drugs for 5 to 7 years can decrease their risk of heart disease by about 30%.2

• The estimated direct and indirect costs of all types of cardiovascular disease in

2006 totaled $403.1 billion; this included the costs associated with coronary

heart disease, which exceed $142 billion.1

• Screening for lipid disorder allows patients and clinicians to begin lipidlowering treatment. Reducing low-density lipoprotein cholesterol levels to a

normal level reduces the risk of coronary heart disease and thereby reduces a

person’s risk of cardiovascular disease events, such as heart attacks and strokes.

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force strongly recommends that clinicians

screen men aged 35 and older and women aged 45 and older for lipid disorders

and that they treat abnormal lipid levels in persons who are at increased risk of

coronary heart disease (based on such factors as age, total or low-density

lipoprotein cholesterol level, high-density lipoprotein cholesterol level, smoking

status, and systolic blood pressure).3

The USPSTF found good evidence that lipid measurement can identify

asymptomatic middle-aged people at increased risk of coronary heart disease and

good evidence that lipid-lowering drug therapy substantially decreases the incidence

of coronary heart disease in such people with abnormal lipids and causes few major

harms. The USPSTF concluded that the benefits of screening for and treating lipid

disorders in middle-aged and older people substantially outweigh harms.3

The USPSTF recommends that clinicians routinely screen younger adults (men

aged 20 to 35 and women aged 20 to 45) for lipid disorders if they have other

risk factors for coronary heart disease.3

The USPSTF found good evidence that lipid measurement can identify younger

people at increased risk for coronary heart disease, that risk is highest in those

with other risk factors, and that the absolute benefits of lipid-lowering treatment

depend on a person’s underlying risk of coronary heart disease. The USPSTF

concluded that benefits of screening for and treating high-risk young adults

outweigh harms.3

EVIDENCE-STATEMENT:

LIPID DISORDERS (Screening, Counseling, and Treatment)
350

EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)

Centers for Disease

Control and

Prevention (CDC)

Guidance

Other

Recommendations 

National Cholesterol

Education Program

Adult Treatment

Panel-III

Evidence Rating:

Note: The National Cholesterol Education Program’s Adult Treatment Expert

Panel-III is the most recent national guideline for lipid screening and treatment.4

Please refer to the “Other Recommendations” section.

The Centers for Disease Control and Prevention (CDC) supports the National

Cholesterol Education Program’s Adult Treatment Expert Panel-III

recommendations. More information is available on the CDC website

(www.cdc.gov/dhdsp/library/fs_cholesterol.htm). 

Since the release of the U.S. Preventive Services Task Force recommendation in

2001, the National Heart, Lung, and Blood Institute’s (NHLBI) National

Cholesterol Education Program (NCEP) has updated its guidelines for lipid

screening and treatment. The NCEP’s Adult Treatment Expert Panel-III

recommends that clinicians routinely screen all adults aged 20 and older for elevated

blood cholesterol levels every 5 years.4 Screening should involve a complete

lipoprotein profile that includes low-density lipoprotein cholesterol levels.4

The Adult Treatment Expert Panel-III also recommends that clinicians counsel all

patients at risk for cardiovascular disease about healthy lifestyles, including

methods for lowering saturated fat intake, losing weight, and increasing exercise

levels. Persons considered at high risk include those with elevated low-density

lipoprotein or diminished high-density lipoprotein cholesterol levels.4

The Adult Treatment Expert Panel-III contains both evidence statements and

recommendations based on those statements. The panel’s recommendations are

based on large randomized controlled clinical trials, prospective epidemiological

studies, and smaller clinical trials. An expert panel assigned each statement to a

category of type of evidence (based on the source of the evidence) and strength of

evidence as follows4:

Category of Type of Evidence:

A Large randomized controlled clinical trials.

B Smaller clinical trials and meta-analyses of clinical trials.

C Observational and metabolic studies.

D Clinical experience.

Strength of Evidence:

1 Very strong evidence.

2 Moderately strong evidence.

3 Strong trend.

The Adult Treatment Expert Panel-III states that the benefits of screening for lipid

disorders outweigh the risks and costs1 for the reasons listed below. The codes for

type of evidence and strength of evidence are provided for each statement.

1. Elevated low-density lipoprotein cholesterol levels increase a person’s risk of

coronary heart disease, coronary artery disease, and other forms of

cardiovascular disease {A1, B1, C1}.
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EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)

Information Sources

Explanation of

Condition

2. Total cholesterol levels in young adults correlate with coronary heart disease

rates in later life {C1}.

3. Screening for lipid disorders can identify persons at increased risk of coronary

heart disease {A1, B1, C1}.

4. Treating abnormal lipids in persons at increased risk of coronary heart disease

can substantially decrease their risk of cardiovascular disease events, such as

heart attacks, and their risk of coronary heart disease mortality {A1, B1}.

The recommendations and supporting information contained in this document

came from several sources, including the:

• Agency for Health Care Research and Quality (AHRQ)

• American Heart Association 

• Centers for Disease Control and Prevention (CDC)

• National Center for Health Statistics (NCHS)

• National Cholesterol Education Program Adult Treatment Expert Panel-III 

• National Heart, Lung, and Blood Institute (NHLBI)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information in this document is based on a

compilation of research findings. All information presented in this document

should be attributed to its referenced sources and should not be considered a

reflection of the opinions of other organizations cited in the text. 

Condition/Disease-Specific Information

Lipid disorders, which result from abnormal levels of cholesterol in the blood,

increase the risk of cardiovascular diseases, including coronary heart disease.

Some amount of cholesterol in the blood is normal and, in fact, necessary.

However, high levels of low-density lipoprotein cholesterol increase the risk 

of — and can even cause — coronary heart disease. In contrast, low levels of

high-density lipoprotein cholesterol are strongly associated with increased risks 

of coronary heart disease and high levels of high-density lipoprotein are

associated with protection. Elevated serum triglycerides are associated with

increased risk of coronary heart disease.4
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EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)

Epidemiology of

Condition/Disease

Table 1: Classification of Low-Density Lipoprotein Cholesterol, High-Density

Lipoprotein Cholesterol, Total Cholesterol, and Triglyceride Levels

Low-Density Lipoprotein (bad) Classification by Association with 

Cholesterol Levels (mg/dL) Cardiovascular Disease Risk

Less than 100 Optimal

100-129 Near or above optimal

130-159 Borderline high

160-189 High

190 and above Very high

High-Density Lipoprotein (good) Classification by Association with 

Cholesterol Levels (mg/dL) Cardiovascular Disease Risk

Less than 40 Low (major risk factor for coronary heart disease)

60 and above High (protective against heart disease)

Total cholesterol levels (mg/dL)

Less than 200 Desirable

200-239 Borderline high

240 and above High

Triglyceride levels (mg/dL)

Less than150 Desirable

150-199 Borderline high

200-499 High

500 and above Very high

Adapted from: National Heart, Lung, and Blood Institute’s Third Report of the National Cholesterol

Education Program (NCEP) on Detection, Evaluation, and Treatment of High Blood Cholesterol in

Adults (Adult Treatment Panel III); May 2001, p. 3.

Reducing low-density lipoprotein cholesterol levels to normal reduces the risk of

coronary heart disease and cardiovascular events such as heart attacks and strokes.

Because low-density lipoprotein cholesterol levels are so strongly correlated with

coronary heart disease and reducing low-density lipoprotein cholesterol has been

shown to reduce coronary heart disease risk, goals and thresholds for low-density

lipoprotein cholesterol have been established.4 Please refer to Table 2 for

information about recommended target low-density lipoprotein cholesterol levels.

Between 1999 and 2002, about 17% of adults aged 20 years and over in the

United States had high cholesterol levels (total cholesterol 240 mg/dL or higher).5

Clinical studies have repeatedly shown a strong and graded relationship between

increasing levels of low-density lipoprotein cholesterol (“bad” cholesterol) and

increasing risk of coronary heart disease events. Low levels of high-density

lipoprotein cholesterol levels are strongly associated with increased risks of

coronary heart disease. Evidence from clinical trials suggests that increasing highdensity lipoprotein cholesterol (“good” cholesterol) levels reduces the risk of

coronary heart disease.1

Elevated lipid levels contribute to the development of cardiovascular diseases,

including coronary heart disease, stroke, and coronary atherosclerosis.6 Coronary

heart disease, which kills more Americans than any other single disease, can lead

to angina pectoris (heart pain), heart attack, or both.1 One American has a heart
353

EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

attack about every 26 seconds, and about 40% will die from the heart attack in

any given year.1 At age 40, a man in the United States has a 49% chance and a

woman has a 32% chance of having a coronary heart disease event (such as a

heart attack) in his or her lifetime.7

About 65 million adults require therapeutic lifestyle changes (such as dietary

changes, increased physical activity, and weight control) to reduce their lowdensity lipoprotein cholesterol levels. Of these people, about 36 million also

require both drug therapy and therapeutic lifestyle changes to reduce their lowdensity lipoprotein cholesterol levels to safe amounts. 

Risk factors that are associated with high cholesterol levels include a family

history of cardiovascular disease (including familial hypercholesterolemia, an

inherited genetic condition), older age, male sex, a diet high in fats, overweight,

and lack of exercise. 

Many of these risk factors including diet, overweight, and lack of exercise are

modifiable4

:

• Diets high in saturated fat increases low-density lipoprotein (low-density

lipoprotein) cholesterol levels more than any other factor in the human

diet. Trans-fatty acids, formed when vegetable oil is hydrogenated to

harden it, also increase cholesterol levels. These fatty acids are found in

such foods as stick margarine, crackers, and French fries. Cholesterol is

found in foods from animal sources, such as egg yolks, meat, and cheese. 

• Being overweight tends to increase low-density lipoprotein levels, decrease

high-density lipoprotein levels, and increase total cholesterol levels.

• Lack of regular exercise can lead to weight gain, which can increase lowdensity lipoprotein cholesterol levels. Poor physical fitness appears to be

associated with cardiovascular disease, even if it has not produced

overweight or obesity.

Value of Prevention

The economic burden of lipid disorders is substantial due to the impact of lipid

levels on the risk of cardiovascular disease and coronary heart disease events. The

direct and indirect costs of all types of cardiovascular disease in 2006 were

estimated to be $403.1 billion, including costs associated with coronary heart

disease (estimated to exceed $142 billion annually).1 The cost of cardiovascular

disease exceeds that of many other high-cost medical conditions. For example, in

2004, the estimated total cost of all cancers was $190 billion and in 1999, the

estimated total cost of HIV infections was $28.9 billion.1

Heart disease and stroke are not only a major cause of premature death in

persons younger than 65 years but are also major causes of serious disability in

the United States.1 The indirect costs of cardiovascular disease, including those

related to lost productivity, are enormous; it is estimated that the indirect cost of

cardiovascular disease will total over $145 billion in 2006.1
Cost-effectiveness analyses show that reducing low-density lipoprotein cholesterol

levels can reduce costs in three ways4:

1)Direct economic savings from decreased hospital and ambulatory services

from angina, myocardial infarction, revascularization procedures, stroke,

and heart failure.

2)Prevention of coronary heart disease mortality, which increases rates of

gainful employment and productivity.

3)Prevention of the disability, distress, and pain associated with coronary

heart disease, which increases quality-adjusted life expectancy as well as

rates of gainful employment and productivity. 

The cost of implementing a lipid screening program varies by location, provider

base, method of screening, which cholesterol measurements are taken, and other

factors. The average cost of a single cholesterol or lipid profile test is relatively

low but the cumulative costs of screening can be substantial, especially if all

recommended screening and follow-up procedures are followed.8 In 2004, the

private-sector cost of cholesterol and lipids screening averaged $13;

approximately 95% of all paid claims fell within the range of $0 to $32.9

Preventive medicine counseling averaged $39 and approximately 95% of all paid

claims fell within the range of $0 to $129.9

The total cost of reducing low-density lipoprotein includes the costs of physician

services, lifestyle counseling, screening, case finding and monitoring, dietary and

exercise modifications, medications, and treatment of side effects. The annual

cost of statin drugs to reduce low-density lipoprotein cholesterol levels can range

from $100 to $1,500 per year.4 The cost of follow-up or treatment-related

appointments varies by type of provider, location, and practice setting. Although

the cost of reducing low-density lipoprotein cholesterol levels can be high, it is

much lower than the direct and indirect costs of cardiovascular disease.

In 2002, the National Cholesterol Education Program (NCEP) panel found that,

based on current retail prices for lipid-lowering drugs, low-density lipoproteinlowering drug therapy is highly cost-effective for persons with established coronary

heart disease (including a prior coronary heart disease event); cost-effective for the

primary prevention of coronary heart disease in persons with a coronary heart

disease risk equivalent (the person does not have coronary heart disease but does

have an absolute 10-year risk of developing major coronary events, such as

myocardial infarction and coronary death, equal to that of persons with coronary

heart disease), and those at high risk for coronary heart disease; and acceptable for

the primary prevention of coronary heart disease in persons whose 10-year risk of

“hard coronary heart disease” (heart attack and death from coronary heart

disease) is between 10% and 20%.4,10

The National Cholesterol Education Program recommends using dietary therapy,

which is more cost-effective than low-density lipoprotein-lowering drugs, as the

first-line therapy in persons with a 10-year risk of coronary heart disease that is

less than 10% per year. (Information about dietary therapy is found in the

Other Important Information section of this document).

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EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Counseling and

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention
355

EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)

Preventive

Intervention: 

Purpose of Screening,

Counseling, and

Treatment

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval 

Screening 

Counseling and

Treatment

Intervention Process

Risk Assessment 

Preventive Intervention Information

Screening for lipid disorders allows patients and clinicians to begin 

lipid-lowering treatment before cardiovascular disease develops or progresses.

Most patients agree to be screened for lipid disorders, even when the screening

involves fasting.7

Clinical trials have shown that reducing low-density lipoprotein levels reduces

coronary heart disease risk, but the benefits of increasing high-density lipoprotein

levels have not yet been fully demonstrated. In short-term clinical trials, a 1%

reduction in low-density lipoprotein cholesterol levels, on average, reduced the

risk of hard coronary heart disease events by about 1%. Persons who take lowdensity lipoprotein cholesterol-lowering drugs for about 5 years reduce their lowdensity lipoprotein levels by approximately 30% and decrease their risk of

cardiovascular disease, including heart attacks, by about 30%.2 However, only

about half of those who would benefit from lipid treatment receive it.11

In persons with established coronary heart disease, low-density lipoproteinlowering therapy reduces risk of stroke by about 30%.7 Statin therapy for the

primary and secondary prevention of cardiovascular disease can reduce adverse

cardiovascular events (including heart attacks and stokes) by 32% among patients

aged 65 and older.12 Primary prevention trials using statins have shown a

significant reduction in coronary heart disease mortality, no increase in noncoronary heart disease mortality, and a strong trend toward lower overall mortality.

All adults aged 20 and older should be screened for abnormal lipid and elevated

blood cholesterol levels every 5 years. Evidence is insufficient to determine the

age at which screening is no longer necessary; therefore decisions regarding when

to stop screening are left to the discretion of the clinician.4

Beginning at the initial visit with a patient who has a high level of cholesterol,

the clinician should counsel and encourage the patient to make therapeutic

lifestyle changes — such as dietary changes, increased physical activity, and

weight control — and monitor the patient’s progress.4,11 The clinician should

evaluate the patient’s low-density lipoprotein cholesterol level at the 6-week, 12-

week, and 4 to 6-month follow-up visits, or more often if necessary.4

Low-density lipoprotein cholesterol levels should be the primary target of

cholesterol-lowering therapy.4 The first step in selecting a low-density lipoproteinlowering therapy is assessing the patient’s coronary heart disease risk status, which

requires measuring low-density lipoprotein cholesterol levels as part of

lipoprotein analysis; identifying risk factors, such as family history; and

determining whether the patient has coronary heart disease, other clinical forms

of atherosclerotic disease, or the major risk factors for coronary heart disease

other than low-density lipoprotein cholesterol.4

Patients are considered to be at high risk of coronary heart disease if they have

coronary heart disease or coronary heart disease risk equivalents (the person does
not have coronary heart disease but does have an absolute 10-year risk of

developing major coronary events, such as myocardial infarction and coronary

death, equal to that of persons with coronary heart disease), including: 

• Other clinical forms of atherosclerotic disease (such as peripheral arterial

disease, abdominal aortic aneurysm, or symptomatic carotid artery disease).

• Diabetes.

• Multiple risk factors that confer a 10-year risk of coronary heart disease of at

least 20%.

Risk status in persons without coronary heart disease or other forms of

atherosclerotic disease is determined by a two-step procedure. 

First, the clinician counts the number of risk factors for coronary heart disease,

including: 

• Cigarette smoking.

• Hypertension (blood pressure of 140/90 mmHg or higher, or the patient is

taking antihypertensive medication).

• Diminished high-density lipoprotein cholesterol level (less than 40 mg/dL).

• Family history of premature coronary heart disease (in male first degree relative

younger than 55 or a female first degree relative younger than 65).

• Age (men aged 45 years or older; women aged 55 years or older).

If the clinician determines that the patient has at least two of these risk factors,

the Framingham scoring is used to determine the patient’s 10-year risk of

coronary heart disease.4 Risk factors used in Framingham scoring include age,

total or low-density lipoprotein cholesterol level, high-density lipoprotein

cholesterol level, smoking status, systolic blood pressure, and whether the

individual is taking antihypertensive therapy. Persons with several of these risk

factors are assigned to one of three categories of 10-year risk of coronary heart

disease: higher than 20%, 10% to 20%, or less than 10%. A person with 

10-year risk that is higher than 20% is categorized as “coronary heart disease 

risk equivalent,” meaning that the person does not have coronary heart disease

but does have an absolute 10-year risk of developing major coronary events, 

such as myocardial infarction and coronary death, equal to that of persons 

with coronary heart disease, or the person has diabetes. Framingham scoring is

the most reliable method available for identifying high-risk persons to 

determine the appropriate low-density lipoprotein level goal and treatment

intensity.4 A Framingham-based risk assessment tool is available online

(http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof).

Lipid measurement should include a comprehensive lipoprotein profile in

addition to assessing other risk factors such as family history, smoking status,

weight, blood pressure, and age. 

The National Cholesterol Education Program (NCEP) recommends a 9 to 12-hour

fasting lipoprotein profile of total cholesterol, low-density lipoprotein, high-density

lipoprotein cholesterol, and triglycerides every 5 years for adults aged 20 and over,

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EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)

Screening
although total cholesterol and high-density lipoprotein cholesterol can be measured

on either fasting or non-fasting samples (venous or capillary blood samples). The

results of the lipoprotein profile should be used to assess coronary heart disease risk

as recommended in the Adult Treatment Expert Panel-III guidance.

Beginning at the initial visit with a patient who has a high level of cholesterol,

the clinician should counsel and encourage the patient to make therapeutic

lifestyle changes — such as dietary changes, increased physical activity, and

weight control — and monitor the patient’s progress.4,11 The clinician should

evaluate the patient’s low-density lipoprotein cholesterol level at the 6-week, 12-

week, and 4 to 6-month follow-up visits, or more often if necessary.4

Target goals for low-density lipoprotein levels and treatment are based on the

person’s 10-year risk of coronary heart disease, as described in the “Risk

Assessment” section. 

The first line of therapy for elevated low-density lipoprotein cholesterol levels is

therapeutic lifestyle changes; drug therapy can be combined with therapeutic

lifestyle changes if additional low-density lipoprotein reduction is required. 

Therapeutic Lifestyle Interventions (Initial Treatment/“First-Line” Therapy):

On the therapeutic lifestyle change diet, saturated fat should account for no more

than 7% of calories, no more than 200 mg of cholesterol should be consumed

per day, and total fat intake may range from 25% to 35% of all calories.4,11

Trans-fat intake should be as low as possible. The person’s diet should also

include 2–3 g/day of plant stanol esters (sitostanol and sitostanol esters, found in

soft margarine), 10–25 g/day of soluble fiber (fruits, vegetables, and whole

grains), and 400 mg/day of folate consumed largely from dietary sources.

Carbohydrates should be limited to 60% of total calories. Therapeutic lifestyle

interventions also include smoking cessation, weight management, regular

physical exercise, and moderation of alcohol intake — no more than two drinks

per day for men and one drink per day for women (one alcoholic drink is

defined as 5 ounces of wine, 12 ounce of beer, or 1.5 ounces of hard liquor). If,

after 3 months, therapeutic lifestyle interventions in a patient who is not at high

risk have not reduced low-density lipoprotein cholesterol levels sufficiently, the

addition of drug therapy to the treatment plan should be considered. In high-risk

patients, drug therapy should be considered together with therapeutic lifestyle

changes at the initiation of treatment if the low-density lipoprotein level is at

least 100 mg/dL. The intensity of risk-reduction therapy should be adjusted to an

individual’s absolute 10-year risk of coronary heart disease, which is based on age,

lipoprotein profile, previous history of coronary heart disease events, and other

risk factors. 

A combination of sustained changes in diet, weight loss, and exercise can lower

low-density lipoprotein cholesterol levels by as much as 20% to 30%.4

If the patient’s target low-density lipoprotein cholesterol level has not been

achieved by the 6-week visit, the clinician should intensify the low-density

lipoprotein-lowering therapy by adding plant stanol/sterol esters and viscous

357

EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)

Counseling and

Treatment
(soluble) fiber to the diet (refer to “Treatment Information and Therapeutic

Lifestyle Interventions” for more information). If the low-density lipoprotein goal

is not achieved by the 12-week follow-up visit, the therapeutic lifestyle changes

should be intensified by increasing the emphasis on physical activity and weight

control. Drug treatment, such as statins, should also be considered. After the 12-

week visit, adherence to therapeutic lifestyle changes and drug treatment should

be monitored every 4 to 6 months, or more often if necessary.4

The recommended first-line therapy for elevated serum triglycerides is

therapeutic lifestyle changes, including reduced intake of fat, avoidance of very

high carbohydrate intake (no more than 60% of calories), increased physical

activity, weight control, and restriction of alcohol intake.

Therapeutic lifestyle changes and drug therapy by risk category are summarized

in Table 2.

Table 2: Target Low-Density Lipoprotein Cholesterol Levels and Treatment

Recommendations

Risk Category Target Low-Density Low-Density Lipoprotein Low-Density Lipoprotein

Lipoprotein Level Levels (mg/dL) at Which Levels (mg/dL) at Which 

(mg/dL) to Initiate Therapeutic to Consider Drug Therapy

Lifestyle Changes 

High Risk: <100 100 100

Coronary heart disease (<70 optional goal for (if lipoprotein levels are

or a 10-year coronary patients with coronary <100, a lipid-lowering 

heart disease risk heart disease) drug is a therapeutic 

equivalent (including option, based on 

diabetes or two or clinical trials)

more risk factors 

and a 10-year risk 

of at least 20%)

Moderately High Risk: <130 130 130 (after 3 months

Two or more risk factors of therapeutic 

(10-year risk 10% lifestyle changes)

to 20%)

Moderate Risk: <130 130 160 (after 3 months

Two or more risk factors of therapeutic

(10-year risk <10%) lifestyle changes)

Lower Risk: <160 160 190 (after 3 months

No risk factors or one of therapeutic lifestyle 

risk factor changes) 

(at 160-189 mg/dL, 

low-density lipoproteinlowering drugs are optional)

Table adapted from: Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake

DB, Implications of recent clinical trials for the National Cholesterol Education Adult Treatment

Panel III (ATP III) guidelines. Circulation 2004; 110:227-39.

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EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)
359

EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)

Other Important Information

Physicians should have primary responsibility for implementing the Adult

Treatment Expert Panel-III treatment guidelines. In addition, a multidisciplinary

team, potentially including nurses, dieticians, nurse practitioners, pharmacists,

and health educators, should be involved in and reimbursed whenever possible

for these services. The model of a multidisciplinary case management approach

for patients with lipid disorders encompasses primary and secondary prevention

across the lifespan and nutritional and exercise management, defines the

indications for pharmacological therapy, and emphasizes the importance of

treatment adherence.13 Use of this collaborative approach for the treatment of

lipid disorders will ultimately reduce cardiovascular and cerebrovascular (stroke)

morbidity and mortality. 

More information on adherence methods that payers can use to improve

beneficiary adherence to lipid-lowering treatments is available in Part VI of the

Purchaser’s Guide, Leveraging Benefits.

More information on the therapeutic lifestyle intervention diet is available in the

National Heart, Lung, and Blood Institute tipsheets

(www.nhlbi.nih.gov/chd/Tipsheets/daily.htm).

Information on ways to reduce low-density lipoprotein cholesterol levels is

available in Your Guide to Lowering your Cholesterol Level with Therapeutic

Lifestyle Changes (www.nhlbi.nih.gov/health/public/heart/chol/_tlc.pdf).

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained in this chapter

is described below.

Evidence-Based Research:

The U.S. Preventive Services Task (USPSTF)

Strength of Evidence: A (Strongly Recommended / Good Evidence)

• The USPSTF force strongly recommends that clinicians screen men aged

35 and older and women aged 45 and older for lipid disorders and that

they treat abnormal lipid levels in persons who are at increased risk of

coronary heart disease (based on such factors as age, total or low-density

lipoprotein cholesterol level, high-density lipoprotein cholesterol level,

smoking status, and systolic blood pressure).3

Recommended Guidance:

Adult Treatment Expert Panel-III, National Cholesterol Education Program

(NCEP) Strength of Evidence: The Adult Treatment Expert Panel-III

recommendations are based on large randomized controlled clinical trials,

prospective epidemiological studies, and smaller clinical trials. An expert panel

assigned each recommendation to a category of type of evidence (based on the
source of the evidence) and strength of evidence as follows4

: 

Category of Type of Evidence:

A Major randomized controlled clinical trials.

B Smaller randomized controlled clinical trials and 

meta-analyses of clinical trials.

C Observational and metabolic studies.

D Clinical experience.

Strength of Evidence:

1 Very strong evidence.

2 Moderately strong evidence.

3 Strong trend.

The Adult Treatment Expert Panel-III recommended that:

• Clinicians screen all adults aged 20 and older for elevated blood

cholesterol levels every 5 years {A1, B1, C1}.4 Screening should involve a

complete lipoprotein profile, including an evaluation of low-density

lipoprotein cholesterol level.4

• Clinicians treat all patients with abnormal lipid levels to decrease their

risk of cardiovascular disease events, such as heart attacks. The first line of

treatment should be counseling about healthy therapeutic lifestyle

changes.4

• Reducing low-density lipoprotein cholesterol levels should be the primary

target of cholesterol-lowering therapy {A1, B1, C1}.4

These recommendations are supported by the:

• Centers for Disease Control and Prevention (CDC)

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EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)

Authored by: 

Matson Koffman D. Lipid disorders evidence-statement: screening, counseling, and treatment. In:

Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to

Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on

Health; 2006.
References: 

1. American Heart Association. Heart disease and stroke statistics: 2006 update. Dallas (TX): American Heart Association;

2005.

2. Agency for Health Care Research and Quality. What’s new from the U.S. Preventive Services Task Force. Screening adults for

lipid disorders. AHRQ Publication No. APPIPO1-0011. Available from: http://www.ahrq.gov/clinic/prev/lipidwh.htm. 

3. U.S Preventive Services Task Force. Lipid disorder screening. Summary of Recommendations. Rockville, MD; Agency for

Healthcare Research and Quality; 2001 [cited 2006 Oct 6]. Available from: http://www.ahrq.gov/clinic/uspstf/uspschol.htm. 

4. National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol

in Adults. Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and

Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III): final report. Circulation 2002;106:3143-421.

5. Ford ES, Mokdad AH, Giles WH, Mensah GA. Serum total cholesterol concentrations and awareness, treatment, and control

of hypercholesterolemia among U.S. adults: findings from the National Health and Nutrition Examination Survey, 1999 to

2000. Circulation 2003;107:2185–9.

6. National Institute of Neurological Disorders and Stroke. Blood cholesterol levels. Available from:

http://www.ninds.nih.gov/disorders/stroke/detail_stroke.htm#60791105. 

7. Pignone MP, Phillips CJ, Atkins DA, Teutsch SM, Mulrow CD, Lohr KN. Screening and treating adults for lipid disorders: a

summary of the evidence. Am J Prev Med 2001;20 (3 Suppl):77-89.

8. Prosser LA, Stinnett AA, Goldman PA, Williams LW, Munink MGM, Goldman L, et al. Cost-effectiveness of cholesterollowering therapies according to selected patient characteristics. Ann Intern Med 2000;132:769-79.

9. Thomson Medstat. Marketscan. 2004.

10. National Guidelines Clearinghouse. Screening and management of lipids. Available from:

http://www.guideline.gov/summary/summary.aspx?doc_id=4114&nbr=3159. 

11. Cleeman JI. National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood

Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) Expert

Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III). JAMA 2001;285:2486-97.

12. Morgan JM, Capuzzi DM. Hypercholesterolemia: the NCEP Adult Treatment Panel III Guidelines. Geriatrics 2003;58:33-8.

13. Cohen JD. A population-based approach to cholesterol control. Am J Med 1997;102:23–5.

361

EVIDENCE-STATEMENT: Lipid Disorders (Screening, Counseling, and Treatment)
362
363

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

American Academy

of Family Physicians

(AAFP)

Evidence Rating: R

(Recommended)

• Motor vehicle-related injuries kill more children and young adults than any

other single cause in the United States.1 In 2004, 1,638 children ages 14 years

and younger died as occupants in motor vehicle-related crashes, and

approximately 214,000 were injured resulting in an average of 6 deaths and

673 injuries each day.2

• In a given year, 41,000 Americans will die in motor vehicle crashes, 500,000

will have crash injuries requiring hospitalization, and 4 million will have crash

injuries requiring a visit to an emergency department.1

• Motor vehicle-related deaths and injuries cost the United States a total of $230

billion dollars per year (in year 2000 dollars).3 Costs due to motor vehiclerelated injuries in children are estimated to approach $20 billion annually. The

average cost, per child, for a motor-vehicle related injury is estimated to be

$10,600 (updated to year 2000 dollars).4

• The workplace burden of motor vehicle-related crashes is also substantial: each

year, motor vehicle-related crashes result in $61 billion in lost productivity and

$5 billion in workplace administrative costs (in year 2000 dollars).3

• Motor vehicle-related fatal and nonfatal injuries are highly preventable.

Seatbelts, child safety seats, safety helmets (for motorcycles), and not driving

while impaired by alcohol or drugs, are proven to reduce the risk of motor

vehicle-related injuries.5-11

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) issued a recommendation on

counseling to prevent motor vehicle crash injuries in 1996. Given the availability

of new evidence, the USPSTF decided to update its 1996 recommendation. This

work is currently in progress. Please refer to the USPSTF website for updates

(www.ahrq.gov/clinic/prevenix.htm).

The American Academy of Family Physicians (AAFP) recommends that

physicians counsel all parents and patients over the age of 2 years regarding

accidental injury prevention including, as appropriate: child safety seats, lap and

shoulder belt use, bicycle safety, motorcycle helmet use, and driving while

intoxicated.12

Although evidence exists which demonstrates net benefit, either the benefit is

only moderate in magnitude or the evidence supporting a substantial benefit is

only fair. The intervention is perceived to be cost effective and acceptable to most

patients. The AAFP Summary of Recommendations for Clinical Preventive

Services (RCPS) originated in the Commission on Clinical Policies and Research

and was approved by the AAFP Board of Directors in August 2005.

The starting point for the recommendations is the rigorous analysis of scientific

knowledge available as presented by the U.S. Preventive Services Task Force

(USPSTF) in their Guide to Clinical Preventive Services, 2nd Edition and ongoing

releases of evidence reports and recommendations from the 3rd Edition. 

EVIDENCE-STATEMENT:

MOTOR VEHICLE-RELATED INJURY PREVENTION

(Counseling)
364

EVIDENCE-STATEMENT: Motor Vehicle-Related Injury Prevention (Counseling)

Other Recommended

Guidance

American Medical

Association (AMA)

Evidence Rating: 

American Academy

of Pediatrics (AAP)

Evidence Rating:

The AMA urges physicians to educate their patients about the dangers of alcohol

abuse and operating a motor vehicle while under the influence of alcohol.13

The AMA recommends that all adolescents receive health guidance annually to

promote the reduction of injuries.14 Health guidance for injury prevention

includes the following:

• Counseling to avoid the use of alcohol or other substances while using motor

or recreational vehicles, or where impaired judgment may lead to injury;

• Counseling to use safety devices, including seat belts, and motorcycle and

bicycle helmets.

Expert Opinion. The AMA developed its recommendations with contributions

from a Scientific Advisory Panel, comprised of national experts, as well as

representatives of primary care medical organizations and the health insurance

industry. The body of scientific evidence indicated that the periodicity and

content of preventive services can be important in promoting the health and

well-being of adolescents.

The American Academy of Pediatrics (AAP) recommends that pediatricians

counsel parents of most children (those who weigh more than 12 lbs at 4 months

of age) to encourage use of a convertible car safety seat that will accommodate

them rear facing at higher weights.15 Further, the AAP encourages pediatricians to

emphasize to parents and teenagers repeatedly the paramount importance of safe

driving behavior. During office visits, pediatricians can address risk factors,

especially driving while impaired by alcohol or other drugs and nighttime

driving. Pediatricians are encouraged to counsel parents that adolescents, despite

their physical maturity, are still developing their driving skills and need time to

master this complex task by practicing while supervised in a low-risk

environment. The pediatrician should address the tendency of some parents to

deny that their teenagers might be unsafe drivers. Pediatricians should advise

parents that their parenting responsibilities include the following15: 

• Setting a good driving example (e.g., no drinking and driving, no speeding,

and requiring all occupants to use safety belts);

• Establishing driving behavior limits on their teenagers, such as limiting the

number and age of passengers, restricting nighttime driving for novice drivers,

and delaying the onset of unsupervised driving as they see fit; 

• Showing that they expect responsible driving behavior from their teenagers and

imposing penalties for irresponsible actions; Supervising novice drivers in a

vehicle; 

• Ensuring the mechanical safety of any car used by a teenager.

Not Specified
365

EVIDENCE-STATEMENT: Motor Vehicle-Related Injury Prevention (Counseling)

Information Sources

Epidemiology 

of Injury

Injury Risk Factors

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Family Physicians (AAFP)

• American Academy of Pediatrics (AAP)

• American Medical Association (AMA)

• Centers for Disease Control and Prevention (CDC), National Center for

Injury Prevention and Control

• National Highway Traffic Safety Administration (NHTSA)

• Peer-reviewed research

• U.S. Department of Transportation (DOT)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Motor vehicle-related injuries kill more children and young adults (18 to 34 years

of age) than any other single cause in the United States.1 In a given year, 41,000

Americans will die in motor vehicle crashes, 500,000 will have crash injuries

requiring hospitalization, and 4 million will have crash injuries requiring a visit

to an emergency department.1

In the United States during 2004, 1,638 children ages 14 years and younger died

as occupants in motor vehicle-related crashes, and approximately 214,000 were

injured resulting in an average of 6 deaths and 673 injuries each day.2

During 2004, 16,694 people in the United States died in alcohol-related motor

vehicle crashes, representing 39% of all traffic-related deaths.16 Drugs other than

alcohol (e.g., marijuana and cocaine) are involved in about 18% of motor vehicle

deaths. These drugs are usually used in combination with alcohol.17 Nearly three

quarters of those convicted of driving while impaired are either frequent heavy

drinkers (alcohol abusers) or alcoholics (alcohol dependent).17

Risk factors for motor vehicle-related injuries among children include failing to

use occupant protection, improper use of occupant protection, and being a

passenger in a vehicle driven by a person under the influence of alcohol or other

drugs. Restraint use among young children often depends upon the driver’s

restraint use. Almost 40% of children riding with unbelted drivers were

themselves unrestrained.18 Even children who do use child restraints are at risk if

they are improperly secured. A survey of more than 17,500 children found that

only 15% of children in safety seats were correctly harnessed into correctly

installed seats.18
366

EVIDENCE-STATEMENT: Motor Vehicle-Related Injury Prevention (Counseling)

Economic Burden 

of Injury

Workplace Burden 

of Injury

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment 

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Value of Prevention

The economic burden of motor vehicle-related deaths and injuries is enormous,

costing the United States more than $230 billion each year (year 2000 dollars).3

Of the estimated $230 billion, $61 billion is due to lost workplace productivity,

$59 billion due to property damages, $34 billion due to medical expenses, $25

billion due to delayed transit, $20 billion due to lost household productivity, $15

billion due to insurance administration, $11 billion due to legal fees, and $5

billion due to workplace administration.3

Costs due to motor vehicle injuries in children are estimated to approach $20

billion annually. Costs per child injured (when a child occupies a vehicle involved

in a crash) are estimated at $10,600 per injury (updated to year 2000 dollars).4

Alcohol-involved crashes pose a great economic burden in the United States. The

economic costs for motor vehicle injuries involving alcohol are estimated at $50.9

billion annually (year 2000 dollars).3

As stated above, the workplace burden of motor vehicle-related crashes is

substantial. Each year, motor vehicle-related crashes result in $61 billion in lost

productivity and $5 billion in workplace administrative costs (year 2000 dollars).3

The savings associated with preventable medical-care costs, lost productivity, and

other injury-related expenditures constitute the major economic benefit of

counseling to prevent motor vehicle-related injuries. Including intangible

consequences such as pain and suffering, the total value of preventing a motor

vehicle-related death was estimated to be $3.4 million (in year 2000 dollars) per

life saved.19

In 2004, the private-sector cost of injury prevention counseling averaged $38 per

session; approximately 95% of paid claims fell within the range of $0 to $129

per session.19

The cost of motor-vehicle injuries varies tremendously depending on the type

and severity of the injury. 

Injury prevention counseling by pediatricians has been shown to be cost-saving in

some studies. The studied intervention included 11 brief sessions of

approximately 1.5 minutes each, one of which was related to the use of child

safety seats. Cost savings from the child safety seat counseling session ranged

from $24 to $69 per child counseled. These counseling costs are comparable with

the costs of counseling for other prevention messages.20-22

Counseling trauma patients (an injured patient treated in an emergency

department or admitted to a hospital) on the dangers of alcohol was estimated to

have a net cost-savings of $330 per patient intervention due to reduced future

alcohol related trauma. The counseling included a brief screening and

intervention session by a healthcare professional.23
367

EVIDENCE-STATEMENT: Motor Vehicle-Related Injury Prevention (Counseling)

Preventive

Intervention: 

Purpose of

Counseling

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Counseling

Preventive Intervention Information

Motor vehicle-related fatal and nonfatal injuries are highly preventable. Seatbelts,

child safety seats, safety helmets (for motorcycles), and not driving while

impaired by alcohol or drugs, are proven to reduce the risk of motor vehiclerelated injuries.5-11 The rates of fatal and non-fatal motor vehicle-related injuries

have declined in recent years, partially due to program and policy interventions

designed to prevent these injuries.5-11 For example, over 80% of all adults use seat

belts. However, children remain at high risk for motor-vehicle related injuries

because only 15% of children are correctly harnessed into correctly installed

safety seats.18

Several studies have evaluated counseling parents to increase seat belt usage

among their children24-29 and to use safety seats for infants and newborns.30-40

Other studies have shown that counseling adolescents and adults can increase seat

belt usage.26,41-44 In general, most of the evidence suggests that there is a relatively

short-term effect of clinician counseling on the use of occupant restraints,

indicating the need for periodic reinforcement of this message.

While little is known about how effectively clinicians can influence patients to

refrain from driving while impaired by alcohol or other drugs, there is good

evidence that brief clinician counseling can reduce alcohol consumption in

problem drinkers, which may, in turn, result in reduced drinking and driving.45-47

Studies also find that counseling provided as a component of trauma care (care

delivered to an injured patient in an emergency department of through

hospitalization) significantly reduces injuries and the rate of trauma recidivism

(re-injury).48-50 Further, despite the fact that there are over 159 million episodes of

alcohol-impaired driving each year, only 1.5 million persons are arrested annually

for driving under the influence of alcohol.51 Thus, it is likely that many patients

would benefit from clinician counseling to modify their behaviors as drivers and

passengers in motor vehicles. Since motor vehicle crashes represent a leading

cause of death and nonfatal injury in the United States, even modest successes

through clinical interventions could have major public health benefits. 

Although the harms associated with counseling are not well-studied, they may

include stigma, psychological stress, and anxiety. It is likely that these risks are

minimal, and the harms associated with counseling are far outweighed by the

benefits. 

There is insufficient evidence to determine the optimal ages at which to begin

and cease counseling to prevent motor vehicle-related injuries. Experts agree that

counseling for motor vehicle-related injuries should be initiated and stopped

when deemed appropriate by the clinician. 

