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