[Federal Register Volume 65, Number 13 (Thursday, January 20, 2000)]
[Notices]
[Pages 3368-3374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1358]



[[Page 3367]]

-----------------------------------------------------------------------

Part IV





Department of Health and Human Services





-----------------------------------------------------------------------



Office of the Secretary



-----------------------------------------------------------------------



Determination on Newborn HIV Testing; Notice

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

[[Page 3368]]


-----------------------------------------------------------------------

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 HIV-exposed 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

[[Page 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

[[Page 3370]]

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.
    <bullet> 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.
    <bullet> 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.
    <bullet> More than 90% of women known to be HIV-infected who are in 
prenatal care receive zidovudine (AZT) prophylaxis.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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%.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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 HIV-infected after one year. In the first half of 1997, 60 
perinatally exposed children were born, none of whom were determined to 
be HIV-infected.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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

[[Page 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:
    <bullet> 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

[[Page 3372]]

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:
    <bullet> 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.
    <bullet> 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 
population-based 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.
    <bullet> Conduct of research to further evaluate the effectiveness 
of perinatal HIV prevention efforts. The CDC-sponsored 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 HIV-
infected pregnant women, and access to follow-up care.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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

    <bullet> 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 co-
factors 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

[[Page 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.
    <bullet> 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.
    <bullet> 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 non-
WITS 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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-of-the-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 HIV-
Positive 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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

[[Page 3374]]

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.
    <bullet> 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

    <bullet> 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.
    <bullet> 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

    <bullet> 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.
    <bullet> 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