Likely initiation periods might be: 1) when patients first begin to drive (age 15,

16 or older depending on state law), 2) when patients first become parents, 3)

when patients seek other preventive services for young children, 4) when patients

present with alcohol or other drug dependencies, and 5) when patients receive

trauma care for alcohol-related injuries. 
Evidence is insufficient to determine the optimal interval to counsel patients

about motor vehicle-related injuries. Thus, clinicians are encouraged to use their

judgment in deciding how frequently to counsel patients for motor vehiclerelated injuries. Clinicians should be encouraged to periodically reinforce

prevention messages with all patients (at least once per year), particularly with

those patients at high-risk of motor vehicle-related injuries (patients aged 18 to

33 years, parents of small children or adolescents, and substance and alcohol

abusers).

The specific method of counseling is left to the discretion of the clinician.

Common methods of counseling include brief clinician counseling (3 minutes or

less) and intensive counseling.

The provider of any patient who has suffered an alcohol-related motor vehicle

crash should screen the individual for alcohol misuse. For more information on

alcohol misuse screening and counseling please refer to the Alcohol Misuse

Screening and Counseling Evidence-Statement. 

Not Applicable

Strength of Evidence for the Clinical Preventive Service 

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research:

American Academy of Family Physicians (AAFP)

Strength of Evidence: R (Recommended)

• The AAFP recommends that physicians counsel all parents and patients over

the age of 2 years regarding accidental injury prevention including, as

appropriate: child safety seats, lap and shoulder belt use, and driving while

intoxicated.12

Recommended Guidance:

American Medical Association (AMA)

Strength of Evidence: Not Specified

• The AMA urges physicians to educate their patients about the dangers of

alcohol abuse and operating a motor vehicle while under the influence of

alcohol.2

• The AMA recommends that all adolescents receive health guidance annually to

promote the reduction of injuries.14 Health guidance for injury prevention

includes the following:

> Counseling to avoid the use of alcohol or other substances while using

motor or recreational vehicles, or where impaired judgment may lead to

injury;

368

EVIDENCE-STATEMENT: Motor Vehicle-Related Injury Prevention (Counseling)

Intervention Process

Treatment

Information
369

EVIDENCE-STATEMENT: Motor Vehicle-Related Injury Prevention (Counseling)

> Counseling to use safety devices, including seat belts, and motorcycle and

bicycle helmets.

American Academy of Pediatrics (AAP)

Strength of Evidence: Not Specified

• The AAP recommends that pediatricians counsel parents of most children

(those who weigh more than 12 lb at 4 months of age) to encourage use of a

convertible car safety seat that will accommodate them rear facing at higher

weights.5

• The AAP encourages pediatricians to emphasize to parents and teenagers

repeatedly the paramount importance of safe driving behavior. During office

visits, pediatricians can address risk factors, especially driving while impaired

by alcohol or other drugs and nighttime driving. Pediatricians are encouraged

to counsel parents that adolescents, despite their physical maturity, are still

developing their driving skills and need time to master this complex task by

practicing while supervised in a low-risk environment. The pediatrician should

address the tendency of some parents deny that their teenagers might be unsafe

drivers.5

Authored by: 

Corso P. Motor vehicle-related injury prevention evidence-statement: counseling. In: Campbell KP,

Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical

Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on 

Health; 2006.

References:

1. Centers for Disease Control and Prevention. Web-based Injury Statistics Query and Reporting System (WISQARS) 2005.

National Center for Injury Prevention and Control, Centers for Disease Control and Prevention. Available from:

www.cdc.gov/ncipc/wisqars. 

2. Department of Transportation. National Highway Traffic Safety Administration (NHTSA). Traffic Safety Facts 2004:

Children. Washington, DC: NHTSA; 2005.

3. Blincoe L, Seay A, Zaloshnja E, Miller T, Romano E, Luchter S, et al. The Economic Impact of Motor Vehicle Crashes, 2000.

Washington, DC: Dept of Transportation, National Highway Traffic Safety Administration (NHTSA); 2002.

4. Miller TR, Romano EO, Spicer RS. The cost of childhood unintentional injuries and the value of prevention. Future Child

2000; 10(1), 137-163.

5. Shults RA, Nichols JL, Dinh-Zarr TB, Sleet DA, Elder RW. Effectiveness of primary enforcement safety belt laws and

enhanced enforcement of safety belt laws: a summary of the Guide to Community Preventive Services systematic reviews. J

Safety Res 2004; 35(2):189–96.

6. Shults RA, Elder RW, Sleet DA, Thompson RS, Nichols JL. Primary enforcement seat belt laws are effective even in the face

of rising belt use rates. Accid Anal Prev 2004; 36:491-3.

7. Elder RW, Shults RA, Sleet DA, Nichols JL, Zaza S, Thompson R. Effectiveness of sobriety checkpoints for reducing alcoholinvolved crashes. Traffic Inj Prev 2002; 3:266-274.
370

EVIDENCE-STATEMENT: Motor Vehicle-Related Injury Prevention (Counseling)

8. Zaza S, Sleet DA, Thompson RS, Sosin DM, Bolen JC, Task Force on Community Preventive Services. Reviews of evidence

regarding interventions to increase the use of child safety seats. Am J Prev Med 2001;21(4S):31–47.

9. Dinh-Zarr TB, Sleet DA, Shults RA, Zaza S, Elder RW, Nichols JL, Thompson RS, Sosin DM, Task Force on Community

Preventive Services. Reviews of evidence regarding interventions to increase use of safety belts. Am J Prev Med 2001;21

(4S):48–65.

10. Dept of Transportation. National Highway Traffic Safety Administration (NHTSA). Traffic Safety Facts 2004: Occupant

protection. Washington DC: NHTSA; 2005.

11. National Highway Traffic Safety Administration. Traffic Safety Facts 1992: Motorcycles. Washington, DC: Department of

Transportation; 1993.

12. American Academy of Family Physicians. Clinical Preventive Services. Revision 6.0, August 2005. Available from:

http://www.aafp.org/online/en/home/clinical/exam.html.

13. American Medical Association. Policy H-30.945, Drivers impaired by alcohol. Available from: http://www.amaassn.org/ama1/pub/upload/mm/388/underage_drnkndrive.pdf.

14. American Medical Association. Guidelines for Adolescent Preventive Services (GAPS) Recommendations. Chicago, IL: American

Medical Association; 1997; [cited 2006 Jul 3]. Available from: http://www.ama-assn.org/ama/upload/mm/39/gapsmono.pdf. 

15. American Academy of Pediatrics Committee on Injury and Poison Prevention. Selecting and using the most appropriate car

safety seats for growing children: guidelines for counseling parents. Pediatrics 2002 Mar; 109(3):550-3. Available from:

http://www.guideline.gov/summary/summary.aspx?doc_id=3182#s24.

16. Department of Transportation. National Highway Traffic Safety Administration (NHTSA). Traffic safety facts 2004: alcohol.

Washington, DC: NHTSA; 2005.

17. Miller BA, Whitney R, Washousky R. Alcoholism diagnoses for convicted drinking drivers referred for alcoholism evaluation.

Alcohol Clin Exp Res 1986;10(6):651–6.

18. National Center for Injury Prevention and Control (NCIPC). Child passenger safety: fact sheet. Atlanta, GA: Centers for

Disease Control and Prevention; 2005. Available from: http://www.cdc.gov/ncipc/factsheets/childpas.htm.

19. Thomson Medstat. Marketscan. 2004.

20. Walensky RP, Weinstein MC, Kimmel AP, Seage III GR, Losina SD, Zhang PE, Smith HE Freedberg KA, Paltiel AD.

Routine human immunodeficiency virus testing: An economic evaluation of current guidelines. Am J Med 2005;118:

292–300.

21. Ekwueme DU, Pinkerton SD, Holtgrave DR, Branson BM. Cost comparison of three HIV Counseling and testing

technologies. Am J Prev Med 2003; 25(2): 112-121.

22. Varghese B, Peterman TA. Cost-effectiveness of HIV counseling and testing in U.S. prisons. J Urban Health 2001; 78(2):

304-312.

23. Gentilello L, Ebel B, Wickizer T, Salkever D, Rivara F. Alcohol interventions for trauma patients treated in emergency

departments and hospitals: a cost-benefit analysis. Ann Surg 2005; 241(4): 541-550.

24. Bass JL, Christoffel KK, Widome M, et al. Childhood injury prevention counseling in primary care settings: a critical review

of the literature. Pediatrics 1993;92:544–550.

25. Bass JL, Wilson TR. The pediatrician’s influence in private practice measured by a controlled seat belt study. Pediatrics 1964;

33:700–704.

26. Macknin ML, Gustafson C, Gassman J, et al. Office education by pediatricians to increase seat belt use. Am J Dis Child

1987;141:1305–1307.

27. Logsdon DN, Lazaro CM, Meier RV. The feasibility of behavioral risk reduction in primary medical care. Am J Prev Med

1989;5:249–256.

28. Kelly RB. Effect of a brief physician intervention on seat belt use. J Fam Pract 1987;24:630–632.

29. Weinstein ND, Grubb PD, Vautier JS. Increasing automobile seat belt use: an intervention emphasizing risk susceptibility. J

Appl Psychol 1986;71:285–290.

30. Allen DB, Bergman AB. Social learning approaches to health education: utilization of infant auto restraint devices. Pediatrics

1976;58:323–328. 
371

EVIDENCE-STATEMENT: Motor Vehicle-Related Injury Prevention (Counseling)

31. Kanthor HA. Car safety for infants: effectiveness of prenatal counseling. Pediatrics 1976;58:320–322.

32. Scherz RG. Restraint systems for the prevention of injury to children in automobile accidents. Am J Public Health

1976;66:451–455.

33. Reisinger KS, Williams AF, Wells JK, John CE, Roberts TR, Podgainy HJ. Effect of pediatricians’ counseling on infant

restraint use. Pediatrics 1981;67:201–206.

34. Kelly B, Sein C, McCarthy PL. Safety education in a pediatric primary care setting. Pediatrics 1987; 79:818–824.

35. Greenberg LW, Coleman AB. A prenatal and postpartum safety education program: influence on parental use of infant car

restraints. J Dev Behav Pediatr 1982;3:32–34.

36. Christophersen ER, Sullivan MA. Increasing the protection of newborn infants in cars. Pediatrics 1982;70:21–25.

37. Robitaille Y, Legault J, Abbey H, Pless IB. Evaluation of an infant car seat program in a low-income community. Am J Dis

Child 1990;144:74–78.

38. Reisinger KS, Williams AF. Evaluation of programs to increase the protection of infants in cars. Pediatrics 1978; 62:280–287.

39. Miller JR, Pless IB. Child automobile restraints: evaluation of health education. Pediatrics1977; 59:907–911. 

40. Berger LR, Saunders S, Armitage K, Schauer L. Promoting the use of car safety devices for infants: an intensive health

education approach. Pediatrics 1984; 74:16–19.

41. DiGuiseppi C, Roberts I. Individual-level injury prevention strategies in the clinical setting. Future Child. 2000; SpringSummer; 10(1):53-82.

42. Johnston B, Rivara F, Droesch R, Dunn C, Copass M. Behavior Change Counseling in he Emergency Department to Reduce

Injury Risk: A Randomized, Controlled Trial. Pediatrics 2002; 110(2): 267-274.

43. Guyer B, Gallagher S, Chang BH, Azzara C, Cupples L, Colton T. Prevention of childhood injuries: evaluation of the

statewide childhood injury prevention program. Am J Public Health 1989; 79:1521-1527.

44. Beck L, Gilbert B, Shults R. Prevalence of seat belt use among reproductive-aged women and prenatal counseling to wear seat

belts.

45. Worden JK, Flynn BS, Merrill DG, Waller JA, Haugh LD. Preventing alcohol-impaired driving through community selfregulation training. Am J Public Health 1989; 79:287–290.

46. Okene, J, Adams A, Hurley T, Wheeler E, Hebert J. Brief physician-and nurse practitioner-delivered counseling for high-risk

drinkers. Arch Intern Med 1999; 159(18): 2198-205.

47. Longabaugh R, Woolard RE, Nirenburg TD, Minugh AP, Becker B, Clifford PR et al. Evaluating the effects of a brief

motivational intervention for injured drinkers in the emergency department. J Stud Alcohol 2001; 62(6):806-16.

48. Rivara F, Tollefson S, Tesh E, Gentilello L. Screening trauma patients for alcohol problems: Are insurance companies barriers?

J Trauma 2000; 48(1): 115-8.

49. Spirito A, Monti P, Barnett N, Colby S, Sindelar H, Rohsenow D, et al. A randomized clinical trial of a brief motivational

intervention for alcohol-positive adolescents treated in an emergency department. J Pediatr 2004; 145(3): 396-402.

50. Gentilello L, Rivara F, Donovan D, Jurkovich G, Daranciang E, Dunn C, et al. Alcohol interventions in a trauma center as a

means of reducing the risk of injury recurrence. Ann Surg 1999; 230(4):473-80.

51. Quinlan KP, Brewer RD, Siegel P, Sleet DA, Mokdad AH, Shults RA, et al. Alcohol-impaired driving among U.S. adults,

1993–2002. Am J Prev Med 2005;28(4):346–350.
372
373

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/At

Least Fair Evidence)

• Obesity is epidemic in the United States. Between 1976 to 1980 and 1999 to

2002, the proportion of adults classified as obese doubled. During that period,

the proportion of children (aged 6 to 11 years) classified as overweight doubled

and the proportion of overweight adolescents (aged 12 to 19 years) tripled.1

• Nearly 80% of obese adults suffer from diabetes, high blood pressure, coronary

artery disease, high cholesterol, osteoarthritis, or a combination of these

conditions.2

• Because it contributes to so many other serious conditions, obesity is

considered to be one of the most important, underlying, and preventable

causes of poor health and premature death.3

• Obesity contributes significantly to medical costs in the United States.4

• The cost to employers of obesity-related health problems in 1994 was

estimated to be $13 billion per year, including $8 billion in medical claims,

$2.4 billion in paid sick leave, $1.8 billion in life insurance, and almost $1

billion in disability insurance.5

• Each year, an estimated 39 million work days are lost to obesity-related

illnesses.6

• For adults, losing excess weight has positive effects on overall health status. A

5% to 7% reduction in body weight decreases the risk of type 2 diabetes,

reduces blood pressures, and improves lipid profiles.7 Among patients with

existing glucose intolerance, weight loss through lifestyle change is associated

with as much as a 58% reduction in incidence of diabetes.8

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians

screen all adult patients for obesity and offer intensive counseling and behavioral

interventions to promote sustained weight loss for obese adults.9

The USPSTF found good evidence that body mass index (BMI), calculated as

weight in kilograms divided by height in meters squared, is reliable and valid for

identifying adults at increased risk for mortality and morbidity due to overweight

and obesity. There is fair to good evidence that high-intensity counseling —

about diet, exercise, or both — together with behavioral interventions aimed at

skill development, motivation, and support strategies produces modest, sustained

weight loss (typically 3 to 5 kg for 1 year or more) in adults who are obese (as

defined by BMI  30 kg/m2

). Although the USPSTF did not find direct

evidence that behavioral interventions lower mortality or morbidity from obesity,

the USPSTF concluded that changes in intermediate outcomes, such as improved

glucose metabolism, lipid levels, and blood pressure, from modest weight loss

provide indirect evidence of health benefits.9

EVIDENCE-STATEMENT:

OBESITY (Screening and Counseling)
374

EVIDENCE-STATEMENT: Obesity (Screening and Counseling)

Other EvidenceBased Research

Food and Drug

Administration (FDA)

Evidence Rating:

Recommended

Guidance

The National Heart,

Lung, and Blood

Institute (NHLBI)

Evidence Rating:

Information Sources

Epidemiology of

Condition/Disease

The FDA has approved two medications for the treatment of obesity that can

reduce patient weight by an average of 2.6 to 4.8 kg (5.7 to 10.6 lbs) for at least

2 years: orlistat (Xenical®) and sibutramine (Meridia®).10-11

Clinical Trials

The NHLBI recommends that surgical procedures for obese patients be reserved

for patients with class III obesity (BMI  40) and patients with class II obesity

(BMI of 35 to 39.9) who also have at least one obesity-related illness.12

Not Specified

The recommendations and supporting information contained in this document

came from several sources, including the:

• American Academy of Bariatric Surgery

• American Academy of Family Physicians (AAFP)

• American Academy of Pediatrics (AAP)

• American Medical Association (AMA)

• Food and Drug Administration (FDA)

• National Academy of Sciences, Institute of Medicine (IOM)

• National Center for Education in Maternal and Child Health

• National Heart, Lung, Blood Institute (NHLBI)

• Peer-reviewed research

• U.S. Department of Health and Human Services

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information in this document is based on a

compilation of research findings. All of the information presented in this

document should be attributed to its referenced source and should not be

considered a reflection of the opinions of other organizations cited in the text. 

Condition/Disease-Specific Information

The Body Mass Index (BMI) is widely used as an index of body composition and

weight. BMI’s in the range of 18.5 to 24.9 are generally considered to be optimal

for adults. “Underweight” is generally defined as a BMI less than 18.5,

“overweight” as BMI between 25 to 29.9, and “obesity” as a BMI greater than

30. Age- and gender-specific standards also exist for children and adolescents that

take into account the changes in body composition that occur as children grow

(See “Other Important Information,” below).

Obesity is epidemic in the United States. Between 1976 to 1980 and 1999 to

2002, the proportion of adults classified as obese doubled.1 Nearly 80% of obese
375

EVIDENCE-STATEMENT: Obesity (Screening and Counseling)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

adults suffer from diabetes, high blood pressure, coronary artery disease, high

cholesterol, osteoarthritis, or a combination of these conditions.2 Research has

also documented that obesity is associated with decreased quality of life.13

During this period, the proportion of children (aged 6 to 11 years) classified as

overweight doubled and the proportion of overweight adolescents (aged 12 to 

19 years) tripled.1 The complications of being overweight are particularly severe

for children due to the years of life they are at risking of losing as a result of

early-onset chronic diseases, such as diabetes14 and cardiovascular disease.15

For adults, losing excess weight has positive effects on overall health status. A 5%

to 7% reduction in body weight decreases the risk of type 2 diabetes, reduces

blood pressures, and improves lipid profiles.7 Among patients with existing

glucose intolerance, weight loss through lifestyle change is associated with as

much as a 58% reduction in incidence of diabetes.8 The USPSTF found limited

data on the positive effect that weight loss may have on overall mortality, mental

health, and daily functioning.9

Obesity is more common among adult women, Native Americans, AfricanAmericans, Native Hawaiians, and Hispanics than other populations.7

Value of Prevention

Obesity contributes significantly to medical costs in the United States. In 1998,

9.1% of total annual medical expenditures could be attributed to obesity.4

Between 1987 and 2001, 27% of the growth in inflation-adjusted per-capita

healthcare spending was associated with obesity.6 The annual cost of obesity is

estimated to range from $69 billion to $117 billion (including $61 billion for

direct medical expenses and $56 billion for indirect expenses such as lost

productivity [in year 2000 dollars]).16

The expected lifetime costs of cardiovascular disease (including coronary heart

disease, heart attack, and stroke) increase by 20% with mild obesity (class I: BMI

of 30 to 34.9), 50% with moderate obesity (class II: BMI of 35 to 39.9), and

nearly 200% with severe obesity (class III: BMI of 40 or higher).5 One large

health plan found that its yearly total medical claims were 18% higher for

overweight individuals and 32% higher for obese than for healthy-weight

individuals.17

A 2001 study found obese adults had, on average, about 37% higher healthcare

expenses per person than normal-weight adults. This excess expense increased

private healthcare spending by nearly 12% (more than $36 billion).6

The cost to employers of obesity-related health problems in 1994 was estimated

to be $13 billion per year, including $8 billion in medical claims, $2.4 billion in

paid sick leave, $1.8 billion in life insurance, and almost $1 billion in disability

insurance.5
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EVIDENCE-STATEMENT: Obesity (Screening and Counseling)

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

and Counseling

Obesity and related illnesses are also a major cause of disability. Each year, an

estimated 39 million work days are lost to obesity-related illnesses.6

Nutrition education, diet, and exercise counseling are effective interventions for

obesity prevention and have the potential to significantly reduce the direct and

indirect costs of obesity-related illnesses. Researchers have estimated that even a

modest reduction of 10% in body weight in an obese individual might reduce

the expected lifetime healthcare costs of major obesity-related diseases for the

individual by $2,200 to $5,300, depending on age, sex, and initial BMI.18

The cost of BMI screening is negligible when height and weight measurements

are already recorded as part of a routine physical exam. In 2004, the privatesector cost of obesity counseling averaged $39 per session; approximately 95% of

all paid claims fell within the range of $0 to $129 per session.19

In the United States, the costs associated with treating obesity vary by location,

provider type, and treatment modality. For example, in 2006 the average wholesale

price of a 1-month supply of pharmacological therapy for obesity was $207.04 for

orlistat (Xenical“) (120 mg three times daily) and $423.60 for a 3-month supply of

sibutramine (Meridia“) (15 mg daily).28 In contrast, the average price of a surgical

procedure for obesity in 2004 ranged from $20,000 to $35,000.21

The cost-effectiveness of screening for and treating obesity is unclear. Because

obese individuals are at risk for serious and costly complications, such as diabetes

and cardiovascular disease, screening for obesity and early intervention to reduce

excess weight could improve lives and increase the cost-effectiveness of healthcare

dollars. However, few studies have tested the cost-effectiveness of screening for

and treating obesity in the United States, although several cost-effectiveness

studies have been conducted in England, Australia, and Northern Europe. The

studies conducted abroad applied their-effectiveness analyses to morbidly obese

patients (i.e., persons with BMIs 40, which is approximately 100 pounds over

normal weight for a typical person). The studies found that a range of

interventions (such as pharmacotherapy, surgery, and intensive diet and

behavioral therapy) can be inexpensive or even cost-saving, depending on the

population’s risk and the interventions used.22 These results cannot be generalized

to patients who are not morbidly obese. Further, the results may not be

generalizable to the U.S. population because of differences between the

populations studied and the U.S. population and differences in healthcare system

funding and delivery mechanisms in the countries studied.

Preventive Intervention Information

Because obesity is a modifiable major risk factor for several serious conditions,

screening for obesity and treating it successfully can be expected to produce

significant health benefits. Screening for obesity allows clinicians to identify

patients at risk and begin treatment before serious weight-related complications

occur. Unfortunately, weight is frequently overlooked in primary care practice;

only 42% of obese patients report receiving advice to lose weight during a

routine check-up in the previous year.23
Although the USPSTF did not find direct evidence that behavioral interventions

lower mortality or morbidity from obesity, the USPSTF concluded that changes

in intermediate outcomes, such as improved glucose metabolism, lipid levels, and

blood pressure, from modest weight loss provide indirect evidence of health

benefits.9

The USPSTF was unable to find studies that suggested harms associated with

screening or counseling obese patients.24 However, the USPSTF notes that

because obesity carries a stigma, there is a potential risk in labeling patients as

obese. The USPSTF found evidence that dieting among overweight and obese

adults does not lead to problems in psychological functioning or eating disorders.

However, the USPSTF notes that the evidence is limited and conflicting on the

harms of weight cycling (losing and then regaining a large amount of weight). In

addition, the USPSTF notes that some forms of treatment, specifically

pharmacological therapy and surgical intervention, carry potential harm.24

The USPSTF concluded that the benefits of screening and behavioral

interventions outweigh potential harms.

The USPSTF did not find evidence to determine the optimal times for the

initiation, cessation, or interval of obesity screening. Several health organizations,

including the American Academy of Family Physicians (AAFP),25 the American

Heart Association (AHA),26 and the American College of Preventive Medicine

(ACPM),27 agree on the importance of screening for obesity and recommend

periodically measuring the height and weight of all patients. Some authorities

have recommended that height and weight be recorded and BMIs calculated at

every healthcare visit. 

High-intensity counseling is defined by the USPSTF as 2 or more person-toperson sessions per month for at least the first 3 months of treatment for a total

of 6 counseling sessions per calendar year.

The USPSTF notes that the most effective interventions for obesity combine

nutrition education, diet and exercise counseling, and behavioral strategies to

help obese patients acquire the skills they need to successfully change their eating

habits and to become more physically active.9

The preferred method of screening an adult patient for obesity is to measure their

body-mass index (BMI). This is a reliable and valid measurement of adult weight

status. BMI is defined as weight in pounds divided by height in inches squared

and multiplied by 703, or as weight in kilograms divided by height in meters

squared. BMI charts provide completed calculations and can be used to

determine BMI by simply entering weight and height. The following definitions

from the Clinical Guidelines on the Identification, Evaluation, and Treatment of

Overweight and Obesity in Adults12 should be used to classify weight status:

Screening for obesity may also include measurement of waist circumference

because central adiposity (excess fat around the middle) can also increase an

individual’s risk of developing cardiovascular disease. A waist circumference

377

EVIDENCE-STATEMENT: Obesity (Screening and Counseling)

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval

Screening

Counseling

Intervention Process

Screening
378

EVIDENCE-STATEMENT: Obesity (Screening and Counseling)

Counseling and

Treatment

Information

greater than 102 centimeters for men and 88 centimeters for women is associated

with an increased risk of cardiovascular disease. However, waist measurements are

not reliable indicators of cardiovascular disease risk in obese patients with a BMI

of 35 or above.24

The most effective behavioral interventions for obesity combine nutrition

education, diet and exercise counseling, and behavioral strategies to help obese

patients acquire the skills they need to change their eating habits and become

more physically active.28

Clinicians should offer a treatment plan of intensive counseling and behavioral

interventions to obese patients. Intensive counseling is defined as 2 or more

person-to-person individual or group sessions per month for at least 3 months.24

If clinicians are unable to offer obese patients intensive counseling and behavioral

interventions, they should refer patients to a program or provider that can offer

these services. However, this should not undermine the existing patient-physician

relationship because research has shown that clinicians’ advice plays a role in

many health outcomes.29-30

No evidence exists to show that one counseling method is better than another for

obese patients. Clinicians must therefore use their own judgment to select an

appropriate counseling method for a given patient. The “5-A” framework31 that is

used for smoking cessation counseling might be useful for the initial evaluation

and counseling of an obese patient and might be helpful in broaching the subject

of weight loss with patients:

• Assess the patient’s weight by measuring his or her BMI and waist and evaluate

the patient’s factors that affect choice of behavior change goals/methods.

• Advise the patient to lose weight through physical activity and a healthy diet

using clear, specific, and personalized messages.

• Agree with the patient on specific changes he or she can make to reach his or

her target weight.

• Assist the patient in making changes by offering support services, education,

and resources.

• Arrange for follow-up and support services.

Experts recommend that pharmacological therapy for obesity, such as

medications that induce weight loss or suppress appetite, only be used as part of a

BMI Chart for Adults

Classification BMI

Underweight Less than 18.5

Healthy 18.5 to 24.9

Overweight 25 to 29.9

Obese (class I) 30 to 34.9

Obese (class II) 35 to 39.9

Obese (class III) 40 and above
379

EVIDENCE-STATEMENT: Obesity (Screening and Counseling)

treatment plan that also includes lifestyle modifications such as intensive diet,

exercise, and behavioral counseling.9 The Food and Drug Administration (FDA)

has approved two medications for the treatment of obesity that can reduce

patient weight by an average of 2.6 to 4.8 kg (5.7 to 10.6 lbs) for at least 2 years:

orlistat (Xenical®) and sibutramine (Meridia®).10-11 While these drugs are effective,

they may produce unwanted side effects and few data are available on the safety

of their long-term use. 

The National Heart, Lung, and Blood Institute (NHLBI) recommends that

surgical procedures be reserved for obese patients with class III obesity (BMI

greater than 40) and patients with class II obesity (BMI of 35 to 39.9) who have

at least one obesity-related illness. Surgical procedures, such as bariatric surgery,

are effective for treating obesity in the short-term (on average, extremely obese

patients lose 10 to 159 kg [22 to 349.8 lbs] in 1 to 5 years).12

Bariatric surgery produces improvements in health for most of the patients. For

example, a meta-analysis of bariatric surgery studies found that 60% to 70% of

patients lost all of their excess weight and that diabetes was brought under

control in almost 77% of patients who had had diabetes prior to the surgery.32

Although the long-term health effects of surgery for obesity are not well

characterized, surgical cohort studies suggest that large amounts of weight loss

may be linked to dramatic improvements in glucose metabolism. In addition,

some evidence indicates that surgically treated patients are more likely to have

resolution of diabetes, hypertension, and certain lipid disorders than patients who

do not undergo surgery.28

However, bariatric surgery is associated with serious risks, including the risk of

death, and 25% of patients may need a second operation within 5 years.28

Other Important Information

The USPSTF concluded that the evidence was insufficient to recommend for or

against routine screening for overweight in children and adolescents as a means to

prevent adverse health outcomes.33

The USPSTF found 1) fair evidence that BMI is a reasonable measure for

identifying children and adolescents who are overweight or are at risk for

becoming overweight, 2) fair evidence that overweight adolescents and children

(8 years old)are at increased risk for becoming obese adults, 3) insufficient

evidence for the effectiveness of behavioral counseling or other preventive

interventions with overweight children and adolescents that can be conducted in

primary care settings or to which primary care clinicians can make referrals, and

4) insufficient evidence to ascertain the magnitude of the potential harms of

screening or prevention and treatment interventions. The USPSTF was unable to

determine the balance between potential benefits and harms of routine screening

of children and adolescents for overweight.

Although the USPSTF found insufficient evidence to recommend for or against

screening children and adolescents for overweight, many health organizations
380

EVIDENCE-STATEMENT: Obesity (Screening and Counseling)

have created guidelines for this type of screening. For example, the American

Academy of Family Physicians (AAFP),34 American Academy of Pediatrics

(AAP),35 National Center for Education in Maternal and Child Health,36 and

American Medical Association (AMA) have developed guidelines that include

recommendations for measuring height and weight as part of periodic health

examinations for children and adolescents. 

In 2003, the AAP published a policy statement on the prevention of pediatric

overweight and obesity. In this report, the AAP stated that a BMI between the

85th and 95th percentiles for age and sex indicates that the child or adolescent is

at risk for overweight and a BMI at or above the 95th percentile indicates that

the child or adolescent is overweight or obese.35 Because obesity is associated with

significant health problems in children, the AAP proposed strategies to foster

prevention and early detection of overweight and obesity. In addition to the

healthy nutrition recommendations, the AAP developed a policy statement on

active healthy living for the prevention of childhood obesity.37 According to this

policy, physicians and other healthcare professionals should advocate for policy

changes at the community, state, and national levels to support healthy nutrition,

reduce sedentary time, and increase physical activity levels in children and

adolescents while providing education and supervision of the child’s health on the

importance of regular physical activity and reduced sedentary time to families. 

Strength of Evidence for the Clinical Preventive Service 

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of evidence: B (Recommended/At Least Fair Evidence)

• The USPSTF found fair to good evidence to support screening all adult

patients for obesity and offering intensive counseling and behavioral

interventions to promote sustained weight loss for obese adults.9

Food and Drug Administration (FDA)

Strength of Evidence: Clinical Trials

The FDA has approved two medications for the treatment of obesity that can

reduce patient weight by an average of 2.6 to 4.8 kg (5.7 to 10.6 lbs) for at least

2 years: orlistat (Xenical®) and sibutramine (Meridia®).10-11

Recommended Guidance::

The National Heart, Lung, and Blood Institute (NHLBI)

Strength of evidence: Not Specified

• The NHLBI recommends that surgical procedures for obese patients be

reserved for patients with class III obesity (BMI 40) and patients with class

II obesity (BMI of 35 to 39.9) who also have at least one obesity-related

illness.12
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EVIDENCE-STATEMENT: Obesity (Screening and Counseling)

References:

1. Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US

children, adolescents, and adults, 1999-2002. JAMA 2004;291:2847-50.

2. Must A, Spandano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and

obesity. JAMA 1999;282:1523-9. 

3. Mokdad A, Marks JS, Stroup DE, Gerberding JL. Actual causes of death in the United States. JAMA 2004; 291(10): 1238-

1245. Corrected and republished from: JAMA 2005; 293(3): 293-294.

4. Finkelstein EA, Fiebelkorn IC, Wang G. National medical spending attributable to overweight and obesity: How much, and

who’s paying? Health Aff 2003;W3; 219-26. 

5. Thompson D, Edelsberg J, Kinsay KL, Oster G. Estimated economic costs of obesity to U.S. business. Am J Health Promot

1998;13:120-7. 

6. Thorpe KE, Florence CS, Howard DH, Joski P. The impact of obesity on rising medical spending. Health Aff 2004;

W4:480-6.

7. NHLBI Obesity Education Initiative. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and

Obesity in Adults: the Evidence Report. Bethesda (MD): National Heart, Lung, and Blood Institute, National Institutes of

Health; 1998. NIH Publication No. 98-4083.

8. Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or

metformin. N Engl J Med 2002;346:393-403.

9. U.S. Preventive Services Task Force. Guide to Clinical Preventive Services. 3rd ed. Rockville, MD: Agency for Health Care

Research and Quality; 2003.

10. Food and Drug Administration. FDA approves orilstat for obesity. FDA Talk Paper. [cited 2006 Oct 21]. Available from:

http://www.fda.gov/bbs/topics/ANSWERS/ANS00951.html. 

11. Food and Drug Administration. FDA approves sibutramine to treat obesity. FDA Talk Paper. [cited 2006 Oct 21]. Available

from: http://www.fda.gov/bbs/topics/ANSWERS/ANS00835.html. 

12. National Heart, Lung, and Blood Institute. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight

and Obesity in Adults. Available from: http:/www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.htm. 

13. Livingston EH, Fink AS. Quality of life: cost and future of bariatric surgery. Arch Surg 2003;138:383-8.

14. Ludwig DS, Ebbeling CB. Type 2 diabetes mellitus in children, primary care and public health considerations. JAMA

2005;286:1427-30. 

15. Must A, Jacques PF, Dallal GE, Bajema CJ, Dietz WH. Long-term morbidity and mortality of overweight adolescents. A

follow-up of the Harvard Growth Study of 1922 to 1935. N Engl J Med 1992;327:1350-5.

16. U.S. Department of Health and Human Services. Estimated economic costs of obesity to U.S. businesses. In: Prevention

Makes Common ‘Cents’ Washington, DC: Department of Health and Human Services; 2004.

17. Kaiser Network. Blue Cross and Blue Shield of North Carolina introduces benefits package featuring obesity treatments.

Kaiser Daily Health Policy Report, 2004. Available from:

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=3&DR_ID=26217. 

381

Authored by: 

Tohill BC, Campbell KP, Chattopadhyay S. Obesity evidence-statement: screening, counseling, and 

treatment. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors.

A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC:

National Business Group on Health; 2006.
382

18. Oster G, Thompson D, Edelsberg J, Bird AP, Colditz GA. Lifetime health and economic benefits of weight loss among obese

persons. Am J Public Health 1999;89:1536-42.

19. Thomson Medstat. Marketscan. 2004.

20. Fleming T. 2006 Redbook: Pharmacy’s Fundamental Reference. Thomson PDR; Rev Ed edition. May 2006.

21. National Institute of Diabetes and Digestive and Kidney Disease Weight-control Information Network. Gastrointestinal

Surgery for Severe Obesity. NIH Publication No. 04-4006. National Institutes of Health; 2004. 

22. Avenell A, Broom J, Brown TJ, Poobalan A, Aucott L, Stearns SC, et al. Systematic review of the long-term effects and

economic consequences of treatments for obesity and implication for health improvement. Health Technol Assess 2004;8:iiiiv,1-182.

23. Galuska DA, Will JC, Serdula MK, Ford ES. Are health care professionals advising obese patients to lose weight? JAMA

1999;282:1576-78.

24. Berg AO. Screening for obesity in adults: Recommendations and rationale. Ann Intern Med 2003;139: 930-932.

25. American Academy of Family Physicians. Summary of recommendations for clinical preventive services. Revision 6.0.

Leawood (KS): American Academy of Family Physicians; 2005. 

26. Klein S, Burke LE, Bray GA, Blair S, Allison DB, Pi-Sunyer X, et al. Clinical implications of obesity with specific focus on

cardiovascular disease: a statement for professionals from the American Heart Association Council on Nutrition, Physical

Activity, and Metabolism: endorsed by the American College of Cardiology. Circulation 2004;110:2952-67.

27. Nawaz H, Katz DL. American College of Preventive Medicine practice policy statement. Weight management counseling of

overweight adults. Am J Prev Med 2001;21:73-8.

28. McTigue KM, Harris R, Hemphill B, Lux L, Sutton S, Bunton AJ, et al. Screening and interventions for obesity in adults:

summary of the evidence for the US Preventive Services Task Force. Ann Intern Med 2003;139:933-49.

29. Safran DG, Taira DA, Rogers WH, Kosinski M, Ware JE, Tarlov AR. Linking primary care performance to outcomes of care.

J Fam Pract 1998;47:213-20.

30. Stewart MA. Effective physician-patient communication and health outcomes. A review. CMAJ 1995;15:1423-33.

31. Whitlock E, Orleans C, Pender N. Allan J. Evaluating primary care behavioral counseling interventions: an evidence-based

approach. Am J Prev Med 2002;22:267-84.

32. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and

meta-analysis. JAMA 2005;292:1724-37.

33. U.S. Preventive Services Task Force. Screening and interventions for overweight children and adolescents: recommendation

statement. Rockville (MD): Agency for Healthcare Research and Quality; July 2005. Available from:

http://www.ahrq.gov/clinic/uspstf/uspsobch.htm. 

34. American Academy of Family Physicians. Age charts for periodic health examination. Kansas City (MO): American Academy

of Family Physicians; 1994. Reprint no. 510. 

35. American Academy of Pediatrics. Policy statement. Prevention of pediatric overweight and obesity. Pediatrics 2003;119:424-

30.

36. Green M, editor. Bright futures: national guidelines for health supervision of infants, children, and adolescents. Arlington

(VA): National Center for Education in Maternal and Child Health; 1994.

37. American Academy of Pediatrics. Active healthy living: prevention of childhood obesity through increased physical activity.

Policy statement. Pediatrics 2006;117:1834-42.

EVIDENCE-STATEMENT: Obesity (Screening and Counseling)
383

Why This Chapter is

Important for

Employers:

An Overview 

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended / At

Least evidence)

Other EvidenceBased Research

Food and Drug

Administration (FDA)

• Approximately 44 million Americans — 55% of the adult population over the

age 50 — have either osteoporosis or osteopenia. Many of the 10 million

Americans who have osteoporosis are undiagnosed.1

• Approximately 50% of postmenopausal women will suffer a fracture as a result

of osteoporosis at some point during their lifetime.2 Twenty-five percent

(25%) of these women will suffer a deformity in their spines and 15% will

fracture their hips.3

• Fractures are a costly and common events associated with osteoporosis.

Approximately 1.5 million osteoporotic fractures occur in the United States

each year, which result in more than 500,000 hospitalizations, over 800,000

emergency room visits, more than 2,600,000 physician office visits, and nearly

180,000 nursing home admissions.4

• The estimated annual direct-care expenditure for osteoporotic fractures ranges

from $12 billion to $18 billion (in year 2002 dollars).4 In 2001, the cost of

osteoporotic care delivered in hospitals and nursing homes totaled $17 billion.5

• Osteoporosis will continue to grow as a major public health problem for both

women and men as the population ages.1 By the year 2020 experts predict

that, combined, osteoporosis and osteopenia will affect 61 million Americans

over the age of 50 and by the year 2040 the number of hip fractures is

estimated to triple or quadruple.4

• Screening offers the opportunity to intervene early in the course of disease and

prevent further weakening of the bones, thus reducing an individual’s risk of

fracture. 

• Osteoporosis can be effectively treated with medication to improve bone

density and reduce the risk of fractures. 

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians

screen all women over the age of 65 for osteoporosis. The USPSTF also

recommends that clinicians screen women at high risk of osteoporosis beginning

at age 60. Age and lower body weight (less than 70 kg) are the best predictors of

low bone density. There is some evidence to support other risk factors, such as

white race, smoking, weight loss, family history, decreased physical activity,

alcohol or caffeine use, or low calcium and vitamin D intake.6

The USPSTF found good evidence that the risk for osteoporosis and fracture

increases with age and other factors, that bone density measurements accurately

predict the risk for fractures in the short-term, and that treating asymptomatic

women with osteoporosis reduces their risk for fracture. The USPSTF concluded

that the benefits of screening and treatment are of at least moderate magnitude

for women at increased risk by virtue of age or presence of other risk factors.6

The Food and Drug Administration (FDA) has approved the following classes of

medications for the treatment of osteoporosis4,7: 

• Bisphosphonates such as alendronate (Fosomax®), risedronate (Actonel®), and

ibandronate (Boniva®).

