3368 Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Notice of the Secretary’s

Determination on Newborn HIV Testing

AGENCY: Department of Health and

Human Services (HHS).

ACTION: Notice.

AUTHORITY: Section 2626(d) of the Public

Health Service Act (42 U.S.C. 300 ff–34).

SUMMARY: The Secretary is required

under Public Law 104–146 to make a

determination as to whether it has

become routine practice in the United

States to carry out a number of

counseling, testing and disclosure

activities pertaining to a newborn

infant’s HIV serostatus. In making this

determination, the Secretary has

consulted with the States and with other

public and private entities that have

knowledge and expertise relevant to this

determination. This notice is issued in

fulfillment of the requirement of Section

2626(d) of PL 104–146. The Secretary

determines, that with regard to the

statutory provisions and legislative

intent as defined by the Committee on

Conference in Conference Report 104–

545, it has not become routine practice

to require testing of newborn infants for

HIV infection in the United States.

DATES: The Secretary’s Determination

on Newborn HIV Testing is effective

upon January 20, 2000.

FOR FURTHER INFORMATION CONTACT:

Office of HIV/AIDS Policy, Office of

Public Health and Science in the Office

of the Secretary, 200 Independence

Avenue SW, Room 736–E, Washington,

D.C. 20201.

SUPPLEMENTARY INFORMATION:

I. Overview of the Secretary’s

Determination

Section 2626(d) of the Public Health

Service Act, as added by the Ryan White

CARE Act Amendments of 1996 (Public

Law 104–146), requires the Secretary of

the Department of Health and Human

Services to make a determination as to

whether it has become routine practice

in the United States to carry out a

number of counseling, testing and

disclosure activities pertaining to a

newborn infant’s HIV serostatus. This

document will review the relevant

statutory provisions and legislative

history; summarize the findings of

consultations conducted as required by

the statute; review the data regarding

reductions in perinatal transmission and

current HIV counseling, testing and

disclosure practices; and provide the

determination required of the Secretary

in Section 2626(d). Attachment A

highlights some of the Department’s

activities to reduce perinatal HIV

transmission and ensure that HIVexposed and HIV-infected infants and

children have access to quality care.

II. Legislative Background

The Ryan White CARE Act

Amendments of 1996 placed a new

legislative emphasis on Federal and

state efforts to reduce the perinatal

transmission of the human

immunodeficiency virus (HIV). The

Congress required all States to certify

that regulations or measures were in

effect to adopt the guidelines issued by

the Centers for Disease Control and

Prevention for HIV counseling and

voluntary testing for pregnant women,

and it authorized a new grant program

to assist States in their efforts to reduce

perinatal HIV transmission. Additional

provisions in Sections 2626, 2627, and

2628 directed the Secretary to make a

determination about whether certain

practices have become routine regarding

HIV counseling and testing of newborns

and disclosure of their HIV serostatus,

and to request a study by the Institute

of Medicine on State efforts to reduce

perinantal transmission. The following

section reviews both the statutory

language and legislative background

provided in the Joint Explanatory

Statement of the Committee on

Conference, as each of these sections are

central to the Secretary’s determination

required under Section 2626(d).

Statutory Provisions

Section 2626(d) requires the Secretary

to publish in the Federal Register a

determination ‘‘whether it has become a

routine practice in the provision of

health care in the United States to carry

out each of the activities described in

paragraphs (1) through (4) of section

2627. In making the determination, the

Secretary shall consult with the States

and with other public or private entities

that have knowledge or expertise

relevant to the determination.’’ Section

2627 lists the activities or requirements

for which the Secretary is required to

make the determination of whether each

has become a routine practice in the

United States. Section 2627(5) was

subsequently removed, through a

technical amendment, as an element of

the determination required under

Section 2626, and thus is not further

discussed here. The four activities or

requirements to be included in the

Secretary’s determination are: ‘‘(1) In

the case of newborn infants who are

born in the State and whose biological

mothers have not undergone prenatal

testing for HIV disease, that each such

infant undergo testing for such disease.

(2) That the results of such testing of a

newborn infant be promptly disclosed

in accordance with the following, as

applicable to the infant involved: (A) To

the biological mother of the infant

(without regard to whether she is the

legal guardian of the infant). (B) If the

State is the legal guardian of the infant:

(i) To the appropriate official of the

State agency with responsibility for the

care of the infant. (ii) To the appropriate

official of each authorized agency

providing assistance in the placement of

the infant. (iii) If the authorized agency

is giving significant consideration to

approving an individual as a foster

parent of the infant, to the prospective

foster parent. (iv) If the authorized

agency is giving significant

consideration to approving an

individual as an adoptive parent of the

infant, to the prospective adoptive

parent. (C) If neither the biological

mother nor the State is the legal

guardian of the infant, to another legal

guardian of the infant. (D) To the child’s

health care provider. (3) That, in the

case of prenatal testing for HIV disease

that is conducted in the State, the

results of such testing be promptly

disclosed to the pregnant woman

involved. (4) That, is disclosing the test

results to an individual under paragraph

(2) or (3), appropriate counseling on the

human immunodeficiency virus be

made available to the individual (except

in the case of a disclosure to an official

of a State or an authorized agency).

