A BILL

To expand and promote research and data collection on reproductive health conditions, which are the leading causes of infertility, and provide training opportunities for medical professionals to learn how to diagnose and treat reproductive health conditions, and for other purposes.

Section 1. TITLE

This Act may be cited as the “Reproductive Empowerment and Support Through Optimal Restoration (RESTORE) Act.”

Section 2. FINDINGS

The General Assembly finds that:

1. There is a growing interest among women and men to proactively assess their overall health and understand how factors, such as their age and medical history, contribute to their reproductive health and fertility.
2. Women and men are worthy of the highest standard of medical care, including the opportunity to assess, understand, and improve their reproductive health. Yet, many women and men do not receive adequate information about their reproductive health nor have access to restorative reproductive medicine.
3. Reproductive health conditions are the leading cause of infertility, affecting 11 percent of women and 9 percent of men in the United States. Leading conditions include endometriosis, polycystic ovary syndrome (PCOS), blocked fallopian tubes, and male-factor infertility.
4. Research shows that male and/or female infertility is typically due to four or more conditions or factors, with the diagnosis shared equally between men and women.
5. There is a gap in research and care for reproductive health conditions that affect a majority of women struggling with “unexplained infertility.” Unexplained infertility accounts for 15 percent to 30 percent of all diagnoses of infertility.
6. Restorative reproductive medicine aims to examine how women’s reproductive functions and cycle interact with the rest of the female body.
7. Male-factor infertility and reproductive dysfunction has been on the rise since the 1970s, with a 1 percent decrease in sperm count, testosterone, and total fertility per year.
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 alleviates other difficult symptoms associated with reproductive health conditions, including but not limited to painful periods, painful flare-ups, bloating, inflammation, heavy periods, irregular periods, nerve pain, bowel symptoms, pain during sexual intercourse, and back pain. It also addresses common symptoms related to male factor infertility, including erectile dysfunction.

Section 3. DEFINITIONS

In this Act:

1. 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 live child to term where it should otherwise be possible through intercourse with a person of the other sex. A diagnosis of infertility often occurs after 12 months of targeted intercourse for women under 35, or after six months of targeted intercourse without the use of a chemical, barrier, or other contraceptive method for women 35 and older.
2. Restorative Reproductive Medicine (RRM)—The term “restorative reproductive medicine” means any scientific approach to reproductive medicine that seeks to cooperate with or restore the normal physiology and anatomy of the human reproductive system. It does not employ methods that are inherently suppressive, circumventive, or destructive to the human body.
3. Restorative Reproductive Health (RRH)—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-led reproductive health education, restorative reproductive medicine, Natural Procreative Technology (NaProTechnology), fertility awareness-based methods, and fertility education and medical management.
4. 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.
5. Natural Procreative Technology (NaProTechnology)—The term “Natural Procreative Technology” means an approach to healthcare 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.
   1. Endometriosis—The term “endometriosis” means a disease where tissue resembling endometrial lining tissue grows outside of the uterus. The tissue often sticks 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 cancer growth. Endometriosis is often diagnosed in stages, with Stage I the mildest form and Stage IV the most severe and widespread form. The average diagnosis delay for endometriosis is 10 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.
   2. Adenomyosis—The term “adenomyosis” means a disease that occurs when endometrial tissue (tissue that would normally line the inside of the uterus, distinct from endometriosis tissue) grows down 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.
   3. Polycystic ovary syndrome (PCOS)—The term “polycystic ovary syndrome” means 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. Accurate and timely diagnosis and treatment can correct underlying hormonal imbalances, critical for both long-term health improvements as well as for fertility outcomes.
   4. Uterine fibroids—The term “uterine fibroids” means muscular tumors that grow in the wall of the uterus. While not all women 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 be a hysteroscopic myomectomy, abdominal myomectomy, uterine fibroid embolization (UFE), or uterine artery embolization (UAE). 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.
   5. Blocked Fallopian Tubes—The term “blocked fallopian tubes” means 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 one in four women with infertility have a tubal blockage. This condition makes achieving pregnancy difficult, if not impossible. Treatments for a blockage include fallopian tube recanalization, tubotubal anastomosis (tubal ligation reversal), and neosalpingostomy/fimbrioplasty.
7. Fertility Awareness-Based Methods (FABMs)—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 symptothermal method, the Marquette method, the Creighton method, and the Billings ovulation method.
8. Fertility Education and Medical Management (FEMM)—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 healthcare 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.

