[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4533 Introduced in Senate (IS)]

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118th CONGRESS
  2d Session
                                S. 4533

  To expand and promote research and data collection on reproductive 
   health conditions, to provide training opportunities for medical 
 professionals to learn how to diagnose and treat reproductive health 
                  conditions, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 13, 2024

Mrs. Hyde-Smith (for herself, Mr. Lankford, Mr. Cornyn, Mr. Wicker, Mr. 
Ricketts, Mr. Mullin, and Mr. Grassley) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To expand and promote research and data collection on reproductive 
   health conditions, to provide training opportunities for medical 
 professionals to learn how to diagnose and treat reproductive health 
                  conditions, 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 ``Reproductive Empowerment and Support 
through Optimal Restoration Act'' or the ``RESTORE Act''.

SEC. 2. FINDINGS.

     Congress finds the following:
            (1) In vitro fertilization and other assisted reproductive 
        technologies are not under threat at the Federal level or in 
        any State or territory of the United States.
            (2) There is a growing interest among women to proactively 
        assess their overall health and understand how factors such as 
        age and medical history contribute to reproductive health and 
        fertility.
            (3) Women are worthy of the highest standard of medical 
        care, including the opportunity to assess, understand, and 
        improve their reproductive health. Unfortunately, many women do 
        not receive adequate information about their reproductive 
        health and do not have access to restorative reproductive 
        medicine.
            (4) Reproductive health conditions are the leading causes 
        of infertility, which affects 15 to 16 percent of couples in 
        the United States. Such conditions include the following:
                    (A) Endometriosis, a disease where tissue 
                resembling endometrial lining tissue grows outside of 
                the uterus. The tissue often adheres to different 
                organs, disfiguring them and, through scar tissue or 
                adhesions, can make the organs stick to one another or 
                to the pelvic walls. It has been found in the abdominal 
                organs, the bowel, the diaphragm, the lungs, the brain, 
                and the eye. It is a progressive disease and has been 
                compared to growing like cancer. Endometriosis is often 
                diagnosed in stages, with Stage I as the mildest form 
                and Stage IV as the most severe and widespread form. 
                The average diagnosis delay for endometriosis is 6 to 
                12 years. Endometriosis frequently goes undiagnosed, 
                and women may suffer for years with painful periods, 
                pelvic pain, or infertility. The cause of endometriosis 
                is unknown.
                    (B) Adenomyosis, a disease that occurs when 
                endometrial tissue (tissue that would normally line the 
                inside of the uterus) grows into the muscle layer of 
                the uterus. Adenomyosis is different from, but can 
                exist concurrently with, endometriosis. Adenomyosis may 
                increase the risk of miscarriage and preterm labor and 
                may contribute to infertility. The cause of adenomyosis 
                is unknown.
                    (C) Polycystic ovary syndrome, a reproductive 
                hormonal disorder that causes cysts to grow on the 
                ovaries, usually as a result of hormonal imbalances. 
                Polycystic ovary syndrome affects approximately 15 
                percent of women overall but is more common among women 
                with infertility. It is more prevalent among women with 
                obesity and insulin resistance. Women with polycystic 
                ovary syndrome who are trying to achieve pregnancy are 
                commonly prescribed oral ovulation medication and 
                hormonal injections that stimulate ovulation. Effective 
                diagnosis and treatment exist, and should be made 
                available for all women. Accurate and timely diagnosis 
                and treatment can correct underlying hormonal 
                imbalances, critical for both long-term health 
                improvements as well as for fertility outcomes.
                    (D) Uterine fibroids, which are muscular tumors 
                that grow in the wall of the uterus. While not all 
                women will experience symptoms associated with 
                fibroids, if the tumors are large enough or embedded 
                far enough in the uterine lining, they can lead to pain 
                and heavy bleeding. Treatment for fibroids may include 
                assessment of underlying hormonal imbalances, 
                hysteroscopic myomectomy, abdominal myomectomy, uterine 
                fibroid embolization, and uterine artery embolization. 
                Uterine fibroids can increase risks of preterm labor, 
                pregnancy complications leading to a cesarean section, 
                and placental abruption, among other risks. The cause 
                of uterine fibroids is unknown.
                    (E) Blocked fallopian tubes, a condition where the 
                fallopian tubes are blocked by tubal spasm, scarring 
                from inflammatory conditions, debris, tubal polyps, 
                tubal ligation, prior ectopic pregnancy, pelvic 
                adhesions, endometriosis, prior pelvic infection 
                (pelvic inflammatory disease or ``PID''). Approximately 
                1 in 4 women with infertility have a tubal blockage. 
                This condition makes achieving pregnancy difficult, if 
                not impossible. Treatments for a blockage include 
                fallopian tube recanalization, tubo-tubal anastomosis 
