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Jennifer Klein's Files
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THE WHITE HOUSE
WASHINGTON
August 13, 1996
INFORMATION
MEMORANDUM FOR THE PRESIDENT
FROM:
Carol H. Rasco, Assistant to the President for Domestic Policy
DHR
Patricia S. Fleming, Director, Office of National AIDS Policy
TSF
SUBJECT: HIV-related legislation
cc:
The First Lady
Background:
The proposed HIV Prevention Act of 1996 (H.R. 3937), introduced August 1st by Rep. Tom
Coburn (R-OK), has received some attention from conservative commentators recently. While
it is unlikely to move this year, we thought it would be useful to summarize the
Administration's position on the various issues this legislation raises.
As you know, Rep. Coburn was the author of legislation requiring mandatory HIV testing of
newborns. This was opposed by most in the public health community, and a compromise was
attached to the Ryan White CARE Act, which you signed in May, that would require mandatory
testing of newborns in the year 2000 if states have not achieved a 95 percent acceptance rate of
voluntary testing or have not reduced their rate of perinatal transmission by 50 percent. Reports
from the International Conference on HIV/AIDS in Vancouver indicate that many health care
providers are achieving high rates of voluntary testing and that the hoped for decline in perinatal
transmission is beginning to be seen. (There already is a 10% decrease reported between 1994
and 1995.)
Key elements of H.R. 3937:
This new bill offered by Coburn would legislate in areas that have traditionally been left to
public health professionals. In each area, the Centers for Disease Control and Prevention and
state and local health departments already have the authority to act and in some cases they have.
This is a case where rigidly legislated standards could result in inappropriate public health
responses to a constantly evolving epidemic.
(1) Requires reporting of the names of all individuals who test positive for HIV to state health
departments. This would be an intrusion on the discretion of the states to determine appropriate
public health policies. Twenty-seven states already have names reporting policies and CDC
provides additional funds to encourage states to adopt such a policy.
(2) Requires states to have notification programs for sex and needle sharing partners of those
who are HIV positive. This is unnecessary. The CDC already requires such programs as a
condition of receipt of Federal prevention funds.
(3) Permits the involuntary testing of defendants in sexual assault cases -- both to inform the
victim and as relevant information in a prosecution. Again, this is unnecessary. The Omnibus
Crime Act of 1994 allows sexual assault victims to request HIV testing of an accused offender.
(4) Allows health care professionals to make HIV testing of patients a pre-condition for
performing invasive procedures. This is counter to the current guidelines of the Public Health
Service, which say it is critical that health professionals take universal precautions for all
invasive procedures regardless of the patient's HIV status.
(5) Requires HIV positive health care workers to notify patients before performing invasive
procedures. This policy already is reflected in PHS guidelines on HIV-infected health care
workers; all states are required to adopt these policies.
(6) Establishes the sense of Congress that it is a felony for HIV positive individuals to engage in
behaviors that an individual knows places others at risk, even if no transmission occurs. This is
an issue for state criminal codes. There have already been numerous prosecutions under
existing law in such cases.
Summary:
In summary, this legislation is unnecessary. Many of the provisions reflect existing policy
while others would override the judgment of public health professionals and eliminate the
flexibility they need to adapt policies based on new scientific knowledge.
None of Coburn's proposals would actually promote the behavior change necessary to reduce
HIV transmission. Your Administration has made great strides in improving HIV prevention
programs -- primarily through the introduction of a community planning process that gives
states and localities much greater flexibility in their use of federal funds to target interventions
based on the demographics of the epidemic in their jurisdiction. Funding has increased by
$85.1 million (or 17 percent) since 1993, and you have requested another $33.5 million for FY
1997.
The legislation also fails to address the problem that far too many people with HIV do not know
their status. The CDC estimates that only 62% of the 650,000-900,000 people with HIV in the
U.S. do not know their status. With the growing consensus in the scientific community that the
earliest possible intervention in the course of HIV infection is probably the most appropriate
intervention, it will be critical to convince more people to take advantage of testing. This will
require a combination of actions -- including stronger outreach to those at risk and a change in
attitude toward testing by those most at risk to HIV. At the request of the Office of National
AIDS Policy, the CDC and the Health Resources and Services Administration will be funding a
project to examine how programs and policies related to encouraging people to seek HIV testing
and care should be modified. This project is expected to be completed by the end of the year.
Orig. has been
Jen Ulein
Sent to staff Secretary
APR 5 1996
Z
THE WHITE HOUSE
WASHINGTON
April 8, 1996
MEMORANDUM FOR THE PRESIDENT AND THE FIRST LADY
FROM:
Carol H. Rasco, Assistant to the President for Domestic Policy
Patricia S. Fleming, Director, Office of National AIDS Policy
SUBJECT: Amendment regarding mandatory HIV testing of newborns
cc:
Jennifer Klein
We are writing to bring you up to date on the status of congressional consideration of the
issue of mandatory HIV testing of newborns. House-Senate conferees met last week to try to
resolve differences regarding an amendment on HIV testing of newborns that was added to
the Ryan White CARE Act reauthorization bill during House consideration. However, no
final conclusion was reached.
Coburn-Waxman Amendment
The House amendment, sponsored by Reps. Coburn (R-OK) and Waxman (D-CA), would
trigger mandatory HIV testing of newborns if certain conditions are not met. It would
require the Secretary of Health and Human Services to determine, within two years, if HIV
testing of newborns is the standard of care when the HIV status of the mother is unknown.
If it is the standard of care, the Secretary must then determine, after another 18 months, that
newborn testing is occurring voluntarily in 95 percent of the infants born to mothers who
have not been tested. If the Secretary determines that 95 percent of such newborns have not
been voluntarily tested, then mandatory HIV testing of newborns would be required in those
states not in compliance. The states would have three-and-a-half years to reach the 95
percent level through voluntary testing.