Section 4. RULES OF CONSTRUCTION

1. RELIGIOUS AND CONSCIENCE PROTECTIONS.—Notwithstanding any other provision of law, nothing in this Act shall be construed to require hospitals, individuals, employees, grantees, contractors, or entities to violate their consciences, religious beliefs, or moral convictions by requiring them, or holding them liable for refusing, to provide any healthcare referenced in this Act.

Section 5. ASSISTED REPRODUCTIVE TECHNOLOGY—PROHIBITION ON DISCRIMINATION AGAINST NONPARTICIPATING HEALTHCARE PROVIDERS

Notwithstanding any other state law, a person or entity, including state and local government agencies, that receives state financial assistance or local government assistance (any entity that receives state funds, including state-administered federal funds or local government funds) shall not penalize, retaliate against, or otherwise discriminate against a healthcare provider on the basis that the healthcare 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 under subdivision (1) of this section in a manner that violates the healthcare provider’s sincerely held religious beliefs or moral convictions.

Section 6. IMPLEMENTING DATA COLLECTION ON THE STANDARD OF CARE FOR THE DIAGNOSIS OF INFERTILITY

1. DATA COLLECTION.—The [State health department Secretary] shall implement data collection and produce a report every three years on the standard of care for women with infertility diagnoses.
2. TOPICS.—In carrying out the data collection under section (1), the [State health department Secretary] must—
   1. collect and assess data related to restorative reproductive medicine prior to referral for or use of assisted reproductive technology;
      1. Restorative reproductive medicine may include ultrasounds, blood tests, hormone panels, laparoscopic and exploratory surgeries, examining the woman’s overall health and lifestyle, eliminating environmental endocrine disruptors, and assessing her partner’s health and fertility;
   2. collect and assess data related to access to information and training for fertility awareness-based methods; and
   3. assess group health plans or issuers of group or individual health insurance coverage of the treatments, tests, and training under subsections (2a) and (2b).
3. PRIVACY REQUIREMENTS.—In carrying out the data collection under section (1), the [State health department Secretary] shall ensure that the privacy and confidentiality of individual patients are protected in a manner consistent with relevant privacy and confidentiality laws.
4. REPORT.—No later than two years after the date of enactment of this Act, the [State health department Secretary] shall submit the report to [the Governor or the legislature or a relevant legislative committee] and make publicly available on the website of the [State health department] a report on the data collection carried out under this section.

Section 7. IMPLEMENTING DATA COLLECTION ON THE STANDARD OF CARE FOR WOMEN AND MEN SEEKING A REPRODUCTIVE HEALTH CONDITION DIAGNOSIS

1. DATA COLLECTION.—The [State health department Secretary] shall implement data collection and produce a report every three years on the standard of care for women and men seeking reproductive health condition diagnoses.
2. TOPICS.—In carrying out the data collection under section (1), the [State health department Secretary] must—
   1. collect and assess data related to access to restorative reproductive medicine and restorative reproductive health, including access to medical professionals trained in NaProTechnology and FEMM;
   2. collect and assess data related to access to information and training on fertility awareness-based methods; and
   3. assess group health plans or issuers of group or individual health insurance coverage of the treatments, tests, and training under subsections (2a) and (2b).
3. PRIVACY REQUIREMENTS.—In carrying out the data collection under section (1), the [State health department Secretary] shall ensure that the privacy and confidentiality of individual patients are protected in a manner consistent with relevant privacy and confidentiality laws.
4. REPORT.—No later than two years after the date of enactment of this Act, the [State health department Secretary] shall submit the report to [the Governor or the legislature or a relevant legislative committee] and make publicly available on the website of the [State health department] a report on the data collection carried out under this section.