‘‘Section 2628 directs the Secretary to

undertake the following activities: ‘‘(a)

The Secretary shall request that the

Institute of Medicine of the National

Academy of Sciences conduct an

evaluation of the extent to which State

efforts have been effective in reducing

the perinatal transmission of the human

immunodeficiency virus, and an

analysis of the existing barriers to the

further reduction in such transmission.

(b) The Secretary shall ensure that, not

later than 2 years after the date of

enactment of this section, the evaluation

and analysis described in subsection (a)

is completed and a report summarizing

the results of such evaluation and

analysis is prepared by the Institute of

Medicine and submitted to the

appropriate committees of Congress

together with the recommendations of

the Institute.’’ Joint Explanatory

Statement of the Committee on

Conference: In Conference Report 104–

545, the House receded with an

amendment described in the conference

report as follows: ‘‘(1) Within four

months of enactment of this Act, the

CDC, in consultation with states, will

Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Notices 3369

develop and implement a reporting

system for states to use in determining

the rate of new cases of AIDS resulting

from perinatal transmission and the

possible causes for that transmission.

The Secretary of HHS is directed to

contract with the Institute of Medicine

to conduct an evaluation of the extent

to which state efforts have been effective

in reducing perinatal transmission of

HIV and an analysis of the existing

barriers to further reduction in such

transmission. The Secretary shall report

these findings to Congress along with

any recommendations made by the

Institute. (2) Within two years following

the implementation of such a system,

the Secretary will make a determination

whether mandatory HIV testing of all

infants born in the U.S. whose mothers

have not undergone prenatal HIV testing

has become a routine practice. This

determination will be made in

consultation with states and experts. If

the Secretary determines that such

mandatory testing has become a routine

practice, after an additional 18 month

period, a state will not receive Title II

Ryan White funding unless it can

demonstrate one of the following: (A) A

50% reduction (or a comparable

measure for low-incidence states) in the

rate of new AIDS cases resulting from

perinatal transmission, comparing the

most recent data to 1993 data; (B) At

least 95% of women who have received

at least two prenatal visits with a health

care provider or provider group have

been tested for HIV; or (C) A program of

mandatory testing for all newborns

whose mothers have not undergone

prenatal HIV testing.’’ p. 45–46,

Conference Report 104–545.

III. Review of Consultation Processes

The Department undertook several

activities to respond to the statutory

requirements for external consultations

found in Sections 2626 and 2628, the

most extensive of which was a study

conducted by the Institute of Medicine

(IOM) of the National Academy of

Sciences. The other activities included

a formal consultation with state and

local government organizations, and an

invitation for public comment through a

Federal Register notice to supplement

those comments provided in the course

of the IOM study. Each of these

activities is described more fully below.

Report of the Institute of Medicine—

Reducing the Odds: Preventing Perinatal

Transmission of HIV in the United

States

In 1997, the Department contracted

with the IOM for an evaluation of the

extent to which State efforts have been

effective in reducing the perinatal

transmission of HIV and an analysis of

the existing barriers to the further

reduction in such transmission. The

IOM assembled a 14-member expert

committee with combined expertise in

obstetrics and gynecology, pediatrics,

preventive medicine, and other relevant

specialities, social and behavioral

sciences, public health practice,

epidemiology, program evaluation,

health services research, bioethics, and

public health law. This committee,

formally known as the Committee on

Perinatal Transmission of HIV, reviewed

a wide variety of quantitative and

qualitative information pertaining to the

prevention of perinatal HIV

transmission, including current clinical

practices to reduce such transmission.

The committee held two public

workshops which afforded the

opportunity to consult with a wide array

of state and local public health officials

and other policy makers, health care

providers, consumers, ethicists,

advocacy groups for women and

children with HIV, and others affected

and concerned with these policy issues.

The committee also conducted field

visits to identify and discuss issues with

women who are HIV-infected or at risk

of HIV infection, health care providers,

and state and local policy makers. On

October 14, 1998, the IOM issued a

report, Reducing the Odds: Preventing

Perinatal Transmission of HIV in the

United States, which reviewed the

implementation and impact of the

Public Health Service (PHS) counseling

and testing guidelines and made

recommendations on strategies to

further reduce perinatal HIV

transmission. In brief, the IOM study

identified that 22 States have policies

on HIV testing, monitoring or treatment

of newborns; 9 states permit disclosure

of HIV test results to foster agencies or

families; and 15 states permit disclosure

to the newborn’s pediatrician. Only one

state, New York, required mandatory

newborn HIV testing at the time of the

report. Since that time, Connecticut has

passed a legislative mandate to test all

newborns whose HIV serostatus is

unknown, but full implementation of

this is pending litigation. A discussion

of the major IOM study findings follows

under the upcoming section on reducing

perinatal transmission.