Leading medical groups (such as the American Academy of Pediatrics, the American College
of Obstetricians and Gynecologists, and the Pediatric AIDS Foundation) oppose this
amendment and support voluntary HIV testing of pregnant women. In addition, AIDS
advocacy organizations are nearly universally opposed to this amendment.
Testing of Pregnant Women
During Senate consideration of the Ryan White CARE Act, an amendment offered by
Senator Kassebaum was approved that would require states to adopt the Public Health
Service's guidelines making routine counseling and voluntary testing of all pregnant women
the standard of care. The emphasis on the prenatal period, of course, has the greatest
potential for preventing transmission to newborns. Newborn testing will have virtually no
impact on HIV transmission to newborns. Prenatal HIV testing would permit HIV infected
mothers to take AZT during pregnancy and childbirth, which has been demonstrated to
Memorandum for the President and the First Lady/Page 2
reduce the likelihood of transmission by as much as two-thirds.
It is worth noting that there are already encouraging results confirming that the combination
of routine HIV counseling, voluntary testing, and AZT by choice is highly effective at
reducing perinatal transmission. A study from North Carolina indicates that, after being
counseled about HIV, most women choose to be tested and that, if positive, most choose to
take AZT. The rate of perinatal transmission fell from 21 percent of all infants born to HIV-
positive mothers in 1993 to just 8.5 percent in 1994, on a par with the original NIH study.
Results from hospitals in major urban centers -- such as Miami, Atlanta, and Harlem, show
similar high rates of testing and AZT use.
Current Status
Discussions in conference have focused on possible changes to the Coburn-Waxman
amendment, such as changing the trigger for mandatory HIV testing of newborns to a failure
to achieve a 50 percent reduction in perinatal transmission. But the underlying mandatory
nature of the amendment remains.
The Administration has deliberately not taken a position on Coburn-Waxman. Instead, we
have consistently emphasized the importance of implementing the PHS recommendations for
voluntary prenatal testing as the most effective intervention and the various HHS agencies
have taken major steps to assure that testing and treatment are readily available to those
women who need it. At the White House Conference on HIV/AIDS on December 6th, you
stated that this is an issue that should be left to the public health officials to resolve, not
politicians.
It is not clear how the conferees will resolve this issue, but it is quite possible that the final
bill will contain something along the lines of the Coburn-Waxman amendment. While all the
AIDS groups oppose the amendment, it is quite likely that they will be very divided over the
issue of whether the CARE Act should be vetoed if it comes with a mandatory testing
amendment. Some will consider reauthorization of Ryan White to be a higher priority;
others will be more concerned about the precedent of signing mandatory testing legislation.
At this time, we are giving no indication of future action until it is clear what the conference
will do.
THE WHITE HOUSE
WASHINGTON
September 15, 1995
MEMORANDUM FOR THE FIRST LADY
FROM:
Carol Rasco and Patsy Fleming
P
SUBJECT: Amendment regarding mandatory HIV testing of newborns
On Monday, the House of Representatives is expected to take up the reauthorization of the
Ryan White CARE Act. As part of the bill, the managers have added an amendment co-
sponsored by Reps. Coburn and Waxman regarding HIV testing of newborns.
The amendment requires the Secretary of Health and Human Services to determine if HIV
testing of newborns is the standard of care when the HIV status of the mother is unknown.
If it is the standard of care, the Secretary must then determine that newborn testing is
occurring voluntarily in 95 percent of the infants born to mothers who have not been tested.
If the Secretary determines that 95 percent of such newborns have not been voluntarily
tested, then mandatory HIV testing of newborns would be required in those states not in
compliance. The states would have three-and-a half years to reach the 95 percent level
through voluntary testing.
During Senate consideration of the Ryan White CARE Act, an amendment offered by
Senator Kassebaum was approved that would require states to adopt the Public Health
Service's guidelines making routine counseling and voluntary testing of all pregnant women
the standard of care. The emphasis on the prenatal period, of course, has the greatest
potential for preventing transmission to newborns. It is not clear how these two amendments
will be reconciled in conference.
The AIDS Policy Office has been working closely with Jennifer Klein to encourage the
Department of Health and Human Services to move as rapidly as possible to assure that all
federally funded services reaching pregnant women are linked to counseling and testing
programs for pregnant women. The most significant advance in that regard has been a
decision by the Health Care Financing Administration to advise the states that counseling and
testing of pregnant women is the standard of care and therefore should be part of basic
coverage for Medicaid recipients. Until now, Medicaid only required coverage of the AZT
therapy of those women who had already been identified as HIV infected.
CC: Melanne jen
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AMENDMENT TO H.R. 1872, AS REPORTED
OFFERED BY MR. COBURN OF OKLAHOMA
Page *[21], after line *[19], insert the following sec-
tion (and redesignate provisions and conform cross-ref-
erences accordingly):
1 SEC. 204. ADDITIONAL REQUIREMENTS FOR GRANTS.
2
(a) FINDINGS.-The Congress funds as follows:
3
(1) Research studies have demonstrated that
4
administration of antiviral medication during prag-
5
nancy can significantly reduce the transmission of
6
the human immunodeficiency virus (commonly
7
known as HIV) from an infected mother to her
8
baby.
9
(2) The Centers for Disease Control and Pre-
10
vention have recommended that all pregnant women
11
receive HIV counseling; voluntary, confidential HIV
12
testing; and appropriate medical treatment (includ-
13
ing antiviral therapy) and support services.
14
(3) The provision of such testing without access
15
to such counseling, treatment, and services will not
16
improve the health of the woman or the child.
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2
1
(4) The provision of such counseling, testing,
2
treatment, and services can reduce the number of
3
pediatric cases of acquired immune deficiency syn-
4
drome, can improve access to and provision of medi-
5
cal care for the woman, and can provide opportuni-
6
ties for counseling to reduce transmission among
7
adults.