EVIDENCE-STATEMENT:

OSTEOPOROSIS (Screening and Treatment)
384

EVIDENCE-STATEMENT: Osteoporosis (Screening and Treatment)

Evidence Rating:

Information Sources

Epidemiology of

Condition/Disease

• Selective Estrogen Receptor Modulators (SERMs) such as raloxifene (Evista®).

• Calcitonin (Miacalcin®)

• Parathyroid hormone (Forteo®)

FDA-approved drug therapies have been shown through clinical trials to

effectively reduce osteoporotic or fragility fractures at various sites in the body.

The recommendations and supporting information contained in this document

came from several sources, including the:

• Agency for Healthcare Research and Quality (AHRQ)

• Food and Drug Administration (FDA)

• National Osteoporosis Foundation (NOF)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

• U.S. Surgeon General

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Osteoporosis is a common and serious disease associated with aging; it is a

skeletal disorder characterized by compromised bone strength.4 Osteoporosis

weakens the bones though a thinning of the bone mass, thereby increasing an

individual’s chance of experiencing a fracture.2 Fractures occur at different and

often multiple sites including the hip, vertebrae, wrist, and forearm.

Osteoporosis can also cause chronic pain and loss of height due to compression

of the spine. Osteoporosis is defined as a bone mineral density (BMD) 2.5

standard deviations or more below the mean BMD of healthy adult women.

Authoritative diagnostic criteria for men are not established, but a BMD value

2.0 to 2.5 below normal for men with an appropriate clinical history has been

proposed as a threshold for intervention.8 Osteopenia is a milder reduction in

bone mass (BMD 1- 2.5 SD’s below mean of healthy persons), which results in

some increased risk of fracture, but not as great as the increased risk associated

with osteoporosis. Because osteopenia covers a wide range of BMD values, not

everyone with osteopenia is at the same risk of fracture, and therefore the best

approach to minimize fracture risk in this group will vary.

Approximately 44 million Americans — 55% of the adult population over the

age 50 — have either osteoporosis or osteopenia. Many of the 10 million

Americans who have osteoporosis are undiagnosed.1 Although women have a

higher risk of developing osteoporosis than do men, osteoporosis is not only a

disease of women and many men experience osteoporotic fractures. 
385

EVIDENCE-STATEMENT: Osteoporosis (Screening and Treatment)

Condition/Disease

Risk Factors

Osteoporosis will continue to grow as a major public health problem for both

women and men as the population ages.1 By the year 2020 experts predict that,

combined, osteoporosis and osteopenia will affect 61 million Americans over the

age of 50.4 With such a rise in prevalence, the number of osteoporotic fractures

— particularly hip fractures — is likely to increase. In fact, by the year 2040 the

number of hip fractures is estimated to triple or quadruple.4

There is a strong and direct relationship between declining bone density and

increasing risk of fracture. According to a recent research study, women diagnosed

with osteoporosis are 4 times as likely to suffer a fracture in the year after they are

diagnosed with osteoporosis compared to their peers without osteoporosis.3

Approximately 50% of postmenopausal women will suffer a fracture as a result of

osteoporosis at some point during their lifetime.2 Twenty-five percent (25%) of these

women will suffer a deformity in their spines and 15% will fracture their hips.3

Each year, 1.5 million Americans suffer a fracture as a result of bone diseases such

as osteoporosis and osteopenia including1,4: 

• 700,000 vertebral fractures

• 300,000 hip fractures

• 250,000 wrist fractures

• 300,000 fractures at other sites

Vertebral fractures range in severity and can cause severe pain and disfigurement.

Vertebral fractures cause 150,000 hospitalizations each year for adults over the

age of 65, require approximately 161,000 physician office visits, and lead to over

5 million days of restricted activity.9

Hip fractures are one of the most serious complications of osteoporosis.

Approximately 10 million men and women over the age of 50 suffer from

osteoporosis of the hip, and an additional 33.6 million Americans suffer from

osteopenia of the hip.4 Hip fractures are associated with high mortality rates and

are a major cause of disability. Individuals who suffer hip fractures have a 2.8 to 4

greater risk of dying during the first 3 months after the fracture than do fracturefree individuals of similar age, gender, and health status. Individuals who survive

a hip fracture often suffer pain, loss of independence, and a reduced quality of

life. For example, only 15% of patients are able to walk across a room without

assistance six months after a hip fracture.1 It is estimated that 1 in 5 individuals

who suffer a hip fracture is forced to enter a nursing home.4 Further, hip fractures

often initiate a downward spiral in health; 24% of individuals who suffer a hip

fracture die within a year of the fracture.1

Two major risk factors for the presence and severity of osteoporosis are gender

and increasing age. Eighty-percent (80%) of those affected by osteoporosis are

women.1 Osteoporosis strikes mainly postmenopausal women in their 60s, 70s,

and 80s and the percentage of women with osteoporosis increases markedly with

age. Nearly 70% of white women age 80 and older have osteoporosis.1

Another major risk factor for osteoporosis is personal history. Individuals who
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Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

experienced a fracture in adulthood are at high risk of experiencing a subsequent

fracture. Because of this relationship, it is recommended that any individual with

a history of a low-trauma fracture should be assessed for osteoporosis if they have

not been previously evaluated.4 Unfortunately, many of those at risk for

subsequent fractures fail to be evaluated and treated for osteoporosis.

Other major risk factors for osteoporosis include low body weight, no current use

of estrogen, and Caucasian descent. Physical inactivity, tobacco use, weight loss, a

family history of osteoporosis and osteoporotic fractures, alcohol and caffeine use,

and insufficient calcium or vitamin D intake are also risk factors.4

Certain medications, particularly glucocorticoids and other steroids, can induce

osteoporosis. Other medications such as those used to treat rheumatoid arthritis,

endocrine disorders, and seizure disorders may also increase an individual’s risk of

osteoporosis.

Rates of osteoporosis vary by ethnicity. The prevalence of osteoporosis is highest

in elderly white women. African-American women experience osteoporosis at half

the rate of white women, but other ethnic minorities such as Mexican-Americans

experience rates similar to whites.3

Value of Prevention

The economic burden of fractures resulting from osteoporosis is substantial. Each

year there are approximately 1.5 million osteoporotic fractures in the United

States, which result in more than 500,000 hospitalizations, over 800,000

emergency room visits, more than 2,600,000 physician office visits and nearly

180,000 nursing home admissions. Hip fractures are the most severe osteoporotic

fracture, accounting for 60% of all osteoporotic hospitalizations each year.4 A

recent study that analyzed a private insurance claims database and the Medicare

Supplemental and Coordination of Benefits (COB) database, found that

osteoporosis patients with concurrent fractures represent just 7% of all

osteoporosis patients but are responsible for 61% of the costs attributable to the

disease.10 The estimated annual direct-care expenditure for osteoporotic fractures

ranges from $12 billion to $18 billion (in year 2002 dollars).4 In 2001, the cost

of osteoporotic care delivered in hospitals and nursing homes totaled $17 billion.5

The indirect costs associated with osteoporosis have not been well-studied but

would likely raise the direct cost estimates by several billion dollars.1

Osteoporosis dramatically reduces an individual’s functional status. Many

individuals who suffer fractures are unable to care for themselves during their

recuperation, and some are unable to care for themselves ever again. The burden

of care often falls on family members who must take time off work to care for

affected parents or spouses. Osteoporosis can thus be a direct or indirect cause of

lost productivity and absenteeism. While it is rare for working-age adults to suffer

severe fractures as a result of osteoporosis, it can — and does — happen,

resulting in lost work time and possibly long-term disability. As the workforce

ages, the workplace burden of osteoporosis is certain to increase unless preventive

measures are implemented.
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EVIDENCE-STATEMENT: Osteoporosis (Screening and Treatment)

Economic Benefit of

Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of 

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

and Treatment

Benefits and Risks 

of Intervention

The economic benefits of screening for osteoporosis mainly result from decreases

in treatment and rehabilitation costs associated with a reduction in osteoporotic

fractures. A full analysis of the economic benefits of screening and early

treatment should also include averted mortality and morbidity costs.

The cost of screening for osteoporosis varies depending on locality, provider type,

and measurement tool used. In 2004, the private-sector cost of the initial health

risk assessment averaged $23 and approximately 95% of all paid claims fell

within the range of $0 to $81.11 In 2004, the private-sector cost of osteoporosis

screening, bone density scans, and ultrasonography averaged $55 and

approximately 95% of all paid claims fell within the range of $0 to $132.11

The cost of treatment varies substantially depending on the type of medication

used and its dosage. Average wholesale price (AWP) figures are noted below for a

1-month supply of FDA-approved medications for the treatment of osteoporosis.12

Drug Name 2006 Average Wholesale Price (AWP) 

alendronate (Fosomax®) $72.23

calcitonin (Miacalcin®) $47.08

ibandronate (Boniva®) $80.90

parathyroid hormone (Forteo®) $608.72

raloxifene (Evista®) $80.64

risedronate (Actonel®) $64.28 (dose pack)

risedronate (Actonel®) $68.86 (daily)

A recent study found that, compared to no intervention, universal screening with

bone densitometry combined with alendronate therapy for those diagnosed with

osteoporosis is highly cost-effective for women aged 65 years and older and may

be cost-saving for ambulatory women age 85 and older.5

Preventive Intervention Information

Screening for osteoporosis allows clinicians to identify affected patients and begin

treatment early in the course of disease. Established treatments can reduce bone

loss and improve bone density, thereby reducing the risk of fractures and their

associated complications. 

While no controlled studies have specifically evaluated the effect of screening for

osteoporosis on fracture-related mortality, screening does offer the opportunity to

intervene early in the course of disease and prevent further weakening of the

bones, thus reducing an individual’s risk of fracture.

Screening for and treating osteoporosis does carry risks. Women who are

diagnosed with osteoporosis report increased fear and anxiety in their daily lives.

As with all screening tests, false-positive results can precipitate unnecessary

treatment.7 In the past, women who were screened for osteoporosis were more

likely to begin hormone replacement therapy than women who were not screened.
Hormone replacement therapy (HT) carries additional risks. Some of the

medications used to treat osteoporosis increase the risk of other serious medical

complications such as gastrointestinal disorders, ulcer disease, thromboembolic

events, endometrial cancer, and cholecystis.3 Despite these risks, experts agree that

the benefits of screening for osteoporosis and treating osteoporosis in its earliest

stages have substantial benefits that outweigh the risks involved. 

Screening for osteoporosis should begin for normal-risk women at age 65 and for

high-risk women at age 60. The benefits of screening increase with age because

osteoporosis affects older women more frequently than younger women and because

osteoporosis is more likely to result in fractures in older women.3 The age at which

screening no longer offers substantial benefit is not known and there is little

information on screening or treating women over the age of 85 for osteoporosis.

Clinicians should cease screening for osteoporosis when a woman and her physician

agree that the risks of screening outweigh the benefits of screening. Although there is

not yet wide consensus regarding screening in men, some groups have recommended

screening healthy men starting at age 70, with earlier testing of men with risk factors

such as fracture, primary hyperparathyroidism, or use of GNRH agonists or

glucocorticoids.4

The optimal interval for screening has not been established. Evidence suggests

that screening intervals of no less than 2 years is reasonable because the bone

density tests are not precise enough to measure a change in bone density reliably

in a shorter period of time. Evidence suggests that less frequent screening may be

reasonable in younger women.7

Medications used to treat osteoporosis should be used — and covered — as

prescribed by a clinician. 

Several methods of screening for osteoporosis are currently used. The best

predictor of hip fracture is the dual-energy x-ray absorptiometry of the hip

(DXA). Other bone density tests include DXA of the spine, whole body or

forearm, ultrasound, radiographic absorptiometry, single-energy absorptiometry,

peripheral dual-energy x-ray absorptiometry, and peripheral quantitative

computed tomography.3 The likelihood of a diagnosis of osteoporosis depends on

the type of measurement tool used, the site of the measurement, the number of

sites tested, the brand of the measurement tool, and the relevance of the reference

range.3

Physician- or self-administered verbal or written screening instruments used to

detect and assess the risk of low bone density generally have high sensitivity but

low specificity; therefore false-positive results are a greater problem than falsenegative results. One validated instrument is the Osteoporosis Risk Assessment

Instrument (ORAI), a 3-item tool that uses an individual’s age, weight, and

hormone replacement therapy history to quantify the risk of osteoporosis.

Another instrument is the Simple Calculated Osteoporosis Risk Estimation tool

(SCORE), a similar 6-item measure of risk based on age, weight, ethnicity,

estrogen use, presence of rheumatoid arthritis, and history of fractures.3

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Initiation, Cessation,

and Interval 

Screening

Treatment

Intervention Process

Screening
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EVIDENCE-STATEMENT: Osteoporosis (Screening and Treatment)

Treatment

Treatment

Information

Health benefits should include provisions for treatment services. 

Osteoporosis can be effectively treated with medication to improve bone density

and reduce the risk of fractures. The Food and Drug Administration (FDA) has

approved the following classes of medications for the treatment of osteoporosis4,7: 

• Bisphosphonates such as alendronate (Fosomax®), risedronate (Actonel®),

and ibandronate (Boniva®)

• Selective estrogen receptor modulators (SERMs) such as raloxifene

(Evista®)

• Calcitonin (Miacalcin®)

• Parathyroid hormone (Forteo®)

Any decision to use hormone therapy (HT) must take into consideration its

impact on overall health outcomes, including its potential to reduce the risk of

fractures and its potential to increase the risk of other health problems. The FDA

has advised that postmenopausal women who use, or are considering using,

estrogen or estrogen with progestin discuss the therapy’s benefits and risks with

their physicians. These products are approved therapies for relief from moderate

to severe hot flashes and symptoms of vulvar and vaginal atrophy. Although HT

is effective for the prevention of postmenopausal osteoporosis, it should only be

considered for women at significant risk of osteoporosis who cannot take nonestrogen medications. The FDA recommends that estrogens and progestins

should be used at the lowest possible doses for the shortest amount of time

needed to achieve treatment goals. It is not yet clear whether following this

advice will lead to long-term benefits for bone health.4

Note: The USPSTF recommends against (“D” rating) routine use of HT to

prevent chronic diseases in postmenopausal women because the harmful effects of

unopposed estrogen are likely to exceed the chronic disease prevention benefits in

most women.13

Because the purpose of treating osteoporosis it to prevent the poor health outcomes

associated with fractures, treatment is considered a preventive intervention. Please

refer to “Intervention Process” for information on treatment services. 

In addition to medications, physical activity, in general, and resistance-weighttraining, in particular, is very helpful in preventing fractures. Resistance training

helps retard bone loss. Moreover, physical activity reduces the risks of falls by a

variety of mechanisms (e.g., increased agility, increased strength, etc), thereby

indirectly influencing fracture rates. While there is no direct mechanism for

purchasers to cover the promotion of physical activity through health plan

benefits, purchasers should encourage their at-risk beneficiaries to partake in

physical activity.
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EVIDENCE-STATEMENT: Osteoporosis (Screening and Treatment)

Authored by: 

Campbell KP, Lanza A, Looker A. Osteoporosis evidence-statement: screening and treatment.

In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s 

Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National 

Business Group on Health; 2006.

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendations contained 

in this chapter is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

• The USPSTF found good evidence to support screening all women over the

age of 65 for osteoporosis. The Task Force also recommends that clinicians

screen women at high-risk of osteoporosis beginning at age 60. Age and lower

body weight (less than 70 kg) are the best predictors of low bone density.

There is some evidence to support other risk factors, such as: white race,

smoking, weight loss, family history, decreased physical activity, alcohol or

caffeine use, or low calcium and vitamin D intake.6

Food and Drug Administration (FDA)

Strength of Evidence: FDA approved drug therapies have been shown through

clinical trials to effectively reduce osteoporotic or fragility fractures at various sites

in the body.

• The Food and Drug Administration (FDA) has approved the following classes

of medications for the treatment of osteoporosis4,7: 

• Bisphosphonates such as alendronate (Fosomax®), risedronate (Actonel®),

and ibandronate (Boniva®)

• Selective estrogen receptor modulators (SERMs) such as raloxifene

(Evista®)

• Calcitonin (Miacalcin®)

• Parathyroid hormone (Forteo®)
References:

1. National Osteoporosis Foundation. Fast facts on osteoporosis. National Osteoporosis Foundation; 2005 [cited 2005 Mar 28].

Available from: http://www.nof.org/osteoporosis/diseasefacts.htm. 

2. Agency for Healthcare Research and Quality. What’s new from the U.S. Preventive Services Task Force. Screening for

osteoporosis in postmenopausal women. AHRQ Publication No. APPIP02-0025. Rockville, MD: Agency for Healthcare

Research and Quality; September 2002.

3. Berg AO, Atkins D. Screening for osteoporosis in postmenopausal women: Recommendations and rationale. U.S. Preventive

Services Task Force. Ann Intern Med 2002;137(6): 526-528.

4. U.S. Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville,

MD: U.S. Department of Health and Human Services, Office of the Surgeon General; 2005.

5. Cummings SR, Melton LJ. Epidemiology and outcomes of osteoporotic fractures. Lancet 2002; 359: 1761-67.

6. U.S. Preventive Services Task Force. Screening for osteoporosis. Summary of recommendations. Rockville, MD; Agency for

Healthcare Research and Quality; 2002 [cited 2006 Oct 2]. Available from: http://www.ahrq.gov/clinic/uspstf/uspsoste.htm. 

7. Nelson HD, Helfand M, Woolf SH, Allan JD. Screening for postmenopausal osteoporosis: A summary of the evidence. Ann

Intern Med 2002; 137(6): 529-541.

8. Campion JM, Maricic MJ. Osteoporosis in men. Am Fam Physician 2003; 67:1521-6.U.S. Preventive Services Task Force.

Osteoporosis screening. Summary of recommendations / Supporting documents. Clinical Guide to Clinical Preventive Services

3rd ed. Rockville, MD: Agency for Healthcare Research and Quality.

9. U.S. Preventive Services Task Force. Osteoporosis screening. Summary of recommendations / Supporting documents. Clinical

Guide to Clinical Preventive Services 3rd ed. Rockville, MD: Agency for Healthcare Research and Quality.

10. Orsini LS, Rousculp MD, Long, SR, Wang S. Health care utilization and expenditures in the United States: a study of

osteoporosis-related fractures. Osteoporos Int 2005; 16: 359-371.

11. Thomson Medstat. Marketscan. 2004.

12. Fleming T. 2006 Redbook: Pharmacy’s Fundamental Reference. Thomson PDR; Rev Ed edition. May 2006.

13. U.S. Preventive Services Task Force. Hormone therapy for the prevention of chronic conditions in postmenopausal women:

Recommendation statement. AHRQ Publication No. 05-0576. Rockville, MD: Agency for Healthcare Research and Quality;

May 2005 [cited 2006 Oct 2]. Available from: http://www.ahrq.gov/clinic/uspstf05/ht/htpostmenrs.htm. 

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392
393

Why This Chapter is

Important for

Employers: 

An Overview 

This chapter covers screening and counseling interventions for the following

sexually transmitted infections: chlamydia, gonorrhea, human immunodeficiency

virus (HIV), and syphilis.

• Sexually transmitted infections (STIs) are among the most common infections

that occur in the United States today, and they affect men and women of all

backgrounds and economic levels. 

• Untreated STIs can result in significant complications including major

infections, infertility, and death. 

• Screening allows for early identification and treatment, which improves

outcomes and can prevent transmission of infections to others. Generally, early

treatment is also less expensive. For example, the baseline cost of treating earlystage syphilis was estimated to be $41.26 (in year 2001 dollars) compared to

$2,061.70 for late-stage syphilis.1

• Sexually transmitted infections are a substantial economic burden to the U.S.

healthcare system and to employers.

• The most recent estimate of the annual cost of chlamydial infection and its

sequelae is $460 million.2

• In women, some STIs can progress to pelvic inflammatory disease (PID). A

conservative estimate of $1,334, based on a national insurance claims dataset,

was reported as the cost per case of PID in year 2000 dollars.2 The average

lifetime cost for women who develop major complications of PID is $6,350 for

chronic pelvic pain, $6,840 for an ectopic pregnancy, and $1,270 for

infertility. Approximately 79% of these costs occur within 5 years of the

precipitating infection.3

• HIV/AIDS often affects people during their prime working years and

HIV/AIDS-induced morbidity and mortality can result in significant

economic losses to businesses. Considering only the changes in insurance

premiums, disability payments, unemployment benefits, retirement and

pension benefits, and lost productivity, a recent study found that, in 2002, an

asymptomatic HIV-infected employee would cost an employer in the United

States an estimated $37,320 and a symptomatic HIV-infected employee would

cost $50,347 per person-year.4

• Screening for sexually transmitted infections is especially important because

many people with STIs do not experience symptoms in the early phases of

disease. For example, it is estimated that 70% to 90% of women and a

substantial percentage of men with chlamydia do not have symptoms.5

Counseling to Prevent Sexually Transmitted

Infections(STIs) (Counseling)

Physicians and other healthcare providers play a critical role in preventing and

treating sexually transmitted infections (STIs).1 Clinicians have the opportunity

to provide client education and counseling and to participate in identifying and

treating persons with STIs as well as their infected sex partners.

EVIDENCE-STATEMENT:

SEXUALLY TRANSMITTED INFECTIONS 

(Screening and Counseling)
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EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/

Good Evidence)

CDC

Recommendation

Evidence Rating:

Information Sources

The USPSTF recommends that clinicians educate all adolescents and adults on

the risk factors for HIV and other sexually transmitted infections (STIs) and

counsel patients on effective measures to reduce their risk of infection.

Counseling should be tailored to the needs of the individual and should take into

consideration the abilities of each patient.2

Interactive counseling approaches directed at a patient’s personal risk, the

situations in which risk occurs, and use of goal-setting strategies are effective in

STI prevention.3 Results from randomized controlled trials demonstrate that,

compared with traditional approaches to providing information, certain brief

risk-reduction counseling approaches can reduce the occurrence of new sexually

transmitted infections by 25% to 40% among STI clinic patients.4

Physicians and other providers should counsel their sexually active patients on

the following STIs: chlamydia, gonorrhea, hepatitis B, HIV, and syphilis.

Chlamydia (Screening)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) strongly recommends that

clinicians routinely screen all sexually active women aged 25 years and younger

for chlamydia.1 Other asymptomatic women at increased risk (e.g., prior history

of a sexually transmitted disease, having cervical ectopy, having multiple or new

sex partners, using barrier contraceptives inconsistently) should also be screened

for chlamydial infection. However, the USPSTF suggests clinicians consider the

characteristics of the communities they serve, particularly prevalence information,

in determining appropriate screening strategies.

The USPSTF found good evidence that screening women at risk for chlamydial

infection reduces the incidence of pelvic inflammatory disease (PID) and fair

evidence that community-based screening reduces prevalence of chlamydial

infection. The USPSTF concluded that the benefits of screening substantially

outweigh the potential harms, such as adverse effects of a false-positive or falsenegative diagnoses on patients and their partners, and adverse reactions to

antibotic treatment.1

CDC also recommends screening all sexually active women aged 25 years and

younger and older women with risk factors (e.g., those who have a new sex

partner or multiple sex partners).2 All pregnant women should be routinely tested

at the first prenatal visit. Pregnant women aged 25 years and younger and those

at increased risk should be re-tested during the third trimester to prevent

maternal postnatal complications and chlamydial infection in the infant.2

Not Specified

The recommendations and supporting information contained in this document

came from several sources, including the:
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EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Chlamydia is the most commonly reported bacterial STI in the United States. In

2004, 930,000 cases of chlamydia were reported by state health departments in

the United States; a 5% increase compared to 2003.3 If untreated, chlamydia can

result in significant complications in both men and women.

Among women, 20% to 40% of cases of untreated chlamydia infection may

progress to pelvic inflammatory disease (PID), a serious condition resulting in

chronic pelvic pain, an increased risk of ectopic pregnancy due to scaring of the

fallopian tubes, and infertility.4 Approximately 8% of U.S. women are diagnosed

with PID in their lifetime, and over 1 million women are treated for PID each

year.5 Among pregnant women, there is some evidence that chlamydial infection

increases the risk of pregnancy complications including premature rupture of the

membranes, pre-term delivery, low-birth-weight infants, and postpartum

endometritis. A chlamydial infection can be transmitted to an infant by an

infected mother during labor and delivery and may cause neonatal conjunctivitis

(a severe eye infection) and/or pneumonia. 

In men, untreated chlamydia infection can lead to urethritis or acute

epididymitis, which can result in infertility, chronic prostatitis, reactive arthritis,

and problems with the urethra.6

Infection with chlamydia increases both men and women’s susceptibility to HIV.

Adolescents (of both sexes) and women under the age of 20 are at the highest risk

for chlamydial infection; the highest reported rates occur in girls aged 15 to19

years.7 Chlamydial infections are also prevalent among women aged 20 to 25

years.6 The prevalence of chlamydia is also higher among African-American

populations and among individuals who are unmarried, have a prior history of

STIs, have multiple sexual partners, suffer from cervical ectopy, and/or who use

barrier contraceptives incorrectly or inconsistently.6

Value of Prevention

The most recent estimate of the annual cost of chlamydial infection and its

sequelae is $460 million.8 The lifetime medical cost of chlamydia has been

estimated at $20 per case for men and $244 per case for women (in year 2000

dollars).8
Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost 

of Preventive

Intervention

Estimated Cost 

of Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

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EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Up to 40% of untreated and 6% of treated cases of acute chlamydia may progress

to pelvic inflammatory disease (PID), a serious condition that is expensive to

treat. It is estimated that treatment for a single case of PID costs between $1,060

and $3,626.9 A conservative estimate of $1,334, based on a national insurance

claims dataset, was reported as the cost per case of PID in year 2000 dollars.9

The reproductive and other health problems of chlamydia impose a significant

cost to employers by way of health and disability insurance costs. The lifetime

productivity losses for young working-age adults suffering from the long-term

health effects of chlamydial infection are high. An untreated case of chlamydia is

estimated to result in $130 in lost productivity costs and an acute case of PID is

estimated to result in $632 in lost productivity costs (in year 2001 dollars).10

Because screening allows for the early recognition of disease and subsequently an

earlier initiation of treatment, it can prevent the costly complications of late-stage

disease such as PID and infertility. 

In 2004, the private-sector cost of chlamydia screening averaged $42;

approximately 95% of all paid claims fell within the range of $0 to $87.11

The estimated direct cost (including office visits, diagnostic testing, and

medication) of acute care ranges from $23 to $109 per case.8

Annual screening among women 15 to 29 years of age followed by semiannual

screening for those with a history of infection was estimated to cost less than

$25,000 per quality-adjusted life year (QALY) compared with the annual

screening only.12

A review of 10 cost-effectiveness studies found that screening was more costeffective than simply testing symptomatic women. The models showed that in

some instances, screening was cost-saving (compared to testing symptomatic

women) even at prevalence rates as low 1.1%.10

Preventive Intervention Information

Screening for chlamydia allows clinicians to identify affected patients and begin

treatment earlier in the course of disease, thereby improving outcomes and

avoiding the health and economic consequences of latent disease such as PID and

infertility. In fact, a recent well-designed randomized trial demonstrated that

screening women at risk for chlamydia reduces the incidence of PID by 50%.13

Routine screening for chlamydia is especially important because of its

asymptomatic nature. It is estimated that 70% to 90% of women (and a

substantial percentage of men) with chlamydia do not have symptoms.6 
Few studies have documented the risks associated with screening for chlamydia.

Potential risks include partner discord, stigma, and side effects of treatment. As

with all types of screening, the risk of false-positive results may cause undue

anxiety or unnecessary treatment. The benefits of screening for chlamydia

substantially outweigh the harms. Screening allows for early recognition and

treatment, reducing complications and long-term effects. Screening programs can

lead to reduced person-to-person transmission of infection and can substantially

lower infection rates at the population level; states implementing new screening

programs have reported up to a 67% decrease in new chlamydial infection rates.7

Reducing the rate of chlamydia within a population has substantial positive

health effects including lower rates of PID.

Average-risk women should be screened annually from the onset of sexual activity

through age 25. Women with known risk factors and women who have

experienced a previous infection should continue screening beyond the age of 25,

as medically indicated. Re-screening at 6 to 12 months may be appropriate for

previously infected women because of high rates of reinfection.6

Asymptomatic sex partners of individuals infected with chlamydia should also be

screened.

The optimal time for screening during pregnancy is unknown. Screening for

chlamydia early in pregnancy offers greater opportunities in reducing the risk of

low birth weight and premature delivery. However, screening during the third

trimester is thought to be more effective in preventing transmission to the infant

during labor and delivery. 

Several effective methods of screening for chlamydia are currently available6: 

• Nucleic acid amplification tests (NAAT) such as polymerase chain reaction

(PCR), strand displacement assay (SDA), and transcription-mediated

amplification (TMA) on endocervical/urethral or urine specimens. 

• Non-amplified nucleic acid hybridization tests on endocervical specimens.

• Culture analysis of an endocervical or urethral swab.

• Antigen detection tests such as direct fluorescent antibody (DFA) assay and

enzyme immunoassay (EIA) on endocervical specimens.

• Point-of-care antigen detection tests on endocervical specimens and leukocyte

esterase on urine.

• Culture of swab specimens from exposed sites urethra (male), endocervix,

throat, or rectum (male).

Health benefits should include provisions for diagnostic and treatment services.

Treatment, usually a 7-day course of oral antibiotics or a single dose of

azithromycin, is easy, inexpensive, and noninvasive. Side effects of treatment

(gastrointestinal distress, nausea) occur infrequently. Moreover, treatment is

highly effective (97% of nonpregnant women and men treated for chlamydia are

cured).6

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EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening

Intervention Process

Treatment

Information
398

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: B

(Recommended/

At Least Fair

Evidence)

Information Sources

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendation in this section is 

described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The USPSTF found good evidence to support routine screening of all sexually

active women age 25 years and younger and other asymptomatic women at

increased risk for infection.1

Centers for Disease Control and Prevention (CDC)

Strength of Evidence: Not Specified

• CDC recommends screening all sexually active women aged 25 years and

younger and older women with risk factors (e.g., those who have a new sex

partner or multiple sex partners).2 All pregnant women should be routinely

tested at the first prenatal visit. Pregnant women aged 25 years and younger

and those at increased risk should be re-tested during the third trimester to

prevent maternal postnatal complications and chlamydial infection in the

infant.2

Gonorrhea (Screening)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians

screen all sexually active women, including those who are pregnant, for

gonorrhea infection if they are at increased risk for infection (that is, if they are

young or have other individual or population risk factors).1

The U.S. Preventive Services Task Force found at least fair evidence that

screening tests can accurately detect gonorrhea infection and good evience that

antibiotics can cure gonorrhea infection. There is at least fair evidence that

screening pregnant women at high risk for gonorrhea, including women at high

risk because of younger age, may prevent other complications associated with

gonococcal infection during pregnancy, such as preterm delivery and

chorioamnionitis.1

The recommendations and supporting information contained in this document

came from several sources, including the:

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research

• U.S. Preventive services Task Force (USPSTF)
399

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Approximately 335,000 cases of gonorrhea were reported by state health

departments in the United States in 2004, a slight decrease when compared to

2003 data.2

Complications of gonorrhea for women include pelvic pain, pelvic inflammatory

disease (PID), ectopic pregnancy, and infertility. Pregnant women infected with

gonorrhea are at an increased risk for pregnancy complications such as

chorioamnionitis, premature rupture of membranes, preterm labor, and

stillbirth.3 Infected women may also pass the disease to their infants during

pregnancy, labor, and delivery. Gonococcal opthalmia can cause conjunctivitis

leading to corneal scarring and blindness. 

In men, gonorrhea can cause urethritis or epididymitis, but few serious or longterm complications. 

Gonorrhea also increases both men and women’s susceptibility to other STIs,

including HIV. 

Risky sexual behavior is the major risk factor for gonorrhea. As with most STIs,

younger populations are at highest risk. The highest reported rates of gonorrhea

are among female adolescents 15 to 19 years of age and adult males and females

20 to 24 years of age.1 The rate of gonorrhea among African-Americans is 20

times higher than the rate among whites.1 Persons with other types of STIs (e.g.,

chlamydia) may be more susceptible to contracting gonorrhea. 

Value of Prevention

The lifetime medical care cost of gonorrhea has been estimated at $53 per case for

men and $266 per case for women (in year 2000 dollars).4

In addition medical and disability-related costs, the workplace burden of the

disease includes:

• Productivity losses among gonorrhea-infected employees; 

• Direct medical costs for infected adolescents who are covered by their parent’s

insurance plan; and

• Productivity losses associated with the time employee caregivers dedicate to

attending to sick dependents (i.e., children or spouses). 

Because screening for gonorrhea allows for the early recognition of disease and

leads to earlier treatment, it may prevent the costly complications of late-stage

disease such as PID. The average lifetime cost of PID has been estimated to range
400

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks of

Intervention

Initiation, Cessation,

and Interval of

Screening

from $1,060 to $3,626 in year 2000 dollars.4 The average lifetime cost for

women who develop major complications of PID is $6,350 for chronic pelvic

pain, $6,840 for an ectopic pregnancy, and $1,270 for infertility; 79% of these

costs have been found to occur within 5 years of the precipitating infection.5

In 2004, the private-sector cost of screening for gonorrhea screening averaged

$17; approximately 95% of paid claims fell within the range of $0 to $63.6

The cost of treatment for gonorrhea will vary depending on the type of antibiotic

chosen. 

A recent study that focused on gonorrhea screening in urban emergency

departments found that screening women between 15 and 29 years of age using

urine-based nucleic acid amplification tests (NAAT) saved $177 (in year 2002

dollars) per patient compared to no screening.7

Preventive Intervention Information

Screening for gonorrhea allows clinicians to identify affected patients and begin

treatment earlier in the course of disease, thus potentially improving outcomes

and avoiding the health and economic consequences of latent disease. Screening

is particularly important for women because many women who are infected with

gonorrhea have no symptoms and are thus unaware of their condition.8

The benefits of screening for gonorrhea are substantial. Screening allows for early

recognition and treatment, dramatically reducing complications, other long-term

effects, and the transmission of the infection to others. Few studies have

documented the risks associated with screening for gonorrhea. Possible risks

include partner discord, stigma, opportunity costs (in terms of time and

resources) for both the clinician and the patient, and side effects of treatment. As

with all types of screening, the risk of false-positive results may cause undue

anxiety or unnecessary treatment. The USPSTF found that the benefits of

screening outweigh the risks associated with screening.1

Routine screening for gonorrhea is recommended for all women under the age of

25 and women over the age of 25 who are at risk of infection, especially women

who are in one or more of the following established high-risk groups: commercial

sex workers, women with a prior history of gonorrhea, and women who live in

regions where infection rates are high. 

The frequency of screening is left to the discretion of the provider and should be

based on the individuals’ risk factors and previous history of STIs. 

All pregnant women at risk for gonorrhea should be screened during the first

trimester, ideally during the first prenatal care visit. Pregnant women at

continued risk of infection should be re-screened again during the third

trimester.1
401

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Intervention Process

Treatment

Information

Special Notice

Several effective methods of screening for gonorrhea are currently available1:

• Culture of swab specimens from exposed sites (urethra [male], endocervix,

throat or rectum [male]).

• Nucleic acid amplification assays such as polymerase chain reaction (PCR),

strand displacement assay (SDA), and transcription-mediated amplification

(TMA) on genital swab or urine specimens. 

• Microscopic examination of Gram-stained urethral or cervical specimen.

• Non-amplified nucleic acid hybridization tests on genital swab specimens. 

• Point-of-care antigen detection tests on genital swab specimens and urine

dipstick for leukocyte esterase (LE).

Gonorrhea can be effectively treated with antibiotics. Health benefits should

include provisions for diagnostic, follow-up, and treatment services. 

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendation in this section is 

described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: B (Recommended/At Least Fair Evidence)

• The U.S. Preventive Services Task Force found at least fair evidence that

screening tests can accurately detect gonorrhea infection and good evidence

that antibiotics can cure gonorrhea infection. There is at least fair evidence that

screening pregnant women at high risk for gonorrhea, including women at

high risk because of younger age, may prevent other complications associated

with gonococcal infection during pregnancy, such as preterm delivery and

chorioamnionitis.1

Human Immunodeficiency Virus (HIV)

(Screening and Counseling)

Clinical Preventive Service Recommendations

This special notice is included to alert readers about differences between Centers

for Disease Control and Prevention (CDC) and U.S. Preventive Services Task

Force (USPSTF) HIV screening recommendations for individuals who are not at

increased risk for HIV infection. 

In 2006, the CDC issued new HIV testing guidance for healthcare settings that

recommends screening all patients aged 13 to 64 years for HIV. In 2005, the

USPSTF considered HIV screening and issued a “C”-rating, thereby making no

recommendation for or against routinely screening adults and adolescents who

are not considered to be at increased risk for HIV infection. 
The Purchaser’s Guide recommendation reflects the broader CDC

recommendation. The CDC recommendation is preferred because clinicians are

not consistently able to distinguish between high- and no-risk testing candidates1-2

and because spread often occurs between individuals who do not know that they

are infected.3

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians

screen all adolescents and adults with an increased risk of infection for human

immunodeficiency virus (HIV). Increased risk is defined by the USPSTF as

having one or more individual risk factor STIs or receiving healthcare in a highprevalence or high-risk clinical setting. Please refer to the “Condition/Disease

Risk Factors” section for additional information.4

The USPSTF recommends that clinicians screen all pregnant women for HIV.4

The USPSTF found good evidence that both standard and U.S. Food and Drug

Administration (FDA)-approved rapid screening tests accurately detect HIV

infection. The USPSTF also found good evidence that appropriately timed

clinical intervention, particularly highly active antiretroviral therapy (HAART),

lead to improved health outcomes for many of those screened, including reduced

risk for clinical progression and reduced mortality.4

The USPSTF found good evidence that both standard and FDA-approved rapid

screening tests accurately detect HIV infection in pregnant women and fair

evidence that the introduction of universal prenatal counseling and voluntary

testing increases the proportion of HIV-infected women who are diagnosed and

are treated before delivery. There is good evidence that recommended regimens of

HAART are acceptable to pregnant women and lead to significantly reduced

rates of mother-to-child transmission.4

The Centers for Disease Control and Prevention (CDC) recommends that

providers screen all patients aged 13 to 64 years for HIV unless prevalence of

undiagnosed HIV infection among the provider’s patient population has been

documented to be less than 0.1%.5

Subsequent HIV tests should be provided to all persons likely to be at high risk

(i.e., sex partners of HIV infected persons, men who have sex with men,

heterosexuals who themselves or whose sex partners have had a new sex partner

or more than one sex partner since their most recent HIV test, injection drug

users, and persons who exchange sex for money or drugs) all patients seeking

treatment for an STI, and those who are initiating a new sexual relationship.5

The Centers for Disease Control and Prevention (CDC) also recommends that

clinicians screen all pregnant women for HIV.6 

CDC recommendations were developed with guidance from the scientific

literature and expert technical opinion. Information was also drawn from a

survey CDC conducted with HIV CTR practitioners. Internal CDC edits and

public comments were obtained.5 

402

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/Good

Evidence)

Evidence Rating: A

(Strongly

Recommended/Good

Evidence)

CDC

Recommendation

Evidence Rating:
The recommendations and supporting information contained in this document

came from several sources, including the:

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Human immunodeficiency virus (HIV), the virus that causes acquired immune

deficiency syndrome (AIDS), is a retrovirus that attacks helper T cells of the

immune system. It causes immune deficiency because it reduces the number and

functionality of CD4 lymphocytes. HIV is transmitted when the infected blood,

semen, or vaginal secretions of an infected person comes into contact with the

broken skin or mucous membranes of an uninfected person. Infected pregnant

women can pass HIV to their babies during pregnancy or delivery, or when

breastfeeding. 

HIV is known to affect between 1,039,000 and 1,185,000 persons in the United

States; a quarter of those infected with the virus are unaware of their status.7

There are approximately 40,000 new HIV infections diagnosed each year in the

United States.8 Untreated HIV infection eventually develops into AIDS and

ultimately leads to death.9 More than 500,000 people in the United States have

died from AIDS; 18,000 in 2003 alone.8

While antiretroviral therapies can slow the damage that HIV does to the body’s

immune system by decreasing the amount of virus is the body, HIV infection is

not curable. An HIV-positive person will develop AIDS when CD4 lymphocyte

levels have dropped so low as to allow opportunistic infections and/or cancers. 