Consultation With State and Local

Government Organization

The IOM committee convened a broad

spectrum of state and local government

and public health organizations as part

of its efforts to identify the range of

scientific data and public health

expertise regarding perinatal HIV

transmission. The Department also held

a second, separate consultation with

representatives of state and local

governmental organizations on

December 4, 1998. Eight organizations

were represented at the meeting,

including the National Governors

Association (NGA), U.S. Conference of

Mayors (USCM), National Association of

Counties (NACo), National Association

of County and City Health Officials

(NACCHO), National Organization of

Black County Officials (NOBCO),

National Alliance of Latino Elected

Officials (NALEO), the National

Association of State and Territorial

AIDS Directors (NASTAD) and National

Association of State Alcohol and Drug

Abuse Directors (NASADAD). NASTAD

provided written comments at the

meeting, as did NGA subsequently,

which stated that HIV testing of each

newborn whose biological mother has

not undergone prenatal testing for HIV

disease is not a routine practice in the

United States. All organizations

attending the consultation supported

this statement. Subsequently, the

National Governor’s Association

provided the Department with a

Resolution on HIV/AIDS that the

Governors adopted at the NGA’s 1999

Winter Meeting. Sections 38.2.2 and

38.5 of the Resoulation state that HIV

testing of newbords is not a routine

practice in the United States.

Federal Register Notice Soliciting Public

Comment

The Institute of Medicine study and

subsequent Departmental activities

represented an extensive effort to gather

and review the breadth of scientific data

and professional, public health and

consumer experience relevant to the

issue of preventing perinatal HIV

transmission. While recognizing the

substantial outreach of the IOM

committee in identifying and engaging

knowledgeable voices on these issues,

the Department pursued a supplemental

strategy of inviting further public

comment through publication of a

notice in the Federal Register on

November 9, 1998 following release of

the IOM report. A total of 287 written

comments were received in response to

this notice, including 21 letters from

state health departments stating that

HIV testing of newborns was not routine

practice in their jurisdictions. Three

additional state health departments did

not support mandatory HIV testing of

newborns and described public health

strategies, other than mandatory testing,

to accomplish the goals of identifying

HIV-exposed newborns. Two elected

officials from one state provided

comment that their state has

implemented mandatory HIV testing of

3370 Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Notices

newborns. A form letter submitted by

234 organizations and individuals who

oppose mandatory testing of pregnant

women and newborns accounted for the

majority of comments received.

IV. Reducing Perinatal Transmission

Overview

It has been estimated that between

6,000 and 7,000 HIV-infected U.S.

women delivered infants each year from

1989 to 1995. Without intervention, a

25% mother-to-infant HIV transmission

rate would result in the birth of an

estimated 1,750 HIV-infected infants

annually in the United States. To reduce

rates of perinatal HIV transmission, CDC

published, in 1994, the U.S. Public

Health Service (PHS) recommendations

for using zidovudine (ZDV, also known

as AZT) to reduce perinatal HIV

transmission and, in 1995, PHS

recommendations for routine counseling

and voluntary HIV testing for pregnant

women. In 1998, the earlier 1994

chemoprophylaxis guidelines were

revised to include discussion of the use

of newer antiretroviral drugs during

pregnancy to treat maternal infection.

Since the publication of these

guidelines, nearly all relevant health

professional organizations (including

the American College of Obstetricians

and Gynecologists and American

Academy of Pediatrics) developed

practice recommendations that

generally conformed with the PHS

recommendations for routine counseling

and voluntary testing of pregnant

women (the American Medical

Association was alone in recommending

a more stringent approach—that of

mandatory testing of pregnant women

and infants), and providing zidovudine

chemoprophylaxis. Additionally, most

states moved quickly to implement

them through law, regulation, or policy;

they also supported broad

implementation of the guidelines

through active dissemination, public

and provider education, and health

professional training. States and health

care providers have placed their

emphasis on reaching pregnant women

with HIV counseling and testing so that

the full benefits of HIV prevention

through use of antiretroviral

medications can be achieved among

women with HIV infection. States have

not made a specific investment in

additional surveillance systems to track

the HIV status of each newborn infant,

with the exception of a very few States.

Currently, only two states (New York

and Connecticut) require mandatory

HIV testing of newborns whose mothers

did not undergo prenatal HIV testing

and only New York has fully

implemented this requirement. This

section describes the impact of efforts

by the Center for Disease Control and

Prevention (CDC) and the Health

Resources and Services Administration

(HRSA) to reduce perinatal HIV

transmission. It also summarizes the

major findings and central

recommendation of the Institute of

Medicine’s report Reducing the Odds:

Preventing Perinatal Transmission of

HIV in the United States.

Impact of Implementing PHS

Recommendations for Routine

Counseling and Voluntary Testing of

Pregnant Women

The CDC has established a number of

surveillance and research studies to

evaluate the impact of these guidelines

as an intervention, and the effect of this

intervention has been substantial.

• HIV/AIDS surveillance data

indicate that the number of perinatally

acquired AIDS cases in the United

States declined by 74% between 1993

and 1998 due in part to increased HIV

testing among pregnant women and

receipt of ZDV by HIV-infected women.