8
(5) The provision of such counseling, testing,
9
treatment, and services can reduce the overall cost
10
of pediatric cases of acquired immune deficiency
11
syndrome.
12
(6) The cancellation or limitution of health in-
13
surance or other health coverage on the basis of
14
HIV status should be impermissible under applicable
15
law. Such cancellation or limitation could result in
16
disincentives for appropriate counseling, testing,
17
treatment, and services.
18
(7) For the reasons specified in paragraphs (1)
19
through (6)-
mandatory
voluntary
20
(A) routine counseling and routine tosting
21
of pregnant women should be the standard of
22
care; and
23
(B) the relevant medical organizations as
24
well as public health officials should issue
August 1. 1995
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3
]
guidelines making such counseling and testing
2
the standard of care.
3
(h) ADDITIONAL REQUIREMENTS FOR GRANTS.-
4 Part B (42 U.S.C. 300ff-21 et seq.) is amended-
5
(1) in section 2611, by adding at the end the
6
following sentence: "The authority of the Secretary
7
to provide grants under this part is subject to sec-
8
tion 2673D (relating to the testing of pregnant
9
women and newborn infants).' and
10
(2) by inserting after section 2616 the following
11
section:
12 "SEC. 2616A. REQUIREMENT RECARDING HEALTH INSUR-
13
ANCE.
14
"(a) IN GENERAL.-Subject to subsection (c), the
15 Secretary shall not make a grant under this part to a
16 Stute unless the State bas in effect a statute or regula-
17 tions regulating insurance that imposes the following re-
18 quirements:
19
"(1) That, if health insurance is in effect for an
20
individual, the insurer involved may not (without the
21
consent of the individual) discontinue the insurance,
22
or alter the terms of the insurance (except HN pro-
23
vided in paragraph (3)), solely on the basis that the
24
individual is infected with HIV disease or solely on
August 1, 1995
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4
1
the basis that the individual has been tested for the
2
disease.
3
"(2) That paragraph (1) does not apply to an
4
individual who, in applying for the health insurance
5
involved, knowingly misreprosented any of the fol-
6
lowing
7
"(A) The HIV status of the individual.
8
"(B) Facts regarding whether the individ-
9
ual has been tested for IIIV disease.
10
"(C) Facts regarding whether the individ-
1]
usl has engaged in any hehavior that places the
12
individual at risk for the discase.
13
"(8) That paragraph (1) does not apply to any
14
reasonable alteration in the terms of health insur-
15
ance for an individual with HIV disease that would
16
have been made if the individual had a serious die-
17
ease other than HIV disease.
18
"(b) REGULATION OF HEALTH INSURANCE.-A stat-
19 ate or regulation shall be deemed to regulate insurance
20 for purposes of this section only to the extent that it is
21 treated as regulating insurance for purposes of section
22 514(b)(2) of the Employee Retirement Income Security
23 Act of 1974.
24
"(e) APPLICABILITY OF REQUIREMENT.-
August 1, 1995
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5
1
"(1) IN GENERAL.-Excopt as provided in para-
2
graph (2), this section applies upon the expiration of
3
the 120-day period beginning on the date of the en-
4
autment. of the Ryan White CARE Act Amendments
5
of 1995.
6
"(2) DELAYED APPLICABILITY FOR CERTAIN
7
STATES.-In the case of the State involved, if the
8
Secretary determines that a requirement of this sec-
9
tion cannot be implemented in the State without the
10
enactment of State legislation, then such require-
11
ment applies to the State on and after the first day
12
of the first calendar quarter that begins after the
13
close of the first regular session of the State legiala-
14
ture that begine after the date of the enactment of
15
the Ryan White CARE Act Amendments of 1995.
16
For purposes of the preceding sentence, in the case
17
of a State that has a 2-year legislative session, each
18
year of such session is deemed to be a separate reg-
19
ular session of the State legislature.".
20
(c) TESTING OF NEWBORNS; PRENATAL TESTING-
21 Part D (42 U.S.C. 300ff-71 et seq.) is amended by insert-
22 ing before section 2674 the following sections:
August 1. 1995
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6
1 "SEC. 2673C. TESTING OF PREGNANT WOMEN AND NEW-
2
BORN INFANTS; PROGRAM OF GRANTS.
3
"(a) PROGRAM OF GRANTS-The Secretary may
4 make grants to States described in subscction (b) for the
5 following purposes:
6
"(1) Making available to pregnant women ap-
7
propriate counseling on HIV disease.
8
"(2) Making available to such women testing
9
for such disease.
10
"(3) Testing newborn infants for such disease.
11
"(4) In the case of newborn infants who test
12
positive fur such disease, making available counsel-
13
ing on such disease to the parents or other legal
14
guardians of the infant.
15
"(5) Collecting data on the number of prognant
16
women and newborn infants in the State who have
17
undergone testing for such disease.
18
"(b) ELIGIBLE STATES.Subject to subsection (c),
19 a State referred to in subsection (a) is a State that has
20 in effect, in statute or through regulations, the following
21 requirements:
22
"(1) In the case of newborn infants who are
23
born in the State and whose biological mothers have
24
not undergone prenatal testing for HTV disease, that
25
each such infant undergo testing for such disease.
August 1. 1895
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7
1
"(2) That the results of such testing of a new-
2
born infant be promptly disclosed in accordance with
3
the following, as applicable to the infant involved:
4
"(A) To the biological mother of the infant
5
(without regard to whether she is the legal
6
guardian of the infant).
7
"(B) If the State is the legal guardian of
8
the infant:
9
"(i) To the appropriate official of the
10
State agency with responsibility for the
11
care of the infant.
12
"(ii) To the appropriate official of
13
each authorized agency providing assist-
14
ance in the placement of the infant.
