I
116TH CONGRESS
2D SESSION
H. R. 6383
To provide for research and education with respect to uterine fibroids, and
for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 24, 2020
Ms. CLARKE of New York (for herself, Ms. KELLY of Illinois, Mrs. WATSON
COLEMAN, Mr. DAVID SCOTT of Georgia, Ms. LEE of California, Ms.
PLASKETT, Ms. FUDGE, Ms. JOHNSON of Texas, Mr. RUSH, Mr. BROWN
of Maryland, Ms. PRESSLEY, Mr. DANNY K. DAVIS of Illinois, Mr.
THOMPSON
of Mississippi, Mr. CLYBURN, Mr. RICHMOND, Mr.
BUTTERFIELD, Mr. BISHOP of Georgia, Mr. CLEAVER, Mr. HASTINGS,
Mr. JEFFRIES, Mr. MEEKS, Mr. CARSON of Indiana, Ms. JACKSON LEE,
Mr. JOHNSON of Georgia, Mrs. LAWRENCE, Ms. BASS, and Ms. NORTON)
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce
A BILL
To provide for research and education with respect to uterine
fibroids, and for other purposes.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Uterine Fibroid Re-
4
search and Education Act of 2020’’.
5
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SEC. 2. FINDINGS.
1
Congress finds as follows:
2
(1) It is estimated that between 20 and 30 per-
3
cent of women of reproductive age have clinically
4
recognized uterine fibroids, and screening studies in-
5
dicate the prevalence of uterine fibroids in women
6
may be much higher.
7
(2) In the United States, an estimated
8
26,000,000 women between the ages of 15 and 50
9
have uterine fibroids. Uterine fibroids may cause sig-
10
nificant morbidity through their presence in the
11
uterus and pelvic cavity, causing significant pelvic
12
pain, iron-deficiency anemia, miscarriages, infer-
13
tility, and heavy bleeding—one of the most common
14
and bothersome symptoms.
15
(3) The pain, discomfort, stress, and other
16
physical and emotional symptoms of living with
17
fibroids may significantly interfere with a woman’s
18
quality of life, compromising her ability to function
19
normally or work or care for her family, and may
20
lead to more severe health and wellness issues.
21
(4) The development of uterine fibroids is a
22
common and significant health problem, affecting
23
women, primarily of reproductive age, across all
24
ages, racial backgrounds, and socioeconomic levels.
25
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(5) Most women will experience uterine fibroids
1
by the age of 50, yet few data exist describing the
2
overall patient experience with fibroids. Women with
3
fibroids or symptoms suggestive of fibroids experi-
4
ence significant distress that reduces quality of life
5
and many women are likely undiagnosed, under-
6
scoring the need for improved awareness and edu-
7
cation.
8
(6) Minority women are more likely to develop
9
uterine fibroids. It is estimated that more than 80
10
percent of African-American women and about 70
11
percent of Caucasian women develop fibroids by the
12
time they reach menopause. African-American
13
women have also been shown to have more severe
14
symptoms and develop early-onset uterine fibroids
15
that develop into larger tumors.
16
(7) The exact number of affected women is un-
17
known, because only 1 out of 4 women who have a
18
uterine fibroid tumor exhibit symptoms severe
19
enough to require treatment.
20
(8) Current research and available data do not
21
provide adequate information on the rates of preva-
22
lence and incidence of fibroids in Asian, Hispanic,
23
and African-American minority women. There is no
24
quantitative data available in regard to the costs as-
25
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sociated with treating fibroids, and the methods by
1
which fibroids may be prevented in these women
2
available.
3
(9) Symptomatic uterine fibroids can cause
4
heavy menstrual bleeding, pain, and reproductive
5
problems, including infertility. Women with uterine
6
fibroids are much more likely to miscarry during
7
early pregnancy than women without them.
