Comparative analysis of infertility healthcare utilization before and after insurance coverage of assisted reproductive technology: A cross-sectional study using National Patient Sample data.

Infertility refers to the inability to conceive within one year of normal, unprotected sexual intercourse [ 1 ]. While infertility and subfertility are generally viewed as interchangeable, infertility is used primarily in the assessment and diagnosis of disease. Moreover, a diagnosis of infertility does not refer to “sterility,” a state of permanent infertility. The term “infertility” is used throughout the manuscript [ 2 ]. The causes of infertility in women include ovulatory dysfunction; fallopian tube disorders; and uterine-related factors, such as endometriosis, uterine fibroids, and congenital uterine abnormality [ 3 ]. Ovulatory dysfunctions, such as anovulation and oligo-ovulation, account for 21% of all causes of female infertility [ 4 ]. The causes of male infertility can be divided into four broad categories: spermatogenic failure, sperm transport issues, systemic or endocrine disorder leading to hypogonadism, and idiopathic male infertility [ 5 ]. Approximately 30–40% of infertility cases are of unknown cause, in which abnormalities cannot be detected by standard tests such as hysterosalpingography and semen testing [ 6 ]. A woman’s age, the duration of infertility, and the number of previous treatment sessions must be accounted for in infertility care, along with the primary cause of infertility. Ovulatory dysfunctions caused by hypogonadism are treated with gonadotropins. Ovulatory dysfunctions caused by polycystic ovary syndrome can be treated with weight loss and combination therapy of medications using the anti-estrogen drug clomiphene with insulin-sensitive agonist metformin or with assisted reproductive technology (ART). It may be possible to treat a uterine structural problem with surgical correction [ 7 ], but in vitro fertilization (IVF) should be considered if there is a fallopian tube problem [ 3 ]. In males, primary testicular failure, including oligozoospermia, is the most common cause of infertility, but there is no established treatment [ 8 ]; in such cases, artificial insemination or IVF can be considered [ 9 ]. For sperm transport issues such as obstructive azoospermia, epididymal obstruction can be corrected surgically [ 10 ]; hypogonadism can be treated by injecting gonadotropin [ 11 ]. For infertility of unknown cause, the recommendation to patients is to try conceiving naturally for two years before attempting IVF and embryo transfer [ 12 , 13 ]. The prevalence of infertility is approximately 8–12% in couples of childbearing age worldwide [ 3 ]. According to the Centers for Disease Control and Prevention in the United States, approximately 6.7% of married women of childbearing age (15–49 years) were diagnosed with infertility [ 14 ]. In South Korea, the number of individuals diagnosed with infertility has risen consistently over the years, from 120,000 in 2004 to 220,000 in 2017 [ 15 ]. Total insurance payments for infertility care in South Korea rose steadily from 19.9 billion Korean won (KRW) in 2010 to 33.2 billion KRW in 2017. After expansion of insurance coverage to ART, total insurance payments rose by approximately 3.75 times over a year to 124.6 billion KRW in 2018 [ 16 ]. South Korea was ranked as having the lowest total fertility rate (TFR; 0.81) among Organization for Economic Co-operation and Development countries in 2021 [ 17 ]. The fertility rate is declining owing to increased later marriages and infertility prevalence, contributing to the population decline. In recognition of the elevated prevalence of infertility and the gravity of the associated financial burden, the South Korean government began to provide insurance coverage for infertility diagnostic care and testing in 2001. ART was not covered by health insurance at that time, as it was not perceived as life-affecting treatment. However, the government implemented policies and support projects over time to alleviate the financial burden of infertile individuals to increase their access to ART. In 2006, the South Korean government launched the “infertility support project” to provide financial assistance for IVF; a project to provide financial assistance for artificial insemination has been in existence since 2010. In Korean medicine (KM), the number of local governments participating in the KM treatment support project has been increasing continuously. In October 2017, ART was included in health insurance coverage; women aged 44 years and younger are provided insurance coverage for four rounds of fresh embryo transfer and three rounds of frozen embryo transfer as part of IVF treatment, as well as up to three rounds of artificial insemination. Insurance coverage of infertility-related medical services can impact both healthcare utilization by consumers and health outcomes, including childbirth [ 18 ]. In Taiwan, the government provided financial assistance for ART for the first time in 2007 with the enactment of the Artificial Reproduction Act. A study analyzed the effect of that health policy, finding a 157.8% relative increase in ART treatment frequency three years after the enactment and a 78.51% relative increase in the number of births by ART five years after the