15
"(iii) If the authorized agency is giv-
16
ing significant consideration to approving
17
an individual as a foster parent of the in-
18
fant, to the prospective fuster parent.
19
"(iv) If the authorized agency is giv-
20
ing significant. consideration to approving
21
an individual as an adoptivo parent of the
22
infant, to the prospective adoptive parent.
23
"(C) If neither the biological mother nor
24
the State is the legal guardian of the infant, to
25
another legal guardian of the infant.
August 1, 1995
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8
1
"(3) That, in the case of prenatal testing for
2
HIV disease that is conducted in the State, the re-
3
smits of such testing be promptly disclosed to the
4
pregnant woman involved.
5
"(4) Tbat, in disclosing the test results to an
6
individual under paragraph (2) or (3), appropriate
7
counseling on the human immunodeficiency virus be
8
made available to the individual (except in the case
9
of a disclosure to an official of a State or an author-
10
ized agency).
11
"(o) LIMITATION REGARDING AVAILABILITY OF
12 GRANT FUNDS.-With respect to an activity described in
13 any of paragraphs (1) through (4) of subsection (b), the
14 requirement established by a State under such subsection
15 that the activity be carried out applies only to the extent
16 that the following sources of funds are available for carry-
17 ing out the activity:
18
"(1) Federal funds provided to the State in
19
grants under subsection (a).
20
"(2) Funds that the State or private entities
21
have elected to provido, including through entering
22
into contracts under which health benefits are pro-
23
vided. This section does not require any entity to ex-
24
pend non-Federal funds.
August 1, 1995
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9
1
"(d) DEFINITIONS.-Fur purposes of this section, the
2 term 'authorized agency', with respect to the placement
3 of a child (including An infant) for whom A. State is a. legal
4 guardian, means an entity licensed or otherwise approved
5 by the State to assist in such placement.
6
"(e) AUTHORIZATION OF APPROPRIATIONS.-For the
7 purpose of carrying out this section, there are authorized
8 to be appropriated $10,000,000 for each of the fiscal years
9 1996 through 2000.
10 "REC. 2673D. TESTING OF PREGNANT WOMEN AND NEW.
11
BORN INFANTS: CONTINGENT REQUIREMENT
12
REGARDING STATE GRANTS UNDER PART B.
13
"(a) DETERMINATION BY SECRETABY.-During the
14 first 30 days following the expiration of the 2-year period
15 beginning on the date of the enactment of the Ryan White
16 CARE Act Amendments of 1995, the Secretary shall pub-
17 lish in the Federal Register a determination of whether
the standard of care
18 it has become @ routine practice in the provision of health
19 care]in the United States to carry out each of the activities
20 described in paragraphs (1) through (4) of section
21 2673C(h). In making the determination, the Secretary
22 shall consult with the States and with other public or pri-
23 vate entities that have knowledge or expertise relevant to
24 the determination.
25
"(b) CONTINGENT APPLICABILITY.-
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10
1
"(1) TN GENERAL-If the determination pub-
2
lished in the Federal Register under subsection (a)
3
is that (for purposes of such subsection) the activi-
4
ties involved have become routine practices, para-
5
graph (2) applies to a State on and after the date
6
applicable to the State under subsection (d).
7
"(2) REQUIREMENT.--Subject to subsection (c),
8
the Secretary shall not make a grant under part R
9
to a State unless the State meets not less than one
10
of the following requirements:
11
"(A) The State has in effect, in statute or
12
through regulations, the requirements specified
13
in paragraphs (1) through (4) of section
14
2673C(b).
15
"(B) The State demonstrates that, of the
16
newborn infants born in the State for the most
17
recent 1-year period for which the data we
18
available, the HIV status of 95 percent of the
19
infants is known.
20
"(n) LIMITATION REGARDING AVAILABILITY OF
21 FUNDS.-With respect to an activity described in any of
22 paragraphs (1) through (4) of section 2673O(b), the re-
23 quirements established by a State under subsection
24 (a)(2)(A) that the activity be earried out applies only to
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11
1 the extent that the following sources of funds are available
2 for carrying out the activity:
3
"(1) Federal funds provided to the State in
4
grants under part B.
5
"(2) Federal funds provided to the State in
6
grants under section 2673C.
7
"(8) Funds that the State or private entities
8
have elected to provide, including through entering
9
into contracts under which health benefits are pro-
10
vided. This section docs not requiro any entity to ex-
11
pend non-Foderal funds.
12
"(d) APPLICABILITY OF REQUIREMENT.-
13
"(1) IN GENERAL--Except as provided in para-
14
graph (2), the date applicable to a State for pur
15
poses of subsection (b)(1) is the expiration of the
16
120-day period beginning on the date on which the
17
determination referred to in such subsection is pub-
18
lisbed.
19
"(2) DELAYED APPLICABILITY FOR CERTAIN
20
STATES-In the case of the State involved, if the
21
Secretary determines that the State has not met the
22
requirement described in subsection (b)(2)(B), and
23
that a requirement under subsection (b)(2)(A) can-
24
not be implemented in the State without the enact-
25
ment of State legislation, then the date applicable to
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12
1
a State for purposes of subsection (b)(1) regarding
2
the requirement is the first day of the first calendar
3
quarter that begins after the close of the first regu-
4
lar session of the State logislature that begins after
5
the date on which the determination referred to in
6
subsection (b)(1) is published. For purposes of the
7
preceding sentence, in the case of a State that has
8
a 2-year legislative session, each year of such session
9
is deemed to be a separate regular session of the
10
State legislature.".