Section 8. STATE-MANDATED INCORPORATION OF FERTILITY AWARENESS-BASED METHODS INTO TITLE X PROGRAMS

(a) All Title X-funded facilities in [State] must include fertility awareness-based methods as part of covered family planning and reproductive health services.

(b)(1) The [State health department] shall work with Title X‐funded facilities to integrate fertility awareness-based methods into existing programs within twelve (12) months of the effective date of this section.

(2) The department shall provide guidance and support to facilities in implementing the fertility awareness-based methods, including:

(A) Training for healthcare providers on fertility awareness-based methods; and

(B) Development of patient education materials on fertility awareness-based methods.

(c) Consistent with federal law, Title X‐funded facilities shall allocate a portion of existing Title X funds to cover implementing and providing fertility awareness-based methods.

(d) Compliance with this section is a condition of state licensing of Title X facilities.

Section 9. INCLUDING ACCESS TO TITLE X AWARD FUNDS FOR RESTORATIVE REPRODUCTIVE MEDICINE GRANTEES

(a)(1) The [State health department, or whichever entity administers Title X sub-grants] shall not exclude entities that provide restorative reproductive medicine, as defined in this Act, from receiving the grants and contracts provided to other Title X entities, provided they meet all other qualifications.

(a)(2) The [State health department] may not exclude entities that provide training and education for medical students and professionals in restorative reproductive medicine, as defined in this Act, from receiving the grants and contracts provided to other Title X entities, provided they meet all other qualifications.

Section 10. ADVANCING EDUCATION ON REPRODUCTIVE HEALTH CONDITIONS AND WOMEN’S NATURAL CYCLE

1. APPLICATION.—The [State health department Secretary] shall develop within the already existing [State] health education standards and public health program curricula to include information on reproductive health conditions, restorative reproductive medicine, restorative reproductive health, and fertility awareness-based methods.
   1. Public health programs include: (1) family planning services, (2) maternal and child health programs, and (3) women’s health initiatives.
2. REPORT.—No later than 18 months after the date of enactment of this Act, the [State health department Secretary] shall make publicly available a report on the updated curriculum standards for public health programs and a plan for regular reporting on their outcomes.
3. GRANT ACCESS.—The [State health department Secretary] shall ensure that any grant or partnership opportunities within these programs are advertised to and inclusive of organizations that specialize in restorative reproductive health and fertility awareness education.

Section 11. ADVANCING RESTORATIVE REPRODUCTIVE MEDICINE AND FERTILITY AWARENESS-BASED METHODS TRAINING

1. IN GENERAL.—The [State health department Secretary] shall ensure, by oversight, that the [State medical board and licensing agency] update professional education and licensing requirements as needed to include training in restorative reproductive medicine, restorative reproductive health, and fertility awareness-based methods through the management of their healthcare license.
2. TRAINING.—The [State health department] must provide training to staff working at Title X providers on reproductive health conditions, restorative reproductive medicine, restorative reproductive health, and fertility awareness-based methods.
   1. This training may include RRM, FEMM, and FABMs toolkits, peer learning opportunities, NaProTechnology educational fellowships, FEMM and FABMs education, short videos on reproductive health conditions and restorative reproductive medicine, and contracts with medical professionals for seminars and training on RRM, NaProTechnology, FEMM, and FABMs.

Section 12. EXPANDING RESEARCH ON REPRODUCTIVE HEALTH CONDITIONS, FERTILITY AWARENESS-BASED METHODS, AND INFERTILITY.