enactment [ 19 ]. In Germany, ART had been fully covered by the statutory health insurance until December 31, 2003, but only 50% of the cost was covered after that date; since then, the frequency of infertility treatment dropped by 55%, and childbirth by ART dropped by 51% in 2005 compared to 2002 [ 20 ]. In South Korea, a 2009 study analyzed the frequency of ART procedures [ 21 ]. Another study assessed childbirth after a diagnosis of infertility and the socioeconomic characteristics of infertile patients using Health Insurance Review and Assessment Service-National Patient Sample (HIRA-NPS) data from 2005–2013 [ 22 ]. However, none of these studies performed a comprehensive review of changes in healthcare utilization for infertility in both Western medicine (WM) and KM since the inclusion of ART in health insurance coverage in South Korea. Changes in clinical practice since the inclusion of ART in the health insurance payment system in South Korea in 2017 should be examined through a review of data related to infertility medical practices, medications, and cost of care by service category. In addition, the financial and social burden of infertility before and after health insurance coverage, including total cost of care and out-of-pocket (OOP) cost, should be assessed. This study analyzed the clinical practice and cost of care for patients who utilized healthcare for infertility treatment in 2016 and 2018—before and after health insurance coverage included ART, respectively—using HIRA-NPS data. The study’s goal was to find out the effect of the national health policy and provide information for establishing infertility-supportive policies and decision-making on insurance coverage of ART.

A total of 68,091 claims with female infertility (N97) or male infertility (N46) as the primary diagnosis were submitted in 2016 and 2018. After excluding two cases with a medical institution coded as psychiatric nursing hospital, dental hospital, maternity center, or public health facility; 60 cases with total cost or number of visits recorded as 0 or missing; and 9,528 cases of patients under the age of 30 years, 58,501 cases for 11,951 patients were analyzed ( Fig 1 ). HIRA—NPS = Health Insurance Review Assessment—National Patient Sample; KCD = Korean Standard Classification of Diseases; KM = Korean medicine. In both 2016 and 2018, healthcare utilization for infertility tended to decline with advancing age. However, compared to 2016, in 2018 the percentage of patients aged 30–34 years declined, while the percentages in other age groups increased. Among women, the 30–34 years group was significantly the largest patient group in 2016, but the gap between the 30–34 years and the 35–39 years groups narrowed substantially in 2018. Among men, the 30–34 years group was the largest patient group in 2016, but the 35–39 years group was the largest in 2018. The percentage of women was notably higher than men in both 2016 and 2018. However, while the number of female patients decreased slightly, the number of male patients increased considerably, resulting in an increased percentage of male patients in the infertility patient population. The NHIS was the payer in most cases in 2016 and 2018 ( Table 1 ). NHI: National Health Insurance; a Veteran health service = 1 case Regarding the number of claims, most patients who presented to a healthcare facility with infertility in both 2016 and 2018 utilized outpatient services, with only a small percentage of patients receiving inpatient services. The most frequently visited medical institution was a clinic; the percentage of patients utilizing a clinic increased slightly in 2018 compared to 2016. Visit type trends were similar across sex and total study sample. While healthcare facility utilization trends were nearly identical between the female sample and the total sample, male patients barely visited a KM clinic ( Table 2 ). a KM = Korean medicine. In 2016, the most common comorbidities of infertility in women were gastritis and duodenitis, followed by gingivitis and periodontal disease, acute bronchitis, and vasomotor and allergic rhinitis. In 2018, the most common comorbidities were gastritis and duodenitis, followed by gingivitis and periodontal disease, childbirth management, and vasomotor and allergic rhinitis ( S3 Table ). In men, in 2016 the most common comorbidities of infertility were gastritis and duodenitis, followed by gingivitis and periodontal disease, acute bronchitis and vasomotor and allergic rhinitis. In 2018, the most common comorbidities of infertility in men were gastritis and duodenitis, followed by gingivitis and periodontal disease, childbirth management, and vasomotor and allergic rhinitis ( S4 Table ). In both men and women in 2016 and 2018, gastritis and duodenitis were the most common comorbidities of infertility, followed by gingivitis and periodontal disease, ranked second, and vasomotor and allergic rhinitis, ranked fourth. The third-most common comorbidity of infertility was acute bronchitis in 2016, but the third-most common comorbidity was childbirth management in 2018 among both men and women. Acute bronchitis did not appear in the top 20 comorbidities of infertility in 2018; childbirth management entered the top 20 comorbidities in both men and women in 2016. Regarding the number of claims, most patients who