August 1. 1995
JUL-25-1995
16:25
FROM
WHITE
HOUSE
AIDS
POLICY
TO
94562878
P.02
HHS NAPO
002
07/25/95 18:13 202 690 7560
Rough Draft
Talking Points for Secretary Shalala Senator Kassebaum
*
I appreciate your hard work in bringing the Ryan White CARE
Act reauthorization to the Senate floor. This bill has our full
support and we hope the Senate will complete action on it
quickly.
I have rd of your interest in sponsoring an amendment to
require mandatory prenatal HIV testing of women in certain
states. This is an issue of concern to me, and I'd like to
discuss it with you.
As you knew, the Public Health Service convened an extensive
process through the CDC examining how best to address HIV
prevention opportunities and treatment needs facing pregnant
women. PHS recommendations were released earlier this month
strongly supporting routine counseling and encouragement of
voluntary testing for all pregnant women.
It's clear that by helping women to learn their HIV status
early in pregnancy, HIV transmission to their newborns can be
reduced by two thirds if they follow a medical treatment plan.
*
There's strong evidence that when routine HIV counseling is
included in prenatal care, over 90% of women will accept HIV
testing. I believe this is the way we ought to proceed.
There is real concern that mandatory HIV testing of pregnant
women may discourage them from seeking prenatal care. Many women
at highest risk for HIV are mistrustful of health care systems to
start with, and coercively requiring an HIV test may
alienate them further. This way we lose the mother, and the
opportunity for prevention.
Should women avoid prenatal care, we face the potential of a
double tragedy higher rates of low birthweight and birth
defects among children never exposed to HIV, along with lost
opportunities to prevent new HIV infection among infants.
We have heard from many providers in both private practice
and public hea h clinics that building a trusting doctor-patient
relationship 13 essential in order for patients to follow a plan
of care. Manda ory HIV testing would be a hollow step if women
lose trust in Their providers and refuse to accept their
guidance.
Across Pub ic Health Service programs, our goal has been to
encourage early and continuous prenatal care. We've come a long
way, but we have a long way to go. I am very concerned that we
not jeopardize our progress in bringing high risk women into
care. Instead, we need creative, targeted efforts to reach them.
*
I would look forward to working with you on alternative
approaches to INE ndatory testing, and hope you will consider this.
JUL-21-95 19:19 FROM: OMB LA
ID:
PAGE 2/4
THE WITH PRESIDENT SINS UNITED
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF MANAGEMENT AND BUDGET
WASHINGTON, D.C. 20503
July 21, 1995
(Senate)
STATEMENT OF ADMINISTRATION POLICY
(THIS STATEMENT HAS BEEN COORDINATED BY OMB WITH THE CONCERNED AGENCIES.)
S. 641 -- Ryan White CARE Reauthorization Act of 1995
(Kassebaum (R) KS and 62 cosponsors)
The Administration strongly supports S. 641, consistent with the
attached July 5th letter from the President to the Senate
Majority Leader.
*******
JUL-21-95 19:19 FROM:OMB LA
ID:
PAGE
3/4
THE WHITE HOUSE
WASHINGTON
July 5, 1995
Dear Mr. Leader:
I am writing to urge you to lead the Congress in passing the
reauthorization of the Ryan White CARE Act before the summer
recess. We cannot allow this crucial program to lapse.
There is strong bipartisan support for the Ryan White CARE
Act. The initial legislation was approved by overwhelming
margins in both houses (95-4 in the Senate and 408-14 in the
House) and signed into law by President Bush. Funding for this
program has been endorsed from both sides of the aisle throughout
the five years of the program and the reauthorization bill in the
Senate has 60 co-sponsors. It is a program vital to the lives of
Americans living with HIV and AIDS. Its existence has had a
dramatic impact on the quality and length of their lives while
helping to reduce the cost of their care.
The CARE Act provides direct services to people living with
HIV and AIDS through grants to states, cities, community
organizations, and local clinics. It emphasizes outpatient care
in clinics and other facilities and is designed to relieve the
burden on public hospitals and other more expensive inpatient
facilities.
It has been a tremendous success in meeting this mandate.
By lessening the demand on public hospitals and other facilities,
valuable inpatient resources have been freed to care for patients
with other diseases, and people with HIV and AIDS have been able
to lead more productive lives in their communities. The CARE Act
approach serves as a model for delivering more cost-effective
health care for people with all diseases.
In 1994, the CARE Act provided care to more than 200,000
uninsured and underinsured people living with HIV or AIDS and
early intervention services to another 85,000 people. The Act
also funded HIV counseling and testing to nearly 100,000
Americans, provided pharmaceutical assistance to 75,000
individuals, and supported more than 15,000 women and children
participating in AIDS-related clinical trials.
Let me share with you the story of one person who has been
helped by this program -- one person whose experience with the
CARE Act is typical of literally hundreds of thousands of other
JUL-21-95 19:20 FROM OMB LA
ID:
PAGE 4/4
The Honorable Bob Dole
Page Two
Americans who have benefitted from this law. "Debbie" is a 27
year old woman living with AIDS in a rural part of South
Carolina. Until recently, few doctors in Debbie's hometown were
willing to treat AIDS patients in part because so many were
uninsured. With funding from the Ryan White CARE Act, the County
Health Department opened a clinic in the town of Orangeburg that
operated six days a month with a rotating staff of five
physicians and three nurses. The clinic's staff has taught
Debbie's mother to care for her daughter at home. When Debbie is
too sick to come to the clinic, the staff come to her. Not only
has this prevented more costly hospitalizations, but it provides
Debbie and her mother peace of mind. Debbie's Mom calls the
clinic's staff her "guardian angels."
The Ryan White CARE Act is a model of compassionate caring
for people in need. At a time when AIDS is the leading cause of
death of young adults, we cannot let reauthorization of the CARE
Act be held up by divisive arguments about how people contracted
HIV. Nor should we be deterred by the false argument that people
with HIV or AIDS are getting more help than those with other
diseases. In fact, total federal spending in FY 1995 for
research, treatment, prevention, Medicaid, Medicare, and income
supplements for AIDS is less than one-third that for cancer and
less than one-sixth that for heart disease. (AIDS spending is $6
billion, cancer is $17.5 billion, and heart disease is $38
billion.)
