Introduction

Infertility is one of the most common diseases affecting reproductive-aged individuals with 12% to 18% of couples in the United States being affected. ^, As of 2018, 13% of the approximately 72 million reproductive-aged American women have received infertility services. ^, Unfortunately, less than half of couples and individuals with infertility historically have been able to access fertility care. Despite numerous studies that have demonstrated the medical, social, economic, and psychological harms associated with infertility, ^, treatments for the conditions have long been considered elective and remained primarily paid for out-of-pocket (OOP). ^,

Economic factors are the chief contributors to disparities in access to effective treatments for infertility, especially in vitro fertilization (IVF). ^, The American Society for Reproductive Medicine (ASRM) has estimated IVF to cost $12,400 per cycle ; however, it is unclear if this estimate includes the cost of medications for ovarian stimulation. One US-based, multicenter, prospective cohort study appraised the median OOP costs per IVF cycle, including medications, at $19,200. A separate study from California estimated a single IVF cycle to cost approximately $24,000 and each successful IVF pregnancy to cost upward of $61,000. Without insurance coverage, IVF remains cost-prohibitive for many patients.

In 2014, the Centers for Disease Control and Prevention (CDC) released its first National Public Health Action Plan for the Detection, Prevention, and Management of Infertility, which calls for eliminating disparities in access to high-quality infertility services. State infertility insurance mandates have emerged as a key mechanism for increasing access to care in the United States. As of 2021, 19 states had passed legislation mandating insurance coverage for infertility, 13 of which currently require some form of coverage for IVF. ^, However, state infertility mandates are extremely heterogeneous with wide variation in the specific services covered, degree of coverage, qualifications for coverage, and exemptions.

Previous studies have demonstrated that state infertility insurance mandates lead to significant changes in IVF utilization, outcomes, and practice patterns. Mandates have led to major increases in patient access to care. The promotion of single embryo transfer by mandates has been associated with a reduction in both the number of embryos per transfer ^{, ,} and IVF-associated multiple births. ^{, ,} Contrary to these positive observations, some studies have indicated that mandates may also be associated with lower live birth rates per cycle. ^{, , , ,}

Since the first published study on the impact of insurance coverage on IVF outcomes in 2002, 4 states have passed new infertility mandates and several states have revised the existing mandates. Given this new legislation and the lag between passage and effect, an updated analysis of the impact of a state mandates is warranted. In this study, our primary objective was to characterize the current impact of state infertility mandates on IVF utilization, outcomes, and embryo transfer practices in the United States. Specifically, we hypothesized that state insurance mandates requiring comprehensive IVF coverage would be associated with higher IVF utilization, lower multiple birth rates, lower live birth rates, and fewer embryos per transfer.

Materials and Methods

IVF cycle data were collected from the 2018 CDC Assisted Reproductive Technology (ART) Fertility Clinic Success Rates Report. The Fertility Clinic Success Rate and Certification Act of 1992 mandates reporting of the success rates of ART performed by fertility clinics in the United States to the CDC. This single year was chosen because it represented the most up-to-date sample of IVF utilization and outcomes data for the purpose of our analyses. Presently, IVF accounts for nearly all ART cycles. Only IVF cycles using nondonor oocytes were analyzed. Additional data necessary for our analyses were requested and obtained following written communication with the CDC’s National ART Surveillance System.

Cycles were assigned to 1 of the following 2 groups based on the degree of mandated insurance coverage for IVF in the state in which they occurred: comprehensive and noncomprehensive. Classification of state infertility insurance mandates are outlined in the Figure . As of 2018, 16 states had active legislation mandating insurers to cover or offer coverage for services related to the diagnosis and treatment of infertility. ^, Delaware’s infertility mandate was not effective until June 30, 2018, and was thus classified as a noncomprehensive state. Eight states specifically required insurance providers to cover the cost of IVF. Arkansas and Hawaii were excluded from the comprehensive group because of population eligibility limitations and extremely limited lifetime coverage for IVF. These exclusions are supported by the ASRM’s own list of states with comprehensive coverage. Thus, 6 states (CT, IL, MD, MA, NJ, RI) comprised the comprehensive IVF mandate group. The other 44 states, Washington District of Columbia, and Puerto Rico comprised the noncomprehensive group.