presented to a healthcare facility with infertility in both 2016 and 2018 utilized outpatient services, with only a small percentage of patients receiving inpatient services. The most frequently visited medical institution was a clinic; the percentage of patients utilizing a clinic increased slightly in 2018 compared to 2016. Visit type trends were similar across sex and total study sample. While healthcare facility utilization trends were nearly identical between the female sample and the total sample ( Table 2 ). The number of infertility treatment cases rose by 1.4 times. Total cost of care rose by 4.8 times and per-patient expense rose by 4.5 times. Average visits per patient increased by about 1 day. The average visits per patient gap between the sexes widened from 3.7 days to 5.9 days ( Table 3 ). All expenses were converted with an annual average exchange rate (KRW/USD, see S3 Table ); Total visits = number of days in outpatient or inpatient care; Average visits = annual average number of days in outpatient or inpatient care The number of cases and the costs for services claimed for infertility in 2016 and 2018 were analyzed for the following services: injection, examination, test, medication/drug-related, treatment and surgery, special equipment and diagnostic radiology, KM acupuncture and electroacupuncture, and KM other. In 2016 and 2018, the three most frequently claimed service codes for both female and male patients were examinations, tests, and injections, and the least frequent service code, treatment and surgery, rose markedly (Tables 4 and 5 ). The number of cases rose in all service categories, including KM-related services, although KM healthcare facilities have relatively decreased in the proportion of medical institution utilization. All expenses were converted with annual average exchange rate (KRW/USD), see S2 Table ; a KM = Korean medicine. All expenses were converted with annual average exchange rate (KRW/USD, see S2 Table ). Among women, in 2016, examinations were the highest in the cost per service code, followed by tests, special equipment and diagnostic radiology, KM acupuncture and electroacupuncture, and injections. In 2018, treatment and surgery ranked the highest in the cost per service code, followed by examinations, special equipment and diagnostic radiology, tests, and injections. The cost for treatment and surgery rose dramatically, becoming the service code with the highest total cost and annual per-patient cost in 2018 ( Table 4 ). Among men, in 2016, tests were the highest in the cost per service code, followed by examinations and injections. In 2018, treatment and surgery ranked the highest in the cost per service code, followed by tests, examinations, and injections. There were zero claims submitted for treatment and surgery in 2016, but this service code incurred the highest total cost and annual per-patient cost in 2018. Other service codes, including medication/drug-related, special equipment and diagnostic radiology, KM acupuncture and electroacupuncture, and KM other, did not account for 0.1% of all infertility-related claims in men ( Table 5 ). High-frequency drug usage (≥ 0.1% of all prescriptions for infertility) and the associated costs were analyzed for the total sample, including both female and male patients. In 2016, ovulation stimulants were the most frequently prescribed, followed by gonadotropins and systemic antibacterials. In 2018, gonadotropins were the most frequently prescribed, followed by systemic antibacterials and ovulation stimulants. In 2016, the total cost for gonadotropins was highest, followed by contrast media and systemic antibacterials. In 2018, the total cost for gonadotropins was highest, followed by systemic hormones and endocrine therapy. Gonadotropins incurred the highest annual per-case and per-patient cost in both 2016 and 2018 ( Table 6 ). Analyzed by sex (only for drugs representing ≥ 0.1% of all prescriptions for infertility for each sex), this overall trend of drug usage in total study samples was nearly identical among women ( S5 Table ). In men, systemic antibacterials were the most frequently prescribed drugs and incurred the highest total annual cost in both 2016 and 2018. However, the number of prescriptions of gonadotropins rose markedly and incurred the highest per-patient cost in 2018 ( S6 Table ). All expenses were converted with annual average exchange rate (KRW/USD, see S2 Table ).

As no previous study investigated infertility healthcare utilization changes since the launch of health insurance coverage of ART, this study is significant in revealing the effects of national health policies on the management, treatment, and cost of care of infertility. The percentage of patients aged 35 years or older and the proportion of male patients utilizing infertility healthcare increased. It was confirmed that the total cost of care for infertility increased substantially, and the number of medical procedures and the use of medications related to ART increased markedly. These findings could also be used for decision-making on insurance coverage of ART outside of South Korea. Subsequent studies should analyze the evolving health policies and healthcare utilization trends for infertility in the longer term, including childbirth outcomes, to assess the effectiveness of these policies.