HIV infection is more common in certain segments of the U.S. population.

There is some evidence that about half of all HIV infections are acquired by

those under the age of 25.6 Of newly diagnosed HIV infections in 2003, CDC

estimates that 63% were among men who have sex with men (MSM), 50% were

among blacks, 32% were among whites, and 16% were among Hispanics.10

Individual risk factors include: 

• Men who have had sex with men (MSM) after 1975.

• Men and women who have unprotected sex with multiple partners.

• Past or present injection drug users.

• Men and women who exchange sex for money or drugs or have sex partners

who do.

403

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Information Sources

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors
• Persons whose past or present sex partners were HIV-infected, bisexual, or

injection drug users.

• Persons being treated for sexually transmitted infections (STIs).

• Persons with a history of blood transfusion between 1978 and 1985. 

Persons who request an HIV test despite reporting no individual risk factors may

also be considered at increased risk. High-risk settings include STI clinics,

correctional facilities, homeless shelters, tuberculosis clinics, clinics serving men

who have sex with men, and adolescent health clinics with a high prevalence of

STIs. High-prevalence settings are defined by the CDC as those known to have a

1% or greater prevalence of infection among the patient population being served.

Value of Prevention

The economic burden of HIV in the United States is substantial. The average

lifetime cost per case (in year 2000 dollars) is estimated at $199,800.11

Accounting for the 15,000 new cases reported annually among 15 to 24-yearolds, the total direct cost of HIV in the United States was approximately $3.0

billion in 2000.11

HIV/AIDS often affects people during their prime working years and

HIV/AIDS-induced morbidity and mortality can result in significant economic

losses to businesses. Considering only the changes in insurance premiums,

disability payments, unemployment benefits, retirement and pension benefits,

and lost productivity, a recent study found that, in 2002, an asymptomatic HIVinfected employee would cost an employer in the United States an estimated

$37,320 and a symptomatic HIV-infected employee would cost $50,347 per

person-year.12

Earlier diagnosis of HIV infection is associated with less expensive treatment. For

those with CD4 counts greater than 500, monthly expenditures for treatment

total approximately $500. This figure increases to $2,300 per month for those

with CD4 counts less than 50. Generally, the earlier HIV infection is detected,

the higher the CD4 count.13

In 2004, the private-sector cost of HIV screening averaged $23; approximately

95% of all paid claims fell within the range of $4 to $75.14 In 2004, the privatesector cost of HIV counseling averaged $39 and approximately 95% of all paid

claims fell within the range of $0 to $129.14

The average annual cost of treating an HIV-infected patient is estimated to range

between $18,000 and $20,000.15

Researchers studied the costs associated with screening and treating HIV/AIDS

in pregnant women and found that universal screening can be cost-saving in this

population. For example, compared to no screening, a universal screening

program targeting pregnant women would save an estimated $3.69 million

dollars and prevent 64.6 cases of pediatric HIV infection for every 100,000

pregnant women screened.16 404

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention
405

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Preventive

Intervention: 

Purpose of Screening

Purpose of

Counseling

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval

Screening

Counseling

Intervention Process

Screening

Preventive Intervention Information

Screening allows for the earlier diagnosis of HIV infection, which is associated

with less expensive treatment, better health outcomes, and reduced risk of spread

of infection to other persons.

Counseling services are required to educate screening candidates on 1) the

benefits and risks of screening, 2) risk reduction strategies, and, for those who

screen positive, 3) treatment options.

The benefit of screening and counseling includes early diagnosis of HIV

infection, the potential for a longer life (due to earlier initiation of treatment),

and the opportunity to prevent disease transmission. Counseling also allows

prevention and risk-reduction messages to be conveyed. The benefits associated

with screening pregnant women are also substantial. Screening allows for early

detection and treatment and can prevent mother-to-child transmission. There is

no evidence of an increase in fetal anomalies or other fetal harm associated with

recommended antiretroviral regimens.4

Risks associated with screening for HIV include false-positive test results and

partner discord. Information about the effects of false-positive test results (e.g.,

anxiety, labeling) is predominately anecdotal. The standard method of diagnosing

HIV infection (a repeatedly-reactive enzyme immunoassay followed by

confirmation Western blot of immunoflourescent assay) has a 1 in 250,000 test

chance of false-positive identification in a low prevalence setting.8 Newer HIV

detection technologies, specifically the rapid HIV tests, are similar to traditional

tests with extremely low false-positive rates. False- and true-negative test results

may give false reassurance to those engaging in high-risk behavior, leading to its

continuation. Finally, notification of a positive HIV test can cause emotional or

psychological distress. 

Although no studies have evaluated the optimal frequency of screening for

HIV/AIDS, it is recommended that screening be conducted at the discretion of a

clinician with frequency determined by an individual’s risk factors and the

characteristics of the region in which the clinician practices.

All pregnant women should be screened as early as possible, ideally at the first

prenatal care visit.17 Pregnant women at high risk for infection or all women

living in an area with high HIV prevalence among women of childbearing age

should be re-tested during the third trimester.17

Counseling should be provided before and after screening, as medically indicated.

The standard method of screening for HIV/AIDS uses an enzyme immunoassay

on serum or plasma; if the enzyme immunoassay is repeatedly reactive, a

confirmatory Western blot or immunoflourescent assay is then performed.

Several HIV tests that provide results within 10 to 30 minutes are available. The
Food and Drug Administration (FDA) has also approved a home collection kit,

which uses a blood sample from a finger prick for testing purposes. 

There are three approved methods of screening for HIV, including:

• Repeatedly-reactive enzyme immunoassay followed by confirmatory Western

blot or immunoflourescent assay on serum or plasma.

• Rapid HIV tests with result in 10-30 minutes; two point-of-care rapid tests are

available (Uni-Gold Recombigen & Oraquick Advance) and one rapid test is

intended for laboratory use. 

• A home collection kit (Home Access) that uses a dried blood spot.

All patients should receive counseling and educational information on HIV and

HIV screening before they are screened. Patients that have behaviors that place

them at high risk for acquiring HIV infection (e.g., multiple sex partners, history

of STIs, substance abuse, etc) should be referred to an HIV risk-reduction service

(e.g., HIV centers with personnel trained in HIV counseling, drug treatment

centers, etc).18

Health benefits should include provisions for follow-up and treatment services. 

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendation in this section is 

described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The USPSTF found good evidence to support routine screening for HIV

among all adolescents and adults with an increased risk of infection for human

immunodeficiency virus (HIV).4

• The USPSTF found good evidence to support routine screening for HIV

among all pregnant women.4 

Recommended Guidance:

Centers for Disease Control and Prevention (CDC)

Strength of Evidence: CDC recommendations were developed with guidance

from the scientific literature and expert technical opinion. Information was also

drawn from a survey CDC conducted with HIV CTR practitioners. Internal

CDC edits and public comments were obtained.

• The CDC found good evidence to support routine screening for HIV among

all pregnant women.5

• The CDC found good evidence to support the provision of HIV-related

counseling, testing, and referral (CTR) to all patients on a routine basis to

ensure that those clients that may benefit from the service have the

opportunity to do so.5

406

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Counseling

Treatment

Information
407

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

U.S. Preventive

Services Task Force

Recommendation

Evidence Rating: A

(Strongly

Recommended/Good

Evidence)

A (Strongly

Recommended/Good

Evidence)

CDC

Recommendation

Information Sources

Epidemiology of

Condition/Disease

Syphilis (Screening)

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) strongly recommends that

clinicians screen all persons at increased risk for syphilis infection. Increased risk

includes men who have sex with men (MSM) and engage in high-risk sexual

behavior, commercial sex workers, persons who exchange sex for drugs, and those

in adult correctional facilities. Clinicians should consider the characteristics of the

communities they serve in determining appropriate screening strategies.1

The USPSTF strongly recommends that clinicians screen all pregnant women for

syphilis infection.1

Although the USPSTF found no new direct evidence that screening for syphilis

infection leads to improved health outcomes in persons at increased risk, there is

adequate evidence that screening tests can accurately detect syphilis infection and

that antibiotics can cure syphilis.1

The USPSTF found observational evidence that the universal screening of

pregnant women decreases the proportion of infants with clinical manifestations

of syphilis infection and those with positive serologies.1

CDC also recommends screening of all pregnant women, and all persons at

increased risk for syphilis infection, per the USPSTF definition.

The recommendations and supporting information contained in this document

came from several sources, including the:

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 

Condition/Disease Specific Information

Approximately 33,289 cases of syphilis were reported by state health departments

in the United States in 2004, a slight decrease when compared to 2003 data.2

Syphilis rates vary dramatically by region and are highest in the Southeastern

United States and in concentrated pockets of metropolitan areas such as Atlanta,

Baltimore, Chicago, Detroit, Indianapolis, Memphis, New Orleans, Newark,

Richmond, St. Louis, and Washington, D.C.3 Surveillance data from the Centers

for Disease Control and Prevention (CDC) indicate that the rate of syphilis

increased nationwide by 19% between 2000 and 2003.4
Syphilis is a serious condition that, if left untreated, may result in cardiovascular

and neurological complications leading to disability and ultimately death.1

Syphilis can be transmitted from an infected mother to her infant during labor

and delivery. Congenital syphilis can be particularly severe and results in fetal or

infant death in 40% of cases.1 Infants who survive may suffer serious central

nervous system abnormalities, deafness, bone and joint deformities, skin

abnormalities, blood disorders, and other problems.

Populations at increased risk for syphilis infection (as determined by incident

rates) include men who have sex with men and engage in high-risk sexual

behavior, commercial sex workers, persons who exchange sex for drugs, and those

in adult correctional facilities.1

The prevalence of syphilis infection varies widely among communities and

patient populations.1 Some populations have a particularly high risk of infection,

specifically African-Americans and people living in the Southeastern United

States.5 In 2004, the incidence of P&S syphilis was highest among women aged

20 to 24 years (3.0 cases per 100,000 population) and among men aged 35 to 39

years (12.4 cases per 100,000 population).6

Value of Prevention

The lifetime cost per case of syphilis has been estimated at $444 (in year 2000

dollars).7 The economic burden of syphilis would be much higher if the costs of

congenital syphilis and HIV infections occurring from the facilitating effect of

syphilis were included in cost analyses.

The health, disability, and life insurance costs of syphilis-infected employees

impose a significant economic burden on employers. Lost productivity may also

accrue when infected employees seek medical attention for their condition. 

Screening and early detection are key to averting costs associated with disease

progression and long-term complications. The avertable syphilis-attributable HIV

cost was estimated to be $4,653 (in year 1996 dollars) for each new syphilis case.8

Treatment for early stage syphilis is also much less expensive than treatment for

later stage disease: the baseline cost of treating early syphilis was estimated to be

$41.26 (in year 2001 dollars) compared to $2,061.70 for late syphilis.9

In 2004, the private-sector cost of screening for syphilis averaged $12;

approximately 95% of all paid claims fell within the range of $0 to $32.10

The cost of treating syphilis will vary depending on the treatment medication

and other factors. The public-sector cost of standard IM benzathine penicillin

therapy (first-line treatment) ranged from $18.64 to $22.22 (in year 2001

dollars).9 Treatment for late-stage syphilis can cost upwards of $2,000 (in year

2001 dollars).9

408

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment
One study compared the per-case cost and cost-effectiveness of two alternative

strategies – selective screening and partner notification — from the perspective of

a health department. When prophylactic treatment of sexual contacts was not

considered, selective screening proved to be more cost-effective. Cost, in general,

was low for both strategies for all cases of infectious syphilis considered.11 

Serological screening of pregnant women can be cost-effective even when there is

a very low prevalence of maternal infection because screening is inexpensive while

treating congenital syphilis is costly.12

Preventive Intervention Information

Screening for syphilis allows clinicians to identify affected patients and begin

treatment earlier in the course of disease, potentially improving outcomes and

avoiding the health and economic consequences of latent disease. Treatment also

reduces the likelihood of spread to others.

No studies have documented the harms associated with screening for syphilis.

Potential harms include partner discord, stigma, unnecessary anxiety or treatment

in the case of a false-positive result, and opportunity costs (in terms of time and

resources) to both the clinician and the patient. Harms of treatment include

allergic reaction to penicillin, and side effects of the medication including the

Jarisch-Herxheimer reaction (fever, headache, and pain that occurs during the 24

hours after initiating antibiotic treatment for syphilis due to the release of

treponema antigens).1

The benefits associated with screening are great. Screening allows for early

detection and treatment, preventing complications that may occur in later stages

of disease, and it reduces the risk that syphilis will be spread to others. Antibiotic

treatment for syphilis is effective and inexpensive. The USPSTF concluded that

the benefits of screening persons at increased risk for syphilis infection

substantially outweigh the potential harms.1

The optimal screening interval for syphilis is unknown. Experts recommend that

clinicians base the frequency at which they screen patients for syphilis on the

patient’s risk factors and the characteristics of the community in which they

practice. Pregnant women at risk of syphilis should be screened at the first visit of

every pregnancy and, if at high risk, again during the third trimester (28 weeks)

and at delivery.5

A variety of syphilis tests are available and in development. Screening for syphilis

typically involves the use of 2 different tests, a nontreponemal test and a

treponemal-specific test, for screening and confirmation. For example, a

nontreponemal blood test such as the venereal disease research laboratory

(VDRL) or the rapid plasma reagin (RPR) may be performed, a second, different

kind of test, such as the fluorescent treponemal antibody absorbed (FTA-ABS) or

the T. palladium particle agglutination (TP-PA) may then be used to confirm the

results of the nontreponemal test.1 

409

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval of

Screening

Intervention Process
The tests for syphilis screening that are approved or pending FDA approval

include:

• Nontreponemal test such as the venereal disease research laboratory (VDRL) or

the rapid plasma regain (RPR) on serum specimens followed by a fluorescent

treponemal antibody absorbed (FTA-ABS) or T. palladium particle

agglutination (TP-PA) for confirmation.

• Immunochromatographic strip (ICS) point-of-care test on blood specimen,

when FDA approved.

• Line Immunoassay (LIA) point-of-care test on blood specimen, when FDA

approved.

• Enzyme-linked immunosorbent assay (ELISA) for treponemal antibody in

serum specimens. 

• RPR point-of-care test for nontreponemal antibody in serum specimens. 

• Dark field microscope examination of lesion specimens.

Follow-up tests should be performed using the same nontreponemal test initially

used to document infection (e.g., VDRL or RPR) to ensure comparability.

Syphilis is treated with penicillin. Health benefits should include provisions for

treatment. 

Strength of Evidence for the Clinical Preventive Service

The level of evidence supporting the recommendation in this section is 

described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The USPSTF found good evidence to support screening for syphilis among all

persons at increased risk for syphilis infection.1

• The USPSTF found good evidence to support screening for syphilis among all

pregnant women.1

410

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)

Treatment

Information

Authored by: 

Campbell KP, Lentine D. Sexually transmitted infections (STIs) evidence-statement: screening and

counseling. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A

Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC:

National Business Group on Health; 2006.
References: 

Why This Chapter is Important for Employers: An Overview

1. Blandford JM, Gift TL. The cost-effectiveness of single-dose azithromycin for treatment of incubating syphilis. Sex Transm

Dis 2003;30(6):502-8.

2. Chesson HW, Blanford JM, Gift TL, Tao G, Irwin KL. The estimated direct medical cost of sexually transmitted diseases

among American youth, 2000. Perspect Sex Reprod Health 2004;36(1):11-19.

3. Yeh JM, Hook EW, Goldie SJ. A refined estimate of the average lifetime cost of pelvic inflammatory disease. Sex Transm Dis

2003;30(5):369-78.

4. Liu GG, Guo JJ, Smith SR. Economic costs to business of the HI/AIDS epidemic. Pharmacoeconomics 2004;22(18) 1181-

1194.

5. U.S. Preventive Services Task Force. Screening for chlamydial infection. Summary of recommendations / Supporting

documents. Guide to Clinical Preventive Services 3rd ed. Rockville, MD: Agency for Health Care Research and Quality; 2001.

Counseling to Prevent Sexually Transmitted Infections (Counseling)

1. Centers for Disease and Prevention. Sexually transmitted diseases treatment guidelines. MMWR 2002;51(RR06):1-80.

2. U.S. Preventive Services Task Force. Counseling: HIV infection and other sexually transmitted diseases. Guide to Clinical

Preventive Services 2nd ed. Washington, DC: Agency for Healthcare Research and Quality, U.S. Government Printing

Office; 1996. 

3. Kamb ML, Fishbein M, Douglas JM, et al. HIV prevention counseling reduces high risk behaviors and sexually transmitted

diseases: results from a multicenter, randomized controlled trial (Project RESPECT). JAMA 1998;280:1161--7.

4. Centers for Disease and Prevention National Prevention Information Network (NPIN). STIs Today [cited 2005 Apr 18].

Available from: http://www.cdcnpin.org/scripts/std/std.asp#1c. 

Chlamydia (Screening)

1. U.S. Preventive Services Task Force. Screening for chlamydial infection. Summary of recommendations / Supporting

documents. Guide to Clinical Preventive Services 3rd ed. Rockville, MD: Agency for Health Care Research and Quality; 2001.

2. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR 2006;55 (No.

RR-#11).

3. Centers for Disease Control and Prevention. Chlamydia. In: STD Surveillance Report 2004. [cited 2006 Oct 1]. Available

from: http://www.cdc.gov/std/stats/toc2004.htm. 

4. Kohl KS, Markowitz LE, Koumans EH. Developments in the screening for Chlamydia trachomatis: A review. Obstet

Gynecol Clin North Am 2003 Dec;30(4):637-58.

5. Haggerty CL, Ness RB. Epidemiology, pathogenesis and treatment of pelvic inflammatory disease. Expert Rev Anti Infect

Ther 2006 Apr;4(2)235-47.

6. Berg AO, Adkins DA. Screening for chlamydial infection: Recommendations and rationale. U.S. Preventive Services Task

Force. Am J Prev Med 2001;20(suppl 3):90-93.

7. Agency for Healthcare Research and Quality (AHRQ). What’s new from the U.S. Preventive Services Task Force. Screening

for chlamydial infection. AHRQ Publication No. APPIP01-0010. March 2001.

8. Chesson HW, Blandford JM, Gift TL, Tao G, and Irwin KL. The estimated direct medical cost of sexually transmitted

diseases among American youth, 2000. Perspect Sex Reprod Health 2004;36(1):11-19.

9. Yeh JM, Hook EW, Goldie SJ. A refined estimate of the average lifetime cost of pelvic inflammatory disease. Sex Transm Dis

2003;30(5):369-78.

10. Blandford JM, Gift TL. Productivity losses attributable to untreated chlamydial infection and associated pelvic inflammatory

disease in reproductive-aged women. Sex Transm Dis. In press.

411

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)
412

11. Thomson Medstat. Marketscan. 2004.

12. Hu D, Hook EW, Goldie SJ .Screening for chlamydia trachomatis in women 15 to 29 years of age: A cost-effectiveness

analysis. Ann Intern Med 2004;141(7):501-513.

13. U.S. Preventive Services Task Force. Screening for chlamydial infection: Recommendations and rationale. Am Fam Physician

2002;65(4): 673-76.

Gonorrhea (Screening) 

1. Glass N, Nelson H, Villemyer K. Screening for gonorrhea: Recommendation statement. U.S. Preventive Services Task Force.

AHRQ Publication No. 05-0579-A. Rockville, MD: Agency for Healthcare Research and Quality; May 2005.

2. Centers for Disease Control and Prevention. 2004 STD Surveillance report. [cited 2006 Oct 18]. Available from:

http://www.cdc.gov/std/stats/toc2004.htm. 

3. Glass N, Nelson HD, Villemyer K. Screening for gonorrhea: Update of the evidence for the U.S. Preventive Services Task

Force. AHRQ Publication No. 05-0579-B. Rockville, MD: Agency for Healthcare Research and Quality; May 2005. 

4. Chesson HW, Blandford JM, Gift TL, Tao G, Irwin KL. The estimated direct medical cost of sexually transmitted diseases

among American youth, 2000. Perspect Sex Reprod Health 2004;36(1):11-19.

5. Yeh JM, Hook EW, Goldie SJ. A refined estimate of the average lifetime cost of pelvic inflammatory disease. Sex Transm Dis

2003;30(5):369-78.

6. Thomson Medstat. Marketscan. 2004.

7. Aledort JE, Hook III EW, Weinstein MC, Goldie SJ. The cost-effectiveness of gonorrhea screening in urban emergency

departments. Sex Transm Dis 2005;32(7):425-436). 

8. Center for Disease Control and Prevention. Gonorrhea – STD Fact Sheet. Atlanta, GA: Centers for Disease Control and

Prevention; 2004. [cited 2006 Oct 18]. Available from:

http://www.cdc.gov/std/Gonorrhea/STDFactgonorrhea.htm#symptoms. 

Human Immunodeficiency Virus (Screening and Counseling)

1. Klein D, Hurley LB, Merrill D, Quesenberry CP Jr. Review of medical encounters in the 5 years before a diagnosis of HIV-1

infection: Implications for early detection. J Acquir Immune Defic Syndr 2003;32:143-52.

2. Chen Z, Branson B, Ballenger A, Peterman TA. Risk assessment to improve targeting of HIV counseling and testing services

for STD clinic patients. Sex Transm Dis 1998;25:539-43.

3. Marks G, Crepaz N, Senterfitt JW, Janssen RS. Meta-analysis of high-risk sexual behavior in persons aware and unaware they

are infected with HIV in the United States: Implications for HIV prevention programs. J Acquir Immune Defic Syndr

2005;39:446-53.

4. U.S. Preventive Services Task Force. Screening for HIV: Recommendation statement. AHRQ pub No. 05-0580-A. Rockville,

MD: Agency for Healthcare Research and Quality; July 2005. 

5. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant

women in health care settings. MMWR 2006;55(RR14):1-17.

6. Centers for Disease and Prevention. Advanced HIV Prevention: New strategies for a changing epidemic – United States,

2003. MMWR 2003;52(15);329-332. 

7. Glynn, K. Estimated HIV prevalence in the United States at the end of 2003. National HIV Prevention Conference, Atlanta,

GA; June 2005.

8. Centers for Disease Control and Prevention. Perspectives in disease prevention and health promotion public health Service

guidelines for counseling and antibody testing to prevent HIV infection and AIDS. MMWR 1987;36(31):509-515.

9. Jaffe HW, Bregman DJ, Selik RM. Acquired immune deficiency syndrome in the United States: the first 1,000 cases. J Infect

Dis 1983;148:339-45.

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)
10. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report, 2003 (Vol.15). Atlanta: US Department of

Health and Human Services, Center for Disease Control and Prevention; 2004. 

11. Chesson HW, Blandford JM, Gift TL, Tao G and Irwin KL. The estimated direct medical cost of sexually transmitted

diseases among American youth, 2000. Perspect Sex Reprod Health 2004;36(1):11-19.

12. Liu GG, Guo JJ, Smith SR. Economic costs to business of the HIV/AIDS epidemic. Pharmacoeconomics 2004;22(18):

1181-1194.

13. Bozzette SA, Joyce G, McCafrey DF, Leibowitz AA, Morton SC, Berry SH, et al. Expenditures for the care of HIV-infected

patients in the era of highly active antiretroviral therapy. N Engl J Med 2001;344(11):817-823. 

14. Thompson Medstat. Marketscan. 2004. 

15. Kates J. Financing HIV/AIDS: A Quilt with Many Holes. HIV/AIDS Policy Issue Brief. Menlo Park, CA: The Henry J Kaiser

Family Foundation. May, 2004.

16. Immergluck LC. Cull WL. Schwatrz A. Elstein AS. Cost-effectiveness of universal compared with voluntary screening for

human immunodeficiency virus among pregnant women in Chicago. Pediatrics 2000;105(4): E54.

17. Centers for Disease Control and Prevention. Revised recommendations for HIV screening of pregnant women. MMWR

2001;50 (RR19):59-86.

18. Centers for Disease Control and Prevention. Revised Guidelines for HIV Counseling, Testing, and Referral. MMWR

2001;50(RR19): 1-58.

Syphilis (Screening)

1. U.S. Preventive Services Task Force. Screening for syphilis infection. Summary of recommendations / Supporting documents.

Rockville, MD: Agency for Healthcare Research and Quality; 2004

2. Centers for Disease Control and Prevention. 2004 STD Surveillance report. [cited 2006 Oct 18]. Available from:

http://www.cdc.gov/std/stats/toc2004.htm. 

3. The National Cervical Cancer Coalition. CDC issues new report on STD epidemics. [cited 2005 May 3]. Available from:

http://www.nccc-online.org/hpv_2.php. 

4. Centers for Disease Control and Prevention. STD Prevention. New U.S. data show fewer Americans have herpes but rates of

other sexually transmitted diseases still high. [cited 2005 May 3]. Available from:

http://www.cdc.gov/std/2004STDConf/MediaRelease/Trends.htm. 

5. Nelson HD, Glass N, Huffman L, Villemyer K, Hamilton A, Frame A, et al. Screening for syphilis: Brief update for the U.S.

Preventive Services Task Force. AHRQ Publication No. 04-0545-B. Rockville, MD: Agency for Healthcare Research and

Quality; 2004.

6. Centers for Disease Control and Prevention. Syphilis. In: STD Surveillance Report 2004. [cited 2006 Sept 21]. Available

from: http://www.cdc.gov/std/stats/syphilis.htm. 

7. Chesson HW, Blandford JM, Gift TL, Tao G and Irwin KL. The estimated direct medical cost of sexually transmitted

diseases among American youth, 2000. Perspect Sex Reprod Health 2004; 36(1):11-19.

8. Chesson HW, Pinkerton SD. Sexually transmitted diseases and the increased risk for HIV transmission; implications for costeffectiveness analyses of sexually transmitted disease prevention interventions. JAIDS 2000;24:48-56.

9. Blandford JM, Gift TL. The cost-effectiveness of single-dose azithromycin for treatment of incubating syphilis. Sex Transm

Dis 2003;30(6):502-8.

10. Thomson Medstat. Marketscan. 2004.

11. Reynolds SL, Kapadia AS, Leonard L, Ross MW. Examining the direct costs and effectiveness of syphilis detection by

selective screening and partner notification. J Public Health Med 2001:23(4):339-345.

12. Schmid G. Economic and programmatic aspects of congenital syphilis prevention. Bull World Health Organ 2004;82(6):

402-409.

413

EVIDENCE-STATEMENT: Sexually Transmitted Infections (Screening and Counseling)
414
415

Why This Chapter is

Important for

Employers: 

An Overview 

U.S. Preventive

Services Task Force

Recommendation

(USPSTF)

Evidence Rating: A

(Strongly

Recommended/

Good Evidence)

• Tobacco use is the leading cause of preventable death in the United States.

Each year, approximately 440,000 individuals die as a result of smoking1,

accounting for 20% of all deaths in the United States annually.2

• In the United States the direct medical costs associated with smoking total

$75.5 billion per year.2 Smoking also costs an estimated $92 billion per year in

lost productivity due to sickness and premature death.3

• Smokers who successfully stop smoking reduce their potential medical costs

associated with cardiovascular disease by an average of $47 during the first year

and approximately $853 during the following 7 years (in year 1995 dollars).4

• Cost analyses have shown that tobacco-cessation benefits, from an employer’s

perspective, are cost-saving.5 An employer’s cost to implement a tobaccocessation program becomes cost-neutral at 3 years and begins to save

healthcare dollars at 5 years.6

• Screening for tobacco use allows clinicians to identify tobacco users and offer

them effective cessation treatments such as counseling and pharmacotherapy

(nicotine replacement products or cessation medications). Counseling and

pharmacotherapy have each been proven to double quit rates.7

Clinical Preventive Service Recommendations

The U.S. Preventive Services Task Force (USPSTF) strongly recommends that

clinicians screen all adults for tobacco use and provide tobacco cessation

interventions for those who use tobacco products.8

The USPSTF found good evidence that brief smoking cessation interventions,

including screening, brief behavioral counseling (less than 3 minutes), and

pharmacotherapy delivered in primary care settings, are effective in increasing the

proportion of smokers who successfully quit smoking and remain abstinent after

1 year. The USPSTF and the Surgeon General’s Report on the Health

Consequences of Smoking found good evidence that smoking cessation lowers

the risk for heart disease, stroke, cancer, and lung disease.9-10 The USPSTF

concluded that there is good evidence that even small increases in the quit rates

from tobacco cessation counseling and/or medication would produce important

health benefits.8

The USPSTF strongly recommends that clinicians screen all pregnant women for

tobacco use and provide augmented pregnancy-tailored counseling to those who

smoke.8

The USPSTF found good evidence that extended or augmented smoking

cessation counseling (5 to 15 minutes) using messages and self-help materials

tailored for pregnant smokers, compared with brief generic counseling

interventions alone, substantially increases abstinence rates during pregnancy and

leads to increased birth weights. Although relapse rates are high in the postpartum period, the USPSTF concluded that reducing smoking during pregnancy

is likely to have substantial health benefits for both the baby and the expectant

mother. 

EVIDENCE-STATEMENT:

TOBACCO USE TREATMENT 

(Screening, Counseling, and Treatment)
416

EVIDENCE-STATEMENT: Tobacco Use Treatment (Screening, Counseling, and Treatment)

CDC

Recommendation

Evidence Rating:

Strongly

Recommended/

Strong Evidence

Other Recommended

Guidance

U.S. Public Health

Service

Evidence Rating:

Strongly

Recommended/

Strong Evidence

Centers for Medicare

and Medicaid

Services (CMS)

Evidence Rating:

Information Sources 

The Community Guide to Preventive Services strongly recommends providing

coverage for tobacco dependence treatment and initiating provider reminder

systems to enhance treatment.11

Recommendations are based on the strength of the evidence of effectiveness

found through a systematic review of published studies conducted by a team of

experts on behalf of the Task Force. Strong evidence indicates that there are a

number of supportive studies that recommend the action.12

The U.S. Public Health Service Clinical Practice Guideline, Treating Tobacco Use

and Dependence (PHS Guideline) strongly recommends screening for tobacco use

and providing tobacco cessation treatment (including counseling and/or

medication).13 The U.S. Public Health Service found good evidence that benefits

covering screening for tobacco use and providing cessation treatment (counseling

and pharmacotherapy) to those who use tobacco are effective in increasing the

proportion of smokers who successfully quit and remain abstinent at one year.7

Recommendations are based on research from multiple, well-designed

randomized clinical trials, directly relevant to the recommendation that yielded a

consistent pattern of findings.

The Centers for Medicare and Medicaid Services (CMS) recommends that

physicians provide tobacco screening, counseling, and treatment services. Medicare

provides coverage for 2 cessation attempts per year. Each attempt includes a

maximum of 4 intermediate or intensive counseling cessations for a total

maximum benefit of 8 counseling sessions in a 12-month period. Medicare Part D

covers all smoking cessation medications that are prescribed by a physician.13

CMS Mandate

The recommendations and supporting information contained in this document

came from several sources, including the:

• Center for Medicaid and Medicare Services (CMS)

• Centers for Disease Control and Prevention (CDC)

• Community Guide to Preventive Services

• George Washington University, Center for Health Services Research and Policy

• Partnership for Prevention

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

• U.S. Public Health Service (PHS)

• U.S. Surgeon General

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text. 
417

EVIDENCE-STATEMENT: Tobacco Use Treatment (Screening, Counseling, and Treatment)

Epidemiology of

Condition/Disease

Condition/Disease

Risk Factors

Condition/Disease Specific Information

Tobacco use contributes to many diseases and is the primary underlying cause of

death in the United States. Each year, approximately 440,000 individuals die as a

result of smoking1, accounting for 20% of all deaths in the United States

annually.2 Approximately 155,000 of these deaths result from cancer, 80,000

result from ischemic heart disease, and 17,000 result from cerebrovascular

disease. 

Among the estimated 43.4% (91.5 million) of persons alive in 2003 who had

ever smoked, 50.3% (45.9 million) were former smokers and 49.7% (45.4

million) were current smokers. Current smokers make up 20.9% of the adult

population in the United States. If these current smokers continue smoking, half

will die due to their tobacco use.2

Tobacco use also affects the health of non-smokers. Second-hand smoke exposure

at work or at home (also called environmental tobacco smoke) increases nonsmokers’ risk of developing heart disease by 25% to 30% and increases their risk

of lung cancer by 20% to 30%.14 Second-hand smoke exposure contributes to the

deaths of 38,000 people each year; 3,000 die as a result of lung cancer and

35,000 die as a result of cardiovascular disease.2 In addition, each year in the

United States 300,000 children suffer from respiratory tract infections and

asthma as a result of being exposed to secondhand smoke.15 Smoking during

pregnancy is particularly dangerous because it increases the risks of premature

birth, miscarriage, stillbirth, and low birth weight.10 Prenatal tobacco use resulted

in an estimated 1,007 infant deaths annually between 1995 and 1999.16

There is substantial evidence that smoking cessation improves health by lowering

an individual’s risk for diseases caused by smoking such as heart disease, stroke,

and cancer.1 Yet despite the documented risks of smoking, 20.8% of the United

States population continues to smoke.2 Seventy percent (70%) of smokers say

they want to quit and each year 41% of smokers make a quit attempt of at least

24 hours.6 Without assistance, only 7% are abstinent at 1 year.17

There are numerous risk factors for cigarette smoking, including: younger age,

male sex, race, a lower level of education, and low socioeconomic status.18

Young adults (18 to 24-year-olds and 25 to 44-year-olds) are more likely to

smoke than older adults (45 to 64-year-olds and persons above the age of 65).18

Nearly 80% of all adult smokers began smoking before they were 18 years old,

and it is estimated that more than 2,000 adolescents become daily smokers each

day.19 During 2005, 23% of high school students smoked cigarettes daily.20

Men are also at increased risk of tobacco use; while 23.4% of men smoke

cigarettes, only 18.5% of women smoke.18 
418

EVIDENCE-STATEMENT: Tobacco Use Treatment (Screening, Counseling, and Treatment)

Economic Burden of

Condition/Disease

Workplace Burden of

Condition/Disease

Economic Benefit 

of Preventive

Intervention

Estimated Cost 

of Preventive

Intervention

The prevalence of cigarette smoking by race is highest among American

Indians/Alaska Natives (33.%), followed by whites (22.2 %), AfricanAmericans (20.2%), Hispanics (15%), and Asians [excluding Native

Hawaiians and other Pacific Islanders] (11.3%).18 

Approximately 39.6% of adults with a General Education Development

(GED) diploma and 34% of adults with 9 to 11 years of education smoke,

while only 11.7% of adults who complete an undergraduate degree and 8%

of adults who complete a graduate college degree smoke.18 Cigarette smoking

is also more common among adults who live below the poverty level (29.1%)

than among those living at or above the poverty level (20.6%).18

Value of Prevention

The cost of smoking-related illnesses and the loss of productivity

associated with smoking are considerable. In the United States, the direct

medical costs associated with smoking are $75.5 billion per year.3 During

1997 to 2001, these expenditures plus productivity losses exceeded $167

billion per year.3

Individuals who smoke have higher total medical expenses than do

nonsmokers due to their higher burden of illness. Men who smoke incur

$15,800 and women who smoke incur $17,500 more in lifetime medical

expenses than do nonsmokers (in year 2002 dollars).3

In addition to direct medical costs, smokers incur higher costs related to

disability, lost productivity, and absenteeism than do nonsmokers. For

example, men who smoke use 4 more sick days per year than do

nonsmoking males, and women who smoke use 2 more sick days per year

than do nonsmoking females.6 In 1999, lost productivity due to smoking

and smoking-related illnesses cost employers $1,897 per smoking

employee. Excess medical expenses due to smoking and smoking-related

illnesses cost employers $1,850 per smoking employee (both figures are

adjusted to year 2002 dollars).3

Smokers who successfully stop smoking reduce potential medical costs

associated with cardiovascular disease by about $47 during the first year

and by about $853 during the following 7 years (in year 1995 dollars).4,21

An annual drop of 1 percentage point in smoking prevalence among

pregnant women would prevent 1,300 low birth weight live births and

save 21 million in direct medical costs in the first year of a smoking

cessation program.22 Besides the savings in healthcare costs, economic

benefits of preventive intervention include reductions in absenteeism

costs, on-the-job productivity loss, life-insurance costs, and costs

associated with fire and property damage due to smoking.6,23

The cost of implementing a comprehensive tobacco cessation program

including screening, counseling, and treatment, will vary by location and

provider base, but is generally considered to be low. Research has shown
that the average cost of providing a comprehensive tobacco cessation program for

all employees ranges from 10 cents to 40 cents per member, per month.24

In 2004, the private-sector cost of screening for tobacco use averaged $39;

approximately 95% of all paid claims fell within the range of $0 to $129.25 In

2004, the private-sector cost of counseling averaged $39 per session;

approximately 95% of all paid claims fell within the range of $0 to $134 per

session.25

The cost of pharmacological interventions vary depending on type and dosage.

The average wholesale price (AWP) of a 1-month supply of bupropion ranges

from $86.54 to $196.07 depending on the brand and type chosen; a 1-month

supply of varenicline (ChantixTM) is $89.60.26

Research has shown that tobacco screening and cessation-treatment efforts are

cost-effective from a societal perspective. Cost analyses have shown that the

provision of tobacco-cessation benefits are cost-saving from an employer’s

perspective.12 The cost to employers of implementing a tobacco cessation

program equalizes at 3 years and begins to save healthcare dollars at 5 years.6

Smokers who successfully stop smoking reduce potential medical costs associated

with cardiovascular disease (including heart attack and stroke) by about $47

during the first year and by about $853 during the following 7 years.4 In fact,

treating tobacco use ranked the highest among adult preventive services in terms

of health impact, cost-effectiveness and cost, yet, according to a recent study by

the Partnership for Prevention, the service is provided to less than 35% of

tobacco users.12

The most cost-effective population to target for smoking cessation programs is

pregnant women.4 Pregnant women incur an additional $704 in neonatal

healthcare costs compared to nonsmokers. Clinical trials have shown that, for

every $1 invested in smoking cessation programs for pregnant women, $7.75 are

saved in short-term medical costs and an additional $7.63 (in year 2002 dollars)

are saved in long-term costs by preventing disability among low birth weight

infants who survive.5

The manner in which tobacco cessation programs are crafted influences their

cost-effectiveness. For example, reducing the patient out-of-pocket costs for

effective cessation therapies provides a net benefit of $362 to $1,449 per

enrollee.27 In fact, subsidizing the out-of-pocket expense for patients who wish 

to quit smoking increases the use of effective cessation therapies, increases the

number of people who attempt to quit, and — most importantly — increases 

the number of people who quit successfully.28

419

EVIDENCE-STATEMENT: Tobacco Use Treatment (Screening, Counseling, and Treatment)

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention
420

EVIDENCE-STATEMENT: Tobacco Use Treatment (Screening, Counseling, and Treatment)

Preventive

Intervention: 

Purpose of

Screening,

Counseling, and

Treatment

Benefits and Risks 

of Intervention

Initiation, Cessation,

and Interval

Screening

Counseling 

Treatment

Preventive Intervention Information

Screening for tobacco use allows clinicians to identify tobacco users and offer

them effective cessation treatments such as counseling and pharmacotherapy

(nicotine replacement products or cessation medications). Counseling and

pharmacotherapy have each been proven to double quit rates.7

Despite the strong evidence supporting tobacco use screening, cessation

counseling, and medication use, and the fact that 70% of smokers report they

want to quit smoking, few adults receive recommended care for tobacco use

treatment. For example, only 71.2% of smokers are advised to quit by their

providers and only 39% of smokers are offered prescription medication or

counseling to support the quitting process.29-30

The benefit of screening for tobacco use and cessation counseling and treatment

is substantial. Smoking cessation is proven to lower an individual’s risk for

diseases caused by smoking such as heart disease, stroke, and cancer.1 There are

no documented risks to screening for tobacco use.

The benefit of providing smoking-cessation coverage is considerable. As

mentioned above, subsidizing the out-of-pocket expense for patients who wish to

quit smoking increases the use of effective cessation therapies, increases the

number of people who attempt to quit, and — most importantly — increases the

number of people who quit successfully.28 Additional workplace interventions,

such as establishing smoke-free workplaces, add even more benefit. Smoke-free

workplaces and the provision of comprehensive coverage presumably act together

to reduce smoking, and they have been demonstrated to increase quit attempts.11 

All adults should be screened for tobacco use at every provider visit. Adults who

screen positive for tobacco use should be advised to quit and offered counseling

and medication at every medical encounter.10 There is limited evidence on the

efficacy of screening and counseling children and adolescents for tobacco use.

