[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4397 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 4397

To provide for research and education with respect to uterine fibroids, 
                        and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 3, 2020

Ms. Harris (for herself, Mr. Van Hollen, and Mr. Booker) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Uterine Fibroid Research and 
Education Act of 2020''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) It is estimated that between 20 and 30 percent of women 
        of reproductive age have clinically recognized uterine 
        fibroids, and screening studies indicate the prevalence of 
        uterine fibroids in women may be much higher.
            (2) In the United States, an estimated 26,000,000 women 
        between the ages of 15 and 50 have uterine fibroids. Uterine 
        fibroids may cause significant morbidity through their presence 
        in the uterus and pelvic cavity, causing significant pelvic 
        pain, iron-deficiency anemia, miscarriages, infertility, and 
        heavy bleeding--one of the most common and bothersome symptoms.
            (3) The pain, discomfort, stress, and other physical and 
        emotional symptoms of living with fibroids may significantly 
        interfere with a woman's quality of life, compromising her 
        ability to function normally or work or care for her family, 
        and may lead to more severe health and wellness issues.
            (4) The development of uterine fibroids is a common and 
        significant health problem, affecting women, primarily of 
        reproductive age, across all ages, racial backgrounds, and 
        socioeconomic levels.
            (5) Most women will experience uterine fibroids by the age 
        of 50, yet few data exist describing the overall patient 
        experience with fibroids. Women with fibroids or symptoms 
        suggestive of fibroids experience significant distress that 
        reduces quality of life and many women are likely undiagnosed, 
        underscoring the need for improved awareness and education.
            (6) Minority women are more likely to develop uterine 
        fibroids. It is estimated that more than 80 percent of African-
        American women and about 70 percent of Caucasian women develop 
        fibroids by the time they reach menopause. African-American 
        women have also been shown to have more severe symptoms and 
        develop early-onset uterine fibroids that develop into larger 
        tumors.
            (7) The exact number of affected women is unknown, because 
        only one out of 4 women who have a uterine fibroid tumor 
        exhibit symptoms severe enough to require treatment.
            (8) Current research and available data do not provide 
        adequate information on the rates of prevalence and incidence 
        of fibroids in Asian, Hispanic, and African-American minority 
        women. There is no quantitative data available in regard to the 
        costs associated with treating fibroids, and the methods by 
        which fibroids may be prevented in these women available.
            (9) Symptomatic uterine fibroids can cause heavy menstrual 
        bleeding, pain, and reproductive problems, including 
        infertility. Women with uterine fibroids are much more likely 
        to miscarry during early pregnancy than women without them.
            (10) According to the Evidence Report Summary on the 
        Management of Uterine Fibroids, as compiled by the Agency for 
        Healthcare Research and Quality of the Department of Health and 
        Human Services, there is a ``remarkable lack of high-quality 
        evidence supporting the effectiveness of most interventions for 
        symptomatic fibroids''.
            (11) The presence of symptomatic uterine fibroids is the 
        most common reason for hysterectomies, accounting for 
        approximately one-third of hysterectomies, or 200,000 
        procedures annually. Twenty-two percent of African-American 
        women and 7 percent of Caucasian women have hysterectomies as a 
        result of uterine fibroids. Lack of patient and provider 
        awareness of less invasive alternatives to hysterectomies lead 
        to an estimated 80,000 to 120,000 unnecessary hysterectomies 
        annually. Uterine fibroids are also the leading cause of 
        hospitalization related to a gynecological disorder.
            (12) The personal and societal costs of uterine fibroids in 
        the United States are significant. Uterine fibroid tumors have 
        been estimated to cost the United States $5,900,000,000 to 
        $34,400,000,000 annually. The annual direct costs, including 
        surgery, hospital admissions, outpatient visits, and 
        medications, were estimated at $4,100,000,000 to $9,400,000,000 
        annually. Estimated lost work-hour costs ranged from 
        $1,550,000,000 to $17,200,000,000 annually. Obstetric outcomes 
        that were attributed to fibroid tumors resulted in costs of 
        $238,000,000 to $7,760,000,000 annually.

SEC. 3. RESEARCH WITH RESPECT TO UTERINE FIBROIDS.

