The CDC's Case Definition of AIDS:

Implications of Proposed Revisions

June 1992

OTA-BP-H-89

NTIS order #PB92-216126
OTA PROJECT STAFF--THE CDC’S CASE DEFINITION OF AIDS:

IMPLICATIONS OF THE PROPOSED REVISIONS

BACKGROUND PAPER

Roger C. Herdman, Assistant Director, OTA ,

Health and Life Sciences Division

Clyde J. Behney, Health Program Manager

Robert S.

Jacqueline

Project Staff

McDonough, Study Director

A. Corrigan, Senior Analyst

Sharon Y. Hamilton, Research Assistant

Kerry B. Kemp, Senior Analyst

Michelle Odom, Research Assistant

Sarah Sa’adah, Research Assistantl

Administrative Staff

Marian Grochowski, Office Administrator

Kimberly Holmlund, Word Processor Specialist

, Eileen Murphy, P.C. Specialist

Kelly Faulks, Secretary

●

This background paper was prepared as part of OTA’s

ongoing HIV-related assessment

1 Until June 1991.

May 1992
FOREWORD

The Centers for Disease Control’s (CDC) AIDS case definition is used to

monitor trends in the number and distribution of AIDS cases in the United

States. The AIDS case definition measures severe morbidity due to infection

with the human immunodeficiency virus (HIV). This information is then used in

formulating Federal and State policies for the prevention, treatment, and

control of AIDS. In addition, the AIDS case definition has been used in

disability determinations by the Social Security Administration.

Congress has been concerned about recent reports that the present AIDS

case definition does not include some severe manifestations of HIV infection

that occur in women and injection drug users. This is of particular concern

because most HIV-infected women and injection drug users are African Americans

or Hispanics. The CDC proposes to implement a revised definition of AIDS in

the summer of 1992. The CDC believes that this revised definition of AIDS

will adequately capture severe manifestations of HIV infection in these

populations.

This background paper examines the epidemiologic evidence used by the

CDC in deciding to revise the AIDS case definition and the impact the proposed

definition will have on surveillance. The paper also explores the logistical

consequences and other implications of the revised definition, including its

impact on Social Security disability determinations. The issues discussed in

this paper were the subject of a workshop conducted by OTA on October 22,

1991.

This background paper was prepared in response to a request by the

Subcommittee on Human Resources and Intergovernmental Relations of the House

“Committee on Government Operations.

This background paper is the eighth in OTA’s series of studies on HIVrelated issues. The preceding papers in this series were: Do Insects

Transmit AIDS? (9/87); AIDS and Health Insurance: An OTA Survey (2/88); How

Effective is AIDS Education? (6/88); The Impact of AIDS on the Kaiser

Permanence Medical Care Program (Northern California Region) (7/88); How Has

Federal Research on AIDS/HIV Disease Contributed to Other Fields (4/90); The

Effectiveness of Drug Abuse Treatment: Implications for Controlling UDS/HIV

Infection (9/90); and HIV in the Health Care Workplace (11/91).

Previous OTA reports addressing AIDS-related issues include: 1) Blood

Policy and Technology (1/85); 2) Review of the Public Health Service’s

Response to AIDS (technical memorandum, 2/85); 3) The Costs of AIDS and other

HIV Infections: Review of the Estimates (staff paper, 5/87); and 4) Medical

Testing and Health Insurance (8/88).

JOHN H. GIBBONS

Director

i i i
The Definition of AIDS: Epidemiological, Clinical, and Policy

Implications

Tuesday, October 22, 1991

Office of Technology Assessment

Workshop Participants

Ruth Berkelman, M.D.

Acting Director, Division of HIV/AIDS

Centers for Disease Control

Atlanta, GA

G. Steve Bowen, M. D:, M.P.H.

Acting Associate Administrator for AIDS

Health Resources and Services Administration

Bureau of Health Resources Development

Rockville, MD

Mary Ann Chiasson, Ph. D., M. P.H., M.S.

Acting Assistant Commissioner

Disease Intervention Research

New York City Department of Health

New York, N.Y.

Judith Cohen, P.h.D., M. P.H., M.A.

San Francisco, CA

Elizabeth Cooper, J.D.

ACLU AIDS Project

New York, NY

Judith S. Currier, M.D.

Clinical Director for AIDS

Associate in Medicine

Beth Israel Hospital

Boston, MA

Jack DeHovitz, M.D.

Director, AIDS Prevention Center

SUNY Health Science Center at Brooklyn

Brooklyn, NY

Don Des Jarlais, Ph.D.

Direcor of Research

Chemical Dependency Institute

New York, NY

Karen M. Ezrine, M.D.

Chief, Medical Evaluation Branch

Office of Disability

Social InSecurity Administration

Baltimore, M D

iv
THE CDC’S CASE DEFINITION OF AIDS: IMPLICATIONS OF

THE PROPOSED REVISIONS

CONTENTS

I. Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1

A.

II. The

A.

B.

c.

D.

E.

Summary of the Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-3

1. The Impact of the New CDC Definition on AIDS

Surveillance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-5

2. Federal Funding Allocations and the

New Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-7

3. Privacy Issues and the New Definition of AIDS . . . . . . . . . . . . . . I-8

4. Social Security Disability Determinations and

the CDC Definition of AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

CDC AIDS Definition: Implications of the CD4+

Lymphocyte Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-1

The Case Definition of AIDS: Purpose, History, and

Proposed Changes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-3

1. The Proposed AIDS Case Definition. . . . . . . . . . . . . . . . . . . . . . . . . II-7

a. CDC’s Decision Not to Increase the Number

of AIDS-Defining Conditions . . . . . . . . . . . . . . . . . . . . . . II-9

Issues Surrounding the Implementation of the Proposed

Revision of the CDC Definition of AIDS . . . . . . . . . . . . . . . . . . . . . . 11-15

1. Accuracy of CD4+ Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15

2. Accessibility of CD4+ Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-17

3. AIDS Surveillance Under the New Definition. . . . . . . . . . . . . . . 11-18

a. Concerns About the Accuracy of AIDS Surveillance

Under the New Definition. . . . . . . . . . . . . . . . . . . . . . . . II-20

4. The Impact on Federal Funding Allocations. . . . . . . . . . . . . . . . II-26

a. Title I Funding Allocations Under the

Ryan White Act. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-27

b. Title II and Title III Funding Allocations

Under the Ryan White Act. . . . . . . . . . . . . . . . . . . . . . . . II-29

c. AIDS Housing Opportunity Act of 1990 . . . . . . . . . . . . . . . II-32

Privacy Concerns and the Change in the

Definition of AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-33

6. Name Reporting of AIDS and Confidentiality. . . . . . . . . . . . . . . II-34

a. AIDS Name Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-35

b. Confidentiality of HIV-Related

Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-36

c. Protections Against Discrimination. . . . . . . . . . . . . . . . . II-41

7. The Privacy Implications of Using a CD4+

Lymphocyte Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . II-43

a. Laboratory Reporting of AIDS . . . . . . . . . . . . . . . . . . . . . . . II-43

b. Increased Use of CD4+ Counts and

Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-46

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-51

1. CD4+ Testing as a Surveillance Tool . . . . . . . . . . . . . . . . . . . . . . 11-51

2. The AIDS Case Definition

and Clinical Care. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-53

3. The Costs of Implementing the Proposed AIDS

Case Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-57

v
4. Federal Funding Allocation and the New

Definition of AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-57

5. Privacy Concerns and the New CDC Definition

of AIDS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-59

III. The Use of the CDC Definition of AIDS in Social Security

A.

B.

c.

D.

E.

F.

G.

Disability Determinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-1

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-1

The SSA Disability Program--General Procedures

and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-4

1. Applying for Disability Benefits . . . . . . . . . . . . . . . . . . . . . . . . . III-4

2. The SSA’s Sequential Disability Process . . . . . . . . . . . . . . . . . . III-5

3. Presumptive Disability Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . III-7

The Link Between Social Security Disability

Programs and Medicaid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-8

Disability Determinations and HIV/AIDS . . . . . . . . . . . . . . . . . . . . . . . . . III-9

1. Disability Determinations for Persons

With AIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Disability Determinations for Persons With

HIV Infection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Criticisms of the SSA’s Disability Process . . . . . . . . . . . . . . . . . . . .

1. The SSA Disability Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. Legal Challenges to the SSA’s Disability

Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

a. S.P. v. Sullivan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

b. Rosetti v. Sullivan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. The SSA’s Assessment of Residual Functional

Capacity and Vocational Ability . . . . . . . . . . . . . . . . . . . . . .

a. Procedural Issues and Evaluation of Residual

Functional Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . .

b. Differences Between DDS Determinations and

Administrative Law Judge Decisions . . . . . . . . . . . . .

c. SSA’s Implementation of Federal Court of

Appeals Decisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The SSA’s New Proposed Regulations for HIV

Infection Disability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1. The ‘HIV Infection Listing” . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. General Criticisms of the

‘HIV Infection Listing’’ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. The Functional Limitation Test . . . . . . . . . . . . . . . . . . . . . . . . . .

4. The Impact of the SSA’s New ‘HIV Infection

Listingnon Women. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . .

5. Presumptive Disability and HIV Infection. . . . . . . . . . . . . . . .

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

APPENDIXES

A. Glossary of Acronyms and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

111-10

111-11

111-14

111-15

111-16

111-17

111-19

111-21

III-22

III-23

III-24

III-2 7

III-2 9

111-31

III-34

III-39

111-41

III-43

A-1

B. Evolution of the CDC’s Case Definition of

AIDS (3 tables) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

c. The CDC’s AIDS Case Reporting Form (figure) . . . . . . . . . . . . . . . . . . . . . . . . . C-1

vi
D.

E.

F.

G.

H.

I.

J.

K.

Epidemiology of AIDS in Women, Injection Drug Users,

African Americans, and Hispanics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1

The CDC’s Current and Proposed Classification System for

HIV Infection (2 boxes) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1

HIV Testing and Reporting Requirements in the States

and the District of Columbia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1

Social Security Administration’s Sequential Disability

Determination Process (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-1

Social Security Administration’s Disability

Appeals Process (figure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . H-1

Case Histories From S.P. v. Sullivan Litigation . . . . . . . . . . . . . . . . . . . . . 1-1

The Social Security Administration’s New “HIV Infection

Listing” for Use in Disability Determinations . . . . . . . . . . . . . . . . . J-1

The Social Security Administration’s Presumptive

Disability Form for Physicians. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . K-1

REFERENCES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . R-1

vii
Executive Summary

.

The surveillance case definition for acquired immunodeficiency syndrome

(AIDS) developed by the Centers for Disease Control (CDC) in the U.S.

Department of Health and Human Services (DHHS) is the primary public health

surveillance tool for determining the scope of the AIDS epidemic. The CDC’s

case definition of AIDS in use as of April 1992 was developed in 1987. This

complex case definition specifies 23 AIDS-defining conditions that are

strongly associated with severe immune deficiency caused by the human

immunodeficiency virus (HIV). In addition to being used for surveillance, the

CDC’s case definition of AIDS has been used as a clinical definition by

physicians, in research protocols, in the allocation of Federal funds under

the Ryan White Comprehensive Resources Emergency Act of 1990, and as a measure

of disability in benefit programs administered by the Social Security

Administration within the DHHS.

The CDC’s existing case definition of AIDS has been criticized because

some of the severe manifestations of HIV infection found in women and

injection drug users are not encompassed by the current case definition, and

therefore, the impact of the epidemic in these populations may be

underestimated. This is of particular concern because a disproportionate

number of HIV-infected women and injection drug users are African Americans or

Hispanics.l,2 In particular, several small studies and case reports have

1 These groups are not mutually exclusive. The majority of HIV-infected women

are injection drug users or the sexual partners of injection drug users.

2 Some estimates of the number of HIV-infected persons by race/ethnicity, sex,

and exposure category are extrapolated from the reported number of AIDS cases

in these groups; but other corroborating methods are also used (122).

-I- 1
found that gynecological conditions-- cervical dysplasia, pelvic inflammatory

disease, and recurrent vulvovaginal candidiasis--occur more commonly in HIVinfected women than in other women. There is also evidence that HIV-infected

injection drug users are more likely to have pulmonary tuberculosis,

endocarditis, sepsis, and bacterial pneumonias.

A controversy has also arisen over the use of the CDC surveillance case

definition of AIDS as a disability definition by the Social Security

Administration, a purpose that the case definition was not intended to serve.

The concern was that some HIV-infected women and injection drug users were

being denied disability benefits because their illnesses were not included in

the AIDS case definition.

This OTA background paper is one in a series of papers on issues

relating to HIV and AIDS that OTA has published since 1987, under a general

authority from the OTA’s Technology Assessment Board. This particular paper

was requested by the Subcommittee on Human Resources and Intergovernmental

Relations, House Committee on Government Operations.

OTA was asked to examine the CDC’s 1987 surveillance definition of AIDS

in light of the criticisms discussed above. In the fall of 1991, however, the

CDC proposed to change its AIDS case definition and this paper focuses on

proposed definition. The remainder of this chapter provides a summary of

main findings of this report. Chapter 2 discusses the purpose of the CDC

definition of AIDS and describes how the definition has changed over the

course of the AIDS epidemic. It also examines the proposed change in the

t h e

the

definition of AIDS, including the major criticisms of the proposed definition.

Finally, it examines issues surrounding the implementation of the new

I-2
definition, including its impact on AIDS surveillance, the States, allocation

of Federal resources, and individual privacy rights. Chapter 3 examines the

controversy over the use of the CDC definition in Social Security disability

determinations and recent changes in the Social Security disability process

for HIV-infected persons.

SUMMARY OF THE FINDINGS

In November 1991, the CDC proposed to expand its AIDS case definition.

Under the new definition, a person has AIDS if: 1) he or she has one of the 23

AIDS-defining conditions included in the 1987 definition of AIDS, or 2) he or

she is HIV-positive and his or her CD4+ lymphocyte count is below 200 cells

per cubic millimeter (/mm3

) of blood. The CDC plans to implement the new case

definition in 1992, but has not set a specific date for implementation.

According to the CDC, there are several objectives for these changes in the

case definition of AIDS: to more accurately reflect the number of persons with

severe HIV-related immunosuppression; to simplify the AIDS case reporting

process, in part by making the AIDS case definition consistent with standards

of medical care for HIV-infected persons; and to make possible laboratorybased reporting of AIDS cases, which will help State and local health

departments to more efficiently identify persons who are likely to have AIDS.

Several critics of the CDC’s current case definition of AIDS have argued

that the definition

that commonly occur

are associated with

should be expanded to include HIV-associated conditions

in women and injection drug users because these conditions

profound immunosuppression and poor prognosis. In

addition, critics argue that, unless these conditions are included in the AIDS

case definition, physicians may not consider the possibility of HIV infection

I-3
in patients

for some of

presenting with these conditions, or physicians may fail to look

these HIV-associated conditions in patients that are known to be

HIV infected. Other observers argue that physicians should have a much

broader view of severe manifestations of HIV infection than is appropriate for

inclusion in an AIDS case definition designed for survillance purposes.

The CDC has opposed adding new HIV-related conditions to the AIDS case

definition for several reasons. One is that doing so will add to the

complexity of that definition, and this complexity will present an obstacle to

reporting. The CDC has also opposed adding any infections and cancers to the

AIDS case definition that do not appear to be specific for HIV infection or

whose relationship to HIV infection is not adequately established. The

current CDC AIDS case definition only includes opportunistic infections and

cancers that rarely occur in persons whose immune systems are not compromised.

The CDC believes that a profoundly depressed CD4+ lymphocyte count in an HIVpositive patient is more specific for HIV-induced immunosuppression than are

non-opportunistic infections and cancers. Finally, the CDC believes that the

CD4+ lymphocyte count cutoff is a more objective marker of HIV-induced

immunosuppression than is the diagnosis of certain non-opportunistic

illnesses, such as pelvic inflammatory disease. The CDC also argues that many

of the concerns about the proposed definition would conceptually apply to

alternative approaches to expanding the AIDS case definition, such as adding

more diseases to the list of AIDS-defining conditions.

There is a considerable amount of variability in CD4+ lymphocyte counts,

although the amount of variability is within the range of other commonly used

diagnostic tests. Moreover, the accuracy of CD4+ tests is less important when

interpreting population-based survillance data than for clinical care of

individual patients.

I-4
The Impact of the New CDC Definition on AIDS Surveillance

In the long term, the increased efficiency of laboratory-based reporting

of AIDS cases may enable some State and local health departments to save money

in AIDS surveillance. Health departments, however, will need additional money

to handle the initially larger AIDS case load, to establish new systems to

more efficiently identify cases, and to provide CD4+ lymphocyte testing to

uninsured individuals who cannot afford it. According to the CDC, a typical

CD4+ lymphocyte test costs about $50 plus personnel costs to perform, and the

average charge to the patient is $150.00 per test. The CDC’s appropriations

for 1993 do not provide additional funds for CD4+ lymphocyte testing; however,

the CDC will allow States to use money allocated for HIV testing and

counseling to fund CD4+ lymphocyte testing.

.

In the first years after implementation of the proposed case definition

of AIDS, epidemiologists anticipate that the CDC will lose its ability to

follow trends in the incidence3 of AIDS. Once all prevalent4 cases (i.e.,

those persons who currently have a CD4+ lymphocyte count below 200 cells/mm3

but who do not meet the 1987 AIDS case definition) are reported, the CDC will

regain its ability to monitor the incidence of AIDS. The CDC, however, will

have more difficulty using AIDS case reports to track changes in the incidence

of each of the 23 AIDS-defining conditions included in the 1987 definition of

3 Incidence is defined as the frequency of new occurrences of disease within a

defined time internal.

4 Prevalence is the number of cases of disease present at a particular time

and in relation to the size of the population. A prevalent case of a disease

is a single case that exists at a particular time.

I-5
AIDS because many AIDS cases are likely to be reported on the basis of a

positive HIV antibody test and a low CD4+ lymphocyte count. The CDC may,

however, be able to track these changes by having selected centers report on

the incidence of AIDS-defining conditions as well as on the incidence of AIDS.

Although the proposed definition will increase the number of reported

AIDS cases, the completeness of reporting will be difficult to assess, making

interpretation of trends difficult. HIV-infected individuals with CD4+

lymphocyte counts below 200 cells/mm3 may not be counted as AIDS cases because

they are either symptom free and do not seek health care, or they are

symptomatic but they do not yet know they are infected with HIV. Availability

of CD4+ lymphocyte testing will also influence the accuracy of AIDS

surveillance

of new cases

definition.

● Lack of access to CD4+ lymphocyte testing would blunt the surge

that would otherwise be anticipated under the proposed

In particular, poorer women and injection drug users, who

generally have sporadic access to care, may have less access to CD4+

.

lymphocyte testing. Populations of HIV-infected individuals with better

access to CD4+ lymphocyte testing will have proportionately greater increases

in AIDS cases, and a distortion in the contribution of various risk groups to

the pattern of the epidemic could result.

Estimates of the increase in the number of AIDS cases that will result

from the change in the definition vary among jurisdictions. The CDC estimates

that the proposed expansion in the AIDS case definition will result in a 52

percent increase in the total number of living AIDS cases in the United

States, with an increase in the proportion of AIDS cases reported among women

and injection drug users. Other States estimate that the increase in the

number of prevalent AIDS cases will be in the range from 36 to 135 percent.

I-6
Federal Funding Allocations and the New Definition

The proposed change in the definition of AIDS will affect the

distribution of funds under the Ryan White Comprehensive AIDS Resources

Emergency Act of 1990 (henceforth referred to as the Ryan White Act). Title I

of the Ryan White Act provides Federal money to metropolitan areas for

ambulatory medical and support services for low-income individuals infected

with HIV. In order to receive Title I funding, a metropolitan area must have

at least 2,000 cases of AIDS documented with the CDC (or a per capita

cumulative AIDS incidence rate of 0.0025). With an increase in the number of

AIDS cases under the proposed definition, more cities will become eligible for

funds distributed under Title I. Appropriations under Title I may therefore

need to increase if the current level of funding for each metropolitan area is

to be maintained. In addition, some deserving metropolitan areas may not

receive Title “I funds because they are not adequately prepared to identify

AIDS cases under the new definition.

Title II authorizes the distribution of Federal funds to States and

.

territories for health care and support services for poor HIV-infected

individuals. The funds are distributed among States and territories based on

the number of AIDS cases in each State (or territory) as a proportion of the

number of AIDS cases reported in the entire United States. Although in theory

the proposed change in the CDC’s case definition of AIDS should not

significantly influence the distribution of Title II funds among States (one

would expect the number of AIDS cases in each State to increase by the same

amount), in practice, the distribution of funds may not be proportional to the

actual needs of each State if some States are much better able than others to

identify AIDS cases. Approximately 50 percent of Title I funds are also

I-7
distributed by a similar formula and therefore metropolitan areas that are

better able to identify AIDS cases may receive proportionately more Title I

funds.

Privacy Issues and the New Definition of AIDS

The proposed change in the AIDS case definition raises privacy concerns

because there will be an increased number of persons with AIDS reported by

name to the

departments

to the CDC.

State and local health departments. State and local health

report information on AIDS cases, absent the individuals’ names,

Advocates are concerned that the States may not be adequately

prepared for the increase in reported AIDS cases, and that inadvertent

breaches of confidentiality are more likely to result. Although all States

take measures to protect the confidentiality of the names of AIDS patients,

and to date no unauthorized disclosure has taken place, the risk of

unauthorized disclosure exists. In addition, most State laws authorize

disclosure of an individual’s HIV status to third parties who have, or may

.

have been, exposed to the blood of HIV-infected persons (e.g., health care

workers, emergency care providers, funeral directors, sexual assault victims,

laboratory workers, and even schools). Advocates are concerned that States

may expand the number of situations in which disclosure of an individual’s HIV

status is permissible in order to stem further transmission of the virus.

With the expansion of the AIDS case definition, more HIV-infected persons will

face this potential threat to confidentiality because more HIV-infected

persons will be reported as AIDS cases to the State and local health

departments.

I-8
On the other hand, any expansion of the CDC definition of AIDS would

result in more names being reported to State health departments. In addition,

as more States require name reporting of HIV-infection, more HIV-infected

persons will have their names reported to the State and local health

departments even before they develop AIDS.

With the change in the CDC definition of AIDS, laboratories that perform

CD4+ lymphocyte tests will become involved in AIDS case reporting, and thus

there is an additional point at which confidentiality may be breached. Again,

there is no evidence that laboratories cannot adequately maintain the

confidentiality of CD4+ lymphocyte test results; however, in planning to

implement the new AIDS definition, State and local public health departments

and clinical laboratories should reassess current laws and operational

procedures that protect the confidentiality of CD4+ lymphocyte test results.

Some advocates have suggested that special informed consent and

counseling requirements should accompany CD4+ lymphocyte testing, as is done

for HIV antibody testing, but this counseling need not be of the same nature

.

as the counseling that accompanies HIV tests. In addition, it has been

suggested that anonymous CD4+ lymphocyte testing should be made available so

that people won’t avoid seeking early medical treatment because of concerns

about confidentiality. Nevertheless, people who know they are HIV positive

have an incentive to seek medical treatment that may outweigh their fears

about breach of confidentiality.

I-9
Social Security Disability Determinations and the CDC Definition of AIDS

The public debate over whether the CDC definition of AIDS adequately

includes severe manifestations of HIV infection in injection drug users and

women arose in large part because the Social Security Administration used the

CDC definition of AIDS in evaluating disability under the Social Security

Disability Insurance (DI) program and the Supplemental Security Income (SSI)

program.

SSA regulations set forth a five-step process that is used by the SSA

disability adjudicators to determine disability for SSI or DI. The first two

steps are to determine (1) that the claimant is not working, and (2) that the

claimant has a disabling condition that significantly limits the ability to

work. The third step is to see if the claimant’s condition is included in, or

is equal in severity to, one of the medical conditions included in the SSA’s

“Listing of Impairments;" a list of medical impairments that the SSA has

designated as so severe as to entitle that person to disability benefits. If

.

the claimant’s medical condition meets or equals, in terms of severity, one of

the medical impairments from the “Listing of Impairments,” the claimant is

said to have met a Listing and is awarded disability. Claimants who do not

have a listed impairment must demonstrate that they are unable to perform

their previous job (step 4) or any other job in the national economy (step 5)

(see app. G).

Since 1983, the SSA has treated AIDS, as defined by the CDC, as a

Listing, and persons with CDC-defined AIDS were almost always awarded

disability. Advocates claimed that SSA adjudicators denied disability

benefits to other seriously ill HIV-infected claimants because their HIVassociated conditions were not included in the AIDS case definition. The

1-10
advocates argued that the SSA’s disability adjudicators did not adequately

evaluate the disabling effect of other HIV-associated conditions because they

assumed that only persons with AIDS are disabled. The SSA strongly denied

this was the case and the SSA’s written instructions demonstrate their

policies did not preclude other HIV-infected claimants from being awarded

disability. In addition, their statistics show some HIV-infected persons who

did not have AIDS were awarded disability. Nonetheless, a number of seriously

ill HIV-infected claimants were denied disability and the reasons for these

denials are not clear.

In December, 1991, the SSA published a ruling and proposed regulations

that create a Listing for HIV infection (hereinafter ‘HIV Infection Listing”) .

This new criteria for evaluating disability in persons with HIV infection

changes the focus of the debate. First, the SSA will no longer tie its

disability determinations to the CDC’s definition of AIDS, and therefore the

expansion of the CDC’s definition of AIDS will not enable more HIV-infected

persons to obtain disability. Second, the new disability criteria include a

.

number of HIV-associated conditions that advocates previously claimed the SSA

did not adequately consider in its disability determinations for HIV-infected

women and injection drug users.

The “HIV Infection Listing” incorporates all of the conditions included

in the 1987 CDC definition of AIDS as well as other non-AIDS-defining diseases

and symptoms, including pulmonary tuberculosis, endocarditis, bacterial

pneumonia, bacterial or fungal sepsis, and vulvovaginal candidiasis. However,

the “HIV Infection Listing” also requires that, in combination with many of

these HIV-related conditions, the claimant demonstrate marked functional

limitations in performing activities of daily living and/or work-related

activities.

1-11
The functional limitation test for the “HIV Infection Listing” was

derived from a functional limitation test used by the SSA in evaluating the

severity of mental disorders, and it is unclear whether this functional

limitation test is appropriate for evaluating the medical disabilities of HIVinfected persons. Moreover, a number of advocates have questioned the need to

demonstrate marked functional limitations in two separate areas given that

HIV-infected persons have already demonstrated that they have severe HIVrelated medical conditions. Documenting functional limitations to the degree

required under the new ‘HIV Infection Listing” may be especially difficult for

poor claimants because they often do not have access to a regular physician

who can document the existence of their functional limitations based upon

their treatment history.

It is too early to evaluate what impact the new “HIV Infection Listing”

will have on disability determinations, and the final regulations will not be

issued until the SSA reviews the approximately 3000 comments it has received.

The SSA does not expect the new Listing will result in an increase in the

.

overall number of persons awarded disability, but does believe it will shorten

the time between filing an application for benefits and the receipt of those

benefits. The new “HIV Infection Listing” does, however, separate the debate

over the proper disability definition for HIV-infected persons from the debate

over the AIDS case definition, which is a surveillance definition.

1-12
Chapter II

The CDC AIDS Definition: Implications of the CD4+ Lymphocyte Count

INTRODUCTION

The surveillance case definition of acquired immunodeficiency syndrome

(AIDS) developed by the Centers for Disease Control (CDC) in the U.S.

Department of Health and Human Services (DHHS) is the primary public health

surveillance tool for determining the scope of the AIDS epidemic (8). In all

50 States, the District of Columbia, Puerto Rico, and other territories,

physicians and medical institutions are required to send information on new

AIDS cases, including the names of persons with AIDS, to State or local health

departments. The States then send information about each AIDS case to the

CDC, absent the name of the individual, which is only retained by State or

local health departments (34). The CDC uses this information to monitor

trends in the number and distribution of AIDS cases and in the scope of severe

morbidity due to infection with the AIDS virus, human immunodeficiency virus

(HIV).

The CDC’s case definition of AIDS in use as of April 1992 was developed

in 1987 (208) (see app. B). This complex case definition specifies 23 AIDSdefining conditions, including Pneumocystis carinii pneumonia, Kaposi’s

sarcoma, esophageal candidiasis, toxoplasmosis of the brain, and HIV wasting

syndrome. The AIDS-defining conditions are distinguishable from other HIVassociated illness because they are strongly associated with severe

immunodeficiency, occur frequently in HIV-infected individuals and rarely in

uninfected individuals, and cause serious illness or death. A person who has

II-1
any one of these AIDS-defining conditions and who meets other conditionspecific criteria (e.g. , an age requirement, in some cases a requirement

positive HIV test) is considered to have AIDS.

for a

For some time now, the CDC’s existing case definition of AIDS has been

attacked by advocates and others (1,2,243). One of the criticisms has been

that some of the severe manifestations of HIV

drug users are not encompassed by the current

claim that the 23 AIDS-defining conditions in

are, for the most part, severe manifestations

infection in women and injection

case definition. The critics

the existing case definition

of HIV infection found most

commonly in HIV-infected white men who have sex with men.1 As a consequence,

critics charge, the CDC’s current case definition of AIDS probably leads to

undercounting of AIDS-related morbidity among the growing population of HIVinfected women and injection drug users. This is of particular concern

because most HIV-infected women and injection drug users are African Americans

or Hispanics (223) .2’

3

In November 1991, the CDC proposed to expand the surveillance case

definition of AIDS to include as AIDS cases all HIV-positive persons with CD4+

lymphocyte counts below 200 cells per cubic millimeter (/mm3) of blood,

1 These critics allow, however, that these AIDS-defining conditions are not

limited in occurrence to white men who have sex with men; the AIDS-defining

conditions occur in all groups of HIV-infected persons with late-stage HIV

infection. They argue that in addition to the AIDS-indicator conditions, a

broader spectrum of illness occurs, and the pattern of both AIDS-defining

conditions and these other illnesses varies among different groups.

2 These groups are not mutually exclusive. The majority of HIV-infected women

are injection drug users or the sexual partners of injection drug users (223).

3 Some estimates of the number of HIV-infected persons by race/ethnicity, sex,

and exposure category are extrapolated from the reported number of AIDS cases

in these groups; but other corroborating methods are also used (122).

II-2
regardless of whether they have any AIDS-defining conditions (219).4 The CDC

believes this revised AIDS case definition will more accurately and completely

measure the extent of severe immunosuppression in the HIV-infected population.

Moreover, the CDC believes this proposed revision to the AIDS case definition

will more adequately capture severe HIV-induced immunosuppression in women and

injection drug users than would addition of more HIV-associated conditions to

the definition.

This chapter provides a history of the CDC definition of AIDS and

describes the ways in which the definition has been used. It also examines

the arguments for and against the CDC’s proposed revision of the AIDS

definition, focusing on the impact of the revision on AIDS surveillance and

.

clinical care. Finally, this chapter evaluates the impact of the change in

the definition on Federal funding for AIDS care -and services and the privacy

implications of the change.

THE CASE DEFINITION OF AIDS: PURPOSE, HISTORY, AND PROPOSED CHANGES

In 1982, soon after the first cases of what is now known as AIDS were

identified, the CDC developed a case definition to be used for AIDS

surveillance (201). Based largely on illnesses noted in men who have sex with

men,

5 the AIDS case definition included reliably diagnosed “opportunistic”

diseases that are at least moderately indicative of an underlying defect in

cell-mediated immunity in the absence of known causes of immune defects. The

4 A low CD4+ lymphocyte count in an HIV-infected person is a sign of severe

HIV-related immunodeficiency.

5 Over 90 percent of the first 159 cases that were documented by 1982 were

found in men who had sex with men (119),

II-3
case definition of AIDS was revised in 1985 with the discovery of HIV as the

etiologic agent of AIDS (203). It was revised again in 1987, as clinicians

gained experience with opportunistic diseases associated with the end stages

of HIV infection (208). The 1987 expansion resulted in proportionately more

HIV-infected injection drug users, women, and minorities being diagnosed with

AIDS (156,211).6 As mentioned above, the 1987 definition, which is still in

use, includes 23 AIDS-defining conditions; a person who has any of these 23

conditions and who meets other condition-specific criteria is considered to

have AIDS.

The CDC’s definition of AIDS has been used as a surveillance definition

to monitor trends in the incidence and prevalence of AIDS over time, to

.

characterize persons with end stage HIV disease, to identify risk factors and

modes of transmission, and to predict the future course and impact of the AIDS

epidemic (8). In addition to being used for surveillance, the CDC’s case

definition of AIDS has been used for other purposes. Specifically, it has

.

been used as:

8 a clinical definition by physicians,

■ a definition for research, and

8 a measure of disability in benefits and entitlement programs.

6 A large part of the rationale underlying the 1987 definition was recognition

of the pattern of care and types of illnesses seen in the increasingly diverse

population of persons with HIV-associated conditions, particularly injection

drug users (15). The 1987 definition allowed practitioners to make diagnoses

of some AIDS-defining conditions presumptively (i.e. , on the basis of

clinically observed signs and symptoms) rather than definitively (i.e. , with

confirmation of the diagnosis by a laboratory test). One rationale for

including presumptive diagnoses of certain conditions was to accommodate the

practices of overburdened public hospitals, where the pressures of providing

care to large numbers of patients precluded consistent use of definitive

diagnostic tests. It also accommodated situations where the urgency of the

patient’s critical condition requires presumptive diagnosis and empirical

treatment.

II-4
In addition, AIDS surveillance data have been used to allocate Federal

resources for HIV-related care and services among the States and metropolitan

areas (40,58,185).

Some physicians have used the CDC’s case definition of AIDS as a

clinical definition. It is argued that, particularly for those physicians

with relatively little experience treating patients with symptomatic HIV

infection, the AIDS case definition directs the physician to consider the

possibility of HIV infection in individuals with conditions included in the

AIDS case definition (72). It is not known, however, to what extent the AIDS

case definition guides clinical care (i.e. , whether physicians who treat HIVinfected patients focus only on identifying those manifestations of HIV

infection that are included in the AIDS case definition). It is also not

known to what extent physicians suspect HIV infection in patients who display

HIV-associated conditions that are not included in the AIDS case definition.

For some other diseases, such as Lyme disease or toxic shock syndrome,

clinicians use-a broader definition in clinical practice than is used by the

CDC for surveillance purposes (37).

The CDC’s AIDS case definition has been used as a research definition.

Some researchers have used CDC-defined AIDS as the outcome that is measured.7

In some instances, the use of this outcome is appropriate, such as when a

researcher wishes to measure the occurrence of late-stage HIV infection (68) .

In other instances, the use of other outcomes is appropriate. In one analysis

of data from the Multicenter AIDS Cohort Study (MACS), for example, the

7 Researchers can select outcome variables depending on the clinical

parameters they are measuring (231).

II-5
endpoints included both clinical symptomatology and CD4+ lymphocyte counts

(129) . These endpoints were more appropriate because the current AIDS case

definition does not accommodate the immunological component of the disease.8

The AIDS

Administration

the Ryan White

case definition has been used by the Health Resources Services

(HRSA) of the DHHS in allocating benefits and resources under

Comprehensive AIDS Resources Emergency Act of 1990 (Public Law

101-381). As discussed later in this paper, the distribution of Federal funds

under three of the four titles of this act is tied to the number of reported

AIDS cases in metropolitan areas and the States. Finally, the AIDS case

definition has also been used by the Federal government in determining

eligibility for entitlement programs. Perhaps, most notably, the AIDS case

definition has been used in determining eligibility for Federal disability

programs administered by the

DHHS. Such programs include

program and the Supplemental

Social Security Administration (SSA) within the

the Social Security Disability Insurance (DI)

Security Income (SSI) program.

8 Certain research protocols exclude participants who do not have CDC-defined

AIDS, and critics have argued that this practice may cause underrepresentation

of women and injection drug users in research protocols (13). Furthermore,

some have argued that much of HIV research has focused on AIDS itself--

opportunistic infections and cancers included in the CDC’S current case

definition, as well as on viral replication-- and less emphasis has been placed

on manifestations of HIV infection other than AIDS-defining conditions (100).

It is important to note, however, that several factors other than the CDC’S

definition of AIDS may lead to the exclusion of injection drug users and women

from research protocols (101,114). The failure to include these groups in

clinical research protocols may be more related to lack of access to health

care, and to the concerns of pharmaceutical manufacturers and researchers

about liability with respect to women of reproductive age (116).

II-6
The Proposed AIDS Case Definition

In November of 1991, the CDC announced

case definition (219) . HIV-infected persons

a proposal to expand its AIDS

diagnosed with any one of the 23

AIDS-defining conditions in the 1987 AIDS case definition will continue to be

considered to have AIDS. In addition, the new definition will include all

HIV-positive persons with CD4+ lymphocyte counts below 200 cells/mm3 (see app.

B).9 CD4+ lymphocytes are the primary target cell for HIV, and CD4+

lymphocyte counts are a recognized marker of the progression of HIV-related

immunosuppression. The CDC plans to implement the new case definition in

1992, but has not set a specific date for implementation.

According to the CDC, there are several objectives for this change in

the case definition of AIDS. One objective is to make the AIDS case

definition consistent with standards of medical care for HIV-infected persons

(39,219). Monitoring CD4+ lymphocyte counts in HIV-infected patients has

become a standard of clinical care,l0 and the proposed expansion of the AIDS

case definition is based on this recognized clinical standard.

9 The CDC’S case definition of AIDS allows for the use of the

lymphocytes when the CD4+ lymphocyte count cannot be obtained

infected persons with a CD4+ lymphocyte percent below 14 will

proposedeAIDS case definition.

10 CD4+ lymphocyte counts are used to guide the initiation of

CD4+ percent of

(219). HIVmeet the

antiretroviral

therapy (224) and prophylaxis against Pneumocystls carinii pneumonia (210).

Antiretroviral therapy is currently recommended for all persons with CD4+

lymphocyte counts below 500 cells/mm3 (224), and prophylaxis of Pneumocystis

carinii pneumonia, the most common initial AIDS-defining condition, is

recommended for all persons with CD4+ lymphocyte counts below 200 cells/mm3

(210).