8
(10) According to the Evidence Report Sum-
9
mary on the Management of Uterine Fibroids, as
10
compiled by the Agency for Healthcare Research and
11
Quality of the Department of Health and Human
12
Services, there is a ‘‘remarkable lack of high-quality
13
evidence supporting the effectiveness of most inter-
14
ventions for symptomatic fibroids’’.
15
(11) The presence of symptomatic uterine
16
fibroids
is
the
most
common
reason
for
17
hysterectomies, accounting for approximately one-
18
third of hysterectomies, or 200,000 procedures an-
19
nually. Twenty-two percent of African-American
20
women and 7 percent of Caucasian women have
21
hysterectomies as a result of uterine fibroids. Lack
22
of patient and provider awareness of less invasive al-
23
ternatives to hysterectomies lead to an estimated
24
80,000 to 120,000 unnecessary hysterectomies an-
25
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nually. Uterine fibroids are also the leading cause of
1
hospitalization related to a gynecological disorder.
2
(12) The personal and societal costs of uterine
3
fibroids in the United States are significant. Uterine
4
fibroid tumors have been estimated to cost the
5
United States $5,900,000,000 to $34,400,000,000
6
annually. The annual direct costs, including surgery,
7
hospital admissions, outpatient visits, and medica-
8
tions,
were
estimated
at
$4,100,000,000
to
9
$9,400,000,000 annually. Estimated lost work-hour
10
costs
ranged
from
$1,550,000,000
to
11
$17,200,000,000 annually. Obstetric outcomes that
12
were attributed to fibroid tumors resulted in costs of
13
$238,000,000 to $7,760,000,000 annually.
14
SEC. 3. RESEARCH WITH RESPECT TO UTERINE FIBROIDS.
15
(a) RESEARCH.—The Director of the National Insti-
16
tutes of Health (in this section referred to as the ‘‘Direc-
17
tor of NIH’’) shall expand, intensify, and coordinate pro-
18
grams for the conduct and support of research with re-
19
spect to uterine fibroids.
20
(b) ADMINISTRATION AND COORDINATION.—The Di-
21
rector of NIH, acting through Director of the Office of
22
Research on Women’s Health, shall carry out research
23
conducted pursuant to subsection (a), in coordination with
24
the appropriate institutes, offices, and centers of the Na-
25
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tional Institutes of Health, including the National Insti-
1
tute of Child Health and Human Development, the Na-
2
tional Institute of Environmental Health Sciences, the Of-
3
fice of Women’s Health, the Office of Minority Health,
4
and the National Center on Minority Health and Health
5
Disparities, and any other relevant Federal agency, as de-
6
termined by the Director.
7
(c) AUTHORIZATION OF APPROPRIATIONS.—For the
8
purpose of carrying out this section, there are authorized
9
to be appropriated $30,000,000 for each of fiscal years
10
2021 through 2025.
11
SEC. 4. RESEARCH WITH RESPECT TO MEDICAID COV-
12
ERAGE OF UTERINE FIBROIDS TREATMENT.
13
(a) RESEARCH.—The Administrator of the Centers
14
for Medicare & Medicaid Services (referred to in this sec-
15
tion as the ‘‘Administrator’’) shall expand the Chronic
16
Conditions Data Warehouse research database of such
17
Centers for Medicare & Medicaid Services to collect data
18
on items and services furnished to women diagnosed with
19
uterine fibroids and fibroids-related symptoms under a
20
State plan (or a waiver of such a plan) under the Medicaid
21
program under title XIX of the Social Security Act (42
22
U.S.C. 1396 et seq.) or under a State child health plan
23
(or a waiver of such a plan) under the Children’s Health
24
Insurance Program under title XXI of such Act (42
25
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U.S.C. 1397aa et seq.) for the treatment of such fibroids
1
and symptoms for purposes of assessing the frequency at
2
which such women are furnished such items and services.