                (tubal ligation reversal), or neosalpingostomy/
                fimbrioplasty.
            (5) Research shows 4 or more conditions or factors are the 
        cause of most male and female infertility.
            (6) There is a gap in research and care for male and female 
        reproductive health conditions, which affect many Americans 
        struggling with unexplained infertility.
            (7) Restorative reproductive medicine aims to diagnose and 
        treat underlying hormonal and other imbalances, restore health 
        where possible, and improve women's health functioning and 
        long-term outcomes.
            (8) Restorative reproductive medicine can eliminate 
        barriers to successful conception, pregnancy, and birth. It can 
        also address some causes of recurrent miscarriages.
            (9) Restorative reproductive medicine often alleviates 
        other difficult symptoms associated with reproductive health 
        conditions, including hormonal acne, hormonal weight gain, 
        hormonal mood and depression, painful periods, painful flare-
        ups, bloating, inflammation, heavy periods, irregular periods, 
        nerve pain, bowel symptoms, pain during sexual intercourse, and 
        back pain.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Assisted reproductive technology.--The term ``assisted 
        reproductive technology'' means any treatments or procedures 
        that involve the handling of a human egg, sperm, and embryo 
        outside of the body with the intent of facilitating a 
        pregnancy, including artificial insemination, intrauterine 
        insemination, in vitro fertilization, gamete intrafallopian 
        fertilization, zygote intrafallopian fertilization, egg, 
        embryo, and sperm cryopreservation, and egg or embryo donation.
            (2) Fertility awareness-based methods.--The term 
        ``fertility awareness-based methods'' means modern, evidence-
        based methods of tracking the menstrual cycle through 
        observable biological signs in a woman, such as body 
        temperature, cervical fluid, and hormone production in the 
        reproductive system, including luteinizing hormone (LH) and 
        estrogen. Such methods include Fertility Education and Medical 
        Management, the sympto thermal method, the Marquette method, 
        the Creighton method, and the Billings ovulation method.
            (3) Fertility education and medical management.--The term 
        ``fertility education and medical management'' means the 
        program developed in collaboration with the Reproductive Health 
        Research Institute for medical research, protocols, and medical 
        training for health care professionals in order to enable the 
        clinical application of important research advances in 
        reproductive endocrinology, by providing education for women 
        about their bodies and hormonal health and medical support, as 
        appropriate.
            (4) Infertility.--The term ``infertility'' means a symptom 
        of an underlying disease or condition within a person's body 
        that makes it difficult or impossible to successfully conceive 
        and carry a child to term, which is diagnosed after 12 months 
        of intercourse without the use of a chemical, barrier, or other 
        contraceptive method for women under 35 or after 6 months of 
        targeted intercourse without the use of a chemical, barrier, or 
        other contraceptive method for women 35 and older, where 
        conception should otherwise be possible.
            (5) Natural procreative technology; naprotechnology.--The 
        term ``Natural Procreative Technology'' or ``NaProTECHNOLOGY'' 
        means an approach to health care that monitors and maintains a 
        woman's reproductive and gynecological health, including 
        laparoscopic gynecologic surgery to reconstruct the uterus, 
        fallopian tubes, ovaries, and other organ structures to 
        eliminate endometriosis and other reproductive health 
        conditions.
            (6) Reproductive health conditions.--The term 
        ``reproductive health conditions'' includes endometriosis, 
        adenomyosis, polycystic ovary syndrome, uterine fibroids, 
        blocked fallopian tubes, hormone imbalances, 
        hyperprolactinemia, thyroid conditions, ovulation dysfunctions, 
        and other health conditions that make it difficult or 
        impossible to successfully conceive a child where conception 
        should otherwise be possible.
            (7) Restorative reproductive health.--The term 
        ``restorative reproductive health'' includes empowering women 
        and men to know and understand their bodies and appreciate the 
        importance of natural reproductive health to overall health and 
        well-being, including through the use of body literacy programs 
        that incorporate science-based charting methods, teacher lead 
        reproductive health education, restorative reproductive 
        medicine, Natural Procreative Technology, fertility awareness-
        based methods, and fertility education and medical management.
            (8) Restorative reproductive medicine.--The term 
        ``restorative reproductive medicine''--
                    (A) means any scientific approach to reproductive 
                medicine that seeks to cooperate with, or restore the 
                normal physiology and anatomy of, the human 
                reproductive system, without the use of methods that 
                are inherently suppressive, circumventive, or 
                destructive to natural human functions; and
                    (B) may include ultrasounds, blood tests, hormone 
                panels, laparoscopic and exploratory surgeries, 
                examining the man's or woman's overall health and 
                lifestyle, eliminating environmental endocrine 
                disruptors, and assessing the health and fertility of 
                the individual's partner, Natural Procreative 
                Technology, fertility awareness-based methods, and 
                fertility education and medical management.