• A CDC-funded study in eleven

states indicated that 60–84% of

pregnant women are counseled about

HIV, and that acceptance of testing is

high—over 70%—in most settings.

• More than 90% of women known to

be HIV-infected who are in prenatal care

receive zidovudine (AZT) prophylaxis.

• Studies indicate that HIV

transmission rates among HIV-positive

women in the U.S. are dropping to as

low as 5%.

Similarly, HRSA has instituted

several activities to increase HIV

counseling and testing, particularly

during the perinatal period, and to

monitor the progress of Ryan White

grantees in further reducing perinatal

HIV transmission. The results in many

geographic sites have been remarkable.

Some examples of these achievements

appear below.

• In a St. Louis care center, 100% of

pregnant women living with HIV who

were counseled about ZDV also

accepted prenatal ZDV. Perinatal HIV

transmission decreased from 44.4% in

1994 to 0% in both 1996 and 1997.

• In Massachusetts, ZDV acceptance

has risen dramatically among pregnant

women living with HIV. In 1993,

acceptance of ZDV chemoprophylaxis

was 9%; acceptance rose to 74% in 1994

and 93% in 1995. In the latter half of

1995, acceptance actually rose to 95%.

• At a Seattle program, approximately

20–30 pregnant women with HIV

receive care each year. No child has

been diagnosed with perinatal HIV

infection from 1994 through 1997.

• Ninety-one percent of women

accepted testing among all of those who

received pre-test counseling through the

HRSA Special Projects of National

Significance Adolescent Care projects.

This percentage increased to 94% for

pregnant women.

• At the University of Miami, 158

pregnant women living with HIV were

served in 1996, 95% of whom accepted

ZDV prophylaxis. Of the perinatally

exposed children born, two out of 110

(2%) were determined to be HIVinfected after one year. In the first half

of 1997, 60 perinatally exposed children

were born, none of whom were

determined to be HIV-infected.

• In 1995, 28 perinatally exposed

children were born to mothers living

with HIV in one HRSA-supported

agency in Chicago. Only 10 of these

women (36%) participated fully in the

ZDV regimen, and thus 32% of the

children born were HIV-infected. In

1996, 50% of the HIV-infected pregnant

women elected to participate in the ZDV

regimen. The rate of perinatal

transmission decreased 15% in this

population. In the first three months of

1997, six additional infants were born,

none of whom were determined to be

HIV-infected. Despite these promising

findings, some children in the U.S.

continue to become infected with HIV

through maternal transmission. Some of

the possible reasons for continuing

perinatal HIV transmission include:

• Nationally, less than 2 percent of all

pregnant women receive no prenatal

care. However, in a four State study, 14

percent of pregnant women with HIV

infection receive no care. Moreover,

35% of HIV-infected pregnant women

who use drugs receive no prenatal care,

compared with only 8% of HIV-infected

pregnant women who do not use drugs.

• Some providers still do not offer

HIV testing to pregnant women. Reasons

cited by these providers include a lack

of time and resources, the perception

that the woman is not at risk, and legal

requirements for pretest counseling.

• While test acceptance rates are high

and improving, not all women who are

offered HIV testing accept it. Some of

the major reasons for refusal of testing

include the belief that one is not at risk

for HIV, and the lack of a provider’s

strong recommendation for testing.

Additionally, some women continue to

express mistrust of provider information

and concerns about being forced to

accept testing and/or ZDV

chemoprophylaxis.

Summary of Institute of Medicine Study

Findings and Recommendations

The Institute of Medicine study found

that: (1) There have been substantial

Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Notices 3371

public and private efforts to implement

the PHS recommendations; (2) prenatal

care providers are more likely now than

in the past to counsel their patients

about HIV and the benefits of ZDV, and

to offer and recommend HIV tests; (3)

women are more likely to accept HIV

testing, and accept ZDV when indicated;

and (4) there has been a large reduction

in perinatally transmitted cases of AIDS.

The IOM also found that: (1) for a

variety of reasons, prenatal testing of

pregnant women has not yet become

universal; (2) even when testing is

conducted, it does not always lead to

care; and (3) not all women necessarily

receive the quality treatment and

services they need. The IOM concluded

that the reduction in the number of

children born with HIV infection, while

substantial to date, could be greater. The

primary IOM recommendation for

further decreasing rates of perinatal HIV

transmission in the United States is

summarized below:

• The IOM committee recommends

the adoption of a national policy of

universal HIV testing, with patient

notification, as a routine component of

prenatal care.

* HIV tests would be integrated into

the standard battery of prenatal tests for

all pregnant women, regardless of their

risk factors or local prevalence rates.

* Women would be informed that the

HIV test will be conducted and that they

have a right to refuse it.

* Requirement for extensive pre-test

HIV counseling should be eliminated.

* Initial refusal of the HIV test by

women should not necessarily be

considered final; clinical circumstances

may suggest that counseling should be

provided on the benefits of testing at

later prenatal care visits. Patients who

continue to refuse testing should never

be coerced or denied services.

For a complete discussion of the IOM

findings and recommendations, the full

report Reducing the Odds: Preventing

Perinatal Transmission of HIV in the

United States can be found at the

National Academy Press website (http:/

/www.nap.edu.).