II-7
Another objective of the new AIDS case definition is to simplify the

AIDS reporting process (219). The CDC believes it will be both practical and

simple for physicians to use CD4+ lymphocyte counts in AIDS case reporting

because monitoring CD4+ lymphocyte counts in HIV-infected persons has become

standard clinical care.11

The new AIDS case definition may also make it easier for State and local

health departments to identify persons who are likely to have AIDS but who

have not been reported (56).12 The proposed AIDS definition, by incorporating

a laboratory marker of immune suppression into the definition, makes possible

laboratory based reporting of AIDS cases. Once a laboratory identifies a

patient with a CD4+ count below 200 cells/mm3

, the laboratory can report the

name of the person and the test result to the State or local health

department. The health department can then prompt the physician who ordered

the test to report the patient to the health department if the patient meets

the criteria for an AIDS diagnosis.

Another objective of these changes in the AIDS case definition is to

more accurately record the number of persons with severe HIV-related

immunosuppression (219).13 Numerous conditions other than the 23 included in

11 A simplified AIDS case definition is particularly important as a greater

proportion of AIDS patients is reported from outpatient clinics, which have

had less experience with AIDS case reporting (219).

12 Currently in each State, health departments have identified unreported AIDS

cases through reviews of hospital records, outpatient records, and death

certificates. Each of these mechanisms to “capture” additional AIDS cases

requires a substantial commitment of State health department staff time (56).

13 Epidemiologists’ ability to track trends in HIV infection and AIDS may have

been compromised by recent advances in therapy (60,142). There is evidence

that AIDS-defining conditions have appeared later in the course of HIV

infection because of the use of prophylaxis for l%eumocystis carinii pneumonia

and antiretroviral therapy (234), and the appearance of AIDS-defining

conditions have therefore become a less reliable measure of severe immune

suppression in HIV-infected persons.

II-8
the CDC’s 1987 case definition of AIDS are diagnosed in HIV-infected persons

(15). These conditions, which are also diagnosed in persons with normal

immune function, tend to increase in frequency and severity among persons who

are immunosuppressed. Under the CDC’s proposed definition of AIDS, persons

who are severe HIV-related immunosuppressed, as determined by measurement of

CD4+ lymphocyte counts, will be considered to have AIDS (219).

CDC’s Decision Not to Increase the Number of AIDS-Defining Conditions

As mentioned earlier, the CDC’s 1987 AIDS case definition currently in

use has been criticized by individuals who claim that a significant proportion

of HIV-infected persons have severe manifestations of HIV infection that are

not included in the current AIDS case definition (1,2,243) . Excluded, in

particular, critics argue, are some manifestations of HIV infection that occur

in women and injection drug users. An increasing number of AIDS cases in the

United States are occurring among women

reports that, through February of 1992,

percent of all AIDS cases in the United

and injection drug users. The CDC

injection drug users accounted for 29

States (223). Women accounted for

10.5 percent of AIDS cases reported through February 1992 (223).

Approximately 50 percent of women with AIDS are injection drug users (223) .

(See app. D.) Among men who have sex with men (excluding those who use

injection drugs), the rate of increase in the number of AIDS cases began to

decline in 1987; however, the rate of increase in the number of AIDS cases

associated with injection drug use and heterosexual transmission has continued

to rise. The rate of increase in the number of reported AIDS cases in women

now exceeds that in men (124).

Many illnesses occur more frequently in HIV-infected persons compared to

persons with normal immune function (15). At issue is whether all or some

subset of conditions that are worse or more common in the presence of HIV

II-9
infection should be included in the AIDS case definition. Some observers have

noted that several gynecological conditions--cervical dysplasia

(23,52,74,81,96,103,104, 155,171,180,214,233) , pelvic inflammatory disease

(75,148,155), and chronic and recurrent vulvovaginal candidiasis

(26,27,82,140)--occur more commonly in HIV-infected women than in other women.

Substantial evidence shows that HIV-infected women have an increased incidence

of abnormal pap tests and cervical dysplasia (abnormal cells in the epitheliums

of the cervix, thought to sometimes progress to cervical cancer)

(52,104,133,151,233). There are also several cases where cervical cancer in

HIV-infected women proceeded more rapidly than usual and where HIV-infected

women were diagnosed with advanced disease (103). However, there are only 15

reported cases in the literature of cervical cancer in HIV-infected women

(244).14 Given the

survival time after

not surprising that

long incubation time of cervical cancer and the short

reaching a CD4+ lymphocyte count of 200 cells/mm3

, it is

an epidemic of cervical cancer among HIV-infected women

has not developed or been documented (232). At present, an association

between HIV infection and invasive cervical cancer has not been established

(37,134,214).

Several reports provide evidence that pelvic inflammatory disease in

women immunosuppressed by HIV infection is more likely to be chronic,

recurrent, and more severe than pelvic inflammatory disease in women with

normal immune function (75,148). The studies that have been done involve

limited numbers of patients, and the results may not be applicable to other

populations (114).15

a

14 Also, there has been no increase in cervical cancer rates in States with

the highest prevalence of HIV infection in women (135,214).

15 In addition, the diagnosis of pelvic inflammatory disease is often made

imprecisely to explain pelvic pain or tenderness. This may lead to

overdiagnosis of this condition (15).

II-10-
There is some evidence that vaginal candidiasis (yeast infection of the

vagina) is more common in HIV-infected women than in women without HIV

infection (26,82,140). Although women not infected with HIV frequently

contract vaginal candidiasis, studies suggest that the symptoms are often more

severe in HIV-infected women. Vaginal candidiasis in an HIV-infected woman is

not life-threatening, can occur in women with normal immune function or

moderate degrees of immune dysfunction, and is usually well controlled with

fungicides. In these respects, it differs from esophageal candidiasis, an

AIDS-defining condition, which occurs in profoundly immunocompromised patients

and is associated with a poor prognosis.

These conditions --cervical dysplasia, cervical cancer, pelvic

inflammatory disease, and vaginal candidiasis --occur in women with normal

immune function with and without HIV infection; hence, these conditions are

not specific to HIV infection (114). By contrast, AIDS-defining conditions

rarely occur among those who are not HIV-infected, except among persons who

are severely immunocompromised for other reasons.

Several observers have noted that HIV-infected injection drug users, in

.

addition to having AIDS-defining conditions, are more likely to have certain

manifestations of HIV infection than men who have sex with men or those in

other risk groups (159,160,174,209). In recent years, there has been an

increase in the incidence of certain infections among injection drug users

that has occurred coincident with the increased prevalence of HIV infection

and AIDS (43,158,159,160,174, 209).16 These infections include pulmonary

16 Much of these data, however, were collected prior to implementation of the

1987 expanded AIDS case definition (176). In New York City, the Department of

Health is investigating whether many of the injection drug users who failed to

meet the pre-1987 AIDS case definition would be counted with the 1987 AIDS

case definition (181).

11-11
tuberculosis (33,79,130,131,179,204, 206,207), endocarditis (inflammatory

alterations of lining of the heart cavities) (117), sepsis (the presence in

the blood of pathogenic micro-organisms or their toxins) (105), and bacterial

pneumonias (177). It is argued that this increase in infections among

injection drug users is a consequence of the HIV epidemical’

Pneumonia, sepsis, endocarditis, and pulmonary tuberculosis occur more

commonly in HIV-infected injection drug users than in injection drug users who

are not infected with HIV. Although one would expect these nonopportunistic

illnesses to occur more frequently in immunosuppressed persons and follow a

more severe course, these clinical conditions have a much less specific

relationship to profound immunosuppression caused by HIV infection than do the

23 AIDS-defining clinical conditions listed in the CDC’s 1987 case definition

of AIDS. Pulmonary tuberculosis, bacterial pneumonias, sepsis, and

endocarditis are frequently seen among injection drug users who are not

infected with HIV (67,138,178,230,239) ; hence” it is difficult to evaluate the

extent to which these conditions are related to infection with HIV.

Several critics of the CDC’s current case definition of AIDS have argued

.

that the case definition should be expanded to include HIV-associated

conditions that frequently occur in HIV-infected women and injection drug

users because they are associated with profound immunosuppression and poor

prognosis (175). In addition, they argue that physicians may overlook these

HIV-associated conditions in HIV-infected patients or fail to suspect HIV

infection in high-risk patients who exhibit these HIV-associated conditions

17 Diseases such as bacterial pneumonia and sepsis are not conditions that

occur exclusively in injection drug users, women, African Americans, and

Hispanics. For example, Redd and colleagues documented an increase in

pneumococcal septicemia in San Francisco, where the overwhelming majority of

AIDS cases have occurred in men who have sex with men (137).

11-12
(243). (This latter argument has been made particularly with respect to

gyecologic conditions, which are absent from the current AIDS case definition

(72).) This argument assumes that physicians are informed by the CDC case

definition. A number of observers, however, reject this assumption, arguing

that physicians are educated from medical journals and other sources.18 No

study has examined the extent to which physicians’ diagnostic practices are

influenced by the CDC’s case definition of AIDS. If the problem lies in

physician education, however, then the most direct solution may be changes in

physician education rather than in the CDC’s case definition.

Some observers argue that clinicians should have a much broader view of

severe manifestations of HIV infection than is appropriate for inclusion in an

AIDS case definition designed for surveillance purposes (37,185). For a

surveillance definition intended to monitor trends in the incidence and

prevalence of disease, a limited definition encompassing only severe

manifestations of end-stage HIV infection may be appropriate.19 In contrast,

a clinician needs to identify and treat the broad spectrum of manifestations

of HIV infection, and hence a broad clinical definition is more useful.

The CDC has opposed adding conditions to the AIDS case definition for

several reasons (219). One is that doing so will add to the complexity of

that definition. The 1987 case, definition currently in use has 23 AIDS18 At an OTA workshop, several physicians argued that they were educated by

medical journals and other sources (194). This, however, was not a

representative sample of clinicians because physicians at the workshop were

AIDS experts.

19 One expert notes that the CDC’S HIV classification system (See app. E),

which is being revised in parallel with the AIDS case definition, acknowledges

and accounts for many of the HIV-associated conditions seen in women and

injection drug users, which, although not deemed AIDS-defining, nevertheless

receive recognition as serious HIV-associated illnesses (161). Clinical

staging and social senice disability determinations could more appropriately

be linked to the HIV classification system, and not to the AIDS case

definition itself.

11-13
.

defining conditions, each with its own set of criteria. The CDC argues that

the complexity of the definition presents an obstacle to reporting, especially

since clinical care and reporting have moved from inpatient settings to

ambulatory settings. The CDC points out that there is a broad spectrum of

conditions that can occur with increased frequency and severity in HIVinfected persons, ranging from necrologic manifestations, dermatologic

manifestations, infections, and other organ system conditions (15,134,135).

The CDC and other experts argue that adding such conditions would increase the

complexity of the case definition.

The CDC has also opposed adding any infections and cancers to the AIDS

case definition that do not appear to be specific for HIV infection or whose

relationship to HIV infection is not adequately

believes that a depressed CD4+ lymphocyte count

more specific for HIV-induced immunosuppression

established (217). The CDC

in an HIV-infected patient is

than nonopportunistic

infections and cancers (219). The CDC also believes that the CD4+ lymphocyte

count cutoff is a more objective marker of HIV-induced immunosuppression than

nonopportunistic illnesses.20

20 The CDC argues that the CD4+ lymphocyte count is an objective marker of

immunosqppression, whereas a clinician must use considerable subjective

interpretation in determining whether clinical conditions such as recurrent

vaginal candidiasis or pelvic inflammatory disease are present. Others have

argued that, given the variability of the CD4+ lymphocyte count, its

interpretation is also subjective.

11-14
ISSUES SURROUNDING THE IMPLEMENTATION OF THE PROPOSED REVISION OF THE CDC

DEFINITION OF AIDS

From an epidemiologic perspective, the CD4+ lymphocyte count may appear

to be a better measure of severe HIV-induced immunosuppression than the

presence of nonopportunistic infections or cancers. The accuracy of AIDS

surveillance will largely depend, however, upon the accuracy and accessibility

of the CD4+ testing. As is discussed below, there is substantial variability

in CD4+ testing. This variability, however, may be of more concern in

clinical care than in AIDS surveillance. Accessibility of CD4+ testing will

depend upon the availability of test sites and the affordability of the test.

The new AIDS case definition is expected to increase the number of HIVinfected persons considered to have AIDS. This increase in the number of AIDS

cases will affect allocations of Federal funds and will have implications for

the privacy of the individuals with AIDS whose names will be reported to the

State and local health departments. The following sections discuss these

issues.

Accuracy of CD4+ Testing

There is a considerable amount of variability21 in CD4+ counts, although

the amount of variability seen in flow cytometry is within the range of other

commonly used diagnostic tests (e.g. , serum thyroxine measurements to diagnose

thyroid abnormalities, serum cholesterol measurements to diagnose

hypercholesterolemia, and creatine kinase measurements to diagnose heart

21 The variability of a test refers to the accuracy and reproducibility of a

test (141).

11-15
attack) (76). However, because CD4+ counts require interpretation of results

within a narrow range of values, variability must be more tightly controlled

than with other tests where the diagnostic alternative covers a broad range of

values (152).22

The variability in CD4+ testing means that some HIV-infected

individuals’ CD4+ test results are likely to be higher than their "true"

value, and therefore these immunocompromised individuals will not be counted

as AIDS cases. Conversely, some relatively immunocompetent persons will be

diagnosed with AIDS because their CD4+

test results are lower than the "true"

value. The CDC states that the CD4+ lymphocyte count that should be used for

a diagnosis of AIDS should be the one that the physician considers the most

accurate (219). A physician who suspects that a CD4+ lymphocyte count is not

accurate could validate the reading with a separate determination on a

separate sample (78). The accuracy of CD4+ tests is far less important in

interpreting population-based surveillance data than in clinical care of

individual patients (17,162).23 Confirmatory repeat testing, therefore, is

not required under the new AIDS definition for the identification of cases of

AIDS for surveillance.

22 One cannot compare the analytic variability of different tests without

considering the clinical use of tests and associated diagnostic variability

that can be tolerated. The amount of variability that can be tolerated for a

clinical test, however, depends on the need to distinguish among diagnostic

alternatives. If the diagnostic alternative covers a broad range of values

(e.g., creatine kinase), the amount of analytic variability that can be

tolerated is wide. However, if diagnostic alternatives require interpretation

of results in a narrow range of values, such as with CD4+ lymphocyte counts,

analytic variability must be more tightly controlled (152).

23 Others believe that confirmatory repeat testing is important from an

epidemiological standpoint (77). Populations of individuals who receive CD4+

testing frequently will on average qualify as AIDS cases more rapidly than

populations of individuals who are tested less frequently. Confirmatory

repeat testing makes it less likely an individual who is frequently tested

will qualify as an AIDS case on the basis of one spuriously low CD4+ count.

11-16
Accessibility of CD4+ Testing

States’ capacity to perform CD4+ lymphocyte testing of HIV-positive

patients is related both to the availability of flow cytometry capacity

(equipment and personnel) and to the costs of CD4+ tests. Some critics have

argued that the CDC’s new AIDS case definition should not be implemented until

adequate resources are available to accomplish the CD4+ testing that needs to

be done (99).24

Clinical flow cytometers cost approximately $80,000 to $100,000 each

(123). Most small hospitals and clinics do not have a flow cytometer and

therefore must send a patient’s blood sample to a laboratory with flow

cytometry equipment to obtain the CD4+ percent of lymphocytes. Nearly 1,000

laboratories in the United States have capabilities to perform CD4+ testing

(229). According to a CDC survey, in most of these labs, flow cytometry

capacity exists to perform additional tests. Although the number of flow

cytometers may be sufficient for additional testing, new personnel will

probably need to be trained to run the tests.25

The extent to which flow cytometry can be performed at central

facilities is limited because CD4+ lymphocyte percents are affected by the

storage time and temperature of a blood sample. The CDC recommends running

CD4+ lymphocyte percents within 24 hours after a blood sample is collected,

and recommends rejecting samples that are over 48 hours old (109).

24 Many HIV-infected persons are either uninsured or are receiving Medicaid.

See discussion in Chapter III of this report.

25 In a CDC survey of flow cytometry laboratories, most responded that it

would take 6 to 24 weeks for flow cytometer operators to become proficient at

performing CD4+ testing (229).

11-17
As of early 1992, only six State public health departments currently

have an adequate number of flow cytometers to perform the CD4+ testing of HIVpositive patients that would be required under the CDC’s new case definition

of AIDS (9,28). In many States, however, private and university laboratories

may have sufficient available flow cytometry capacity to handle most or all of

a State’s flow cytometry requirements, and State health departments with

adequate funds could contract with these laboratories to perform CD4+ testing

(152). According to the CDC, a typical CD4+ test costs about $50, plus

personnel costs, to perform, and the average charge to the patient is $150 for

a CD4+ test (108,152).

AIDS Surveillance Under the New Definition

In the long term, the increased efficiency of laboratory-based reporting

of AIDS may enable some State and local public health departments to save.

money in prompting physicians to report AIDS cases (56).26 Health

departments, however, will continue to need money to collect risk factor

information and other information on AIDS cases from physicians. Also, as the

26 Others anticipate that costs will increase over the long term. As one

epidemiologist notes, “In New York City, I believe that exactly the opposite

will occur. Patients with CD4+ counts of less than 200 who are reported by

laboratories will need to be investigated to obtain the bulk of the AIDS case

report information. With the extensive hospital contacts of our present

suneillance system, this will not present a great problem for patients whose

CD4+ tests were requested by hospitals. However, a CD4+ count of less than

200 in patients whose CD4+ tests are requested by private physicians will

necessitate a large number of visits or telephone calls to literally hundreds

of private physicians’ offices that are not currently required” (70).

11-18
change takes place, public health departments may need additional money to

handle the larger AIDS caseload, to establish new systems to more efficiently

identify cases, and to provide CD4+

testing to uninsured individuals who

cannot afford these tests (56).

The CDC has not clarified whether additional monies will be made

available to manage the additional AIDS cases that are identified under its

new case definition. In the past, the CDC has provided States, the District

of Columbia, and U.S. territories with $15 million for AIDS surveillance (15).

Under cooperative agreements with the public health departments in the States,

the District of Columbia, U.S. territories, and six metropolitan areas (New

York, Houston, Los Angeles, Chicago, Philadelphia, and San Francisco), the CDC

.

supports 65 HIV testing and counseling programs (220). The CDC has revised

its agreement with the States to allow them to use some of the $120 million

provided under these agreements to fund CD4+ testing (56).

. .

Some States will be placed in a dilemma over whether to provide

.

additional funds to State public health departments for AIDS surveillance. On

one hand, States will need to expend additional funds to identify a larger

number of AIDS cases. In addition, although the expansion of the AIDS case

definition will not increase the number of persons who need care, the

surveillance system may identify more immunocompromised individuals who are in

need of care. States may need additional funds to

care for the immunocompromised individuals who are

testing. On the other hand, those States that are

provide appropriate medical

identified through CD4+

better able to identify

AIDS cases will get proportionately more Federal funds. The reason is that

Federal funding is divided among States, in part, based on the number of AIDS

cases identified. This point is discussed in more detail below.

11-19
/

Concerns About the Accuracy of AIDS Surveillance Under the New Definition

In the first years after the CDC’s case definition of AIDS is changed in

1992, there

AIDS cases;

individuals

counts, but

definition.

is likely to be a large increase in the reported number of new

this increase will reflect the identification and reporting of

who are diagnosed with AIDS on the

who would not have been considered

After the initial large increase,

basis of their CD4+ lymphocyte

AIDS cases under the 1987

the reporting rate of new AIDS

cases is likely to return to a rate nearer to the rate of previous years (most

of the individuals who are identified as AIDS cases under the new definition

on the basis of their CD4+ lymphocyte counts will eventually develop AIDSdefining conditions; with the development of such conditions, they would have

.

been identified as AIDS cases under the 1987 definition) (32).27

In the first years after implementation of the CDC’s proposed case

definition of AIDS, epidemiologists anticipate that the CDC will lose its

ability to use AIDS case reports to follow trends in the incidence of AIDS

(50).28 The reporting of prevalent cases that meet the criteria for AIDS

under the proposed case definition but do not meet the criteria for AIDS under

the 1987 case definition will obscure changes in the incidence of AIDS. Once

the prevalent cases are reported, however, the CDC will regain its ability to

monitor the incidence of AIDS.

27 As HIV-infected persons are diagnosed with AIDS earlier in the course of

infection, the number of persons living with AIDS will increase with

implementation of the new definition.

28 The CDC could, however, create special studies to count cases meeting the

1987 definition as a subset of all reported cases. The CDC could also monitor

trends in AIDS mortality as a substitute for AIDS incidence during the

transition’period.

11-20
Following the implementation of the proposed case definition of AIDS, it

will be more difficult for epidemiologists to use AIDS case reports to track

changes in the incidence of each of the 23 AIDS-defining conditions that are

included in the 1987 definition of AIDS. The change in the definition will

also make it difficult to compare AIDS surveillance data before and after the

change is implemented. The CDC may possibly be able to monitor trends in the

incidence of AIDS-defining conditions after the case definition is changed by

having selected centers report on the incidence of AIDS-defining conditions as

well as reporting new AIDS cases (182).29

Not all

200 cells/mm3

definition is

of the HIV-infected persons with CD4+ lymphocyte counts below

are likely to be counted as AIDS cases after the new case

put into effect. Severely immunocompromised individuals who are

aware that they are HIV-infected and who receive CD4+ testing will be counted

as AIDS cases. But other HIV-infected individuals with CD4+ counts below 200

cells/mm3 may not be counted because they are either symptom free and do not

seek health care, or because they are symptomatic but their symptoms are not

recognized as HIV-related.

.

Although the proposed definition will increase the number of reported

AIDS cases, the completeness of reporting will be difficult to assess (47,50).

The completeness of reporting under the proposed system will depend on

diagnosis of HIV infection and regular monitoring of CD4+ lymphocyte counts.

In contrast, completeness of reporting can more readily be assessed with the

1987 AIDS case definition. This is because almost all patients who develop an

29 In fiscal year 1991, the CDC awarded funds to five areas to test simplified

methods of AIDS surveillance. In anticipation of implementation of the

revised definition of AIDS; the CDC is planning to shift the focus of this

project to the type of evaluation described here (15).

11-2 1
AIDS-defining condition seek medical care. Once they enter the health care

system, persons with AIDS-defining conditions may be diagnosed and reported as

AIDS cases.30

How many AIDS cases are identified after the new case definition is

implemented will depend to some extent on the availability of CD4+ testing.

Lack of access to CD4+ testing would blunt the surge of new cases that would

otherwise be anticipated under the proposed definition. The size of the surge

in case reports will also be related to the capacity of health departments to

implement new surveillance procedures.

Differences in access to CD4+ testing may make interpretation of trends

difficult (47). Populations of HIV-infected individuals with better access to

CD4+ testing will have proportionately greater increases in AIDS cases, and a

distortion in the contribution of various risk groups to the pattern of the

epidemic could result. Critics of the case definition of AIDS argue that”

injection drug users and the poor are more likely to be diagnosed with AIDS

based on the presence of AIDS-defining conditions rather than on the basis of

low CD4+ counts (243). This is because persons of lower socioeconomic status

and injection drug users have access to emergency rooms and hospitals when

they are acutely ill, but they have much more limited access to outpatient

care (10,25,62,164). Individuals with AIDS-defining conditions are likely to

be diagnosed in an emergency room or when hospitalized. CD4+ testing,

however, is unlikely to be performed in an emergency room because typically

only the emergent problem is addressed. Although CD4+ counts may be obtained

30 Not all diagnosed AIDS cases are reported. This is particularly a problem

when a private practice physician is responsible for reporting because the

physician may be more responsive to the patient’s wishes that his or her

disease not be reported (83). Also, some HIV-infected persons, particularly

injection drug users, seek care late in the course of an AIDS-defining

condition and die before AIDS is diagnosed (175).

II-22
. . —

on a person who is hospitalized, CD4+ testing is not an indication for

hospitalization. Surveillance methods, however, are available to detect and

adjust for this reporting bias (15). Surveillance data may help to identify

inequities in access to HIV diagnosis and treatment (e.g. , by comparing

persons reported because they have a low CD4+ count to those reported because

they have an AIDS-indicator illness). Furthermore, under the current AIDS

definition or any other surveillance system, only those persons having some

interaction with the health care system (either through the emergency room,

clinic, or hospital) will be detected (15).

Several States have attempted to estimate the number of AIDS cases that

will result from the change in the definition, and the estimates vary among

jurisdictions. The variation in estimates may reflect differences in the data

upon which the estimates were calculated, differences in the assumptions used

in the calculations, or both.

The CDC estimates that there will be a 52 percent increase in the total

number of living AIDS cases in the United States if the proposed expanded CDC

.

AIDS case definition is used (218).31 For its estimate, the CDC relied on

data from the Adult/Adolescent Spectrum of HIV Disease Project.32 The project

includes nine centers in the United States: Los Angeles, Denver, Atlanta, New

Orleans, Houston, Dallas, Detroit, San Antonio, and Seattle. The project

31 This estimate is based on the number of persons with CD4+ lymphocyte counts

less than 200 cells/mm3 and the number of prevalent AIDS cases in the

Adult/Adolescent Spectrum of HIV Disease Project. If the number of incident

cases is used (only those AIDS cases diagnosed in a 12-month interval) then

the percent increase from the Adult/Adolescent Spectrum of HIV Disease Project

would be approximately 75 percent (15).

32 The CDC’S Adult/Adolescent Spectrum of HIV Disease Project analyzed data

from 10,342 HIV-infected men and women in nine cities across the United

States. The purpose of the project is to examine the spectrum of disease

associated with HIV infection in men and women (15).

II-23
includes HIV-infected patients from public and private hospitals and

ambulatory care clinics (16). One observer has noted that New York City and

other northeastern cities with large numbers of HIV-infected injection drug

users and other HIV-infected persons with poorer access to care are not

included in these studies; thus conclusions from these studies may not be

generalizable to these parts of the United States (175).

South Carolina is one of two States that currently provides CD4+ tests

to all individuals known by the State to be HIV-positive; extrapolating from

data that have been collected there, one would anticipate that the number of

living AIDS cases in South Carolina will increase by approximately 80 percent

after the definition of AIDS is changed (88) . Estimates of the increase in

the number of living AIDS cases in San Francisco following the implementation

of the new case definition of AIDS range from 92 percent to 135 percent

(31,98,150,163). Estimates of the increase in the number of living AIDS cases

in New York City range from 36 percent to 100 percent (70,181,182). .The Los

Angeles Department of Health Services anticipates an increase in number of

living AIDS cases of approximately one-third (94,118).

As discussed earlier, some people have argued that HIV-infected women

and injection drug users, many of whom are African American or Hispanic, are

less likely than white men who have sex with men to be identified under the

 CDC's proposed case definition of AIDS. It is interesting to note that among

participants in the CDC’s Adult/Adolescent Spectrum of HIV Disease Project,

people from different sexes, races, and risk groups were all about equally

likely to have received CD4+ testing (218). These data have been used by the

CDC to suggest that HIV-infected persons of different sexes, races, and risk

groups who are aware of their HIV status and are able to receive clinical care

are about equally likely to obtain CD4+ lymphocyte counts. These data do not,

II-24
——

however, reveal whether HIV-infected women and injection drug users are as

likely to obtain clinical care as are members of other HIV-infected

populations. These data do suggest, however, that once HIV-infected women and

injection drug users enter clinical care, they receive

frequently as HIV-infected individuals from other risk

Data from the CDC’s Adult/Adolescent Spectrum of

indicate that women and injection

of AIDS cases diagnosed under the

under the 1987 definition (218) .

with AIDS is expected to increase

drug users will make

CD4+ testing as

groups.

HIV Disease Project

up a greater proportion

proposed AIDS case definition than they do

Whereas the total number of persons living

by 52 percent under the new AIDS case

definition, the number of women living with AIDS is expected to increase by 61

percent. Data from the Adult/Adolescent Spectrum of HIV Disease Project also

indicate that there will be a 55 percent increase in number of injection drug

users living with AIDS under the new definition.

The CDC expects the proposed AIDS case definition to capture many of the

profoundly immunosuppressed (with CD4+

women and injection drug users who are

conditions such as cervical dysplasia,

counts less than to 200 cells/mm3)

.

suffering from HIV-associated

pelvic inflammatory disease, chronic or

recurrent vaginal candidiasis, pulmonary tuberculosis, sepsis, endocarditis,

and nonopportunistic bacterial pneumonias. These conditions also occur,

however, in HIV-infected persons who are relatively immunocompetent. The CDC

argues that when these conditions occur in persons with lesser degrees of

immunosuppression (i.e., whose CD4+ lymphocyte counts equal or exceed 200

cells/mm3), they are more likely to be merely coincidental to HIV infection

(15). Therefore, the proposed AIDS case definition will capture those HIVinfected women and injection drug users whose symptoms are most likely to be

related to HIV-induced immunosuppression.

II-2 5
Although some HIV-positive individuals with CD4+ lymphocyte counts below

200 cells/mm3 will not have any symptoms, the probability is high they will

develop symptoms within 12 months (78). Data from the Multicenter AIDS Cohort

Study (MACS) show that one-third of the individuals whose CD4+ lymphocyte

counts fell below 200 cells/mm3 were asymptomatic (129).33 Under the CDC’s

proposed AIDS case definition, asymptomatic individuals with CD4+ counts below

200 cells/mm3 will be diagnosed with AIDS, and some of these individuals may

experience adverse psychological and social consequences (47,50). This is in

contrast to previous definitions, which only included as cases persons who

were diagnosed with AIDS-defining conditions.

The Impact on Federal Funding Allocations

In 1990, Congress passed the Ryan White Comprehensive AIDS Resources

Emergency Act (Public Law

Act). The Ryan White Act

.

year period for education

101-381) (henceforth referred to as the Ryan White

authorized payments of up to $1.1 billion over a 2-

about HIV infection and the prevention and treatment

of HIV infection. Total Ryan White Act funding for 1991 and 1992 was

approximately $500 million, and the President’s 1993 budget requests just over

$306 million in funding for the act (57).

33 The MACS primarily represents middle-class, white men who have sex with

men. For the reasons discussed previously, the proportion of HIV-infected

women and injection drug users who are asymptomatic with CD4+ counts less than

200 cells/mm3 is likely to be lower. Furthermore, persons in this study were

‘asymptomaticn if they did not have AIDS or one of a limited number of

conditions often referred to as AIDS-related complex (which includes fatigue,

fever, weight loss, persistent skin rash, oral hairy leukoplakia, herpes

simplex, and oral thrush) (129). Hence, some persons characterized as

asymptomatic may indeed be experiencing some HIV-related symptoms.

II-26
The Ryan White Act allocates funds under four separate titles, and for

three of the titles, the numbers of reported AIDS cases are used in formulas

for allocating funds among States and cities.34 The change in the number of

AIDS cases will only affect the allocation of funds under Titles I and II of

the Ryan White Act, since Title III, Subpart 1, of the Ryan White Act is not

currently funded. Moreover, the change will not affect funding allocations

until 1994, because Ryan White funding is based upon the number of AIDS cases

reported to the CDC as of March 31 in the year (or two years) prior to the

fiscal year for funding.

The AIDS Housing Opportunity Act of 1990 (P.L. 101-625) also distributes

funds based in part on the number of cases of CDC-defined AIDS. The act

authorizes the U.S. Department of Housing and Urban Development (HUD) to

distribute grants to cities and States for housing low-income persons infected

with HIV. The grants are to be allocated among cities and States based on the

number of AIDS cases; however, no funds have been distributed to date.

Title I Funding Allocations Under the Ryan White Act

Under Title I of the Ryan White Act, the Health Resources and Services

Administration (HRSA) provides funds to metropolitan areas for ambulatory

medical and support services for low-income individuals with HIV infection.

In order to be eligible for Title I funding, a metropolitan area must have at

least 2,000 cases of AIDS reported to the CDC by March 31 of the year prior to

the year in which funding is appropriated, or a per capita cumulative AIDS

incidence rate of 25 per 10,000 (0.0025) or greater (42 U.S.C. § 300ff-13).

34 Title IV authorizes funds for research to explore the impact and costeffectiveness of AIDS care. Funds are to be distributed on a grant basis.

However, to date, no funds have been authorized under this title (57).

II-27
Half of Title I funds are divided among eligible metropolitan areas

based on the ratio of the number of AIDS cases in each metropolitan area to

the total number of AIDS cases in all eligible metropolitan areas. The other

half of Title I funds are distributed to metropolitan areas that demonstrate

to HRSA, among other things, that they have severe need for funds and they are

able to use these funds immediately and in a cost-effective manner (42 U.S.C.

§ 300ff-13).

In 1992, 18 metropolitan areas shared $121.8 million in Title I funds

(196). In 1993, HRSA estimates that 24 metropolitan areas will qualify for

Title I funds.35 HRSA has estimated that by 1994 (the first year in which the

new AIDS case definition will have an impact on the allocation of Ryan White

Act funds), between 32 and 41 metropolitan areas may qualify for Title I funds

(20).

before

of new

Because the new AIDS definition will include some people up to 2 years

their first serious opportunistic infection, the increase in the number

AIDS cases that accompanies the change in the definition may not

directly translate into a dramatic increase in health care needs. However,

all HIV-infected persons with CD4+ counts of 200 cells/mm3 or less will need

both antiretroviral therapy and pneumocystis prophylaxis. In addition, most

of these persons with AIDS will require more comprehensive services within a

year or less, which is approximately when the funding will actually be

distributed to the cities. Because a larger number of metropolitan areas will

be eligible for Title I funds

money appropriated to Title I

maintain the current level of

area.

under the proposed definition, the amount of

will need to substantially increase by 1994 to

funds that is provided to each metropolitan

35 This estimate is based on the predicted number of AIDS cases that will be

reported to the CDC as of March 31, 1992, prior to the proposed change in the

CDC AIDS case definition (57).

II-28
Fifty percent of the funds

formula grant that provides each

based on the ratio of the number

under Title I are distributed through a

metropolitan area with a proportion of funds

of AIDS cases in the metropolitan area (and

the per capita incidence of AIDS) to the total number of AIDS cases in all

eligible metropolitan areas (and total per capita incidence of AIDS). Some

cities may be less able than others to identify AIDS cases because, for

example, they have a

access to ambulatory

disproportionate number of HIV-infected persons with no

services, or because the local health department may not

have adequate funds to carry out a comprehensive AIDS surveillance program

(19). These cities may receive proportionately less Ryan White funds than

other cities that are better prepared to document the number of AIDS cases.36

.

Title II and Title III Funding Allocations Under the Ryan White Act

Title II of the Ryan White Act provides States and territories with

Federal funds for health care and support services for poor HIV-infected

individuals and their families (42 U.S.C. §§ 300ff-22 to 300ff-41). Each

State and territory receives a proportion of these funds that is equivalent to

the proportion of AIDS cases in the United States that were reported from that

State or territory in the 2 years prior to the fiscal funding year. For

example, if a State reported 10 percent of all AIDS cases in the Nation in

those years, it would receive approximately 10 percent of the funds allocated

under Title II, subject to adjustments and supplemental grants.

36 Only 50 percent of Title I funds are distributed by a formula that uses the

percentage of AIDS cases. The availability of supplemental grants may limit

the impact on Title I funding of disproportionate resources among metropolitan

areas for AIDS surveillance.

II-29
The Ryan White Act authorized $275 million under Title II for 1991 and

1992, but Congress only appropriated $87.8 million for Title II in 1991 and

$108 million in 1992 (57). Title II funds are divided over 57 States and

territories, and in 1991 the majority of the funds was distributed as follows:

New York and California (approximately $13 million each); Florida ($7

million); Puerto Rico ($5 million); Texas and New Jersey (approximately $4

million each); Georgia, Illinois and Pennsylvania (approximately $2 million

each); District of Columbia, Louisiana, Maryland, Massachusetts, Michigan,

Missouri, North Carolina, Ohio and Washington (approximately $1 million each);

and Alabama, Colorado, Connecticut, Indiana, Mississippi, Oregon, South

Carolina, and Tennessee (between $500,000 and 800,000 each) (197). The

President’s proposed budget for 1993 would maintain

million (57).

Because the amount of funds distributed under

allocated on the basis of percentage of AIDS cases,

.

of AIDS that increases the absolute numbers of AIDS

Title II funding at $108

Title II of Ryan White is

a change in the definition

cases will not affect the

allocation of funds unless the change results in disproportionate increases in

the numbers of cases identified in certain areas. A disproportionate increase

could occur because: 1) some States have HIV name reporting and a few even

have records of CD4+ counts on HIV-infected persons, and may be better able to

target AIDS surveillance; 2) States with a large number of AIDS cases may not

be able to carry out detailed case investigations required for reporting; 3)

States may have a disproportionate number of HIV-infected persons who have

limited access to ambulatory care and CD4+ testing; and 4) Some States may

have a disproportionate number of HIV-infected persons who are profoundly

immunosuppressed but who do not have one of the AID-defining conditions

11-30
included in the current case definition (19). In sum, States that have

difficulty carrying out AIDS surveillance may receive less funds than

deserved.

Title III of the Ryan White Act provides money for early intervention

services, including HIV antibody testing and counseling, and other clinical

and diagnostic services, such as CD4+ testing. Under Subpart I of Title III,

CDC is authorized to distribute

Columbia, and Puerto Rico using

under Title 1l--i.e. , funds are

grants to each State, the District of

a formula that is similar to the formula used

distributed among States in proportion to the

number of AIDS cases in each State in relation to the total number of AIDS

cases in all States.

No money is currently being distributed under Subpart I of Title III

because Title III requires a

testing activities and would

appropriations (63,195). As

program continues to be

Service Act, which does

services (61). The CDC

substantial expansion of CDC’s counseling and

therefore require a substantial increase in

a result, the CDC’s counseling and testing

carried out

not mandate

distributes

under the authority of Public Health

funding of clinical and diagnostic

funds for counseling and testing to the

States and certain cities on the basis of need,

adhere to a formula that is based on the number

(61,220).

but the CDC does not strictly

of AIDS cases in each State

Title III, Subpart II, of the Ryan White Act, which is administered by

HRSA, provides specific grants to public and nonprofit entities, such as

migrant health centers and family planning centers, to be used for the same

type of early intervention services specified for Subpart I. The funds are

not distributed by a formula and therefore the change in the CDC definition of

AIDS will not affect the allocation of funds under this title.

