Although infertility is now recognized as a disease by multiple organizations including the World Health Organization and the American Medical Association, private insurance companies rarely include coverage for infertility treatments. In this review, the authors assess the current state of care delivery for male infertility care in the United States. They discuss the scope of male infertility as well as the unique burdens it places on patients and review emerging market forces that could affect the future of care delivery for male infertility.
Key points
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Although infertility is considered a disease and male factor infertility contributes to almost half of infertile couples, it is frequently not covered by insurance.
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States are increasingly passing state-level mandates to include coverage for fertility evaluation and treatment, and about half of these mandates include mention of male factor infertility in some form.
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Employers are increasingly electing to include fertility coverage to improve employee wellness and satisfaction.
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Venture capital firms are investing in fertility startups and clinics, including a growing number of companies focused on male infertility products.
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Reproductive health clinics should include initial evaluation of male and female partners to deliver the most effective and cost-efficient care.
Introduction
Infertility is defined as failure to conceive a pregnancy after 12 or more months of regular, unprotected intercourse or therapeutic donor insemination. According to the American Society for Reproductive Medicine (ASRM), 8% to 15% of couples are unable to conceive during this period, and male factor is solely responsible in about 20% of these couples and contributes in an additional 30% to 40% of couples with infertility. Although the ASRM, The National Institute for Healthcare and Care Excellence, and Centers for Disease Control and Prevention all recommend that both partners in a couple diagnosed with infertility should receive an evaluation, one survey from the National Survey of Family Growth indicates that male partners do not receive an evaluation in 18% to 27% of cases. Indeed, although 17% of women aged 25 to 44 years reported ever using infertility services, only 9% of men in the same age range reported ever doing so.
There are numerous potential reasons for this discrepancy, including social and cultural expectations and lack of insurance coverage for evaluation and treatment of male factor infertility. Infertility has been officially classified as a disease by numerous organizations, including the World Health Organization and the American Medical Association. , However, many insurance plans in the United States do not cover diagnostic testing or treatment of infertility and instead require patients to pay out of pocket for evaluation and care, even if they have coverage for other diseases and health conditions. This lack of coverage can affect patient’s health as well as place significant financial burden on patients and their families.
In this review, the authors assess the current state of care delivery for male infertility care in the United States. They begin by examining the scope of male infertility as well as the unique burdens it places on patients. The authors then examine the importance of insurance coverage for male infertility care and current and proposed legislation relevant to male infertility. Next, they discuss the costs associated with male infertility care review increasing public awareness of male factor infertility and increasing market demand for services and coverage of infertility care broadly as well as specifically for men. Finally, this article is concluded with a discussion of potential systems-level innovations to policy, reimbursement, and practice structure to improve male infertility treatment delivery.
Scope of male infertility and importance of male infertility evaluations and treatments
Scope of Male Infertility
Male factor infertility contributes to 40% to 50% of overall infertility and affects approximately 7% of all men. Despite this, 18% to 27% of infertile couples report that the male partner did not receive evaluation or treatment. Given the large scope and potential impact of male infertility, it is important to consider why so few men get evaluated and the possible risks associated with this lack of care.
Importance of Male Fertility Evaluations
Evaluation of male infertility can benefit an infertile couple in 3 main ways. First, evaluation can identify and correct reversible causes of male infertility, such as varicoceles or hormone imbalances; second, it may identify irreversible conditions that may be amenable to assisted reproductive techniques and technologies, such as iatrogenic low sperm counts; third, it may identify irreversible conditions from which a male patient’s sperm is not obtainable, such as certain Y chromosome microdeletions and therefore guide future reproductive decisions.
When men are not evaluated or treated for infertility, the burden of evaluation and treatment falls on the female partner. Treatments for male infertility, such as varicocelectomy, can down-stage the level of treatment and intervention necessary for couples to achieve pregnancy; as one study of 540 couples demonstrated, about 50% (271 patients) achieved a greater than 50% increase in total motile sperm count after varicocelectomy and 36.6% achieved pregnancy with a mean time to conception of 7 months, thus potentially decreasing the level of additional treatments or technology needed to bypass male factor infertility.