3
(b) REPORT.—
4
(1) IN GENERAL.—Not later than the date that
5
is one year after the date of the enactment of this
6
Act, the Administrator shall submit to Congress a
7
report on the amount of Federal and State expendi-
8
tures with respect to items and services furnished
9
for the treatment of uterine fibroids and fibroids-re-
10
lated symptoms under State plans (or waivers of
11
such plans) under the Medicaid program under such
12
title XIX and State child health plans (or waivers of
13
such plans) under the Children’s Health Insurance
14
Program under such title XXI.
15
(2) COORDINATION.—The Administrator shall
16
coordinate the development and submission of the
17
report required under paragraph (1) with each of
18
the following:
19
(A) Within the Centers for Medicare &
20
Medicaid Services—
21
(i) the Office of Minority Health;
22
(ii) the Center for Medicaid and
23
CHIP Services;
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(iii) the Office of Enterprise Data and
1
Analytics; and
2
(iv) any other office or center deter-
3
mined appropriate by the Administrator.
4
(B) Any other relevant Federal agency, as
5
determined by the Administrator.
6
(c) AUTHORIZATION OF APPROPRIATIONS.—For the
7
purpose of carrying out this section, there are authorized
8
to be appropriated such sums as may be necessary for
9
each of the fiscal years 2021 through 2025.
10
SEC. 5. EDUCATION AND DISSEMINATION OF INFORMATION
11
WITH RESPECT TO UTERINE FIBROIDS.
12
(a) UTERINE FIBROIDS PUBLIC EDUCATION PRO-
13
GRAM.—The Secretary of Health and Human Services,
14
acting through the Director of the Centers for Disease
15
Control and Prevention, shall develop and disseminate to
16
the public information regarding uterine fibroids, includ-
17
ing information on—
18
(1) the awareness, incidence, and prevalence of
19
uterine fibroids among women, including all minority
20
women;
21
(2) the elevated risk for minority women to de-
22
velop uterine fibroids; and
23
(3) the availability, as medically appropriate, of
24
the range of treatment options for symptomatic
25
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uterine fibroids, including non-hysterectomy treat-
1
ments and procedures.
2
(b) DISSEMINATION
OF INFORMATION.—The Sec-
3
retary may disseminate information under subsection (a)
4
directly or through arrangements with intra-agency initia-
5
tives, nonprofit organizations, consumer groups, institu-
6
tions of higher education (as defined in section 101 of the
7
Higher Education Act of 1965 (20 U.S.C. 1001)), or Fed-
8
eral, State, or local public private partnerships.
9
(c) AUTHORIZATION OF APPROPRIATIONS.—For the
10
purpose of carrying out this section, there are authorized
11
to be appropriated such sums as may be necessary for
12
each of fiscal years 2021 through 2025.
13
SEC. 6. INFORMATION TO HEALTH CARE PROVIDERS WITH
14
RESPECT TO UTERINE FIBROIDS.
15
(a) DISSEMINATION
OF INFORMATION.—The Sec-
16
retary of Health and Human Services, acting through the
17
Administrator of the Health Resources and Services Ad-
18
ministration and the Director of the Agency for
19
Healthcare Research and Quality shall, in consultation
20
and in accordance with guidelines from relevant medical
21
societies, develop and disseminate to health care providers
22
information on uterine fibroids for the purpose of ensuring
23
that health care providers remain informed about current
24
information on uterine fibroids. Such information shall in-
25
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clude the elevated risk for minority women to develop uter-
1
ine fibroids and the range of available options for the
2
treatment of symptomatic uterine fibroids, including non-
3
hysterectomy drugs and devices approved under the Fed-
4
eral Food, Drug, and Cosmetic Act.
5
(b) AUTHORIZATION OF APPROPRIATIONS.—For the
6
purpose of carrying out this section, there are authorized
7
to be appropriated such sums as may be necessary for
8
each of the fiscal years 2021 through 2025.
9
SEC. 7. DEFINITION.
10
In this Act, the term ‘‘minority women’’ means
11
women who are members of a racial and ethnic minority
12
group, as defined in section 1707(g) of the Public Health
13
Service Act (42 U.S.C. 300u–6(g)).
14
Æ
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