In the United States, an average of 220 Americans are being
diagnosed with AIDS every day and an average of 109 Americans are
dying of this disease each day. Now is not the time to retreat
in our national response to this terrible disease. We must move
forward to meet the very real needs of Americans living with HIV
and AIDS. We can certainly do more, we cannot do any less.
I hope you will join me in urging the Congress to move
forward promptly with a five-year reauthorization of this vital
program without complicated amendments so that we can once again
show the American people that their government can provide the
assistance they deserve.
Sincerely,
Biu Chinten
The Honorable Bob Dole
Majority Leader
United States Senate
Washington, D.C. 20510
EXECUTIVE OFFICE OF THE PRESIDENT
10-Jul-1995 03:02pm
TO:
(See Below)
FROM:
Emily Bromberg
Intergovernmental Affairs
SUBJECT: mandatory testing
FYI, the NGA will send a letter tomorrow to Chairman Bliley and others stating
that the NGA opposes mandatory AIDS testing for pregnant women because it is an
umfunded mandate. The NGA is sending this letter because they heard rumors on
the Hill that NGA had changed their position to support Coburn, and wanted to
reiterate their opposition. The letter will be signed by Ray Scheppach.
Distribution:
TO: Carol H. Rasco
TO: George Stephanopoulos
TO: Jennifer L. Klein
TO: Barbara C. Chow
TO: Patsy Fleming
CC: Marcia L. Hale
HIV Testing Column
Two Decisions:
(1)
Timing of article -- before or after Coburn comes up on floor in early August
Need to consider reaction of groups
(2)
Need to decide whether targeting makes sense
Won't appease Coburn
Won't appease groups that oppose testing
Notes on Column:
Everyone agrees that all pregnant women should know their HIV status. The good news is
that we now know that treatment dramatically reduces the risk of transmission. Now that
there is something we can do to reduce transmission, we owe to ourselves and our children to
take whatever steps we can. That means getting prenatal care, getting tested and getting
treated if a woman tests positive.
The complex issue that has been debated so passionately in newspapers, television reports,
professional meetings and living rooms across the country is whether women should be
required to be tested themselves or to have their newborns tested. I support the Coburn
amendment that requires all states to test newborns for HIV infection in order to qualify for
federal funding under the Ryan White Care Act. If a woman does not know her HIV status
when she delivers her baby, the baby should be tested. We know that HIV positive babies
can be treated with PCP prophylaxis to prevent deadly pneumonia in their first months of life
and to keep them healthy longer.
But I also believe [may or may not yet be in Coburn] that we need to protect those women
and children who test positive. We also know that women whose babies test positive are
positive themselves -- in fact, the test result is a more accurate report of her status than her
child's status ( -- % of whom will actually test negative a few months later). Sadly, people
who live with HIV today also continue to live with discrimination. We need to ensure that
HIV results are confidential so that no woman whose baby tests positive risks losing her job
or her home because of her HIV status. And we must ensure that no women whose baby
tests positive risks losing her child, simply because she and her baby are HIV-infected.
[Could get into medical neglect, but very controversial.]
However, waiting until a baby is born to find out that the child has been infected is too little
too late. As guidelines recently published by the Centers for Disease Control recommend, we
need aggressive counseling and voluntary testing of all pregnant women -- so that we can
prevent infection during pregnancy rather than treat it after it happens. We've seen that
voluntary counseling and testing work. [Cite studies in Atlanta, Kaiser, Yale/New Haven]
Women who have taken part in decisions about their medical care and consented to testing
will trust their doctors and comply with treatment recommendations (many of which require
cooperation over a period of months or years). For these reasons, the CDC guidelines are
supported by the American Academy of Pediatrics, the Pediatric AIDS Foundation and the
American College of Obstetrics and Gynecology [other groups]. In September, ACOG will
release guidelines making it the standard of practice for all obstetricians to counsel and test
their patients. [Statement about force of guidelines.]
That is why it is most important that all women get prenatal care. And that's why it is so
important that:
We preserve Medicaid as a safety net -- because for many HIV-positive women,
Medicaid is the only chance they have to get prenatal care.
Medicaid cover prenatal testing -- 40% of births in the United States are covered by
Medicaid.
Medicaid continue to cover AZT treatment for pregnant women and newborns, so that
all women who know their HIV status can get treatment for themselves and their
children.
EXECUTIVE OFFICE OF THE PRESIDENT
13- Jul- 1995 01:52pm
TO:
Carol H. Rasco
FROM:
Jeffrey Levi
AIDS Policy Council
CC:
Jeremy D. Benami
CC:
Jennifer L. Klein
SUBJECT:
Newborn testing amendment
At this morning's Commerce Committee markup of Ryan White, Coburn
withdrew with newborn testing amendment, with the understanding
that he would try to work something out with Waxman before thebill
goes to the floor. Waxman was prepared to offer a compromise
amendment that would have created a discretionary fund for states
to tap if they opt to require newborn screening when the mother's
status is unknown.
Interestingly, the NGA opposition to the Coburn amendment had not
moved any members. Pay-go issues with Coburn's amendment are what
caused him to withdraw it at this time.
Stay tuned.
