Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 2007 To provide for research and education with respect to uterine fibroids, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 18, 2021 Ms. CLARKE of New York (for herself, Ms. KELLY of Illinois, Mrs. WATSON COLEMAN, and Mr. DAVID SCOTT of Georgia) introduced the following bill; which was referred to the Committee on Energy 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 ‘‘Stephanie Tubbs Jones 4 Uterine Fibroid Research and Education Act of 2021’’. 5 SEC. 2. FINDINGS. 6 Congress finds as follows: 7 (1) It is estimated that 20 percent to 50 per- 8 cent of women of reproductive age currently have 9 VerDate Sep 11 2014 03:14 May 15, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2007.IH H2007 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 2007 IH uterine fibroids, and up to 77 percent of women will 1 develop fibroids before menopause. 2 (2) In the United States, an estimated 3 26,000,000 women between the ages of 15 and 50 4 have uterine fibroids, and approximately 15,000,000 5 of these individuals experience symptoms. Uterine 6 fibroids may cause significant morbidity through 7 their presence in the uterus and pelvic cavity, and 8 symptoms can include pelvic pain, several menstrual 9 bleeding, iron-deficiency anemia, fatigue, bladder or 10 bowel dysfunction, infertility, and pregnancy com- 11 plications and loss. 12 (3) The pain, discomfort, stress, and other 13 physical and emotional symptoms of living with 14 fibroids may significantly interfere with a woman’s 15 quality of life, compromising her ability to function 16 normally or work or care for her family, and may 17 lead to more severe health and wellness issues. 18 (4) Most women will experience uterine fibroids 19 by the age of 50, yet few data exist describing the 20 overall patient experience with fibroids. 21 (5) Many people with fibroids are likely 22 undiagnosed. Patients wait on average 3.6 years be- 23 fore seeking treatment, and over 40 percent of pa- 24 tients see two or more health care providers prior to 25 VerDate Sep 11 2014 03:14 May 15, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2007.IH H2007 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 2007 IH receiving a diagnosis, underscoring the need for im- 1 proved awareness and education. 2 (6) People of color are more likely to develop 3 uterine fibroids. It is estimated that more than 80 4 percent of Black women and about 70 percent of 5 white women develop fibroids by the time they reach 6 menopause. Black individuals with fibroids have also 7 been shown to have more severe symptoms and de- 8 velop early-onset uterine fibroids that develop into 9 larger tumors. 10 (7) Current research and available data do not 11 provide adequate information on the prevalence and 12 incidence of fibroids in Asian, Hispanic, and Black 13 individuals. 14 (8) Symptomatic uterine fibroids can cause re- 15 productive problems, including infertility. People 16 with uterine fibroids are much more likely to mis- 17 carry during early pregnancy than people without 18 them. 19 (9) According to the Evidence Report Summary 20 on the Management of Uterine Fibroids, as compiled 21 by the Agency for Healthcare Research and Quality 22 of the Department of Health and Human Services, 23 there is a ‘‘remarkable lack of high-quality evidence 24 VerDate Sep 11 2014 03:14 May 15, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2007.IH H2007 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 2007 IH supporting the effectiveness of most interventions for 1 symptomatic fibroids’’. 2 (10) Most medical options for managing fibroid 3 symptoms regulate or suppress menstruation and 4 prevent pregnancy. There is a great need for mini- 5 mally invasive, fertility-friendly therapies, as well as 6 biomarkers, imaging assessments, or risk-based algo- 7 rithms that can help predict patient response to 8 therapy. 9 (11) The presence of symptomatic uterine 10 fibroids is the most common reason for 11 hysterectomies, accounting for 39 percent of 12 hysterectomies annually in the United States. Ap- 13 proximately 42 per 1,000 women are hospitalized 14 annually because of uterine fibroids, but Black pa- 15 tients have higher rates of hospitalization, 16 hysterectomies, and myomectomies compared to 17 white women. Uterine fibroids are also the leading 18 cause of hospitalization related to a gynecological 19 disorder. 20 (12) The personal and societal costs of uterine 21 fibroids in the United States are significant. Uterine 22 fibroid tumors have been estimated to cost the 23 United States $5,900,000,000 to $34,400,000,000 24 annually. The annual direct costs, including surgery, 25 VerDate Sep 11 2014 03:14 May 15, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2007.IH H2007 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 2007 IH hospital admissions, outpatient visits, and medica- 1 tions, were estimated at $4,100,000,000 to 2 $9,400,000,000 annually. Estimated lost work-hour 3 costs ranged from $1,550,000,000 to 4 $17,200,000,000 annually. Obstetric outcomes that 5 were attributed to fibroid tumors resulted in costs of 6 $238,000,000 to $7,760,000,000 annually. 7 (13) At the federal level, uterine fibroid re- 8 search remains drastically underfunded as compared 9 to patient disease burden. In 2019, fibroid research 10 received about $17,000,000 in funding from the Na- 11 tional Institutes of Health, putting it in the bottom 12 50 of 292 funded conditions. 