Flow diagram of state infertility insurance mandate classifications

IVF , in vitro fertilization.

Peipert etal. Impact of state comprehensive insurance mandates on in-vitro fertilization. Am J Obstet Gynecol 2022.

The CDC ART Fertility Clinic Success Rates Report conveys data at the clinic level; individual cycle characteristics and outcomes are not available within the data set. Raw data, reported as percentages, were converted to numbers, assigned to 1 of the 2 state mandate groups, and then reconverted into percentages when appropriate. The specific outcomes that were calculated from the data set included utilization rate of IVF per 1000 women aged 25 to 44 years, live birth rate, multiple birth rate, number of embryos per embryo transfer procedure, and percentage of transfers performed with frozen embryos. Live birth rates were reported as the percentage of initiated IVF cycles ending in a live birth. Since 2017, the CDC’s cumulative live birth rate calculation includes all embryo transfers that occurred within 1 year after a single egg retrieval cycle. The multiple birth rate was calculated by subtracting the number of singleton births from the number of IVF cycles ending in a live birth divided by total cycles. Outcomes were pooled separately for comprehensive and noncomprehensive states. A subanalysis was performed looking at cycles and transfers stratified by patient age as follows as reported by the CDC: age <35, 35 to 37, 38 to 40, 41 to 42, and >42 years. The 2018 United States census population estimates were used to calculate utilization rates per 1000 women aged 25 to 44 years. This age range was selected because it accounts for the vast majority of women undergoing IVF and is in line with other analyses of IVF utilization rates. ^,

Age-specific IVF utilization rates were standardized to the age distribution of all states with the use of direct standardization methods. Chi-square tests were used to compare IVF utilization, live birth rates, multiple birth rates, and percentage of frozen transfers according to mandate status. A 2-sample t test was used to compare the mean number of embryos per transfer procedure using IBM SPSS Statistics version 23 (SPSS Inc, Chicago, IL). A P value of <.05 was used to indicate statistical significance. This study was declared exempt by the Northwestern University institutional review board.

Results

In 2018, 456 clinics reported data on 134,997 nondonor cycles to the CDC. Of these, 32,029 and 102,968 cycles were performed in states with and without comprehensive IVF mandates, respectively. Per the 2018 United States census estimates, 5,126,338 and 38,388,344 women aged 25 to 44 years lived in states with and without comprehensive mandates, respectively. Overall and age-stratified IVF utilization rates per 1000 women aged 25 to 44 years as a function of state mandate status are reported in Table 1 . IVF utilization in states with comprehensive IVF mandates was 132% compared with states without these mandates (6.23 vs 2.68 cycles per 1000 women; P <.001). Significantly increased IVF utilization was seen, regardless of age group, with the greatest increase in utilization seen among women aged 35 to 37 years and 38 to 40 years (249%) and the lowest seen among women aged >42 (164%).

Live birth and multiple birth rates are reported in Table 2 . Live births per cycle were significantly higher in comprehensive states than in noncomprehensive states (35.4% vs 33.4%; P <.001). After age stratification, this association remained significant among patients aged 35 to 37 years (39.7% vs 36.9%; P <.01), 41 to 42 years (11.9 vs 9.2%; P <.001), and >42 years (4.0% vs 2.2%; P <.001). Multiple births per live birth were significantly lower in the comprehensive states than in the noncomprehensive states (10.2% vs 13.8%; P <.001). This association remained significant among patients aged <35 years (10.2% vs 15.1%; P <.001) and 35 to 37 years (10.7 vs 13.0%; P <.001).

Table 2

Live birth and multiple birth rates according to category of state in vitro fertilization insurance mandate

Mandate group	Live birth rate (per cycle)
	Overall	Age <35 y	Age 35–37 y	Age 38–40 y	Age 41–42 y	Age >42 y
Comprehensive	35.4%	52.6%	39.7%	23.9%	11.9%	4.0%
Noncomprehensive	33.4%	51.7%	36.9%	22.5%	9.2%	2.2%
P value	<.001	.08	<.01	.054	<.001	<.001
Multiple birth rate (per live birth)
Comprehensive	10.2%	10.2%	10.7%	10.3%	7.0%	7.1%
Noncomprehensive	13.8%	15.1%	13.0%	11.1%	10.5%	4.8%
P value	<.001	<.001	<.001	.35	.04	.43

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