EXECUTIVE OFFICE OF THE PRESIDENT
13-Jul-1995 05:50pm
TO:
Carol H. Rasco
TO:
Jennifer L. Klein
TO:
William G. White
TO:
Gordon P. Agress
FROM:
Jeffrey Levi
AIDS Policy Council
CC:
Jeremy D. Benami
SUBJECT:
Newborn screening-- II
A compromise has been worked out between Coburn and Waxman
(drafting still under way) that would (a) create a $10 million
authorization (presumably from CDC funds) for two years that could
be used by states to implement mandatory testing of newborns whose
mother's status is not known - - if the states choose to implement
such testing, in other words -- no federal mandate, but federal
funds to assist those states that impose such a mandate; and (b) a
requirement that the Secretary report back within two years her
finding as to whether newborn screening should be the standard of
care and, if yes, whether that standard of care is being
implemented. If it is not being implemented as the standard of
care, then there would be a requirement for mandatory testing
across the nation, which would take effect 18 months after the
Secretary's determination and which would be a condition of Ryan
White funds. In other words, a federal mandate could not occur
before 3-1/2 years from now.
The plan is that Coburn and Waxman would bring this to the Rules
committee together, and that this would close off other floor
amendments on this subject.
P.1/1
NATIONAL
"GOVERNORS
Post-It™ brand fax transmittal memo 7671
# of pages 3
ASSOCIATION
Co. To
Co. From 42 Ruan
Gw. caupa
Dept.
Phone #
Fax # 456-2889
Fax #
July 12, 1995
Representative Thomas J. Bliley Jr.
Chairman, Committee on Commerce
Room 2125 Rayburn House Office Building
Washington, DC 20515-6065
Dear Chairman Bliley:
We are writing to you concerning the proposed amendment by Representative Coburn to H.R. 1872
the reauthorization of the Ryan White CARE Act. Versions of the amendment made available to us
would make AIDS funding to states under the Act contingent upon passage of state laws requiring the
mandatory testing of all newborns for HIV disease. While individual Governors may support the
concept of such testing, the National Governors' Association (NGA) has no position on that part of
the Cobum proposal. However, the NGA does have long standing policy and stands in opposition to
the unfunded federal mandates provision of this amendment. These provisions are inconsistent with
the spirit of recently enacted unfunded mandates legislation.
We also believe that the amendment has implication for state Medicaid programs. Medicaid now
pays for about one-third of all births in the United States. While the amendment is silent on who
pays, one can be sure that Medicaid will be billed for the testing required in this amendment. As
such. it creates an unfunded Medicaid mandate at a time when the Congressional leadership has begun
to acknowledge the adverse impact of such actions on states.
We are concerned that the costs resulting from this amendment may not be trivial. Attached. for your
information, is a preliminary estimate of its financial impact that was developed by the National
Alliance of State and Territorial AIDS Directors (NASTAD). While it may not be exact, it shows
some of the operational details required for its implementation and gives a better understanding of the
range of costs that would be incurred. They estimate that the amendment will cost more than $600
million over five years. With regard to Medicaid. state Medicaid programs currently pay for about
one-third of all births in the nation. The NASTAD analysis would suggest an annual national cost to
the Medicaid program of more than $40 million. Additional costs to states and local government
would be incurred for uninsured and underinsured births.
We understand that as an alternative to an unfunded mandate, the committee may require the use of
Title II dollars to fund this testing program. Since Title II provides a critical source of treatment
funds in all states. such an action would seriously impair states' abilities to provide this much needed
care.
Finally, we believe that an amendment may be offered that gives states with high incidence of
pediatric AIDS. incentive funds to establish a mandatory program like. the one proposed in
Mr. Coburn's amendment. The NGA supports such incentive programs.
LIZ RYAN
STATE OF DELAWARE
SUITE 230
Representative. Thomas J. Bliley Jr.
July 12, 1995
Page 2.
Thank you for your attention to our concerns and we look forward to working with you and the
committee in the future on these and other issues.
Sincerely,
Hond Dear
Governor Howard Dean M.D.
Jonny. Jommy ice Chair G. Thempson G. Thompson
Chair
cc:
Representative John D. Dingell
Members of the Commerce Committee
attachment
Fiscal Impact of Proposed Coburn Amendment
to the Ryan White CARE Act
The Coburn Amendment would require, as a condition of Ryan White CARE Act funding, that
states create laws mandating HIV antibody testing of all newborn infants. In order to implement
the testing laws, substantial costs would be borne by states to conduct the following activities:
1.
HIV testing of newborns (or in the case of prenatal testing, pregnant women);
2.
Confirmatory laboratory tests for those testing HIV positive;
3.
Disclosure of test results and appropriate HIV counseling to individuals tested;
4.
Community outreach and follow-up for non-compliant or hard to reach patients;
5.
State monitoring, assurance, surveillance and evaluation of testing, counseling and
outreach programs.
Yearly cost estimates are based on 4,000,000 live births (based on 1994 provisional U.S. natality
statistics provided by the National Center for Health Statistics). The cost projection does not
include estimated costs of health care and supportive services, AZT therapy. or clinical
education for providers 10 conduct testing and counseling (which represent components of Ryan
White CARE Act funded services germane 10 this issue). The following is a preliminary estimate
of cost:
1.
Elisa (HIV antibody) testing of all 4 million live births
at average $10 per laboratory test:
40,000,000
2.
Confirmatory (Elisa and Western Blot) testing of all HIV
positives and false positives (estimated 7,000 HIV positives
and 8,000 false positives at $75 per confirmatory test):
1,125.000
3.
Disclosure of test results and counseling of all patients
(based on national average of 60 FTE health care providers
per every 100,000 patients tested and counseled X $25,000
average yearly salary):
60.000,000
4.
Community outreach and follow-up for non-compliant patients:
(based on cost of New York model program providing outreach
to mothers and newborns, extrapolated nationally based on
estimated cases of pediatric AIDS).
$ 8.000,000
5.