11-31
AIDS Housing Opportunity Act of 1990

The AIDS Housing Opportunity Act of 1990 (P.L. 101-625) is designed to

provide housing for low income persons with AIDS. Ninety percent of the funds

are designated for: 1) metropolitan areas with populations in excess of

500,000 and which have over 1500 AIDS cases; and 2) States with more than

1,500 cases of AIDS outside of these metropolitan areas (42 U.S.C. §

12903(c)(1)). Metropolitan areas and States can be awarded grants only if

they submit a housing strategy that is approved by HUD. Grants will be

allocated among eligible metropolitan areas and States in proportion to the

number of AIDS cases in each metropolitan area or State. The minimum grant to

eligible areas will be $200,000 (42 U.S.C. § 12903(c)(2)).

Currently, approximately 27 metropolitan areas and 12 States are

eligible for grants based on the

through December 1991 (64,222).

regulations that will govern the

number of AIDS cases reported to the CDC

Because HUD has not yet promulgated

grant application process, it is not known

how many metropolitan areas and States will apply for grants. HUD recently

announced it will publish regulations in June 1992, thereby allowing for

disbursement of the $50 million appropriated under this act by late summer of

1992 (5).

II-32
PRIVACY CONCERNS AND THE CHANGE IN THE DEFINITION OF AIDS

The proposed change in the CDC’s case definition of AIDS

concerns about the confidentiality of CD4+ test results and the

has raised

privacy of

persons with AIDS. Because more HIV-infected persons will be diagnosed with

AIDS under the proposed definition, an increased number of men and women will

be reported by name as AIDS cases to State and local health departments. For

persons with AIDS, name reporting raises serious privacy concerns. HIV

infection has predominately affected men who have sex with men, injection drug

users, and the sexual partners of members of these risk groups. Widespread

societal condemnation of these risk behaviors, coupled with irrational fears

of transmission (53,84,107), has led to discrimination against, and social

ostracization of, persons with AIDS or HIV infection (4,120,193).

The States protect the confidentiality of information gathered through

AIDS surveillance activities; however, the States also authorize disclosure of

an individual’s HIV status to third parties when necessary to stem the spread

of the virus (45). Although these exceptions to the confidentiality of HIVrelated information are limited, any unauthorized disclosure may be

threatening to an HIV-infected individual. There are State and Federal laws

that protect HIV-infected persons from discrimination, but these laws are

effective only to the extent that they are enforced and they mainly redress

wrongful discrimination only after it has occurred.

The incorporation of the CD4+ lymphocyte count into the CDC definition

of AIDS will enable States to involve private and public clinical laboratories

in AIDS case reporting. In addition, the debate over the change in the AIDS

case definition has led to increased attention on the confidentiality of CD4+

II-33
lymphocyte test results. Although most State laws afford greater protections

to the confidentiality of HIV antibody test results than other medical

records, the States are split on whether this heightened confidentiality

applies to other HIV-related information, such as the results of CD4+

lymphocyte tests. At issue is whether CD4+ lymphocyte test results should be

afforded the same confidentiality protections as HIV antibody test results and

whether the requirement for specific informed consent that applies to HIV

antibody testing should also apply to CD4+ lymphocyte testing.

Name Reporting of AIDS and Confidentiality

The proposed change in the CDC’s case definition of AIDS will increase

the number of AIDS cases reported in each State and hence increase the number

of names kept on the States’ AIDS registries. It is important to note,

however, that any expansion of the CDC definition, not just that which has

been proposed, would result in more names being reported as AIDS cases to the

State and local health departments. In addition, a number of States already

require name reporting of all HIV-infected individuals to the State and local

health departments (see app. H). In these States, the health departments are

already responsible for protecting the confidentiality of all HIV-infected

persons’ names in their registries.

The CDC and the State and local health departments insist that name

reporting of AIDS cases is essential to ensure the accuracy of surveillance.

Some advocates for people with AIDS are concerned that States may not be

adequately prepared to handle the surge of AIDS cases that will be reported

upon implementation of the proposed definition, and they fear that breaches of

confidentiality will be more likely to occur. They are also concerned about

II-34
the increase in the number of HIV-infected persons that are reported as AIDS

cases to the States because they believe that States have become increasingly

willing to allow the disclosure of a person’s HIV status to third parties in

order to stem further spread of infection with HIV. The following sections

examine this debate.

AIDS Name Reporting

In all 50 States, the District of Columbia, Puerto Rico, and other

territories, information on every confirmed AIDS case, including the name of

the person with AIDS, is sent to the State or local health department. This

AIDS case information, absent the person’s name, is shared with the CDC for

purposes of AIDS surveillance using a CDC form called the “Acquired

Immunodeficiency Syndrome (AIDS) Adult Confidential Case Report” (see app. C)

(34).37

The CDC insists that name reporting of AIDS cases is necessary to

identify and remove duplicate reports from multiple sites, to collect followup data as necessary, and to assess completeness of reporting (15) .38

Underreporting or overreporting may distort information about the pattern of

the AIDS epidemic and bias interpretation of trends in the epidemic (186).

For example, epidemiologists may make incorrect inferences about patterns of

transmission, the relative contribution of various risk groups to the

37 Names of persons with AIDS are not reported to the CDC; rather each case is

identified by a Soundex code.

38 In lieu of names being reported to State health departments, Soundex codes

or other systems could be used. Without name repotting, however, duplicate

reports cannot be eliminated because more than one person may have the same

Soundex code (32).

II-35
epidemic, and the effects of treatment. With anonymous reporting,

epidemiologists could not go back to the source for additional information,39

perform survival analysis, or perform special studies on the data (32).

About one-half of the States require that the names of all persons

infected with HIV be reported to the State or local health department (see

app. H); however, information on the number of HIV-infected persons identified

by the States is not yet being used by the CDC for surveillance purposes.

Moreover, because most of these States permit persons to be tested anonymously

for HIV (119), a substantial percentage of HIV-infected persons is not

reported to State health departments. Nonetheless, in those States that

require name reporting of persons with HIV infection, confidentiality is a

concern to HIV-infected persons regardless of whether they have CDC-defined

AIDS.

.

Confidentiality of HIV-Related Information

.

The States have a legal

information that is collected

takes measures to protect the

duty to protect the confidentiality of medical

in disease surveillance (238) and every State

confidentiality of the names of persons in its

AIDS case registry (45). In some States, laws governing the

of reports of sexually transmitted and communicable diseases

case reports.40 A number of States also has confidentiality

confidentiality

apply to AIDS

laws that

specifically apply to AIDS and HIV-related information (45,97). According to

39 For example, approximately 10 percent of reported AIDS cases in New York do

not list risk factors with the AIDS case report (32).

40 See, e.g., WYO. STAT. ss 35-4-130, 35-4-132 (1991); OR. REV. S~AT. s

3701.24(C) (1989)); N.D. CENT. CODE s 23-07-02.2 (%PP. 1991); NEV. REV. STAT.

S 441A.220 (SUPP. 1989); MASS. GEN. LAWS ANN. ch. 1llD, s 6 (West 1991,

Supp.); DEL. CODE ANN. tit. 16, ss 3702, 3711 (1991).

II-36
one informed commentator, State and local health departments have an excellent

record of protecting the confidentiality of reported cases (239). Indeed, OTA

has found no reports of inadvertent disclosure of AIDS- or HIV-related

information from State or local health departments.

Despite the fact that the States protect the confidentiality of HIVrelated information, a number of States also authorize limited disclosure of a

person’s HIV status to third parties if necessary to protect them from being

infected with HIV or to inform them that they may have been exposed to HIV.

These disclosure laws are very controversial because they involve serious

compromises of HIV-infected persons’ privacy rights

instances the disclosure protects against seemingly

benefits of the disclosure are questionable (45).

and yet in a number of

small risks and the

Most State HIV and AIDS confidentiality statutes have a general

statement that all protected information must be kept confidential and the

statutes enumerate specific exceptions to that confidentiality. The types of

persons to whom HIV test results and other HIV-related information can be

disclosed often include the following: 1) another party pursuant to an

.

authorized release by the person who was subject to an HIV antibody test, or

whose medical records contain HIV-related information; 2) the public health

department or Federal officials as required by law, or in order to protect

public health; 3) the sexual and needle-sharing partners of an HIV-infected

individua141; 4) for statistical purposes if the data is disclosed without

identifiers; 5) third-party payers, as authorized; 6) facilities that use,

process, or distribute human tissues and organs; 7) committees and other

parties authorized to conduct oversight and quality reviews

41 This type of disclosure usually requires the cooperation

infected individual (183).

of health care

of the HIV11-37
facilities; 8) health care workers who may have been exposed to HIV; 9)

firefighters, emergency medical workers, and police who may have been exposed;

10) agencies involved in providing foster care services; and 11) schools.

HIV-related information can also be disclosed in other situations as required

by law (45,65). The laws and regulations that allow such disclosure vary from

State to State.42

Many State statutes also allow third parties to petition a court for

permission to obtain information about whether a

HIV.43 Some statutes, however, limit the court’s

related information to situations in which there

evidence” of a “compelling need,” or in cases in

that the public interest outweighs the potential

person is infected with

authority to reveal HIVis “clear and convincing

which the court determines

harm due to the breach of the

42 See, e.g., ARIZ. REV. STAT. ANN. s 366-664 (!hpp. 1991); COLO. REV. STAT. s

25-4-1404 (1991); CONN. GEN. STAT. ANN. s 19a-503 (1990); FLA. STAT. ANN. s

381.004 (West 1990, Supp.); HAW. REV. STAT. s 325-101 (SUpp. 1990); ILL. ANN.

STAT. ch. 111 1/2, para. 7309 (Smith-Hurd 1990, Supp.); KAN. STAT. ANN. s 65-

6002 (SUpp. 1990); ME. REV. STAT. ANN. tit. 6-7, s 19203-D (1991); MICH. COMP.

LAWS ANN. s 333.5131 (West 1991, Supp.); N.D. CENT. CODE, ss 23-07.1-02.1, 23-

07.3-02 (SUpp. 1991); N.J. STAT. ANN. ss 26C:5C-6 - 26:5C-14 (West 1991,

SUpp.); N.Y. PUB. HEALTH LAW s 2782 (McKinney 1992, Supp.); 1989 N.M. Laws

Chap. 227, House Bill 490; OHIO REV. CODE ANN.s- 3701.243 (Anderson 1990,

Supp.); OR. REV. STAT. s 443.045 (1989); R.I. GEN. LAWS, S 23-6-17 (SUpp.

1991); VA. CODE ANN. S 32.1-36.1 (SUpp. 1991); WASH. REV. CODE ANN. S

70.24.105 (SUpp. 1991).

43 See, e.g., CONN. GEN. STAT. s 19a-583 (1990); GA. CODE ANN. s 24-9-47(r)

(SUpp. 1991); HAW. REV. STAT. S 325-101 (Supp. 1990); ILL. ANN. STAT. ch. 111

1/2, para. 7309 (Smith-Hurd 1990, Supp.); MICH. COMP. LAWS ANN. s 333.5131

(West 1991, Supp.); N.J. STAT. ANN. s 26:5C-9 (West 1991, Supp.); N.Y. PUB.

HEALTH LAW s 2785 (McKinney 1992, Supp.); OHIO REV. CODE ANN. s 3701.243

(Anderson 1990, Supp.); PA. STAT. ANN. tit. 35, s 37608 (Purdon 1991, Supp.);

VA. CODE ANN. SS 32.1-36.1 (SUPP. 1985).

II-38
HIV-infected individual’s privacy.44 However, these standards do not

guarantee that courts will make reasonable decisions based on objective

evidence of risk (4).

Most State statutes give public health departments the discretion to

disclose HIV-related information when necessary to protect public health (45).

The U. S. Supreme Court has ruled that States have “broad latitude in

experimenting with possible solutions to problems of vital local concern,”

even when the solution involves disclosure of confidential medical information

that could “reflect unfavorably on the character of the patient” (238).45

Therefore, this exception potentially allows for disclosure in a number of

different situations.

While some people may not object to current State laws that permit

disclosure, there is the possibility that, in the future, State laws may be

changed to allow for broader exceptions to the confidentiality of HIV-related

information. In 1991, for example, the Illinois legislature passed a statute

.

that requires the Illinois department of health to inform patients that they

may have been exposed to HIV when they have been subject to an invasive

44 See, e.g., CONN. GEN. STAT. s 19a-583 (1990)(compelling need); GA. CODE

ANN. s 24-9-47 (Supp. 1991) (clear and convincing evidence); ME. REV. STAT.

ANN. tit. 6-7, s 19203-D (1991)(good cause); MICH. COMP. LAWS ANN. s 333.5131

(West 1991, Supp.) (publjc need outweighs potential injury); N.J. STAT. ANN.

ss 26C:5C-8, 26:5C-9 (West 1991, Supp.)(good cause); N.Y. PUB. HEALTH LAW s

2785 (McKinney 1992, Supp.)(compelling need; clear and imminent danger); OHIO

REV. CODE ANN. s 3701.243 (Anderson 1990, Supp.)(clear and convincing evidence

of compelling need) ; PA. STAT. ANN. tit. 35, s 7608 (Purdon 1991,

Supp.)(compelling need).

45 In Whalen, the Court upheld a New York State law that required pharmacists

to provide the New York Public Health Department with copies of all

prescriptions of Schedule 11 drugs, including cocaine, opium, methadone,

amphetamines, and methaqualone. These drugs are often used illegally and the

New York legislature hoped to use the name reporting system to prevent the use

of stolen or revised prescriptions, over-prescribing by physicians, repeated

refills by pharmacists, and to prevent drug users from obtaining multiple

prescriptions from different sources.

II-39
procedure in which an HIV-infected health care worker participated.46

Conversely, health care workers who have performed invasive procedures on HIVinfected patients must be told that they may have been exposed to HIV (Ill.

Ann. Stat. ch. 111 1/2, para. 7405.5 (Lexis 1991)). The health department is

authorized to review medical records to determine who is at risk. The statute

provides, however, that all records relating to these investigations shall be

confidential. In addition, the health department must inform persons who are

notified that they may have been exposed to HIV that the Illinois AIDS

Confidentiality Act prohibits them from further disclosing this HIV-related

information, and that willful and malicious disclosure is a Class A

misdemeanor (Ill. Ann. Stat. ch. 111 1/2, para. 7405.5 (Lexis 1991))0

Despite these protections, and despite the fact that disclosure is only

required if there is a risk of transmission, the statute is seen as setting a

dangerous precedent by many advocates because it requires disclosure in

circumstances where the risk of HIV transmission is considered very small

(194). If aggressively implemented, the Illinois law could result in many

patients being told that their physician, dentist, podiatrist, or nurse is

infected with HIV, or it could result in medical workers being told that

they’ve been put at risk of HIV infection by their patients. Even if the

Illinois Department of Health does not reveal the name of the HIV-infected

health care worker, the patient may be able to identify the health care worker

or make assumptions about who put them at risk, and this will probably damage

46 The act states that it will use the CDC’S list of invasive procedures. The

CDC planned to develop a list of invasive procedures to be used to prevent HIV

transmission from health care workers to patients. Strong opposition to the

development of such a list, however, led the CDC to suspend its drafting of

this list (3).

11-40
these health care workers’ reputations and careers. (It is likely to be more

difficult for health care workers to determine which of their patients may

have exposed them to HIV if HIV-infected patients’ names are not revealed.)

Protections Against Discrimination

If there are breaches in confidentiality, there are laws to protect a

HIV-infected person from discrimination. The most important Federal law that

protects HIV-infected persons from discrimination is the recently enacted

Americans With Disabilities Act of 1990 (ADA)(P.L. 101-336), a comprehensive

statute that prohibits many types of discrimination against persons with

disabilities, including all persons infected with HIV.47 In short, the ADA

prohibits discrimination against the disabled by both public and private

employers,

by private

respect to

discrimination by State and local governments, and discrimination

entities that operate public accommodations and services. With

public accommodations, HIV-infected persons and other disabled

persons must be afforded the opportunity for ‘full and equal enjoyment of

goods, services, facilities, privileges, advantages, or accommodations” in any

place of public accommodation- -e.g. , hotels, restaurants, theaters,

auditoriums, laundromats, museums, parks, ZOOS, private schools, day care

centers, professional offices of health care providers, and gymnasiums (42

U.S.C. § 12181(7), § 12182(a) (89). The ADA therefore insures that irrational

fears will not prevent HIV-infected individuals from using public and private

services and accommodations, including health care services (89).

47 The statute itself does not explicitly state that HIV-infected individuals

are disabled. In the legislative history of the act, however, Congress stated

that persons infected with HIV would be considered disabled and therefore

subject to the full protections of the act (125).

11-41
In addition to the protections provided by the ADA, virtually every

State has laws that protect the disabled from various types of discrimination,

and in at least 34 States, legal opinions or pronouncements of State Attorneys

General have indicated that infection with HIV is a protected disability (65).

Many of these State laws also prohibit housing discrimination, which is of

particular concern to persons infected with HIV (66).48

Ironically, HIV-infected persons and persons with AIDS are routinely

discriminated against in obtaining health insurance. In every State, an

insurance company may refuse to provide an individual insurance policy to a

person who is HIV positive, and in many States, an insurance company can

request an HIV test prior to issuing an individual policy or a small group

policy (51,54,149). It is estimated that 20 percent of people with private

insurance have individual policies (51).49 The ADA does not prohibit

insurance companies from discriminating among insureds on the basis of risk.

(42 U.S.C. § 12201(c))(89).

The importance of the issue of discrimination against HIV-infected

.

persons is demonstrated by the large amount of attention paid to this issue by

legislatures and courts. Anti-discrimination laws, however, can provide

redress only after the wrong has occurred and the damage is done. Even then,

wrongs can be redressed only if persons who have been discriminated against

48 The Federal Fair Housing Amendments of 1988 also prohibit private owners

and landlords from discriminating against persons with disabilities--including

HIV-infected persons- -in the sale or rental of housing (Public Law 100-430).

49 Even those persons who obtain insurance through their employer may not be

safe from discrimination. Employers who self-insure their employees may be

able to place a cap on medical benefits for treatment of AIDS. In a recent

case, a record company lowered the maximum payable amount for AIDS-related

claims from $1 million to $5000.00 shortly after it found out that one of its

employees had AIDS. No limitations were placed on any other catastrophic

medical coverage (110)

II-42
are willing and able to enforce their rights. Several factors may make HIVinfected persons less likely to sue. Perhaps most obviously, HIV-infected

persons who are ill may not be able to endure the stresses of a lawsuit. Many

HIV-infected persons who have suffered from discrimination may lack the

financial resources to seek legal relief, and some may not even know that

there are legal remedies available to them. In addition, HIV-infected persons

who have been wrongfully discriminated against may not want to spend their

remaining years fighting in court (236). Finally, anti-discrimination laws

cannot prevent the more subtle forms of discrimination by colleagues and

acquaintances that may have a substantial negative psychological impact on

HIV-infected individuals. Therefore, for most persons infected with HIV, the

best protection against wrongful discrimination is to limit disclosure of HIVrelated information.

The Privacy Implications of Using a CD4+ Lymphocyte Count

The use of the CD4+ lymphocyte count in AIDS surveillance raises new

issues about the involvement of public and private laboratories in case

reporting. In addition, given the implications of a low CD4+ lymphocyte

count, there is a debate over the appropriate counseling that should accompany

CD4+ testing and over the confidentiality protections that should apply to

CD4+ test results.

Laboratory Reporting of AIDS

With the implementation of the proposed definition of AIDS, many States

plan to require that laboratories report the names of all persons who have a

CD4+ lymphocyte count below 200 cells/mm3 to the State or local health

II-43
department. The State or local health department can then prompt physicians

to report these patients as AIDS cases if they have a positive HIV test result

or an AIDS-defining condition. (14,86,88,182). Advocates for HIV-infected

persons believe that States, in an effort to ensure completeness of AIDS case

reporting, may fail to enact laws and policies that adequately protect the

confidentiality of these laboratory data.

.

These concerns, however, are theoretical, and there are reasons to

conclude the laboratories will not be the weak link in the chain of

confidentiality. First, laboratories are already responsible for protecting

the confidentiality of all laboratory test results, including CD4+ test

results, and there is no indication that they do not have adequate procedures

in place to protect the results of CD4+ tests from wrongful disclosure. In

addition, clinical laboratories are subject to State laws and regulations

governing confidentiality of medical records, and these laws and regulations

usually permit laboratories to disclose test results only to the State or

local departments of health or to the physicians who ordered the test.

(38,102,242)(see e.g. ARIZ. REV. STAT.ANN. § 36-470 (Supp. 1990); CAL. [BUS. &

PROF.] CODE § 1288 (West Supp. 1991); D.C. CODE ANN. § 32-1511 (Supp. 1991);

N.J. STAT. ANN. § 45:9-42-34 (West 1990); OR. REV. STAT. s 438.310 (1989)).

If a laboratory employee breaches confidentiality, it is not unusual for him

or her to be discharged (28,38). Laboratories are also governed by State HIV

confidentiality laws and a number of these laws extend their protections to

all information that may indicate that a person is infected with HIV or has

II-44
AIDS, including CD4+ lymphocyte counts.50 In addition, CD4+ test results that

are reported to the State or local health departments are subject to State

laws regarding the confidentiality of reportable information for communicable

or sexually transmitted diseases.51

One could argue that, although laws are necessary to protect the

confidentiality of HIV-related information, they may not be sufficient;

institutional procedures are probably more important in protecting against

wrongful disclosures. Most laboratories have policies to protect against

breaches of confidentiality (36,184). It may, however, be necessary to

reevaluate security measures for CD4+ test results. The Association of State

and Territorial Laboratory Directors has recommended that CD4+ test results be

.

treated with the same degree of confidentiality as HIV antibody test results

(38).

One way to ensure that the confidentiality of all HIV-related laboratory

.

information is adequately protected is to require laboratories to codify

security procedures in writing (184). Some State legislatures have enacted

laws that require health care facilities to do this. In Maine, for example,

health care providers with patient records that contain information about

50 GWU, IHPP, “Confidentiality/Laboratories, State Laws Regarding

Confidentiality,” (December 1991); ARIZ. REV. STAT. ANN. s 36-664 (Supp.

1990); COLO. REV. STAT. s 25-4-1404(3) (1991); CONN. GEN. STAT. ANN. s 19a-583

(West 1990); GA. CODE ANN. s 24-9-47 (Supp. 1991); HAW. REV. STAT. s 325-101

(!hlpp. 1990); KAN. STAT. ANN. s 56-6002(c) (SUpp. 1990); MICH. COMP. LAWS ANN.

s 333.5129 (Supp. 1991); N.J. STAT. ANN. s 26:5C-6 (West 1991, Supp.); N.Y.

PUB. HEALTH LAW s 2782 (McKinney 1992, Supp.); OHIO REV. CODE ANN. s 3701.243

(Anderson 1990, Supp.); PA. STAT. ANN. tit. 35, ss 7603, 7607 (Purdon 1991,

Supp.); WASH. REV. CODE ANN. s 70.24.105 (Supp. 1991)).

51 In order to ensure utmost confidentiality for CD4+ lymphocyte counts,

however, the State departmefit of health or Attorney General could issue an

opinion that CD4+ test results are covered by the State’s AIDS confidentiality

statutes or fall within the confidentiality provisions of their communicable

disease laws.

II-45
patients’ HIV status must have a written policy regarding the confidentiality

of patient information that is consistent with the Maine HIV

statute. These written policies

employment for violations of the

19203-D (West 1991)). A similar

handle HIV-related information.

must require, at a minimum,

confidentiality policy (ME.

confidentiality

termination of

REV. STAT. ANN. §

statute could apply to laboratories that

A final issue that is raised by laboratory-based reporting of CD4+

lymphocyte counts is that some persons who are not infected with HIV will be

reported to State health departments as suspected AIDS cases. This is because

certain other viral infections, as well as some bacterial infections and

hematological malignancies, may lower a person’s CD4+ lymphocyte count (123).

.

If laboratories report the names of all persons with CD4+ counts below 200

cells/mm3 to State health departments as suspected AIDS cases, a number of

persons who are not infected with HIV may be reported.52

. .

A reporting

immunosuppression

lymphocyte counts

lymphocyte subset

requirement that would be more specific for HIV-induced

would be to report only the names of persons whose CD4+

are below 200 cells/mm3, but whose counts of other Tare normal or elevated. HIV infection differs from most

other medical conditions that depress T-lymphocyte counts because HIV

selectively attacks the CD4+ subset of T-lymphocytes (106).

Increased Use of CD4+ Counts and Confidentiality

In addition to the confidentiality of CD4+ test results held by clinical

laboratories, there is also concern about the confidentiality of CD4+ test

results generally. Several advocates have argued that the laws that protect

52 The Maryland legislature is considering reporting all CD4+ lymphocyte

counts below 500 cells/mm3 (22). This could result in a large amount of

private medical information being unnecessarily reported to the health

department.

II-46
the confidentiality of HIV-test results should be extended to protect the

confidentiality of CD4+ test results. A number of State HIV confidentiality

laws already protect all information that may indicate that a person is

infected with HIV or has AIDS, and these laws should therefore apply to CD4+

test results. 53 These States have recognized that there is no distinction

between the stigma attached to the disclosure of a positive HIV test and the

stigma attached to the disclosure of any other information that may show that

a person is infected with HIV. States whose HIV confidentiality statutes

apply only to HIV antibody test results may need to consider broadening the

scope of these statutes to also include CD4+ lymphocyte test results. It is

important to note, however, that even in those States that do not have laws

specifically aimed at protecting the confidentiality of CD4+ test results,

these results are protected under State laws governing the privacy of medical

records generally. Laws governing the confidentiality of medical records,

however, may not provide as complete a protection of confidentiality as laws

that specifically protect the confidentiality of HIV-related information.

(127,245)

.

53 In Georgia, for example, confidential AIDS information includes all

information that discloses that a person: 1) has an AIDS diagnosis; 2) has

been treated for AIDS; 3) has been determined to be infected with HIV; 4) has

submitted to an HIV test; 5) has had a positive or negative result from an HIV

test; 6) has sought or received counseling regarding AIDS; or 7) has been

determined to be at risk for HIV infection (GA. CODE ANN. s 31-22-9.1 (Supp.

1991)); see also ARIZ. REV. STAT. ANN. ss 36-661, 36-664 (SUpp. 1991); COLO.

REV. STAT. s 25-4-1402 (1991); CONN. GEN. STAT. s 19a-581 (1990); HAW. REV.

STAT. s 325-101 (SUpp. 1990); KAN. STAT. ANN. s 65-6002, (Supp. 1990)(protects

information indicating that a person is suffering from AIDS); MICH. COMP. LAWS

ANN. s 333.5131 (Supp. 1991)(protects records, reports, data, tests, etc.,

associated with a diagnosis of AIDS, HIV infection, or HIV-related illnesses) ;

N.J. STAT. ANN. s 26C:5C-7 (West 1991, Supp.); N.Y. PUB. HEALTH LAW s 2780

(McKinney 1992, Supp.); N.D. CENT. CODE, s 23-07-02.2 (Supp. 1991) (protects

records on HIV status, AIDS, HIV-related illness reported to States); OHIO

REV. CODE ANN. s 3701.243 (Anderson 1990, Supp.); PA. CONS. STAT. ANN. s 7603

(Purdon 1991); WASH. REV. CODE ANN. s 70,24,105 (Supp. 1992) (protects any

information relating to diagnosis or treatment of HIV infection) .

II-47
One argument against extending special confidentiality protections to

all diagnostic tests that may be indicative of AIDS or HIV infection is that

such protections may unduly complicate the practice of medicine. CD4+

lymphocyte counts are also used to monitor diseases other than HIV infection.

The interference of these confidentiality laws with clinical practice should

be limited, however, because most of these laws allow for free exchange of

information among health care providers and their agents involved in treatment

and care of HIV-infected persons.

Many State laws governing HIV testing also require special counseling

and informed consent (65), and the question arises whether CD4+ testing should

also be subject to these requirements. Counseling and informed consent for

HIV antibody tests are required in order to: 1) educate the person about the

HIV virus, the HIV antibody test, and risk behaviors that can lead to

transmission of the virus; and 2) prepare person psychologically for the

results of the HIV test (53).

It is standard medical practice to” perform an HIV antibody test prior to

a CD4+ test; thus most persons whose CD4+ lymphocyte counts are measured will

have already received counseling about HIV infection. There may, however, be

additional psychological implications of being told one has AIDS. Itisnot

clear that this psychological impact warrants imposing mandatory pre- and

post-test counseling and written consent requirements for CD4+ testing. Such

requirements could greatly hinder the provision of medical services,

especially in busy inner-city public clinics (182). As for any clinical test,

physicians that order CD4+ lymphocyte counts should inform their patients

about the purpose and implications of the test. It is not clear, however,

whether physicians should have to obtain specific consent for CD4+ testing as

they do for HIV testing (194).

II-48
Advocates for persons with HIV infection, however, are concerned that

CD4+ lymphocyte counts will be used as a proxy for HIV antibody tests in order

to avoid the cost and time involved in providing pre- and post-HIV test

counseling. The extent to which CD4+ tests are used as a proxy for such HIV

antibody tests is not known, although OTA has been told that it does

occasionally happen in hospital settings (41). The potential use of CD4+

lymphocyte

definition

such tests

counts in this manner is present regardless of whether the CDC

of AIDS is changed. Physicians who are in the position to order

are already aware of the connection between a low CD4+ lymphocyte

count and HIV infection. Moreover, a low CD4+ lymphocyte count is not a very

good proxy for HIV infection because other viral infections as well as certain

bacterial infections and hematological malignancies may lower the CD4+

lymphocyte count (123).

Another debate is over whether HIV-infected persons should be able to

have a CD4+ test performed anonymously. Unlike other clinical tests, HIV

antibody tests are often provided anonymously. Anonymous HIV antibody tests

are offered to encourage persons without symptoms to find out about their HIV

status. There is an assumption that persons may avoid obtaining HIV tests if

they fear that others may learn that they are infected or that they sought

testing (53). In addition, as discussed earlier, a person known to be HIV

positive may have a difficult time in obtaining individual health insurance.

It has been suggested that anonymous CD4+ tests should be made available for

similar reasons, especially since, under the proposed AIDS case definition,

persons with CD4+ lymphocyte counts below 200 cells/mm3 may have their names

reported to State health departments.

It is not clear, however, whether people who know that they are HIV

positive will avoid CD4+ testing and medical treatment because of concerns

about confidentiality. While the guarantee of anonymity may induce some

II-49
people to find out whether they are infected with HIV, once they know they are

HIV positive, they have a greater incentive to seek health care, including

CD4+ testing, and this may outweigh their concerns about confidentiality.

Anonymous testing gives HIV-infected persons more control over who has

knowledge of their infection, which may be very important because HIV-infected

persons have been subject to irrational discrimination. OTA has found one

medical clinic, the NO/AIDS Task Force located

started to offer anonymous CD4+ testing.54 The

claims that many of the clients--which include

in New Orleans, which recently

clinic’s medical director

men who have sex with men, a

few African American and Hispanic male injection drug users, and a number of

women who were tested for HIV at sexually transmitted disease and family

planning clinics --place a high priority on confidentiality (90). The fact

that the CD4+ test is free, however, may also have been an important reason

that these clients sought testing at the clinic.

Anonymous CD4+ testing also presents several problems, the primary one

being that, in the event that medical care is necessary, it is not possible to

.

contact an individual who fails to return for their test results. Anonymous

testing may therefore hinder programs designed to bring people into care and

it may not be a cost-effective use of the limited resources for care of HIVinfected persons. ●

54 The clinic opened in August of 1991. The CD4+ tests are done by a State

lab free of charge and by a private laboratory which charges $40 per test

(90).

11-50
SUMMARY

CD4+ Testing as a Surveillance Tool

The proposed incorporation of the CD4+ lymphocyte count in the CDC case

definition of AIDS will have several advantages for surveillance. The CD4+

lymphocyte count provides a more objective guide to AIDS diagnosis55; HIVinfected persons with CD4+ lymphocyte counts below 200 cells/mm3 will have

AIDS. The CD4+ lymphocyte count also has the advantage of simplicity; HIVpositive patients may be diagnosed with AIDS on the basis of a single

laboratory value. AIDS surveillance data will better reflect the extent of

severe immune suppression due to HIV infection in the population.

The incorporation of CD4+ lymphocyte counts in the AIDS case definition

may also increase the cooperation of physicians in AIDS case reporting, as

regular CD4+ lymphocyte testing is already a part of the clinical management

of HIV-infected patients. (The CD4+ lymphocyte count has been correlated with

.

the appearance of opportunistic illnesses and is used by physicians to guide

initiation of antiretroviral therapy and pneumocystis prophylaxis.) The

cooperation of physicians in AIDS case reporting is also likely to be enhanced

because use of a single test will simplify AIDS diagnosis and reporting.

Finally, it seems likely that AIDS reporting will be facilitated through

laboratory-based reporting of cases identified through CD4+ testing; hence,

States may expend fewer resources in making sure that AIDS cases are reported.

55 The CDC argues that a diagnosis based on a laboratory value is less prone

to subjective interpretation than diagnoses based on the presence of clinical

conditions (219). Given the variability inherent in CD4+ lymphocyte testing,

however, diagnoses based on the CD4+ lymphocyte count will also involve some

degree of subjective interpretation.

11-51
Despite its advantages, however, the CD4+ lymphocyte count is not a

perfect AIDS surveillance tool. Individuals can only be diagnosed with AIDS

through CD4+ lymphocyte counts if they have access to health care and if their

physician knows or suspects HIV infection. Because many persons with AIDS

under the proposed definition will be without symptoms, the completeness of

reporting will be difficult to assess. Furthermore, population groups with

less access to CD4+ testing will be underrepresented among identified cases of

AIDS, and the interpretation of trends in the epidemic among major risk groups

may therefore be subject to substantial bias. Those persons with less access

to health care or who receive only discontinuous or emergency health care are

unlikely to be diagnosed until they become ill with one of the AIDS-defining

conditions. In particular, HIV-infected women and injection drug users, most

of whom are African American or Hispanic, are on average poorer than members

of other AIDS risk groups; members of these poorer groups may have less access

to CD4+ lymphocyte testing and may be underrepresented in AIDS surveillance.56

Differences in access to CD4+ lymphocyte counts could lead to a

.

distortion of the trends in AIDS cases reported to the CDC. Once the proposed

case definition of AIDS is implemented, the CDC should investigate instances

where there appears to be substantial bias in AIDS case reporting that might

be attributable to a lack of access to HIV testing and CD4+ testing and adjust

for this bias when interpreting trends in the epidemic. The CDC, the National

Institute of Allergy and Infectious Diseases, and other Federal agencies

should continue to study the spectrum of disease associated with HIV

infection, and improve our understanding in the differences in manifestations

of HIV infection in injection drug users and women.

56 The poor are more likely to use public clinics, however, and a greater

proportion of AIDS cases are reported that are identified in public clinics

than are identified in private clinics (186).

II-52
Once the new case definition of AIDS is implemented, epidemiologists

will lose their ability to use AIDS case reports to track trends in specific

AIDS-defining conditions. Special epidemiologic studies will be necessary to

track these trends. Epidemiologists may also have substantial difficulty

linking data collected under the new case definition of AIDS with data

collected under the existing case definition.

The CDC argues that many of the concerns about the proposed definition

would conceptually apply to alternative approaches to expanding the AIDS case

definition, such as adding more diseases to the list of AIDS-defining

conditions. In particular, the CDC argues that any expansion of the

surveillance definition will complicate the ability to monitor trends in AIDS

and in specific AIDS-defining conditions.57 Lack of access to care will

hamper surveillance under any definition, not just one that includes CD4+

testing. The need for CD4+ testing is not changed by the proposed definition,

because CD4+ counts are also. used to guide clinical care of HIV-infected

patients.

The AIDS Case Definition and Clinical Care

The CDC’s proposed case definition of AIDS is not an ideal clinical

definition, although the CDC did not intend it to be. There is mounting

evidence that there is a broad spectrum of illnesses whose incidence or

clinical course is affected by HIV-induced immune suppression. Although the

proposed AIDS case definition captures a greater percentage of HIV-infected

persons with profound immunosuppression, there are a number of serious HIV57 This effect was seen after the 1987 revision, which complicated trend

analyses (211).

II-53
associated illnesses that are not among the 23 AIDS-defining conditions and

which may occur in persons with CD4+ lymphocyte counts that exceed 200

cells/mm3. The HIV classification system, however, can be used by clinicians

and includes a broad range of HIV-associated conditions.

Some experts have argued that we need two definitions of AIDS: a

surveillance definition and a clinical definition. For epidemiologic

purposes, it is useful to retain a definition that is highly specific for

severe manifestations of HIV infection. A clinical definition may be less

specific for HIV infection and more sensitive for symptoms that may be related

to HIV infection. For example, one may look for manifestations of HIV

infection in persons with pneumococcal pneumonia or Hemophilus influenzae

pneumonia. These pneumonias are not specific for HIV infection, but more

people with HIV-induced immune dysfunction will be captured (37). There are

other diseases, such as Lyme disease and toxic shock syndrome, where the

clinical definition is broader than the CDC, case definition (37). By

maintaining these important distinctions between surveillance instruments and

clinical classification schemes, the various goals -- i.e. , consistent

II-54
epidemiologic monitoring and surveillance, along with appropriate clinical and

social service intervention for serious and disabling illnesses -- could be

sened.58

The new CDC definition of AIDS was developed primarily for surveillance

needs. Therefore, clinicians should be made aware of the broad spectrum of

HIV infection, including manifestations of HIV infection in women, injection

drug users, African Americans, and Hispanics. There is growing evidence that

there are a number of HIV-associated conditions in injection drug users and

women that are not included in the AIDS case definition. Physicians’

awareness of the relationship of HIV infection to some of these conditions,

such as pulmonary tuberculosis and cervical dysplasia, is particularly

.

important because early intervention may have an impact on outcome. These

HIV-associated conditions are less- useful markers for AIDS surveillance

because they are not specific for HIV infection. The CDC’s case definition of

AIDS was designed for surveillance, and should not be expected to substitute

.

58 One expert notes that the competing agendas may be satisfied by linking

clinical staging and social senice disability determinations to the HIV

classification system, and not just to the AIDS case definition itself (161).

The CDC HIV classification system, which will be revised in parallel with the

AIDS case definition, does acknowledge and account for many of the HIVassociated conditions seen in women and injection drug users. (For a

description of the current and revised HIV classification systems, see app.

