S. 1882 — RESTORE Act

This section states congressional findings on reproductive health conditions that cause infertility affecting 15-16% of U.S. couples—including endometriosis (with 6-12 year average diagnosis delay), adenomyosis, polycystic ovary syndrome (affecting ~15% of women), uterine fibroids, and blocked fallopian tubes (in 1 in 4 infertile women)—as well as research gaps, multiple underlying factors in most cases, and benefits of restorative reproductive medicine for diagnosis, treatment, fertility, and symptom relief.

This section defines eight terms for purposes of the Act: (1) assisted reproductive technology, as treatments or procedures handling human egg, sperm, or embryo outside the body to facilitate pregnancy (e.g., in vitro fertilization, cryopreservation); (2) fertility awareness-based methods, as evidence-based menstrual cycle tracking via biological signs (e.g., sympto-thermal, Marquette, Creighton, Billings ovulation methods); (3) fertility education and medical management, as a program developed with the Reproductive Health Research Institute for women's hormonal health education and medical protocols; (4) infertility, as a disease symptom diagnosed after 12 months (women under 35) or 6 months (women 35 and older) of unprotected intercourse where conception should otherwise be possible; (5) Natural Procreative Technology (NaProTECHNOLOGY), as health care monitoring women's reproductive health including corrective surgeries; (6) reproductive health conditions, such as endometriosis, polycystic ovary syndrome, uterine fibroids, and hormone imbalances impeding conception; (7) restorative reproductive health, as programs empowering body literacy, fertility awareness, and restorative medicine; and (8) restorative reproductive medicine, as approaches restoring reproductive physiology without suppressive or destructive methods (e.g., ultrasounds, surgeries, lifestyle assessments).

This section prohibits the federal government, recipients of federal financial assistance (including state and local governments), and other specified entities from discriminating against health care providers who decline to assist in, train for, provide, perform, refer for, pay for, or otherwise participate in assisted reproductive technology (i.e., fertility treatments such as in vitro fertilization), or to facilitate or arrange for such activities, when doing so would violate the provider's sincerely held religious beliefs or moral convictions. The prohibition applies notwithstanding any other law.

This section directs the Assistant Secretary for Health in the Department of Health and Human Services to collect data on three specified topics related to infertility and, not later than two years after the date of enactment of this Act and every three years thereafter, issue a report on the standard of care for women diagnosed with infertility. The topics are (1) peer-reviewed studies on referrals to restorative reproductive medicine prior to referrals for or use of assisted reproductive technology, (2) peer-reviewed studies related to access to patient and health care provider information and training for fertility awareness-based methods, and (3) the extent to which the treatments, tests, and training described in (1) and (2) are covered under public and private health plans.

This section directs the Assistant Secretary for Health in the Department of Health and Human Services to collect data and, not later than two years after the date of enactment of this Act and every three years thereafter, issue a report on the standard of care for women and men seeking reproductive health condition diagnoses. In doing so, the Assistant Secretary must assess (1) peer-reviewed studies related to access to restorative reproductive medicine and restorative reproductive health, including access to medical professionals trained in NaProTechnology (i.e., a fertility-awareness-based medical approach) and fertility education and medical management; (2) peer-reviewed studies related to access to information and training on fertility awareness-based methods; and (3) the extent to which the treatments, tests, and training described in (1) and (2) are covered under public and private health plans. The Assistant Secretary must ensure patient privacy and confidentiality consistent with applicable law.

This section directs the Director of the Centers for Disease Control and Prevention (CDC) to evaluate the National Survey of Family Growth (NSFG)—conducted by the CDC's National Center for Health Statistics to collect data on marriage, divorce, contraception, infertility, reproductive health services, and related topics—and consider modifying its questions to address (1) restorative reproductive health, (2) reproductive health conditions and infertility, (3) availability and utilization of restorative reproductive medicine, and (4) availability and training on fertility awareness-based methods. The Director must submit a report to Congress on the evaluation not later than three years after enactment and every three years thereafter.

This section deems entities primarily engaged in providing restorative reproductive medicine (as defined in the RESTORE Act) or in providing training and education for medical students and professionals in restorative reproductive medicine eligible for grants and contracts under Title X of the Public Health Service Act notwithstanding applicant experience requirements, provided the entity is otherwise eligible. (Title X authorizes federal grants to states and other entities to plan, establish, maintain, coordinate, and evaluate voluntary family planning services.)

