II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Uterine Fibroid Re5 search and Education Act of 2020’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds as follows: 

8 (1) It is estimated that between 20 and 30 per9 cent of women of reproductive age have clinically 

10 recognized uterine fibroids, and screening studies inVerDate Sep 11 2014 03:58 Aug 19, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4397.IS S4397

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1 dicate the prevalence of uterine fibroids in women 

2 may be much higher. 

3 (2) In the United States, an estimated 

4 26,000,000 women between the ages of 15 and 50 

5 have uterine fibroids. Uterine fibroids may cause sig6 nificant morbidity through their presence in the 

7 uterus and pelvic cavity, causing significant pelvic 

8 pain, iron-deficiency anemia, miscarriages, infer9 tility, and heavy bleeding—one of the most common 

10 and bothersome symptoms. 

11 (3) The pain, discomfort, stress, and other 

12 physical and emotional symptoms of living with 

13 fibroids may significantly interfere with a woman’s 

14 quality of life, compromising her ability to function 

15 normally or work or care for her family, and may 

16 lead to more severe health and wellness issues. 

17 (4) The development of uterine fibroids is a 

18 common and significant health problem, affecting 

19 women, primarily of reproductive age, across all 

20 ages, racial backgrounds, and socioeconomic levels. 

21 (5) Most women will experience uterine fibroids 

22 by the age of 50, yet few data exist describing the 

23 overall patient experience with fibroids. Women with 

24 fibroids or symptoms suggestive of fibroids experi25 ence significant distress that reduces quality of life 


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1 and many women are likely undiagnosed, under2 scoring the need for improved awareness and edu3 cation. 

4 (6) Minority women are more likely to develop 

5 uterine fibroids. It is estimated that more than 80 

6 percent of African-American women and about 70 

7 percent of Caucasian women develop fibroids by the 

8 time they reach menopause. African-American 

9 women have also been shown to have more severe 

10 symptoms and develop early-onset uterine fibroids 

11 that develop into larger tumors. 

12 (7) The exact number of affected women is un13 known, because only one out of 4 women who have 

14 a uterine fibroid tumor exhibit symptoms severe 

15 enough to require treatment. 

16 (8) Current research and available data do not 

17 provide adequate information on the rates of preva18 lence and incidence of fibroids in Asian, Hispanic, 

19 and African-American minority women. There is no 

20 quantitative data available in regard to the costs as21 sociated with treating fibroids, and the methods by 

22 which fibroids may be prevented in these women 

23 available. 

24 (9) Symptomatic uterine fibroids can cause 

25 heavy menstrual bleeding, pain, and reproductive 


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1 problems, including infertility. Women with uterine 

2 fibroids are much more likely to miscarry during 

3 early pregnancy than women without them. 

4 (10) According to the Evidence Report Sum5 mary on the Management of Uterine Fibroids, as 

6 compiled by the Agency for Healthcare Research and 

7 Quality of the Department of Health and Human 

8 Services, there is a ‘‘remarkable lack of high-quality 

9 evidence supporting the effectiveness of most inter10 ventions for symptomatic fibroids’’. 

11 (11) The presence of symptomatic uterine 

12 fibroids is the most common reason for hysterecto13 mies, accounting for approximately one-third of 

14 hysterectomies, or 200,000 procedures annually. 

15 Twenty-two percent of African-American women and 

16 7 percent of Caucasian women have hysterectomies 

17 as a result of uterine fibroids. Lack of patient and 

18 provider awareness of less invasive alternatives to 

19 hysterectomies lead to an estimated 80,000 to 

20 120,000 unnecessary hysterectomies annually. Uter21 ine fibroids are also the leading cause of hospitaliza22 tion related to a gynecological disorder. 

23 (12) The personal and societal costs of uterine 

24 fibroids in the United States are significant. Uterine 

25 fibroid tumors have been estimated to cost the 


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1 United States $5,900,000,000 to $34,400,000,000 

2 annually. The annual direct costs, including surgery, 

3 hospital admissions, outpatient visits, and medica4 tions, were estimated at $4,100,000,000 to 

5 $9,400,000,000 annually. Estimated lost work-hour 

6 costs ranged from $1,550,000,000 to 

7 $17,200,000,000 annually. Obstetric outcomes that 

8 were attributed to fibroid tumors resulted in costs of 

9 $238,000,000 to $7,760,000,000 annually. 

10 SEC. 3. RESEARCH WITH RESPECT TO UTERINE FIBROIDS. 

11 (a) RESEARCH.—The Director of the National Insti12 tutes of Health (in this section referred to as the ‘‘Direc13 tor of NIH’’) shall expand, intensify, and coordinate pro14 grams for the conduct and support of research with re15 spect to uterine fibroids. 

16 (b) ADMINISTRATION AND COORDINATION.—The Di17 rector of NIH, acting through Director of the Office of 

18 Research on Women’s Health, shall carry out research 

19 conducted pursuant to subsection (a), in coordination with 

20 the appropriate institutes, offices, and centers of the Na21 tional Institutes of Health, including the National Insti22 tute of Child Health and Human Development, the Na23 tional Institute of Environmental Health Sciences, the Of24 fice of Women’s Health, the Office of Minority Health, 

25 and the National Center on Minority Health and Health 


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1 Disparities, and any other relevant Federal agency, as de2 termined by the Director. 