F.) Although these HIV-associated conditions seen in women and injection drug .

users are not deemed AIDS-defining, they nevertheless receive recognition in

the HIV-classification system as serious HIV-associated illness. Others

argue, however, that we need a single definition of AIDS as a common

vocabulary (231). One expert believes that all three goals can be

accommodated with one definition. He suggests revising the AIDS case

reporting form to place those AIDS-defining conditions which virtually always

occur at less than 200 CD4+ cells/mm3 in a sublist placed after the shorter

list of conditions that can occur at greater than or equal to 200 CD4+

cells/mm3. The majority of patients would be diagnosed with AIDS either on

the basis of CD4+ lymphocyte criteria or the short list of conditions that

occur at higher counts, and physicians would only rarely have to refer to the

longer list of AIDS-defining conditions that virtually always occur in persons

with CD4+ lymphocyte counts less than 200 CD4+ cells/mm3.

II-55
for proper physician education as to what screening tests should be done in

HIV-infected persons. If

direct solution may be in

The CD4+ lymphocyte

the problem is in physician education, the most

physician education.

count is not an ideal clinical marker because it is

highly variable and not well

variability is not important

standardized. Although the high degree of

when one is measuring the extent of severe

immunosuppression in a population, on an individual basis, an accurate

assessment of the CD4+ lymphocyte count is important because it is used to

guide therapy. Therefore, a physician should validate the CD4+ lymphocyte

count by repeating the test if the initial count appears to be inaccurate,

such as when a patient has a sudden large drop in CD4+ lymphocyte count.

On an individual basis, a number of HIV-positive individuals with CD4+

lymphocyte -counts below 200 cells/mm3 will not have any symptoms, although the

probability that they will develop symptoms within a year is high. Data from

the Multicenter AIDS Cohort Study (MACS) show that one-third of the

.

individuals whose CD4+ lymphocyte counts fell below 200 cells/mm3 were

asymptomatic (129).59 Under the CDC’s proposed AIDS case definition,

asymptomatic HIV-positive individuals with CD4+ counts below 200 cells/mm3

will be diagnosed with AIDS, and some of these individuals are likely to

experience adverse psychological consequences as a result of this diagnosis.

59 MACS participants are primarily middle-class, white men who have sex with

men. For the reasons discussed previously, the proportion of HIV-infected

women and injection drug users who are asymptomatic with CD4+ lymphocyte

counts less than 200 cells/mm3 is likely to be lower than that for HIVinfected white men who have sex with men. Furthermore, persons in this study

were “symptomatic” if they did not have AIDS or one of a limited number of

conditions often referred to as AIDS-related complex (which includes fatigue,

fever, weight loss, persistent skin rash, oral hairy leukoplakia, herpes

simplex, and oral thrush). Hence, some persons characterized as asymptomatic

in this study may have been experiencing some HIV-related symptoms.

II-56
The Costs of Implementing the Proposed AIDS Case Definition

Each State will be responsible for implementing the CDC definition of

AIDS. State health departments may need additional resources to implement the

new definition, including money to establish flow cytometry facilities where

necessary, to set up new systems to efficiently identify cases through

laboratory-based reporting, and to handle the initial dramatic increase in

caseloads. States may also need additional resources to provide adequate

access to C D4

+ testing.

who in the past have had

relationship and receive

Outreach programs are needed to ensure that persons

little access to medical care can enter into a care

CD4+ testing.

States may invest in increasing the access of the medically underserved

to CD4+ lymphocyte testing. One benefit of increased access

is that more asymptomatic HIV-infected individuals with low

counts will be alerted to the need for medical treatment.60

to CD4+ testing

CD4+ lymphocyte

States may need

additional funds to provide access to medical care for the profoundly

immunosuppressed individuals who are identified through such surveillance.

Federal Funding Allocations and the New Definition of AIDS

The proposed CDC definition of AIDS may still be appropriate to use in

allocating Ryan White funds because AIDS surveillance data, if accurate, will

reflect the health care needs in each State. Some States, however, may be

60 This does not necessarily mean that clinicians provide the same type of

pre- and post-test counseling to persons obtaining a CD4+ lymphocyte count

that is required for persons who are tested for HIV antibody. Clinicians

should provide patients with an explanation of diagnostic and therapeutic

implications of the CD4+ lymphocyte count.

II-57
less able than others to document AIDS cases because they may be unable to

offer CD4+ testing to HIV-infected individuals who cannot this test.

Physicians may also fail to cooperate with AIDS case reporting, or the State

department of health may be overwhelmed

reported and may be unable to carry out

by the number of AIDS cases that are

the detailed case investigations that

are necessary.

Under the

areas will have

funds under the

increase if the

current levels.

of AIDS and the

proposed AIDS case definition, a larger number of metropolitan

the threshold number of cases necessary to qualify for Title I

Ryan White Act. Appropriations for Title I will need to

funding for each metropolitan area is to be maintained at

In theory, the proposed change in the CDC’s case definition

expected increase in the total number of AIDS cases should not

significantly influence the distribution of funds among States and

metropolitan areas under Titles I or II of the Ryan White Act, since they are

distributed according to the proportion of AIDS cases, rather than absolute

numbers of AIDS cases in each State. In practice, however, the distribution

of funds may not be proportional to the’ actual needs of each State or

metropolitan area if some States and cities are not as capable as others in

implementing the new AIDS case definition.

The Office of Technology Assessment (OTA) has not determined whether the

current Ryan White Act funding is meeting the States’ needs. The President’s

Commission on AIDS, however, has repeatedly urged the President to recommend

that the Ryan White Act be funded up to its full level (73,120). In addition,

it is unfortunate that Title III, Subpart I, which authorized money for

diagnostic tests for management of HIV infection, such as CD4+ lymphocyte

counts, is not currently being funded.

II-58
As of April 1992, no money under the AIDS Housing Opportunity Act of

1990 had been distributed. Money will be distributed among eligible areas in

proportion to the number of AIDS cases that are reported in each area.

Therefore, allocations under this act may also be affected by the ability of

the States and cities to document AIDS cases under the new definition.

Privacy Concerns and the New CDC Definition of AIDS

With the proposed expansion of the AIDS case definition, HIV-infected

persons will be reported to the State and

the course of their infections, and there

local health departments earlier in

consequently will be a greater

number of names held in the AIDS registries of State and local health

departments. Thus, there will be a greater number of HIV-infected individuals

who will risk having their names disclosed to third parties whom the State

decides need to know this information. On the other hand, in States that

require name reporting of all HIV-infected persons, those individuals known by

the State to be HIV-infected will have their names placed in an HIV registry

regardless of whether the CDC definition of AIDS is expanded. In addition,

any substantial expansion of the case definition would lead to large increases

● in case reports.

The States have an incentive to document as many of their AIDS cases as

possible in order to obtain a larger share of Federal funds under the Ryan

White Act. This goal should not overshadow the privacy concerns of the

individuals whose names are being collected. States will have a

responsibility to ensure that, in pursuing the goal of conducting

comprehensive AIDS surveillance, the privacy rights of persons with AIDS are

protected. In making plans to implement the new AIDS case definition, States

II-59
should reassess current laws and operational procedures that protect the names

of HIV-infected persons. In particular, States should consider whether HIV

confidentiality laws should be extended to protect the confidentiality of all

information that may indicate that a person is infected with HIV, including

the results of CD4+ lymphocyte counts.

State or local health departments may in the future expand the number of

situations where the disclosure of the names of persons with AIDS is permitted

in. order to protect the public health. Some commentators see a disturbing

trend toward expanding the instances where such disclosure is permitted. They

believe the privacy rights of HIV-infected individuals are being unduly

compromised in order to protect against small risks of transmission. Because

more HIV-infected individuals will be reported to State and local health

departments under the proposed AIDS case definition, more HIV-infected

individuals will be subject to this potential disclosure risk. It is

important to note, however, that any expansion of the CDC definition of AIDS,

not just that which has been proposed, would result in more names of HIVinfected persons being reported to State and local health departments.

Under the proposed definition, States may enlist flow cytometry

laboratories in identifying suspected AIDS cases. The enlistment of clinical

laboratories in AIDS case reporting has highlighted concerns about the

confidentiality of the results of CD4+ testing. A number of State HIV

confidentiality laws also extend to other HIV-related information, including

CD4+ lymphocyte counts. In addition, laboratories are subject to State laws

governing the confidentiality of medical records generally. Laws protecting

the confidentiality of HIV-related information may not be enough; laboratories

should consider developing written policies to guard the confidentiality of

CD4+ test results. It is important to note, however, that to date, flow

11-60
cytometry laboratories have protected the results of CD4+ tests and there is

no indication that they will not continue to keep this information

confidential.

States should evaluate the privacy implications of having flow cytometry

laboratories send the names of all persons with depressed CD4+ lymphocyte

counts to State or local health departments, because a number of diseases

other than HIV infection can also depress CD4+ lymphocyte counts. In

Maryland, the State legislature is considering a bill that requires that

laboratories report the names of all persons with CD4+ lymphocyte counts below

500 cells/mm3 to the State health department. If this bill is enacted,

laboratories would send the names of a large number of persons who are not

HIV-infected to the Maryland Department of Health for investigation. If a

State decides to implement laboratory reporting of CD4+ lymphocyte test

results, a preferable alternative would be to have laboratories send to the

.

State only the names of persons who have a depression of the CD4+ subset of Tlymphocytes and normal or elevated levels of other T-lymphocyte subsets. This

is because the selective depression of the CD4+ subset of T-lymphocytes is a

more specific indicator of HIV-induced immunosuppression.

There are strong arguments for treating CD4+ lymphocyte counts, along

with other HIV-related information, with the same degree of confidentiality as

HIV test results; however the arguments for requiring special informed consent

or permitting anonymous testing are more compelling for HIV testing than they

are for CD4+ testing. Persons who know they are HIV positive have additional

incentives to obtain medical care and CD4+ tests, and therefore it may not be

essential to offer anonymous testing to bring these HIV-infected persons into

e

the health care system.

11-61
Chapter III

The Use of the CDC Definition of AIDS in Social Security Disability

Determinations

INTRODUCTION

The controversy over the Centers for Disease Control (CDC) definition of

acquired immune deficiency syndrome (AIDS) did not primarily arise among

epidemiologists and public health professionals concerned about proper

tracking of the AIDS epidemical The issue was brought to the public’s

attention by AIDS activists and lawyers who represent HIV-infected women and

injection drug users. These advocates were seeking to obtain access to

Federal disability and medical insurance programs because their clients were

no longer able to work. In particular, they

and medical care under

■ the Social

m the Social

the following Federal

Security Supplemental

were seeking financial assistance

programs:

.

Security Income (SSI) program;

Security Disability Insurance (DI) program; and

8 the Medicaid program.

SSI and DI are administered at the Federal level by the Social Security

Administration (SSA) in the U.S. Department of Health and Human Services

(DHHS) . Medicaid is administered at the Federal level by the Health Care

Financing Administration in the DHHS.

1 The CDC has been exploring ways to simplify its definition of AIDS since

1989; however, this is not what sparked the public debate (16).

III-1
The SSI and DI programs are Federal entitlement programs designed to

provide income support for persons who are aged, disabled, or blind.

Individuals under 65 years of age are eligible for SSI or DI only if they are

blind or disabled. In almost all States and the District of Columbia,

qualification for SSI benefits, and to a lesser extent qualification for DI

benefits, provides an individual with the opportunity to receive health

insurance under Medicaid, which is a Federal/State jointly financed health

care program for low-income individuals who are aged, blind, or disabled,

members of families with dependent children, and certain other pregnant women

and children (189).

The SSA began using the CDC definition of AIDS in evaluating disability

under its DI and SSI programs in 1983, although it did not issue a ruling

acknowledging its use until 1984. The SSA’s initial decision to use the CDC

definition in disability determinations for HIV-infected individuals was not

objectionable. The agency’s continued reliance on the CDC definition and its

failure to develop specific disability criteria for other HIV-infected persons

.

who were seriously ill but did not have AIDS brought the SSA under

considerable criticism from AIDS activists, disability attorneys, and certain

members of Congress (113,147).

AIDS activists and legal service attorneys asserted that, while persons

with AIDS were almost always awarded disability, the SSA failed to award

disability benefits to other seriously ill HIV-infected women and men, many of

whom are minorities. They argued that the SSA’s instruction that all persons

with AIDS are disabled created a perception that symptomatic HIV-infected

individuals who did not have AIDS were not disabled. This contradicts the

SSA’s written instructions to its disability adjudicators and, to some degree,

the SSA’s own statistics which demonstrate that a number of HIV-infected

individuals who did not have AIDS were awarded disability benefits.

III-2
This debate is difficult to sort out because there has not been an

objective, comprehensive examination of the disposition of disability claims

made by symptomatic HIV-infected persons who do not have AIDS. Most of the

evidence that deserving claimants with HIV infection are not being awarded

disability comes from examples provided by legal services attorneys. Although

these examples are quite compelling (see app. I), they may represent only the

most egregious cases.

number of HIV-infected

disability benefits.

The SSA, however,

Nonetheless, this does not discount the fact that a

persons who appear to be very ill were unable to get

has recently revised its criteria for evaluating

disability of persons with HIV infection, and this revision changes the nature

of the debate. First, it demonstrates that the SSA will not tie its

disability determinations to the CDC’s new definition of AIDS. HIV-infected

individuals who have one of the 1987 AIDS-defining conditions (except Kaposi’s

sarcoma) will continue to be considered disabled on the basis of their medical

conditions alone. HIV-infected persons with CD4+ lymphocyte counts below 200

cells per cubic millimeter (/mm3) , however, will be evaluated in the same

manner as HIV-infected individuals with pulmonary tuberculosis, recurrent

vaginal candidiasis, endocarditis, and a list of other HIV-associated

conditions. The new disability criteria includes a number of HIV-associated

conditions that are frequently seen in HIV-infected women and injection drug

users. However, as discussed below, the new criteria are not without its

critics. Indeed, the SSA has received approximately 3000 comments on their

proposed regulations, an unprecedented number (95) .

The following sections present an overview of the SSA’s disability

programs and the debate over disability determinations for persons with HIV

infection. This background enables one to better evaluate the SSA’s new

disability criteria for HIV infection.

III-3
THE SSA DISABILITY PROGRAM--GENERAL PROCEDURES AND STANDARDS

The DI program is a publicly funded disability

order to qualify for DI benefits, a person must have

number of years, and thus have paid into the Federal

insurance system. In

worked for a certain

Social Security program.

The SSI program, on the other hand, is an income-assistance program for

financially needy persons who are disabled, blind, or 65 years of age or

older. The SSA uses the same definition for disability for both DI and SSI--

an inability to engage in any substantial gainful activity (defined as earning

more than $500 per month) by reason of any physical or mental impairment which

can be expected to result in death or which lasts for a continuous period of

not less than 12 months (42 U.S.C. § 423(d)(l)(A) (DI); s 1382(a)(3)(A)

(SSI)). Applicants

their previous work

with medical conditions that prevent them from performing

or any job that would qualify as substantial gainful

activity will be awarded disability benefits, assuming they meet the program’s.

financial requirements and other criteria (e.g., the citizenship

requirements) .

Applying for Disability Benefits

Applications for SSI or DI disability benefits are filed at one of the

SSA’s approximately 1,300 field offices. Each field office is staffed by

trained clerical personnel who help initiate a claim and determine whether an

applicant meets the financial, age, and citizenship requirements. In some

cases (described below), field office personnel can determine that a claimant

is presumptively disabled and award interim benefits. In all cases, however,

III-4
the ultimate determination that a claimant is disabled is made by one of the

54 State and territorial Disability Determination Service (DDS) offices (42

U.S.C. § 421(a))(188).2 The disability determinations are made by a team of

disability adjudicators, which includes a physician, a trained disability

examiner, and, if needed, one or more vocational experts.

If the State DDS denies an application for disability benefits, the

applicant has the right to have the disability determination reconsidered by

another

this is

DDS adjudicator who was not involved in making the initial decision;

known as a “reconsideration” (20 C.F.R. §§ 404.907-404.922, 416.1407-

416.1413(c)) (see app. H). If the application is denied upon reconsideration,

the applicant has the right to a de novo hearing before an administrative law

judge (20 C.F.R. §§ 404.929-40~.965, 416.1429-1461). If this decision is also

adverse to the claimant, he or she can appeal to SSA’s Appeals Council, which

reviews the decisions of administrative law judges (20 C.F.R. §§ 404.967-

.

404.979, 416.1468-1484). The final stage of review is in the Federal court

system (42 U.S.C. §§ 405(g), 1383(c)(3); 20 C.F.R. §§ 404.981, 404.1482).

The SSA’s Sequential Disability Process

SSA regulations set forth a five-part sequential procedure that is used

by SSA’s disability examiners and administrative law judges to determine

disability for DI or SSI (see app. G). The disability adjudicator must first

determine the following: 1) whether the claimant is working, and 2) whether

the claimant has a disabling condition that significantly limits his or her

ability to work (20 C.F.R. §§ 416.920(a)(c), 404.1520(b)(c)). If the claimant

2 The State offices only focus on medical disability; the examiners in the

State offices do not see the financial information (146).

III-5
—-. -—— —.

is not working because of a disabling condition that significantly

or her ability to work, the disability adjudicator

in the disability process.

The third step is to compare the applicant’s

proceeds to the

limits his

third step

alleged disability with the

SSA’s "Listing of Impairments," a list of medical conditions that SSA has

designated as being so severe as to “prevent a person from doing any gainful

employment” (20 C.F.R. § 416.925). The SSA has designated over 100 medical

conditions in its ‘Listing of Impairments” in the Code of Federal Regulations

(20 C.F.R. Part 404, Subpt P, Appendix 1). (The medical conditions in the

“Listing of Impairments” are often referred to by the SSA as a “Listing,” a

‘listed impairment,” or a “listing-level impairment.”) The SSA’s State

disability adjudicators are instructed that if an applicant for SSI or DI

presents medical evidence establishing that he or she has one of the listed

impairments, that person is disabled and will be awarded disability benefits

if he or she meets the financial and other program requirements. In addition,

a person will be awarded disability benefits if the evidence demonstrates that

.

his or her medical condition equals, in terms of severity, one of the

Listings. Approximately 75 percent of favorable disability decisions are made

at this step in the process (189).

If an applicant for disability benefits does not have a medical

condition that meets or equals one of the Listings, the SSA disability

adjudicator must evaluate the applicant’s residual physical and mental

capacity to perform in a work environment. In the fourth step of the

sequential disability process, the SSA disability adjudicator determines, on

the basis of the person’s residual capacity, whether the applicant can still

perform his or her previous job. If the applicant can perform his or her

previous job, the application for disability benefits is denied (20 C.F.R. §§

III-6
416.920(e), 404.1520(e)). If the applicant cannot perform his or her previous

job, the SSA will determine, taking into account education, age, and prior

work experience, whether the applicant can perform any full-time job in the

national economy (20 C.F.R. §§ 416.920(f), 404.1520(f)). This is the final

step in the disability process.

Presumptive Disability Benefits

Under the SSI program, claimants who have medical impairments that are

highly predictive of disability can be awarded presumptive disability benefits

during the time their claim is being evaluated under the five-step disability

process. Presumptive disability benefits continue for 6 months while the SSA

disability adjudicators gather necessary medical evidence to confirm that the

person is disabled (42 U.S.C. § 1383(a)(4)(B)) . Presumptive disability

benefits can be awarded at any point in the disability process when a

disability examiner from one of the 54 State and territorial DDS offices has

sufficient medical evidence to conclude that a person is disabled.

The SSA also permits the field offices to award presumptive disability

benefits to certain claimants. The medical conditions for which the field

offices can award presumptive disability are specified in the SSA’s

regulations (21 C.F.R. § 416.936), and are usually restricted to conditions

that are either easily identified by a trained lay person or can be easily

confirmed with a single call to a medical practitioner (e.g., the amputation

of two limbs, amputation of a leg at the hip, or allegation of total

deafness). By permitting the field office to award presumptive disability

benefits, the SSA enables applicants for SSI who are clearly disabled to

receive their benefits promptly.

III-7
THE LINK BETWEEN SOCIAL SECURITY DISABILITY PROGRAMS AND MEDICAID

An important consideration in the controversy over the SSA’s disability

decisions for persons with HIV-associated conditions is that SSA’s disability

programs serve as an entry to federally funded health insurance, primarily

Medicaid.3 Medicaid is a Federal-State funded medical insurance system for

low-income individuals who are aged, blind or disabled, and certain other

pregnant women and children, or members of families with dependent children.

Federal funds account for approximately 57 percent of total funds (192).

The majority of SSI recipients are eligible to receive Medicaid.4 DI

recipients cannot automatically qualify for Medicaid because DI benefits

generally exceed State Medicaid income levels. If DI recipients’ medical

expenses greatly exceed their income, however, they may qualify for Medicaid

under State programs for the ‘medically needy” (189). As of 1991, 35 States,

the District of Columbia,

(198).

Medicaid is rapidly

and Puerto Rico had “medically needy” programs

becoming the primary insurer of persons with AIDS.

Researchers have estimated that Medicaid covers approximately 40 percent of

individuals with AIDS, private insurance covers 29 percent, Medicare covers 2

3 Medicare is not available to persons receiving 7DI until 24 months after DI

benefits are awarded. (42 U.S.C. s 1395e). In the past, most HIV-infected

individuals who qualified for DI did not live long enough to qualify for

Medicare (12). This may change, however, as treatment extends the life

expectancy of persons with HIV infection.

4 All but 12 States automatically allow SS1 recipients to receive Medicaid

(198). The other 12 States have more restrictive disability or financial

requirements (121). In those States that use more restrictive financial

requirements, SS1 recipients may become eligible for Medicaid if their medical

bills greatly exceed their income (189).

III-8
percent, and approximately 29 percent of persons with AIDS are without

insurance coverage (120). This trend towards the “Medicaidization” of AIDS

(69) demonstrates the demand for publicly funded health care for HIV-infected

persons. This demand is likely to continue to grow as there appears to be an

increasing number of HIV-infected persons who are poor and who do not have

adequate health insurance. Even among those with private insurance, there is

some evidence that HIV-infected persons may lose their insurance once they can

no longer work (92) .

The costs of providing medical care for HIV-infected individuals without

Medicaid or other health insurance will probably be borne by the States

(167a). In 1991, the States spent approximately $168 million on medical

services for people with AIDS and HIV, excluding State Medicaid funds. The

majority of care was provided in outpatient settings (85).

Although many disability claimants may need medical care immediately,

they will not be able to get medical care through Medicaid until they are

determined to be disabled. The SSA cannot alter the statutory disability

definition to make more people eligible for Medicaid; however, if the SSA

incorrectly denies a person disability benefits, this decision may also affect

the person’s ability to obtain

●

DISABILITY

federally financed health care.

DETERMINATIONS AND HIV/AIDS

The debate over disability determinations for HIV-infected claimants has

focused on the SSA’s decision to use the CDC definition of AIDS as a Listing

and in presumptive disability determinations. The decision to use the AIDS

case definition in disability determinations did not preclude HIV-infected

claimants without AIDS from receiving disability benefits; adjudicators had

III-9
the discretion to conclude that HIV-infected claimants without AIDS were

disabled because their condition was equal in severity to a Listing.

Alternatively, HIV-infected claimants could be found disabled at a later stage

in the disability process, based upon their residual functional capacity. By

1990, however, the SSA concluded that it needed a Listing that enumerates

specific disability criteria for HIV-infected claimants without AIDS. The

development of this Listing is discussed below.

Disability Determinations for Persons With AIDS

Since 1983, the SSA has instructed its disability adjudicators to use

the CDC definition of AIDS as a Listing, although it has never published

regulations formally incorporating the CDC definition of AIDS into its

“Listing of Impairments.” The SSA’s instruction on AIDS was maintained in an

internal policy manual, the Program Operations Manual System (POMS), until

1984, when the SSA outlined this policy in the first of two Social Security

Rulings (SSRs) (224a,224b).5 (These rulings were not published in the Federal

Register.) The SSA used the CDC definition of AIDS as a disability

definition and incorporated all of the CDC’s subsequent revisions of the case

●

5 Social Security Rulings are not regulations; instead the rulings draw upon

and codify the policies and criteria used at all levels of the administrative

adjudication process (e.g., administrative law judge and Appeals Council

decisions, decisions by SSA disability examiners, opinions of the SSA’S Office

of Disability or Office of the General Counsel, and other policy

interpretations by SSA). These rulings are binding on all components of the

SSA, including State DDS examiners, administrative law judges, and the SSA’S

Appeals Council (20 C.F.R. s 422.406(b)(l)) . Because they do not have the

force and effect of law or SSA regulations, however, they are not binding on

Federal or State courts (56 FR 65498).

111-10
definition into the disability definition. In 1990, however, the SSA added

Hodgkin’s lymphoma, a condition that is not included in the CDC AIDS

definition, to its AIDS disability definition.

In 1985, the SSA published regulations making AIDS one of the conditions

for which “presumptive disability” could be awarded at the field office level

(50 F.R. 5573). This enabled claimants with AIDS to receive disability

benefits quickly6

, and the decision was generally well received. It was also

the first time that the appropriateness of using the CDC definition of AIDS in

disability determinations was subject to public debate.’

The SSA recognized that a surveillance definition is designed for a

different purpose than a definition for determining disability. Nonetheless,

the SSA concluded that it was unlikely that any person with AIDS who had

stopped working could engage in substantial gainful activity (53 F.R. 3740).

The decision to use the CDC definition of AIDS in field office presumptive

disability determinations and as a Listing facilitated the processing of

disability claims for persons with AIDS, and almost 100 percent of claimants

.

whom the SSA recognized as having AIDS were awarded disability benefits (225) .

The

Disability Determinations for Persons with HIV Infection

SSA also recognized that persons with HIV infection could become ill

and disabled prior to developing AIDS. In the 1986 Social Security ruling on

AIDS and disability, the SSA instructed its adjudicators that persons with HIV

6 Presumptive disability benefits are often awarded within 3 weeks, while an

initial determination by the DDS may take 3 months or longer (49,227).

7 The regulations were issued as interim regulations, effective immediately,

but public comments were accepted. These comments were addressed in 1988,

when SSA renewed the regulations (53 F.R. 3740).

111-11
infection might suffer from a number of potentially disabling conditions prior

to developing AIDS, including recurrent fevers, lymphadenopathy, prolonged

diarrhea, fatigue, weight loss, night sweats, and recurrent infections such as

oral candidiasis. The SSA wrote that HIV-infected individuals who suffer from

one or more of these conditions may be disabled and their degree of disability

should be assessed on a case-by-case basis (224b).

By 1987, the SSA announced that it would soon publish regulations

creating a Listing for HIV infection and AIDS (56 F.R. 65704). The SSA failed

to publish these regulations, and mounting public and Congressional pressure

led the SSA to reconsider its instructions on HIV infection and disability.8

As a result, in 1988, the SSA decided that it needed more specific criteria

for evaluating disability in HIV-infected claimants without AIDS (113).

In February of 1990, the SSA published a new disability definition

entitled “Symptomatic HIV Infection Not Indicative of AIDS.” This new

criteria was published in the POMS, an internal policy manual.

does not have input into the development of the POMS, and it is

available by request to the SSA (5 U.S.C. § 552(2)). Moreover,

not bind the administrative law judges in their decisions.

The POMS disability definition “Symptomatic HIV Infection

The public “

only made

the POMS does

Not Indicative

of AIDS” (henceforth referred to as POMS “Symptomatic HIV Infection”)

functioned as a Listing for HIV-infected persons who do not have AIDS. In

8 In 1988, Congress mandated that the SSA conduct an internal review of

disability determinations for persons alleging HIV infection but not AIDS

(Public Law 100-647, Sec. 8019). In attempting to complete this report (it

has never been completed (115), the SSA found that close to half of the State

DDS offices collected no data separating AIDS ‘and other HIV infection claims,

and other DDS offices often inaccurately classified AIDS and HIV infection

claims. Among those States with data, SSA found significant variation in

allowance and denial rates for HIV infection claims that were not AIDS

(147,235).

111-12
other words, if an HIV-infected claimant documented that he or she had the

combination of medical conditions and symptoms that were included in, or were

equal in

would be

In

claimant

1)

2)

3)

4)

severity to, the POMS “Symptomatic HIV Infection” criteria, he or she

awarded disability benefits at step 3 in the disability process.

order to meet the POMS “Symptomatic HIV Infection” criteria, a

needed to document:

Evidence of HIV infection (e.g., HIV antibody or viral testing); AND

A CD4+ lymphocyte count less than or equal to 200 cells/mm3 (or a

CD4+ percent of lymphocytes less than or equal to 25); AND

Two or more of the following persisting over a 2-month period:

a. anemia (hematocrit value below 30 percent)

b. granulocytopenia

c. thrombocytopenia

d. documented fever

e. weight loss >/- 10 percent of baseline

f. oral candidiasis

g. oral hairy leukoplakia

h. recurrent herpes zoster

i. persistent, unresponsive diarrhea;

AND

Marked restriction of activities of daily living (such that

individual needs help with most activity including climbing stairs,

shopping, cooking, or housework) or

Deficiencies of concentration, persistence, or pace, resulting in

frequent failure to complete tasks in a timely manner (in work

settings or elsewhere) (POMS).

Advocates for people with HIV infection were generally pleased that the

SSA created more specific disability criteria for persons with HIV infection,

but they claimed that the POMS ‘Symptomatic HIV Infection” criteria did not go

far enough. Most of the HIV-associated conditions included in the POMS

“Symptomatic HIV Infection” criteria were derived from the same epidemiologic

111-13
studies used to develop the CDC definition of AIDS, in which the cohorts

largely consisted of white men who have sex with men (168). The conditions

identified by these studies--e.g. , fever, weight loss, fatigue, chronic

diarrhea, night sweats, lymphadenopathy, oral thrush, and hairy leukoplakia

(241a)--do occur in other HIV-infected populations, including women and

injection drug users. There are other disabling conditions, however, that are

seen particularly in HIV-infected women and injection drug users--e.g. ,

endocarditis, pneumonia, sepsis, pelvic inflammatory disease, genital herpes,

and persistent vaginal candidiasis- -that were not included in the POMS

“Symptomatic HIV’ Infection” criteria.

CRITICISMS OF THE SSA’s DISABILITY PROCESS

By the late 1980s, as more individuals infected with HIV were

identified, it became apparent that some of the serious medical conditions

that were seen particularly in HIV-infected women

were not included in the CDC definition of AIDS.

and injection drug users

Legal service attorneys and

other advocates for HIV-infected persons charged that the SSA routinely denied

disability benefits to HIV-infected women and injection drug users whose HIVassociated conditions were not included in the

after 1990, in the SSA’s POMS “Symptomatic HIV

CDC definition of AIDS or,

Infectionw criteria. This is

the main argument made in the lawsuit S.P. v. Sullivan,

The SSA, on the other hand, stated that it had no

discussed below.

policy that prevented

HIV-infected persons who did not have AIDS or meet the POMS “Symptomatic HIV

Infection” criteria from obtaining disability. The SSA specifically

instructed its disability adjudicators that HIV-infected persons who did not

have AIDS or meet the SSA’s POMS “Symptomatic HIV Infection” criteria should

111-14
— — —

be evaluated under the full sequential disability process. In other words, if

HIV-infected claimants were not awarded disability on the basis of a Listing,

the DDS adjudicator would determine their residual functional capacity to work

and evaluate whether they can perform any full-time work

economy. If they were unable to work, they were awarded

Legal service attorneys claim that, while this may

in practice their clients with HIV-associated conditions

in the national

disability.

be the stated policy,

not included in the

POMS “Symptomatic HIV Infection” criteria were not able to receive disability

at these last steps in the disability process. In addition, attorneys have

challenged the legality of the SSA’s decision to use the POMS and SSRs to

establish that AIDS and the POMS “Symptomatic HIV Infection” equals a Listing.

The SSA Disability Statistics

The SSA’s statistics reveal that, in 1990, almost 100 percent of persons

.

with AIDS who applied for either SSI or DI benefits were awarded these

benefits. In addition, approximately 50 percent of claimants who alleged HIV

infection on their disability claims, but who did not have AIDS, received

disability benefits at the initial or reconsideration stage (225). The

statistics do not reveal the condition of the other 50 percent of HIV-infected

persons who were denied disability, nor do the statistics reveal the race or

socioeconomic class of the persons who were awarded disability benefits versus

those who were denied benefits.

The SSA states that, when the analysis is limited to claims made by

symptomatic HIV-infected individuals,

awarded disability (49,225). The DDS

symptomatic HIV-infected if he or she

approximately 60 percent or more are

examiners only classify a person as

has the symptoms described in the POMS

111-15
“Symptomatic HIV Infection” criteria (115) . Therefore, HIV-infected

disability applicants who claimed they were disabled on the basis of

gynecological conditions, endocarditis, bacterial pneumonia, pulmonary

tuberculosis, or sepsis, would not be classified as symptomatic HIV-infected

individuals.

When one only examines claims made by HIV-infected persons who were not

classified by the SSA as having AIDS or symptomatic HIV-infection, only 23

percent were awarded disability (49,225). The SSA’s position is that the 77

percent of claimants who were not awarded disability did not have disabling

symptoms of HIV infection. Legal service attorneys argue that many of these

HIV-infected claimants are their clients who were incorrectly denied

disability.

Legal Challenges to the SSA’s Disability Process

.

Two lawsuits have been filed against the SSA challenging its disability

criteria for persons with HIV infection. The first suit alleges, among other

things, that the SSA’s use of the CDC definition of AIDS and the POMS

“Symptomatic HIV Infection” criteria has resulted in discrimination against

women, minorities, and other persons who have HIV-related conditions that are

not included in these definitions. The second case alleges that the SSA’s

decision to develop criteria for listing-level impairments through the POMS

and SSRs, rather than through notice and comment rule making, violated the

Administrative Procedure Act (5 U.S.C. §§ 551 et. seq.). The suit seeks to

have adverse disability decisions that were made using these criteria

readjudicated with properly promulgated regulations.

111-16
The merits of these cases have not been ruled upon by the respective

courts. Both suits, however, have survived requests by the Secretary of

Health and Human Services 9 to have the cases dismissed for failure to state a

legal claim (143,169)

S.P. v. Sullivan

In 1990, legal service attorneys in New York filed a lawsuit against the

SSA stating that the SSA’s disability process discriminated against HIVinfected women and other HIV-infected persons who have disabling medical

conditions that are not included in the CDC definition of AIDS or the POMS

“Symptomatic HIV Infection” criteria (165). The 19 named plaintiffsl0 

were

denied disability benefits by the State DDS, and many had been denied

disability benefits upon reconsideration or by an administrative law judge.

As of April 1992, almost all of the plaintiffs had received their disability

benefits, beginning from the date they originally claimed they were disabled;

yet, as a result of being initially denied benefits by the State DDS, they

often waited 1 to 3 years, and up to 5 years, for their claims to be properly

decided. As their attorney explained, this meant they had to make numerous

trips to her office and the SSA’s offices to fight for benefits (112). The

experiences of these plaintiffs (see app. I) do not necessarily prove a

pattern and practice by the SSA; they do, however, signal that the system for

determining disability has not worked for a number of HIV-infected persons.

9 The suit is brought against the Secretary of Health and Human Semices

rather than the SSA. The Secretary is represented by the U.S. Department of

Justice.

10 The complaint has been amended three times and additional plaintiffs added

(~ 165,166,168).

.

111-17
The Secretary of Health and Human Services contends the arguments made

in SOP. v. Sullivan are

Social Security rulings

considers disabled only

without meritll

, citing language in the POMS and

that contradict the plaintiffs’ assertion that the SSA

HIV-infected persons who have AIDS or meet the POMS

“Symptomatic HIV Infection” criteria. Both of these documents instruct

disability adjudicators that HIV-infected individuals who do not meet these

medical disability definitions should be evaluated on the basis of whether

their residual functional capacity allows them to work; if they cannot work,

they should be awarded disability benefits (167).

The Secretary also correctly asserts there is no statutory requirement

that a particular impairment or disease be treated as a listed impairment.

The Secretary, and hence the SSA, has discretion to “establish [its] own

procedures and evidentiary requirements with respect to the evaluation of

claims for benefits under the Social Security Act’s disability programs”

(167). Furthermore, as stated above, a Person with an HIV-associated

condition that is not included in the POMS ‘Symptomatic HIV-Infection”

criteria is not precluded from being awarded disability.

The plaintiffs in S.P. v. Sullivan concede the SSA is not required to

create a Listing for every disabling medical condition, but argue that, once

the decision is made to create a Listing for a particular disease like HIV

disease, the categories must be created by a rational process that brings

forth a reasoned and nondiscriminatory classification. Furthermore, although

the Secretary correctly asserts that the SSA’s written policies do not

11 The Secretary objected to the suit, in part, because some of the plaintiffs

have not exhausted their administrative remedies--i.e. , all of the plaintiffs

have not had their disability cases adjudicated through to the Appeals Council

(see app. H). This procedural issue is not discussed here because it does not

relate to the substantive issue.

111-18
discriminate against persons with HIV-associated conditions who do not have

AIDS or meet the POMS “Symptomatic HIV Infection” criteria, the plaintiffs

believe their experiences demonstrate that in practice these policies are not

followed.

Rosetti v. Sullivan

In a second lawsuit against the Secretary of Health and Human Services,

the plaintiffs argue that the SSA could not make AIDS or the POMS “Symptomatic

HIV Infection” equal to a Listing without issuing regulations in accordance

with the Administrative Procedure Act (APA) (5 U.S.C. §§ 551 et. seq). The

APA requires an executive agency to publish regulations whenever it issues a

substantive rule- -rules that "grant rights, impose obligations, or produce

other significant effects on private interests” (7). The APA regulatory

procedures require agencies to publish notice of their intent to develop new

regulations and provide interested persons opportunity to participate in

developing regulations through submission of data, arguments, and other views

(11). An executive agency can only use rulings or internal manuals, such as

the POMS, for interpretive rules that “merely clarify or explain existing law

or regulations” (132).

Every Listing in the “Listing of Impairments” was promulgated by

regulation. AIDS, however, was established as equivalent to a Listing by a

SSR, and the POMS ‘Symptomatic HIV Infection” criteria was only published in

the SSA’s internal procedures manual. The issuance of both of these documents

did not provide for public input (144).