This section requires the Deputy Assistant Secretary for Population Affairs at the Department of Health and Human Services to develop, within the existing Teen Pregnancy Prevention Program, access to and advertisement for grant applicants specializing in restorative reproductive medicine, restorative reproductive health, and fertility awareness-based methods, with eligibility limited to entities primarily engaged in related services or education. It further requires such official to submit to Congress, and publicly post on the Office of Population Affairs website, a report on program grant recipients and the services, education, and training they provide, due not later than 18 months after enactment.

This section directs the HHS Assistant Secretary for Health, in coordination with the Office of Population Affairs and Office on Women's Health, to review, revise, and instruct staff of the Reproductive Health National Training Center on reproductive health conditions, restorative reproductive medicine, restorative reproductive health, and fertility awareness-based methods. Beginning not later than two years after the date of enactment, it requires the center's staff to provide such training to staff of other entities receiving grants or contracts under Title X of the Public Health Service Act (i.e., the federal family planning program) as a condition of receiving Title X funding, which may include toolkits, online resources on peer learning opportunities and NaProTechnology educational fellowships, fertility education and medical management, short videos, and contract medical professional seminars.

This section directs the Secretary of Health and Human Services (HHS), in collaboration with the Assistant Secretary for Health and the Deputy Assistant Secretary for Population Affairs, to evaluate and develop education within relevant HHS health programs on awareness of and treatment for male factor infertility (i.e., infertility attributable to male reproductive issues) through lifestyle and metabolic modifications, considering 12 specified topics including sperm count, erectile dysfunction, obesity, insulin resistance, and substance use. It further requires the Secretary to submit to Congress, and make publicly available, plans for such education not later than 18 months after the date of enactment.

This section directs the Secretary of Health and Human Services (HHS), in collaboration with the Centers for Medicare & Medicaid Services (CMS) Administrator, Centers for Disease Control and Prevention National Center for Health Statistics Director, and American Medical Association CPT Editorial Panel, to update, not later than one year after enactment, diagnostic and procedural codes related to infertility treatments to reflect current practices in restorative reproductive medicine (i.e., treatments addressing underlying causes of infertility such as endometriosis rather than assisted reproductive technologies). In carrying out this directive, the Secretary must (1) review and revise ICD-10-CM codes for conditions including endometriosis, polycystic ovary syndrome, uterine fibroids, adenomyosis, blocked fallopian tubes, and male infertility; (2) develop new ICD-10-PCS codes for laparoscopic excision, hysteroscopic procedures, and other minimally invasive surgeries such as fibroid, ovarian cyst, and adenomyosis tissue excision; (3) revise International Classification of Diseases codes to reflect severe, chronic reproductive conditions; (4) develop new Current Procedural Terminology (CPT) codes for specified minimally invasive surgeries and interventions—including laparoscopic excision (differentiating from ablation) of endometriosis, endometriosis-related appendectomy or bowel resection, hysteroscopic or abdominal myomectomy, cystectomy, and female cycle charting instruction for family planning; (5) establish new Healthcare Common Procedure Coding System (HCPCS) codes for Medicare and Medicaid reimbursement of reproductive health surgeries, postoperative care, and family planning services including female cycle charting instruction; (6) conduct an actuarial analysis to set reimbursement rates and relative value units (RVUs) reflecting procedure complexity, time, physician visits, surgical interventions, education, and care coordination; and (7) implement a bundled payment model under CPT codes for restorative reproductive medicine—including diagnostics, medical management, surgery, education, care coordination, and extended physician time—with actuarial analysis for appropriate rates and RVUs.

This section directs the Secretary of Health and Human Services (HHS), in coordination with the Assistant Secretary for Health, the directors of the Agency for Healthcare Research and Quality, Advanced Research Projects Agency for Health, Centers for Disease Control and Prevention, National Institutes of Health, and other relevant HHS entities, to expand and coordinate programs to conduct and support research on reproductive health conditions. The research may address (1) causes, diagnosis, and treatments for conditions such as endometriosis, adenomyosis, uterine fibroids, and polycystic ovary syndrome; (2) endocrine disruptors, premenstrual syndrome, hormone dysfunction, and related factors; (3) disease progression and recurrence; (4) sexually transmitted infections' effects on fertility; (5) microplastics' impacts on reproductive organs and sperm quality; (6) male infertility mechanisms; and (7) effectiveness of restorative reproductive medicine for pregnancy and live birth. This section further requires the Secretary to make an ongoing report on the research publicly available on the HHS website not later than two years after enactment.

This section establishes a severability clause, providing that if any provision of the Act or its application to any person, entity, government, or circumstance is held unconstitutional, the remainder of the Act and its application to others remain unaffected.