However, because most adult smokers began smoking during their teenage years,

the USPSTF recommends that clinicians screen and counsel this population at

their discretion.10

At least two courses of 4 to 6 counseling sessions of at least 30 minutes each

should be provided annually, for a total of 12 sessions per calendar year until the

patient successfully quits smoking. Some patients may require additional sessions. 

Guidelines for the duration of medication treatment are specified in the PHS

Guideline and differ depending on the medication type.10

Patients identified as recently quit should be eligible for up to 4 additional

counseling sessions and/or 4 to 8 weeks of medication to maintain tobacco

abstinence (depending on the medication).10
The USPSTF10 and the PHS Guideline7 recommend the use of the “5-A’s”

behavioral counseling framework for tobacco screening and counseling. This

framework is composed of 5 steps aimed at engaging the patient in a discussion

about their tobacco use and their intention to quit:

• Ask about tobacco use.

• Advise the patient to quit through clear and personalized messages.

• Assess the patient’s willingness to quit.

• Assist to quit, develop a quit plan, and set a quit date.

• Arrange for medications and support services.

The PHS Guideline recommends several effective methods of tobacco cessation

counseling including brief counseling (3 minutes or under), intensive counseling

(5 to 15 minutes), telephone based counseling (4 to 6 sessions), and tailored

counseling (with information and support specific to the population, e.g.,

pregnant women).7 The USPSTF further recommends that clinicians provide

problem-solving guidance for smokers to develop a quit plan and to overcome

common barriers to quitting. Practices that complement the 5-A framework

include provision of medications, motivational interviewing or other methods of

intensive counseling, referral for those who may need extra help, and referral to

telephone quitlines.10 

The USPSTF and the PHS Guideline note that there is a dose-response

relationship between the intensity and frequency of counseling and tobacco

abstinence rates.7,10 For example, brief counseling interventions (under 3 minutes)

are more effective than no counseling, but intensive counseling sessions (5 to 15

minutes) are more effective than brief counseling sessions. The more time a

patient is exposed to counseling, the more likely it is that the patient will be

successful in quitting.7 Although there is limited evidence on the optimal amount

of counseling, there is evidence that counseling up to 300 minutes per course of

treatment has the most effectiveness.7

Counseling and pharmacotherapy have each been proven to double quit rates7:

therefore, a tobacco use treatment benefit should include brief counseling (inperson) and intensive counseling (in-person or telephonic) as described above,

and:

• All first-line FDA-approved over-the-counter (OTC) and prescription nicotine

replacement products such as nicotine replacement gum, patches, lozenges,

inhalers, and nasal sprays.

• All FDA-approved tobacco cessation prescription medications such as

bupropion (e.g., Wellbutrin® and Zyban®)

7 and varenicline (ChantixTM). 

Because reducing out-of-pocket costs for tobacco use treatment medications and

nicotine replacement products has proven to further reduce quit rates27, FDAapproved medications/products should not be subject to the deductible and

copayments should be reduced or eliminated.

421

EVIDENCE-STATEMENT: Tobacco Use Treatment (Screening, Counseling, and Treatment)

Intervention Process

Screening

Counseling

Treatment
422

EVIDENCE-STATEMENT: Tobacco Use Treatment (Screening, Counseling, and Treatment)

Prescription and Over-the-Counter Tobacco Cessation Medications Approved by 

the Food and Drug Administration (FDA) 

**Received FDA approval in October 2002; therefore not addressed in the 2000 PHS Guidelines.

*** Received FDA Approval in May 2006; therefore not addressed in the 2000 PHS Guidelines.

Some populations of smokers require specialized and tailored interventions. For

example, pregnant women who smoke should be offered tailored and intensive

counseling (5 to 15 minutes) and self-help materials as brief counseling has been

found to be less effective in this population.7 The PHS Guideline recommends 

that pharmacotherapy be considered on a case-by-case basis for tobacco cessation

during pregnancy.7

Strength of Evidence for the Clinical Preventive Service 

The level of evidence supporting the recommendations contained in this 

chapter is described below.

Evidence-Based Research:

U.S. Preventive Services Task Force (USPSTF)

Strength of Evidence: A (Strongly Recommended/Good Evidence)

• The USPSTF found good evidence to recommend that clinicians screen all 

adults for tobacco use and provide tobacco cessation interventions 

(counseling, medication, and follow-up) for those who use tobacco products.8

• The USPSTF found good evidence to recommend that clinicians screen all

pregnant women for tobacco use and provide augmented pregnancy-tailored

counseling to those who smoke.8

The Centers for Disease Control and Prevention (CDC)

Strength of Evidence: Strong Evidence (Systematic review of published studies

conducted by a team of experts).

• The Community Guide to Preventive Services11 strongly recommends 

establishment of provider reminder systems within health care systems, 

Type Form Common Brand Name(s) Availability

Nicotine

Replacement

Therapy

Gum Nicorette® Over-the-counter

(OTC)

Patch Nicoderm® Habitrol®

Prostep® Nicotrol®

OTC and

prescription

Inhaler Nicotrol® Prescription

Nasal Spray Nicotrol® Prescription

Lozenge Commit®** OTC

Buproprion SR Pill Zyban® Wellbutrin® Prescription

Varenicline Pill ChantixTM*** Prescription
provision of telephone counseling services and establishment of effective media

campaigns. 

U.S. Public Health Service (USPHS)

Strength of Evidence: Strong Evidence (Research from multiple, well designed

randomized clinical trials, directly relevant to the recommendation that yielded a

consistent pattern of findings).

• The Public Health Service Clinical Practice Guideline, Treating Tobacco Use

and Dependence (PHS Guideline)3 strongly recommends screening for tobacco

use and providing tobacco cessation treatment (counseling and medication).

Recommended Guidance:

The Centers for Medicare and Medicaid Services (CMS) 

Strength of Evidence: CMS Mandated

• CMS recommends that physicians provide tobacco screening, counseling, and

treatment services. Medicare provides coverage for two cessation attempts per

year. Each attempt includes a maximum of 4 intermediate or intensive

counseling cessations for a total maximum benefit of 8 counseling sessions in a

12-month period. Medicare Part D covers all smoking cessation medications

that are prescribed by a physician.13

423

EVIDENCE-STATEMENT: Tobacco Use Treatment (Screening, Counseling, and Treatment)

Authored by: 

Rosenthal AC, Campbell KP, Chattopadhyay S. Tobacco use treatment evidence-statement: screening,

counseling, and treatment. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA,

editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington,

DC: National Business Group on Health; 2006.

References:

1. Centers for Disease Control and Prevention. Mortality trends for selected smoking-related cancers and breast cancer —

United States, 1950-1990. MMWR 1993 Nov 12;42(44):857,863-866.

2. Centers for Disease Control and Prevention. Cigarette smoking among adults, – United States, 2003. MMWR

2005;54(20):509-13.

3. Centers for Disease Control and Prevention. Annual smoking-attributable mortality, years of potential life lost, and economic

costs—United States, 1997–2001. MMWR 2005;54(25):625-628.

4. Lightwood JM, Glantz S. Short-term economic and health benefits of smoking cessation. Circulation 1997;96(4):1089-1096.

5. Marks JS, Koplan JP, Hogue CJR, Dalmat ME. A cost-benefit/cost-effectiveness analysis of smoking cessation for pregnant

women. Am J Prev Med 1990;6(5):282-291.

6. Warner KE, Smith RJ, Smith DG, Fries BE. Health and economic implications of a work-site smoking-cessation program: a

simulation analysis. J Occup Environ Med 1996;38(10):981-92.

7. Fiore MC, Bailey WC, Cohen SJ, Dorfman SF, Goldstein MG, Gritz ER, et al. A Clinical Practice Guideline for Treating

Tobacco Use and Dependence. Rockville, Maryland. U.S. Department of Health and Human Services, Public Health Service.

June 2000.
424

8. U.S. Preventive Services Task Force. Summary of Recommendation. Counseling: Tobacco use. Rockville, MD: Agency for

Healthcare Research and Quality; 2003 [cited 2006 Jan 3]. Available from: http://www.ahrq.gov/clinic/uspstf/uspstbac.htm.

9. U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General.

Atlanta, GA: U.S. Department of Health and Human Services , Centers for Disease Control and Prevention, National Center

for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2004.

10. Berg AO. U.S. Preventive Services Task Force. Counseling to prevent tobacco use and tobacco-caused disease.

Recommendation Statement. Rockville, MD: Agency for Health Care Research and Quality. 2003.

11. Hopkins DP, Briss PA, Ricard CJ, Husten CG, Carande-Kulis VG, Fielding JE, et al; Task force on community preventive

services. Am J Prev Med 2001;20(2 Suppl):16-66.

12. Maciosek MV, Coffield AB, Edwards NM, Goodman MJ, Flottemesch TJ, Solberg LI. Priorities among effective clinical

preventive services: Results of a systematic review and analysis. Am J Prev Med 2006;31(1):52-61.

13. Centers for Medicare and Medicaid Services. Medicare & You 2007. [Cited 2006 Jul 26]. Available from:

http://www.medicare.gov/publications/pubs/pdf/10050.pdf. 

14. U.S. Department of Health and Human Services. The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report

of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services , Centers for Disease Control and

Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2006.

15. United States Environmental Protection Agency. Respiratory health effects of passive smoking: lung cancer and other

disorders. Office of Research and Development, EPA/600/6-90/006F, Washington, D.C: December 1992. Available from:

http://cfpub2.epa.gov/ncea/cfm/recordisplay.cfm?deid=2835. 

16. Centers for Disease Control and Prevention. Annual smoking-attributable mortality, years of potential life lost, and economic

costs — United States, 1995–1999. MMWR 2002;51(14):300-303.

17. Zhu S, Melcer T, Sun J, et al. Smoking cessation with and without assistance: a population-based analysis. Am J Prev Med

2000 May;18(4):305-11.

18. Centers for Disease Control and Prevention. Cigarette smoking among adults—United States, 2004. MMWR

2005;54(44):1121–1124.

19. U.S. Department of Health and Human Services. Substance Abuse and Mental Health Services Administration. 2004

National Survey on Drug Use and Health. Table 4.18A, Numbers (in thousands) of persons who began daily cigarette use in

the United States, their mean age at first use, and rates of first use (per 1,000 person-years of exposure): 1965-2002, based on

2002 and 2003 NSDUHs. [cited 2006 Jul 26]. Available from:

http://www.oas.samhsa.gov/nhsda/2k3tabs/Sect4peTabs1to60.htm. 

20. Centers for Disease Control and Prevention. Cigarette smoking among high school students, United States, 1991-2005.

MMWR 2006;55(26):724-726.

21. Thun MJ. Cover Essay: Mixed progress against lung cancer. Tob Control 1998;7:223-226.

22. Lightwood JM, Phibbs CS, Glantz S. Short-term health and economic benefits of smoking cessation: low birth weight.

Pediatrics. 1999;104:1312-1320.

23. Centers for Disease Control and Prevention, American Cancer Society, and Wellness Councils of America. Making Your

Workplace Smokefree—A Decision Maker’s Guide. 1996 [cited 2005 April 5]. Available from:

http://www.cdc.gov/tobacco/research_data/environmental/etsguide.htm. 

24. Curry SJ, Grothaus MA, McAfee T, et al. Use and cost effectiveness of smoking-cessation services under four insurance plans

in a health maintenance organization. N Engl J Med 1998;339(10):673-79.

25. Thomson Medstat. Marketscan. 2004.

26. Fleming T. 2006 Redbook: Pharmacy’s Fundamental Reference. Thomson PDR; Rev Ed edition. May 2006. Note: varenicline

was not included in the 2006 Redbook because it was approved by the FDA after Dec 31, 2005. The cost quote for

varenicline was provided by its producer, Pfizer, on October 2, 2006. 

27. Hodgson T. Cigarette smoking and lifetime medical expenditures. Milbank Q 1992;70(1):81-125. 

28. Centers for Disease Control and Prevention. Cigarette smoking among adults – United States 2000. MMWR

2004;53(23):499-502.

EVIDENCE-STATEMENT: Tobacco Use Treatment (Screening, Counseling, and Treatment)
425

EVIDENCE-STATEMENT: Tobacco Use Treatment (Screening, Counseling, and Treatment)

29. National Committee for Quality Assurance. The State of Health Care Quality 2005: Industry Trends and Analysis. Washington,

DC; National Committee for Quality Assurance; 2006.

30. National Committee for Quality Assurance (NCQA). HEDIS 2007 Summary Table of Measures and Product Lines. Measure

List. Washington, DC: National Committee for Quality Assurance. 2006 [cited 2006 Sep 15]. Available from:

http://www.ncqa.org/Programs/HEDIS/2007/MeasuresList.pdf. 

425
426
427

EVIDENCE-STATEMENT:

TUBERCULOSIS (Screening)

Why This Chapter is

Important for

Employers: 

An Overview

U.S. Preventive

Services Task Force

Recommendation

CDC

Recommendation

• An estimated 3% to 5% of persons (or 9.8 to 15.1 million persons) residing in

the United States have latent tuberculosis infection (LTBI),1 a condition in

which an individual is infected with Mycobacterium tuberculosis but does not

currently have tuberculosis (TB) disease. Individuals who have LTBI have no

signs or symptoms and cannot spread TB. Approximately 5% to 10% of

persons with LTBI will develop clinical TB disease at some point in their

lifetime.2-3 When active TB disease occurs, these persons may become

infectious and then transmit the infection to others. 

• The global TB burden is substantial and increasing. Immigration to the United

States from areas of the world where TB is common is continually

supplementing the pool of persons in the United States with TB and LTBI. 

• Preventing TB involves preventing those with LTBI from progressing to TB

disease. Therefore, testing and treatment for LTBI is recommended for those at

high risk for TB disease, especially those from regions with high TB rates. 

• Identifying and properly treating persons with TB disease early can prevent

extensive transmission and costly contact investigations.

• Businesses that employ workers from countries or regions where TB is

common or that are based in those countries may face a heightened risk of a

TB outbreak. In addition, businesses that employ workers at high risk for TB

(such as HIV-infected or other immunosuppressed persons or low-income

minorities) or have clients who are at high risk for TB need to be aware and

knowledgeable about TB and include prevention activities in their plans.

Clinical Preventive Service Recommendations

In 1996, the U.S. Preventive Services Task Force (USPSTF) recommended

screening for LTBI with tuberculin skin testing (TST) for asymptomatic high risk

persons.4

The USPSTF recognizes the importance of targeted screening for tuberculosis.

However, the USPSTF has decided not to update its 1996 recommendation and

rather defers to the guidelines of the Centers for Disease Control and Prevention

(CDC) referenced below.

CDC has published guidelines on screening for LTBI,2 preventing transmission

in health-care settings,5 investigating contacts of infectious TB patients,6 treating

TB disease,7 and controlling TB in the United States.8

The CDC recommends conducting targeted testing of persons at high risk for

TB (see below) to identify LTBI and TB disease early and treating those who

have TB and LTBI to prevent transmission and prevent progression of LTBI to

disease.2 Targeted testing programs should be conducted among groups at risk for

recent infection with M. tuberculosis and those who, regardless of duration of

infection, are at increased risk for progression to TB disease. 
428

EVIDENCE-STATEMENT: Tuberculosis (Screening)

Evidence Rating:

Information Sources

Epidemiology of

Condition/Disease

The CDC does not recommend targeted testing of persons at low risk for TB,

with the exception of initial (baseline) testing of persons whose future activity

will place them at increased risk of exposure, such as some healthcare workers

who may require serial screening.

Not Specified. Each of the referenced CDC guidelines describes the evidence

basis for the recommendations, but not all provide ratings.

The recommendations and supporting information contained in this document

came from several sources, including the:

• Centers for Disease Control and Prevention (CDC)

• Peer-reviewed research

• U.S. Preventive Services Task Force (USPSTF)

The background and supporting information contained in this document is a

compilation of research findings. All information presented in this document

should be attributed to its referenced source and should not be considered a

reflection of other organizations cited in the text.

Condition/Disease Specific Information

Tuberculosis is a bacterial disease caused by Mycobacterium tuberculosis, which

usually attacks the lungs (pulmonary TB) but can attack any part of the body,

including the kidney, spine, and brain. Symptoms of TB disease include a

productive cough lasting more than 2 to 3 weeks, chest pain, coughing up blood,

fever, chills, night sweats, appetite loss, weight loss, and easy fatigue. A person

who has developed infectious pulmonary or laryngeal TB disease can spread

infection to others through coughing, sneezing, speaking, or singing. 

When exposure to infectious TB occurs, the health department conducts a

contact investigation.6 Studies of contact investigations in the United States reveal

that 30% to 40% of close contacts of persons having infectious TB disease

become infected with LTBI (as evidenced by a positive tuberculin skin test or

“TST”) and identify an additional two percent with active TB disease.9-10

Approximately 5% to 10% of persons with LTBI will progress to clinically active

TB disease at some point in their lives.2-3 About half of those who progress will

do so in the first 2 years after initial infection (i.e., recent infection). Treatment

of LTBI reduces the risk of developing TB disease by 70% to 90%.2

Populations at high risk for TB include persons who had recent close contact

with an infectious TB patient, foreign-born persons from areas where TB is

common, HIV-infected and other immunosuppressed persons, homeless persons,

substance users (e.g., injection drug users, crack cocaine users, alcoholics), lowincome minorities, young children exposed to high-risk adults, health care

workers who serve high-risk clients, residents and employees of high-risk

congregate settings such as homeless shelters, correctional institutions, nursing

homes, or mental institutions. 
429

EVIDENCE-STATEMENT: Tuberculosis (Screening)

Condition/Disease

Risk Factors

Economic Burden of

Condition/Disease

The proportion of TB cases in the United States occurring among foreign-born

persons increased progressively during the 1990s; in 2004, persons born outside

the United States accounted for 54% of reported cases.11 Although foreign-born

persons who received a diagnosis of TB in 2004 were born in approximately 150

countries worldwide, 5 countries of origin accounted for over half of foreignborn persons with TB: Mexico (25%), the Philippines (11%), Vietnam (8%),

India (7%), and China (5%). The number of states in which greater than 50% of

the total reported cases occurred among foreign-born persons increased from 5

(10%) in 1992 to 22 (44%) in 2004.11 Among U.S. states and cities, this profile

can change rapidly, reflecting changes in patterns of immigration and refugee

settlement.12 Globally, half of new TB cases each year occur in India, China,

Indonesia, Bangladesh, and Pakistan.13

In the United States, the majority of healthcare workers do not have a high risk

for TB, but some, such as respiratory therapists, appear to be at greater risk.5,14

Persons who work in, or are served by, clinics or community health organizations

providing care to HIV-infected persons are considered a priority population for

targeted testing and treatment of TB and LTBI because of the risk of

transmission to this highly vulnerable population.8

An individual at high risk for TB has one or more of the following characteristics:

recent exposure to a person having infectious TB; history of previous TB disease

or positive tuberculin skin test or QuantiFERON-TB Gold result; HIV infection

or other immunosuppressive medical condition; being a young child with contact

to a high-risk adult; history of injection or non-injection drug use; birth outside

the United States in a region where TB is common; being a resident or employee

of a high-risk congregate setting; being a member of a low-income minority

population; or being a health care worker who serves high-risk persons. However,

TB should be suspected in any patient who has had a persistent cough for more

than 2 to 3 weeks, with at least one additional symptom, including fever, night

sweats (sufficient to require changing of bed clothes or sheets), weight loss, or

hemoptysis (coughing up blood). 

Value of Prevention

From the late 1980s through the early 1990s, outbreaks of TB among HIVinfected persons in the United States contributed to a surge in TB, reversing a

steadily declining trend. Billings or charges for inpatient TB care increased 3.2-

fold from 1985 through 1990.15 During that period, an estimated 77,700 TB

hospitalizations resulted in about 1.1 million days of care. The total direct

medical expenditures for TB in a 1991 study of TB outpatient treatment,

screening, and treatment for LTBI, contact investigation, and surveillance were

estimated at $703 million and TB costs were estimated at $574 million (in year

1991 dollars.) In addition, 20,803 TB hospitalizations resulting in 413,980 days

of inpatient care occurred.16 Extrapolating from a 1996 study at 10 mostly urban

sites, an estimated 12,631 TB hospitalizations and approximately 270,650 days

of inpatient care occurred in the United States in 1996.17 A study in 2000

estimated that there were over 11,000 TB hospitalizations resulting in more than

160,000 inpatient days.18 Approximately half of TB patients are hospitalized,
430

EVIDENCE-STATEMENT: Tuberculosis (Screening)

Workplace Burden of

Condition/Disease

which adds approximately $19,000 to the cost of treatment.17 While it

appears that there might be a slight downward trend in TB

hospitalizations as management practices have improved and the total

number of TB patients declines each year, TB still places a substantial

burden on the U.S. economy.

More recently, direct medical TB costs have been estimated (and updated

to 2004 dollars) from several studies17-21 with the costs varying according

to the kinds of treatment needed. Direct medical costs of LTBI screening

and treatment caused by exposure to strains susceptible to normally-used

drugs were approximately $208 to $311 per person without directly

observed treatment (DOT).19 DOT improves the likelihood of completion

of a full course of treatment. If drug susceptible TB disease is diagnosed,

outpatient treatment costs are approximately $4,000 under daily DOT.20

Costs associated with MDR TB are likely to be much higher than for

drug-susceptible tuberculosis due to longer hospitalization, longer and

more complex treatment with more expensive and toxic medications, and

higher mortality. Direct medical costs associated with MDR TB

hospitalization range from $15,000 to $137,000 per case.21 In-patient

MDR TB costs average $30,740 per person and $1,232 per person-day of

hospitalization. Outpatient costs average $22,625, or $52 a day per

person. Direct medical costs for both inpatient and outpatient MDR TB

care average approximately $53,000 per person. For each infected contact

of a patient with multidrug-resistant (MDR) TB in California, the cost of

two years of follow-up and treatment to prevent the development of

MDR TB was estimated to be $11,125.22

These direct medical costs are underestimates because they exclude the

additional public health program costs of providing culturally appropriate

outreach, interpreters, and transportation services. Also, in areas where

the cost-of-living is much higher, such as San Francisco and New York

City, medical costs may be 80% to 95% higher.23 Additional costs to

society include the productivity losses associated with TB deaths and

productivity losses for the 6 months of treatment when patients are

unable to work. 

The workplace burden of TB includes lost productivity, absenteeism, high

hospitalization costs, and disease transmission to other employees.

Hospitalization burdens include not only direct medical costs, but also

the lost productivity of workers during hospitalization days. Outpatient

care involves workers’ lost productivity due to clinic visits or fatigue and

other effects of the illness. In fact, productivity losses may last for months

or longer if permanent physical effects are experienced.24 Disease

transmission may result in a costly contact investigation as well as

stigmatization and disruption of business. However, the risk of TB

transmission in the workplace is highly variable, depending on factors

such as the TB risk of clients served, the activities conducted by the

business, and the TB risk posed by coworkers.5
EVIDENCE-STATEMENT: Tuberculosis (Screening)

Economic Benefit 

of Preventive

Intervention

Estimated Cost of

Preventive

Intervention

Estimated Cost of

Treatment

Cost-Effectiveness

and/or Cost-Benefit

Analysis of

Preventive

Intervention

Preventive

Intervention: 

Purpose of Screening

Benefits and Risks 

of Intervention

431

Successfully completing a treatment regimen for LTBI and thereby eliminating

the preventable direct medical cost of illness due to TB disease saves $4,000 per

case.20 Benefits rise if the case of disease that is prevented would have required

hospitalization ($19,000 benefit) and even more if that case would have required

treatment of a multi-drug-resistant strain ($15,000 to $137,000 benefit).17, 21

Additional benefits include the reduction of worker productivity losses due to

illness and the avoidance of stigmatization or work disruption that often follows a

TB outbreak in a worksite.

Early identification of TB disease can also be expected to substantially reduce the

costs of contact investigations, which would be less extensive than if the patient

were undiagnosed for a long period, and costs of secondary TB cases among

contacts, which would be fewer than for contacts of later diagnosed cases.

In 2004, the private-sector cost of tuberculosis screening averaged $22;

approximately 95% of all paid claims fell within the range of $0 to $49 per

screen.25

Direct medical costs of LTBI screening and treatment (without DOT) for

infection by presumed M. tuberculosis strains that can be treated by first-line

drugs are approximately $208 to $311 per person.19 If employees miss work for

the screening and treatment, productivity losses for the standard 9 months of

treatment might also occur. The direct medical cost of illness due to TB disease is

approximately $4,000 per case of drug susceptible TB disease treated by DOT.20

Costs rise if the case of disease requires hospitalization ($19,000) and even more

for treatment of a multi-drug-resistant strain ($15,000 to $137,000).17, 21

For individuals at high risk for TB, the benefits of screening for LTBI and

completion of treatment outweigh the costs if treatment reduces the risk of —

and costs associated with — TB disease and hospitalization.26 Reducing the risk

of medication-induced adverse events and any potential productivity losses

associated with LTBI treatment would add to the benefit. 

Preventive Intervention Information

Screening/testing individuals at high risk for TB allows clinicians to identify

affected persons and begin treatment. Early identification and treatment of TB

disease improves outcomes and reduces the risk of transmission. Identification of

LTBI and completion of LTBI treatment reduces an individual’s risk of

developing TB disease by 70% to 90%.2

Clinicians should individualize their decision to conduct targeted testing and

treatment for TB and LTBI to the specific patient’s risks and environment.

Routine testing for TB or LTBI is not recommended for persons who are not at

high risk for TB. The TST is subject to variability like all medical tests, but many

of the inherent variations in administering and reading tests can be avoided by

careful attention to details and the clinical provider should be aware of these

details. Interferon gamma release assays (IGRA), such as the QuantiFERON-TB®
(QFT) Gold blood test can be used instead of the TST for LTBI screening. CDC

has published guidelines for the use of approved IGRAs,27 and will do so for

additional tests as they become available. For individuals at high risk for TB, the

benefits of LTBI screening and completion of treatment outweigh the costs.26

Screening high-risk populations for TB disease by asking about the major TB

symptom, a cough of 2 to 3 weeks duration, has been shown to be effective,28

and is likely to be cost-effective over routine screening using chest radiographs.

This intervention is simple, inexpensive, and is potentially cost-effective in many

settings.

TB and LTBI testing programs should be conducted among groups at high risk

for recent infection with M. tuberculosis and those who, regardless of duration of

infection, are at increased risk for progressing to TB disease (e.g., HIV-infected or

other immunosuppressed persons with certain medical conditions, injection drug

users, those with a history of inadequately treated TB disease). 

Workers in health-care settings who have face-to-face contact with patients with

suspected or confirmed TB disease or clinical TB specimens should be included

in a screening program.5 In settings where routine screening is mandated but

classified as low risk for TB exposure (where persons with TB disease are not

expected to be encountered), workers should receive baseline testing using a twostep TST or an IGRA upon hiring (with appropriate follow-up evaluation for

those found to have positive TST or IGRA results); additional screening is not

necessary unless TB exposure occurs. In settings classified as medium risk (where

workers will or will possibly be exposed to persons with TB disease or TB clinical

specimens), workers should receive baseline two-step TST and annual screening

for TB symptoms; workers who are TST-negative at baseline should also receive

annual TST. If the setting has potential ongoing TB transmission, more frequent

TST may be needed until infection control lapses have been corrected.5

For the majority of infected persons, the only evidence of LTBI is an immune

response to mycobacterial antigens, demonstrated by a positive TST or IGRA

result. In the United States, the preferred skin test for LTBI is the intradermal, or

Mantoux method, injection of 0.1 ml (5 TU) of purified protein derivative

(PPD). Tests should be read by a trained professional 48 to 72 hours after the

skin test has been applied. Multiple puncture tests (e.g., Tine and Heaf) and

PPD strengths of 1 TU and 250 TU should not be used.2

IGRAs have been shown to have a lower likelihood of giving false-positive

readings.27 IGRAs provide significant advantages in delivery (e.g., no patient

return for test reading) that may actually make them more cost-effective than the

TST in populations that are likely to have high rates of false-positive TST results

because of prior vaccination with the Bacille Calmette-Gerin (BCG). However,

data on IGRA performance in high-risk populations are being evaluated.

Screening high-risk populations for TB disease by asking about the major TB

symptom, a cough of 2 to 3 weeks duration, is simple, inexpensive, and is

potentially cost-effective in many settings.

432

EVIDENCE-STATEMENT: Tuberculosis (Screening)

Initiation, Cessation,

and Interval of

Screening

Intervention Process
433

EVIDENCE-STATEMENT: Tuberculosis (Screening)

Treatment

Information

Health benefits should include provisions for follow-up and treatment services. 

A daily 9-month regimen of isoniazid (300 mg for adults, 10 to 15 mg/kg up to

300 mg for children) is recommended for treatment of LTBI caused by isoniazidsusceptible strains of M. tuberculosis. Completion of 270 doses within a 12-

month period is optimal.2 Twice-weekly dosing is an acceptable alternative (76

doses within 12 months).2 A daily regimen of rifampin (10 to 20 mg/kg, 600 mg

maximum) for 4 months is also an acceptable alternative and is the

recommended choice for contacts to isoniazid-resistant TB patients; completion

is considered optimal with 120 doses taken within 6 months.2 Directly-observed

treatment (DOT) improves the outcome of TB disease treatment and is therefore

recommended over self-administered therapy (SAT), and has been shown to be

cost-effective to prevent the development of drug resistant TB disease.29 DOT is

also recommended for LTBI treatment of vulnerable populations, such as HIVinfected persons or young children.

Strength of Evidence for the Clinical Preventive Service

The strength of evidence for the recommendations contained in this chapter is

described below.

Recommended Guidance:

Centers for Disease Control and Prevention (CDC)

Strength of Evidence: Not Specified. Each of the referenced CDC guidelines

describes the evidence basis for the recommendations, but not all provide ratings.

• The CDC recommends conducting targeted testing of persons at high risk for

TB and treating those who have TB and LTBI to identify TB disease early,

prevent transmission, and prevent progression of LTBI to disease.2

• The CDC recommends, if routine TB screening is mandated in low-risk

settings, the provision of baseline LTBI testing upon hiring, with the addition

of annual screening for TB symptoms in medium-risk settings.5

Authored by: 

Marks S. Tuberculosis evidence-statement: screening. In: Campbell KP, Lanza A, Dixon R, Chattopadhyay

S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into

Coverage. Washington, DC: National Business Group on Health; 2006.
References:

1. Bennett DE, Courval JM, Onorato IM, Agerton T, Daugherty-Gibson JM, MSN, McQuillan G, et al. Prevalence of TB

infection in the US population, 1999-2000. [Abstract 67921]. In: Program and abstracts, 131st annual meeting of the

American Public Health Association; San Francisco, California, November 15-19, 2003.

2. Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection.

MMWR 2000;49(RR-6):1-54.

3. Ferebee SH. Controlled chemoprophylaxis trials in tuberculosis. A general review. Bibl Tuberc 1970;26:28-106.

4. U.S. Preventive Services Task Force. TB screening recommendations: Summary of recommendations / Supporting documents.

Rockville, MD: Agency for Healthcare Research and Quality. [Cited 2006 Apr 4]. Available from:

http://www.ahrq.gov/clinic/uspstf/uspstubr.htm.

5. Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in

health-care settings, 2005. MMWR 2005;54 (RR-17):3, 10-11.

6. Centers for Disease Control and Prevention. Guidelines for the investigation of contacts of persons with infectious

tuberculosis: Recommendations from the National Tuberculosis Controllers Association and Centers for Disease Control and

Prevention. MMWR 2005;54(RR-15):1-47.

7. Centers for Disease Control and Prevention. Treatment of tuberculosis. MMWR 2003;52(RR-11):1-80.

8. Centers for Disease Control and Prevention. Controlling tuberculosis in the United States. MMWR 2005;54(RR-12):1-81.

9. Marks SM, Taylor Z, Quallls NL, Shrestha-Kuwahara RJ, Wilce MA, Nguyen CH. Outcomes of contact investigations of

infectious tuberculosis patients. Am J Respir Crit Care Med 2000;162:2033-2038.

10. Reichler MR, Reves R, Bur S, et al. Evaluation of investigations conducted to detect and prevent transmission of tuberculosis.

JAMA 2002;287:991-5.

11. Centers for Disease Control and Prevention. Reported tuberculosis in the United States, 2004. Atlanta, GA; US Department

of Health and Human Services, CDC; 2004.

12. Talbot EA, Moore M, McCray E, Binkin NJ. Tuberculosis among foreign-born persons in the United States, 1993-1998.

JAMA 2000;284:2894-900.

13 Dye C. Global epidemiology of tuberculosis. Lancet 2006;367:938-40.

14. McKenna MT, Hutton M, Cauthen G, Onorato IM. The association between occupation and tuberculosis. A populationbased survey. Am J Respir Crit Care Med 1996;154(3 Pt 1);587-93.

15. Rosenblum LS, Castro KG, Dooley S, Morgan M. Effect of HIV infection and tuberculosis on hospitalizations and cost of

care for young adults in the United States, 1985 to 1990. Ann Intern Med 1994;121(10): 786-792.

16. Brown RE, Miller B, Taylor WR, Palmer C, Bosco L, Nicola RM, et al. Health-care expenditures for tuberculosis in the

United States. Arch Intern Med 1995;155:1595-1600.

17. Taylor Z, Marks SM, Rios Burrows NM, Weis SE, Stricof RL, Miller B. Causes and costs of hospitalization of tuberculosis

patients in the United States. Int J Tuberc Lung Dis 2000;4:931–9. Updated to 2004 dollars by using a factor of 1.28.

18. Hansel NN, Merriman B, Haponik EF, Diette GB. Hospitalizations for tuberculosis in the United States in 2000: Predictors

of in-hospital mortality. Chest 2004;126(4):1079-1086.

19. Lambert L, Rajbhandary S, Qualls N, et al. Costs of implementing and maintaining a tuberculin skin test program in

hospitals and health departments. Infect Control Hosp Epidemiol 2003;24:814–20. Updated to 2004 dollars by using a

factor of 1.18.

20. Marks SM. Potential TB treatment cost savings using moxifloxacin-based regimens. TB Notes 2006;1:13–15. Available from:

http://www.cdc.gov/nchstp/tb/notes/notes.htm. 2004 dollars

21. Rajbhandary SS, Marks SM, Bock NN. Costs of patients hospitalized for multidrug-resistant tuberculosis. Int J Tuberc Lung

Dis 2004;8:1012–6. Updated to 2004 dollars by using a factor of 1.19.

22. Porco T. California Department of Health Services TB Control Program, personal communication, 2005.

23. United States Bureau of the Census. Cost of living index—selected metropolitan areas. Statistical abstract of the United

States: 1996. 116th Edition. Washington, DC. 1996. Table 749.

434

EVIDENCE-STATEMENT: Tuberculosis (Screening)
435

EVIDENCE-STATEMENT: Tuberculosis (Screening)

24. Hansel NN, Wu AW, Chang B, Diette GB. Quality of life in tuberculosis: Patient and provider perspectives. Qual Life Res

2004;13:639-652.

25. Thompson Medstat. Marketscan. 2004. 

26. Marks SM, Taylor Z, Miller BI. Tuberculosis prevention versus hospitalization: Taxpayers save with prevention. J Health Care

Poor Underserved 2002;13(3):392-401.

27. Centers for Disease Control and Prevention. Guidelines for using the QuantiFERON-TB Gold test for detecting

Mycobacterium tuberculosis infection, United States. MMWR 2005;54(RR-15):49-55

28. Golub JE, Mohan CI, Comstock GW, Chaisson RE. Active case finding of tuberculosis: Historical perspective and future

prospects. Int J Tuberc Lung Dis 2005;9(11):1183-1203.

29. Burman WJ, Dalton CB, Cohn DL, Butler JR, Reves RR. A cost-effectiveness analysis of directly observed therapy vs selfadministered therapy for treatment of tuberculosis. Chest 1997 Jul;112(1):63-70.

4 The Prioritization and Strategic

Implementation of Clinical

Preventive Service Benefits

Overview:

Practical advice about the 

prioritization and strategic 

implementation of clinical 

preventive service benefits.

Sections include:

• The Purpose and Process of

Prioritizing Recommended

Clinical Preventive Services in

order to:

- Provide Economic and 

Health Value

- Address Demographic Needs

- Address Beneficiary Risk and 

Reduce Specific Healthcare 

Costs

• Employer Scenarios

Prioritizing Clinical Preventive 

Service Benefits

437

The Purpose and Process of Prioritizing Recommended

Clinical Preventive Services

Employers with limited resources, or those facing competing demands, may not be able to

add all of the 46 recommended clinical preventive service benefits in a single benefit revision

cycle. These employers should consider a strategic implementation approach and prioritize

benefit expansion. 

There are multiple ways to prioritize the clinical

preventive services recommended in the Purchaser’s Guide.

Several methods of prioritization are listed below.

Prioritization methods are not listed in preferential

order; nor are they mutually exclusive. Each method has

its own strengths and weaknesses and employers may

want to consider combining multiple approaches.

Employers should evaluate their current clinical

preventive service benefits and the needs of their own

beneficiary population, before selecting prioritization

methods.

Prioritization of Clinical

Preventive Services 

in a Strategic 

Implementation Plan

4

Health outcomes in the United

States could be improved at less

expense if the healthcare system,

clinicians, and patients gave priority 

to services that were most beneficial

and offered the greatest value.1

Partnership for Prevention 

Priorities for America’s Health, 2006

Value – An Important Variable

Like any investment aimed at keeping a workforce healthy and productive, clinical preventive

services offer value. The “value” of an individual preventive service is determined by its ability

to prevent a significant amount of morbidity and mortality in relation to the cost of offering the

service. Because offering a clinical preventive service has a real (monetary) cost and an

opportunity cost (there is a finite amount of services that can be delivered/received in a given

period of time), it is important for purchasers to quantify the value of clinical preventive 

services in relation to one another when making coverage decisions.
438

4 Prioritization of Clinical Preventive Services in a Strategic Implementation Plan

Employer Guidance

Strength of evidence for a given clinical preventive service should be the first filter used in

prioritization and strategic implementation efforts. The U.S. Preventive Services Task Force

(USPSTF) uses a lettered grading system:

A-B: Employers should implement coverage for all services recommended in the

Purchaser’s Guide, (particularly the USPSTF “A” and “B” recommendations and all

ACIP recommended services immediately.)

I: Employers have discretion as to whether to provide coverage for services with limited

or conflicting evidence (services that received an “I” rating). The provision of coverage

for “I”-rated services should be secondary to the provision of coverage for all

recommended services featured in the Purchaser’s Guide (“A” and “B”-rated services and

equivalencies*).

C: Employers should provide coverage for USPSTF “C”-rated services only if there is a

population-specific and compelling reason to do so as there appears to little or no

health value derived from these interventions. The provision of coverage for “C”-rated

services should be secondary to the provision of coverage for all recommended services

featured in the Purchaser’s Guide (“A” and “B”-rated services and equivalencies*). 

D: Employers should not provide coverage for “D”-rated clinical preventive services for

their asymptomatic beneficiary population. However, employers may choose to cover

these services on a case-by-case basis as determined by beneficiary risk or medical

necessity criteria. Further, these services should be covered when part of a medical

treatment plan for an existing condition/disease or when an individual is determined to

be at high risk for the respective condition/disease. 

*Other organizations have comparable rating systems. For example, the American

Academy of Family Physicians (AAFP) uses a SR (Strongly Recommended), R

(Recommended), NR (No Recommendation), RA (Recommend Against), I

(Insufficient Evidence to Recommend Either For or Against) rating system. For more

information on AAFP’s grading system please refer to the Introduction of the

Purchaser’s Guide.
Figure 4.0: Methods of Prioritization in a Strategic Implementation Plan

Method of

Prioritization Explanation Purpose Requires

Provide Economic

and Health Value

Rank order clinical

preventive services by

their economic value

and health impact.

Provide cost-effective

and life-saving

benefits

Current list of highvalue clinical

preventive services

Address

Demographic Needs

Rank order clinical

preventive services by

their ability to meet

the needs of a defined

population based on

age and gender. 

Address populationspecific needs based

on age and gender

Beneficiary

demographic data 

Address Beneficiary

Risk and Reduce

Specific Healthcare

Costs

Rank order clinical

preventive services by

their ability to

address 1) the risk

profile of a

population based on

results from an

employer-sponsored

health risk appraisal

(HRA) and/or 2)

conditions and

diseases frequently

seen in healthcare

cost data.