1. IN GENERAL.—The [State health department Secretary] shall expand and coordinate programs to conduct and support research on reproductive health conditions.
2. RESEARCH.—The [State health department Secretary] shall implement this research initiative within the [State health department] and any other subagency, public health research division, or research university already conducting research on reproductive health conditions, infertility, and maternal health.
3. TOPICS.—In carrying out the research under section (1), the [State health department Secretary] may—
   1. direct research on the causes of reproductive health conditions, especially endometriosis, adenomyosis, uterine fibroids, and polycystic ovary syndrome;
   2. direct research on ways to diagnose reproductive health conditions;
   3. direct research on restorative reproductive medicine and new treatment options for reproductive health conditions;
   4. direct targeted research on endocrine-disrupting chemicals in endometriosis, the relationship of endometriosis and cancer, and prenatal and epigenetic influences on the risk for endometriosis;
   5. direct research on the growth and progression of reproductive health conditions and recurrence post-surgical procedures;
   6. direct research on male mechanisms of infertility, such as low sperm count, low sperm motility, erectile dysfunction, low testosterone, varicocele, and testicular torsion;
   7. direct research on the effectiveness of fertility awareness-based methods to achieve pregnancy and increase the number of live births;
   8. direct research on premenstrual syndrome (PMS), hormonal dysfunctions, ovulation defects, abnormal uterine bleeding, adhesion prevention, tubal corrective surgery, and preconception health;
   9. direct research on the prevalence of sexually transmitted infections and their effects on fertility in both men and women; and
   10. direct research on the impact of exposure to environmental factors like microplastics on male and female reproductive health (including sperm quality).
4. REPORT.—No later than 24 months after the date of enactment of this Act, the [State health department Secretary] shall make a report on the research publicly available. This report should be updated annually.

Section 13. ADVANCING TREATMENTS FOR MALE FACTOR INFERTILITY

1. IN GENERAL.—The [State health department] shall expand and coordinate programs, within existing public health or family planning initiatives, for the development of education, awareness, and treatment for male factor infertility through lifestyle and metabolic modifications.
2. TOPICS.—This new integration includes, but is not limited to: low sperm count, motility, morphology, hormonal imbalances, STIs, obesity, varicoceles, and erectile dysfunction.
3. REPORT.—No later than 24 months after the date of enactment of this Act, the [State health department Secretary] shall make an report on the research publicly available, along with the developed plans for education and treatment for male factor infertility within the existing state public health and family planning programs. This report should be updated annually.

Section 14. ADOPTION OF NEW MEDICAL CODING

1. IN GENERAL.—The [State health department Secretary] shall collaborate with local and federal policymakers to recommend updated diagnostic and procedural codes related to infertility treatments to reflect the latest knowledge and practices in restorative reproductive medicine.
2. REQUIREMENTS.—[State lawmakers] shall recommend a thorough federal review of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS), the Current Procedural Terminology (CPT) code set, and the Healthcare Common Procedure Coding System (HCPCS). Codes should be revised and developed for:
   1. endometriosis, polycystic ovary syndrome, uterine fibroids, adenomyosis, blocked fallopian tubes, and male mechanisms of infertility to ensure accurate classification of severe, chronic reproductive health conditions requiring medical or surgical intervention;
   2. laparoscopic excision, hysteroscopic procedures, and other minimally invasive surgeries aimed at addressing such conditions, including the excision of fibroids, ovarian cysts, and adenomyosis-related tissue removal;
   3. minimally invasive surgeries and other interventions that target infertility-related conditions, specifically including laparoscopic excision, differentiation between laparoscopic ablation and laparoscopic excision of endometriosis, appendectomy related to endometriosis, bowel resection related to endometriosis, hysteroscopic myomectomy, abdominal myomectomy, cystectomy, other minimally invasive procedures that directly treat underlying reproductive health conditions, and for family planning services, specifically including female cycle charting instruction;
   4. ensuring appropriate reimbursement under the Medicare and Medicaid programs for reproductive health-related surgical procedures, postoperative care, and family planning services, specifically including female cycle charting instruction.

Section 15. SEVERABILITY

1. 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.