Ongoing Challenges

Many challenges remain in further

reducing the number of children with

perinatally-acquired HIV infection. Of

great importance is increasing the use of

prenatal care by women at risk for HIV

infection, with a particular emphasis on

bring women with substance abuse

addictions into prenatal care, and the

continued development of more

effective antiretroviral regimens and

other methods to prevent or reduce

perinatal transmission. Other challenges

include the monitoring for emergence of

antiretroviral resistance to current

therapies, addressing the potential

toxicities of antiretroviral therapies,

assisting HIV-positive pregnant women

to remain adherent to antiretroviral

therapy, and increasing provider

practices to routinely offer and

encourage HIV testing of all pregnant

women regardless of perception of risk.

Diligence and commitment will be

required by individual care providers,

program planners, and prevention

organizations at every level—public and

private local, state and national—to

make substantial further reductions in

perinatal HIV transmission a reality.

The Department of Health and Human

Services continues to address these

challenges through a variety of HIV

prevention and service delivery

programs, provider training, research

efforts, substance abuse prevention and

treatment, and the Medicaid program.

Highlights of these efforts appear in

Attachment A.

V. Findings and The Secretary’s

Determination

Pursuant to Section 2626 (d), the

Secretary must determine ‘‘whether it

has become a routine practice in the

provision of health care in the United

States to carry out each of the activities

described in paragraphs (1) through (4)

of section 2627.’’ The term routine

practice is not defined in statute, and

the legislative intent must be derived

from the Joint Explanatory Statement of

the Committee on Conference. On page

46 of Conference Report 104–545, the

following explanatory text is provided:

‘‘Within two years following the

implementation of such a system, the

Secretary will make a determination

whether mandatory HIV testing of all

infants born in the U.S. whose mothers

have not undergone prenatal HIV testing

has become a routine practice.’’ The

Conference Report did not provide

guidance for Sec. 2627 paragraphs (2),

(3), or (4). To address the issue of

routine practice for these elements,

information is provided on what has

been recommended and the available

data on compliance with those

recommendations. It should be noted

that health care providers usually do not

record information regarding to whom

test results are disclosed.

Findings

Newborn HIV Testing

States have widely implemented the

PHS guidelines for universal HIV

counseling and voluntary testing of

pregnant women and their infants. Only

two States (New York and Connecticut)

have a requirement for the mandatory

HIV testing of all newborn infants and

only New York is currently collecting

data on all registered births in that State.

Mandatory newborn HIV testing is not

routine practice, as this term is defined

in Conference Report 104–545, in other

States. Provisions in two States for

newborn HIV testing are conditional

upon a provider’s assessment that the

test is medically necessary (FL, IN), and

a third State requires newborn testing

unless a parent objects (TX). The IOM

study made no recommendation

regarding mandatory newborn testing,

but noted that it has limited utility in

preventing HIV transmission from

mother to child.

Disclosure of Newborn HIV Test Results

Timely disclosure of the results of a

newborn’s HIV test to the biological

mother or guardian and to the health

care provider is consistent with national

and local recommendations for HIV

counseling and testing. Surveillance and

other data indicate that the majority of

HIV-infected pregnant women are aware

of their serostatus during pregnancy and

their newborns are receiving therapy.

However, no standardized data are

regularly documented in medical

records or collected on the disclosure of

new HIV test results to the biological

mother, legal guardian, or agents of the

State (where the State is the legal

guardian) upon which to certify that this

is routine practice. Other studies

indicate that failure to disclose results

in a timely manner is often due to

logistical issues such as a lengthy

interval before specimens are tested and

results noted, or failure of the baby’s

guardian to return to the testing site for

receipt of test results. Improving

strategies to increase the number of

tested persons who learn of their test

results, including guardians of

newborns, is an ongoing activity of CDC

in partnership with the States. Specific

research and programmatic efforts are

being directed at pregnant women who

have not received prenatal care to assure

that they are offered rapid HIV testing

in a timely manner to begin preventive

therapy for the newborn.

Disclosure of HIV Test Results to

Pregnant Women

Timely disclosure of test results to all

tested persons, including pregnant

women, is consistent with national and

local guidelines for HIV counseling and

testing. However, as with disclosure of

newborn test results, standardized data

are not consistently recorded in medical

records or collected to document that

the results of prenatal HIV tests are

promptly disclosed to the pregnant

women involved. Such prompt

3372 Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Notices

disclosure remains the goal of

appropriate medical care. Available

HIV/AIDS surveillance data indicate

that over 80% of HIV-infected pregnant

women in 1996 were aware of their

status before or during their pregnancy.

This percentage has likely increased in

1997 and 1998, although data are not yet

available to confirm this increase.

Post-test Counseling

Both national and local guidelines

recommended post-test counseling at

the time of disclosure of HIV test

results. There is no standardized data

system that directly measures

performance and quality of post-test

counseling among all pregnant women

in the U.S. Likewise, data are not

routinely collected or documented in

the medical record to assess whether, in

disclosing an infant’s HIV test results to

the biological mother or legal guardian,

appropriate HIV counseling is made

available to that individual.

