H.R. 3589 — RESTORE Act

This section states congressional findings on reproductive health conditions that contribute to infertility affecting 15-16% of U.S. couples—including endometriosis (with average diagnosis delay of 6-12 years), adenomyosis, polycystic ovary syndrome (affecting approximately 15% of women), uterine fibroids, and blocked fallopian tubes (affecting 1 in 4 infertile women)—as well as the role of restorative reproductive medicine in diagnosing and treating underlying causes to improve fertility, health outcomes, and related symptoms.

This section defines eight terms for purposes of the Act: (1) assisted reproductive technology (i.e., treatments or procedures involving handling of human egg, sperm, or embryo outside the body to facilitate pregnancy, including artificial insemination, IVF, and cryopreservation); (2) fertility awareness-based methods (i.e., evidence-based menstrual cycle tracking via biological signs such as body temperature and cervical fluid, including the sympto-thermal, Marquette, Creighton, and Billings ovulation methods); (3) fertility education and medical management (i.e., program developed with the Reproductive Health Research Institute providing education on women's hormonal health and medical support); (4) infertility (i.e., disease or condition hindering conception after 12 months of unprotected intercourse for women under 35 or 6 months for women 35 and older); (5) Natural Procreative Technology or NaProTECHNOLOGY (i.e., approach monitoring women's reproductive health, including surgery to address endometriosis and related conditions); (6) reproductive health conditions (i.e., endometriosis, PCOS, uterine fibroids, and similar conditions impeding conception); (7) restorative reproductive health (i.e., programs using body literacy, fertility awareness methods, and restorative medicine to promote natural reproductive health); and (8) restorative reproductive medicine (i.e., approaches restoring normal reproductive physiology without suppressive or destructive methods, including surgeries, hormone tests, and NaProTECHNOLOGY).

This section prohibits the Federal Government and any person or entity receiving federal financial assistance—including state and local governments—from penalizing, retaliating against, or discriminating against a health care provider who 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 such activities in a manner that violates the provider's sincerely held religious beliefs or moral convictions.

This section directs the Assistant Secretary for Health in the Department of Health and Human Services to assess peer-reviewed studies on specified topics and, not later than two years after the date of enactment and every three years thereafter, issue a report on the standard of care for women diagnosed with infertility. The topics are (1) referrals to restorative reproductive medicine (i.e., treatments to restore natural fertility function) prior to assisted reproductive technology such as in vitro fertilization; (2) access to patient and health care provider information and training on fertility awareness-based methods (i.e., natural cycle-tracking methods); and (3) coverage of such treatments, tests, and training under public and private health plans. In carrying out this requirement, the Assistant Secretary must protect patient privacy consistent with applicable law.

This section directs the Assistant Secretary for Health of the Department of Health and Human Services to collect data and, not later than two years after enactment and every three years thereafter, issue a report on the standard of care for women and men seeking reproductive health condition diagnoses. The report 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 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. In carrying out this requirement, the Assistant Secretary must protect 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—conducted by the CDC's National Center for Health Statistics to collect data on marriage, divorce, contraception, infertility, and reproductive health among the U.S. population—and consider modifying its questions to address (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. The Director must submit a report to Congress on this evaluation not later than three years after enactment of this Act and every three years thereafter.

This section deems entities primarily engaged in providing restorative reproductive medicine (RRM)—or in training and educating medical students and professionals in RRM, as defined in section 3 of the RESTORE Act—eligible for Title X grants and contracts notwithstanding applicant experience requirements, provided the entities are otherwise eligible. (Title X authorizes federal grants to public and nonprofit entities for voluntary family planning services.)

This section directs the Deputy Assistant Secretary for Population Affairs of HHS, within the existing Teen Pregnancy Prevention Program, to develop access to and advertise grant opportunities for entities primarily engaged in restorative reproductive medicine, restorative reproductive health, or fertility awareness-based methods. (As background, the program provides grants to public and private entities for evidence-based strategies to prevent teen pregnancy.) It further requires such official to submit to Congress, and make publicly available on the Office of Population Affairs website, a report on recipients of grants under such program and the services, education, and training provided by such recipients not later than 18 months after the date of enactment.

This section directs the Assistant Secretary for Health, in coordination with the Office of Population Affairs and the 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 enactment, it requires such center staff, as a condition for grants or contracts under Title X of the Public Health Service Act (i.e., the federal family planning program), to provide related training to staff of other Title X grantees, which may include toolkits, online resources on peer learning opportunities and NaProTechnology educational fellowships, fertility education and medical management, short videos, and 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 through lifestyle and metabolic modifications, considering 12 specified topics: (1) sperm count; (2) sperm motility; (3) sperm morphology; (4) erectile dysfunction; (5) hormonal imbalance; (6) sexually transmitted infections; (7) endocrine-disrupting chemicals; (8) testicular torsion; (9) varicoceles; (10) obesity; (11) insulin resistance; and (12) substance use. The Secretary must submit to Congress, and make publicly available, plans for such education not later than 18 months after enactment of this Act.

This section directs the Secretary of Health and Human Services, in collaboration with the CMS Administrator, CDC's National Center for Health Statistics Director, and the AMA's CPT Editorial Panel, to update diagnostic and procedural codes related to infertility treatments to reflect restorative reproductive medicine (i.e., treatments addressing underlying causes such as endometriosis or polycystic ovary syndrome) not later than 1 year after enactment. In doing so, 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 procedures such as laparoscopic excision and hysteroscopic surgeries; (3) revise ICD codes to reflect severe chronic reproductive conditions; (4) develop new CPT codes for specified minimally invasive surgeries (e.g., laparoscopic excision vs. ablation of endometriosis, hysteroscopic myomectomy) and family planning services including female cycle charting instruction; (5) establish new HCPCS codes for Medicare and Medicaid reimbursement of related surgical procedures, postoperative care, and family planning services; (6) conduct an actuarial analysis to set reimbursement rates and relative value units accounting for procedure complexity, physician time, education, and care coordination; and (7) implement a bundled payment model for restorative reproductive medicine—including diagnostics, medical management, surgery, education, and care coordination—with corresponding CPT codes and actuarial analysis for rates and relative value units.

This section directs the Secretary of Health and Human Services (HHS), in coordination with the Assistant Secretary for Health, directors of the Agency for Healthcare Research and Quality, Advanced Research Projects Agency for Health, Centers for Disease Control and Prevention, National Institutes of Reproductive Empowerment and Support Through Optimal Restoration Act Health, and other relevant HHS offices, to expand and coordinate programs conducting and supporting research on reproductive health conditions (e.g., endometriosis, adenomyosis, uterine fibroids, polycystic ovary syndrome), infertility, and related topics such as restorative reproductive medicine, endocrine disruptors, microplastics exposure, sexually transmitted infections, and male infertility mechanisms (e.g., low sperm count, low testosterone). Not later than two years after enactment, the Secretary must make an ongoing report on the research publicly available on the HHS website.

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 the application of such provision to others shall not be affected.