Address populationspecific needs based

on risk; Address

preventable

healthcare costs

HRA data

Medical claims data

Disability claims data

439
Methods of Prioritization: An Overview 

Rank order clinical preventive services by their economic and health value. The National

Commission on Prevention Priorities has rank-ordered clinical preventive services according

to their cost-effectiveness and ability to prevent disease, injury, or premature death. “Highvalue” services are those services that, when delivered

appropriately, are both cost-effective and reduce the burden of

disease within a population. Employers interested in providing

coverage for the clinical preventive services that provide a good

value for their money should consider this method.

Rank order clinical preventive services by their ability to meet the needs of a defined

population based on age and gender. Many employers have beneficiary populations that are

demographically homogeneous (i.e., their beneficiary population is mostly male or mostly

female, mostly young adults [20s, 30s, 40s], mostly older adults [50s, 60s, 70s]). Similarly,

many clinical preventive services are relevant only for one age or

gender group (e.g., cervical cancer screening is only recommended

for women). Employers who have a relatively homogenous

beneficiary population and who want to provide coverage for

the clinical preventive services that are most likely to meet the

needs of that population should consider this method. 

Rank order clinical preventive services by their ability to address the risk profile of a

population based on results from a population risk assessment such as an health risk

appraisal (HRA) or conditions and diseases frequently seen in healthcare cost data.

Employers who sponsor HRAs can use the results of the assessment to establish a beneficiary

risk profile. This group risk profile can then inform the selection of clinical preventive

service benefits. Similarly, analyzing healthcare cost data (e.g., medical claims data, disability

claims data) can alert employers to high-frequency and/or high-cost claims that are a result

of a preventable disease (e.g., hospitalization for chickenpox) or modifiable behavior (e.g.,

tobacco use). Clinical preventive service benefits can then be

prioritized for implementation based on their ability to address

the preventable conditions reflected in the employer’s healthcare

cost data. Employers interested in providing coverage for

clinical preventive services that 1) address the specific health

risks of their beneficiary population and/or 2) address their

beneficiaries’ preventable healthcare costs should consider 

this method.

440

4 Prioritization of Clinical Preventive Services in a Strategic Implementation Plan

Address

Demographic 

Needs

Address

Beneficiary Risk &

Reduce Specific

Healthcare Costs

Provide Economic

and Health Value
441

High-Value Clinical

Preventive Service

As noted in the

Purchaser’s Guide

Clinically

Preventable

Burden of

Disease (CPB)

Max Score = 5

CostEffectiveness

(CE) Max

Score = 5

Combined

Score (CPB)

and CE, Max

Score = 10

Figure 4.1: Top 25 High-Value Preventive Services (evaluated in terms of the preventable

burden of disease and cost-effectiveness)2

Aspirin

Chemoprophylaxis

Aspirin Therapy for the

Prevention of Cardiovascular

Disease, Counseling

5 5 10

Childhood

Immunization Series

Immunizations (Child,

Adolescent, Adult)

5 5 10

Tobacco Use

Screening and Brief

Intervention

Tobacco Use Treatment,

Screening, counseling, 

and treatment

5 5 10

Problem Drinking

Screening and Brief

Counseling

Alcohol Misuse, Screening

and counseling

4 4 8

Hypertension

Screening

Hypertension, Screening,

counseling, and treatment

5 3 8

Colorectal Cancer

Screening

Colorectal Cancer, 

Screening

4 4 8

Continued on next page

Provide Economic and Health Value

Rank order clinical preventive services by their economic and health value. 

The National Commission on Prevention Priorities (NCPP), a blue-ribbon panel of

thought-leaders on prevention chaired by former Surgeon General Dr. David Satcher and

staffed by Partnership for Prevention, recently ranked the 25 preventive services

recommended by the U.S. Preventive Services Task Force (USPSTF) and the Advisory

Committee on Immunization Practices (ACIP) according to health impact and costeffectiveness. 

NCPP used a rigorous methodology to rank the selected clinical preventive services. A

clinical preventive services was deemed “high-value” when it was determined to be both

cost-effective (it cost a “reasonable” amount of money for the added quality of life or lifeyears gained) and impacts the clinical preventable burden of a disease (the service prevented

a substantial proportion of disease, injury, or

premature death when delivered appropriately).

Employers interested in maximizing the value of their

investment in preventive services, within a large

population and over a sustained period of time, may

want to consider using this approach to prioritization.

Additional information on the

National Commission on Prevention

Priorities is available online at:

www.prevent.org/content/view/46/96/
442

4 Prioritization of Clinical Preventive Services in a Strategic Implementation Plan

High-Value Clinical

Preventive Service

As noted in the

Purchaser’s Guide

Clinically

Preventable

Burden of

Disease (CPB)

Max Score = 5

CostEffectiveness

(CE) 

Max Score = 5

Combined

Score (CPB)

and CE,

Max Score = 10

Figure 4.1: Top 25 High-Value Preventive Services (evaluated in terms of the preventable

burden of disease and cost-effectiveness)2 (Continued)

Pneumococcal

Immunization

Immunizations (Child,

Adolescent, Adult)

3 5 8

Osteoporosis

Screening

Osteoporosis, Screening and

treatment

2 2 4

Cholesterol Screening

(High-Risk)

Lipid Disorders, Screening,

counseling, and treatment

1 1 2

Vision Screening

(Adults)

Not included in the

Purchaser’s Guide

3 5 8

Injury Prevention

Counseling

Motor Vehicle-Related Injury

Prevention, Counseling

1 3 4

Cervical Cancer

Screening

Cervical Cancer, Screening 4 3 7

Cholesterol 

Screening

Lipid Disorders, Screening,

counseling, and treatment

5 2 7

Breast Cancer

Screening

Breast Cancer, Screening 4 2 6

Calcium

Chemoprophylaxis

Not included in the

Purchaser’s Guide

3 3 6

Obesity Screening Obesity, Screening,

counseling, and treatment

3 2 5

Chlamydia Screening Chlamydia, Screening 2 4 6

Depression Screening Depression, Screening 3 1 4

Vision Screening

(Children)

Vision, Screening 2 4 6

Hearing Screening Newborn Hearing, Screening 2 2 4

Diabetes Screening Diabetes (type 2), Screening 1 1 2

Diet Counseling Healthy Diet, Counseling 1 1 2

Tetanus and

Diphtheria Booster

Immunizations (Child,

Adolescent, Adult)

1 1 2

Folic Acid

Chemoprophylaxis

Folic Acid Supplementation,

Counseling and preventive

medication

2 3 5

Influenza

Immunization

Immunizations (Child,

Adolescent, Adult)

4 4 8
Method suggested for: Employers with large and diverse populations (in terms of age and

gender) and who want to provide services with the greatest value to their employees. 

Employer Scenario: Employer A has 100,000 employees, 60,000 dependents, and 10,000

retirees. Employer A provides health insurance coverage for all beneficiaries, including

Medicare Part B coverage for retirees. The beneficiary population is very diverse: 49% of

beneficiaries are female and the average age of a beneficiary is 35 (but ranges from 0 to 81

years). After reviewing HRA information and medical claims data, no single preventable

condition emerges as a major health or cost problem. Rather, many preventable conditions

affect the population. Employer A is facing cost cutbacks relative to medical spending and

wants to ensure it receives a good value for any new benefit it implements. In order to

receive the most value from its clinical preventive service benefit expansion, employer A

decides to implement “high-value” clinical preventive services that received a score of > 8

immediately, and then implement the remaining services over the next two benefit revision

cycles.

In the abovementioned scenario, employer A would implement benefits for the following

services:

Immediate Implementation

High-Value Clinical

Preventive Service

As noted in the

Purchaser’s Guide

Combined Score

(CPB) and CE,

Max Score =10

Aspirin Chemoprophylaxis Aspirin Therapy for the Prevention of

Cardiovascular Disease, Counseling

10

Childhood Immunization

Series

Immunizations (Child, Adolescent,

Adult)

10

Tobacco Use Screening and

Brief Intervention

Tobacco Use Treatment, Screening,

counseling, and treatment

10

Problem Drinking Screening

and Brief Counseling

Alcohol Misuse, Screening and

counseling

8

Hypertension Screening Hypertension, Screening, counseling,

and treatment

8

Pneumococcal

Immunization

Immunizations (Child, Adolescent,

Adult)

8

Vision screening (Adults) Not included in the Purchaser’s Guide 8

Colorectal Cancer Screening Colorectal Cancer, Screening 8

Influenza Immunization Immunizations (Child, Adolescent,

Adult)

8

443
Subsequent Implementation – Benefit Revision Cycle 2

Subsequent Implementation – Benefit Revision Cycle 3

444

4 Prioritization of Clinical Preventive Services in a Strategic Implementation Plan

High-Value Clinical

Preventive Service

As noted in the

Purchaser’s Guide

Combined Score

(CPB) and CE,

Max Score =10

Cholesterol Screening Lipid Disorders, Screening, counseling,

and treatment

7

Cervical Cancer Screening Cervical Cancer, Screening 7

Breast Cancer Screening Breast Cancer, Screening 6

Calcium Chemoprophylaxis Not included in the Purchaser’s Guide 6

Chlamydia Screening Chlamydia, Screening 6

Vision Screening (Children) Vision, Screening 6

High-Value Clinical

Preventive Service

As noted in the

Purchaser’s Guide

Combined Score

(CPB) and CE,

Max Score =10

Folic Acid

Chemoprophylaxis

Folic Acid Supplementation,

Counseling and preventive medication

5

Obesity Screening Obesity, Screening, counseling, and

treatment

5

Cholesterol Screening 

(High-Risk)

Lipid Disorders, Screening, counseling,

and treatment

2

Injury Prevention

Counseling

Motor Vehicle-Related Injury

Prevention, Counseling

4

Depression Screening Depression, Screening 4

Depression Screening Depression, Screening 2

Diabetes Screening Diabetes (type 2), Screening 2

Diet Counseling Healthy Diet, Counseling 2

Tetanus and Diphtheria

Booster

Immunizations (Child, Adolescent,

Adult)

2

Osteoporosis Screening Osteoporosis, Screening and treatment 4

Hearing Screening Newborn Hearing, Screening 4
Address Demographic Needs

Rank order clinical preventive services by their ability to meet the needs of

a defined population based on age and gender. 

Many clinical preventive services are specifically intended for a particular group of people

based on their age, gender, or other risk factor. For example, newborn hearing screening is

only relevant for beneficiaries who have (or who are) infants that will need this agedependent service. When an employer’s beneficiary population is relatively homogenous

(e.g., mostly male, mostly old) it may be wise to first implement the specific clinical

preventive services that are most relevant for the majority population.

Method suggested for: Employers with a homogenous beneficiary population that is heavily

weighted towards one gender or age group. 

Employer Scenario: Employer B has 7,000 employees and provides health insurance for an

additional 2,000 dependents, and 4,000 retirees. The beneficiary population is homogenous;

the average age of a beneficiary is 53 and 73% of the beneficiary population is male. In

order to best address the needs of the majority population, employer B decides to implement

clinical preventive services recommended for normal risk males in their 40s, 50s, and 60s in

the first year of the implementation program and then add benefits for clinical preventive

services that address the needs of other populations over the subsequent 5 years.

In the abovementioned scenario, employer B would implement benefits for the following

services immediately. Examples are listed in alphabetical order, but could be implemented

according to health impact and economic value.

• Abdominal Aortic Aneurysm, Screening

• Alcohol Misuse, Screening and counseling

• Aspirin Therapy for the Prevention of Cardiovascular Disease, Counseling

• Colorectal Cancer, Screening

• Depression, Screening

• Diabetes (type 2), Screening

• Healthy Diet, Counseling

• Hypertension, Screening, counseling, and treatment

• Influenza, Immunization

• Lipid Disorders, Screening, counseling, and treatment

• Obesity, Screening, counseling, and treatment

• Pneumococcal disease, Immunization

• Tobacco Use Treatment, Screening, counseling, and treatment

445
Address Beneficiary Risk and Reduce Specific 

Healthcare Costs

Rank order clinical preventive services by their ability to address:

1. The risk profile of a population based on results from a population risk assessment 

such as an health risk appraisal (HRA); and/or 

2. Conditions, diseases, or behaviors frequently seen in healthcare cost data.

Analyzing healthcare cost data can help employers identify the specific health problems that

are afflicting their beneficiaries. Targeting these behaviors, conditions, or diseases may

provide the “biggest bang for the buck” by reducing beneficiaries’ burden of disease and

overall healthcare costs simultaneously.

Method suggested for: Employers who currently have a HRA (or other population risk

assessment tool) in place and the ability to analyze those data to determine a beneficiary

population risk profile and employers who are able to analyze their healthcare cost data and

determine which preventable behaviors, conditions or disease account for a substantial

proportion of medical, disability, or other health-related claims costs.

Employer Scenario 1: Employer C has 15,000 employees and provides health insurance for

an additional 13,000 dependents. For the past three years, employer C has required all

beneficiaries to complete an HRA. Employer C carefully analyzed the group data from the

past year’s HRA and determined the following,

1. Beneficiaries are significantly overweight; the average BMI of a beneficiary is 

30 kg/m2.

2. Beneficiaries do not get an adequate amount of physical activity; the average

beneficiary reports only 15 minutes of physical activity per week. 

3. Beneficiaries report unhealthy diets; they consume excess amounts of total fat,

saturated-fat, and cholesterol, and inadequate amounts of fruits, vegetables, and

whole grains. 

4. Forty-five percent (45%) of employees use tobacco products, far above the national

average. 

5. Thirty-seven percent (37%) of adult beneficiaries consume more than 7 alcoholic

beverages per week. 

Based on this data, employer C knows that its beneficiary population is at high risk for

alcohol misuse, cancer, obesity, type 2 diabetes, heart disease, hypertension, and smokingrelated illnesses. To best address the risks of its beneficiary population, employer C decides

to immediately implement benefits for the clinical preventive services that address these

behaviors and diseases, including (examples are listed in alphabetical order, but could be

implemented according to health impact and economic value):

• Alcohol Misuse, Screening and counseling

• Breast Cancer, Counseling and preventive medication

446

4 Prioritization of Clinical Preventive Services in a Strategic Implementation Plan
• Breast Cancer, Screening

• Cervical Cancer, Screening

• Colorectal Cancer, Screening

• Diabetes (type 2), Screening

• Healthy Diet, Counseling

• Hypertension, Screening, counseling, and treatment

• Lipid Disorders, Screening, counseling, and treatment

• Motor Vehicle Related Injury Prevention, Counseling

• Obesity, Screening, counseling, and treatment

• Tobacco Use Treatment, Screening, counseling, and treatment

Employer Scenario 2: Employer D provides health benefits for 36,000 employees and

40,000 dependents. Over three-quarters of the employee population is female and most are

relatively young. Further, employee demographic data show that 45% of beneficiaries are

African-American. A large portion of employer D’s medical claims are for labor and delivery

charges and a large proportion of employer D’s disability claims are paid for short- and longterm disabilities related to complications of pregnancy. Employer D’s beneficiaries have a

higher than normal rate of preterm births and neonatal intensive care (NICU) admissions.

Employer D knows that African-Americans are at increased risk for poor birth outcomes

including preterm birth, low birth weight, and infant mortality.3 Employer D would like to

reduce its medical claims related to pregnancy complications and reduce racial and ethnic

disparities in healthcare by ensuring that all its beneficiaries have access to high-quality

preconception, prenatal, and postpartum care. 

To promote access, employer D decides to immediately implement benefits for all clinical

preventive services related to pregnancy, infant care, and childhood health promotion.

Further, employer D decides to provide “safe-harbor” coverage for preventive services in

HDHP and HSA-qualified plans and to eliminate copays for preventive care in HMO,

PPO, and POS plans.

Clinical preventive services aimed at promoting healthy pregnancies include:

• Alcohol Misuse, Screening and counseling

• Asymptomatic Bacteriuria, Screening

• Breastfeeding, Counseling

• Prenatal Diagnosis of Chromosomal Abnormalities and Neural Tube Defects (NTDs),

Screening and testing

• Folic Acid Supplementation, Counseling and preventive medication

• Group B Streptococcal Disease (GBS), Screening and preventive medication

• Hepatitis B Virus (HBV), Screening, immunization, and treatment

• Human Immunodeficiency Virus (HIV), Screening, counseling, preventive medication

• Influenza, Immunization

447
• Preeclampsia, Screening

• Rh (D) incompatibility, Screening and preventive medication

• Rubella, Screening

• Syphilis, Screening

• Tetanus, Immunization

• Tobacco Use Treatment, Screening and counseling

Clinical preventive services specific to infants and children include: 

• Child Development, Screening

• Child Immunizations, Immunization

• Dental Caries Prevention through Oral Fluoride Supplementation, Preventive

medication

• Lead, Elevated Blood Level, Screening

• Newborn Screening for Genetic and Endocrine Disorders, Screening, medical foods,

and treatment

• Newborn Hearing, Screening

• Vision, Screening

References:

1. Partnership for Prevention. Priorities for America’s Health: Capitalizing on Life-Saving, Cost-Effective 

Preventive Services. Washington, DC: Partnership for Prevention. [Cited 2006 Jun 29]. Available from: 

http://www.prevent.org/images/stories/clinicalprevention/executive%20summary.pdf. 

2. Maciosek MV, Coffield AB, Edwards NM, Goodman MJ, Flottemesch TJ, Solberg LI. Priorities among 

effective clinical preventive services: results of a systematic review and analysis. Am J Prev Med 2006; 

31(1):52-61. Table reprinted from Am J Prev Med 2006; 31(1):52-61 with permission from the American 

Journal of Preventive Medicine.

3. Alexander GR, Kogan M, Bader D, Carlol W, Allen M, Mor J. U.S. birth weight/gestational age-specific 

neonatal mortality: 1995–1997 rates for whites, Hispanics, and blacks. Pediatrics 2003; 111(1): e61-e66. 

448

4 Prioritization of Clinical Preventive Services in a Strategic Implementation Plan

The United States spends billions on healthcare services of questionable value

while basic, evidence-based preventive services are not getting done as often as they

should. Yet the time available to deliver healthcare services is limited. Brief clinician 

office visits must address chronic conditions, acute illness, and preventive are. In this

environment, prioritization of healthcare services is occurring, but it is rarely systematic

or rational. And the consequences of misplaced priorities are high: people die and 

illnesses worsen because the most important preventive services do not get done.1

Partnership for Prevention

Priorities for America’s Health: Capitalizing on Life-Saving, Cost-Effective

Preventive Services, 2006
I Statements and C and D

Recommendations of the U.S.

Preventive Services Task Force

(USPSTF)

5

Overview:

Information on clinical preventive

services that were reviewed by

the USPSTF, but not included in

the Purchaser’s Guide. This 

information may assist benefits

staff in determining which clinical

preventive services currently

offered in their health plan(s)

should be re-evaluated.

I Statements and C and D

Recommendations of the USPSTF

449

The vast majority of recommendations featured in the

Purchaser’s Guide to Clinical Preventive Services are

recommended by the U.S. Preventive Services Task

Force (USPSTF). 

The USPSTF grades clinical preventive services based

on the strength of evidence available to support a

particular clinical preventive service and the magnitude of net benefit for that service. 

The net benefit of a clinical preventive service is defined as the benefits of the service 

(e.g., years of life saved through early cancer detection) minus the harms of the service 

(e.g., risks associated with false-positives). The USPSTF

assigns each clinical preventive service it reviews a

grade. The Purchaser’s Guide includes all USPSTF “A”

(Strongly Recommended) and “B” (Recommended)

rated recommendations (as of March 2006).

The USPSTF also identifies other services that, for one

reason or another, are not recommended: 

• “I”-rated (Insufficient Evidence to Recommend 

For or Against)

• “C”-rated (No Recommendation Either For 

or Against)

• “D”-rated (Recommend Against)

I Statements and C and D

Recommendations of the U.S.

Preventive Services Task

Force (USPSTF)

5

In a resource-constrained 

environment, employers must 

carefully consider which preventive

services to offer. Many preventive

services are available. Some are

known to be effective; others are

known to be relatively ineffective or

even harmful; others may be effective

but the proof of effectiveness is weak.

In addition to adding coverage for

services recommended in the

Purchaser’s Guide, employers should

evaluate their current preventive service

benefits and consider removing benefits

for services that are ineffective or

harmful (“D”-rated services).

Important Note: 

Several services recommended in the Purchaser’s Guide received an “I” rating from the

U.S. Preventive Services Task Force (USPSTF). These services are recommended for 

inclusion in benefit plans by the National Business Group on Health because they are 

recommended by other respected organizations, but they are not endorsed by the USPSTF.

For more information on the U.S.

Preventative Services Task Force 

(USPSTF) please refer to the 

Introduction of the Purchaser’s Guide.
450

5 I Statements and C and D Recommendations of the U.S. Preventive Services 

Employer Action

Employers have discretion as to whether to provide coverage for services with

limited or conflicting evidence (services that received an “I” rating). The

provision of coverage for “I” rated services should be secondary to the provision of

coverage for all recommended services featured in the Purchaser’s Guide. 

It is important to remember that “insufficient evidence” means just that: the evidence is not

now adequate for evidence-based decisions. On occasion, employers may need to resort to

the informed opinions of unbiased experts about such interventions. There are several

reasons why an intervention may have insufficient evidence. It may be a new intervention

for which there has been insufficient time to conduct and publish the large, rigorous studies

needed to assess it. In other instances, such as with vaccines that have been widely used for

decades, it is generally agreed that it would be unethical to conduct controlled studies,

where a vaccine would be tested against a placebo. Similarly, if a preventive intervention has

made a condition so rare that it almost never occurs, but experience suggests that removing

the preventive intervention from use would threaten the health of people, the preventive

service would be imprudent to test in the United States. It is also possible that an

intervention has minimal effectiveness and that, despite considerable study, its small effects

have been insufficient to allow a decision about its value. 

Employers should provide coverage for “C”-rated services only if there is a

population-specific and compelling reason to do so. The USPSTF issues a “C”

rating to services in which the balance of benefits and harms is too close to justify a

general recommendation. Therefore, the provision of coverage for “C”-rated services should

be secondary to the provision of coverage for all recommended services featured in the

Purchaser’s Guide. 

Employers are discouraged from providing coverage for clinical preventive

services that received a “D” rating from the USPSTF, as these services have been

found to be ineffective or to have more harms than benefits. 

Important Note: 

“D”-rated services are not recommended for the general asymptomatic population and

therefore should not be covered as preventive services within a medical benefit plan.

However, these services may play an important role in the treatment or management of

existing conditions and should be covered for all populations under the health plan’s 

treatment benefit.

I

C

D
A Strongly Recommended

The USPSTF strongly recommends that clinicians provide the service to

eligible patients. The USPSTF found good evidence that the service improves

important health outcomes and concludes that the benefits substantially

outweigh harms.1

B Recommended

The USPSTF recommends that clinicians provide the service to eligible

patients. The USPSTF found at least fair evidence that the service improves

important health outcomes and concludes that the benefits outweigh harms.1

C No Recommendation Either For or Against

The USPSTF makes no recommendation either for or against routine provision

of the service. The USPSTF found at least fair evidence that the service can

improve health outcomes but concludes that the balance of benefits and harms

is too close to justify a general recommendation.1

D Recommend Against

The USPSTF recommends against routinely providing the service to

asymptomatic patients. The USPSTF found at least fair evidence that the

service is ineffective or that the harms associated with the service outweigh

benefits.1

I Insufficient Evidence in Order to Make a Recommendation

The USPSTF concludes that the evidence is insufficient to recommend for or

against routinely providing the service. Evidence that the service is effective is

lacking, of poor quality, or conflicting, and the balance of benefits and harms

cannot be determined.1

Figure 5.0: U.S. Preventive Services Task Force (USPSTF) Ratings

451
452

5 I Statements and C and D Recommendations of the U.S. Preventive Services 

I Statements of the USPSTF

Explanation: The USPSTF concludes that the evidence is insufficient to recommend for or

against routinely providing [the service]. Evidence that [the service] is effective is lacking, of

poor quality, or conflicting, and the balance of benefits and harms cannot be determined.1

Employers have discretion to cover these services if they choose. However, the provision of

coverage for “I”-rated services should be secondary to the provision of coverage for all

recommended services featured in the Purchaser’s Guide (“A” and “B”-rated services and

equivalencies).

Clinical Preventive Services with

Insufficient Evidence Available to

Make a Recommendation Explanation

*Alcohol Misuse, Screening and

behavioral counseling interventions

The USPSTF concludes that the evidence is insufficient

to recommend for or against screening and behavioral

counseling interventions to prevent or reduce alcohol

misuse by adolescents in primary care settings.

Bacterial Vaginosis in

Pregnancy, Screening

The USPSTF concludes that the evidence is

insufficient to recommend for or against routinely

screening high-risk pregnant women for bacterial

vaginosis.

Breast Cancer, Screening The USPSTF concludes that evident is insufficient to

recommend for or against routine clinical breast exam

(CBE) alone to screen for breast cancer. 

Breast Cancer, Screening The USPSTF concludes that the evidence is

insufficient to recommend for or against teaching or

performing routine breast self-examination.

Breastfeeding, Behavioral

interventions to promote 

The USPSTF found insufficient evidence to

recommend for or against the following interventions to

promote breastfeeding: brief education and counseling

by primary care providers; peer counseling used alone

and initiated in the clinical setting; and written

materials, used alone or in combination with other

interventions.

Important Note: Several services recommended in the Purchaser’s Guide received an “I”

rating from the U.S. Preventive Services Task Force (USPSTF). These services are recommended for

inclusion in benefit plans by the National Business Group on Health because they are recommended

by other respected organizations, but they are not endorsed by the USPSTF.

*Recommended for coverage in the Purchaser’s Guide
453

Cervical Cancer, Screening The USPSTF concludes that the evidence is

insufficient to recommend for or against the routine

use of new technologies to screen for cervical cancer.

Depression, Screening The USPSTF concludes the evidence is insufficient to

recommend for or against routine screening of children

or adolescents for depression.

Developmental Dysplasia of

the Hip, Screening

The USPSTF concludes that evidence is insufficient to

recommend for or against routine screening for

developmental dysplasia of the hip in infants as a

means to prevent adverse outcomes.

Diabetes Mellitus Type 2,

Screening

The USPSTF concludes that the evidence is

insufficient to recommend for or against routinely

screening asymptomatic adults for type 2 diabetes,

impaired glucose tolerance, or impaired fasting glucose. 

Dental Caries (in preschool

children), Preventive medication

The USPSTF concludes that the evidence is

insufficient to recommend for or against routine risk

assessment of preschool children by primary care

clinicians for the prevention of dental disease.

Cervical Cancer, Screening The USPSTF concludes that the evidence is

insufficient to recommend for or against the routine

use of human papillomavirus (HPV) testing as a

primary screening test for cervical cancer. 

Chlamydial Infection, Screening The USPSTF concludes that the evidence is

insufficient to recommend for or against routinely

screening asymptomatic men for chlamydial infection.

Coronary Heart Disease,

Screening

The USPSTF found insufficient evidence to recommend

for or against routine screening with electrocardiography

(ECG), exercise treadmill test (ETT), or electron-beam

computerized tomography (EBCT) scanning for

coronary calcium for either the presence of severe

Coronary Artery Stenosis (CAS) or the prediction of

Coronary Heart Disease (CHD) events in adults at

increased risk for CHD events.

I Statements of the USPSTF (continued)

Diet, Behavioral counseling The USPSTF concludes that the evidence is

insufficient to recommend for or against routine

behavioral counseling to promote a healthy diet in

unselected patients in primary care settings.
454

5 I Statements and C and D Recommendations of the U.S. Preventive Services 

Gonorrhea, Screening The USPSTF found insufficient evidence to

recommend for or against routine screening for

gonorrhea infection in pregnant women who are not

at increased risk for infection.

*High Blood Pressure, Screening The USPSTF concludes that evidence is insufficient

to recommend for or against routine screening for

high blood pressure in children and adolescents to

reduce the risk of cardiovascular disease.

Iron Deficiency Anemia,

Screening children and pregnant

women

The U.S. Preventive Services Task Force (USPSTF)

concludes that evidence is insufficient to recommend

for or against routine screening for iron deficiency

anemia in asymptomatic children aged 6 to 12 months.

Hepatitis C, Screening The USPSTF found insufficient evidence to

recommend for or against routine screening for

hepatitis C virus (HCV) infection in adults at high

risk for infection.

Family and Intimate Partner

Violence, Screening

The USPSTF found insufficient evidence to

recommend for or against routine screening of parents

or guardians.

Dementia, Screening The USPSTF concludes that the evidence is

insufficient to recommend for or against routine

screening for dementia in older adults.

Gonorrhea, Screening The USPSTF found insufficient evidence to

recommend for or against routine screening for

gonorrhea infection in men at increased risk for

infection.

Gestational Diabetes Mellitus,

Screening

The USPSTF concludes that the evidence is

insufficient to recommend for or against routine

screening for gestational diabetes. 

Iron Supplementation for

Children and Pregnant Women,

Preventive medication 

The USPSTF concludes that evidence is insufficient to

recommend for or against routine iron supplementation

for asymptomatic children aged 6 to 12 months who

are at average risk for iron deficiency anemia. The

USPSTF concludes that evidence is insufficient to

recommend for or against routine iron supplementation

for non-anemic pregnant women.

I Statements of the USPSTF (continued)

*Recommended for coverage in the Purchaser’s Guide
*Newborn Hearing, Screening

Oral Cancer, Screening The USPSTF concludes that the evidence is insufficient

to recommend for or against routinely screening adults

for oral cancer.

Physical Activity, Behavioral

counseling

The USPSTF concludes that the evidence is insufficient

to recommend for or against behavioral counseling in

primary care settings to promote physical activity.

Prostate Cancer, Screening The USPSTF concludes that the evidence is insufficient

to recommend for or against routine screening for

prostate cancer using prostate specific antigen (PSA)

testing or digital rectal examination (DRE).

*Overweight in Children and

Adolescents, Screening

The USPSTF concludes that the evidence is insufficient

to recommend for or against routine screening for

overweight in children and adolescents as a means to

prevent adverse health outcomes.

Obesity, Counseling

Obesity, Counseling The USPSTF concludes that the evidence is insufficient

to recommend for or against the use of counseling of

any intensity and behavioral interventions to promote

sustained weight loss in overweight adults. 

The USPSTF concludes that the evidence is

insufficient to recommend for or against routine

screening of newborns for hearing loss during the

postpartum hospitalization.

The USPSTF concludes that the evidence is insufficient

to recommend for or against the use of moderate- or

low-intensity counseling together with behavioral

interventions to promote sustained weight loss in obese

adults. 

I Statements of the USPSTF (continued)

Skin Cancer, Counseling The USPSTF concludes that the evidence is

insufficient to recommend for or against

routine counseling by primary care clinicians

to prevent skin cancer.

*Recommended for coverage in the Purchaser’s Guide

455
456

I Statements and C and D Recommendations of the U.S. Preventive Services 

Speech and Language Delay in

Preschool Children, Screening

The USPSTF concludes that the evidence is

insufficient to recommend for or against routine use

of brief, formal screening instruments in primary care

to detect speech and language delay in children up to

5 years of age.

Vitamin Supplementation to

Prevent Cancer and

Cardiovascular Disease,

Preventive medication

The USPSTF concludes that the evidence is

insufficient to recommend for or against the use of

supplements of vitamins A, C, or E; multivitamins

with folic acid; or antioxidant combinations for the

prevention of cancer or cardiovascular disease.

Thyroid Disease, Screening The USPSTF concludes that the evidence is

insufficient to recommend for or against routine

screening for thyroid disease in adults.

Suicide Risk, Screening The USPSTF concludes that the evidence is

insufficient to recommend for or against routine

screening by primary care clinicians to detect suicide

risk in the general population.

*Tobacco Use (adolescents),

Screening, counseling, and

intervention

The USPSTF concludes that the evidence is

insufficient to recommend for or against routine

screening for tobacco use or interventions to prevent

and treat tobacco use and dependence among children

and adolescents. 

Skin Cancer, Screening The USPSTF concludes that the evidence is

insufficient to recommend for or against routine

screening for skin cancer using a total-body skin

examination for the early detection of cutaneous

melanoma, basal cell cancer, or squamous cell skin

cancer. 

Skin Cancer, Counseling The USPSTF concludes that the evidence is

insufficient to recommend for or against routine

counseling by primary care clinicians to prevent skin

cancer.

I Statements of the USPSTF (continued)

*Recommended for coverage in the Purchaser’s Guide

5
C Recommendations of the USPSTF

Explanation: The USPSTF makes no recommendation for or against routine provision of [the

service]. The USPSTF found at least fair evidence that [the service] can improve health

outcomes but concludes that the balance of benefits and harms is too close to justify a general

recommendation.1

Employers have discretion to cover “C”-services if they choose. However, the provision of

coverage for “C”-rated services should be secondary to the provision of coverage for all

recommended services featured in the Purchaser’s Guide (“A” and “B”-rated services and

equivalencies

Clinical Preventive Services with

No Recommendation Explanation

Abdominal Aortic Aneurysm,

Screening

The USPSTF makes no recommendation for or

against screening for AAA in men aged 65 to 75 who

have never smoked.

Chlamydial Infection, Screening The USPSTF makes no recommendation for or

against routinely screening asymptomatic low-risk

women in the general population for chlamydial

infection.

Chlamydial Infection, Screening The USPSTF makes no recommendation for or

against routine screening for asymptomatic, low-risk

pregnant women aged 26 years and older for

chlamydial infection.

*Human Immunodeficiency

Virus (HIV) Infection,

Screening

The USPSTF makes no recommendation for or

against routinely screening for HIV adolescents and

adults who are not at increased risk for HIV infection. 

*Lipid Disorders in Adults,

Screening

The USPSTF makes no recommendation for or

against screening for lipid disorders in younger adults

(men aged 20 to 35 years or women aged 20 to 45

years) in the absence of known risk factors for

coronary heart disease. 

Osteoporosis (in

postmenopausal women),

Screening

The USPSTF makes no recommendation for or against

routine osteoporosis screening in postmenopausal

women who are younger than 60 or in women aged 60

to 64 who are not at increased risk for osteoporotic

fractures. 

*Recommended for coverage in the Purchaser’s Guide

457
458

I Statements and C and D Recommendations of the U.S. Preventive Services 

D Recommendations of the USPSTF

Explanation: The USPSTF recommends against routinely providing [the service] to

asymptomatic patients. The USPSTF found at least fair evidence that [the service] is

ineffective or that harms outweigh benefits.1

Employers should not provide coverage for these clinical preventive services for their general

asymptomatic beneficiary population. However, employers may choose to cover these

services on a case-by-case basis as determined by beneficiary risk or medical necessity

criteria. Further, these services should be covered when part of a medical treatment plan for

an existing condition/disease or when an individual is determined to be at high-risk for the

respective condition/disease.

Non-Recommended Clinical

Preventive Service Explanation

Abdominal Aortic Aneurysm,

Screening 

The USPSTF recommends against routine screening

for AAA in women.

Asymptomatic Bacteriuria,

Screening

The USPSTF recommends against the routine

screening of men and nonpregnant women for

asymptomatic bacteriuria.

Bacterial Vaginosis in

Pregnancy, Screening

The USPSTF recommends against routinely screening

average-risk asymptomatic pregnant women for

bacterial vaginosis.

Bladder Cancer, Screening The USPSTF recommends against routine screening

for bladder cancer in adults.

Breast Cancer, Preventive

medication

The USPSTF recommends against routine use of

tamoxifen or raloxifene for primary prevention of

breast cancer for women at low or average risk for

breast cancer. 

Cervical Cancer, Screening The USPSTF recommends against routinely screening

women older than age 65 for cervical cancer if they

have had adequate recent screening with normal Pap

smears and are not otherwise at high risk.

Cervical Cancer, Screening The USPSTF recommends against routine Pap smear

screening in women who have had a total

hysterectomy for benign disease.

5
Coronary Heart Disease,

Screening

The USPSTF recommends against screening with

resting electrocardiography (ECG), exercise treadmill

test (ETT), or electron-beam computerized tomography

(EBCT) scanning for coronary calcium for either the

presence of severe coronary artery stenosis (CAS) or the

prediction of coronary heart disease (CHD) in adults at

low risk for CHD events.

Hepatitis B Virus Infection,

Screening

The USPSTF recommends against routinely screening

the general asymptomatic population for chronic

hepatitis B virus infection. 

Hormone Therapy, Prevention of

chronic conditions in

postmenopausal women

The USPSTF recommends against the routine use of

combined estrogen and progestin for the prevention of

chronic conditions in postmenopausal women. The

USPSTF recommends against the routine use of

unopposed estrogen for the prevention of chronic

conditions in postmenopausal women who have had a

hysterectomy.

Idiopathic Scoliosis, Screening The USPSTF recommends against the routine

screening of asymptomatic adolescents for idiopathic

scoliosis. 

Hepatitis C, Screening The USPSTF recommends against routine screening

for hepatitis C virus (HCV) infection in asymptomatic

adults who are not at increased risk (general

population) for infection.

Genetic Risk Assessment and

BRCA Mutation Testing for

Breast and Ovarian Cancer

Susceptibility

USPSTF recommends against routine referral for

genetic counseling or routine breast cancer

susceptibility gene (BRCA) testing for women whose

family history is not associated with an increased risk

for deleterious mutations in breast cancer susceptibility

gene 1 (BRCA1) or breast cancer susceptibility gene 2

(BRCA2).

Gonorrhea, Screening The USPSTF recommends against routine screening for

gonorrhea infection in men and women who are at low

risk for infection.

D Recommendations of the USPSTF (continued)

Ovarian Cancer, Screening The USPSTF recommends against routine screening for

ovarian cancer.

459
460

I Statements and C and D Recommendations of the U.S. Preventive Services 

Pancreatic Cancer, Screening The USPSTF recommends against routine screening

for pancreatic cancer in asymptomatic adults using

abdominal palpation, ultrasonography, or serologic

markers.

Testicular Cancer, Screening The USPSTF recommends against routine screening

for testicular cancer in asymptomatic adolescent and

adult males.

Syphilis Infection, Screening The USPSTF recommends against routine screening

of asymptomatic persons who are not at increased risk

for syphilis infection.

Peripheral Arterial Disease,

Screening

The USPSTF recommends against routine screening

for peripheral arterial disease (PAD).

Source: Agency for Healthcare Research and Quality. The Guide to Clinical Preventive Services: Recommendations of

the U.S. Preventive Services Task Force. Rockville, MD: Agency for Healthcare Research and Quality; 2005. 

D Recommendations of the USPSTF (continued)

5
Leveraging Benefits: Opportunities

to Promote the Delivery and Use

of Preventive Services

6

Overview:

Actions employers can take to

strengthen prevention efforts.

Sections include:

• The Importance of Supporting

Community-Level Interventions

• The Guide to Community

Preventive Services

• Employer Action in the

Absence of Evidence-Based

Guidelines 

• General Advice to Employers

about Health Improvement 

and Maximizing the Value of

Health Coverage 

• Community Guide

Recommendations

• Employer Case Examples,

Success Stories, and 

Action Examples

Opportunities to Promote the Delivery 

and Use of Preventive Services

461

The previous sections of the Purchaser’s Guide

include the scientific evidence and detailed

benefit language employers need to implement

comprehensive and structured clinical preventive

service benefits within their medical benefit

plan(s). They provide actionable strategies for

improving health and reducing healthcare costs, and information on 46 conditions, 

diseases and injuries, that can be prevented through appropriate screening, testing,

counseling, immunizations, preventive medication, and preventive treatment.

Providing coverage for clinical preventive services is an essential step to improving overall

employee health. But, while coverage is necessary to promote the delivery and use of

preventive services, it is not sufficient to optimize the health of employees. Employers are in

a position to affect health behavior and lifestyle choices in multiple ways. 

The Importance of Supporting Community-Level

Interventions

Community-level preventive services include a diverse array of activities that:

• Educate people about the availability or use of preventive services.

• Encourage people to seek preventive services.

• Encourage providers, health plans, and health systems to offer preventive services. 

Employers are in a unique position to assure the use of clinical preventive services and

promote the use of community- or population-level preventive services. By supporting

community-level interventions employers can improve the overall health and safety of the

communities in which they reside, thereby improving the health and quality of life of

current and future employees. Supporting community-level interventions may also benefit

employers. Employers may develop important relationships with potential business partners

in the area, they may increase the positive image of their companies, and they may develop a

new set of knowledge, skills, and abilities that further

enhances or improves their business strategies.

Leveraging Benefits:

Opportunities to Promote 

the Delivery and Use of

Preventive Services

6

Employers have opportunities to 

promote the delivery and use of 

preventive services beyond the 

provision of medical benefits.