Health Risks Associated with Male Infertility
In addition to placing the infertility burden on women, men not receiving male infertility evaluations may increase the risk that other serious medical diseases may be missed. Male infertility has been associated with a variety of significant health conditions, and evaluation and diagnostic testing can identify underlying pathology contributing to infertility and other potential health concerns. In one review of 536 male infertility evaluations, 6% of patients were found to have significant medical pathology, including 24 with cystic fibrosis mutations and other patients with karyotypic abnormalities, testis and prostate cancer, diabetes mellitus, and hypothyroidism. Missing these diagnoses in male patients increases the risk that some of these genetic conditions may be passed on to offspring.
Furthermore, recent studies suggest that male infertility may be associated with increased future health risks, as summarized in Fig. 1 . Male infertility has been associated with an increased risk of cardiovascular disease, increased risk of developing germ cell testicular cancer, increased risk of developing high-grade prostate cancer, and overall increased mortality. In one study of 2238 infertile men in Texas, patients diagnosed with azoospermia were overall 1.7 times more likely to develop cancer than the general population and 2.9 times more likely than other men evaluated for infertility. Another recent retrospective review compared 76,343 men diagnosed with male factor infertility with a control group of 183,742 men who underwent vasectomy using Optum claims data from 2003 to 2016; this study found that infertile men had a higher risk of incidental hypertension, diabetes, hyperlipidemia, and heart disease when compared with those undergoing vasectomy regardless of education, socioeconomic status, race, and geographic location. These studies suggest that infertility and semen quality may be a marker of overall health and that there may be a biological etiology to the relationship between fertility and future health, especially cardiometabolic health.
In addition to a direct impact on the patient’s health, diagnosis of infertility has significant impact on quality of life. Couples are more likely to experience stress and marital discord; male partners in particular are more likely to report depression, erectile dysfunction, and sexual relationship problems. In one study of 149 female patients undergoing treatment of infertility, global symptom scores, as measured by the Symptom Checklist-90, were equivalent to patients with cancer and in treatment of cardiac rehabilitation. Indeed, multiple studies have demonstrated that psychological burden is one of the primary reasons that patients drop out of treatment of infertility.
Insurance coverage for infertility care
Federal Coverage
The 2010 Patient Protection and Affordable Care Act (PPACA) remains the most recent large federal law to mandate insurance policies. Unfortunately, PPACA does not include infertility care in its list of essential health benefits and does not comment on whether insurance policies should cover infertility care, therefore leaving coverage to the discretion of private insurers and individual states. Patients who are covered by federal insurance do not receive coverage for infertility evaluation or treatments. There have been 2 recent federal bills, HR 5965 and S 2960, both titled Access to Infertility Treatment and Care Act and introduced on May 24, 2018, which would have required health insurance coverage for the treatment of infertility; neither bill was passed by the House of Representatives or the Senate, respectively.
Federal legislation has also been introduced for increased infertility care, through fertility preservation, in the Department of Defense. A 2018 survey of 799 service women found that more than 30% of military women reported problems achieving pregnancy, significantly higher than the national average; the survey participants were broken into 4 categories, with the highest percentage of reported challenges (37%) in currently serving service women. A similar 2014 study of 16,056 male veterans found that the prevalence of lifetime infertility was about 14%, also significantly higher than the national average. As the percent of veterans involved in recent conflicts is projected to increase from 30% in 2013 to 45% in 2023, this suggests that a younger patient population with increased prevalence of infertility will have increased need for fertility treatment. As a result, Senate Bill 319, the Women Veterans and Families Health Services Act of 2019, was introduced in February 2019 and “would require the DoD to provide troops the option to freeze their eggs and sperm prior to deployment to a combat zone and store the specimens up to a year after leaving military service… [and] would require the Pentagon to establish a policy for retrieving eggs or sperm from seriously injured service members whose fertility or lives are at risk as a result of a wound or illness.” This legislation, although unlikely at the time of writing to be passed, speaks to an increased awareness of infertility on a federal level.