13 SEC. 3. RESEARCH WITH RESPECT TO UTERINE FIBROIDS. 14 (a) RESEARCH.—The Secretary of Health and 15 Human Services (referred to in this Act as the ‘‘Sec- 16 retary’’) shall expand, intensify, and coordinate programs 17 for the conduct and support of research with respect to 18 uterine fibroids. 19 (b) ADMINISTRATION AND COORDINATION.—The 20 Secretary shall carry out the conduct and support of re- 21 search pursuant to subsection (a), in coordination with the 22 appropriate institutes, offices, and centers of the National 23 Institutes of Health and any other relevant Federal agen- 24 cy, as determined by the Director. 25 VerDate Sep 11 2014 03:14 May 15, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2007.IH H2007 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 2007 IH (c) AUTHORIZATION OF APPROPRIATIONS.—For the 1 purpose of carrying out this section, there are authorized 2 to be appropriated $30,000,000 for each of fiscal years 3 2022 through 2026. 4 SEC. 4. RESEARCH WITH RESPECT TO MEDICAID COV- 5 ERAGE OF UTERINE FIBROIDS TREATMENT. 6 (a) RESEARCH.—The Secretary (or the Secretary’s 7 designee) shall establish a research database, or expand 8 an existing research database, to collect data on services 9 furnished to individuals diagnosed with uterine fibroids 10 under a State plan (or a waiver of such a plan) under 11 the Medicaid program under title XIX of the Social Secu- 12 rity Act (42 U.S.C. 1396 et seq.) or under a State child 13 health plan (or a waiver of such a plan) under the Chil- 14 dren’s Health Insurance Program under title XXI of such 15 Act (42 U.S.C. 1397aa et seq.) for the treatment of such 16 fibroids for purposes of assessing the frequency at which 17 such individuals are furnished such services. 18 (b) REPORT.— 19 (1) IN GENERAL.—Not later than the date that 20 is two years after the date of the enactment of this 21 Act, the Secretary shall submit to Congress a report 22 on the amount of Federal and State expenditures 23 with respect to services furnished for the treatment 24 of uterine fibroids under State plans (or waivers of 25 VerDate Sep 11 2014 03:14 May 15, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2007.IH H2007 pbinns on DSKJLVW7X2PROD with BILLS 7 •HR 2007 IH such plans) under the Medicaid program under such 1 title XIX and State child health plans (or waivers of 2 such plans) under the Children’s Health Insurance 3 Program under such title XXI. 4 (2) COORDINATION.—The Secretary shall co- 5 ordinate the development and submission of the re- 6 port required under paragraph (1) with any other 7 relevant Federal agency, as determined by the Sec- 8 retary. 9 SEC. 5. EDUCATION AND DISSEMINATION OF INFORMATION 10 WITH RESPECT TO UTERINE FIBROIDS. 11 (a) UTERINE FIBROIDS PUBLIC EDUCATION PRO- 12 GRAM.—The Secretary shall develop and disseminate to 13 the public information regarding uterine fibroids, includ- 14 ing information on— 15 (1) the awareness, incidence, and prevalence of 16 uterine fibroids among individuals, including all mi- 17 nority individuals; 18 (2) the elevated risk for minority individuals to 19 develop 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 treat- 23 ments and procedures. 24 VerDate Sep 11 2014 03:14 May 15, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2007.IH H2007 pbinns on DSKJLVW7X2PROD with BILLS 8 •HR 2007 IH (b) DISSEMINATION OF INFORMATION.—The Sec- 1 retary may disseminate information under subsection (a) 2 directly or through arrangements with intra-agency initia- 3 tives, nonprofit organizations, consumer groups, institu- 4 tions of higher education (as defined in section 101 of the 5 Higher Education Act of 1965 (20 U.S.C. 1001)), or Fed- 6 eral, State, or local public private partnerships. 7 (c) AUTHORIZATION OF APPROPRIATIONS.—For the 8 purpose of carrying out this section, there are authorized 9 to be appropriated such sums as may be necessary for 10 each of fiscal years 2022 through 2026. 11 SEC. 6. INFORMATION TO HEALTH CARE PROVIDERS WITH 12 RESPECT TO UTERINE FIBROIDS. 13 (a) DISSEMINATION OF INFORMATION.—The Sec- 14 retary of Health and Human Services shall, in consulta- 15 tion and in accordance with guidelines from relevant med- 16 ical societies, work with health care-related specialty soci- 17 eties and health systems to promote evidence-based care 18 for individuals with fibroids. Such efforts shall include mi- 19 nority individuals who have an elevated risk to develop 20 uterine fibroids and the range of available options for the 21 treatment of symptomatic uterine fibroids, including non- 22 hysterectomy drugs and devices approved under the Fed- 23 eral Food, Drug, and Cosmetic Act. 24 VerDate Sep 11 2014 03:14 May 15, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2007.IH H2007 pbinns on DSKJLVW7X2PROD with BILLS 9 •HR 2007 IH (b) AUTHORIZATION OF APPROPRIATIONS.—For the 1 purpose of carrying out this section, there are authorized 2 to be appropriated such sums as may be necessary for 3 each of the fiscal years 2022 through 2026. 4 SEC. 7. DEFINITION. 5 In this Act, the term ‘‘minority individuals’’ means 6 individuals who are members of a racial and ethnic minor- 7 ity group, as defined in section 1707(g) of the Public 8 Health Service Act (42 U.S.C. 300u–6(g)). 9 Æ VerDate Sep 11 2014 03:14 May 15, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\H2007.IH H2007 pbinns on DSKJLVW7X2PROD with BILLS