Employers can — and should —

enhance the health of the 

communities in which they operate

by supporting population-level

health interventions. Improving 

community health will protect and 

promote the health of present and

future employees.
6 Leveraging Benefits: Opportunities to Promote the Delivery and Use of Preventive Services

The Guide to Community Preventive Services

The Guide to Community Preventive Services (Community

Guide), published by the Centers for Disease Control

and Prevention (CDC), is an important resource for all

stakeholders about population health issues. It addresses

ways to increase the use of clinical and community

preventive services and complements the work of the

Guide to Clinical Preventive Services (Clinical Guide), a

publication of the U.S. Preventive Services Task Force

(USPSTF), and the Purchaser's Guide. 

The Community Guide is developed by the independent

and nonfederal Task Force on Community Preventive

Services, which is composed of experts from a range of

health promotion and related fields. Recommendations

contained in the Community Guide are based on

rigorous and systematic reviews of scientific literature. 

The Community Guide directs purchasers to evidencebased population health recommendations and other

activities that may complement their investments in

clinical preventive services. Some of these activities are

described in Appendix A. Implementing the Community

Guide’s evidence-based recommendations provides the

potential to improve community health by preventing

injury, disease, disability, and premature death. 

Employer Action in the Absence of Evidence-Based

Guidelines 

The presence of an evidence-based guideline generally means that objective measures of

several experiences have credibly and consistently shown that the intervention or policy

improves important health or behavioral outcomes. 

Evidence-based guidelines do not exist for every important topic because studies or

evaluations have not been conducted, such experiences have not been published or otherwise

shared, or results across interventions have not been synthesized. As a result, employers will

often have to consider how to act in the absence of an evidence-based guideline. When

making such judgments, employers should first consider whether there are evidence-based

guidelines that can meet some of their needs.

If there are no guidelines available, employers should consider using general advice (provided

below) to inform the design and implementation of interventions. Appendix B includes case

examples and of worksite population health interventions implemented by large employers.

These brief examples describe just a few of the many population health interventions that can

be effectively implemented in the workplace.

462

Our understanding of opportunities

for population-level prevention is

growing. Therefore, the Community

Guide is a work in progress. As new

information on the effectiveness of

community level interventions is 

gathered the Community Guide will

evolve and expand. Community Guide

recommendations are published in

peer-reviewed journals and posted 

on the Community Guide website

(www.thecommunityguide.org) as

they are developed.

The Guide to Community Preventive

Services (www.thecommunityguide.org)

provides recommendations about

population interventions that have the

potential to positively affect community

health by preventing injury, disease,

disability, and premature death.
General Advice to Employers about Health Improvement

and Maximizing the Value of Health Coverage 

Employers can ensure health improvement and maximize coverage value in many ways. 

At a minimum, an employer’s healthcare strategy should include:

1. Educating beneficiaries about the importance of clinical preventive services and

healthy lifestyles.

2. Encouraging beneficiaries to use their covered preventive services appropriately. 

3. Supporting community-wide disease prevention and health promotion activities.

To promote the appropriate use of clinical preventive services among beneficiaries,

employers should:

• Provide referrals to community-based support services and prevention programs, 

as needed (e.g., tobacco quitlines). 

• Encourage health plans to promote clinical preventive services.

• Encourage providers to increase the use of appropriate preventive services 

(e.g., time-appropriate reminders to patients). 

• Increase preventive service access points (e.g., worksite immunization programs).

To more broadly promote health among their beneficiaries, employers should:

• Make information, data, and recommendations about prevention available to

employees and their families.

• Support employee participation in programs of clinical or community prevention

(e.g., incentives).

• Support healthy worksites (e.g., offer a healthy cafeteria program).

• Support evidence-based health policies (e.g., require smoke-free workplaces).

To promote health generally, employers can:

• Work to increase awareness of critical health problems among employees, health

plans, providers, beneficiaries, other purchasers, and the general public. 

• Provide in-kind or financial support to develop or continue evidence-based health

programs and policies benefiting broader communities. Consider: 

> Sponsoring or providing supplies for school health programs. 

> Partnering with other business and community agencies to develop environmental

health promotion strategies (e.g., changing the physical environment by creating

walking and biking trails, encouraging increases in cigarette taxes and banning of

cigarette smoking in public spaces). 463

Promoting and protecting the health of employees and beneficiaries is critical to the continued health

of American businesses. Providing coverage for clinical preventive services is the first step to improving

overall beneficiary health. Employers should carefully consider integrating population-level health programs 

and policies into both their coverage packages and their overall worksite health promotion plans. This

integrative effort should enhance the effectiveness of medical benefits and increase the likelihood that

beneficiaries will appropriately use the coverage they have.
• Promote public policies that aim to prevent illness, injury, and death (e.g., minimum

legal drinking age laws). 

• Encourage employees to participate in health promotion programs available in their

communities.

Appendix A: Links Between Selected Topics with Particular

Relevance to Purchasers and Community Guide

Recommendations 

6 Leveraging Benefits: Opportunities to Promote the Delivery and Use of Preventive Services

Breast, cervical, and 

colorectal cancers

Diabetes

Immunizations

To increase cancer screenings (client-oriented):

• Use client reminders

• Use multicomponent interventions using media, education and enhanced

access

• Reduce structural barriers

• Use client incentives (with reminders)

• Use small media

• Reduce out-of-pocket costs

• Provide one-on-one education

• Offer provider reminder recalls

• Offer provider assessment and feedback

Note: these approaches have differential effectiveness for different types of screening.

Visit the Community Guide website for more information.

To improve the care of persons with type 2 diabetes: 

• Ensure that disease management and case management programs are

provided in healthcare systems.

• Provide diabetes self-management education in community gathering places

(e.g., community centers or faith institutions) for adults. 

Also see the entry for obesity (below) for more type 2 diabetes-related information.

To increase community demand for immunizations: 

• Provide client recalls and reminders 

• Institute multicomponent interventions with education 

• Require immunizations for attendance at child care and school 

To enhance access to immunization services: 

• Reduce out-of-pocket costs 

• Institute multicomponent interventions for expanding access 

• Offer via home visits 

To improve provider-based interventions: 

• Institute a provider reminder and recall system 

• Provide assessment and feedback for providers 

• Establish standing orders to vaccinate adults

Table 6.0: Community Guide Recommendations that may Complement Clinical Preventive

Services Recommended in the Purchaser’s Guide 

464

TOPICS IN THE RELATED COMMUNITY GUIDE RECOMENDATIONS

PURCHASER’S GUIDE
465

Note: Community Guide content is a work in progress. Additional content will become available over time. Please check

the website (www.thecommunityguide.org) for updated information.

Injury prevention: 

Motor vehicle

occupant injury

Obesity

Tobacco use

The Community Guide’s systematic review of the effectiveness of selected populationbased interventions addressing motor vehicle occupant injuries focused on

interventions within three areas: 

• Increasing the proper use of child safety seats 

• Increasing the use of safety belts 

• Reducing alcohol-impaired driving 

The Community Guide has recommended numerous population-based interventions

for families, schools, and communities, which are proven effective in promoting

physical activity. It also has a growing portfolio of work related to nutrition and

obesity. To increase physical activity, the Community Guide recommends:

• Use of community-wide campaigns

• Use of point-of-decision prompts to increase stair use

• Use of health behavior change programs adapted for individual needs

• School-based physical education

• Social support in community settings

• Creation and/or enhanced access to places for physical 

activity combined with informational outreach

To control overweight or obesity:

• Offer worksite programs combining nutrition and physical 

activity

To increase tobacco cessation: 

• Increase unit price for tobacco products 

• Develop mass media campaigns and use with other interventions (e.g., excise

tax increase, other community educational programs)

• Establish provider reminder systems 

• Establish provider reminder systems with provider education

• Reduce patient costs for treatments 

• Make available telephone support for quitting smoking and use with other

interventions (e.g., cessation counseling)

• Make available telephone support for quitting with the 

possible provision of cessation medications

To decrease environmental tobacco smoke (ETS):

• Implement smoking bans or restrictions 

Table 6.0: Community Guide Recommendations that may Complement Clinical Preventive

Services Recommended in the Purchaser’s Guide (Continued)

TOPICS IN THE RELATED COMMUNITY GUIDE RECOMENDATIONS

PURCHASER’S GUIDE
466

Appendix B: Employer Case Examples, Success Stories,

and Action Examples

Many employers around the country have implemented programs, policies, or procedures to

promote their employees’ health. Some of the approaches used have been evaluated and

published. Other approaches have been reviewed systematically by the Community Guide or

through another systematic review mechanism. In 2005, the Community Guide began a set

of reviews to examine the effectiveness of interventions conducted in worksite settings or

made available by employers. The results of these reviews will begin to be available in late

2006.

Listed below are a few examples of evidence-based practices applied to worksite settings and

examples of worksite health promotion practices that will inform evidence-based practices in

the future. 

Employer Case Examples and Success Stories

Tobacco Cessation: Supporting Quit Attempts

Tobacco use, responsible for approximately 440,000 deaths per year, remains the leading

preventable cause of death in the United States.1 There is substantial evidence that smoking

cessation improves health by lowering an individual’s risk for diseases caused by smoking

such as heart disease, stroke, and cancer.4 Helping tobacco users to quit is one important

goal of a comprehensive effort to reduce morbidity and mortality associated with tobacco

use.2 Approximately 70% of tobacco users want to quit3 and efforts to quit are frequent,

although it is rare for a smoker to quit permanently on a single attempt.

Tobacco use affects productivity and absenteeism, increases use of disability leave, and

increases overall healthcare costs among workers.1 Good quality evidence-based

recommendations are available for clinical and community interventions designed to

motivate and assist the cessation efforts of tobacco users. Many community-based

interventions designed to assist smokers in quitting are directly applicable to the worksite. 

The Community Guide recommends providing coverage for tobacco use treatment and

routine treatment of tobacco use in healthcare systems as two effective interventions to

increase tobacco cessation.5 The Public Health Service Clinical Practice Guideline, Treating

Tobacco Use and Dependence, recommends individual, group, and proactive telephone

6 Leveraging Benefits: Opportunities to Promote the Delivery and Use of Preventive Services

Employer Success Story: Union Pacific Railroad

Union Pacific Railroad experienced a decrease from 40% to 25% in smoking prevalence

among its employees in the 7-year period during which it has offered a cessation benefit

as part of a comprehensive tobacco cessation program. The program included smoking

bans and restrictions and reduced beneficiary out-of-pocket costs for nonsmokers. The

program was implemented incrementally, starting with the removal of smoking areas,

the addition of coverage for tobacco dependence treatment, and finally the move to

smoke-free buildings.4
counseling along with the use of Food and Drug Administration (FDA) approved cessation

medications (e.g., bupropion—Wellbutrin® or Zyban® and varenicline—ChantixTM).7 The

USPSTF strongly recommends that clinicians screen all adults for tobacco use and provide

tobacco cessation interventions for those who use tobacco.5 There is also evidence that

nicotine replacement medications (e.g., Nicorette® gum) increase successful quit rates and

increase tobacco abstinence rates.6

Purchasers can support tobacco cessation efforts by implementing evidence-based guidelines: 

• Promote a smoke-free workplace and campus.7

• Provide coverage for the full range of counseling options (individual, group, and by

telephone) and reduce or eliminate copays and deductibles for counseling.6

• Ensure that all FDA-approved tobacco cessation medications are available in

formularies and reduce or eliminate copays and deductibles for medications.6

• Educate employees about using flexible spending account (FSA) funds to pay for

tobacco cessation medication and nicotine replacement products.

• Provide employees with tobacco quitline numbers and contract with a quitline vendor

to provide services for employees.

• Become active in the communities where workplaces exist: support implementation of

smoke-free workplace laws, appropriate school-based initiatives (including smoke-free

campuses and curricula), and increased excise taxes on cigarettes and tobacco

products.5

Purchasers can ensure that their health plans and delivery systems:

• Aggressively educate plans’ providers and enrollees about the availability of tobacco

cessation benefits.

Purchasers can ensure that their medical offices and employee clinics:

• Integrate tobacco dependence treatment into disease management initiatives.

• Follow the Public Health Service Clinical Practice Guideline, Treating Tobacco Use

and Dependence, which recommend that providers6

:

• Ask every patient, at every visit, if they use tobacco

• Advise to quit

• Assess readiness to quit

• Assist with the quit process

• Arrange for follow-up with counseling and medications

467

Employer Case Example: Centers for Disease Control and Prevention (CDC)7

The Centers for Disease Control and Prevention (CDC) recently implemented a tobacco-free

campus in all CDC-owned buildings nationwide. This included provision of free over-thecounter nicotine replacement medications to federal employees, negotiations with labor

unions to remove previously negotiated smoking huts, provision of smoking cessation

classes, and encouraged access to the national network of tobacco quitlines 

(1-800-QUIT NOW).
Additional information about coverage for tobacco treatment can be found on the CDC

website (www.cdc.gov/tobacco/educational_materials/cessation/index.html.). Employers

interested in making their worksite smoke free can also reference Making Your Workplace

Smokefree – A Decision Makers Guide

(www.cdc.gov/tobacco/research_data/environmental/etsguide.htm.)

Lipid Disorders: Screening and Treatment Adherence

Lipid disorders, which result from abnormal levels of cholesterol in the blood, increase the

risk of cardiovascular disease (CVD), including coronary heart disease (CHD) and coronary

artery disease (CAD). Arteriosclerosis (a thickening or hardening of the arteries) is

particularly sensitive to lipid levels. From 1999 to 2002, about 17% of the U.S. adult

population had high cholesterol (total cholesterol 240 mg/dL or higher).

The National Cholesterol Education Program (NCEP) Adult Treatment Expert Panel-III

(ATP-III) recommends that clinicians routinely screen all adults aged 20 years and above 

for elevated blood cholesterol once every 5 years.9 The goal of screening is to identify and

treat individuals with lipid disorders in order to decrease their risk for CVD events, such as

heart attack. 

The NCEP ATP-III Treatment Guideline states that the first line of therapy for elevated

LDL cholesterol levels is therapeutic lifestyle changes (e.g., diet, exercise, weight loss,

smoking cessation). Drug therapy (e.g., cholesterol-lowering medication), may be used,

when appropriate, to further reduce cholesterol levels. Both therapeutic lifestyle changes 

and cholesterol-lowering medications are proven effective for improving lipid profiles and

reducing the risk of heart disease. Yet, the benefits of lowered cholesterol can only be

realized with quality care and adherence to treatment. 

NCEP ATP-III also includes a series of recommendations to increase adherence to

recommended treatments. The ATP III recommendations are based on large, randomized,

control clinical trials, prospective epidemiological studies, and smaller clinical trials.9 An

expert panel qualified each recommendation according to a category of evidence, which can

be found at the NCEP website: (http://nhlbi.nih.gov/guidelines/cholesterol/atp3_rpt.htm.)

468

6 Leveraging Benefits: Opportunities to Promote the Delivery and Use of Preventive Services

Employer Success Story: Fieldale Farms10

Fieldale Farms, a poultry processor in Georgia, offered mobile screening, a gift card, and

other incentives to all employees participating in its Wellness Program. Those with elevated

cholesterol were offered follow-up nutrition counseling and company-paid fitness 

memberships. Over a 5-year evaluation period, 26% of the participating employees with

high cholesterol normalized their cholesterol levels through diet changes, and/or 

medications. In 2004, the overall healthcare cost for an employee participating in the

Fieldale Farms Wellness Program was $3,052 per year — less than half the national 

average healthcare cost for a manufacturing employee ($6,900).
Employer Action Examples

Opportunities to Supporting Breastfeeding 

Human breast milk is universally recognized to be the optimal food for infants and is

nutritionally superior to formula. Breast milk confers immunity and protects infants from

infections and allergens. Further, research shows that children who were breastfed are at

significantly lower risk for many conditions and diseases such as childhood obesity and type

2 diabetes compared to non-breastfed children.12 Breastfeeding also has important short- and

long-term health benefits for the mother. A woman’s risk of breast cancer is decreased 4.3%

for every 12-month increment of breastfeeding over her lifetime. Her risk of ovarian and

endometrial cancer is decreased through breastfeeding as well.13-14 

Children who are not breastfed contribute to additional healthcare expenditures and

productivity losses for the employers of their parents. A 2001 U.S. Department of

Agriculture (USDA) study estimated that at least $500 million (in year 1998 dollars) could

be saved in healthcare costs if breastfeeding rates were increased to match those

recommended by the Surgeon General and the Healthy People 2010 goals.15

Breastfeeding and Employment: Barriers and Opportunities

Despite the well-documented benefits of breastfeeding, only 70% of new mothers initiate

breastfeeding and only 36% continue to breastfeed for the recommended 6-month

minimum.1 Women who — at the birth of their child — intend to return to work full-time

are even less likely to initiate breastfeeding.16 Employed women also have a shorter duration

of breastfeeding than do women who do not work outside the home.16 Low rates of

breastfeeding among working women should be of great concern to employers. Mothers are

the fastest growing segment of the U.S labor force and approximately 70% of employed

mothers with infants or toddlers work full-time.16 Further, one-third of working mothers

469

Employer Success Story: Johnson & Johnson11

Johnson & Johnson, a manufacturer of healthcare products, offered a comprehensive

health and wellness program to its employees. The program offered on-site fitness centers,

an internet-based lifestyle management program, and a $500 premium incentive to those

who completed a health risk appraisal (HRA) and enrolled in a high-risk intervention

program (as needed). For those with chronic medical conditions, such as hyperlipidemia,

the program also offered lifestyle counseling with a registered nurse, and a comprehensive

disease and care management program. Over a 2.75 year period, the program yielded a

9% decrease in the number of participating employees with high cholesterol levels.

Medical expenses decreased by $225 per participating employee, per year, over four years.

As a result, Johnson & Johnson saw a savings of approximately $8.5 million per year

due to reduced inpatient hospital use, fewer mental health visits, and fewer

outpatient doctor’s office visits. Job absenteeism also decreased.
return to work within 3 months of the birth of their child and two-thirds return within 6

months, the exact time period when breastfeeding is most critical.16 The negative effect of

part- and full-time work on breastfeeding rates is not absolute. Employers who provide

employees with worksite lactation programs effectively increase the number of their

employees who continue breastfeeding after returning to work.

Employers can support breastfeeding mothers in multiple ways:

1. Purchasers can include breastfeeding counseling as a component of their medical

benefit plan. For more information about breastfeeding counseling, please refer to the 

breastfeeding subsection of the “Health Pregnancy” chapter located in Parts II and III

of the Purchaser’s Guide. 

2. Employers can ensure that their beneficiaries have access to baby-friendly hospitals

that promote the initiation of breastfeeding. The World Health Organization (WHO)

provides guidelines on hospital breastfeeding policies and several domestic

organizations track hospitals who comply with this well-recognized international

guideline.17 Employers can preferentially select baby-friendly hospitals to include in

their health plan networks and encourage their beneficiaries to choose baby-friendly

hospitals through education, incentives, or reduced copays/coinsurance. 

3. Employers can provide a worksite lactation program. 

470

6 Leveraging Benefits: Opportunities to Promote the Delivery and Use of Preventive Services

Employer Action Example: Worksite Lactation Program16

The implementation of a worksite lactation program is one way an employer can support its 

breastfeeding employees. The essential components of a worksite lactation program include:

SPACE

A nursing mother’s room (NMR) or other designated space that is centrally located, has 

adequate lighting, ventilation, and privacy; has a sink, an electrical outlet, and a designated 

refrigerator.

EQUIPMENT

Breast-pumps (employers may provide single or multi-user pumps, subsidize employee 

purchased pumps, or require employees to bring their own pumps).

WRITTEN COMPANY POLICIES REGARDING

• Breastfeeding

• Maternity leave

• Use of vacation days, flex time, sick days, personal time, and FMLA.

• Breaks for expressing milk (two breaks and a lunch period for each 8-hour work period).

EDUCATION

• Communicate the breastfeeding support policy to all employees.

• Provide a list of community resources available to support breastfeeding women.

• Train supervisors and managers on the company breastfeeding policy.

Other services such as access to a lactation specialist on an as needed basis at the 

worksite or in the beneficiary’s home can further support breastfeeding.
471

Employer Action Example: Hospital Network Selections to Support Breastfeeding12,17

The World Health Organization (WHO)/UNICEF’s Baby-Friendly Hospital Initiative seeks to

acknowledge hospitals that promote breastfeeding through a variety of programs, policies,

and supports. To qualify as “baby-friendly,” hospitals and birthing centers must prove that

they follow the WHO’s Ten Steps to Successful Breastfeeding Guideline as follows:

• Have a written breastfeeding policy that is routinely communicated to all healthcare

staff.

• Train all healthcare staff in skills necessary to implement this policy.

• Inform all pregnant women about the benefits and management of breastfeeding.

• Help mothers initiate breastfeeding within one hour of birth.

• Show mothers how to breastfeed and how to maintain lactation even if they should

be separated from their infants.

• Give newborn infants no food or drink other than breast milk, unless medically indicated.

• Practice rooming-in (allowing mothers and infants to remain together 24 hours a day).

• Encourage breastfeeding on demand.

• Give no artificial treats or pacifiers to breastfeeding infants.

• Foster the establishment of breastfeeding support groups and refer mothers to them 

on discharge from the hospital or clinic.

To ensure beneficiary access to baby-friendly hospitals that comply with the WHO 

breastfeeding guideline, employers should:

• Direct health plans to include baby-friendly hospitals in-network.

• Work with healthcare consultants, health plans, and benefits staff to develop a

mechanism to encourage women to birth at baby-friendly hospitals. To steer

beneficiaries toward baby-friendly hospitals employers can:

> Educate beneficiaries on the benefits of delivering their baby at a baby-friendly

hospital.

> Educate beneficiaries on the importance of breastfeeding initiation and

maintenance.

> Provide monetary or other types of incentives (e.g., baby car-seats) to

beneficiaries who birth at baby-friendly hospitals.

> Reduce copayment/coinsurance amounts for services rendered at baby-friendly

hospitals.

A list of Baby-friendly hospitals located in the United States can be found at:

www.babyfriendlyusa.org
472

6 Leveraging Benefits: Opportunities to Promote the Delivery and Use of Preventive Services

Employer Success Story: CIGNA18

CIGNA, an insurance and benefits company based in Philadelphia, offers a corporate 

lactation program for all employees who breastfeed. The program was created in 1995

when CIGNA employees asked for assistance in continuing to breastfeed after returning

from maternity leave. To date, over 1,000 women have enrolled in the Working Well Moms

program in more than 250 CIGNA offices. The program provides consultation for mothers

with a professional lactation consultant before and after birth and access to a private room

equipped with a hospital-grade breast pump, refrigerator, carrying case, and supplies.

The Working Well Moms program has enabled CIGNA to surpass the Healthy People 2010

6-month breastfeeding objective by 45%. Breastfeeding duration for women enrolled in the

Working Well Moms program is 72.5% at 6 months post-birth (nationally only 21.1%

employed mothers continue breastfeeding for 6 months). And 36% of women enrolled in

the Working Well Moms continue to breastfeed through the first year of their baby’s life;

nationally only 10.1% of employed mothers breastfeed their babies to 1-year of age.

As a result of the Working Well Moms program, CIGNA saw a savings of $300,000 in

annual healthcare expenses for breastfeeding mothers and their children. The 

program also reduced absenteeism among breastfeeding mothers.
References:

1. U.S. Department of Health and Human Services. The health consequences of smoking: a report of the

surgeon general. Atlanta, GA: U.S. Department of Health and Human Services; 2004.

2. Task Force on Community Preventive Services. Recommendations regarding interventions to reduce

tobacco use and exposure to environmental tobacco smoke. Am J Prev Med 2001;20(2S):10-5.

3. Centers for Disease Control and Prevention. Cigarette smoking among adults—United States, 2000.

MMWR 2002;51(29):642-5.

4. Berg AO, U.S. Preventive Services Task Force. Counseling to prevent tobacco use and tobacco-caused

disease. Recommendation Statement. Rockville, MD: Agency for Health Care Research and Quality;

2003.

5. Centers for Disease Control and Prevention. Guide to Community Preventive Services: tobacco use

prevention and control: reviews, recommendations, and expert commentary. Am J Prev Med 2001;

20(2S): 1–88.

6. U.S. Surgeon General. Public Health Service Clinical Practice Guideline. Treating Tobacco Use and

Dependence. Washington, DC: U.S. Department of Health and Human Services; 2000. Available from:

http://www.surgeongeneral.gov/tobacco/

7. Centers for Disease Control and Prevention. Office of Smoking and Health. Wellness Council of America.

American Cancer Society. Making Your Work Place Smoke Free: A Decision Makers Guide. Washington, DC:

U.S. Department of Health and Human Services. Available from:

http://www.cdc.gov/tobacco/research_data/environmental/etsguide.htm

8. Ford ES, Mokdad AH, Giles WH, Mensah GA. Serum total cholesterol concentrations and awareness,

treatment, and control of hypercholesterolemia among U.S. adults: Findings from the National Health

and Nutrition Examination Survey, 1999 to 2000. Circulation 2003;107:2185–9.

9. National Heart, Lung, and Blood Institute. National Cholesterol Education Program Expert Panel. Detection,

Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel ATP-III). 3rd Report

(Final). Washington, DC: National Institutes of Health Publication No. 02-5215; 2002.

10. Shirreffs A. Fieldale farms shows wellness programs pay. In depth: Georgia 200 market report and

insurance and employee benefits. Atlanta Business Chronicle, April 8, 2005.

11. Ozminkowski RJ, Ling D, Goetzel RZ, Bruno JA, Rutter RR, Isaac F, Wang S. Long-term impact of

Johnson & Johnson’s Health & Wellness program on health care utilization and expenditures. J Occup

Environ Med 2002;44(1):21-29.

12. Shealy KR, Li R, Benton-Davis S, Grummer-Strawn LM. Centers for Disease Control and Prevention.

CDC Guide to Breastfeeding Interventions. Atlanta, GA: U.S. Department of Health and Human

Services, Centers for Disease Control and Prevention; 2005.

13. Berg AO. Behavioral interventions to promote breastfeeding: Recommendations and rationale. U.S.

Preventive Services Task Force. Ann Fam Med 2003; 1(2): 79-80.

14. Guise JM, Palda V, Westhoff C, Chan BKS, Helfand M, Lieu TA. The effectiveness of primary care-based

interventions to promote breastfeeding. U.S. Preventive Services Task Force. Ann Fam Med 2003; 1(2):

70-78.

15. Weimer J. The Economical Cost of Breastfeeding: A Review and an Analysis. ERS Food Assistance and

Nutrition Research Report No. 13, Washington, DC: Economic Research Services, U.S. Department of

Agriculture; 2001.

16. United States Breastfeeding Committee. Workplace breastfeeding support. Issue paper. Raleigh, NC:

United States Breastfeeding Committee; 2002.

17. World Health Organization. UNICEF. Ten steps to successful breastfeeding. The Breast Feeding Initiatives

Exchange. [cited 2005 Dec 21]. Available from:

http://www.unicef.org/programme/breastfeeding/baby.htm#10. 

18. CIGNA. UCLA study of CIGNA corporate lactation program proves that helping working moms

breastfeed is good business. CIGNA Newsroom. [cited 27 Jul 2006] Available from:

http://cigna.mediaroom.com/index.php?s=press_releases&item=335. 

473

7 Resources & Tools

Overview:

Additional information for employers on

clinical preventive services, including:

• Life Course Maps

- Recommended Schedule of 

Preventive Care for Adults

- Recommended Schedule of Preventive 

Care for Children and Adolescents

- Recommended Schedule of 

Preventive Preconception, Prenatal and 

Postpartum Care

• Comparison of A Purchaser’s Guide

to Clinical Preventive Services,

USPSTF Recommendations, NCQA

HEDIS® Measures, NCQA Industry

Trends and Analysis, and Healthy

People 2010 Goals

• Glossary

• Links to Additional Resources and

Cost-Calculators

Resources & Tools

475

Life Course Charts

Visual guides to clinical preventive services across the lifespan:

• Recommended Schedule of Preventive Care for Adults

• Recommended Schedule of Preventive Care for Children and Adolescents

• Recommended Schedule of Preventive Preconception, Prenatal, and Postpartum Care

Crosswalk

A crosswalk between the recommendations proposed in the Guide, the 2007 HEDIS®

Measures, the NCQA State of Healthcare Quality Report, and the Department of Health

and Human Service’s Healthy People 2010 Goals.

Clinical Preventive Services Glossary

Definitions and examples of scientific, medical, and business terms used throughout the

Purchaser’s Guide. 

Cost-Calculators and Additional Resources

Resources 7 & Tools
476
Screening: Testing: Counseling: Immunization: Preventive

Treatment:

Preventive Medication/

Intervention

Notes: * Please refer to the life course chart for children and adolescents for immunization recommendations for this age group.

1. The immunization schedule listed on this chart is a graphic representation of recommendations in force at the time the chart was made. Visit the ACIP website (www.cdc.gov/nip/acip/) for up-to-date recommendations.

Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006. Available online at:

www.businessgrouphealth.org/prevention/purchasers

Chart A

*

*

*

*

*

*

*

*

Colorectal Cancer

Contraceptive Use

Depression

Diabetes (type 2)

Healthy Diet

Hypertension

Immunizations1

• Hepatitis A

• Hepatitis B

• Influenza

• Measles, mumps, and rubella

• Meningococcal

• Pneumococcal

• Tetanus

• Varicella

Lipid Disorders

Medical Foods for Persons with 

Genetic or Endocrine Disorders

Motor Vehicle-Related Injury Prevention

Obesity

Osteoporosis

Sexually Transmitted Infections (STIs)

• Counseling to prevent STIs

• Chlamydia

• Gonorrhea

• Human Immunodeficiency Virus (HIV)

• Syphilis

Tobacco Use Treatment

Tuberculosis

All adults: routine screening

Adults with diagnosed hypertension: 6 counseling, treatment, and monitoring sessions per calendar year

Adults with diagnosed hypertension: drug therapy as medically indicated 

At-risk adults: 2 doses (2nd dose given 6-12 months, or 6-18 months after initial dose)

At-risk adults: 3 doses (2nd dose 1-2 months after initial dose, 3rd dose 4-6 months after initial dose) 

At-risk adults: 1 dose annually

All adults: 1 or 2 doses if no evidence of immunity

At-risk adults: 1 or more doses

All adults: 1 dose At-risk adults: 1-2 doses

All adults: screen once every 5 years

Adults with a lipid disorder: 6 counseling, treatment, and monitoring sessions per calendar year

Adults with a lipid disorder: drug therapy as medically indicated

High-risk adults: screen every 2+ years

Adults with genetic or endocrine disorders: medical foods provided as medically indicated

All adults: counsel as medically indicated and reinforce prevention messages annually

All adults: screen once per calendar year 

All obese (BMI>30) adults: 6 counseling sessions per calendar year 

All adults: education on the risk factors for HIV and other STIs & counseling on effective measures to reduce risk of infection

All women from onset of sexual activity through age 25: screen annually

All women from onset of sexual activity through age 25: screen annually 

At-risk women: screen as medically indicated

At-risk women: screen as medically indicated

All obese adults with a BMI > 40 or BMI > 35 & at least one obesity-related illness: drug therapy and or surgery. Subject to preauthorization requirements.

All adults: screen as medically indicated, at least once per lifetime

All adults undergoing screening: pre- and post-test counseling, maximum of 3 sessions per test cycle 

High-risk adults: screen as medically indicated

All adults: screen at every medical encounter

All adults who use tobacco: 12 counseling sessions per calendar year

All adults who use tobacco: nicotine replacement products/medications and/or tobacco cessation medication, as medically indicated

High-risk adults: targeted testing

All adults: 1-dose booster every 10 years

All adults: 2 doses (2nd dose given 4-8 weeks after initial dose)

if no evidence of immunity At-risk adults: 2 doses (2nd dose given 4-8 weeks

after initial dose)

All adults: 1 dose annually

At-risk adults: 1 dose

All adults: screen whenever medically indicated

All adults: screen every 5 to 10 years

depending on method

All women: medications and devices as medically necessary for the prevention of pregnancy 

All adults: voluntary sterilization covered once per lifetime 

All adults: screen once every 3 years

High-risk adults: screen once every 2 years

All adults: counsel at least once per year & whenever emergency contraception is prescribed 

Adults with hyperlipidemia & other risk factors for cardiovascular & diet-related chronic disease: 3 intensive

counseling sessions per calendar year

All women: screen every 2+ years 

All men: screen as medically indicated 
Screening: Testing: Counseling: Immunization: Preventive

Treatment:

Preventive Medication/

Intervention

Notes: 1. Screen at any age when deemed medically necessary by a risk assessment, clinical signs or symptoms consistent with elevated BLL, or when other evidence indicates possible lead exposure.

2. The immunization schedule listed on this chart is a graphic representation of recommendations for routine vaccination in force at the time the chart was made. Visit the ACIP website (www.cdc.gov/nip/acip/) for up-to-date recommendations.

3. For those children who have completed the recommended childhood DTP/DTaP vaccination series and have not received a Td booster dose.

4. All newborns should receive the hepatitis B vaccine soon after birth and before hospital discharge.

5. Infants born to mothers who are HBsAg-positive should receive the hepatitis B vaccine with HBIG within 12 hours of birth. Infants born to mothers whose HBsAg status is unknown should receive the hepatitis B vaccine within 12 hours of birth.

Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006. Available online at:

www.businessgrouphealth.org/prevention/purchasers

Chart B

Immunization2

• Diphtheria, Tetanus, Pertussis

• Haemophilus influenzae type b

• Hepatitis A

• Hepatitis B

• Human papillomavirus

• Inactivated Poliovirus

• Influenza

• Measles, Mumps, Rubella

• Meningococcal

• Pneumococcal

• Rotavirus

• Varicella (Chicken Pox)

Motor Vehicle-Related Injury 

Prevention

Newborn Hearing

Newborn Screening for Genetic 

and Endocrine Disorders

Obesity

Sexually Transmitted Infections (STIs)

• Counseling to prevent STIs

• Chlamydia

• Gonorrhea

• Human Immunodeficiency 

Virus (HIV)

• Syphilis

Tobacco Use

Vision

Screen as medically indicated

All female adolescents from onset of sexually activity through age 25: screen annually

All female adolescents from onset of sexually activity through age 25: screen annually 

Screen as medically indicated

High-risk adolescents: screen as medically indicated

Screen at every medical encounter

DTaP DTaP DTaP DTaP Tdap3 Tdap (catch-up) DTaP (between 12-18 months, provided 6

months have elapsed since 3rd dose)

Hib Hib Hib Hib

MMR MMR

MCV4 MCV4 (catch-up)

MMR (catch-up)

HepA Series

HepB4

HPV

Series

IPV

PCV

Rota

Varicella Varicella (catch-up)

PCV

Rota

PCV PCV

Varicella

Rota

IPV IPV IPV

Influenza (annually)

HPV Series

(catch-up)

Exposed infants: HBIG prophylaxis5

All children and adolescents with genetic or endocrine disorders: medications and medical foods, as medically indicated 

HepB HepB HepB Series (catch-up)

Screen

Screen At-risk: re-screen as medically indicated

At-risk: re-screen as medically indicated

Screen at all well-child visits

Educate on the risk factors for HIV and other STIs & counsel on effective measure to reduce risk of infection

Counsel as medically indicated

All adolescents undergoing screening: pre- and post-test counseling, maximum of 3 sessions per test cycle

Counsel as medically indicated, reinforce prevention messages annually

Provide nicotine replacement products/medications and/or tobacco cessation medication, as medically indicated
Screening: Testing: Counseling: Immunization: Preventive Medication: 

*The immunization schedule listed on this chart is a graphic representation of recommendations in force at the time the chart was made. Visit the ACIP website (www.cdc.gov/nip/acip/) for up-to-date recommendations.

1. All infants need to receive a single dose of the hepatitis B vaccine. All infants born to women with unknown HBsAG status need to receive a single dose of the hepatitis B vaccine (without HBIG).

2. All women are advised not to become pregnant until 4 weeks after the rubella vaccination.

Campbell KP, Lanza A, Dixon R, Chattopadhyay S, Molinari N, Finch RA, editors. A Purchaser’s Guide to Clinical Preventive Services: Moving Science into Coverage. Washington, DC: National Business Group on Health; 2006. Available online at:

www.businessgrouphealth.org/prevention/purchasers

Chart C

Breastfeeding

Folic Acid

Supplementation

Group B

Streptococcal

Disease

Hepatitis B*

HIV

Influenza*

Preeclampsia

Prenatal Diagnosis

of Chromosomal

Abnormalities 

& NTDs

Rh(D)

Incompatibility

Rubella*

Syphilis

Tetanus*

Tobacco Use

All women: offer structured breastfeeding education and behavioral counseling to promote breastfeeding 

All women: provide information on folic acid 

during routine healthcare visits and prenatal 

care visits through the 1st trimester of pregnancy

All pregnant women and women planning a

pregnancy: folic acid, as medically indicated

All women:

screen

All women:

screen

All women: screen for

blood type and antibodies

All women: screen at 1st clinical encounter

All nonpregnant women2

: immunize at 1st clinical

encounter if not otherwise immune to rubella

All women: screen All women in high-risk groups: repeat screen at 28

weeks and at labor and delivery

All women: screen All susceptible women: immunize during the 2nd or 3rd trimester

All women: screen at every medical encounter

All pregnant women who use tobacco: counsel to quit at every medical encounter

Immunize susceptible women 

immediately after delivery

All women: screen to confirm Rh(D)

antibody status, if medically indicated

All women: repeat screening every 4 weeks until week 28, every 2-3 weeks until week

36, and weekly thereafter (until delivery)

All women who will be pregnant during influenza season (October to mid-May):

immunize with trivalent inactivated influenza vaccine

All women: offer screening to detect chromosomal abnormalities and NTDs

All pregnant women at increased risk: offer testing in place of, or in addition to, screening

All pregnant women at risk

of infection: repeat screen

All pregnant women at risk of infection: immunize at some point during pregnancy

All infants: immunize1

All exposed infants: provide HBIG prophylaxis

All women at increased risk: repeat screen

All women: screen for 

colonization at 35-37 weeks

All colonized women: intrapartum antibiotic

prophylaxis, as medically indicated

All women: screen for infection

477

Crosswalk

A crosswalk between the recommendations proposed in the Guide, the 2007 HEDIS®

Measures, the NCQA State of Healthcare Quality Report, and the Department of Health

and Human Service’s Healthy People 2010 Goals

Categories Purchaser’s Guide

Recommendations

USPTSF

Recommendation

HEDIS® 

2007

Measures

Healthy People

2010 Goal

NCQA 2006 State of

Health Care Quality

% of beneficiaries in the

commercially-insured

population who received

service (2004-2005)2

• Breast Cancer,

Screening

• Breast Cancer

Genetic Risk

Assessment and

BRCA Mutation

Testing,

Counseling, testing,

and preventive

treatment

• Breast Cancer,

Counseling and

preventive

medication

• Cervical Cancer,

Screening

• Colorectal Cancer,

Screening

• Administer

screening

mammography,

with or without

clinical breast

examination

(CBE), every 1-2

years to women

aged 40 and older.

• Women whose

family history is

associated with an

increased risk for

deleterious

mutations in

BRCA1 or BRCA2

genes should be

referred for genetic

counseling and

evaluation for

BRCA testing.

• Screen for cervical

cancer among

women who

are/have been

sexually active and

have a cervix.

• Screen men and

women 50 years 

of age or older for

colorectal cancer.

• Breast cancer

screening

• Cervical cancer

screening

• Colorectal cancer

Screening

• Breast cancer

screening: 72.0%

• Cervical cancer

screening: 81.8%

(women aged 21 

to 64)

• Colorectal cancer

screening: 52.3%

of adults aged 50

years and older.

Cancer 2000: 67% of women age 40

and above have had a

mammogram within the past

2 years^

2010 target: increase

proportion to 70%^

2000: 79% of women age 18

and above have had a pap

smear within the past 3 years^

2010 target: increase

proportion to 90%^

2000: 24% of adults age 50

and above have received a fecal

occult blood test within the

past two years^

2010 target: increase

proportion to 33%

1998: 37% of adults age 50

and above have received a

sigmonoscopy at some point

during their life^

2010 target: increase

proportion to 50% 
478

7 Resources & Tools

• Abdominal Aortic

Aneurysm,

Screening

• Aspirin Therapy for

the Prevention of

Cardiovascular

Disease, Counseling

• Healthy Diet,

Counseling

• Hypertension,

Screening,

counseling, and

treatment

• Lipid Disorders,

Screening,

counseling, and

treatment

• Diabetes (type 2),

Screening

• One-time screening

by ultrasonography

for men aged 65 to

75 who have ever

smoked.