Nonetheless, other data indicate that in

1996 about 85% of HIV-infected

pregnant women who were aware of

their HIV status during pregnancy were

offered zidovudine during pregnancy,

thereby suggesting that at least this

percentage of women likely received

counseling about the benefit of

zidovudine prophylazis.

Secretary’s Determination

With regard to the statutory

provisions and legislative intent as

defined by the Committee on

Conference, the Secretary has

determined that required testing of

newborns of HIV has not become

routine practice in the United States.

The Secretary further notes that even

though disclosure of the results of HIV

testing, accompanied by post-test

counseling, are recommended for all

persons who undergo HIV testing,

specific standardized data systems to

measure these elements are not in place

and such data are not routinely recorded

in medical records nor collected in all

states. All States have placed a focus on

reaching women early in pregnancy to

reduce perinatal HIV transmission,

certifying their implementation of the

PHS guidelines for universal HIV

counseling and voluntary testing of

pregnant women.

The Secretary further finds that

remarkable success has already been

achieved in lowering the incidence of

perinatal transmission of HIV. Further

reduction in transmission can best be

achieved by increasing the number of

HIV-infected women who utilize

prenatal care, including the targeting of

substance abuse treatment services for

women who use drugs; increasing the

number of providers who recommend

HIV testing to all their pregnant

patients; continuing the development of

more effective antiretroviral regimens;

improving access, utilization and

adherence to recommended treatment

and other interventions; enhancing

linkages among HIV prevention,

substance abuse and mental health

providers; and assuring quality health

care, including substance abuse

treatment and mental health services,

for all HIV-infected women and their

children. These activities are the focus

of a new grant program in Section 2625

of the Public Health Service Act, which

received its first appropriation in FY99.

Attachment A Highlights of Federal

Public Health Efforts to Reduce

Perinatal HIV Transmission.

Centers of Disease Control and

Prevention

The CDC has taken a number of steps

towards reduction of perinatal HIV

transmission, including:

• Dissemination of the USPHS

Guidelines for prevention of perinatal

HIV transmission. Following

publication of the U.S. Health Service

Recommendations for HIV Counseling

and Voluntary Testing for Pregnant

Women in July 1995, as part of the

CDC’s Morbidity and Mortality Weekly

Report (MMWR) series, CDC widely

distributed and publicized these

guidelines through numerous avenues.

Additional copies of the MMWR were

mailed to all state and local health

departments, and to both public and

private health organizations and

professional associations. The

guidelines were posted on CDC’s

Internet home page and were widely

promoted in newsletters and additional

mailings. They were also distributed on

request through the CDC National

Prevention Information Network (NPIN,

formerly known as the National AIDS

Clearinghouse) by calling toll free

numbers at NPIN or the CDC National

AIDS Hotline.

• Establishment of a comprehensive

surveillance system to both monitor and

evaluate the impact of the USPHS

guidelines. At the core of this effort is

a surveillance system for HIV and AIDS

case reporting. In addition, ancillary

studies that provide additional data on

reported cases have also been conducted

and results reported. A populationbased survey on prenatal care of

recently-delivered women in 11 states

has also provided data on HIV testing

among pregnant women. Finally,

surveillance of all children under

medical care in seven areas of the

United States who have been exposed to

or are infected with HIV provides

additional information.

• Conduct of research to further

evaluate the effectiveness of perinatal

HIV prevention efforts. The CDCsponsored Perinatal Evaluation Project

was established to examine specific

factors associated with acceptance of

interventions aimed at preventing

perinatal HIV transmission, adherence

to recommended therapies by HIVinfected pregnant women, and access to

follow-up care.

• Training to support implementation

of the USPHS guidelines. CDC

developed a training curriculum, ‘‘HIV

Prevention Counseling for Women of

Reproductive Age,’’ designed to provide

a detailed explanation of each

recommendation and to sensitize

counselors to issues many women of

reproductive age have related to HIV

counseling and testing. In addition to

the normal distribution channels for

CDC training materials for counseling

and testing, this curriculum was mailed

directly to nearly 100 individual HIV

counselors across the country. CDC has

also developed and is in the process of

finalizing a second course specifically

focusing on HIV prevention counseling

in prenatal clinics. This training

curriculum will be released in the near

future.

• Establishment of a new grant

program. Ten million dollars was

appropriated in Fiscal Year 1999 by

Congress to establish a new grant

program to States for prevention of

perinatal HIV transmission. CDC

awarded these funds to the 16 most

heavily affected States to reduce

perinatal HIV transmission.

• Revision of USPHS Guidelines.

CDC has begun the process of examining

the current USPHS guidelines in view of

the recommendations by the Institute of

Medicine. CDC is intending to revise the

current guidelines to incorporate new

scientific information and perspectives

following the standard process of

inviting public comment. These new

guidelines are expected to be released

within the coming year.