111-19
In a preliminary decision,12 the court in Rosetti v. Sullivan stated

that, if the SSA’s POMS and SSRs set forth specific disability criteria for

AIDS and HIV-associated conditions that function as Listings, these criteria

are substantive rules and these policies should have been implemented by

notice and comment rulemaking in accordance with the APA (143). The SSA has

stated that individuals whose medical conditions meet the CDC definition of

AIDS or the POMS “Symptomatic HIV Infection” criteria have met or equaled the

“Listing of Impairments” (224b,226a). Therefore, under the test set forth in

the court’s opinion, the POMS and SSRs concerning HIV infection and disability

are substantive rules. The court stated that a failure to follow APA

procedures for substantive rules could render these disability criteria void;

however, since the SSA recently proposed new regulations governing disability

claims by symptomatic HIV-infected persons, it is not clear what relief the

court will grant the plaintiffs.

12 This decision primarily addressed whether the court had the legal

jurisdiction to hear the claim and a hearing on the merits was scheduled for

May 11, 1992.

111-20
The SSA’s Assessment of Residual Functional Capacity and Vocational Ability

The SSA has maintained that, if an HIV-infected person is disabled but

does not have AIDS or meet the POMS “Symptomatic HIV Infection” criteria, the

DDS adjudicator will determine whether he or she has sufficient residual

functional capacity to continue to work. If the adjudicator determines that

the claimant does not have sufficient residual functional capacity to work,

the claimant will be awarded disability. The SSA is statutorily mandated to

ignore whether suitable job openings are available or whether the claimant

will be able to get a particular job (42 U.S.C. §§ 423(d), 1382c(B)).

Advocates claim that disability examiners interpret the evaluation of

residual functional capacity and ability to work so strictly that their HIVinfected clients are virtually never found disabled at this final stage of the

disability determination evaluation. Advocates do not believe that any single

. .

factor can account for all of these adverse decisions; however, they note that

the vocational assessment is biased against younger individuals because the

SSA assumes that only persons of advanced age (55 years old and older) are

significantly restricted in their ability to ‘adapt and adjust to a new work

situation and do work in competition with others” (21 C.F.R. s 404.1563(a)) .13

It is difficult to know whether the evaluation of residual functional

capacity and ability to work leads to more denials of benefits to younger HIVinfected individuals than is warranted. It may not be possible to craft a

Listing with such specificity that every person who meets the Listing would

actually be found disabled if his or her residual functional capacity was

●

13 The SSA also recognizes that persons approaching advanced age--i.e. , 45

years of age to 55 years of age --may have difficulty adjusting to new work

situations (20 C.F.R.S 404.1563(b)(c)).

111-21
evaluated. In other words, some people who are not yet disabled might fall

within the medical criteria of a Listing.14 Therefore, the disability process

may appear less rigorous for people who obtain disability because they meet a

Listing.

On the other hand, it is difficult to believe that a number of the HIVinfected claimants who were denied disability benefits were not in fact

disabled. Indeed, a number of the plaintiffs in the case S.P. v. Sullivan

eventually were awarded disability on appeal, indicating they were improperly

denied disability benefits by the State DDS examiners. Several reports and

statistics also lend some support to the advocates’ claims.

.

Procedural Issues and Evaluation of Residual Functional Capacity

When HIV-infected claimants establish that they are disabled on the

basis of a medical impairment, they only need to present fairly objective

. .

medical evidence. There is no subjective evaluation of the degree to which a

.

claimant’s medical condition affects his or her ability to concentrate, carry

out certain activities of daily living, or work. It is these subjective

evaluations that may be influenced by the SSA’s procedures and policies.

First, one report concluded that several procedures used by the SSA in

making disability determinations appear to reduce DDS disability examiners’

ability to evaluate cases on an individual basis. The report noted that SSA’s

use of the “Listing of Impairments" and the instructions in its POMS

"clericalizes the task of disability assessment, reducing it to a series of

yes-no questions,” rather than focusing on each individual’s unique problems

14 For example, although all persons with AIDS can receive disability, a

recent study of over 1000 persons with AIDS found that persons with AIDS

exhibit a range of functional abilities depending upon the stage of the

disease and other factors (55). This study is discussed in more detail below.

III-22
—

(188). In addition, initial decisions and reconsiderations by the DDS rely

extensively on paper evidence that claimants and their physicians submit;

there is no face-to-face meeting with claimants.15 Disability examiners may,

however, have difficulty in properly assessing the degree of residual

functional capacity by reviewing only the medical records (187).

Second, advocates argue that the extensive DI quality control system

imparts excessive rigidity to disability determinations. In 1980, Congress

mandated that the SSA review 50 percent of all DI and concurrent DI/SSI

allowances prior to awarding benefits (42 U.S.C. § 421(c)). These “preeffectuation” reviews of DI disability allowances are designed to ensure that

the disability adjudicators make decisions that are consistent with SSA’s

regulations and policies. The review, however, only focuses on allowances,

looking for cases in which disability should not be allowed, rather than on

incorrect denials (190). Because this quality review focuses on incorrect

allowances, it may cause DDS adjudicators to be too conservative in disability

decisions.

.

Differences Between DDS Determinations and Administrative Law Judge Decisions

Evidence that the disability adjudicators might be overly conservative

in their determinations also comes from the statistic that initial denials of

disability benefits by DDS adjudicators have been reversed by administrative

law judges in approximately two out of three cases (42,188). In order to

explore the reasons for this disagreement in disability determinations, the

15 The Social Security Reform Act of 1984 requires the SSA to conduct

demonstration projects in which claimants would be offered the opportunity to

have a personal meeting with the disability determination officer prior to an

initial unfavorable decision. The SSA instituted demonstration projects in 10

States between 1986 and 1988 (188).

III-23
General Accounting Office reviewed 242 disability cases in which

administrative law judges reversed the SSA’s initial disability

determinations. The General Accounting Office found that in most cases the

reversal stemmed from the fact that the DDS examiner overestimated the

claimant’s residual functional capacity (42). Whereas SSA disability

examiners had determined

work, the administrative

that 54 percent of claimants could do medium or heavy

law judges concluded that only 1 percent of these

people could do such work. Conversely, administrative law judges determined

that 71 percent of the claimants could do only sedentary work, if that, while

the SSA disability examiners concluded only 1 percent of the claimants were so

limited in functional capacity (187).

Most of the claimants in the sample suffered from back disorders, lung

disease, diabetes, and anxiety- -conditions that cause decrements in residual

functional capacity that are subjectively measured. Further study is needed

to determine whether similar findings would apply specifically to HIV-infected

claimants. It is of note that certain common symptoms of HIV-infected

patients, such as fatigue, chronic diarrhea, night sweats, gynecological

.

conditions, undefined pain, or early HIV dementia, also cause decrements in

residual functional capacity that are subjectively measured (240).

SSA’s Implementation of Federal Court of Appeals Decisions

The SSA has also been accused of failing to implement certain decisions

of the U.S. Court of Appeals for the Second Circuit (hereinafter Second

Circuit), thereby making it more difficult for certain claimants to obtain

disability.16 In Stieberger v. Sullivan (172) the court found the SSA had

16 The deliberate failure by an executive agency to adopt Appeals Court

decisions is known as “non-acquiescence” (172).

III-24
failed to issue any SSRs implementing Second Circuit decisions regarding

disability determinations, and in at least four areas, there was evidence the

SSA’s inaction led to a “system-wide pattern of mistaken adjudication.”17

For

example, in a series of decisions beginning in 1981, the Second Circuit held

that a treating physician’s opinion on the diagnosis and nature and degree of

disability should be binding on the SSA’s disability adjudicators unless

contradicted by substantial evidence. The courts reasoned that the treating

physician is usually most familiar with the claimant’s medical condition

(172). The SSA did not, however, explicitly adopt this policy until ordered

by the court in 1986, and the final version of the instructions were

implemented in 1988 (153). The SSA also failed to implement a Second Circuit

decision instructing the SSA that a disability decision could not be based on

a report that is issued after the claimant’s hearing before an administrative

law judge, unless the claimant has the opportunity to cross-examine the

authors of the report (172). This decision guaranteed the claimant the

opportunity to rebut evidence in the report. In addition, the SSA failed to

implement Second Circuit decisions that established claimants with good work

records were entitled to substantial credibility when they claimed they were

unable to work because of a disability (172).

In those cases where the SSA applied different policies than the Federal

courts, claimants who could pursue their claims to the Federal courts were

more likely to receive disability (172). Not only would the outcome of

certain claimants’ disability determinations depend upon their ability to

17 The SSA did not formally reject Second Circuit decisions, and therefore in

order to prove non-acquiescence the plaintiffs needed to offer evidence of

individual disability cases that were adversely affected by the SSA’S failure

to implement a Second Circuit holding (172).

III-25
continue to appeal adverse SSA decisions to the Federal courts18, but the

SSA’s policy also led to excessive delay in disability determinations as

claimants went through lengthy appeals process (see app. H).l9

During the course of the litigation, the SSA issued several policy

statements, and finally regulations in 1990, concerning the proper treatment

of Federal Court of Appeals decisions.20 The SSA, however, never published

opinions explaining to its administrative law judges and State disability

examiners why the SSA did not need to adopt certain Second Circuit decisions.

The SSA decided that publishing such explanations would:

(2) . ● . creat[e] the appearance of

“whitewash,” i.e. , repeated claim of no real conflict

between SSA and the court despite the obvious facts

that the conflict was litigated to the circuit court

level and produced a decision rejecting the [SSA’s]

arguments and reversing [SSA’s] decision; and

(3) potentially provide evidence for class

21 to compel the actions seeking writs of mandamus

[SSA] to follow policies she has adopted. Stieberger

v. Sullivan (172)

The court in Stieberger v. Sullivan (172) concluded that the SSA’s

.

failure to implement the Second Circuit’s rulings may have led to

inappropriate denials of disability benefits. In a proposed settlement of the

case, the SSA has agreed to distribute Second Circuit disability decisions to

18 By one estimate, only 6 percent of persons who are* initially denied

disability appeal to the level of the circuit courts (128).

19 According to the court, a policy of non-acquiescence violated Congressional

intent and the Constitution’s Equal Protection Clause (172).

20 The court found that these policy statements and regulations left too much

“room for non-acquiescence" and further noted that “each significant

modification of agency policy came shortly before a major stage of this case”

(172).

21 Inawrit of mandamus, a plaintiff requests a Federal court to compel an

executive agency to perform a non-discretionary duty owed to the plaintiff

(18).

III-26
--

SSA’s administrative law judges and State disability examiners and to instruct

the administrative law judges and examiners to apply the decisions (173). In

addition, a number of adverse disability decisions may be reviewed

(44,93,128). The proposed settlement has yet to be approved by the court, and

the impact the decision will have in other judicial circuits is not yet known.

The case is instructive because it demonstrates how some of SSA’s internal

procedures and policies, which are not included in regulations and SSRs, may

make it more difficult for claimants to obtain disability.

THE SSA’s NEW PROPOSED

In December of 1991, the

REGULATIONS FOR HIV INFECTION DISABILITY

SSA published a ruling and proposed regulations

that create a new Listing for HIV infection (56 FR 65498, 65702). The “HIV

Infection Listing” contains medical and functional criteria for determining

disability for all persons with HIV infection (see app. J) and these criteria

will be subject to public comment before being finally incorporated into the

.

SSA’s “Listing of Impairments.” Because the SSA issued a ruling as well as

proposed regulations, the new “HIV Infection Listing” is presently being used

and will be amended if the final regulations differ from the proposed “HIV

Infection Listing." The SSA also issued a new ruling and proposed regulations

that allow the field offices to award presumptive disability to all persons

who meet the new “HIV Infection Listing” (56 FR 65682, 65714). This could

increase the number of HIV-infected persons awarded presumptive disability

benefits by the field offices; however, according to the SSA, the new “HIV

Infection Listing” will not increase the overall number of HIV-infected

persons that are awarded disability (56 FR 65702)(126).

III-27
The new “HIV Infection Listing” combines the 1987 CDC definition of AIDS

and the POMS “Symptomatic HIV Infection” criteria and also adds a number of

other HIV-associated conditions, including many of the conditions that are

more often found in HIV-infected women and injection drug users. The new "HIV

Infection Listing” demonstrates that the SSA will no longer assume that every

person who meets the CDC definition of AIDS is disabled. HIV-infected

individuals with CD4+ lymphocyte counts below 200 cells/mm3

sarcoma will not be granted disability benefits unless they

they have marked functional limitations.

or Kaposi’s

also document that

The SSA has received a large number of comments on their new "HIV

Infection Listing.” A number of commentators are supportive of the SSA’s

decision to expand the number of HIV-associated conditions that will be

considered in determining whether an HIV-infected claimant meets a Listing.

The commentators are dismayed, however, by the complexity of the Listing, and

more importantly, by the use of the new functional limitation tests. In

particular, they question why the SSA is able to develop strictly medical

.

disability criteria for every non-psychiatric Listing in the “Listing of

Impairments” except for the new ‘HIV Infection Listing.” Under the "HIV

Infection Listing,” a number of HIV-infected claimants must document both

medical impairments and marked functional limitations.

III-28
— .—

The HIV Infection Listing

Under the SSA’s new “HIV-Infection Listing,” all adult claimants22 who

have one of the AIDS-defining conditions included in the 1987 CDC definition

of AIDS (except Kaposi’s sarcoma) will be considered disabled (see app. J).

Adult claimants who show evidence of HIV infection and any of the following

additional conditions will also be considered

Candidiasis, disseminated (beyond the

tract, or oral or vulvovaginal mucous

Herpes simplex virus infection of the

encephalitis;

Extraintestinal strongyloidiasis; or

Nocardiosis;

disabled:

skin, urinary tract, intestinal

membranes) ;

gastrointestinal tract or

Invasive carcinoma of the cervix, International Federation of

Gynecology and Obstetrics (FIGO) Stage II and beyond;23

Anal squamous cell carcinoma;

Hodgkin’s disease;

Cardiomyopathy;

Nephropathy.24

HIV-infected adult claimants with HIV-associated conditions, other than

those noted above, can meet the SSA’s “HIV Infection Listing” only if they

document one of the following medical conditions:

22 The “HIV Infection Listing” contains separate criteria for children;

however, these criteria are not discussed herein.

23 Stage II cervical cancer has progressed beyond the cenix. This is a

different Listing, and arguably easier to meet, than the SSA’S current medical

Listing for cenical cancer, which requires that the cancer be: 1) inoperable

and not controlled by existing therapy; 2) recurrent after total hysterectomy;

or 3) removed by total pelvic exenteration (20 C.F.R., Part 404, Subpt. P.,

App. 1, Sec. 13.25).

24 Cardiomyopathy and nephropathy were already included in the SSA’S “Listing

of Impairmentsn

(20 C.F.R., Part 404, Subpt. P., App. 1, Sees. 4.02, 4.o4,

4.05 (cardiomyopathy) and 6,02, and 6.06 (nephropathy), so their inclusion in

the SSA’S “HIV Infection Listingn is as a cross-reference, not as an addition

to the Listings.

III-29
■ A CD4+ lymphocyte count less than or equal to 200 cells/m.m3

; ❏❒

= Documentation of one or more of the following persistent and/or

resistant to therapy:

1)

2)

3)

4)

5)

6)

7)

8)

a Two or

1)

2)

3)

4)

5)

6)

7)

8)

9)

10)

11)

Pneumonia;

Pulmonary tuberculosis;

Bacterial or fungal sepsis;

Meningitis;

Septic arthritis;

Endocarditis;

Peripheral neuropathy;

Kaposi’s sarcoma; or

more of the following persisting over a 2-month period:

Anemia (hematocrit value less than 30 percent);

Granulocytopenia;

Thrombocytopenia;

Documented fever;

Weight loss >/= 10 percent of baseline;

Mucosal (including vulvovaginal) candidiasis;

Oral hairy leukoplakia;

Recurrent or chronic herpes zoster;

Persistent dermatological conditions such as eczema, or

psoriasis;

Persistent, unresponsive diarrhea;

Persistent or recurring documented sinusitis.

In addition, the claimant must document two of the following functional

impairments:

1)

2)

3)

4)

Marked restriction of activities of daily living;

Marked difficulties in maintaining social functioning;

Marked difficulties completing tasks in a timely manner due to

deficiencies in concentration;

Repeated episodes of decompensation, averaging three times a

year or once every 4 months, lasting 2 weeks or more per

episode, and which cause deterioration in condition.

The SSA also provided its adjudicators with special instructions for

evaluating disability in HIV-infected individuals. The SSA wrote that HIVinfected individuals may suffer from anxiety, depression, apathy, and

cognitive impairment, and that these mental impairments should be documented

with medical evidence and evaluated under the appropriate Listing in the

“Listing of Impairments" and/or be evaluated in determining the individual’s

111-30
residual functional capacity (56 FR 65708). The SSA also noted that, on

occasion, therapy for HIV infection may result in long-term or permanent

adverse affects.

General Criticisms of the “HIV Infection Listing”

The inclusion of additional HIV-related illnesses in the “Listing of

Impairments” comes at the price of more complexity. Critics have stated that

the “HIV Infection Listing” has a “Chinese menu” type layout which requires

different combinations of criteria depending upon the claimant’s symptoms

(30,59) (see app. J). It is arguably one of the most complicated Listings

.

the “Listing of Impairments.” The complexity of the definition, critics

argue, may delay processing of claims. Quick processing of claims is

important because persons with severe manifestations of HIV infection,

in

especially those persons whose health is already compromised by the effects of

injection drug use, may already be close to death.

A number of groups are critical of SSA’s decision to use a functional

limitations test in a Listing because the test requires additional

documentation and subjective assessment. The “Listing of Impairments” is

designed to facilitate a finding of disability by allowing a disability

determination to be made on the basis of fairly objective medical evidence

consisting of: 1) symptoms (claimant’s own perception of his or her physical

or mental impairments) ; 2) signs (anatomical, physiological, or psychological

abnormalities that can be demonstrated by medically acceptable clinical

techniques); and 3) laboratory findings (226). The new “HIV Infection

Listing” relies heavily on documentation of functional limitations,

.

111-31
—-

essentially merging part of the residual functional capacity analysis into

medical listing25 and thereby diminishing the advantage (to the claimants)

the Listings.

a

of

Moreover, the SSA has not explained why certain HIV-related conditions

are disabling per se, whereas persons with other HIV-related conditions must

also demonstrate functional limitations. An HIV-infected person with

Pneumocystis carinii pneumonia or another opportunistic infection is

considered disabled once he or she documents a single incidence of the

disease. HIV-infected persons with serious illnesses, such as bacterial

pneumonia, pulmonary tuberculosis, endocarditis, or bacterial sepsis (which

often require hospitalization and may be fatal), are only considered disabled

.

if they can also document that their illness is persistent and/or resistant to

therapy and that they have marked functional limitations.

The critics contend that the SSA could have developed purely medical

criteria to determine when certain HIV-associated conditions are disabling.

.

The American Medical Association has testified that conditions such as

endocarditis, pulmonary tuberculosis, Kaposi’s sarcoma, and bacterial

pneumonia have a high mortality rate in HIV-infected individuals and that HIVinfected persons with these conditions should not also have to prove

functional limitations (24). The American Medical Association also argues ,

that HIV-infected persons with CD4+ lymphocyte counts below 200 cells/mm3

should be considered disabled because they are likely to succumb to serious

opportunistic illnesses within a short period of time.

25 The residual functional capacity assessment focuses on the activities a

person can perform, while the functional limitation assessment examines what

activities a person cannot perform. Nonetheless, similar evidence is needed

to make each of these assessments.

III-32
Advocates and physicians also claim it is possible to develop medical

criteria that will be highly predictive of disability, even for HIV-associated

conditions that are generally less severe. The National Association of People

with AIDS, for example, has proposed that chronic anemia, which is quite

prevalent in persons who take AZT, is disabling if an HIV-infected person has

any of the following conditions:

■ a persistent hemoglobin of less than 10.0 grams

deciliter;

m a hematocrit of less that 30.0 volume percent

(regardless of AZT intake);

per

■ the need for blood transfusions due to anemia more

often than twice yearly (59) .

HIV-infected persons with chronic anemia who meet these criteria would not

have to meet the SSA’s functional limitation test.

In sum, the critics argue that HIV-infected individuals could more

easily document their disability and obtain benefits if the SSA developed

purely medical criteria for most HIV-associated conditions. The alternative

the SSA has chosen--i.e. , to require that certain HIV-infected claimants

demonstrate medical conditions plus functional limitations--may make it more

difficult for certain HIV-infected claimants to document their disabilities.

The need to document functional limitations in two separate areas may be

particularly difficult for HIV-infected persons who do not have a regular

physician who can attest to their functional limitations on the basis of their

treatment history. An official from SSA noted that a physician’s opinion

about functional limitations under the ‘HIV Infection Listing,N

"while not

definitive, will be given considerable weight (46). Documentation of

functional limitations, however, imposes an additional burden on the physician

that goes beyond making a medical diagnosis. Many poor claimants receive

III-33
their medical care in hospital emergency rooms and busy public clinics and do

not have regular physicians who will be able to adequately document their

functional limitations (6,91).26

The Functional Limitation Test

The functional limitation tests have been the most strongly criticized

part of the SSA’s new “HIV Infection Listing” (191). The POMS “Symptomatic

HIV Infection” criteria contained a functional limitation test,27 but it was

much less stringent than the new SSA functional limitation test, despite the

fact that the new “HIV Infection Listing” includes many of the same conditions

included in the POMS “Symptomatic HIV Infection” criteria. In other words,

the SSA may have made it more difficult for certain individuals with HIVrelated conditions to receive disability.28

The functional limitation test of the new “HIV Infection Listing”

requires that claimants demonstrate marked limitations in two functional

areas. The SSA explains that a claimant has marked restrictions in activities

26 The SSA does provide consultative examinations if a person does not have

sufficient medical evidence to document a claim for disability (95) . From

this medical evidence the DDS adjudicator might be able to ascertain

functional limitations; however, the claimant must wait until the SSA has

ascertained that it cannot obtain enough evidence and has scheduled a

consultative exam.

27 The functional limitation test under the POMS “Symptomatic HIV Infection

Listing” only required that a claimant demonstrate marked restriction in

activities of daily living ~ deficiencies of concentration, persistence, or

pace.

28 The new “HIV Infection Listing” has a stricter functional limitation test

than the POMS “Symptomatic HIV Infection” criteria. The new “HIV Infection

Listing” does not require, however, that an HIV-infected person have both a

CD4+ lymphocyte count at or below 200 cells/mm3 and one or more HIV-associated

conditions. Nonetheless, HIV-infected persons who would have met the “POMS

Symptomatic HIV Infection” criteria must now document more extensive

functional limitations.

III-34
of daily living if most of the time the claimant is unable to perform

activities of daily living, such as household chores, grooming and hygiene,

taking public transportation, or paying bills. The claimant is markedly

restricted in social functioning if most of the time the claimant cannot

interact appropriately and communicate effectively with others. Marked

difficulties in completing tasks in a timely manner due to concentration

deficiencies means that, most of the time, the claimant is unable to sustain

concentration, persistence, or pace to permit timely completion of tasks found

in work settings. To meet the final functional limitation test- -repeated

episodes of decompensation- -the claimant must document repeated episodes of

deterioration or decomposition in work or work-like settings, averaging three

times a year, lasting 2 weeks or more per episode, and which cause his or her

condition to deteriorate (e.g., repeated hospitalizations) (56 F.R. 65496).

The presence of two or more of these functional limitations establishes

that the person cannot perform any substantial gainful activity (46). The

functional limitation test is therefore used to establish the claimant’s

.

disability status and his or her medical condition is needed to establish that

there is an underlying organic cause for the dysfunction (46). This

distinguishes the “HIV Infection Listing” from most other medical listings for

disability which do not require that claimants extensively document their

ability to engage in personal hygiene, interact, or perform in the

workplace.29

29 To the extent a Listing contains functional tests, these are usually quite

general (e.g., documentation of interference with daily activities caused by

neurological impairments or by restrictions in mobility caused by

musculoskeletal impairments (20 C.F.R. Part 404, Subpt. P, App. 1, Sec. 11.01,

1.01)).

III-35
The functional limitation test included in the SSA’s “HIV Infection

Listing” is derived from the functional limitation test included in the Mental

Disorders section of the “Listing of Impairments” (20 C.F.R. Subpt. P, App. 1,

Sec. 12.00). A functional limitation test is appropriate for evaluating

psychiatric illness because it is often difficult to judge the severity or

disabling impact of these conditions using typical medical diagnostic

techniques. The functional limitation test used for evaluating the severity

of disability due to mental impairments may, however, be ill-suited for

evaluating the severity of disability due to physical impairments.

For example, one of the functional limitation tests in the “HIVInfection Listing” requires that the claimant demonstrate repeated episodes of

decompensation or deterioration in work or work-like settings. Decompensation

is a psychological term which means “progressive loss of normal functioning in

favor of psychotic behavior” or “disorganization of the personality under

stress” (31a). For the “Mental Disorders Listing,” a person can establish

decompensation by documenting repeated failure to adapt to stressful

circumstances that cause the person to withdraw from the situation, coupled

with a difficulty in maintaining activities of daily living or maintaining

concentration, persistence, or pace (20 C.F.R. Part 404, Subpt. P, App. 1,

Sec. 1200(C)). It is unclear how a person with a physical impairment would

demonstrate decompensation.

The SSA has responded to this problem by establishing different criteria

for decompensation for the “HIV Infection Listing.” Repeated episodes of

decompensation can be demonstrated by at least three hospitalizations or

absences from work per year lasting at least 14 days each. The decompensation

test used in the “HIV Infection Listing” is, therefore, much less flexible

than the decompensation test used in the ‘Mental Disorders Listing.”

III-36
In the ‘Mental Disorders Listing," impairment of social functioning is

demonstrated by a history of altercations, fear of strangers, avoidance of

interpersonal relationships, social isolation, and a lack of awareness of

others’ feelings (20 C.F.R. Subpt. P., App. 1 Sec. 1200 (C)). For the “HIV

Infection Listing," impairment of social functioning is indicated by an

inability to communicate and interact with people. This may not be a very

sensitive test for determining disability in HIV-infected individuals. As

noted by attorneys for HIV-infected clients, many very ill people with HIV

infection are able to maintain close contacts with family and friends; indeed,

social interaction may be an ‘important and life-sustaining activity” (170).

Advocates for persons with HIV infection argue that having different

definitions for the same functional limitation test may cause confusion. They

are also critical of the fact that a person must document functional

limitations in two separate areas. They argue that many HIV-infected people

will be unable to work if they show a marked functional limitation in just one

area. For example, to demonstrate marked restrictions in activities of daily

living, one must show that most of the time he or she can’t groom or perform

personal hygiene, pay bills, or perform other household chores. State DDS

disability examiners in New York interpret ‘marked” to mean that the person is

unable to perform the activity approximately 80 percent of the time (111) .

This level of disability has been characterized by advocates and physicians’

groups as being close to a nursing home level of functioning (111). A person

is likely to lose his or her job prior to reaching this level of restriction

in activities of daily living (6).

Similarly, to demonstrate marked difficulties in completing tasks, one

must document that most of the time he or she cannot complete work tasks. One

would not expect a person who is unable to complete work tasks more than 50

III-37
percent of the time to be able to perform in the workplace, and it therefore

seems unnecessary to require that person to document another functional

limitation (170). One must remember that these claimants will already have

documented that they are HIV-infected and that they are either severely

immunocompromised (i.e. , they have a CD4+ lymphocyte count at or below 200

cells/mm3

) or suffer from one or more HIV-associated conditions that are

persistent and/or resistant to therapy.

One study has indicated that the ability to perform activities of daily

living may not be the best predictor of disability in persons with AIDS and,

presumably, in other persons with symptomatic HIV-infection. A recent

assessment of disability in 1024 persons with AIDS from various areas--

Atlanta; New Jersey; Seattle; Miami; Ft. Lauderdale; New Orleans; Dallas; and

Nassau County, New York30- -found that, despite the fact that approximately 50

percent of the sample could not work and a quarter needed some assistance,

.

only 2.6 percent had a very difficult time bathing or dressing, and that close

to 60 percent could do heavy housework and walk up 10 steps. Even among

respondents who had been hospitalized within 3 months of the interview, only

4.5 percent said they could not bathe or dress themselves and 40 percent could

do heavy housework and walk up 10 steps (55).31

30 The authors caution that the sample was not randomly selected and that

participants tended to be those persons who were more connected to the medical

service delivery system and may have included a disproportionate number of

persons who were less physically or mentally impaired. In addition, the study

consisted of a majority of ‘whiten males, a significant number identifying

themselves as homosexuals (55).

31 The overwhelming majority of AIDS patients who had significant difficulty

in bathing, washing, and doing heavy household chores, however, died within 11 a

months (55).

III-38
The authors’ analysis of the data led them to conclude that the ability

to engage in activities of daily living is not necessarily the best measure of

the degree of impairment, which they defined as limitations in functioning of

bodily organs or systems. The authors concluded that the ability to do

strenuous activities may be a better measure of the degree of physical

impairment and that the degree of physical impairment was strongly related to

ability to work. In addition, they found that when one controlled for

physical impairment, HIV-related symptoms and depression “had consistent

effects on disability,”32 and in particular, persistent symptoms such as

diarrhea or losing sleep due to night sweats may limit one’s ability to carry

out daily activity roles, such as employment (55). In other words, the

authors imply that disability determinations for HIV-infected persons should

focus primarily on the nature of conditions and symptoms related to HIV

infection and the impact these conditions and symptoms have on a person’s

ability to consistently perform daily life roles, such as occupational roles.

The Impact of the SSA’s New “HIV Infection Listing" on Women

The SSA added cervical cancer to the “HIV Infection Listing” so that

HIV-infected women with Stage II cervical cancer- -cancer that has progressed

beyond the cervix- -need not document functional limitations in order to

receive disability. Gynecologists and other groups contend that a woman may

be disabled before her cancer progresses to Stage II, and recommend that

disability not be limited to Stage II (6,170).

32 Disability was defined as limitations in performing important social roles,

such as occupational roles (55).

III-39
The SSA also added vulvovaginal candidiasis and genital herpes to the

“HIV Infection Listing”; however, to meet the Listing an

must document that these conditions persist continuously

and that she has marked functional limitations.

HIV-infected woman

over a 2-month period

Pelvic inflammatory disease (PID) is not included in the “HIV Infection

Listing,” nor are two other serious gynecological diseases that the American

Medical Association claims may occur more frequently in HIV-infected women:

chronic genital ulcers and recurrent herpes (24). With respect to PID, the

SSA did instruct its adjudicators that this condition, in combination with

other HIV-associated conditions, may be disabling and that the adjudicators

should determine whether the conditions of a claimant with pelvic inflammatory

disease equals the “HIV Infection Listing,” even though the condition is not

included in the Listing.33

Advocates argue that HIV-infected women who document recurrent episodes

of these gynecological conditions should be awarded “disability without having

to also document marked functional limitations. They argue that an HIVinfected woman is disabled if she has had three or more episodes of PID, or

.

one episode of PID that is resistant to therapy and requires hospitalization

and/or surgery (59). Similarly, they contend that recurrent herpes lesions

are disabling if the lesions recur more often than once every 8 weeks and if

the lesions are incompletely suppressed despite continuous therapy (112).

Finally, they question why SSA excluded PID and genital ulcers from the “HIV

Infection Listing,” since HIV-infected women with these conditions would also

need to document functional limitations in order to meet the Listing.

33 These instructions are similar to the instructions given in the March 1991

program circular that the SSA issued on evaluating disability in women (228).

111-40
——. —

The SSA would likely respond that the DDS adjudicators have the

discretion to award a woman disability if her gynecological conditions are

equally severe to the conditions contained in the ‘HIV Infection Listing."

Moreover, if a disabled woman does not meet the “HIV Infection Listing,” she

can still receive disability at a later step in the disability determination

process. At the heart of the controversy over SSA’s disability evaluations,

however, is the question of whether the DDS examiners exercise this discretion

or whether they primarily rely on stated disability criteria. With respect to

SSA’s second point, advocates argue that because HIV infection is ultimately

fatal, the disability process should be simplified so that benefits are

awarded at the earliest stage possible.

Presumptive Disability and HIV Infection

On December 18, 1991, the SSA also issued a notice of proposed

.

rulemaking and a final rule to revise its regulations governing presumptive

disability under SSI (56 F.R. 65682, 65714). Under the final rule, field

offices will no longer be limited to awarding presumptive disability to

persons with CDC-defined AIDS (56 F.R. 65682). Instead, the field offices

will be able to award presumptive disability benefits to all HIV-infected

claimants who meet the SSA’s new “HIV Infection Listing.” The personnel in

the field offices are not trained to evaluate medical evidence, so they will

send checklists to the treating physicians of SSI claimants who allege HIV

infection. The checklist itemizes the HIV-associated conditions and

functional limitations that meet the SSA’s new “HIV Infection Listing" (see

app. K). If the claimant’s physician verifies that the claimant meets the

“HIV Infection Listing,” the field office will award the claimant presumptive

111-41
disability benefits (56 F.R. 65714). In the event that the field office does

not award presumptive disability benefits, the DDS offices may award

presumptive disability benefits when they find sufficient evidence to conclude

that the person is likely to be disabled (56 F.R. 65714).

When the CDC definition of AIDS was used for presumptive disability

determinations, the field office could confirm the case with a phone call to a

physician or other health care provider because the medical community also

uses the CDC definition of AIDS. In contrast, health care providers may not

be familiar with the “HIV Infection Listing” because it will not be used in

clinical care. The SSA has responded to

that will be sent to physicians who will

“HIV Infection Listing." This procedure

continue to award presumptive disability

this problem by devising a checklist

verify that their patients meet the

should enable the field offices to

to a larger group of HIV-infected

individuals. In addition, by using a standard form for all HIV-infected

claimants, the SSA hopes to simplify presumptive disability determinations.

.

However, there is some concern that the confusion

procedure will outweigh its benefits. The physician is

the presumptive disability form and mail it back to the

many State DDS offices also send forms to physicians in

information on specific impairments, such as AIDS.34 If

caused by the new

expected to fill out

field office; yet,

order to gather

a physician first

receives the field office presumptive disability form and then several days

later receives a more detailed medical form from the State DDS, the physician

may only fill out one form because he or she believes this is sufficient, or

because of time constraints (182a). It may be unreasonable to expect

34 Although the SSA did not know how many State DDS offices have such a

system, an official said this system is not unusual, especially in States with

major metropolitan areas (46).

III-42
physicians who are treating a large number of HIV-infected patients to fill

out two similar forms on the same patient, possibly requiring the physician to

review the patient’s record twice (29).

If the treating physician only fills out the field office form,

believing this to be sufficient, then the State DDS either will be left with

little information or will have to go back to the physician to remind him or

her to fill out the DDS form. One State DDS has suggested that the physician

should only be expected to fill out the State DDS form. The DDS can then

award presumptive disability benefits if warranted and proceed with the final

disability determination (182a). This alternative would ensure that the one

document received from the physician would provide all the information that is

needed.

The debate over the CDC definition of AIDS arose in large part because

the case definition was being used in Social Security disability

determinations. Advocates for HIV-infected women and injection drug users

have presented numerous examples of their very ill clients who were denied

disability by SSA. Some of these clients were often awarded disability on

appeal, providing support for the advocates’ position that the clients were

wrongly denied disability. The advocates claim that the use of the CDC

definition of AIDS in disability determinations biased the DDS adjudicators

against HIV-infected individuals who did not have an AIDS-defining illness, a

claim the SSA strongly denied. One court has indicated, however, that SSA’s

failure to issue regulations making AIDS and the POMS “Symptomatic HIV

Infection” criteria equal to a Listing may have violated the Administrative

Procedure Act.

III-43
It is difficult to sort out why seemingly deserving HIV-infected

claimants were being denied disability. They may have been the most egregious

cases, or they may be indicative of a larger problem warranting further

investigation. One cannot discern the way in which claims were decided from

SSA statistics on allowances and denials. However, the statistics do indicate

that persons who had AIDS or who met the POMS “Symptomatic HIV Infection”

criteria were significantly more likely to receive disability benefits.

Moreover, several reports about the SSA’s procedures for determining residual

functional capacity, including concern about the quality control system and

the differing assessments of residual functional capacity among DDS examiners

and administrative law judges, may warrant further investigation. Finally, it

is of note that the Second Circuit court opinions that the SSA failed to

incorporate into its disability process were decisions that appeared to

facilitate a finding of disability for certain claimants.

With the new “HIV Infection Listing,” the SSA has clearly demonstrated

that changes in the CDC definition of AIDS will not necessarily be

incorporated into the disability process and that all persons who meet the

proposed CDC definition of AIDS will not automatically receive disability.

Nonetheless, people with the AIDS-defining conditions included in the 1987

case definition (except Kaposi’s sarcoma) will continue to be judged disabled

on the basis of their medical condition alone, whereas HIV-infected

individuals with other serious diseases, including conditions that may result

in hospitalization and death, will also need to prove that they have

functional limitations in two of the following areas: activities of daily

living, social functioning, difficulties in completing tasks, and repeated

episodes of deterioration or decompensation in work or work-like settings.

III-44
The new debate over SSA’s disability determinations now centers on

whether the functional limitation test included in the new “HIV Infection

Listing” is reasonable. Critics contend that the SSA should have developed

strictly medical criteria for determining disability for persons with any one

of the HIV-associated conditions included in the Listing. A number of medical

experts and persons who are knowledgeable about HIV infection insist that the

functional limitation test is too stringent, especially the requirement that

an HIV-infected claimant must document two out of four possible functional

limitations. HIV-infected persons may be unfairly barred from obtaining

disability because they are unable to document functional limitations to this

degree. It may be especially difficult for poor and uninsured HIV-infected

claimants to document marked functional limitations in two separate areas

because they do not have a continuing relationship with a single physician.

The functional limitation tests appear to demand detailed documentation

involving physician input.

The debate over the SSA’s disability determinations for people with HIV

infection is probably not over, as the overwhelming number of public comments

on the SSA’s new “HIV Infection Listing” demonstrate. The impact that the new

“HIV Infection Listing” will have on HIV-infected women and injection drug

users is not yet known. The SSA claims, however, that the new "HIV Infection

Listing” will not increase the overall number of HIV-infected individuals who

obtain disability.

The new “HIV Infection Listing” does separate the debate on the SSA’s

disability determinations for persons with HIV from the debate about the

appropriate surveillance case definition of AIDS. The CDC’s definition of

AIDS cannot be expected to adequately serve both the purposes of surveillance

and disability.