SEC. 4. PROHIBITING DISCRIMINATION AGAINST HEALTH CARE PROVIDERS WHO DO 
              NOT PARTICIPATE IN ASSISTED REPRODUCTIVE TECHNOLOGY.

    Notwithstanding any other law, the Federal Government, and any 
person or entity that receives Federal financial assistance, including 
any State or local government, may not penalize, retaliate against, or 
otherwise discriminate against a health care provider on the basis that 
the provider does not or declines to--
            (1) assist in, receive training in, provide, perform, refer 
        for, pay for, or otherwise participate in assisted reproductive 
        technology; or
            (2) facilitate or make arrangements for any of the 
        activities specified in paragraph (1) in a manner that violates 
        the provider's sincerely held religious beliefs or moral 
        convictions.

SEC. 5. IMPLEMENTING LITERATURE REVIEWS ON THE STANDARD OF CARE FOR THE 
              DIAGNOSIS OF INFERTILITY.

    (a) In General.--The Assistant Secretary for Health of the 
Department of Health and Human Services (referred to in this section as 
the ``Assistant Secretary'') shall collect data on the topics described 
in subsection (b) and, not later than 2 years after the date of 
enactment of this Act and every 3 years thereafter, issue a report on 
the standard of care for women who have been diagnosed with 
infertility.
    (b) Topics.--In carrying out subsection (a), the Assistant 
Secretary shall--
            (1) assess peer-reviewed studies on referrals to 
        restorative reproductive medicine that are given prior to 
        referrals for or use of assisted reproductive technology;
            (2) assess peer-reviewed studies related to access to 
        patient and health care provider information and training for 
        fertility awareness-based methods; and
            (3) assess the extent to which the treatments, tests, and 
        training described in paragraphs (1) and (2) are covered under 
        public and private health plans.
    (c) Privacy Requirements.--In carrying out subsection (a), the 
Assistant Secretary shall ensure that the privacy and confidentiality 
of individual patients are protected in a manner consistent with 
relevant privacy and confidentiality law.

SEC. 6. IMPLEMENTING LITERATURE REVIEWS ON THE STANDARD OF CARE FOR 
              WOMEN SEEKING A REPRODUCTIVE HEALTH CONDITION DIAGNOSIS.