State monitoring, assurance, surveillance and evaluation:
(based on an estimated 10% of projected cost of counseling,
testing and follow-up implementation):
10,912.500
Estimated Cost for First Year:
120,037,500
Source: The National Alliance of State and Territorial AIDS Directors
JUN-23-1995 18:04 FROM WHITE HOUSE AIDS POLICY
TO
RASCO
P.02
AMENDMENT TO H.R. 1872
OFFERED BY MR. COBURN
Page 21, after line 19, insert the following section
(and redesignate provisions and conform cross-references
accordingly):
1 SEC. 204. ADDITIONAL REQUIREMENTS FOR GRANTS.
2
(a) FINDINGS.-The Congress finds as follows:
3
(1) Research studies have demonstruted that
4
administration of antiviral medication during preg-
5
nancy can significantly reduce the transmission of
6
the human immunodaficiency virus (commonly
7
known as HIV) from an infected mother to her
8
baby.
9
(2) The Conters for Disease-Contrul and Pre-
10
vention have recommended that all preguant women
11
receive HIV counseling; voluntary, confidential HIV
12
testing; and appropriate medical treatment (includ-
13
ing antiviral therapy) and support services.
14
(3) The provision of such testing without access
15
to such counseling, treatment, and services will not.
16
improve. the health of the woman or the chikl.
June 22, 1006 (ast p.ond
JUN-23-1995 18:05 FROM WHITE HOUSE AIDS POLICY
TO
RASCO
P.03
2
1
(4) The provision of such quanseling, testing,
2
treatment, and services can rednes the number of
3
padiatric cases of acquired immuno deficiency syll-
4
drome, can improve access to and provision of medi-
5
cal care for the woman, and can provide opportuni-
0
ties for counseling to reduce transmission among
7
adults.
8
(5) The provision of such counseling, testing,
9
treatment, and services can roduce the overall cost
I0
of pediatric cases of required immune deficiency
11
syndroms.
12
(6) The cancellation or limitation of health in-
13
surance or other health coverage on the basis of
14
HIV status should be impermissible under applicable
15
law. Such cancellation or limitation could result in
16
disincentives for appropriate counseling, testing,
17
treatment, and services.
18
(7) For the reasons specified in paragraphs (1)
19
through (6)-
20
(A) institutory counseling and voluntary
21
tasting of pregnant women should be the stand.
22
and of care; and
23
(B) the relevant accredited modical organis
24
natious as well as public health officials should
June 32. 1095 044 was
JUN-23-1995 18:05 FROM WHITE HOUSE AIDS POLICY
TO
RASCO
P.04
3
1
issue guidelines making such counseling and
2
testing the standard of care.
3
(b) ADDITIONAL REQUIREMENTS FOR GRANTS--
4 Part B (42 U.S.C. 300ff-21 et seq.) is amended by insert-
5 ing after section 2616 the following section:
6 "SEC. 2616A. ADDITIONAL HIV-RELATED REQUIREMENTS.
7
"(a) TESTING OF NEWBORNS; PRENATAL TEST-
8 ING.-Suhject to subsection (d), the Scoretary shall not
9 make a grant under this part to & State unless the State
10 has in effect a law establishing the following requirements:
11
"(1) That each newtorn infant who is born in
12
the State undergo testing for HIV disease (except
13
that such requirement does not apply if the biologi-
14
cal mother of the infant, while in the State, under-
15
went preuatal testing for the disease).
16
"(2) That the results of such testing of a new-
17
born infant be promptly disclosed in accordance with
18
the following, as applicable to the infant involved:
19
"(Д) To the biological mother of the infant
20
(without regard to whether she is the logal
21
guardian of the infant).
22
"(B) If the State is the legal guardian of
23
the infant:
are 22 1995 (258 an)
95 18:06 FROM WHITE HOUSE AIDS POLICY
TO
RASCO
P.05
FMG\H1ST2ACOBURN.003
4
1
"(i) To the appropriate official of the
2
State agency with responsibility for the
3
care of the infant.
4
"(ii) To the appropriate official of
5
cach authorized agency providing assist-
6
ance in the placement of the infant.
7
"(iii) If the authorized agency is giv-
8
ing significant consideration to approving
9
an individual us a foster parent of the in-
10
fant, to the prospective foster parent.
11
"(iv) If the authorised agency is giv-
12
ing significant consideration to approving
13
an individual as an adoptive parent of the
14
infant, to the prospoctive adoptive parent.
15
"(C) If neither the biological mother nor
16
the State is the legal guardian of the infant, to
17
another legal guardian of the infant.
18
"(3) That, in the case of prenatal testing for
19
HIV disease, the results of such testing be promptly
20
disclosed to the pregnant woman involved
21
"(4) That, in disclosing the test results to an
22
individual under paragraph (2) or (3), appropriate
23
counseling on the human immunodeficiency virus be
24
made available to the individual (except in the case
22, 1995 (256 pm)
JUN-23-1995 18:06 FROM WHITE HOUSE AIDS POLICY
TO
RASCO
P.06
5
I
of a disclosure to an official of at State or an author-
2
ived agency).
3
"(b) USALTH INSURANCE - Sabject to subsoction
?
4 (d), the Secretary shall not make 8 grant under this part
5 to a State unless the State has in effect a law providing
6 that, if health insurance is in effoot for an individual, the
Jerry
memorite
7 insurer involved may not (without the consent of the indi-
8 vidual) terminate the insurance, OF alter the terms of the
9 insurance, on the havis that the individual is infected with
10 HIV disease or on the basis that the individual has been
11 tcsted for the disease.
12
"(e) DEFINITIONS.- Mor purposes of this section:
13
"(1) The term 'authorised agency', with respect
14
to the placement of a child (including an infant) for
15
whom a State is a legal guardian, means an entity
16
licensed or otherwise approved by the State to aguist
17
in such placement.
18
"(2) The term health insurance' includes #
19
health plun
20
"(d) APPLICABILITY OF REQUIREMENT.-This sec-
21 tion applies on and after January 15, 1996.".
June an 1986 02:04 and