This cross-sectional study used HIRA-NPS data from 2016 and 2018. The HIRA-NPS data contain claims data generated during the process of reimbursing healthcare providers under the National Health Insurance System (NHIS). The HIRA-NPS data are sampled annually by stratifying a random 3% sample (about 1.4 million people) of the entire population of South Korea (individuals registered with NHI or Medical Aid) by sex and age. This is secondary data statistically sampled from the raw data after the removal of personal and legal-entity-related data [ 23 ]. The datasets can be accessed upon request and review to HIRA( https://opendata.hira.or.kr/ ). The results from this study can be replicated by following the protocol in our Methods section. The authors confirm that no privileges of any kind were granted before, during, or after the analysis. Patients who received WM or KM services with International Classification of Diseases 10th revision (ICD-10) code N97 (female infertility) or N46 (male infertility) at least once in 2016 or 2018 were included in the study. The identified patients’ reimbursement claims data with N97 or N46 as the primary diagnosis were collected for the data analysis. Exclusion criteria were data from patients with claims indicating psychiatric nursing hospital, dental hospital, maternity center, or public health facility as the type of medical institution; patients with claims in which the total cost or number of visits was 0 or missing; and patients younger than 30 years. The frequency and percentage of age, sex, payer type, type of visit, and medical institution for patients with infertility were analyzed for the years 2016 and 2018. Age was divided into four groups of five years over the range of 30 to 45 years or older; payer type was divided into NHI, Medicaid, and other. The age criterion was set considering that the use of ART markedly increases over age 30 [ 21 ] and that the age of patients who use ART is rising gradually [ 24 , 25 ]. Type of visit was classified as outpatient or inpatient, and medical institution was classified as tertiary/secondary/primary hospital, clinic, KM hospital, or KM clinic. Total patients, total cases, total expenses, per-patient expenses, per-case expenses, total visits, and average visits per patient with infertility as the primary diagnosis were analyzed for the entire sample and by sex for the years 2016 and 2018. High-frequency (top 20) comorbidities, excluding infertility, with reference to the Korean Standard Classification of Diseases (KCD) were analyzed for both sexes. KCD coding is the Korean standard disease classification system for high-frequency diseases in Korea. It was developed based on the International Classification of Diseases published by the World Health Organization. Service codes for infertility care (limited to codes that accounted for more than 0.1% of the total cases) were classified for both sexes. Total cases, total patients, total costs, annual cost per case, and annual cost per patient were analyzed by service code. Total cost was defined as the sum of the NHIS payment to providers and patients’ OOP cost: the allowable amount from the total amount claimed. After classifying medications prescribed to treat infertility by pharmacies and hospitals into 15 categories according to the Anatomical Therapeutic Chemical Classification System (ATC code), the frequency and cost of prescriptions of each category were compared between 2016 and 2018. Classification of medication is presented in S1 Table . All costs in this study were converted to the 2018 average South Korean won to US dollar exchange rate and corrected to reflect the consumer price index in the health sector ( S2 Table ). Data were analyzed using SAS 9.4 software (2002–2012 by SAS Institute Inc., Cary, NC, USA). The study’s protocol was approved by the public data provision deliberation committee of the HIRA and was performed in accordance with relevant guidelines and regulations. The current study was reviewed and qualified with an exemption by the Institutional Review Board of Jaseng Hospital of Korean Medicine, Seoul, Korea (JASENG 2021-10-021). As this study analyzed publicly available data, no consent was obtained from participants; all personal information was de-identified by the NHIS prior to public release. The principles expressed in the Declaration of Helsinki were adhered to in the study’s analysis.

(DOCX) Click here for additional data file. This information is available on the following website: Korean Statistical Information Service ( http://kosis.kr ); The price index represents the relative price level of cost adjusted as of 2018. (DOCX) Click here for additional data file. KCD: Korean Standard Classification of Diseases. (DOCX) Click here for additional data file. KCD: Korean Standard Classification of Diseases. (DOCX) Click here for additional data file. (DOCX) Click here for additional data file. (DOCX) Click here for additional data file. (DOC) Click here for additional data file.