National Institutes of Health

• The NIH continues to support

research focused on development,

implementation and direction of a wide

range of domestic and international

research activities. These include study

of the pathogenesis, epidemiology,

natural history, and risk factors and cofactors of HIV and related retroviruses

in pregnant women, mothers, infants,

children, adolescents and the family

unit as a whole. Studies focused on

prevention of perinatal and sexual

transmission and the treatment of HIV

Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Notices 3373

disease and its complications among

HIV-infected pregnant women, infants,

children and adolescents are also

important NIH activities. Examples of

these activities include: (a) Clinical

trials on the prevention of HIV

transmission, including development

and evaluation of prophylactic and

therapeutic vaccines and development

of new, non-AZT-based methods of

preventing perinatal transmission; (b)

Research focused on the etiology and

pathogenesis of HIV infection in infants

and children, including the study of

children exposed in utero to AZT and

other antiretroviral agents and the

etiology of any potential adverse effects

from this exposure; (c) studies of the

natural history of HIV infection and

disease in pregnant and nonpregnant

women, infants, children and

adolescents.

• The current goal of the Pediatric

AIDS Clinical Trials Group (PACTG) is

to lower the rate of perinatal

transmission in the United States to

under 2%. This will entail evaluation of

combination therapies in pregnant

women and newborns, and the

proactive development of alternatives to

AZT, because as AZT resistant strains of

HIV become more common, the efficacy

of the PACTG 076 AZT regimen may

decrease.

• A major prospective study of

perinatal transmission funded by the

NIH is the Women and Infants

Transmission Study (WITS). The WITS

is the only large perinatal observational

cohort study in the U.S. that is

continuing to enroll patients; the study

maintains extensive longitudinal

clinical, virologic and immunological

evaluations of pregnant and postpartum

women and their infants. A critical part

of the study has been the development

of an extensive repository of maternal

and infant specimens which has

enabled both WITS and interested nonWITS investigators to examine the role

of virologic, immunologic, and genetic

factors in perinatal transmission,

particularly in an era of antiretroviral

therapy for pregnant infected women.

• The rational design to additional

interventions to reduce perinatal and

sexual transmission requires a more

complete understanding of factors

contributing to transmission. Since the

majority of perinatal transmission

occurs during birth, viral exposure

during labor and delivery is thought to

be an important mechanism of

transmission. The NIH is funding the

Women’s Interagency Health Study, the

largest multicenter, longitudinal study

of HIV disease in women in the United

States, to define the immunologic

environment of the female genital tract

in uninfected as well as HIV infected

women, the properties of HIV found in

the genital tract, and the factors that

influence these parameters. These

studies will provide insight into how to

develop better interventions to further

the goal of prevention.

Health Resources and Services

Administration

Since the results of the ACTG 076

trial became available in 1994, HRSA

has engaged in numerous activities to

reduce perinatal HIV transmission and

facilitate the development of health care

systems for pregnant women with HIV

and their families. Selected activities are

highlighted below.

• In 1994, HRSA convened two

public meetings which brought together

women living with HIV, providers,

advocates, ethicists, and policy makers

as well as representatives of State and

local governments, and HRSA grantees.

The purpose was to identify issues in

implementing expanded HIV counseling

and voluntary testing and providing

access to zidovudine chemoprophylaxis

for pregnant women with HIV who are

served by HRSA’s programs and to

recommend practical strategies for

implementation. The findings from

these two meetings formed the basis for

subsequent HIV/AIDS program

initiatives.

• HRSA published and disseminated

the Program Advisory ‘‘Use of

Zidovudine to Reduce Perinatal HIV

Transmission in HRSA-Funded

Programs’’ to its grantees in December

1995.

• A collaboration was formed with

the Agency for Health Care Policy and

Research, the Health Care Financing

Administration, and Columbia

University, NY, to produce consumer

educational materials (including written

documents, audio and video tapes) in

English, Spanish, and Haitian Creole,

entitled ‘‘Is AZT the Right choice for

You and Your Baby?’’ Over 20,000

copies of these materials have been

circulated to HRSA and Medicaid

constituents since 1995. HRSA

subsequently commissioned and widely

circulated an updated consumer

document, ‘‘What Women Need to

Know: The HIV Treatment Guidelines

for Pregnant Women’’, based on the

January 1998 USPHS Task Force

Recommendations for the Use of

Antiretroviral Drugs in Pregnant Women

Infected with HIV-1 for Maternal Health

and for Reducing Perinatal HIV-1

Transmission in the United States.

• HRSA produced and implemented

several provider training programs on

the topic of perinatal zidovudine

chemoprophylaxis and reduction of

perinatal HIV transmission. These

include: (1) two international State-ofthe-Art Clinical Conference calls (1994,

1998) and one international satellite

broadcast in 1998; (2) an extensive

training program through the AIDS

Education and Training Centers

utilizing the HRSA manual ‘‘Reduction

of Perinatal HIV Transmission: A Guide

for Providers’’; (3) a National Telephone

Consultation Service that tracks and

analyzes all provider consultations

related to the reduction of perinatal HIV

transmission; (4) a manual entitled

‘‘Creating a Circle of Care:

Comprehensive Service Delivery to HIVPositive Pregnant Women and Their

Newborns’’; and (5) a monograph

entitled ‘‘Comprehensive Services for

HIV-Infected Pregnant Women and

Their Newborns: Seven Case Studies.’’