III-45
—

Appendix A--Glossary of Acronyms and Terms

Abbreviations

ADA

AHCPR

AIDS

APA

ARC

AZT

CAP

CDC

CFR

CNS

CRS

CSTE .

DDS

DHHS

DI

ELISA

FR

FY

GAO

HIV

HPV

HRSA

HTLV - III

HUD

--Americans With Disabilities Act of 1990 (Public Law 101-336)

--Agency for Health Care Policy and Research (Public Health

Service)

--acquired immunodeficiency syndrome

--Administrative Procedure Act

--AIDS-related complex

--azidothymidine (now zidovudine)

--College

--Centers

--Code of

--central

of American Pathologists

for Disease Control (PHS)

Federal Regulations

nervous system

--Congressional Research Service (U.S. Congress)

--Conference of State and Territorial Epidemiologists

--State Disability Determination Service (SSA)

--U.S. Department of Health and Human Services

--Social Security Disability Insurance

--enzyme-linked immunosorbant assay

--Federal Register

--fiscal year

--General Accounting Office (U.S. Congress)

--human immunodeficiency virus

--human papilloma virus

--Health Resources and Services Administration (DHHS)

--human T-cell lymphotropic virus, type 111 (now referred to as

HIV)

--U.S. Department of Housing and Urban Development

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LAV

MACs

NIAID

NIH

OR

OTA

PCP

PHS

PID

POMS

SSA

SSI

SSR

U.S. C.

--lymphadenopathy-associated virus (now referred to as HIV)

--Multicenter AIDS Cohort Study

--National Institute of Allergy and Infectious Diseases (NIH)

--National Institutes of Health (PHS)

--Office of Research (Health Care Financing Administration)

.

--Office of Technology Assessment (U.S. Congress)

--pentachlorophenal

--Public Health Service (DHHS)

--pelvic inflammatory disease

--Program Operations Manual System (SSA)

--Social Security Administration (DHHS)

--Supplemental Security Income

--Social Security Ruling

--United States Code

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Terms

NOTE: # - AIDS-defining condition

Access: Potential and actual entry of a population into the health care

delivery system.

Activities of daily living: Activities related to personal care, including

bathing, dressing, getting in and out of bed or a chair, using the

toilet, and eating.

Acquired immunodeficiency syndrome (AIDS): See AIDS.

Administrative law judge: One who presides at an administrative hearing, with

power to administer oaths, take testimony, rule on questions of

evidence, and make agency determinations of fact.

African Americans: Americans having origin in any of the black racial groups

in Africa.

AIDS (acquired immunodeficiency syndrome): A condition, caused by infection

with the retrovirus human immunodeficiency virus (HIV), in which the

primary defect is an acquired, persistent, and profound functional

depression in cell-mediated immunity; this depression often leads to

infections caused by micro-organisms that usually do not produce

infections in individuals with normal immunity (e.g. , Pneumocystis

carinii pneumonia) or to the development of rare cancers (Kaposi’s

sarcoma, B-cell non-Hodgkin’s lymphoma) that occur more frequently in

immunocompromised individuals than in persons with normal immunity. HIV

infection can be transmitted from one infected individual to another by

means that include the sharing of a contaminated intravenous needle and

engaging in unprotected sexual intercourse (i.e., intercourse without

the use of a condom) with an infected person.See also CDC’s case

definition of AIDS.

AIDS-defining condition: In the Centers for Disease Control’s (CDC) 1987

surveillance case definition of AIDS, a person who has any of the

following 23 indicator conditions --and who meets other conditionspecific criteria specified in the definition (e.g., an age requirement,

a requirement for a positive HIV test)--is considered to have AIDS:

1) candidiasis of bronchi, trachea, or lungs;

2) candidiasis, esophageal;

3) coccidiodomycosis (disseminated or extrapulmonary) ;

4) cryptococcosis (extrapulmonary) ;

5) cryptosporidiosis (chronic intestinal, with diarrhea of more than

l-month’s duration);

6) cytomegalovirus disease of an organ other than the liver, spleen,

or nodes;

7) cytomegalovirus retinitis (with loss of vision)

8) HIV encephalopathy;

9) herpes simplex virus infection causing chronic ulcers or

bronchitis, pneumonitis, or esophagitis;

10) histoplasmosis (disseminated or extrapulmonary) ;

11) isosporiasis (chronic intestinal of more than l-month’s

duration);

APX. A-3
12)

13)

14)

15)

16)

17)

18)

19)

20)

21)

22)

23)

Kaposi’s sarcoma;

lymphoma, noncleaved small cell (Burkitt’s or non-Burkitt’s);

lymphoma, immunoblastic or large cell;

lymphoma, primarily in brain;

Mycobacterium avium complex or M. kansasii (disseminated or

extrapulmonary) ;

Mycobacterium tuberculosis (disseminated or extrapulmonary) ;

Mycobacterium, other species or unidentified species

(disseminated or extrapulmonary);

Pneumocystis carinii pneumonia;

progressive multifocal leukoencephalopathy;

Salmonella septicemia, recurrent;

toxoplasmosis of the brain;

HIV wasting syndrome.

These 23 conditions are strongly associated with severe

immunodeficiency, occur frequently in HIV-infected individuals, and

cause serious morbidity or mortality. Some of these conditions, when

diagnosed definitively or presumptively (i.e., on the basis of clinical

signs and symptoms), are considered indicators of AIDS only if a patient

has a positive test for HIV, but some of these conditions (e.g.,

Pneumocystis carinii pneumonia when diagnosed definitively) are

considered indicators of AIDS even if a patient has a negative test for

HIV.

In children (under 13 years old), additional AIDS-defining conditions

apply that do not apply in adults or adolescents:

1) bacterial infections, serious and multiple or recurrent;

2) lymphoid interstitial pneumonia or pulmonary lymphoid

hyperplasia. .

AIDS dementia: A form of dementia that is due to brain infection by HIV.

AIDS dementia is an AIDS-defining condition (HIV encephalopathy) if

severe (e.g. , interfering with occupation or activities of daily

living). See dementia.

AIDS-related complex (ARC): A complex of signs and symptoms representing a

less severe form of HIV infection than classic AIDS, characterized by

chronic generalized lymphadenopathy, recurrent fevers, weight loss,

minor alterations in the immune system, and minor infections. The term

was used for a period of time by the medical community for persons

infected with HIV and experiencing HIV-associated conditions and

symptoms that were not included in the CDC definition of AIDS.

Recently, however, the term has fallen out of use.

AIDS surveillance: Monitoring trends in the number and distribution of AIDS

cases and in the scope of severe morbidity due to infection with HIV.

The responsibility and authority for AIDS surveillance rests with

individual State and local health departments; these departments share

their data with the Centers for Disease Control (CDC) in the U.S. Public

Health Service.

Ambulatory medical care: Medical goods and services rendered outside of a

hospital or other inpatient health care facility, including such items

as physician office visits, outpatient laboratory diagnostic services,

and outpatient prescription drugs.

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Anal squamous cell carcinoma: A cancer of the anus with scaly or platelike

cells. See also cancer.

Anemia: A condition that exists when the level of hemoglobin in a person’s

blood drops to an abnormally low level (e.g., below 11 grams per

deciliter of whole blood).

Antibody: A blood protein (immunoglobulin) produced by white blood cells in

mammals in response to the introduction of a specific antigen (usually a

protein). Once produced, the antibody has the ability to combine with

the specific antigen that stimulated antibody production. This reaction

to foreign substances is part of the immune response.

Antigen: A specific type of substance, usually a protein or carbohydrate,

that when introduced into the body of a human or other mammal is

capable, under appropriate conditions, of inducing a specific immune

response (including antibody production) and of reacting with the

products of that response (i.e., specific antibody or specifically

sensitized T-lymphocytes or both) .

Antiretroviral therapy: Therapy to combat retroviruses such as HIV.

Antiretroviral therapy consisting of zidovudine to treat HIV-infected

persons is recommended for all persons with a CD4+ lymphocyte count

below 500 cells per cubic millimeter (/mm3).

Aspergillosis: A fungal infection caused by species of Aspergillus and marked

by inflammatory granulomatous lesions in the skin, ear, orbit, nasal

sinuses, lungs, and sometimes in the bones and meninges.

Asymptomatic: Showing or causing no symptoms.

AZT: See zidovudine.

.

Bacteremia: The presence of bacteria in the circulating bloodstream, an

indication of severe bacterial infection.

Bacterial pneumonia: Pneumonia caused by bacteria (e.g., Streptococcus

pneumoniae). Compare Pneumocystis carinii pneumonia.

Bacterium (pi., bacteria): Any of a group of one-celled micro-organisms

having round, rodlike, spiral, or filamentous bodies that are enclosed

by a cell wall or membrane and lack fully differentiated nuclei.

Bacteria may exist as free-living organisms in soil, water, organic

matter, or in the bodies of plants and animals. Some, but not all,

bacteria can cause disease.

Bronchoscopy: Examination of the bronchi (any of the larger air passages of

the lungs) through a bronchoscope (an instrument for inspecting the

interior of the tracheobronchial tree).

#Burkitt’s lymphoma: A type of noncleaved small cell lymphoma, manifested

most often as an osteolytic lesion in the jaw or as an abdominal mass.

The Epstein-Barr virus, a herpes virus, has been implicated as a

causative agent. In the CDC’s 1987 case definition of AIDS, Burkitt’s

lymphoma is considered an AIDS-defining condition.

Apx. A-5
Cancer: A tumor with the potential for invading neighboring tissue and/or

metastasizing to distant sites, or one that has already done so.

Cancers are categorized into major classes by their cell types. Thus,

for example, a carcinoma is a cancer of the epithelia, including the

external epithelia (e.g., skin and linings of the gastrointestinal

tract, lungs, and cervix) and the internal epithelia that line various

glands (e.g., breast, pancreas, thyroid). A sarcoma is a cancer made up

of cells resembling embryonic connective tissue, which normally develops

into tissues such as muscle, fat, bone, and blood vessels; sarcomas are

often highly malignant. A lymphoma is a cancer of cells of the immune

system (i.e. , the various types of lymphocytes).

Candida: A genus of yeastlike fungi of the family Cryptococcaceae, order

Monillales, characterized by producing yeast cells, mycelia,

pseudomycelia, and blastospores. It is commonly part of the normal

flora of the skin, mouth, intestinal tract, and vagina, but can cause a

variety of infections, including candidiasis. Candida albicans is the

usual pathogen.

#Candidiasis: Infection with a fungus of the genus Candida. It is usually a

superficial infection of the moist cutaneous areas of the body and is

generally caused by Candida albicans. In the CDC’s 1987 case definition

of AIDS, candidiasis of the esophagus, trachea, bronchi, or lungs is

considered an AIDS-defining condition.

Carcinoma: A cancer of the epithelia, including the external epithelia (e.g.,

skin and linings of the gastrointestinal tract, lungs, and cervix) and

the internal epithelia that line various glands (e.g., breast, pancreas,

thyroid).

Cardiomyopathy: A general diagnostic term designating primary myocardial

disease, often of obscure or unknown etiology.

.

Case control study: Studies that compare a group of people with a disease (or

other outcome event)--the cases- -to another group without the disease--

the controls- -and then determine whether they differ in their previous

exposure to a presumed causal agent. These studies are retrospective in

nature, the exposure having occurred prior to the identification of the

cases and controls.

Case report form: See AIDS case report form.

CDC’s case definition of AIDS: The definition of AIDS, set forth by the

Centers for Disease Control (CDC) in the Public Health Service of the

DHHS, that is used in AIDS surveillance. In 1982, before HIV was

identified as the agent that causes AIDS, the CDC defined AIDS as a

disease, at least moderately indicative of an underlying defect in cellmediated immunity, occurring in a person with no known cause for

diminished resistance to the disease. With the identification of HIV as

the causative agent for AIDS and the availability of laboratory tests to

detect HIV antibody, the case definition was revised in 1985 and again

in 1987 to reflect an increased understanding of HIV infection. The

1987 case definition lists 23 AIDS-defining conditions; these are severe

Apx. A-6
life-threatening opportunistic diseases highly specific for HIV

infection in persons who are not immunosuppressed for other reasons.

Under the CDC’s proposed case definition, to be implemented in the

summer of 1992, individuals with CD4+ lymphocyte counts below 200

cells/mm 3 would be considered to have AIDS in addition to individuals

who meet the criteria of the 1987 definition.

CDC’s classification system for HIV infection: A classification system

developed by the Centers for Disease Control (CDC) to categorize the

spectrum of manifestations of HIV infection for epidemiologic and

clinical purposes. The classification system currently in use divides

HIV infection into four broad categories (and numerous subcategories)

based on patients’ clinical disease states. In November 1991, the CDC

proposed a new classification system for HIV infection that would divide

HIV infection into nine mutually exclusive categories based on

combinations of three broad categories of clinical conditions associated

with HIV infection and three categories that reflect different ranges of

patients’ CD4+ lymphocyte counts.

CDC’s Adult/Adolescent Spectrum of HIV Disease Project: A project, including

nine centers throughout the United States, that was designed to examine

the spectrum of disease associated with HIV infection. Participants are

not a statistical sample of HIV patients. However, the project includes

both public and private hospitals and clinics, including hospitals and

clinics with a large number of indigent patients.

CD4+ lymphocytes: T-helper lymphocytes. CD4+ lymphocytes are the primary

target cell for HIV infection because of HIV’s affinity for the CD4+

lymphocyte cell surface marker. CD4+ lymphocytes coordinate a number of

important immunologic functions, and a loss of these functions results

in a progressive impairment of the immune response.

CD4+ lymphocyte count: The absolute number of CD4+ lymphocytes per cubic

millimeter of blood. This figure is number calculated as the product of

the total white blood cell count (white blood cells/mm3

) multiplied by

the percentage of lymphocytes (number of lymphocytes/number of

leukocytes * 100) and the percentage of CD4+ lymphocytes (number of CD4+

lymphocytes/number of gated lymphocytes * 100). Calculating the CD4+

lymphocyte count requires a hematologic measurement (the total ●

lymphocyte count) and a flow cytometry measure (the CD4+ percent of

total lymphocytes). The CD4+ lymphocyte count has been found to be a

marker of the progression of HIV-related immunosuppression (i.e. , a

decrease in the number of CD4+ lymphocytes correlates with an increase

in the risk and severity of HIV-related opportunistic infections,

cancers, and other manifestations of HIV-induced immunodeficiency) .

Under the CDC’s proposed case definition of AIDS, to be implemented in

the summer of 1992, any person with a CD4+ lymphocyte count of less than

200 cells/mm3 of blood is considered to have AIDS.

CD4+ percent of lymphocytes: CD4+ lymphocytes as a percentage of total

lymphocytes. This figure is calculated as the number of CD4+

lymphocytes divided by the number of gated lymphocytes (flow cytometry)

multiplied by 100. The CD4+ lymphocyte percent has been proposed as an

alternative to the CD4+ lymphocyte count because there is less

Apx. A-7
..

variability inherent in the measurement of CD4+ lymphocyte percent. The

CD4+ percent of lymphocytes is also technically easier to obtain,

because it involves only a flow cytometry measurement.

CD4+ lymphocyte testing: The use of flow cytometry and hematologic

measurements to determine a person’s CD4+ lymphocyte count or CD4+

percent of lymphocytes. In the United States, there are 600 to 1,000

labs with capabilities to perform CD4+ lymphocyte testing. The CD4+

lymphocyte test costs most labs about $50 plus personnel (an additional

$50) to perform. Charges range from $50 to $600, but the majority of

labs charge between $100 and $150.

Cell: The smallest membrane-bound protoplasmic body (consisting of a nucleus

and its surrounding cytoplasm) capable of independent reproduction.

Cell-mediated immunity: Immunity resulting from increase of activity by

living cells in the blood and other tissues (e.g., T-lymphocytes,

natural killer cells) that directly and nonspecifically destroy foreign

material. See also immunitv.

Cervical cancer: Cancer of the uterine cervix (neck). See also cancer,

Cervical dysplasia: Abnormalities in the cells of the epitheliums of the

uterine cervix (neck). Cervical dysplasia is thought to be a precursor

to cervical cancer.

Cervix: The neck of the uterus.

Class action suit: Litigation in which a small number of plaintiffs.

represents a class of plaintiffs which is similarly situated in terms of

the legal claims and/or factual occurrences.

.

#Coccidioidomycosis: A fungal infection caused by infection with Coccidioides

immitis. In the CDC’s 1987 case definition of AIDS, disseminated or

extrapulmonary coccidioidomycosis is considered an AIDS-defining

condition.

Cofactor: Factors or agents that are necessary for or that increase the

probability of the development of disease in the presence of the basic

etiologic agent of that disease.

.

#Cryptosporidiosis: Infection with protozoa of the genus Cryptosporidium. In

humans, such infection occurs both in immunocompetent persons

(especially those who work with cattle), in which it causes self-limited

diarrhea, and in immunocompromised persons, in whom it is much more

serious, being manifested clinically as prolonged debilitating diarrhea,

weight loss, fever, and abdominal pain. In the CDC’s 1987 case

definition of AIDS, intestinal cryptosporidiosis of more than l-month’s

duration is considered an AIDS-defining condition.

Cytomegalovirus: One of a group of highly host-specific herpes viruses that

infects humans, monkeys, or rodents. Depending on the age and immune

status of the host, cytomegalovirus can cause a variety of clinical

syndromes, known collectively as cytomegalic inclusion disease, although

the majority of infections is very mild or subclinical.

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#Cytomegalovirus disease: Symptomatic conditions caused by infection with

cytomegalovirus. In the CDC’s 1987 case definition of AIDS,

cytomegalovirus disease other than in the liver, spleen, or nodes is

considered an AIDS-defining condition.

#Cytomegalovirus retinitis: Inflammation of the retina of the eye due to

infection with cytomegalovirus. In the CDC’s 1987 case definition of

AIDS, this is considered an AIDS-defining condition.

cytology: The study of cells.

Cytometry: The counting of blood cells.

Cytotoxic: Poisonous to cells.

Decompensation: In psychiatry, it refers to failure of defense mechanisms,

resulting in progressive personality disintegration.

Definitive diagnosis: A diagnosis of a disease that is certainly known

because it is based on conclusive indicators (e.g. , histology, biopsy,

culture, antigen detection, or stool microscopy, as appropriate). For

public health reporting purposes, AIDS-defining conditions are

considered “definitively diagnosed” if they are diagnosed by methods

specified in Appendix II of CDC’s 1987 revision of the AIDS surveillance

definition. Diagnosis by any other methods is considered somewhat less

reliable, is called “presumptive.” Compare presumptive diagnosis.

Dementia: Organic loss of mental function, which may include deterioration of

intellectual function, memory loss, and personality changes, without

altered consciousness. Many types of dementia are thought to involve

structural and biochemical abnormalities in the nervous system. .

Disability: For purposes of the Supplemental Security Income (SSI) and the

Social Security Disability Insurance (DI) programs, disability is

defined as an inability to engage in any substantial gainful activity by

reason of any physical or mental impairment which can be expected to

result in death or which has lasted or can be expected to last for a

continuous period of not less than 12 months.

Disability determination service (DDS): Any of the 54 State and territorial

offices that, under regulatory authority with the Social Security

Administration (SSA) within the U.S. Department of Health and Human

Services, make disability determinations on individual applications for

Social Security disability benefits (e.g., under the Supplemental

Security Income (SSI) program).

Eczema: A pruritic papulovesicular dermatitis (inflammation or irritation of

the skin) occurring as a reaction to many endogenous and exogenous

agents. Also called “eczematous dermatitis.”

Encephalitis: Inflammation of the brain.

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Endocarditis: Inflammatory alterations of the endocardium (the endothelial

lining of the cavities of the heart and the connective tissue bed on

which it lies). Endocarditis may occur as a primary disorder or as a

. complication of or in association with another disease.

Entitlement programs: Government programs that provide a right to benefits or

income which may not be abridged without due process.

Enzyme-linked immunosorbant assay (ELISA) or enzyme immunoassay (EIA): A

method of testing for an antibody. The ELISA test for the HIV antibody

has become the most commonly used screening test for HIV.

Epidemic: A sudden increase in the incidence rate of a human illness,

affecting large numbers of people, in a defined geographic area.

Epidemiology: The scientific study of the distribution and occurrence of

human diseases and health conditions, and their determinants.

Epidemiologic studies: Studies concerned with the relationships of various

factors determining the frequency and distribution of specific diseases

in a human community.

#Esophageal candidiasis: Candidiasis of the esophagus (the musculomembranous

passage from the pharynx to the stomach). In the CDC’s 1987 case

definition of AIDS, this is considered an AIDS-defining condition. See

candidiasis.

Extraintestinal strongyloidiasis: Infection outside the intestine with S.

stercoralis, a species of Strongyloides. See strongyloidiasis.

Federal regulations: A statement by a Federal executive branch agency that

implements, interprets, or prescribes law or policy or describes the

organization, procedure, or practices of an agency. Federal agencies

are given the authority to issue regulations to implement specific

statutes, and the regulations have the same force of law as the statute.

Congress requires, however, that executive branch agencies promulgate

regulations in accordance with the procedures outlined in the

Administrative Procedures Act.

Fluorescence microscopy: A technique of microscopy that involves staining

cells with a fluorescent dye and then examining them under a microscope.

Flow cytometer: An instrument that will analyze thousands of particles (blood

cells, in this case) individually for light scatter and fluorescence

patterns. For CD4+ lymphocyte determinations, it is used to determine

what proportion, or percent, of the lymphocytes (identified by scatter

patterns) are positive for CD4+ lymphocytes (identified by

fluorescence) . This percentage is then used with a white blood cell

count and leukocyte differential to calculate the absolute number of

CD4+ lymphocytes. Each clinical flow cytometer costs approximately

$80,000 - $100,000 purchased new.

Flow cytometry: A technique for counting blood cells that involves the use of

a flow cytometer.

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Functional limitations: Restrictions in the ability to perform activities of

daily living and work-related activities.

Functional limitation test: A measure of degree to which an individual’s

functional activities are hindered by a physical or mental impairment.

The SSA has developed a functional limitation test for evaluating the

degree of impairment caused by HIV infection. The SSA will examine a

person’s ability to engage in activities of daily living (e.g. , ability

to do household chores, groom, perform personal hygiene); and social

activity (e.g. , ability to interact appropriately and communicate

effectively with others); and his or her ability to perform work-related

tasks in a timely and precise manner. The SSA will also take into

account whether the person has repeated episodes of illness or other

symptoms that limit his or her ability to adapt to work or work-like

settings.

Fungicide: An agent that kills fungi.

Fungus (pi., fungi): A general term used to denote a group of eukaryotic

protists, including mushrooms, yeasts, rusts, molds, smuts, etc. , which

are characterized by the absence of chlorophyll and by the presence of a

rigid cell wall composed of chitin, mannans, and sometimes cellulose.

Genital herpes: See herpes simplex virus infections.

Genital warts: See human papilloma virus infection.

Granulocytopenia: A symptom complex characterized by a marked decrease in the

number of granulocytes (cells containing granules, especially leukocytes

containing neutrophyl, basophil, or eosinophil) and by lesions of the

throat and other mucous membranes, of the gastrointestinal tract, and of

the skin.

Herpes genitalis (genital herpes): A sexually transmitted disease caused by

HSV-2. Symptoms include blister-like sores in the genital region, but

diagnosis is by an HSV viral cell culture or antigen detection

technique. Potential complications include aseptic meningitis,

recurrent infections, and possible maternal-to-infant transmission.

#Herpes simplex virus infections: Infections caused by herpes simplex virus

(HSV) type 1 or type 2 and usually characterized by the development of

one or more small fluid-filled vesicles with a raised erythematous base

on the skin or mucous membranes and occurring as a primary infection or

recurring because of reactivation of latent infection. Type 1

infections usually involve nongenital regions of the body (e.g. , herpes

labialis), whereas type 2 infections more commonly causes lesions on the

genital and surrounding areas (e.g., herpes genitalis). In the CDC’s

1987 case definition of AIDS, HSV infection leading to chronic ulcers or

bronchitis, pneumonitis, or esophagitis is considered an AIDS-defining

condition.

Herpes zoster: Also called shingles, this is an acute infectious, usually

self-limited, disease believed to represent activation of latent

varicella-zoster virus in those who have been rendered partially immune

Apx. A-n
after a previous attack of chicken pox. It involves the sensory ganglia

and their areas of innervation, characterized by severe neuralgic pain

along the distribution of the affected nerve.

Hispanics: Persons who identify themselves as of Hispanic origin, or, less

typically, individuals with Hispanic surnames identified by others

(e.g., health care providers identifying patients in surveys) as of

Hispanic origin. Hispanics can be those whose families have emigrated

directly from Spain, or from Cuba, Central America, or South America.

Persons of Hispanic origin can be of any race (e.g., white, black,

American Indian); most have been found to be white.

Histology: The area of anatomy that deals with the minute structure,

composition, and function of the tissues; also called microscopical

anatomy.

#Histoplasmosis: Infection resulting from inhalation, or infrequently, the

ingestion of spores of Histoplasmosis capsulatum. The infection is

asymptomatic in most cases, but in 1 to 5 percent of cases, it causes

acute pneumonia or disseminated reticuloendothelial hyperplasia with

hepatosplenomegaly and anemia. In the CDC’s 1987 case definition of

AIDS, disseminated or extrapulmonary histoplasmosis is considered an

AIDS-defining condition.

HIV(humanimmunodeficiency virus): The virus that causes acquired

immunodeficiency syndrome (AIDS). Two distinct subtypes of HIV have

been identified: HIV-1 was first isolated in 1983 and has a worldwide

distribution. HIV-2 was first isolated in 1986 and is found mainly in

West Africa.

HIV antibody test: A test to detect the presence of antibodies to the human

immunodeficiency virus (HIV) in the blood. The presence of the antibody

indicates infection with the virus. See also Enzyme-linked immunosorbant assay and Western blot.

HIV-associated conditions: A general term that includes medical conditions’

associated with HIV infection. This term is broader than the term AIDSdefining conditions, which refers only to conditions listed in the case

definition of AIDS set forth by the Centers for Disease Control.

#HIV encephalopathy: Degenerative disease of the brain that is due to

infection with HIV. In the CDC’s 1987 case definition of AIDS, this is

considered an AIDS-defining condition.

HIV infection: Infection with HIV (human immunodeficiency virus). Some HIVinfected people are asymptomatic. Some people manifest conditions that

are attributed to HIV infection and/or are indicative of a defect in

cell-mediated immunity; or conditions that are considered by physicians

to have a clinical course or management that is complicated by HIV

infection (e.g., candidiasis, vulvovaginal or oropharyngeal) . Finally,

some people with severe HIV-related immunodeficiency manifest conditions

that are strongly associated with severe immunodeficiency, and cause

serious morbidity or

conditions listed in

Pneumocystis carinii

mortality; these include the 23 AIDS-defining

the CDC’s 1987 case definition of AIDS (e.g. ,

pneumonia).

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HIV negative: Not showing any antibodies to HIV.

HIV positive: Showing antibodies to HIV (indicating infection with HIV).

HIV-related immunosuppression: Decrease in cell-medicated immunity caused by

infection with the human immunodeficiency virus (HIV). See also cellmedicated immunity.

#HIV wasting syndrome: A syndrome in HIV-infected persons characterized by

progressive involuntary weight loss and either chronic diarrhea or

chronic fever and weakness. In the CDC’s 1987 case definition of AIDS,

this is considered an AIDS-defining condition.

Hodgkin’s disease (or Hodgkin’s lymphoma): A form of malignant lymphoma

characterized by painless, progressive enlargement of the lymph nodes,

spleen, and general lymphoid tissue; other symptoms may include

anorexia, lassitude, weight loss, fever, pruritis, night sweats, and

anemia.

HTLV-III: Human T-cell lymphotropic virus, type III--now referred to as HIV.

.

Human immunodeficiency virus: See HIV.

Human papilloma virus infection: A papilloma virus that selectively infects

the skin or mucous membranes. These infections may be asymptomatic,

produce warts, or be associated with a variety at both benign and

. malignant neoplasms.

Immune: Protected against disease by innate or acquired (active or passive)

immunity.

Immune deficiencies: Any of a number of conditions (e.g., adenosine deaminase

deficiency, purine nucleoside phosphorylase deficiency, or AIDS)

resulting from a failure or malfunction of the bodily defense

mechanisms, or immune system.

Immunity: The condition of being immune (i.e. , protected against infectious

disease conferred either by the immune response generated by

immunization or previous infection or by other nonimmunologic factors

(i.e., innate immunity). See also cell-mediated immunity.

# Immunoblastic lymphoma or sarcoma: A malignant lymphoma composed of a

diffuse, relatively uniform proliferation of cells with rough or

convoluted nuclei and scanty cytoplasm. In the CDC’s 1987 case

definition of AIDS, immunoblastic lymphoma is considered an AIDSdefining condition.

Immumcompetent: Having a normal or adequate immune response.

Immunocompromised: Having the immune response attenuated by administration of

immunosuppressive drugs, by irradiation, by malnutrition, or by some

disease processes (e.g., cancer, AIDS).

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Immunodeficiency: A deficiency of immune response or a disorder characterized

by deficiency of immune response; classified as antibody (B cell),

cellular (T cell), combined deficiency, or phagocytic dysfunction

disorders. Cellular immunodeficiencies are marked by recurrent

infections with low-grade or opportunistic pathogens, by graft-versushost reactions following blood transfusions, and by severe disease

following immunization with live vaccines.

Immunophenotyping: The methodology by which cells are identified using

monoclinal antibodies directed at cell surface antigens. For HIVinfected specimens, this methodology commonly involves incubating

anticoagulated blood with fluorochrome-labelled monoclinal antibodies,

then lysing (killing) the red blood cells, so that only leukocytes

(white blood cells) remain. The cells are then analyzed by flow

cytometry for light scatter patterns (which identify various leukocyte

populations) and fluorescence intensity (identifying various

subpopulations of cells based on the presence or absence of antigens

labelled by the monoclinal antibodies).

Immunosuppressed: Having the immune response prevented or attenuated. Also

called immunodepressed.

.

Incidence: The frequency of new occurrences of disease within a defined time

internal. The incidence rate is the number of new cases of specified

disease divided by the number of people in a population over a specified

period of time, usually 1 year. Compare prevalence.

Incident cases: New cases of a disease within a defined time interval.

Informed consent: A person’s agreement to allow something to happen (e.g., a

medical procedure) that is based on a full disclosure of the facts

needed to make the decision intelligently. Informed consent is also the

name for a general principle of law that a physician has a duty to

disclose information about the risks of a proposed treatment to a

patient so that the patient may intelligently exercise his or her “

judgment about whether to undergo that treatment.

Injection drug user: A person who uses a hypodermic needle to inject illicit

drugs (e.g., heroin, amphetamines).

Inpatient care: Care that includes an overnight stay in a hospital or other

medical facility.

#Isosporiasis: Infection with coccidia from the genes Isospora. In the CDC’s

1987 case definition of AIDS, chronic intestinal isosporiasis with

diarrhea of more than l-month’s duration is considered an AIDS-defining

condition.

Apx. A-14

#Kaposi’s sarcoma: A multifocal, spreading cancer of connective tissue,

principally involving the skin; it usually begins on the toes or the

feet as reddish blue or brownish soft nodules and tumors. Previously

seen in older men of Jewish or Mediterranean descent, Kaposi’s sarcoma

is now one of the opportunistic diseases occurring in AIDS patients.
#Leukoencephalopathy: Any of a group of diseases affecting the white matter

of the brain, especially of the cerebral hemispheres, and occurring as a

rule in infants and children. Progressive multifocal

leukoencephalopathy is a generally fatal disease probably of viral

origin. Progressive multifocal leukoencephalopathy is an AIDS-defining

condition.

Listing: Any one of the more than 100 medical conditions that are included in

the Social Security Administration’s “Listing of Impairments”. Also

called “listed impairments.”

“Listing of Impairments”: See Social Security Administration’s “Listing of

Impairments.”

Lymphadenopathy: Lymph node enlargement in a region or regions of the body.

Lymphocytes: Specialized white blood cells involved in the body’s immune

response. B-lymphocytes originate in the bone marrow and when

stimulated by an antigen produce circulating antibodies (humoral

immunity). T-lymphocytes are produced in the bone marrow and mature in

the thymus gland and engage in a type of defense that does not depend

directly on antibody attack (cell-mediated immunity). Approximately 10-

15 percent of the body’s lymphocytes are natural killer cells.

#Lymphoma: Cancer of cells of the immune system (i.e. , the various types of

lymphocytes). In the CDC’s 1987 case definition of AIDS, Burkitt’s

lymphoma, immunoblastic lymphoma, and lymphoma of the brain are “

considered AIDS-defining conditions. See also cancer.

Medicaid: A federally-aided, State-administered program, authorized under

Title XIX of the Social Security Act; that provides medical assistance

to low-income elderly and disabled individuals; low-income pregnant

women and children; and families with dependent children who meet

specific income and family structure requirements. Medicaid regulations

are established by each State within Federal guidelines, and the

eligibility requirements and services covered vary significantly among

the States. In general, Medicaid covers medical, nursing home, and home

health care for individuals who meet the eligibility requirements for

those services. In some States, Medicaid also pays for adult day care

and in-home services such as personal care and homemaker services.

Financial eligibility for Medicaid is determined by a means test, in

which a ceiling is placed on the maximum income and assets an individual

may have in order to qualify for assistance. The income and assets

levels are quite low in all States.

“Medically needy” persons (under Medicaid): Persons who meet the nonfinancial

qualifications for Medicaid (e.g., the disability requirement) but whose

income or resources exceed eligibility levels. Not all States allow

Medicaid eligibility for “medically needy” people. The States with

programs for the medically needy provide a spend-down option so that

persons whose medical expenses greatly exceed eligibility income or

resource levels can obtain Medicaid.

Meningitis: Inflammation of the meninges (the three membranes that envelope

the brain and spinal cord).

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Mortality: Death.

Microscopy: Examination under or observation by means of the microscope.

#Mycobacterium: A genus of bacteria of the family Mycobacteriaceae, order

Actinomycetales, occurring as gram-positive, aerobic, mostly SlOWgrowing, slightly curved or straight rods, sometimes branching and

filamentous. It contains many species, including the highly pathogenic

organisms that cause tuberculosis (M. tuberculosis) and leprosy (M.

leprae). In the CDC’s 1987 case definition of AIDS, Mycobacterium avium

complex or M. Kansasii (disseminated or extrapulmonary) , M. tuberculosis

(disseminated or extrapulmonary), and disseminated or extrapulmonary

infection with other species of Mycobacterium are considered AIDSdefining conditions.

Name reporting of AIDS and HIV: The reporting of the names of persons known

to have AIDS or HIV infection to State or local health departments.

Nephropathy: Disease of the kidneys.

Nocardiosis: An acute or chronic suppurative infection, usually of the lungs

but with a marked tendency to spread to any organ of the body,

especially to the brain; abscess formation occurs in any organ, most

commonly in the lungs, brain, skin, or subcutaneous tissue. Lung

abscesses tend to cavitate with time. The causative agent in most

instances in Nocardia asteroids, but N. “brasiliensis and N. caviae

occasional cause cases.

Non-Hodgkin’s lymphoma: A heterogeneous group of malignant lymphomas, the

only common feature being an absence of the giant Reed-Sternberg cells

characteristic of Hodgkin’s disease. See lymphoma.

Notice of proposed rulemaking (NPRM): A notice of a Federal agency’s intent

to issue new regulations.

Opportunistic illness: The term includes infections caused by a microorganism that does not ordinarily cause disease but which, under certain

conditions (e.g. , impaired immune responses), becomes pathologic. The

term also includes cancers associated with immune suppression. Kaposi’s

sarcoma (a cancer) and Pneumocystis carinii pneumonia (an infectious

disease) in AIDS patients are examples of opportunistic illnesses. In

this paper, the term is often used synonymously with AIDS-defining

condition.

Oral candidiasis: See candidiasis.

Outpatient care: Care that is provided in a hospital and that does not

include an overnight stay.

Pap test: Papanicolaou’s test. A cell-staining procedure used for the

detection and diagnosis of various conditions, particularly malignant

and premalignant conditions of the female genital tract (cancer of the

vagina, cervix, and endometrium) .

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Pelvic inflammatory disease: A disease among females commonly associated with

sexually transmitted pathogens, the symptoms of which include abdominal

pain, fever, chills, vomiting, foul-smelling discharge, and postcoital

bleeding. Potential complications include sterility, chronic pain,

chronic infections, and even death. Methods of prevention include

limiting the number of sexual partners, using condoms, and avoiding the

use of intrauterine contraceptive devices. Treatment is with

antibiotics.

#Pneumocystis carinii pneumonia: A type of pneumonia caused by the protozoan

Pneumocystis carinii, which usually occurs in infants or debilitated

persons (e.g., persons receiving cytotoxic drugs, immunosuppressive

drugs) but is now one of the opportunistic diseases commonly found in

AIDS patients. In the CDC’s 1987 case definition of AIDS, P. carinii

pneumonia is considered an AIDS-defining condition. Diagnosed

definitively, it is considered indicative of AIDS even if a patient

tests negative for HIV if the patient has no other causes of underlying

immunodeficiency.

Pneumocystis pneumonia: See Pneumocystis carinii pneumonia.

Pneumocystis prophylaxis: The prevention of Pneumocystis carinii pneumonia

through the use of agents such as trimethoprim sulfamethoxazole or

aerosolized pentamadine. Prophylaxis against Pneumocystis carinii

pneumonia is recommended for all HIV-infected persons with CD4+

lymphocyte counts below 200 cells/mm3 of blood.

Pneumonia: A disease of the lungs characterized by inflammation and

consolidation, which is usually caused by infection or irritation. See

also Pneumocystis carinii pneumonia, bacterial pneumonia.

.

Presumptive diagnosis: A diagnosis of a disease that is presumed to be

correct but is not certainly known because it is not based on conclusive

indicators (e.g. , histology, biopsy, culture, antigen detection, or

stool microscopy, as appropriate). Compare definitive diagnosis.

Presumptive disability under the Supplemental Security Income (SSI) program:

The Social Security Administration (SSA) is mandated by Congress to

provide claimants who are “presumptively disabled or blind” with SSI

disability benefits during the time that their application is being

reviewed. Presumptive disability can be awarded by the field offices or

by the State Disability Determination Services (DDS). Field office

determinations of presumptive disability are usually restricted to

impairment categories that can be easily identified by a trained lay

person or can be easily confirmed with a single call to a physician or

other health care provider (e.g. , the amputation of two limbs,

allegation of total blindness) ; in 1985, AIDS became part of the

presumptive disability process at the field office level.