3 (c) AUTHORIZATION OF APPROPRIATIONS.—For the 

4 purpose of carrying out this section, there are authorized 

5 to be appropriated $30,000,000 for each of fiscal years 

6 2021 through 2025. 

7 SEC. 4. RESEARCH WITH RESPECT TO MEDICAID COV8 ERAGE OF UTERINE FIBROIDS TREATMENT. 

9 (a) RESEARCH.—The Administrator of the Centers 

10 for Medicare & Medicaid Services (referred to in this sec11 tion as the ‘‘Administrator’’) shall expand the Chronic 

12 Conditions Data Warehouse research database of such 

13 Centers for Medicare & Medicaid Services to collect data 

14 on items and services furnished to women diagnosed with 

15 uterine fibroids and fibroids-related symptoms under a 

16 State plan (or a waiver of such a plan) under the Medicaid 

17 program under title XIX of the Social Security Act (42 

18 U.S.C. 1396 et seq.) or under a State child health plan 

19 (or a waiver of such a plan) under the Children’s Health 

20 Insurance Program under title XXI of such Act (42 

21 U.S.C. 1397aa et seq.) for the treatment of such fibroids 

22 and symptoms for purposes of assessing the frequency at 

23 which such women are furnished such items and services. 

24 (b) REPORT.— 


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1 (1) IN GENERAL.—Not later than the date that 

2 is one year after the date of the enactment of this 

3 Act, the Administrator shall submit to Congress a 

4 report on the amount of Federal and State expendi5 tures with respect to items and services furnished 

6 for the treatment of uterine fibroids and fibroids-re7 lated symptoms under State plans (or waivers of 

8 such plans) under the Medicaid program under such 

9 title XIX and State child health plans (or waivers of 

10 such plans) under the Children’s Health Insurance 

11 Program under such title XXI. 

12 (2) COORDINATION.—The Administrator shall 

13 coordinate the development and submission of the 

14 report required under paragraph (1) with each of 

15 the following: 

16 (A) Within the Centers for Medicare & 

17 Medicaid Services— 

18 (i) the Office of Minority Health; 

19 (ii) the Center for Medicaid and 

20 CHIP Services; 

21 (iii) the Office of Enterprise Data and 

22 Analytics; and 

23 (iv) any other office or center deter24 mined appropriate by the Administrator. 


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1 (B) Any other relevant Federal agency, as 

2 determined by the Administrator. 

3 (c) AUTHORIZATION OF APPROPRIATIONS.—For the 

4 purpose of carrying out this section, there are authorized 

5 to be appropriated such sums as may be necessary for 

6 each of the fiscal years 2021 through 2025. 

7 SEC. 5. EDUCATION AND DISSEMINATION OF INFORMATION 

8 WITH RESPECT TO UTERINE FIBROIDS. 

9 (a) UTERINE FIBROIDS PUBLIC EDUCATION PRO10 GRAM.—The Secretary of Health and Human Services, 

11 acting through the Director of the Centers for Disease 

12 Control and Prevention, shall develop and disseminate to 

13 the public information regarding uterine fibroids, includ14 ing information on— 

15 (1) the awareness, incidence, and prevalence of 

16 uterine fibroids among women, including all minority 

17 women; 

18 (2) the elevated risk for minority women to de19 velop uterine fibroids; and 

20 (3) the availability, as medically appropriate, of 

21 the range of treatment options for symptomatic 

22 uterine fibroids, including non-hysterectomy treat23 ments and procedures. 

24 (b) DISSEMINATION OF INFORMATION.—The Sec25 retary may disseminate information under subsection (a) 


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1 directly or through arrangements with intra-agency initia2 tives, nonprofit organizations, consumer groups, institu3 tions of higher education (as defined in section 101 of the 

4 Higher Education Act of 1965 (20 U.S.C. 1001)), or Fed5 eral, State, or local public private partnerships. 

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 fiscal years 2021 through 2025. 

10 SEC. 6. INFORMATION TO HEALTH CARE PROVIDERS WITH 

11 RESPECT TO UTERINE FIBROIDS. 

12 (a) DISSEMINATION OF INFORMATION.—The Sec13 retary of Health and Human Services, acting through the 

14 Administrator of the Health Resources and Services Ad15 ministration and the Director of the Agency for Health16 care Research and Quality shall, in consultation and in 

17 accordance with guidelines from relevant medical societies, 

18 develop and disseminate to health care providers informa19 tion on uterine fibroids for the purpose of ensuring that 

20 health care providers remain informed about current infor21 mation on uterine fibroids. Such information shall include 

22 the elevated risk for minority women to develop uterine 

23 fibroids and the range of available options for the treat24 ment of symptomatic uterine fibroids, including non25 hysterectomy drugs and devices approved under the FedVerDate Sep 11 2014 03:58 Aug 19, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4397.IS S4397

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1 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

2 seq.). 

3 (b) AUTHORIZATION OF APPROPRIATIONS.—For the 

4 purpose of carrying out this section, there are authorized 

5 to be appropriated such sums as may be necessary for 

6 each of the fiscal years 2021 through 2025. 

7 SEC. 7. DEFINITION. 

8 In this Act, the term ‘‘minority women’’ means 

9 women who are members of a racial and ethnic minority 

10 group, as defined in section 1707(g) of the Public Health 

11 Service Act (42 U.S.C. 300u–6(g)). 

Æ 


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