    (a) Research.--The Director of the National Institutes of Health 
(in this section referred to as the ``Director of NIH'') shall expand, 
intensify, and coordinate programs for the conduct and support of 
research with respect to uterine fibroids.
    (b) Administration and Coordination.--The Director of NIH, acting 
through Director of the Office of Research on Women's Health, shall 
carry out research conducted pursuant to subsection (a), in 
coordination with the appropriate institutes, offices, and centers of 
the National Institutes of Health, including the National Institute of 
Child Health and Human Development, the National Institute of 
Environmental Health Sciences, the Office of Women's Health, the Office 
of Minority Health, and the National Center on Minority Health and 
Health Disparities, and any other relevant Federal agency, as 
determined by the Director.
    (c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $30,000,000 
for each of fiscal years 2021 through 2025.

SEC. 4. RESEARCH WITH RESPECT TO MEDICAID COVERAGE OF UTERINE FIBROIDS 
              TREATMENT.

    (a) Research.--The Administrator of the Centers for Medicare & 
Medicaid Services (referred to in this section as the 
``Administrator'') shall expand the Chronic Conditions Data Warehouse 
research database of such Centers for Medicare & Medicaid Services to 
collect data on items and services furnished to women diagnosed with 
uterine fibroids and fibroids-related symptoms under a State plan (or a 
waiver of such a plan) under the Medicaid program under title XIX of 
the Social Security Act (42 U.S.C. 1396 et seq.) or under a State child 
health plan (or a waiver of such a plan) under the Children's Health 
Insurance Program under title XXI of such Act (42 U.S.C. 1397aa et 
seq.) for the treatment of such fibroids and symptoms for purposes of 
assessing the frequency at which such women are furnished such items 
and services.
    (b) Report.--
            (1) In general.--Not later than the date that is one year 
        after the date of the enactment of this Act, the Administrator 
        shall submit to Congress a report on the amount of Federal and 
        State expenditures with respect to items and services furnished 
        for the treatment of uterine fibroids and fibroids-related 
        symptoms under State plans (or waivers of such plans) under the 
        Medicaid program under such title XIX and State child health 
        plans (or waivers of such plans) under the Children's Health 
        Insurance Program under such title XXI.
            (2) Coordination.--The Administrator shall coordinate the 
        development and submission of the report required under 
        paragraph (1) with each of the following:
                    (A) Within the Centers for Medicare & Medicaid 
                Services--
                            (i) the Office of Minority Health;
                            (ii) the Center for Medicaid and CHIP 
                        Services;
                            (iii) the Office of Enterprise Data and 
                        Analytics; and
                            (iv) any other office or center determined 
                        appropriate by the Administrator.
                    (B) Any other relevant Federal agency, as 
                determined by the Administrator.
    (c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2021 through 2025.

SEC. 5. EDUCATION AND DISSEMINATION OF INFORMATION WITH RESPECT TO 
              UTERINE FIBROIDS.

    (a) Uterine Fibroids Public Education Program.--The Secretary of 
Health and Human Services, acting through the Director of the Centers 
for Disease Control and Prevention, shall develop and disseminate to 
the public information regarding uterine fibroids, including 
information on--
            (1) the awareness, incidence, and prevalence of uterine 
        fibroids among women, including all minority women;
            (2) the elevated risk for minority women to develop uterine 
        fibroids; and
            (3) the availability, as medically appropriate, of the 
        range of treatment options for symptomatic uterine fibroids, 
        including non-hysterectomy treatments and procedures.
    (b) Dissemination of Information.--The Secretary may disseminate 
information under subsection (a) directly or through arrangements with 
intra-agency initiatives, nonprofit organizations, consumer groups, 
institutions of higher education (as defined in section 101 of the 
Higher Education Act of 1965 (20 U.S.C. 1001)), or Federal, State, or 
local public private partnerships.
    (c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of fiscal years 2021 through 2025.

SEC. 6. INFORMATION TO HEALTH CARE PROVIDERS WITH RESPECT TO UTERINE 
              FIBROIDS.

    (a) Dissemination of Information.--The Secretary of Health and 
Human Services, acting through the Administrator of the Health 
Resources and Services Administration and the Director of the Agency 
for Healthcare Research and Quality shall, in consultation and in 
accordance with guidelines from relevant medical societies, develop and 
disseminate to health care providers information on uterine fibroids 
for the purpose of ensuring that health care providers remain informed 
about current information on uterine fibroids. Such information shall 
include the elevated risk for minority women to develop uterine 
fibroids and the range of available options for the treatment of 
symptomatic uterine fibroids, including non-hysterectomy drugs and 
devices approved under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.).
    (b) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2021 through 2025.

SEC. 7. DEFINITION.

    In this Act, the term ``minority women'' means women who are 
members of a racial and ethnic minority group, as defined in section 
1707(g) of the Public Health Service Act (42 U.S.C. 300u-6(g)).
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