Determinations of presumptive disability that require more medical

knowledge are made by the State DDS, which has medically trained

personnel.

Apx. A-17
Prevalence: In epidemiology, the number of cases of disease, infected

persons, or persons with disabilities or some other condition, present

at a particular time and in relation to the size of the population.

Also called “prevalence rate.” Compare incidence.

Prevalent cases: Total number of cases of a disease present in a defined

population at a particular time.

Privacy rights: According to Black’s Law Dictionary, the term “right of

privacy” is a generic term encompassing various rights recognized to be

inherent in ordered liberty and such rights prevent governmental

interference in intimate personal relationships or activities, freedom

of the individual to make fundamental choices involving himself, his

family, and his relationship with others. It is said to exist only so

far as its assertion is consistent with law or public policy. Various

Federal and State statutes prohibit an invasion of a person’s right to

be left alone and also restrict access to personal information (e.g.,

income tax returns) and overhearing of private communications.

Program Operations Manual System: An internal Social Security Administration

(SSA) manual that instructs all SSA employees and the State Disability

Determination Service (DDS) employees on the SSA’s operating procedures.

#Progressive multifocal leukoencephalopathy: Leukoencephalopathy is of a

group of diseases affecting the white matter of the brain, especially of

the cerebral hemispheres, thought to be caused by a papovavirus.

Progressive multifocal leukoencephalopathy is a generally fatal disease

probably of viral origin. In the CDC’s 1987 case definition of AIDS,

this is considered an AIDS-defining condition.

Prophylaxis: The prevention of disease; preventive treatment.

.

Psoriasis: A common chronic squamous dermatosis, marked by exacerbations and

remissions and having a polygenic inheritance pattern. It is

characterized clinically by the presence of rounded, circumscribed,

erythematous, dry, scaling patches of various sizes, covered by grayish

white or silvery white, umbilicated, and lamellar scales, which have a

predilection for the extensor surfaces, nails, scalp, genitalia, and

lumbosacral region. ●

Pulmonary tuberculosis: See tuberculosis.

Regulations: See Federal regulations.

Residual functional capacity: The physical and mental tasks that a person can

still perform despite the physical and mental impairments caused by a

disease or other medical condition. When a SSA disability examiner

determines the applicant’s residual physical and mental capacity, he or

she focuses on the person’s ability to perform in a work environment.

The physical evaluation takes into account his or her ability to lift,

carry, push, pull, and perform other purely physical functions. The

mental evaluation concentrates on the ability to understand, carry out,

and remember instructions, and to respond appropriately to supervision,

coworkers, and work pressures. The assessment of residual functional

Apx. A-18
capacity is used to determine whether a disability claimant can still

perform his or her previous job, or can perform any meaningful job in

the national economy.

Retrovirus: Any of a large group of viruses that contain RNA, not DNA, and

that produce a DNA analog of their RNA through the production of an

enzyme known as ‘reverse transcriptase." (The resulting DNA is

incorporated into the genetic structure of the cell invaded by the

retrovirus.) HIV is a type of retrovirus.

Ryan White Comprehensive AIDS Resources Emergency Act of 1990 (Public Law 101-

381): An act that authorizes Federal funds for treatment, prevention,

and other services related to HIV. Funds are administered by the Health

Resources and Services Administration and the Centers for Disease

Control in the U.S. Department of Health and Human Services.

#Salmonella septicemia: The presence and persistence of bacteria of the genus

Salmonella in the blood. In the CDC’s 1987 case definition of AIDS,

recurrent Salmonella septicemia is considered an AIDS-defining

condition.

Sarcoma: A cancer made up of cells resembling embryonic connective tissue

which normally develops into tissues such as muscle, fat, bone, and

blood vessels; sarcomas are often highly malignant.

Sensitivity (of a test): One measure of the validity (or accuracy) of a

diagnostic or screening test: the percentage of all those who actually

have the condition being tested for who are correctly identified as

positive by the test. Operationally, it is the number of true positive

test results divided by the number of patients that actually have the

disease (true positives divided by the sum of true positives plus false

negatives) . Compare specificity.

Sepsis (bacterial or fungal): The presence in the blood or other tissues of

pathogenic micro-organisms or their toxins.

Septic arthritis: Inflammation of the joints caused by microbial infection.

Septicemia: Systemic disease associated with the presence and persistence of

pathogenic micro-organisms or their toxins in the blood.

Serology: The study of in vitro reactions of immune sera; or the use of such

reactions to measure serum antibody titers to infectious disease.

Sinusitis: Inflammation of a sinus. The condition may be purulent or

nonpurulent, acute or chronic.

Social Security Administration's ‘HIV Infection Listingw for disability

determinations: A proposed addition to the “Listing of Impairments, w

published for review and comment in 1991, that sets forth criteria for

determining disability in persons with HIV infection.

Social Security Administration’s ‘Listing of Impairmentsn

: A list of over 100

physical and mental impairments which the Social Security Administration

(SSA) considers to be so severe as to make a person disabled (i.e.,

Apx. A-19
unable to engage in any substantial gainful activity). The “Listing of

Impairments” is used in making disability determinations under SSA

disability programs. Any claimant who has a “listed impairment,” or an

impairment that is equal in severity to a listed impairment, is to be

considered disabled. The “Listing of Impairments” is published in the

Code of Federal Regulations (20 C.F.R., Part 404, Subpt P, Appendix 1).

Social Security Disability Insurance (DI): A Federal disability social

insurance program, administered at the Federal level by the Social

Security Administration within the U.S. Department of Health and Human

Services, for workers who have contributed to the Social Security

retirement program and have become disabled before retirement age.

Beneficiaries receive monthly cash payments.

Social Security Rulings: Statements by the Social Security Administration

(SSA) that draw upon and codify the policies and criteria used at all

levels of the administrative adjudication process (in administrative law

judge and Appeals Council decisions, in decisions by SSA disability

examiners, etc.). The rulings are binding on all components of the SSA,

including State disability examiners, administrative law judges, and the

SSA Appeals Council. Unlike SSA regulations, however, they are not

binding on Federal or State courts.

Soundex codes: Alpha-numeric codes used by the State or local health

department as a substitute for individuals’ names on AIDS case reporting

forms sent to the Centers for Disease Control (CDC) in the U.S. Public

Health Service. The CDC does not receive the names of persons with

AIDS; names are retained by the State or local health department.

Specificity (of a test): One measure of the validity (or accuracy) of a

diagnostic or screening test: the percentage of all those who do not “

have the condition being tested and who are correctly identified as

negative by the test. Operationally, it is the number of true test

negatives (all those with a negative test result who actually do not

have the condition being tested for) divided by the sum of true

negatives plus false positives (i.e., all those who do not have the

condition). Compare sensitivity.

Strongyloidiasis: Infection with S. stercoralis, a species of Strongyloides.

S. stercoralis (S. intestinalis) is a roundworm occurring widely in

tropical and subtropical countries. The female worm and her larvae

inhabit the mucosa and submucosa of the small intestine, where they

cause diarrhea and ulceration. The larvae expelled from an infected

person with his or her feces develop in the soil and penetrate the human

skin on contact. They eventually are carried in the bloodstream to the

lungs, where they cause hemorrhage (pulmonary strongyloidiasis) ; from

the lungs, they reach the intestine via the trachea and esophagus.

Massive infections may be seen in patients with depressed immune

systems.

Strongyloides: A genus of plasmids belonging to the superfamily Rhabditoidea,

widely distributed as intestinal parasites of mammals.

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Supplemental Security Income (SSI): A Federal income support program for lowincome disabled, aged, and blind persons. Eligibility for the monthly

cash payments is based on the individual’s current status without regard

to previous work or contributions to a trust fund.Some States

supplement the Federal benefit.

Surveillance: See AIDS surveillance.

“Symptomatic HIV Infection Not Indicative of AIDS":A category of disability

adopted by the Social Security Administration for use in disability

determinations under the DI and SSI programs that was equivalent to a

Listing.

Syndrome: The aggregate of symptoms considered to constitute the

characteristics of a morbid entity; used especially when the cause of

the condition is unknown.

T-cells (or T-lymphocytes): Specialized lymphocytes (white blood cells

involved in the body’s, immune response) that are produced in the bone

marrow and mature in the thymus gland and engage in a type of defense

that does not depend directly on antibody attack (cell-mediated

immunity). T-helper lymphocytes are known as CD4+ lymphocytes. Tsuppressor/cytotoxic lymphocytes are known as CD8+ cells. Normally,

about 2/3 of the T-cells are CD4+ lymphocytes, and about 1/3 are CD8+

lymphocytes.

Third-party payment: Payment by a private insurer or government program to a

medical provider for care given to a patient.

Thrombocytopenia: Decrease in the number of blood platelets.

#Toxoplasmosis: An acute or chronic widespread disease of animals and humans

caused by the protozoan Toxoplasma gondii, transmitted by oocysts

containing the pathogen in the feces of cats, usually by contaminated

soil or direct exposure to infected feces. Most human infections are

asymptomatic, but when symptoms occur, they may range from a mild, selflimited disease clinically resembling mononucleosis to a fulminating,

disseminated disease that may cause extensive damage to the brain, eyes,

skeletal and cardiac muscles, liver, and lungs. Severe manifestations

are seen principally in immunocompromised patients. In the CDC’s 1987

case definition of AIDS, toxoplasmosis of the brain is considered an

AIDS-defining condition.

Tuberculosis: A chronic infectious disease of humans and animals caused by

any of several species of mycobacteria. Tuberculosis usually begins

with lesions in the lung but can metastasize (spread) to other parts of

the body. Tuberculosis in the lung is known as pulmonary tuberculosis.

Vaginal candidiasis: See candidiasis.

Virology: The branch of microbiology that specializes in viruses.

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.

virus : Any of a large group of submicroscopic agents infecting plants,

animals, and bacteria and characterized by a total dependence on living

cells for reproduction and by a lack of independent metabolism. A fully

formed virus consists of nucleic acid (DNA or RNA) surrounded by a

protein or protein and lipid coat.

Wasting syndrome due to HIV: See HIV wasting syndrome.

Western blot: A method of separating proteins, such as antibodies, by

electrophoresis. The Western blot for HIV has become the most commonly

used confirmatory test for HIV.

Zidovudine (Retrovir): A drug used to reduce symptoms prolonging the lives of

persons infected with human immunodeficiency virus (HIV). This drug was

formerly called azidothymidine (AZT).

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—.. - .

Appendix B- -Evolution of the CDC's Case Definition of AIDS

In 1981, the Centers for Disease Control (CDC) in the U.S. Department of

Health and Human Services (DHHS) began surveillance for a newly recognized

constellation of diseases, now termed acquired immunodeficiency syndrome

(AIDS). As described below, CDC developed a surveillance case definition for

this syndrome in 1982 and received case reports directly from health care

providers and State and local health departments. Bear in mind that the CDC’s

case definition of AIDS was developed for surveillance purposes. According to

the CDC, the goals of AIDS surveillance are to monitor trends in the number of

AIDS cases and monitor the scope of severe morbidity due to infection with

human immunodeficiency virus (HIV)(219). Since 1982, the CDC’s case

definition has been revised twice, once in 1985 and once in 1987. In November

of 1991, the CDC proposed changing its definition once again.

.

The CDC’s 1982 Case Definition of AIDS

From 1980 to 1981, the CDC received its first reports of five cases

involving homosexual males diagnosed with Pneumocystis carinii pneumonia due

to severe immunodeficiency.1

From 1979 to 1981, CDC also received reports of

26 homosexual males diagnosed with Kaposi’s sarcoma. Of these 26 men, 6 also

had Pneumocystis carinii pneumonia (25 were white and 1 was African American)

(200).

1 Pzzeumocystis carinii pneumonia virtually always occurs in limited to

severely immunocompromised patients (199).

B-1
The CDC published its first case definition of what is now called

acquired immunodeficiency syndrome (AIDS) in September 1982 (201). The case

definition was “a disease, at least moderately predictive of a defect in cellmediated immunity, occurring in a person with no known cause for diminished

resistance to that disease” (see table B-l).

The CDC received reports of 593 cases of what is now called AIDS between

June 1, 1981 and September 15, 1982. Fifty-one percent of these 593 cases had

Pneumocystis carinii pneumonia without Kaposi’s sarcoma (with or without other

opportunistic infections) , 30 percent had Kaposi’s sarcoma without

Pneumocystis carinii pneumonia (with or without other opportunistic

infections) , 7 percent had both Pneumocystis carinii pneumonia and Kaposi’s

sarcoma (with or without opportunistic infections), and 12 percent had

opportunistic infections with neither Pneumocystis carinii pneumonia nor

Kaposi’s sarcoma. Men who have sex with men made up 75 percent of 593 cases

reported, while injection drug users made up 25.5 percent (201).

.

As of December 19, 1983, 3,000 cases that met the case definition of

AIDS had been reported to the CDC (202).2 The pattern of opportunistic

illnesses remained fairly constant with 51 percent of cases reporting

Pneumocystis carinii pneumonia without Kaposi’s sarcoma, 26 percent reporting

both Kaposi’s sarcoma without Pneumocystis carinii pneumonia, 7 percent both

Pneumocystis carinii pneumonia and Kaposi’s sarcoma, and 16 percent reporting

opportunistic infections without either Kaposi’s sarcoma or Pneumocystis

carinii pneumonia. Fifty-nine percent of the 3,000 AIDS cases reported

occurred among whites, 26 percent among African Americans, and 14 percent

2 This figure does not include 42 children under age 5 who met the

surveillance definition for pediatric AIDS.

B-2
among Hispanics. Women accounted for only 7 percent of the cases reported at

this time. The groups at highest risk for contracting AIDS were men who have

sex with men (71 percent) and injection drug users (17 percent) (202).

Men who have sex with men and injection drug users with immunodeficiency

represented the at-risk group for acquiring AIDS in 1982 when the syndrome was

initially defined. The indicators of AIDS were limited to Kaposi’s sarcoma

and opportunistic infections diagnosed without known causes of

immunodeficiency (87). Opportunistic illnesses that were most problematic for

the high-risk groups, and therefore met the criteria for the CDC’s 1982

definition of AIDS, are presented in table B-1. The CDC grouped symptoms into

five etiologic categories: protozoal and helminthic, fungal, bacterial,

viral, and neoplastic.

The CDC’s 1985 Case Definition of AIDS

After the CDC’s first case definition of what is now called AIDS was

published in 1982, researchers identified human immunodeficiency virus (HIV)

as the cause of AIDS.3 Furthermore, laboratory tests were developed to

identify the presence of the HIV antibody. The HIV laboratory test could be

used as a diagnostic indicator for severe manifestations of HIV disease that

were not included in the 1982 case definition. Consequently, the CDC changed

its AIDS surveillance definition in 1985 (see table B-2). Among other things,

the 1985 definition specified that in patients with a positive HIV test, cases

of disseminated histoplasmosis, isosporiasis causing chronic diarrhea,

3 At the time the virus was identified, HIV was termed human T-cell

lymphotropic virus, type III (HTLV-111)/lymphadenopathy-associated virus

(LAv).

B-3
bronchial or pulmonary candidiasis, non-Hodgkin’s lymphoma, and Kaposi’s

sarcoma in persons 60 years of age or over were considered cases of AIDS

(203).

From June 1981 to September 8, 1986, health departments and physicians

in the United States reported 24,576 cases of AIDS to the CDC. Of the

reported cases, 25 percent (6,192) occurred among African Americans and 14

percent (3,488) occurred among Hispanics, although African Americans and

Hispanics only make up 12 percent and 6 percent respectively of the U.S.

population. African American and Hispanic women accounted for 51 percent and

21 percent respectively of women with AIDS, while African American and

Hispanic men accounted for 23 percent and 14 percent respectively of men with

AIDS (205). The CDC estimated that approximately 750,000 people in the United

States were infected with the AIDS virus at the beginning of 1986 (215).

The CDC’s 1987 Case Definition of AIDS

In August of 1987, the CDC’s case definition of AIDS was once again

modified to reflect increases in the understanding of HIV infection, and the

1987 case definition is the definition currently in use (see table B-3). The

CDC’s goals in making the 1987 revision were: 1) to simplify AIDS reporting;

2) to make the definition consistent with standards of medical care for HIVinfected persons; and 3) to more accurately record the number of persons with

severe HIV-related immunosuppression (208).

The CDC expanded the case definition of AIDS to include 23 AIDS-defining

conditions, including bronchial, tracheal, or pulmonary candidiasis;

esophageal candidiasis; HIV encephalopathy; HIV wasting syndrome; and a

broader range of malignancies (208).

B-4
The 1987 case definition of AIDS is arranged in three sections according

to laboratory evidence of HIV infection: unknown or inconclusive HIV test,

positive HIV test, and negative HIV test (see table B-3). With laboratory

evidence of HIV infection, the 1987 definition allows some opportunistic

illnesses to be presumptively (rather than definitively) diagnosed. In other

words, these conditions (e.g. , Pneumocystis carinii pneumonia and Kaposi’s

sarcoma) in HIV-positive persons can be diagnosed on the basis of clinical

signs and symptoms, without confirmation by a laboratory test.

Twenty-nine percent of the 40,836 AIDS cases reported between September

1987 and December 1988 met the criteria of the CDC’s 1987 case definition only

and would not have been reported as AIDS cases under earlier definitions. The

use of the 1987 case definition of AIDS increased the proportions of AIDS

cases in women, injection drug users, and minorities. Of the cases meeting

only the criteria of the 1987 definition, 15 percent were women, as compared

with 9 percent of cases meeting the pre-1987 definition. Thirty-five percent

of the cases meeting only the 1987 definition were heterosexual injection drug

users, as compared with 18 percent meeting the pre-1987 definition. Of cases

meeting the 1987 definition only, 34 percent were African Americans, as

compared with 26 percent meeting the pre-1987 definition; and 21 percent were

Hispanic, as compared with 14 percent meeting the pre-1987 definition (211).

The CDC’s Proposed 1992 Case Definition of AIDS

In November of 1991, the CDC has proposed changing its case definition

of AIDS (219). The proposed case definition would count as AIDS cases persons

with the clinical conditions listed in the 1987 case definition (see table B3). In addition, the proposed case definition would include as AIDS cases all

HIV-infected adolescents and adults who have laboratory evidence of severe

B-5
HIV-related immunosuppression- -defined as a CD4+ lymphocyte count of below 200

cells per cubic millimeter (\mm3

) of blood (or a CD4+ percent of total

lymphocytes below 14 if the absolute count is not available). The proposed

expanded AIDS case definition also includes persons with clinical conditions

listed in the 1987 case definition (table B-3). The case definition of AIDS

is expected to become effective in the summer of 1992 (219).

B-6
Table B-1--CDC’s 1982 Case Definition of AIDS

In 1982, the Centers for Disease Control’s (CDC) case definition of what

is now referred to as acquired immunodeficiency syndrome (AIDS) was “a disease

at least moderately predictive of a defect in cell-mediated immunity,

occurring in a person with no known cause for diminished resistance to that

CDC, MMWR, September 1982). Examples of

opportunistic illnesses associated with the syndrome are listed below.

A. Protozoal and helminthic infections

1.

2.

3.

4.

Cryptosporidiosis, intestinal, causing diarrhea for over one month

(on histology or stool microscopy).

Pneumocystis carinii pneumonia (on histology or on microscopy of a

“touch” preparation or bronchial washings).

Strongyloidosis, causing pneumonia, central nervous system (CNS)

infection, or disseminated infection (on histology) .

Toxoplasmosis, causing pneumonia or CNS infection (on histology or

microscopy of a “touch” preparation).

B. Fungal infections

1. Candidiasis, causing esophagitis (on histology, microscopy of a “wet”

preparation from the esophagus, or endoscopic findings of white

plaques on an erythematous mucosal base).

2. Cryptococcosis, causing pulmonary, CNS, or disseminated infection (on

culture, antigen detection, histology, or India ink preparation of

CSF) .

.

C. Bacterial infection

.

1.

D. Viral

1.

2.

3.

“Atypical” mycobacteriosis (species other than tuberculosis or

lepra), causing disseminated infection (on culture).

infections

Cytomegalovirus, causing pulmonary, gastrointestinal tract, or CNS

infection (on histology).

Herpes simplex virus, causing chronic mucocutaneous infection with

ulcers persisting more than 1 month or pulmonary, gastrointestinal

tract, or disseminated infection (on culture, histology, or

cytology).

Progressive multifocal leukoencephalopathy (presumed to be caused by

papovavirus) (on histology).

E. Cancer

1. Kaposi’s sarcoma in persons less than 60 years of age (on histologic

study).

2. Lymphoma, limited to the brain.

SOURCE: Selik, R.M., Haverkos, H.W., Curran, J.W., “Acquired Immune

Deficiency Syndrome (AIDS) Trends in the United States, 1978-1982, ”

American Journal of Medicine 76(3):493-500, 1984.

B-7
Table B-2--The CDC’s 1985 Case Definition of AIDS

[The Centers for Disease Control agreed] that the following refinements be

adopted in the case definition of AIDS used for national reporting:

A. In the absence of the opportunistic diseases required by the current

[1982] case definition, any of the following diseases will be

considered indicative of AIDS if the patient has a positive serologic

or virologic test for HTLV-III/LAV [human T-cell lymphotropic virus,

type III/lymphadenopathy-associated virus, presently termed human

immunodeficiency virus (HIV)]:

1.

2.

3.

4.

5.

Disseminated histoplasmosis (not confined to lungs or lymph

nodes), diagnosed by culture, histology, or antigen detection;

Isosporiasis, causing chronic diarrhea (over 1 month), diagnosed

by histology or stool microscopy;

Bronchial or pulmonary candidiasis, diagnosed by microscopy or

by presence of characteristic white plaques grossly on the

bronchial mucosa (not by culture alone);

Non-Hodgkin’s lymphoma of high-grade pathologic type (diffuse,

undifferentiated) and of B-cell or unknown immunologic

phenotype, diagnosed by biopsy;

Histologically confirmed Kaposi’s sarcoma in patients who are 60

years old or older when diagnosed. .

B. In the absence of the opportunistic diseases required by the current

case definition, a histologically confirmed diagnosis of chronic

lymphoid interstitial pneumonitis in a child (under 13 years of age)

will be considered indicative of AIDS unless test(s) for HTLV-III/LAV

are negative.

C. Patients who have a lymphoreticular malignancy diagnosed more than 3

months after the diagnosis of an opportunistic disease used as a

marker for AIDS will no longer be excluded as AIDS cases.

D. To increase the specificity of the case definition, patients will be

excluded as AIDS cases if they have a negative result on testing for

serum antibody to HTLV-III/LAV, have no other type of HTLV-III/LAV

test with a positive result, and do not have a low number of T-helper

lymphocytes or a low ratio of T-helper to T-suppressor lymphocytes.

In the absence of test results, patients satisfying all other

criteria in the definition will continue to be included.

SOURCE: U.S. Department of Health and Human Services, Public Health Service,

Centers for Disease Control, Morbidity and Mortality Weekly Report,

“Revision of the Case Definition of Acquired Immunodeficiency

Syndrome for National Reporting--United States," 34(25):373-374,

1985.

B-8
Table B-3--The CDC’s 1987 Case Definition of AIDS

I. Without Laboratory Evidence Regarding HIV Infection

If laboratory tests for HIV were not performed or gave inconclusive

results . . . and the patient had no other cause of immunodeficiency listed in

Section I.A below, then any disease listed in Section I.B indicates AIDS if it

was diagnosed by a definitive method:

A. Causes of immunodeficiency that disqualify diseases as indicators of

AIDS in the absence of laboratory evidence for HIV infection.

1.

2.

3.

High-dose or long-term systemic corticosteriod therapy or other

immunosuppressive/cytotoxic therapy < 3 months before the onset of

the indicator disease.

Any of the following diseases diagnosed < 3 months after diagnosis

of the indicator disease: Hodgkin’s disease, non-Hodgkin’s

lymphoma (other than primary brain lymphoma), lymphocytic

leukemia, multiple myeloma, any other cancer of lymphoreticular or

histiocytic tissue, or angiommunoblastic lymphadenopathy.

A genetic (congenital) immunodeficiency syndrome or an acquired

immunodeficiency syndrome atypical of HIV infection, such as one

involving hypogammaglobulinemia.

B. Indicator diseases diagnosed definitively:

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

II. With

Candidiasis of the esophagus, trachea, bronchi, or lungs.

Cryptococcosis, extrapulmonary.

Cryptosporidosis with diarrhea persisting > 1 month.

Cytomegalovirus disease of an organ other than liver, spleen, or

lymph nodes in a patient”> 1 month of age.

Herpes simplex virus infection causing a mucocutaneous ulcer that

persists longer than 1 month; or bronchitis, pneumonitis, or

esophagitis for any duration affecting a patient > 1 month of age.

Kaposi’s sarcoma affecting a patient < 60 years of age.

Lymphoma of the brain (primary) affecting a patient < 60 years of

age.

Lymphoid interstitial pneumonia and/or pulmonary lymphoid

hyperplasia (LIP/PHL complex) affecting a child < 13 years of age.

Mycobacterium avium complex or M. kansasii disease, disseminated

(at a site other than or in addition to lungs, skin, or cervical

or hilar lymph nodes).

Pneumocystis carinii pneumonia.

Progressive multifocal leukoencephalopathy.

Toxoplasmosis of the brain affecting a patient > 1 month of age.

Laboratory Evidence of HIV Infection

Regardless of the presence of other causes of immunodeficiency (I.A.),

in the presence of laboratory evidence for HIV infection . . . any disease

listed above (1.B) or below (II.A or II.B) indicates a diagnosis of AIDS.

A. Indicator diseases diagnosed definitively:

1. Bacterial infections, multiple or recurrent (any combination of at

least two within a 2-year period), or the following types

affecting a child < 13 years of age:

B-9
2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

septicemia, pneumonia, meningitis, bone or joint infection, or

abscess of an internal organ or body cavity (excluding otitis

media or superficial skin or mucosal abscesses), caused by

Haemophilus, Streptococcus (including pneumococcus), or other

pyogenic bacteria;

Coccidiodomycosis, disseminated (at a site other than or in

addition to lungs or cervical or hilar lymph nodes);

HIV encephalopathy (also called “HIV dementia,” “AIDS dementia,”

or ‘subacute encephalitis due to HIV”) ...;

Histoplasmosis, disseminated (at a site other than or in addition

to lungs or cervical or hilar lymph nodes);

Isosporiasis with diarrhea persisting > 1 month;

Kaposi’s sarcoma at any age;

Lymphoma of the brain (primary) at any age.

Other non-Hodgkin’s lymphoma of B-cell or unknown immunologic

phenotype and the following histologic types:

a. small noncleaved lymphoma (either Burkitt or non-Burkitt type);

b. immunoblastic sarcoma (equivalent to any of the following,

although not necessarily all in combination: immunoblastic

lymphoma, large-cell lymphoma, diffuse histiocytic lymphoma,

diffuse undifferentiated lymphoma, or high-grade lymphoma)

Note: Lymphomas are not included here if they are of T-cell

immunologic phenotype or their histologic type is not described

or is described as “lymphocytic,” “lymphoblastic,” “small

cleaved,” or “plasmacytoid lymphocytic”;

Any mycobacterial disease caused by mycobacteria other than M.

tuberculosis, disseminated (at a site other than or in addition to

lungs, skin, or cervical or hilar lymph nodes),

Disease caused by M. tuberculosis, extrapulmonary (involving at

least one site outside the lungs, regardless of whether there is

concurrent pulmonary involvement) ;

Salmonella (nontyphoid) septicemia, recurrent;

HIV wasting syndrome (emaciation, “slim disease”).

.

B. Indicator diseases diagnosed presumptively:

Note: Given the seriousness of diseases indicative of AIDS, it is

generally important to diagnose them definitively, especially when

therapy that would be used may have serious side effects or when

definitive diagnosis is needed for eligibility for antiretroviral

therapy. Nonetheless, in some situations, a Patient’s condition will

not permit the performance of definitive tests. In other situations,

accepted clinical practice may be to presumptively based on the

presence of characteristic clinical and laboratory abnormalities.

1. Candidiasis of the esophagus;

2. Cytomegalovirus retinitis with loss of vision;

3. Kaposi’s sarcoma;

4. Lymphoid interstitial pneumonia and/or pulmonary lymphoid

hyperplasia (LIP/PHL complex) affecting a child < 13 years of age;

5. Mycobacterial disease (acid-fast bacilli with species not

identified by culture), disseminated (involving at least one site

other than or in addition to lungs, skin, or cervical or hilar

lymph nodes);

6. Pneumocystis carinii pneumonia;

7. Toxoplasmosis of the brain affecting a patient > 1 month of age.

B-10
III. With Laboratory Evidence Against HIV Infection

With laboratory test results negative for HIV Infection . . . a

diagnosis of AIDS for surveillance purposes is ruled out unless:

A. all the other causes of immunodeficiency listed above in Section I.A

are excluded; AND

B. the patient has had either;

1. Pneuznocystis carinii pneumonia diagnosed by a definitive method

. . . ; or

2. a. any of the other diseases indicative of AIDS listed above in

Section I.B diagnosed by a definitive method ...; and

b. a T-helper/inducer (CD4+

) lymphocyte count <400/mm3.

SOURCE: U.S. Department of Health and Human Services, Public Health Service,

Centers for Disease Control, “1987 Revision of Case Definition for

AIDS for Surveillance Purposes,” Morbidity and Mortality Weekly

Report 36(1S):4s-14s, 1987.

B-n
APPENDIX C--THE CDC’s AIDS CASE REPORTING FORM (FIGURE)

.

.

Physician”s Name: Phone No.: ( ) I

.
Appendix D-- Epidemiology of AIDS in Women, Injection Drug Users,

African Americans, and Hispanics

The epidemic of acquired immunodeficiency syndrome (AIDS) in the United

States has now entered its second decade, and the fastest growing populations

of people in the United States with AIDS are women, injection drug users,

African Americans, and Hispanics. Although the rate of increase in the number

of AIDS cases among homosexual and bisexual men (excluding those who are also

injection drug users) began declining by 1987 (215), the rate of increase in

the number of AIDS cases associated with injection drug use and heterosexual

transmission has continued to rise (212).

.

Through February 1992, 29 percent of all AIDS cases reported to the

Centers for Disease Control (CDC) in the U.S. Department of Health and Human

Services (DHHS) were among injection drug users (including male injection drug

‘users who reported having had sex with men)(223), as compared with 25.5

percent in 1982. The increased incidence of AIDS among injection drug users

in this country is associated with an increased incidence of AIDS among

minorities and women. A disproportionate number of HIV-infected injection

drug users are African American or Hispanic. As of February 1992, African

American men and women accounted for 50 percent of U.S. AIDS cases reported

among heterosexual injection drug users, and Hispanic men and women accounted

for 29 percent of AIDS cases among heterosexual injection drug users (223).

Similarly, a large number of AIDS cases among women in the United States

are associated with injection drug use. Approximately 50 percent of women who

were reported as AIDS cases to the CDC through February 1992 had used

injection drugs. An additional 21 percent of female AIDS cases occurred among

women who reported sexual contact with an injection drug user (223) .

D-1
.

The Epidemiology of AIDS in U.S. Women

By the end of February 1992, there were more than 22,000 reported cases

of AIDS among women in the United States (223). The incidence of AIDS among

U.S. women is climbing faster than the AIDS incidence among U.S. men. From

1988 to 1989, the annual number of AIDS diagnoses increased by 29 percent in

women and 18 percent in men (35). Between 1985 and 1990, the percentage of

adult AIDS cases occurring in women increased from 6.6 percent to 11.5 percent

(48).

In 1988, AIDS/HIV accounted for 3 percent of all deaths among U.S. women

of reproductive age(35).1 The number of deaths per year due to HIV/AIDS in

.

women of reproductive age increased from 18 in 1980 (35) to 5,730 in 1991

(222).

AIDS is now the eighth leading cause of death in U.S. women of

reproductive age. In New York and New Jersey, it is the leading cause of

death in women of reproductive age. If current

AIDS will become one of the five leading causes

reproductive age (35).

mortality trends continue,

of death for U.S. women of

African American and Hispanic women represent 72 percent of all U.S.

women diagnosed with AIDS as of 1989 (213). African American women, who

constituted 13.3 percent of U.S. women in 1988, represented 57.6 percent of

all women of reproductive age with AIDS between 1981 and 1989. Hispanic

women, who constituted 7.9 percent of U.S. women in 1988, accounted for 16.8

percent of all AIDS cases reported in women of reproductive age between 1981

1 Reproductive age for women is defined as 15 to 44 years of age.

Approximately 85 percent of women with AIDS are of reproductive age at the

time of their diagnosis (221).

D-2
and 1989. Non-Hispanic white women, who constituted 75.1 percent of the U.S.

women in 1988, accounted for 24.9 percent of the AIDS cases in women between

1981 and 1989 (216).

Death rates associated with HIV infection/AIDS are much higher for

African American women than for white women. In 1988, the death rate from HIV

infection was nine times higher for African American women of reproductive age

than for white women (213). For African American women, the age-adjusted

death rate for HIV/AIDS increased from 4.4 deaths per 100,000 population in

1986 to 10.3 deaths per 100,000 in 1988. For white women, the age-adjusted

death rate for HIV/AIDS increased from 0.6 deaths per 100,000 in 1985 to 1.2

deaths per 100,000 in 1988 (35).

The median survival time from AIDS diagnosis to death for women does not

differ significantly from that for heterosexual men. A recent study by

Ellerbrock and colleagues found that the median survival time from AIDS

diagnosis to death to be 9.8 months for U.S. women and 9.3 months for

heterosexual U.S. men (48). This study-found the 3-year survival rate after a

diagnosis of AIDS to be 20 percent for women and 19 percent for heterosexual

men. These findings differ from the findings of a previous study by

Rothenberg and colleagues, which found that the median survival time from AIDS

diagnosis to death to be shorter for women (263 days) than for men (357 days)

(145). One reason for

that the earlier study

men, including men who

the differences in the two studies’ findings may be

by Rothenberg and colleagues compared women with all

have sex with men; survival time in men who have sex

with men is higher than in other risk groups (in part because a higher

percentage of men who have sex with men have Kaposi’s sarcoma, which is

associated with a longer survival time than other opportunistic diseases)

D-3
(48) . Heterosexual men with AIDS may be a more appropriate comparison group

for women with AIDS because they are more similar demographically and have

risk factors similar to those of women with AIDS.

The Epidemiology of AIDS in U.S. Injection Drug Users

From the beginning of the AIDS epidemic through December 1991, there

have been 58,888 cumulative AIDS cases among injection drug users in the

United States (including male injection drug users who had sex with men)(222).

These cases represent 29 percent of all adult and adolescent AIDS cases

reported to the CDC in that period. In 78 percent (45,753) of the reported

AIDS cases among injection drug users, the only risk factor for HIV infection

reported was injection drug use (222). The high incidence of AIDS among

injection drug users is associated with an increased incidence of AIDS among

sexual partners of injection drug users and an increased

among children whose mothers are injection drug users or

injection drug users.

incidence of AIDS

are sex partners of

Higher HIV antibody seroprevalence rates are observed among African

American and Hispanic injection drug users than among non-Hispanic white

injection drug users. A review of 92 studies of the prevalence of HIV

infection among injection drug users by Hahn and colleagues found that the

risk of HIV infection was associated not only with male homosexual contact and

particular injection drug use practices, but also with African American or

Hispanic ethnicity (71). This racial/ethnic disparity may be explained, in

part, by differences in drug use behavior. In particular, the practice of

sharing needles or syringes among strangers and acquaintances appears to be

more common among African American and Hispanic injection drug users than

among non-Hispanic white injection drug users (154).

D-4
Of the 45,753 AIDS cases reported

users through December 1991, 50 percent

and women and 29 percent occurred among

among heterosexual injection drug

occurred among African American men

Hispanic men and women (222). Of the

AIDS cases reported among heterosexual sex partners of injection drug users,

52 percent were African American men and women and 26 percent were Hispanic

men and women (222) . Of the AIDS cases reported among female injection drug

users in the same time period, 58 percent were among African Americans and 20

percent were among Hispanics (222).

Regional variations in the distribution of AIDS cases in the United

States are evident. The injection-drug-using population most severely

affected by the AIDS virus is concentrated in northeastern cities, primarily

New York City and surrounding metropolitan areas (241), and in Puerto Rico

(71).

The Epidemiology of AIDS in African Americans and Hispanics

In 1991, the annual rate per 100,000 population of AIDS cases was 95.3

(11,059) among African American men and 69.9 (6,850) among Hispanic men. The

annual rate per 100,000 population among non-Hispanic white men was 27.8

(20,716)(222).

28 percent and

percent and 22

in 1991 (222).

Cases of AIDS in African Americans and Hispanics represented

17 percent, respectively, of the 39,093 male AIDS cases, and 52

percent, respectively, of the 4,890 female AIDS cases reported

HIV transmission among African American and Hispanic persons

with AIDS occurred predominantly through injection drug use (222).

As measured in terms of cumulative incidence rate, the relative risk of

AIDS in African Americans and Hispanics was approximately three times the risk

in non-Hispanic whites. The risks of AIDS in African American and Hispanic

men were 2.8 and 2.7 times, respectively, that of non-Hispanic white men

(157).

D-5
Racial disparities in the distribution of AIDS cases are even more

striking among women than among men. Between 1985 and 1990, 52 percent of

women with AIDS were African American and 21 percent were Hispanic (221).2

During this period, African American women had a cumulative

times that of non-Hispanic whites, and Hispanic women had a

incidence rate that was 8 times that of non-Hispanic whites

incidence rate

cumulative

(48).

In 1991, a total of 45,506 new AIDS cases were reported to the CDC.

annual rate of new AIDS cases for the U.S, population as a whole was 17.8

cases per

Hispanics

Americans

100,000 population for 1991. Annual rates for African Americans

were much higher- -49.2 cases per 100,000 in the case of African

and 31.4 cases per 100,000 for Hispanics (222).

the

13

The

and

2 Thirteen percent of all U.S. women are African American and 8 percent are

Hispanic.