    (a) In General.--The Assistant Secretary for Health of the 
Department of Health and Human Services (referred to in this section as 
the ``Assistant Secretary'') shall collect data on the topics described 
in subsection (b) and, not later than 2 years after the date of 
enactment of this Act and every 3 years thereafter, issue a report on 
the standard of care for women seeking reproductive health condition 
diagnoses.
    (b) Topics.--In carrying out paragraph (1), the Assistant Secretary 
shall--
            (1) assess peer-reviewed studies related to access to 
        restorative reproductive medicine and restorative reproductive 
        health, including access to medical professionals trained in 
        NaProTechnology and fertility education and medical management;
            (2) assess peer-reviewed studies related to access to 
        information and training on fertility awareness-based methods; 
        and
            (3) assess the extent to which the treatments, tests, and 
        training described in paragraphs (1) and (2) are covered under 
        public and private health plans.
    (c) Privacy Requirements.--In carrying out subsection (a), the 
Assistant Secretary shall ensure that the privacy and confidentiality 
of individual patients are protected in a manner consistent with 
relevant privacy and confidentiality law.

SEC. 7. EXPANDING THE NATIONAL SURVEY OF FAMILY GROWTH TO INCLUDE 
              REPRODUCTIVE HEALTH CONDITIONS, RESTORATIVE REPRODUCTIVE 
              MEDICINE, AND FERTILITY AWARENESS-BASED METHODS.

    (a) In General.--The Director of the Centers for Disease Control 
and Prevention (referred to in this section as the ``Director'') shall 
evaluate the National Survey of Family Growth conducted by the National 
Center for Health Statistics of the Centers for Disease Control and 
Prevention and consider making modifications to the survey questions 
used for such purposes.
    (b) Topics.--The evaluation by the Director pursuant to subsection 
shall include consideration of adding questions related to--
            (1) restorative reproductive health;
            (2) reproductive health conditions and infertility;
            (3) restorative reproductive medicine availability and 
        utilization; and
            (4) availability of, and training on, fertility awareness-
        based methods.
    (c) Report.--The Director shall submit to Congress a report on the 
evaluation under subsection (a) not later than 3 years after the date 
of enactment of this Act and every 3 years thereafter.

SEC. 8. INCLUDING ACCESS TO TITLE X AWARD FUNDS FOR RESTORATIVE 
              REPRODUCTIVE MEDICINE GRANTEES.

     Section 1006 of the Public Health Service Act (42 U.S.C. 300a-4) 
is amended by adding at the end the following:
    ``(e)(1) Notwithstanding any other requirements relating to the 
experience required for an applicant to qualify for a grant or contract 
under this title, an entity shall be deemed eligible for a grant or 
contract under this title on the basis of being primarily engaged in 
providing restorative reproductive medicine, or providing training and 
education for medical students and professionals in restorative 
reproductive medicine, provided that such entity is otherwise eligible 
for the grant or contract.
    ``(2) In this subsection, the term `restorative reproductive 
medicine' has the meaning given such term in section 3 of the RESTORE 
Act.''.

SEC. 9. ADVANCING EDUCATION ON REPRODUCTIVE HEALTH CONDITIONS AND 
              WOMEN'S NATURAL CYCLE.

    (a) Expanding Grant Access and Application.--The Deputy Assistant 
Secretary for Population Affairs of the Department of Health and Human 
Services (referred to in this section as the ``Deputy Assistant 
Secretary'') shall develop, within the existing Teen Pregnancy 
Prevention program, access to, and advertisement for, applicants for 
grants under such program that specialize in restorative reproductive 
medicine, restorative reproductive health, and fertility awareness-
based methods. To be eligible to receive an award under this 
subsection, an entity shall be primarily engaged in services or 
education relating to restorative reproductive medicine, restorative 
reproductive health, or fertility awareness-based methods.
    (b) Report.--Not later than 18 months after the date of enactment 
of this Act, the Deputy Assistant Secretary shall submit to Congress 
and make publicly available on the website of the Office of Population 
Affairs a report on recipients of grants under the Teen Pregnancy 
Prevention program and the services, education, and training provided 
by such recipients.