• Discuss aspirin

chemoprevention

with adults who are

at increased risk for

coronary heart

disease

• Behavioral dietary

counseling for adult

patients with

hyperlipidemia and

other known risk

factors for

cardiovascular and

diet-related chronic

disease.

• Screen adults aged

18 and older for

high blood

pressure.

• Screen men aged

35 years and older

and women aged

45 years and older

for lipid disorders

and treat abnormal

lipids in people

who are at

increased risk of

coronary heart

disease.

• Screen for type 2

diabetes in adults

with hypertension

or hyperlipidemia.

• Controlling high

blood pressure

• Cholesterol

management for

patients with

cardiovascular

conditions

• Comprehensive

diabetes care

• 68.8% of adults

age 46-85 have

controlled blood

pressure (140/90

mm Hg or lower) 

• LDL-C screening:

92.3%

• LDL-C control

(<130 mg/dL)

67.5%

• LCL-C control

(<100 mg/dL)

43.8%

Comprehensive

diabetes care:

• Eye exams: 54.8%

• HbA1c testing:

87.5% 

• LDL-C screening:

92.3%

• LDL-C control

(<130 mg/dL)

67.5%

• LCL-C control

(<100 mg/dL)

43.8%

Cardiovascular

Health

Diabetes

2000: 26% of adults age 20

and above have high blood

pressure^

2010 target: reduce proportion

to 14%

2000: 25% of adults age 18

and above with high blood

pressure have it under control

2010 target: increase proportion

to 68%^

2000: 67% of adults age 18

and above have had their blood

cholesterol checked in the past

5 years^

2010 target: increase

proportion to 80%^

2000: 64% of adults age 20

and above with diabetes have

been diagnosed^

2010 target: increase rate to

78%^

2000: there are 5.5 new cases of

diabetes per 1,000 population

aged 18-84

2010 target: reduce incidence

to 3.8 new caser per 

1,000 population per year^

Categories Purchaser’s Guide

Recommendations

USPTSF

Recommendation

HEDIS® 

2007

Measures

Healthy People

2010 Goal

NCQA 2006 State of

Health Care Quality

% of beneficiaries in the

commercially-insured

population who received

service (2004-2005)2
• Immunizations

(Adults)

• Newborn

Screening for

Genetic and

Endocrine

Disorders,

Screening, medical

foods, and

treatment

• Newborn hearing,

Screening

• Lead, Elevated

Blood Levels,

Screening

• Dental Caries,

Preventive

medication

• Child

Development,

Screening

• Immunizations

• Vision, Screening

• The Purchaser’s

Guide also

recommends

screening and

counseling

adolescents as

mediacally

indicated for

alcohol misuse,

depression, obesity,

and tobacco use.

• N/A – the

USPSTF defers to

ACIP.

• The USPSTF

determined that

the evidence was

insufficient to

recommend for or

against routine

screening of

newborns for

hearing loss during

postpartum

hospitalization.

• N/A – the

USPSTF defers to

ACIP.

• Primary care

clinicians should

prescribe oral

fluoride

supplementation at

currently

recommended

doses to preschool

children older than

6 months of age

whose primary

water source is

deficient in

fluoride.

• Flu shots for

adults age 50–64

• Flu shots for older

adults

• Pneumonia

vaccination status

for older adults

• Well-child visits in

the first 15

months of life

• Well-child visits in

the third, fourth,

fifth and sixth

years of life

• Childhood

immunization

status

• Annual dental

visits

• Adolescent wellcare visit

• Adolescent

immunization

status

• Flu shots for adults:

36.3%.

• Child

immunizations

(combination 2):

77.7%

• Childhood

immunization for

chickenpox (VZV):

89.9%

• Adolescent

immunizations

status

(combination 2):

53.7%

• Adolescent

immunization for

chickenpox (VZV):

60.2%

Immunizations

Adult

(for 

information 

on child and

adolescent

immunization

please refer to

Infant, Child, 

& Adolescent

Care)

Infant, Child, 

& Adolescent

Care

2002: 66% of adults age 65

and above receive an influenza

vaccine

2010 target: increase

proportion to 90%

2004: 56% of adults age 65

and above receive a

pnemoncoccal vaccine

2010 target: increase

proportion to 90%

1998: 87% of children age 19

to 35 months received 3 does

of hepatitis B vaccine in 1998. 

2010: Increase proportion to

80%

2010 target: Ensure that all

newborns are screened at birth

for conditions mandated by their

State-sponsored newborn

screening programs^

1998: 87% of children age 19 to

35 months received 3 does of

hepatitis B vaccine in 1998. 

2010: Increase proportion to

90%

1994: 4.4% of children aged 1-5

years have blood lead levels

exceeding 10 mg/dL^

2010 target: reduce proportion

to 0%

1998: 73% of children receive all

vaccines that have been

recommended for universal

administration for at least 5 years

(DTaP, polio. MMR, Hib and

HepB vaccines)^

2010 target: increase proportion

to 90%^

1994: 131 per 10,000 children

born suffers from mental

retardation and 32.2 per 10,000

suffer from cerebral palsy^

2010 target: reduce rate of

mental retardation to 124 cases

per 10,000 live births and reduce

the rate of cerebral palsy to 31.5

cases per 10,000 live births^

2001: 66% of newborns receive

screenings for hearing loss before

age 1 month, 56% receive

audiologic evaluation before age

3 month, and 57% are enrolled

in appropriate intervention

services by age 6 months. 

2010 target: increase the

proportion of newborns who are

screened for hearing loss by age 1

month to 90%, have audiologic

Categories Purchaser’s Guide

Recommendations

USPTSF

Recommendation

HEDIS® 

2007

Measures

Healthy People

2010 Goal

NCQA 2006 State of

Health Care Quality

% of beneficiaries in the

commercially-insured

population who received

service (2004-2005)2

479
480

7 Resources & Tools

• Depression,

Screening

• Alcohol Misuse,

Screening and

counseling

• Screen adults for

depression in

clinical practices

that have systems

in place to assure

accurate diagnosis,

effective

treatment, and

follow-up.

• Screen all adults

(including

pregnant women)

for alcohol misuse

and provide

behavioral

counseling

interventions to

reduce alcohol

misuse in primary

care settings.

• Initiation of

treatment: 44.5%

Infant, Child, &

Adolescent Care

(Continued)

Mental Health

and Substance

Abuse

evaluation by age 3 months to

70%, and are enrolled in

appropriate intervention services

by age 6 months to 85%.

2002: 36% of children aged 5

years and under had ever had

their vision screened in 2002.

2010 target: increase the

Increase the proportion of

preschool children aged 5 years

and under who receive vision

screening to 52%. 

1997: 48% of adolescents aged

13-15 years received 3 or more

doses of hepatitis B vaccine,

89% received 2 or more doses

of MMR, 93% received 1 or

more tetanus –diphtheria

booster, and 45% received 1

or more doses of varicella (for

chicken pox)^

2010 target: increase

proportions for all vaccines to

90%^

2002: 26% of adolescents in

12th grade smoke1

2010 target: reduce smoking

rate to 16%

1997: 23% of Adults aged 18

years and older with

depression receive treatment

2010 target: increase

proportion to 50% 

2002: 51% of individuals age

12 and above consume

alcohol

2002: 17.6% of adolescents

ages 12-17 consume alcohol

2002: 10.7% of adolescents

aged 12 to 17 binge drink (5

or more drinks on the same

occasion within the past 30

days)

2010 target: Reduce

adolescents engaging in binge

drinking during the past

month to 3.1%^ 

1998: 24.3% of adults aged

18 and older binge drink^

2010 target: reduce

proportion to 13.4% ^

Categories Purchaser’s Guide

Recommendations

USPTSF

Recommendation

HEDIS® 

2007

Measures

Healthy People

2010 Goal

NCQA 2006 State of

Health Care Quality

% of beneficiaries in the

commercially-insured

population who received

service (2004-2005)2
• Obesity,

Screening,

counseling, 

and treatment

• Alcohol Misuse,

Screening and

counseling

• Asymptomatic

Bacteriuria,

Screening

• Breastfeeding,

Counseling

• Folic Acid

Supplementation,

Counseling and

preventive

medication

• Group B

Streptococcal

Disease, Screening

and preventive

medication

• Hepatitis B Virus

(HBV), Screening,

immunization,

and treatment

• Human

Immunodeficiency

Virus (HIV),

Screening,

counseling, and

preventive

medication

• Influenza,

Immunization

• Preeclampsia,

Screening

• Prenatal Diagnosis

of Chromosomal

Abnormalities and

Neural Tube

Defects (NTDs),

Screening and

testing

• Rh (D)

Incompatibility,

Screening and

preventive

medication

• Rubella, Screening

• Syphilis, Screening

• Tetanus,

Immunization

• Tobacco Use

Treatment,

Screening and

counseling

• Screen all adult

patients for obesity

and offer intensive

counseling and

behavioral

interventions to

promote sustained

weight loss for

obese adults.

• Screening and

behavioral

counseling

interventions to

reduce alcohol

misuse by adults,

including pregnant

women, in primary

care settings.

• Provide structured

breastfeeding

education and

behavioral

counseling

programs to

promote

breastfeeding.

• Routinely screen all

sexually active

women aged 25

years and younger,

and other

asymptomatic

women at increased

risk for infection,

for chlamydial

infection.

• Screen for hepatitis

B virus (HBV)

infection among

pregnant women at

their first prenatal

visit.

• Screen all pregnant

women for HIV.

• Rh (D) blood

typing and

antibody testing

should be

conducted at the

first prenatal visit

for all pregnant

women.

• All women of

childbearing age

should be assessed

for rubella

susceptibility by

history of

vaccination or by

serology at their

first clinical

encounter.

• Prenatal and

postpartum care

• Frequency of

ongoing prenatal

care

• Timelines of

prenatal care:

91.8%

• Timeliness of

postpartum care:

81.5%

Nutrition/

Physical

Activity

Pregnancy

2002: 65% of U.S. adults,

aged 20 and above, are

overweight

2010 target: reduce

proportion to 15% 

2002: 31% of adults aged 20

and above are overweight

2010 target: reduce

proportion to 15% 

2004: 84% of pregnant

women received timely

prenatal care

2010 target: increase rate to

90%

2002: 43% of mothers

breastfeed exclusively for

3months^

2010 target: increase

proportion to 60%^

2002: 13% of mothers

breastfeed exclusively for 6

months^

2010 target: increase

proportion to 25%^

1995: 93% of females 15 to

44 who are at risk of

unintended pregnancy use

contraception.

2010 target: increase rate to

100%

1994: 21% of non-pregnant

women ages 15 to 44 consume

at least 400 mg of folic acid

per day

2010 target: increase rate to

80%

2010 target: Increase the

proportion of pregnant females

screened for sexually

transmitted diseases (including

HIV infection and bacterial

vaginosis) during prenatal

health care visits, according to

recognized standards.

2000: 1,682 chronic hepatitis

B virus infections in children

under age 2 years were

reported in 1995.

2010 target: Reduce chronic

hepatitis B virus infections in

infants and young children

(perinatal infections) to 400

infections.

1996: 6 cases of spina bifida or

other NTD per 10,000 live

births

2010 target: reduce the

number of spina bifida cases to

3 per 10,000 live births

Categories Purchaser’s Guide

Recommendations

USPTSF

Recommendation

HEDIS® 

2007

Measures

Healthy People

2010 Goal

NCQA 2006 State of

Health Care Quality

% of beneficiaries in the

commercially-insured

population who received

service (2004-2005)2

481
482

7 Resources & Tools

• Counseling to

Prevent STIs,

Counseling

• Chlamydia,

Screening

• Gonorrhea,

Screening

• Human

Immunodeficiency

Virus (HIV),

Screening 

• Syphilis, Screening

• Screen all

pregnant women

for syphilis

infection at the

1st prenatal visit

• Screen all

pregnant women

for tobacco use

and provide

augmented

pregnancy-tailored

counseling to

those who smoke.

• Educate all

adolescents and

adults on the risk

factors for HIV

and other sexually

transmitted

infections and

counsel these

patients on

effective measures

to reduce their

risk of infection. 

• Screen all sexually

active women

aged 25 years and

younger, and

other

asymptomatic

women at

increased risk, for

chlamydial

infection.

• Screen all sexually

active women,

including those

who are pregnant,

for gonorrhea

infection if they

are at increased

risk for infection.

• Screen all

adolescents and

adults at increased

risk for HIV

infection.

• Screen persons at

increased risk for

syphilis infection.

• Chlamydia

screening in

women

• Chlamydia

screening: 16 to 20

years: 34.4% 

21 to 25 years:

35.2%

Pregnancy

(Continued)

Sexually

Transmitted

Infection, (STIs)

2002: 11% of pregnant

women smoke*, 1997: 14% of

pregnant women drink

alcohol, 1% binge drink, and

2% use illicit drugs

2010 target: reduce smoking

rate to 1%, alcohol use rate to

6%, binge drinking rate to

0%, and illicit drug use rate to

0% 

1997: fetal alcohol syndrome

occurs in 0.4 per 1,000 live

births^

2010 target: reduce incidence

to 0.1 cases per 1,000 live

births^

2002: 25% of sexually active

women aged 25 and under

enrolled in commercial

managed care organizations

are screened for Chlamydia

infection^

2010 target: increase

proportion to 62%^

2002: there are 279 new cases

of gonorrhea among women

age 15-44 per 100,000

population^

2010 target: reduce the

incidence to 42 new cases per

100,000 population^

1994: 17% of adults age 20-

29 years have a genital herpes

infection^

2010 target: reduce

proportion to 14%^

Categories Purchaser’s Guide

Recommendations

USPTSF

Recommendation

HEDIS® 

2007

Measures

Healthy People

2010 Goal

NCQA 2006 State of

Health Care Quality

% of beneficiaries in the

commercially-insured

population who received

service (2004-2005)2
• Contraceptives,

Counseling and

preventive

medication

• Motor VehicleRelated Injury

Prevention,

Counseling

• Osteoporosis,

Screening and

treatment

• Tobacco Use

Treatment,

Screening,

counseling, and

treatment

• Tuberculosis,

Screening

• Screen women aged

65 and older for

osteoporosis. The

USPSTF

recommends that

routine screening

begin at age 60 for

women at increased

risk for

osteoporotic

fractures

• Screen all adults for

tobacco use and

provide tobacco

cessation

interventions for

those who use

tobacco products.

• Screen for

tuberculosis

infection with

tuberculin skin

testing among

asymptomatic 

high-risk persons.

• Osteoporosis

management in

women who had a

fracture

• Osteoporosis

testing in older

women

• Medical assistance

with smoking

cessation

• Osteoporosis

management after a

fracture: 20.1%

(Medicare rate)

• Advising smokers

to quit: 71.2%

• Discussing

cessation

medications:

39.4%

• Discussing quitting

strategies: 39.0%

Sexually

Transmitted

Infections

(Continued)

Other

1995: 51% of pregnancies in

the U.S. are intended

2010 target: increase rate to

70%

2002: 8.4 per 100,000 deaths

result form a motor vehicle

accident (age-adjusted deaths)

2010 target: reduce rate to 8.0

deaths per 100,000^

2000: 10% of adults age 50

and above have osteoporosis^

2010 target: reduce

proportion to 8%^

2002: 26% of adolescents in

12th grade smoke1

2010 target: reduce smoking

rate to 16% 

1999: 20% of adult females

and 25% of adult males

smoke1

2010 target: reduce adult

smoking rate to 12%^

1998: 6.8 new cases of TB per

100,000 population^

2010 target: reduce incidence

to 1.0 new cases per 100,000

population^

1997: 62% of contacts and

other high-risk persons with

latent TB complete a course of

treatment

2010: Increase treatment

completion to 85%

Categories Purchaser’s Guide

Recommendations

USPTSF

Recommendation

HEDIS® 

2007

Measures

Healthy People

2010 Goal

NCQA 2006 State of

Health Care Quality

% of beneficiaries in the

commercially-insured

population who received

service (2004-2005)2

Notes: 

1 Adolescent smoking definition: an adolescent in grade 9-12 who smoked one or more cigarettes in the past 30 days. Adult

smoking definition: an adult (≥18 years of age) who smoked more than 100 cigarettes in his/her lifetime and who smoked on

some or all days in the past month. 

2 The NCQA Report on the State of Health Care Quality is based on 500 health plans that voluntarily report HEDIS

measurements to NCQA. 

483
484

7 Resources & Tools

Information Sources:

All information on the USPSTF recommendations was adapted from:

U.S. Preventive Services Task Force. Guide to Clinical Preventive Services: Pocket Guide; 2005. [cited

2006 Jun 5]. Available from: http://www.ahrq.gov/clinic/pocketgd.htm. 

All information related to the Healthy People 2010 guidelines, unless otherwise noted by * or a ^ was adapted

from: 

U.S. Department of Health and Human Services. Healthy People 2010. 2nd ed. With Understanding and

Improving Health and Objectives for Improving Health. 2 vols. Washington. DC: U.S. Government

Printing Office; November 2000.

^ U.S. Department of Health and Human Services. Healthy People 2010. Midcourse Review.

Washington, DC: U.S. Department of Health and Human Services. Office of Disease Prevention and

Health Promotion. [cited 2006 Jun 13]. Available from:

http://www.healthypeople.gov/data/midcourse/comments/objectives.asp. 

All information from NCQA was adapted from:

National Committee for Quality Assurance (NCQA). The State of Healthcare Quality: 2006. National

Committee for Quality Assurance (NCQA); Washington, DC; 2006. 

National Committee for Quality Assurance (NCQA). The State of Healthcare Quality: 2004. National

Committee for Quality Assurance (NCQA); Washington, DC; 2004.

National Committee for Quality Assurance (NCQA). HEDIS 2007 Summary Table of Measures and

Product Lines. Measure List. Washington, DC: National Committee for Quality Assurance; 2006.

[cited 2006 Sept 15]. Available from: http://www.ncqa.org/Programs/HEDIS/2007/MeasuresList.pdf. 
485

Glossary

Absenteeism: Missing days from work. In terms of health-related absenteeism, it can be attributed to general

sickness, workers’ compensation, short-term disability, long-term disability, sick leave, Family Medical

Leave Act (FMLA), paid time off (PTO), unpaid leave, and death (premature mortality costs).1

Asymptomatic: Lacking symptoms of a disease or condition. 

At-work productivity decline (also see presenteeism): Reduced normal activity and job output due to a

health problem.2

Bed days: Number of days-of-stay in a healthcare facility (e.g., hospital) used to treat a condition or

population. “Hospital bed days per thousand,” for example, may describe the average number of inpatient

days used in a specified period of time for every 1,000 employees.

Chemoprophylaxis: The prevention of infectious disease through the use of chemical agents3

; such as drugs;

also called preventive medication. 

Clinical preventive services: A comprehensive term referring to a variety of interventions delivered to an

individual (e.g., screenings, counseling, immunizations, and preventive medication) intended to detect

conditions for which the individual has no symptoms of disease or to prevent escalation of an established

disease or condition. 

Cohort: A defined group of individuals; a group of individuals with a common statistical factor (such as birth

year, age, or risk).3

Comorbidity: The presence of multiple diseases or conditions that are simultaneously present and not

necessarily caused by one another. For example, a patient with type 2 diabetes and depression is said to

have comorbid diabetes and depression. Comorbid disorders may interact to affect clinical course, severity,

risk factors for other conditions, or to alter the appropriateness of tests and treatments that are normally

used to manage a single condition. Comorbidity may be used as a prognostic indicator for length of

hospital stay, cost factors, and outcome or survival.5

Complication: A side effect, secondary condition, or adverse effect related to an underlying condition.

Complications may occur because of the natural course of a disease (e.g., death can be a complication of an

untreated heart attack) or may occur as the result of medical procedure or treatment (e.g., post-operative

infection). 

Cost, indirect: Expenses associated with an illness, condition, or disorder that are not immediately related to

treatment. These non-medical expenditures include lost wages, lost workdays, costs related to using

replacement workers, overtime premiums, productivity losses related to unscheduled absences, and

productivity losses of workers while on the job.1

Cost, direct: Dollars spent on health services. Direct costs include out-of-pocket payments, medical insurance

benefits (e.g., medical, pharmacy, dental, mental health), disability payments, and workers' compensation

losses.1

Cost-effective: A determination that the net cost per unit of health generated by an intervention is favorable

in comparison with other health services.

Cost-effectiveness: Minimum cost for a given benefit, the maximum benefit for a given cost, or a balance of

low cost and high benefit that has maximum utility.

Cost-effectiveness analysis (CEA): An economic analysis designed to compare the net cost (expense) of an

intervention with the net expense of one or more other interventions. CEAs usually use a common

outcome measure, such as years-of-extended life or quality-adjusted life years in which all expenditures are

related to a single, common effect, usually in terms of expense per outcome achieved.

Cost-effectiveness (CE) ratio: The ratio of total investment expenditures to total accrued benefits, in terms of

both dollars and benefit value. This is comparable to a Return-on-Investment (ROI) calculation.

Cost, out-of-pocket: Expenditures for a healthcare service that are not covered by a health plan or other third

party and for which an individual is directly responsible.

Cost-saving: The reduction in healthcare expenses resulting from an intervention or program after accounting

for the cost required to develop, implement, and maintain the given intervention or program.

Cost, total: The sum of all direct and indirect costs.

Counseling: An intervention during which a clinical provider gives information to an individual about

changes in personal behavior that can reduce the risk of illness or injury.
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7 Resources & Tools

Disability: Inability to pursue an occupation or perform job tasks because of physical or mental impairment.3

Direct medical expense: The economic value directly attributable to a particular clinical action, purchase,

program or initiative; the amount spent for diagnosis, treatment or prevention of medical problems. Direct

medical expenses include visits to physician’s offices and treatment expenditures. 

Evidence-based medicine: The conscientious, explicit, and judicious use of current best evidence in making

decisions about the care of individual patients. The practice of evidence-based medicine integrates

individual clinical expertise with the best available external clinical evidence from systematic research.4

Evidence-based recommendations: Require “First, good evidence that each test or procedure recommended is

medically effective in reducing morbidity or mortality; second, the medical benefits must outweigh the

risks; third, the cost of each test or procedure must be reasonable compared to its expected benefits; and

finally, the recommended actions must be practical and feasible.”8 [Note: The USPSTF does not consider cost

as a factor in its recommendations.] 

Excess medical costs: Any medical expenditure related to a preventable disease or health condition, for

example, spending for an amputation necessitated by poorly controlled diabetes or expenses related to a

hospital-acquired infection. 

Health economics: A branch of economics concerned with analyzing the costs and consequences of

healthcare. Health economics uses mathematical models to synthesize data from biostatistics and

epidemiology to support medical decision-making, both for individuals and for wider health policy.5

Health promotion program (also see wellness program): Any prevention initiative aimed at changing

lifestyle behaviors associated with greater risk of disease. These initiatives actively encourage healthy

activities such as substance abuse control, weight management, smoking cessation, stress management,

physical activity, or the like.

Health risk appraisal/Health risk assessment (HRA): A standardized assessment tool administered to

employees (or other groups of individuals) that measures an individual’s wellness and disease risk factors,

interest in participating in specific programs, and readiness to change unhealthy lifestyle habits.

Health Plan Employer Data and Information Set (HEDIS®): HEDIS® is a United States program from the

National Committee for Quality Assurance (NCQA) that consists of multiple, diverse measures of clinical

and administrative outcomes by which the performance of a health plan can be compared to other plans,

national or regional benchmarks, or the plan's performance from previous years.

Herd immunity: The immunity of a group or community. When a high proportion of a community is

immunized against a particular communicable disease, the entire community (including those who are

immunized) is resistant to the invasion and spread of an infectious agent because there are not enough nonimmune people to transmit the disease.

High-value: An intervention that is both evidence-based and cost-effective. 

Immunization (also see vaccination): The administration of a substance, usually by injection, oral, or nasal

administration, that produces protective immunity to one or more specific diseases.

Incidence: The number of new cases of a particular illness or condition reported in a given time period (e.g.,

day, week, year). 

Indirect medical expense: Money expenditures associated with an illness, condition, or disorder, but not

immediately related to treatment of that disorder. 

Life-years gained: A measure of value gained from a healthcare intervention: the average number of extra years

of life resulting from treatment when compared with non-treatment. It does not include measures of

quality of life or disability status (e.g., QALY, DALY).

Lost productivity: Total limitation in work experienced by an individual. It is a sum of lost workdays and

productivity decline.2

Lost workdays: Days for which an individual reports being unable to complete normal activities due to a

health condition.

Lost workday cases: Cases that involve consecutive or nonconsecutive days away from a job, on restricted

activity, or both as a result of injury or illness. Counting of lost workday cases should begin following the

day an injury occurs or a disease or illness commences.

Morbidity: The relative frequency and severity of a disease in a defined population; the result of experiencing

illness from a disease or condition (excluding death). For example, untreated type 2 diabetes may result in

morbidities such as blindness, infections, neuropathies, and other problems. 

Mortality: The number of deaths in a defined population or more specifically, the number of deaths
attributable to a particular type of illness or disease.

Premature mortality: The number of deaths of people aged 0 to 74 years. Premature mortality is an

important indicator of the general health of a population as a high premature mortality rate indicates poor

population health status.4

Presenteeism: Describes an employee who is at work but not fully functioning while there. In this context,

presenteeism refers to those situations whereby an employee’s job performance or productivity is impaired

by a health problem.1

Prevalence: The proportion of the general population affected by a specific illness or condition at a specific

point in time or during a defined period of time.

Preventive medication: A medication taken to prevent the occurrence or delay the onset of a disease or

condition.

Primary care: Clinical care provided by family physicians, pediatricians, internal medicine doctors, or

obstetrician/gynecologists who treat general illnesses, provide clinical preventive services, and triage patients

for specialized medical care.

Primary prevention: is aimed at preventing the onset of disease. One way of doing this is by controlling risk

factors in healthy people that may lead to disease. Examples of primary prevention include 1)

immunizations to prevent communicable diseases such as influenza or polio, and 2) promotion of physical

activity to prevent conditions such as obesity that can lead to disease (e.g., type 2 diabetes).

Primary preventive service: Any service, procedure, medication, counseling, or immunization aimed at

avoiding or delaying illness. 

Productivity: The amount of output produced by a worker in a given period of time (hour or day, etc.).2

Recommended guidance: A recommendation or guideline that is based on the best-available information for

a condition, disease, or health service, but that does not yet have the scientific research support to be

considered evidence-based.

Return-on-investment (ROI): A comparison of the money earned (or lost) on an investment to the amount

of money invested. For example, every $1 an employer spends on immunization produces a return of $3 in

avoided healthcare costs. It is important to note that ROI is not a proxy for cost-effectiveness or vice versa.

Interventions that are cost-effective or even cost-saving at the societal level do not necessarily yield a

positive ROI from the business perspective, although they may provide a better value than other services.6

Risk, at-: Possessing a chance of succumbing to a disease or condition due to specific genetic markers, personal

history, behaviors, or other factors.

Risk, high: Possessing a greater chance of succumbing to a disease or condition than the general population

due to specific genetic markers, personal history, behaviors, a lack of immunity, or other factors.

Risk, low: Possessing a lesser chance of succumbing to a disease or condition than the general population due

to specific genetic markers, personal history, behaviors, or other factors.

Screening: A test or examination designed to identify an individual’s risk of developing an illness or condition

(i.e. blood pressure measurement or cholesterol reading).

Secondary prevention: is aimed at treating a disease after its onset, but before it causes serious complications.

Secondary prevention includes 1) identifying individuals with established disease, and 2) treating those

individuals in a timely way so as to prevent further problems (e.g., mammography screening to detect and

treat breast cancer in its earliest stages).

Spontaneous abortion (miscarriage): A sudden unplanned miscarriage of the fetus from the womb. The

terms fetal death and stillborn refer to the spontaneous death of a fetus in later stages of pregnancy. 

Symptomatic: Having characteristics that indicate the presence of a disease or condition.

Tertiary prevention: is aimed at treating the late or final stages of a disease so as to minimize the degree of

disability caused by that disease (e.g., administering a foot check to a person with diabetes to identify

infections that would require amputation if left untreated).

Test: Any technique used to determine whether a condition is present or not or to measure its level of activity

or severity. Tests include, for example, maneuvers such as physical examinations, laboratory-based

examinations of blood and other tissues, X-ray examinations, and questionnaires, among others.

Vaccination (also see immunization): The administration of a substance, usually by injection, oral, or nasal

administration, that produces protective immunity to one or more specific diseases.

487
Wellness program (also see health promotion program): Any prevention initiative aimed at changing

lifestyle behaviors associated with greater risk of disease. These initiatives actively encourage healthy

activities such as substance abuse control, weight management, smoking cessation, stress management,

physical activity, or the like.

Work loss: Time away from a job or an inability to perform normal work activities because of a health problem.

References:

1. American Academy of Occupational and Environmental Medicine. Glossary. [cited 2006 Sept 22]. Available

from: http://www.acoem.org/health_productivity/terms.asp. 

2. Center for Prevention and Health Services. Improving Health Improving Business: An Employer’s Guide to

Clinical Preventive Services. Washington, DC: National Business Group on Health; 2004.

3. National Library of Medicine. National Institutes of Health. Medline Plus. Medical Dictionary. [cited 2006

Sept 22]. Available from: http://www.nlm.nih.gov/medlineplus/mplusdictionary.html.

4. MedNet Online Medical Dictionary. Evidence-Based Medicine. [cited 2006 Sept 22]. Available from:

http://www.medterms.com/script/main/art.asp?articlekey=33300. 

5. Eddy DM. Evidence-based medicine: a unified approach. Health Affairs 2005; 24(1): 9-17.

6. Wikipedia. Return-on-investment. [cited 2006 May 11]. Available from:

http://en.wikipedia.org/wiki/Return_on_investment. 

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7 Resources & Tools
Links to Cost-Calculators and Additional Resources 

Cost-Calculators

Alcohol Misuse

• George Washington University Alcohol Treatment ROI Calculator,

http://www.alcoholcostcalculator.org/roi/

Diabetes

• Diabetes at Work, Conducting a Diabetes Assessment. General Assessment Tool.

http://www.diabetesatwork.org/diabetesatwork/assessing_gen.cfm

Obesity and Physical Activity

• American Cancer Society ROI Calculator for Obesity and Physical Activity,

http://www.acsworkplacesolutions.com/obesitycalculator.asp

• Magellan Health Services Obesity Cost Calculator.

http://www.magellanassist.com/customer/services/obesitycost/default.asp

Tobacco

• American Cancer Society ROI Calculator for Tobacco,

http://www.acsworkplacesolutions.com/tobaccocalculator.asp

• America’s Health Insurance Plans (AHIP) and Center for Health Research, Kaiser

Permanente Tobacco ROI calculator, http://www.businesscaseroi.org/roi/default.aspx

• Free & Clear Employer and Health Plan ROI Calculator for Tobacco,

http://www.freeclear.com/case_for_cessation/econ_impact.aspx?nav_section=2#

Additional Resources

U.S. Department of Health and Human Services (Federal)

• Advisory Committee on Immunization Practices (ACIP),

http://www.cdc.gov/nip/ACIP/default.htm

- Standards for Child and Adolescent Immunization Practices:

http://www.cdc.gov/nip/publications/pink/appendices/H/standards-pediatric.pdf

- Standards for Adult Immunization Practices:

http://www.cdc.gov/nip/recs/rev_stds_adult_AJPM.pdf

• Agency for Healthcare Research and Quality (AHRQ), http://www.ahrq.gov

• Centers for Disease Control and Prevention (CDC), http://www.cdc.gov

• Healthy People 2010 Goals, http://www.healthypeople.gov/

• National Guidelines Clearinghouse, http://www.guideline.gov/

• National Healthcare Quality Report (AHRQ), http://www.qualitytools.ahrq.gov/

• National Institutes of Health (NIH), http://www.nih.gov

• Office of the U.S. Surgeon General, http://www.surgeongeneral.gov/

• Steps to a Healthier U.S., Prevention Portfolio, Department of Health and Human

Services (U.S. DHHS), http://www.healthierus.gov/steps/documents.html#portfolio

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7 Resources & Tools

• U.S. Department of Health and Human Services (USDHHS), http://www.dhhs.gov/

• U.S. Preventive Services Task Force (USPSTF), http://www.ahrq.gov/clinic/prevenix.htm

• U.S. Public Health Service (USPHS), http://www.usphs.gov

Professional Organizations

• American Academy of Family Physicians (AAFP), http://www.aafp.org

• American Academy of Pediatrics (AAP), http://www.aap.org

• American College of Obstetricians and Gynecologists (ACOG), http://www.acog.org

• American College of Occupational and Environmental Medicine (ACOEM),

http://www.acoem.org/

• American College of Preventive Medicine (ACPM), http://www.acpm.org/

• American Medical Association (AMA), http://www.ama.org

• American Speech-Language-Hearing Association (ASHA), http://www.asha.org

• American College of Allergy, Asthma, & Immunology (ACAAI), http://www.acaai.org

• American College of Cardiology, http://www.acc.org/

Other

• Institute of Medicine (IOM), http://www.iom.edu

• National Committee on Quality Assurance (NCQA), http://www.ncqa.org

• HEDIS Data Set, National Committee on Quality Assurance (NCQA),

http://www.ncqa.org/communications/publications/hedispub.htm

Condition/Disease Specific Resources (Federal)

• Joint National Committee on the Prevention, Detection, Evaluation, and Treatment

of High Blood Pressure (JNC 7),

http://hyper.ahajournals.org/cgi/content/full/hypertensionaha;41/6/1178

• National Cancer Institute (NCI), http://www.nci.nih.gov

• National Cholesterol Education Program (NCEP),

http://www.nhlbi.nih.gov/about/ncep/index.htm

• National Heart, Lung, and Blood Institute (NHLBI), http://www.nhlbi.nih.gov

> Dietary Approaches to Stop Hypertension (DASH) Eating Plan,

http://www.nhlbi.nih.gov/health/public/heart/hbp/dash/.

> Framingham-based risk assessment tool,

http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof.

> Healthy diet tip sheets, http://www.nhlbi.nih.gov/chd/Tipsheets/daily.htm.

> Hypertension risk assessment tool,

http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof.

> Therapeutic lifestyle change tip sheets,

http://www.nhlbi.nih.gov/chd/Tipsheets/daily.htm.

> Your Guide to Lowering your Cholesterol Level with Therapeutic Lifestyle Changes,

http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

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491

• National Institute of Alcohol Abuse and Alcoholism (NIAAA),

http://www.niaaa.nih.gov/

• National Institute of Occupational Health and Safety (NIOSH),

http://www.cdc.gov/niosh/homepage.html

Condition/Disease Specific Resources (Non-Federal)

• American Cancer Society (ACS), http://www.acs.org

• American Dental Association (ADA), http://www.ada.org

• American Diabetes Association (ADA), http://www.diabetes.org

• American Dietetics Association (ADA), http://www.eatright.org

• American Heart Association (AHA), http://www.americanheart.org

• American Lung Association (ALA), http://www.lungusa.org

• American Managed Behavioral Healthcare Association (AMBHA),

http://www.ambha.org

• American Stroke Association, http://www.strokeassociation.org

• March of Dimes, http://www.marchofdimes.com

• National Mental Health Association (NHMA), http://www.nmha.org

• National Stroke Association, http://www.stroke.org

Supplemental Guides and Resources

• Agency for Healthcare Research and Quality, The Pocket Guide to Clinical Preventive

Services 2005, http://www.ahrq.gov/clinic/pocketgd.htm

• Agency for Healthcare Research and Quality, 2005 National Healthcare Disparities

Report, http://www.ahrq.gov/qual/nhdr05/nhdr05.htm

• Centers for Disease Control and Prevention, The CDC Guide to Breastfeeding

Interventions, http://www.cdc.gov/breastfeeding/resources/guide.htm

• Centers for Disease Control and Prevention, The Community Guide to Preventive

Services, http://www.thecommunityguide.org/

National Business Group on Health Resources

• Improving Health, Improving Business: the Employer’s Guide to Health

Improvement and Preventive Services,

http://www.businessgrouphealth.org/services/index.cfm

• Consumer Drive Healthcare for Children: An Employer’s Guide to Developing Child

and Adolescent Benefits,

http://www.businessgrouphealth.org/prevention/et_childhealthcareconsumer.cfm

• An Employer’s Guide to Behavioral Health Services: A Roadmap and

Recommendations for Evaluating, Designing, and Implementing Behavioral Health

Services, http://www.businessgrouphealth.org/prevention/et_behavioralhealthreport.cfm
492
ALPHABETICAL INDEX

493

Abdominal Aortic Aneurysm, Screening, 51, 73 107

Alcohol Misuse, Screening and Counseling, 51, 73, 113

Aspirin Therapy for the Prevention of Cardiovascular Disease, Counseling, 51, 73, 125

Breast Cancer, Screening, 52, 73, 131

Breast Cancer, Genetic Risk Assessment and BRCA Mutation Testing,

Counseling, testing, and preventive treatment, 52, 74, 132

Breast Cancer, Counseling and preventive medication, 52, 75, 133

Cervical Cancer, Screening, 53, 76, 145

Childhood Health Promotion, Child Development, Screening, 54, 77, 154

Childhood Health Promotion, Dental Caries, Preventive medication, 54, 77, 160 

Childhood Health Promotion, Immunizations, 54, 88, 337

Childhood Health Promotion, Lead, Elevated Blood Level, Screening, 54, 78, 164

Childhood Health Promotion, Newborn Screening for Genetic and Endocrine

Disorders, Screening, medical foods, and treatment, 55, 78, 169

Childhood Health Promotion, Newborn Hearing, Screening, 55, 78, 175

Childhood Health Promotion, Vision, Screening, 56, 78, 181

Colorectal Cancer, Screening, 57, 79, 195

Contraceptive Use, Counseling and preventive intervention, 57, 79, 201

Depression, Screening, 57, 79, 211

Diabetes (type 2), Screening, 58, 79, 217

Healthy Diet, Counseling, 58, 80, 227

Healthy Pregnancy, Alcohol Misuse, Screening and counseling, 58, 80, 243

Healthy Pregnancy, Asymptomatic Bacteriuria, Screening, 59, 81, 248

Healthy Pregnancy, Breastfeeding, Counseling, 59, 81, 252

Healthy Pregnancy, Folic Acid Supplementation, Counseling and preventive medication, 60, 81, 257

Healthy Pregnancy, Group B Streptococcal Disease (GBS), Screening and 

preventive medication, 60, 81, 262

Healthy Pregnancy, Hepatitis B Virus (HBV), Screening, immunization, and treatment, 61, 81, 266

Healthy Pregnancy, Human Immunodeficiency Virus (HIV), Screening, counseling,

and preventive medication, 62, 82, 272

Healthy Pregnancy, Influenza, Immunization, 63, 83, 277

Healthy Pregnancy, Preeclampsia, Screening, 63, 83, 281

Healthy Pregnancy, Prenatal Diagnosis of Chromosomal Abnormalities,

Screening and testing, 63, 83, 284

Healthy Pregnancy, Rh (D) Incompatibility, Screening and preventive medication, 64, 87, 290

Healthy Pregnancy, Rubella, Screening, 64, 87, 294

Healthy Pregnancy, Syphilis, Screening, 64, 87, 298

Healthy Pregnancy, Tetanus, Immunization, 65, 87, 302
494

Healthy Pregnancy, Tobacco Use Treatment, Screening and counseling, 65, 88, 305

Hypertension, Screening, counseling and treatment, 65, 88, 323

Immunizations (Child, Adolescent, Adult), 66, 88, 337

Lipid Disorders, Screening, counseling, and treatment, 66, 92, 349

Motor Vehicle-Related Injury Prevention, Counseling, 67, 92, 363

Obesity, Screening, counseling, and treatment, 67, 93, 373

Osteoporosis, Screening and treatment, 68, 94, 383

Sexually Transmitted Infections (STIs), Counseling to Prevent STIs, Counseling, 69, 94, 393

Sexually Transmitted Infections (STIs), Chlamydia, Screening, 69, 95, 395

Sexually Transmitted Infections (STIs), Gonorrhea, Screening, 69, 95, 398

Sexually Transmitted Infections (STIs), Human Immunodeficiency Virus (HIV),

Screening and counseling, 70, 96, 401

Sexually Transmitted Infections (STIs), Syphilis, Screening, 70, 96, 407

Tobacco Use Treatment, Screening, counseling, and treatment, 71, 96, 415

Tuberculosis, Screening, 71, 97, 427