All documents have been widely

circulated to HRSA providers.

• Since 1995, all HRSA Ryan White

grantees are expected to annually revise

and implement program plans to

increase routine perinatal HIV

counseling and voluntary testing to

further reduce perinatal HIV

transmission.

• In 1995, the HRSA Ryan White Title

IV program developed and implemented

the Women’s Initiative for HIV Care and

Reduction of Perinatal HIV

Transmission (WIN). WIN is a ten site,

four year demonstration project focusing

on perinatal HIV counseling, voluntary

testing, and improving the care system

for women with HIV disease. In the first

two and a half years of WIN, 33,000

women have been contacted through

outreach and informed of the benefits of

knowing their HIV status and where

they could obtain care. Additionally,

more than 1,300 pregnant women with

HIV and 2,000 infants were enrolled in

care through WIN programs. Within

WIN, both clients and providers have

been interviewed in order to explore the

health services needs of women with

HIV and the training and technical

assistance needs of their providers.

• HRSA has also supported the

Association of Maternal and Child

Health Programs (AMCHP) to survey

state health departments and develop a

guidance document for expanded HIV

counseling and testing and provision of

care for pregnant women with HIV

infection.

Health Care Financing Administration

Maternal HIV Project

HCFA began a consumer information

project in 1995 to inform women of

childbearing age about the findings from

the AIDS Clinical Trials Group 076

which showed that, when a regimen of

3374 Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Notices

zidovudine is given to HIV-infected

women during pregnancy and delivery,

and to the infant after birth, the rate of

transmission of HIV from mother to

child is greatly reduced. This project,

which was initially begun in only four

states, has been greatly expanded.

Currently, 41 States, the District of

Columbia, and Puerto Rico have

campaigns to inform women about the

AZT regimen. HCFA has a National

Performance Review goal to expand this

information campaign to all States by

the year 2000. Materials are now

available in English, Spanish, Haitan

Creole, Russian, Chinese, Japanese,

Vietnamese, Korean, French, and

Bosnian. HCFA intends to publish

materials in four additional languages—

Portuguese, Khmer, Hmong, and Yupik.

A ten minute video targeting all women

of childbearing age will be available in

2000.

• The Maternal HIV Project also

maintains a website to provide

information for both providers and

women of childbearing age regarding

HIV counseling and testing, and

Medicaid coverage of these services.

The website can be accessed from a

banner on the HCFA homepage, http://

www.hcfa.gov.

Substance Abuse and Mental Health

Services Administration

• The Treatment and Systems

Improvement Branch within the Center

for Substance Abuse Treatment

currently funds 9 Residential Women

and Their Children (RWC) and 3

Pregnant and Postpartum women (PPW)

grant programs. Both of these programs

offer comprehensive, high quality

residential treatment services for

women suffering from alcohol and other

drug problems, and their children. The

RWC program serves women and their

children ages birth through age 10. The

PPW program serves pregnant women

and their children up to age one. Both

grant programs include a broad range of

services, including medical and mental

health assessments, screenings and

services which can address the HIV

counseling, testing and health care

needs of pregnant women and their

infants. In each program, education,

counseling and medical services or

referrals are offered around HIV/AIDS.

One of the many goals of these programs

is to reduce the incidence of HIV, TB,

and STDs.

• SAMSHA also supports HIV

counseling and testing activities among

individuals in substance abuse

treatment programs through the HIV Set

Aside in the Substance Abuse

Prevention and Treatment Block Grant.

The Community Outreach Grants

program also targets information,

resources, counseling and testing to

women and men at risk for HIV because

of their injection drug use. While not

specifically targeted at pregnant women,

these efforts reach many women of

childbearing age to increase their

knowledge of serostatus and to provide

referrals for needed services.

Indian Health Service

• The IHS has disseminated the

USPHS Guidelines for HIV Counseling

and Voluntary Testing for Pregnant

Women to IHS health providers. IHS

also sponsors a Postgraduate OB/GYN

course with a comprehensive syllabus,

which has been an excellent vehicle for

disseminating the guidelines to IHS

providers.

• Ongoing assessments of HIV

counseling and testing for pregnant

women are conducted in IHS sites. For

example, in the Phoenix, AZ area, all

IHS Service Units offer HIV testing at

the first prenatal visit. At Phoenix

Indian Medical Center, one to two

women are treated during the prenatal

period for positive HIV tests each year,

but as yet no infant has been born with

HIV infection. A recent audit from the

Navajo Area Office reviewing HIV

counseling rates by primary prenatal

provider specialty showed that rates of

HIV counseling were highest in clinics

where nurses were trained to do all of

the counseling (97% of patients were

provided counseling).

Dated: January 14, 2000.

Donna E. Shalala,

Secretary.

[FR Doc. 00–1358 Filed 1–19–00; 8:45 am]

BILLING CODE 4150–28–M