SEC. 10. ADVANCING RESTORATIVE REPRODUCTIVE MEDICINE AND FERTILITY 
              AWARENESS-BASED METHODS TRAINING UNDER THE REPRODUCTIVE 
              HEALTH NATIONAL TRAINING CENTER.

    (a) In General.--The Assistant Secretary for Health of the 
Department of Health and Human Services (referred to in this section as 
the ``Assistant Secretary'') shall coordinate with the Office of 
Population Affairs and the Office on Women's Health to review, revise, 
and instruct the staff of the Reproductive Health National Training 
Center on reproductive health conditions, restorative reproductive 
medicine, restorative reproductive health, and fertility awareness-
based methods.
    (b) Training.--Beginning not later than 2 years after the date of 
enactment of this Act, as a condition for receipt of a grant or 
contract under title X of the Public Health Service Act (42 U.S.C. 300 
et seq.), the staff of the Reproductive Health National Training Center 
shall provide training to staff working in other entities receiving 
grants or contracts under title X of the Public Health Service Act (42 
U.S.C. 300 et seq.) about reproductive health conditions, restorative 
reproductive medicine, restorative reproductive health, and fertility 
awareness-based methods, which may include providing toolkits and other 
information, including online, about peer learning opportunities, 
NaProTechnology educational fellowships, fertility education and 
medical management, short videos on reproductive health conditions and 
restorative reproductive medicine, and contract medical professional 
seminars and training.

SEC. 11. EXPANDING RESEARCH ON REPRODUCTIVE HEALTH CONDITIONS, 
              FERTILITY AWARENESS-BASED METHODS, AND INFERTILITY.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), in coordination 
with the Assistant Secretary for Health, the Director of the Agency for 
Healthcare Research and Quality, the Director of the Advanced Research 
Projects Agency for Health, the Director of the Centers for Disease and 
Control, the Director of the National Institutes for Health, and the 
heads of other agencies and offices of the Department of Health and 
Human Services that are conducting research on reproductive health 
conditions, infertility, and maternal health, shall expand and 
coordinate programs to conduct and support research on reproductive 
health conditions.
    (b) Topics.--The research directed by the Secretary pursuant to 
subsection (a) may include research on--
            (1) the causes of reproductive health conditions, 
        especially endometriosis, adenomyosis, uterine fibroids, and 
        polycystic ovary syndrome;
            (2) ways to diagnose reproductive health conditions;
            (3) restorative reproductive medicine and new treatment 
        options for reproductive health conditions;
            (4) endocrine disrupting chemicals in endometriosis, the 
        relationship of endometriosis and cancer, prenatal and 
        epigenetic influences on the risk for endometriosis;
            (5) premenstrual syndrome, hormone dysfunction, ovulation 
        defects, abnormal uterine bleeding, adhesion prevention, tubal 
        corrective surgery, and preconception and pregnancy health;
            (6) the growth and progression of reproductive health 
        conditions and recurrence post-surgical procedures;
            (7) the increasing prevalence of sexually transmitted 
        infections and related effects on fertility in men and women;
            (8) male mechanisms of infertility, including low sperm 
        count; and
            (9) the effectiveness of restorative reproductive medicine 
        to achieve pregnancy.
    (c) Report.--Not later than 2 years after the date of enactment of 
this Act, the Secretary shall make an ongoing report on the research 
publicly available on the website of the Department of Health and Human 
Services.

SEC. 12. SEVERABILITY.

    If any provision of this Act, or the application of such provision 
to any person, entity, government, or circumstance, is held to be 
unconstitutional, the remainder of this Act, or the application of such 
provision to all other persons, entities, governments, or 
circumstances, shall not be affected thereby.
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