D-6
Appendix E-- The CDC’s Current and Proposed Classification System

for HIV Infection

The Centers for Disease Control (CDC) has developed a classification

system for human immunodeficiency virus (HIV) infection in adolescents and

adults that categorizes the clinical conditions associated with the broad

spectrum of HIV infection- -from no symptoms of HIV infection to severe

manifestations of HIV infection. This classification system was created for

epidemiologic and clinical purposes. Unlike the CDC’s case definition of

AIDS, this classification system is not used for reporting purposes.

The CDC’s current HIV classification system, published in 1986, uses

clinical disease states to divide HIV infection into four broad clinical

categories. This system is described further in box E-1.

In November 1991, the CDC proposed revising its classification system

for HIV infection. The proposed system would sub-categorize the clinical

conditions associated with HIV infection on the basis of patients’ CD4+

lymphocyte counts.

.

As shown in box E-2, the proposed classification

laboratory categories (i.e., ranges of CD4+ lymphocyte

system includes three

counts) and three

clinical categories, resulting in a matrix of nine mutually exclusive

categories. In incorporating CD4+ lymphocyte counts along with various

clinical conditions, the CDC’s proposed classification system for HIV

infection is similar to the CDC’s proposed case definition of AIDS (see app.

B). The clinical categories in the proposed HIV classification system,

however, differ from those in the CDC’s proposed case definition. As shown in

box E-2, the clinical categories are as follows:

■ Clinical category A includes asymptomatic HIV infection, persistent

generalized lymphadenopathy, and acute primary HIV infection;

E-1
■ Clinical category B includes a variety of symptomatic conditions

are not included in the CDC’s 1987 surveillance case definition

which

of

AIDS, but which may be attributed to HIV infection or whose clinical

course or management is complicated by HIV infection; and

■ Clinical category

surveillance case

Clinical category B

C includes any condition listed in the CDC’s 1987

definition of AIDS.

of the proposed classification system for HIV

infection includes some conditions which a physician judges to be HIV-related

or the management of which is affected by HIV status. This category includes

many of the conditions (e.g., bacterial endocarditis, pneumonia, sepsis, and

pulmonary tuberculosis) that are noted to occur more commonly among HIVinfected injection drug users. Clinical category B also includes femalespecific symptoms that are not included in the CDC’s 1987 case definition of

AIDS. Cervical dysplasia or carcinoma and vulvovaginal candidiasis are

included in category B.

The 23 AIDS-defining conditions in the CDC’s 1987 case definition of “

AIDS, included in clinical category C, have a much stronger relation to

impairment of immune function caused by HIV-infection than do the conditions

included in category B.

E-2
Box E-l--The CDC’s Current Classification System for HIV Infection (HTLVIII/LAV)

The CDC’s current classification system for HIV infection was published

in 1986. At the time, HIV was known as human T-cell lymphotropic virus type

III/lymphadenopathy-associated virus.

The current classification system classifies HTLV-III/LAV infection into

four mutually exclusive groups, designated by Roman numerals I though IV and

described further below. Classification in a particular group is not

explicitly intended to have prognostic significance, nor to designate severity

of illness. However, classification in the four principal groups, I to IV, is

hierarchical, in that persons classified in a particular group should not be

reclassified in a preceding group if clinical findings resolve, since clinical

improvement may not accurately reflect changes in the severity of the

underlying disease.

Group I (Acute HTLV-III/LAV Infection) includes patients with transient

signs and symptoms that appear at the time of, or shortly after, initial

infection with HTLV-III/LAV as identified by laboratory studies. All patients

in Group I will be reclassified in another group following resolution of this

acute syndrome.

Group I is defined as a mononucleosis-like syndrome, with or without

aseptic meningitis, associated with seroconversion for HTLV-III/LAV antibody

(15-16). Antibody seroconversion is required as evidence of initial

infection; current viral isolation procedures are not adequately sensitive to

be relied on for demonstrating the onset of infections.

E-3
Group II (Symptomatic HTLV-III/LAV Infection) includes patients who

have had no signs or symptoms of HTLV-III/LAV infection. Patients in Group II

may be subclassified based on whether hematologic and/or immunologic

laboratory studies have been

with defects associated with

Group II is defined as

infection. To be classified

signs or symptoms that would

performed and whether test results are consistent

HTLV-III/LAV infection.

the absence of signs or symptoms of HTLV-III/LAV

in Group II, patients must have had no previous

have led to classification in Groups III or IV.

Patients whose clinical findings caused them to be classified in Groups III or

IV.should not be reclassified in Group II if those clinical findings resolve.

Patients in this group may be subclassified on the basis of a laboratory

evaluation. Laboratory studies commonly indicated for patients with HTLVIII/LAV infection include, but are not limited to, a complete blood count

(including differential with blood cell count) and a platelet count.

Immunologic tests, especially T-lymphocyte helper (CD4+

) and suppressor (CD8+)

cell counts, are also an important part of the overall evaluation. Patients

whose test results are within normal limits, as well as those for whom a

.

laboratory-evaluation has not yet been completed, should be differentiated

from patients whose test results are consistent with defects associated with

HTLV-III/LAV infection (e.g., lymphopenia, thrombocytopenia, decreased number

of helper (CD4+) T-lymphocytes).

Group III (Persistent

with persistent generalized

Generalized Lymphadenopathy) includes patients

lymphadenopathy, but without findings that would

lead to classification in Group IV. Patients in this category may be

subclassified based on the results of laboratory studies in the same manner as

patients in Group II.

E-4
Group III is defined as palpable lymphadenopathy (lymph node enlargement

of 1 centimeter or greater) at two or more extra-inguinal sites persisting for

more than 3 months in the absence of a concurrent illness or condition other

than HTLV-III/LAV infection to explain the findings. Patients in this group

may also be subclassified on the basis of a laboratory evaluation, as is done

for asymptomatic patients in Group II (see above). Patients with persistent

generalized lymphadenopathy whose clinical findings caused them to be

classified in Group IV should not be reclassified in Group III if those other

clinical findings resolve.

Group IV (other HTLV-III/LAV) includes patients with clinical symptoms

and signs of HTLV-III/LAV infection other than or in addition to

lymphadenopathy. Patients in this group are assigned to one or more subgroups

based on clinical findings: A) constitutional disease; B) necrologic disease;

C) secondary infectious diseases; D) secondary cancers; and E) other

.

conditions resulting from HTLV-III/LAV infection. There is no a priori

hierarchy of severity among subgroups A through E, and these subgroups are not

mutually exclusive.

The clinical manifestations of patients in this group may be designated

by assignment to one or more subgroups (A-E) listed below. Within Group IV, ●

subgroup classification is independent of the presence or absence of

lymphadenopathy. Each subgroup may include patients who are minimally

symptomatic, as well as patients who are severely ill. Increased specificity

for manifestations of HTLV-III/LAV infection, if needed for clinical purposes

or research or for disability determinations, may be achieved by creating

additional divisions within each subgroup.

E-5
■ Subgroup A (Constitutional disease)--Defined as one or more of the

following: fever persisting more than 1 month, involuntary weight

loss of greater than 10 percent of baseline, or diarrhea persisting

more than 1 month; and the absence of a concurrent illness or

condition other than HTLV-III/LAV infection to explain the findings.

Subgroup B (Necrologic disease)--Defined as one or more of the

following: dementia, myelopathy, or peripheral neuropathy; and the

absence of a concurrent illness or condition other than HTLV-III/LAV

infection to explain the findings.

■ Subgroup C (Secondary infectious diseases) --Defined as the diagnosis of

an infectious disease associated with HTLV-III/LAV infection and/or

at least moderately indicative of a defect in cell-mediated

immunity. Patients in this subgroup are divided further into two

categories.

--Category C-l- -Includes patients with symptomatic or invasive

.

disease due to one of 12 specified secondary infectious

diseases listed in the surveillance definition of AIDS:

Pneumocystis carinii pneumonia, chronic cyptosporidiosis,

toxoplasmosis, extraintestinal strongyloidiasis, isosporiasis,

candidiasis (esophageal, bronchial, or pulmonary), ●

cryptococcosis, histoplasmosis, mycobacterial infection with

Mycobacterium avium complex or M. kansasii, cytomegalovirus,

chronic mucocutaneous or disseminated herpes simplex virus

E-6

infection, and progressive multifocal leukoencephalopathy.
--Category C-2--Includes

disease due to one of

diseases: oral hairy

patients with symptomatic or invasive

six other specified secondary infectious

leukoplakia, multidermatomal herpes

zoster, recurrent Salmonella bacteremia, nocardiosis,

tuberculosis, or oral candidiasis (thrush).

■ Subgroup D (Secondary cancers) --Defined as the diagnosis of one or more

kinds of cancer known to be associated with HTLV-III/LAV infection

as listed in the surveillance definition of AIDS and at least

moderately indicative of a defect in cell-mediated immunity:

Kaposi’s sarcoma, non-Hodgkin’s lymphoma (small, noncleaved lymphoma

or immunoblastic sarcoma) , or primary lymphoma of the brain.

■ Subgroup E (Other conditions in HTLV-IIILAV infection) --Defined as the

presence of other clinical findings or diseases, not classifiable

above, that may be attributed to HTLV-III/LAV infection and/or may

be indicative of a defect in cell-mediated immunity. Included are

patients with chronic lymphoid interstitial pneumonitis. Also

included are those patients whose signs or symptoms could be

attributed either to HTLV-III/LAV infection or to another coexisting

disease not classified elsewhere, and patients with other clinical

illnesses, the course or management of which may be complicated or

altered by HTLV-III/LAV infection. Examples include patients with

constitutional symptoms not meeting the criteria for subgroup IV-A;

patients with infectious diseases not listed in subgroup IV-C; and

patients with neoplasms not listed in subgroup IV-D.

SOURCE: U.S. Department of Health and Human Services, Public Health Service,

Centers for Disease Control, ‘Classification System for Human TLymphotropic Virus Type III/Lymphadenopathy-Associated Virus

Infections," Morbidity and Mortality Weekly Report 35(20): 334-339,

1986.

E-7
Box E-2--The CDC’s Proposed Classification System for HIV Infection

The CDC’s proposed classification system for HIV infection divides HIVinfected patients into three laboratory categories and three clinical

categories.

Laboratory Categories

[The three designated laboratory categories correspond to CD4+

lymphocyte counts per cubic millimeter (/mm3) of blood that guide clinical

and/or therapeutic actions in the management of HIV-infected adolescents and

adults. The laboratory categories are as follows]:

m Category 1- -A CD4+ lymphocyte count of more than 500 cells/mm3

m Category 2- -A CD4+ lymphocyte count from 200 through 499 cells/mm3

■ Category 3 --A CD4+ lymphocyte count below 200 cells/mm3

.

Clinical Categories

The clinical categories are defined as follows:

mCategory A- -One or more of the conditions listed below occurring in an

adolescent or adult with documented HIV infection. Conditions

listed in categories B and C (below) must not have occurred.

-- Asymptomatic HIV infection;

-- Persistent generalized lymphadenopathy;

--Acute (primary) HIV infection with accompanying illness or

history of acute HIV infection.

■ Category B- -Symptomatic conditions occurring in an HIV-infected

adolescent or adult which are not included among conditions listed

in clinical category C and which meet at least one of the following

criteria: (a) the conditions are attributed to HIV infection and/or

are indicative of a defect in cell-mediated immunity; or (b) the

conditions are considered by physicians to have a clinical course or

management that is complicated by HIV infection. Examples of

conditions in clinical category B include, but are not limited to:

- -

. .

. .

. .

. -

- .

- -

- -

. -

- -

- .

. .

Bacterial endocarditis, meningitis, pneumonia, or sepsis;

Candidiasis, vulvovaginal; persistent (> 1 month duration), or

poorly responsive to therapy;

Candidiasis, oropharyngeal (thrush);

Cervical dysplasia, severe; or carcinoma;

Constitutional symptoms, such as fever (> 38.5°C) or diarrhea

lasting > 1 month;

Hairy leukoplakia, oral;

Herpes zoster (shingles), involving at least two distinct

episodes or more than one dermatome;

Idiopathic thrombocytopenic purpura;

Mycobacterium tuberculosis, pulmonary;

Nocardiosis;

Pelvic inflammatory disease;

Peripheral neuropathy;

E-8
■ Category C- -Any condition listed in the CDC’s 1987 surveillance case

definition of AIDS and affecting an adolescent or adult . . . . The

conditions in clinical category C are strongly associated with

severe immunodeficiency, occur frequently in HIV-infected

individuals, and cause serious morbidity or mortality. HIV-infected

persons should be classified based on both the lowest accurate (but

not necessarily the more recent) CD4+

lymphocyte determination and

the most severe clinical condition diagnosed, regardless of the

patient’s current clinical condition (e.g., someone previously

treated for oral or persistent vaginal candidiasis but who is now

asymptomatic should be classified in clinical category B). The

classification system is based on the absolute number of CD4+ cells

but allows for the use of CD4+ percent when the counts cannot be

obtained or are outdated in view of the patient’s current clinical

condition . . . .

SOURCE: U.S. Department of Health and Human Services, Public Health Service,

Centers for Disease Control, “1992 Revised Classification System

for HIV Infection and Expanded AIDS Surveillance Case Definition

for Adolescents and Adults,” Draft, Nov. 15, 1991.

E-9
Appendix F-HIV Testing and Reporting Requirements in the States

and the District of Columbia

Names with Anonymous with strictly

opportunities for names reported in anonymous No

Names only anonymous testing specific situations (demographics only) requirements

Alabama Arizona

Idaho Arkansas

Minnesota Colorado

North Dakota Connecticut?

South Dakota Indiana

South Carolina Kentucky

Michigan

Mississippi

Missouri

New Jersey

North Carolina

Oklahoma

Ohio

Utah

Virginia

West Virginia

Wisconsin

Wyoming

TOTAL = 6 TOTAL = 18

California Florida

Delaware Georgia

Oregon Hawaii

Tennessee Illinois

Iowa

Maine

Maryland

Montana

Nevada

New Hampshire

New York

Rhode Island

Texas

Washington

TOTAL = 4 TOTAL = 15.

Alaska

District of Columbia

Louisiana

Massachusetts

Nebraska

New Mexico

Pennsylvania

Vermont

TOTAL = 8

aRequires combined reporting of HIV and tuberculosis. -

bFor example, donation to blood banks.

SOURCE: George Washington University, Intergovernmental Health Policy Project, AIDS Policy Center, Washington, DC,

January 1992.
Appendix G: Social Security Administration’s

Determination Process

Sequential Disability

Yes

SOURCE : U.S. Congress, General Accounting Office, Social Security: SelectiVe

Face to Face Interviews With Disability Claimants Could Reduce

Appeals, GAO/HRD-89-22 (Washington, DC: U.S. Government Printing

Office, April 1989).
. — .

Appendix H: Social Security Administration’s Disability Appeals Process

●

SOURCE : U.S. Congress, General Accounting Office, Social Security: Selective

Face to Face Interviews With Disability Claimants Could Reduce

Appeals, GAO/HR.D-89-22 (Washington, DC: U.S. Government Printing

Office, April 1989).
—

Appendix I- -Case Histories From S.P. v. Sullivan Litigation

Presented below are summaries of case histories of several of the

plaintiffs as described in the Third Amended Class Action Complaint in S.P. v.

Sullivan (168). OTA presents the facts as reported in the Complaint to

provide context for the debate over the Social Security Administration’s (SSA)

disability determinations for HIV-infected persons.

Case History I

■ Mr. R.G. --is a 26-year-old Latino who resides in Manhattan, New York. He

learned that he was infected with HIV in January of 1989. He had been

suffering from ulcers, diarrhea, seborrheic dermatitis, oral thrush, anal

fissures, bronchial asthma, enlargement of the liver, and a severe

borderline personality disorder. In June of 1989, he broke his leg in a car

accident. As of December 1991, his leg had not healed and he uses crutches

to walk.

■ He applied for Supplemental Security Income (SSI) benefits on July 21, 1989.

On November 27, 1989, he was notified that his claim was denied, and he

requested reconsideration on December 13, 1989. He was notified on February

1, 1990, that his reconsideration was denied, and he requested a hearing

before an administrative law judge on March 8, 1990.

■ On May 8, 1990, Mr. R.G. had a hearing before an administrative law judge at

which the following evidence was presented:

(a) A treating physician report, dated September 1988, indicating Mr.

R.G. had diarrhea, asthma, ulcers, migraine headaches, and “fatigue “

[which] limits his ability to function for any more than several hours

at a time.”

(b) A treating psychiatrist report, dated September 1989, documenting

that Mr. R.G. was depressed, that his social functioning was “very

poor,” and that his ability to work was severely compromised due to

his “totally disabling” personality disorder.

(c) A June 1989 blood test indicating that his CD4+ lymphocyte count was

553 and his CD4+

/CD8+ ratio was 0.34, which was indicative of a

compromised immune system. A blood test taken in June 1990 showed

that his CD4+ lymphocyte count had dropped to 425 cells per cubic

millimeter (/mm3).

(d) A November 1989 report of a consultative physician retained by the

SSA diagnosing Mr. R.G. with HIV Group III and possible chronic liver

disease, in addition to a leg fracture which had not healed. The

report documented a history of personality disorder and his complaints

of anxiety, diarrhea, recurrent fevers, and sweats, and noted that Mr.

R.G. receives assistance with shopping and household chores. The

consultative physician noted Mr. R.G.’s complaints of asthma but did

not order a pulmonary function test because Mr. R.G. “tested positive

for HIV.”

I-1
—.

(e) Two reports from Mr. R.G.’s treating physician, both dating from

April 1990, documenting that Mr. R.G. had suffered from AIDS-related

complex (ARC) since 1989. In particular, Mr. R.G. suffered from

asthma, thrush, dermatitis, upper respiratory infection, anxiety, and

short-term memory impairment. In addition, the reports note that Mr.

R.G. was unable to walk due to a fractured leg which had not healed;

that he had to lie down during the day due to fatigue; that he was

only able to stand for a single hour or walk for half an hour in an 8-

hour work day, and that he was unable to climb or reach and was

severely limited in his ability to lift and carry. The doctor

certified Mr. R.G. ‘s need for assistance with many activities of daily

living and recommended that Medicaid provide him with a home

attendant.

■ At the hearing, Mr. R.G. testified about his medical impairments, including

his need for a home attendant, and provided evidence of prescription

medication for the treatment of asthma, herpes, migraine headaches,

allergies, and dermatitis. He also testified that he had been prescribed AT

for his HIV infection.

■ On July 27, 1990, the administrative law judge issued a decision denying Mr.

R.G.’s claim. The judge found that Mr. R.G.’s subjective complaints were

not credible to the extent alleged and found that he did not have a

disabling condition, noting that ‘until we have a full-blown case of AIDS on

our hands. . . this is not a disabling impairment.”

m On August 5, 1990, Mr. R.G. requested that the Appeals Council review the

administrative law judge’s decision. On March 20, 1991, the Appeals Council

remanded Mr. R.G.’s application for a second hearing before a different

administrative law judge. On July 9, 1991, the second administrative law

judge found that R.G. had been disabled since July21, 1989, almost 2 years

earlier, as Mr. R.G. had initially claimed.

Case History II

= Mr. G.S. --is a 31-year-old veteran who resides in Brooklyn, New York. Since

leaving the military service in 1981, Mr. G.S. worked as a machinist,

carpenter, and maintenance mechanic. Mr. G.S. tested HIV positive in 1988.

■ On April 4, 1990, Mr. G.S. applied for Social Security Disability Insurance

(DU) benefits because he was unable to maintain employment. Mr. G.S.

presented medical evidence of the following symptoms and illnesses:

recurrent bouts of bacterial pneumonia, chronic chest pain, an episode of

endocarditis, weakness due to thrombocytopenia, recurrent oral thrush,

hepatomegaly, an enlarged spleen and liver, hepatitis, depression, weight

loss, fevers, chills, chronic fatigue, shortness of breath, and a CD4+

lymphocyte count of 210 cells/mm3.

● In a report dated May 24, 1990, a disability analyst employed by the Office

of Disability Determination Services (DDS) wrote, “claimant has advanced

ARC. Last T4 was 210. Please give RFC [residual functional capacity].” On

the portion of the form entitled “Advice,” the non-examining physician from

I-2
the DDS wrote in response, ‘no opportunistic disease .. .T4(CD4+21010 above the

indicated criteria of 200. Does not equal [POMS Symptomatic HIV Infection

Listing] -RFC light.” The Disability Determination Transmittal Forms on

initial and reconsideration review classified Mr. G.S.’s primary diagnosis

as HIV positive, and indicated no secondary diagnosis.

■ Mr. G.S. was notified that his claims were denied on June 6, 1990. On

August 2, 1990, he filed for reconsideration, and on August 30, 1990, he was

notified that his reconsideration was denied. On September 19, 1990, Mr.

G.S. filed a request for a hearing before an administrative law judge.

■ On April 26, 1991, a year after his initial application, the administrative

law judge found Mr. R.G. disabled as of November 14, 1989, and awarded him

disability benefits.

Case History III

■ Ms. D.C. --is a 31-year-old woman who resides in Brooklyn, New York. She

tested positive for HIV in April of 1987.

■ On October 12, 1990, she applied for SSI after she was unable to work due to

chronic bronchitis, cervical carcinoma, chronic fatigue, headaches, and

vaginal candidiasis. She also documented a CD4+ lymphocyte count of

approximately 300 cells/mm3.

■ In a notice dated January 20, 1991, the SSA denied Ms. D.C.’S application,

noting that although Ms. D.C. has suffered from ‘repeated infections)”

“[t]he reports did not show any conditions of a nature that would prevent

the SSA reconsider its initial

reconsideration, her claim was

D.C. attended a hearing before

she was unable to work because

headaches, constant abdominal pain, depression, chronic

recurrent yeast infections and urinary tract infections, vaginal discharge,

[her] from working.”

■ Ms. D.C. requested that

March 14, 1991, and upon

■ On October 3, 1991, Ms.

judge and testified that

determination on

again denied.

an administrative law

of recurrent

bronchitis,

night sweats, and a precancerous condition of the cervix. During the

hearing, she requested that she be given an opportunity to submit to a

psychiatric examination to document her HIV-related depression. This

request was denied.

■ By notice dated October 30, 1991, the administrative law judge denied Ms.

D.C.’s claim finding that Ms. D.C.’s allegations of multiple symptoms were

not substantiated by the record and were not credible.

■ Ms. D.C. requested that the Appeals Council review her claim and the request

was pending as of December 1991.

Case History IV

I-3
■ Ms. P.S. --is a 39-year-old African-American woman who resides in the Bronx,

New York, with her three minor children. She learned that she was HIV

positive in February of 1988.

■ Ms. P.S. applied for DI and SSIbenefits in April of 1989 because she was

unable to work. Ms. P.S. suffers from recurrent urinary tract infections,

recurrent vaginal candidiasis, irregular menses, chronic fatigue, shortness

of breath, depression, anxiety, and pain. Ms. P.S. requires the assistance

of a home health care worker 5 days a week, 8 hours a day, to do cleaning,

lifting, and shopping, and to assist in meal preparation and dressing and

caring for her children, including a three-year-old who is herself infected

with HIV.

■ Her applications for disability were denied at the initial and

reconsideration stages, and Ms. P.S. appealed. In April of 1991, Ms. P.S.

had a hearing with an administrative law judge. The judge found Ms. P.S. to

be disabled, 2 years after her initial application.

Case History V

■ Ms. B.L. --is a 42-year-old woman who resides in Brooklyn, New York. Ms.

B.L. is HIV positive and suffers from chronic diarrhea, recurrent bacterial

pneumonia, pelvic inflammatory disease, chronic cervicitis, herpes zoster,

seborrheic dermatitis, oral thrush, night sweats, ulcers on her legs and

arms, weakness, fatigue, and shortness of breath. Ms. B.L. rarely leaves

the house because of these conditions, and her physician has ordered an

ambulette to transport her to her medical appointments due to her various

disabling conditions.

■ On November 23, 1989, Ms. B.L. applied for DI and SSI but her application

was denied. Ms. B.L. requested reconsideration of the denial

■ In May of 1990, Ms. B.L. submitted evidence of her medical status to the

SSA, including evidence of HIV infection, a 5-month history of diarrhea,

skin rashes, night sweats, fatigue, and abnormal bruising. She provided SSA

with a letter dated October 30, 1989, from her physician at Woodull

Hospital, which indicated that she had large bilateral leg ulcers that

caused her considerable pain and rendered her unable to work. She also

advised SSA that in 1989 she was treated for leg ulcers at the Emergency

Room at Boston City Hospital as well as at St. Luke’s Hospital. SSA did not

obtain medical records from these hospitals. Ms. B.L. also had an accident

in which her hands and wrists were severely burned resulting in the limited

use of her right wrist. She notified SSA in October of 1989, that, in May

1989, she had an operation and a skin graft on her right wrist at St. Luke’s

Hospital. In January of 1990 the consultative examination physician

retained by SSA to examine Ms. B.L. noted a limited range of motion and

fibrosis in her right wrist. Ms. B.L.’s Social Security file also contained

records dated from April of 1990 which document a rash on the mid-abdomen,

back, and vagina. In June of 1990, an “AIDS or AIDS Related Complex Medical

Report” completed by Woodhull Hospital showed her CD4+ lymphocyte count to be

37 cells/mm3.

■ Ms. B.L. was denied benefits on reconsideration in October of 1990.

I-4
■ At a hearing before a administrative law judge on April 16, 1991, Ms. B.L.

submitted a form filled out by Woodhull Hospital showing her CD4+ lymphocyte

count to be 37 cells/mm3; she also submitted a medical report from her

physician at St. Vincent’s Hospital reporting that she suffered from

hepatitis B, herpes zoster, gynecological problems, a CD4+ lymphocyte count

of 20 cells/mm3, chronic cervicitis, and seborrheic dermatitis.

■ An administrative law judge denied Ms. B.L.’s disability application on May

31, 1991, and on June 20, 1991, Ms. B.L. requested that the Appeals Council

review the administrative law judge’s decision. The Appeals Council

remanded the case to the administrative law judge, and as of December of

1991, the case was still pending.

Case History VI

■ Mr. E.A. --is a 33-year-old male who resides in Brooklyn, New York. Mr. E.A.

suffers from many HIV-related symptoms and conditions, including a CD4+

lymphocyte count below 200 cells/mm3, anemia, thrombocytopenia (low platelet

count), oral thrush, extreme weakness, night sweats, nausea, and bronchitis.

.

■ From March 26, 1991, to April 31, 1991, Mr. E.A. was hospitalized at

Lutheran Hospital for severe anemia. At the time he was admitted, Mr. E.A.

had difficulty breathing and weakness in both legs, and he underwent 10

blood transfusions. In May of 1991, Mr. E.A. had a CD4+ lymphocyte count of

335 cells/mm3. Because he could not longer work, Mr. E.A. applied for SSI

. benefits in June 1991 and received presumptive SSI benefits for 3 months,

from June through September.

■ By September, Mr. E.A.’s CD4+ lymphocyte count had decreased to 193

cells/mm3. On September 9, 1991, Mr. E.A.’s application was denied by the

State DDS.

● On September 30, 1991, Mr. E.A.’s treating physician of 1 year filled out a

Medical Report for Determination of Disability for the SSA, which documented

his low CD4+ lymphocyte count, thrombocytopenia, recent hospitalization due

to severe anemia, oral thrush, and an inability to tolerate AZT. Mr. E.A.’s

treating physician also informed the SSA that Mr. E.A. tested high positive

for exposure to toxoplasma, the protozoa that causes toxoplasmosis, an AIDSdefining condition. Nonetheless, his request for reconsideration was denied

on October 22, 1991.

■ On October 28, 1991, Mr E.A. requested a hearing before an administrative

law judge. No hearing had been scheduled as of December 1991.

I-5
Case History VII

■ Ms. K.P. --is a 37-year-old woman living in Brooklyn, New York. She tested

positive for HIV in 1988. Her impairments included pneumonia, anemia,

pancreatitis, an enlarged liver due to chronic hepatitis, a positive

rheumatoid factor, an elevated erythrocyte sedimentation rate, endocarditis,

reduced white blood and red blood cell counts, a suppressed CD4+ lymphocyte

count in the range of 200 to 300+ cells/mm3

, a reduced CD4+/CD8+ ratio, a low

platelet count, chronic bronchitis, fatigue, and nausea.

■ Ms. K.P. applied for disability benefits in April of 1989. Her application

was denied after the disability determination review classified her primary

diagnosis as HIV positive and her secondary diagnosis as ‘none.” According

to K.P. ‘s attorneys, at a hearing before the administrative law judge in

February of 1990, a medical adviser employed by the SSA testified that a CD4+

lymphocyte count in the range of 200 cells/mm3 and a CD4+/CD8+ cell ratio of

0.47 were not objective medical support for symptoms of chronic fatigue and

weakness. The medical adviser attributed these symptoms to depression. He

also testified that the endocarditis and pneumonia were completely resolved

and were not AIDS-related and that the objective evidence did not support a

finding of symptomatic HIV infection.

●

I-6
—

Appendix J--The Social Security Administration’s New “HIV Infection Listing”

for Use in Disability Determinations

Human Immunodeficiency Virus (HIV) Infection Listingl

The following conditions and symptoms of HIV infection will prevent a person

from performing any gainful activity.

(Conditions with a * to the left are also included in whole or in part in the

CDC’s 1987 case definition of AIDS):

A. If there is no documentation of HIV Infection:

* 1 .

*2.

*3.

*4.

*5.

*6.

*7.

*8.

*9.

*lO.

Candidiasis of the esophagus, trachea, bronchi, or lungs

(demonstrated by biopsy microscopy of a “wet” preparation or

culture); or

Cryptococcosis, extrapulmonary (demonstrated by culture,

antigen detection in the cerebrospinal fluid (CSF), India ink

preparation of the CSF, or by biopsy); or

Cryptosporidiosis with diarrhea for over 1 month (documented

by intestinal biopsy or fecal microscopy); or

Cytomegalovirus disease of an organ other than liver, spleen,

or lymph nodes (demonstrated by culture or histology); or

Herpes simplex virus infection causing a mucocutaneous ulcer

that persists longer than 1 month; or bronchitis,

pneumonititis, or esophagitis for any duration (demonstrated

by culture, histology, or cytology); or

Lymphoma of the brain (primary) affecting a patient less than

60 years of age; or

Mycobacterium avium complex or M. kansasii disease,

disseminated (at a site other than or in addition to lungs,

skin, or cervical or hilar lymph nodes) demonstrated by

culture; or

Pneumocystis carinii pneumonia (documented by lung biopsy,

microscopy of a “touch” preparation, bronchial washings, or

induced sputum); or

Progressive multifocal leukoencephalopathy; or

Toxoplasmosis of the brain.

1 For ease of presentation, the format of the listing has been changed and

therefore designations of sections may differ from original.

J-1
OR

B. Documentation of HIV Infection (e.g., serum specimen that contains

HIV antibodies detected by a screening test (e.g., ELISA) and

confirmed by a more definitive test (e.g. , Western blot,

immunoflourescence assay); and

* 1 .

* 2 .

*3.

*4.

*5.

*6.

*7.

*8.

*9.

*10.

*11.

*12.

Intestinal cryptosporidiosis (documented by intestinal biopsy

or fecal microscopy) that has caused diarrhea for 1 month or

more;

Pneumocystis carinii pneumonia (documented by lung biopsy,

microscopy of a ‘touch” preparation, bronchial washings, or

induced sputum); or

Toxoplasmosis (documented by histology or microscopy of a

‘touch” preparation) with involvement of an organ other than

the liver, spleen, or lymph nodes; or

Isosporiasis (documented by intestinal biopsy or fecal

microscopy) that has caused diarrhea for a month or more; or

Extra-intestinal strongyloidiasis;

Candidiasis, disseminated (beyond the skin, urinary tract,

intestinal tract, or oral or vulvovaginal mucous membranes)

or involving the esophagus, trachea, bronchi, or lungs (and

demonstrated by microscopy of a ‘wet” preparation, or

observation on endoscopy of white plaques on an erythematous .

 base); or

Cryptococcosis, disseminated (beyond the lungs), or involving

the central nervous system and demonstrated by culture,

antigen detection in the CSF, India ink preparation of the

CSF, or by biopsy); or

Disseminated histoplasmosis (beyond the lungs or or lymph

nodes and demonstrated by culture or biopsy); or

Disseminated coccidioidomycosis (beyond the lungs or lymph

nodes and demonstrated by culture or histology); or

Mycobacterial infection, disseminated (beyond the lungs,

lymph nodes, or skin) and demonstrated by culture or by

microscopy showing acid fast bacilli of a species not

identified by culture; or

Cytomegalovirus, causing infection of organs other than the

liver, spleen, or lymph nodes demonstrated by culture or

histology; or

Herpes simplex virus, causing chronic continuous (longer than

1 month) mucocutaneous infection or infection of the

pulmonary gastrointestinal tracts or encephalitis or

disseminated infection demonstrated by culture, histology, or

cytology; or

J-2
*13.

*14.

15.

*16.

*17.

*18.

*19.

*20.

21.

22.

23.

24.

Progressive multifocal leukoencephalopathy; or

Recurrent non-typhoid salmonella bacteremia; or

Norcardiosis (demonstrated by culture); or

HIV encephalopathy; or

HIV wasting syndrome, characterized by involuntary weight

loss (more than 10 percent of baseline body weight) and

either chronic diarrhea (2 or more loose stools per day for 2

months or more) or chronic weakness and documented fever

(greater than 100.4’F for the majority of 2 months or longer)

in the absence of a concurrent illness that could explain the

findings; or

Lymphoma of the brain; or

Other non-Hodgkin’s lymphoma of B-cell or unknown phenotype

and histology indicating either:

a. Burkitt’s or other small noncleaved lymphoma; or

b. Immunoblastic sarcoma; or

Non-Hodgkin’s lymphoma or Hodgkin’s disease; or

Invasive carcinoma of the cervix, FIGO stage 11 and beyond;

or

Anal squamous cell carcinoma; or

Cardiomyopathy as described under the criteria in Listing of

Impairments sections 4.02, 4.04, or 4.05; or

Nephropathy as described under the criteria in Listing of

Impairments sections 6.02, or 6.06.

C. Documentation of HIV Infection, as described in B, above, with the

criteria listed below. (The level of severity is met when the

requirements for both 1 and 4, both 2 and 4, or both 3 and 4 are

satisfied.):

1. Impaired cellular immunity as manifested by a CD4+ (T4)

lymphocyte count of less than or equal to 200 cells/mm3 (or

14 percent or less lymphocytes);

OR

2. Documentation of one or more of the following persistent and

/or resistant to therapy:

a) Pneumonia; or

b) Pulmonary tuberculosis; or

c) Bacterial or fungal sepsis; or

d) Meningitis; or

e) Septic arthritis; or

J-3
f) Endocarditis; or

g) Peripheral neuropathy; or

*h) Kaposi’s sarcoma;

OR

3. TWO or more of the following persisting over a two month

period:

a )

b )

c )

d )

e )

f)

g)

h)

i)

j)

k)

4. At

a)

b)

c)

d)

Anemia (hematocrit (HCT) value less than 30 percent); or

Granulocytopenia (absolute neutrophil count less than or

equal to 1000/mm3

); or

Thrombocytopenia (less than or equal to 40,000/mm3

); or

Documented fever (greater than or equal to 100.4’F or

38’C); or

Weight loss of greater than or equal to 10 percent of

baseline body weight; or

Mucosal (including vulvovaginal) candidiasis other than

listed in A.1 or B.6 above; or

Oral hairy leukoplakia; or

Recurrent or chronic herpes zoster; or

Persistent dermatological conditions such as eczema or

psoriasis; or

Persistent, unresponsive diarrhea; or

Persistent or recurring radiographically documented

sinusitis.

least two of the following:

Marked restriction of activities of daily living; or

Marked difficulties in maintaining social functioning; or

Marked difficulties completing tasks in a timely reamer

due to deficiencies in concentration, persistence or pace;

or

Repeated episodes of decompensation, averaging 3 times a

year or once every 4 months, lasting 2 or more weeks each,

which cause the individual to deteriorate (which may

include a loss of adaptive functioning).

SOURCE: U.S. Department of Health and Human Services, Social Security

Administration, “Federal Old Age, Survivors, and Disability

Insurance; Determining Disability and Blindness; Revision of Part A

and Part B of the Listing of Impairments; Endocrine and Multiple

Body Systems; Immune System-Proposed Rules,” 56 FR 65702.

J-4
APPENDIX K--THE SOCIAL SECURITY ADMINISTRATION’S PRESUMPTIVE

DISABILITY FORM FOR PHYSICIANS
31.

32

E l .

REFERENCES

AIDS Coalition to Unleash Power (ACT UP) Network, New York, NY,

the Centers for Disease Control, New York, NY, 1991.

AIDS Coalition to Unleash Power (ACT UP) Network, New York, NY,

colleagues, May 17, 1991.

Background on

letter to

AIDS Policy and Law, “In Brief,” AIDS Policy and Law, 6(23):3-4, 1991.

AIDS Policy and Law, “U.S.-Sponsored Report on AIDS/HIV Litigation Finds

Judicial ‘Undereducation’ , Discrimination,” AIDS Policy and Law

7(2):1-2, 1992.

AIDS Policy & Law, “HUD to Dole Out $50 Million in AIDS-Related Housing

Funds,” AIDS Policy & Law 7(3):2, 1992.

Allen, M., Obstetrician/Gynecologist, New York University School of Medicine

and Bellevue Hospital, New York, NY, ‘Statement,” Obstacles That

Prevent Women and Children with HIV-Related Disabilities from

Qualifying for Social Security Disability Insurance (DI) and

Supplemental Security Income (SS1), joint hearing before the

Subcommittees on Social Security and Human Resources, House of

Representatives, U.S. Congress, Washington, DC, April 2, 1992.

American Ambulance Senice V. Sullivan, 911 F.2d. 901 (3rd Cir. 1990).

Association of State and Territorial Health Officials, “HIV Committee

Recommendations,” McLean, VA, July 17, 1991.

Association of State and Territorial Public Health Laboratory Directors,

unpublished data from Suney of State Laboratories, December, 1990.

Baker, D.W., Stevens, C.P., Brook, R.H., “Patients Who Leave a Public Hospital

Emergency Department Without Being Seen by a Physician: Causes and

Consequences,” Jouranl of the American Medical Association

266(8):1085-1090, 1991.

Bailey v. Sullivan, 885 F.2d 52 (3rd Cir. 1989).

Baily, M.A., Bilheimer, L., Wooldridge, J., et al., “Economic Consequences for

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