State Coverage
Because the future direction of federal coverage remains unclear due to ongoing judicial challenges to the PPACA, the authors also focus on state and private insurance coverage for male infertility. At the state level, 17 legislatures have passed laws mandating the inclusion of some sort of coverage for infertility evaluations and/or treatments with various exceptions, including employer size, religious status, and type of insurance plan. These variations by state are summarized in Table 1 . Of these 17 states, only 9 included any discussion of evaluation or treatment of male infertility. Recently, Delaware enacted legislation in June 2018 that mandates insurance coverage for infertility treatments including in vitro fertilization (IVF) as well as male-specific treatments such as cryopreservation and thawing of sperm, cryopreservation of testicular tissue, intracytoplasmic sperm injections, and microsurgical sperm aspiration. It included exceptions for vasectomy reversals, religious organizations, and employers with fewer than 50 employees. These exclusions include self-employed and self-insured parties, such as large health care institutions. On January 1, 2020, New Hampshire legislation will go into effect that mandates coverage for diagnosis; “medically necessary” fertility treatment; and fertility preservation for patients undergoing surgery, chemo, radiation, or other medical treatments with a risk of impaired fertility. It specifies male factor as a cause of infertility, specifically azoospermia, but does not define male factor infertility evaluation or treatments. The New Hampshire coverage does not extend to the Small Business Health Options Program (coverage option for businesses with fewer than 50 employees).
| State | Male Factor Evaluation and Treatment Coverage Included in Law | Restrictions | Law/Code | Year(s) Enacted |
|---|---|---|---|---|
| AR | None | – | Ark. State. Ann. § 23-85-137, § 23-86-118 | 1987, 2011 |
| CA | Diagnosis and treatment (medication and surgery) of conditions causing infertility must be offered to employers | – | Cal. Health & Safety Code §1374.55, Cal. Insurance Code §10119.6 | 1989 |
| CT | Diagnosis and treatment of individuals unable to “produce conception” | – | Conn. Gen. Stat. §38a-509, §38a-536 | 1989, 2005 |
| DE | Cryopreservation of sperm and testicular tissue, storage of sperm, surgery including microsurgical sperm aspiration | Correction of elective sterilization, experimental procedures a , religious organizations | Delaware Insurance Code Title 18, § 3342, § 3556 | 2018 |
| HI | None | – | Hawaii Rev. Stat. §431:10A-116.5, §432.1-604 | 1989, 2003 |
| IL | None | – | Ill. Rev. Stat. ch. 215, §5/356m | 1991, 1996 |
| LA | None | – | La. Rev. Stat. Ann. §22:1036 | 2001 |
| MD | None | – | Md. Insurance Code Ann. §15-810, Md. Health General Code Ann. §19-701 | 2000 |
| MA | Diagnosis and treatment of infertility, including sperm procurement, processing, and banking | Correction of elective sterilization; experimental procedures a | Mass. Gen. Laws Ann. Ch. 175, §47H, ch. 176A, §8K, ch. 176B, §4J, ch. 176G, §4; 211 Code of Massachusetts Regulations 37.00 | 1987, 2010 |
| MT | Undefined “infertility services” as a basic health care service | Only mandated for Health Maintenance Organizations (HMOs) | Mont. Code Ann. §33-22-1521, §33-31-102[2] (v), et seq. | 1987 |
| NH | “Medically necessary fertility treatment,” procurement and cryopreservation of sperm | Correction of elective sterilization, experimental procedures a , small businesses | 2020 NH RSA CHAPTER 417-G | 2020 |
| NJ | Diagnosis and treatment of infertility | Correction of elective sterilization; cryopreservation; experimental procedures a | N.J. Stat. Ann. §17:48A-7w, §17:48E-35.22, §17B:27-46.1x | 2001 |
| NY | Semen analysis; testis biopsy; correction of malformation, disease, or dysfunction resulting in infertility; fertility preservation medical treatments for people facing iatrogenic infertility caused by medical intervention; infertility drug coverage; prohibition of discrimination based on age, sex, sexual orientation, marital status, or gender identity | Correction of elective sterilizations; sex change procedure; cloning experimental medical or surgical procedures a ; employers who self-insure are exempt | NY S.B. 6257 -B/A.B. 9759-B, N.Y. Insurance Law §3216 [13], §3221 [6] and §4303, FY 2020 New York State Budget | 1990, 2002, 2011, 2020 |
| OH | Diagnostic and exploratory procedures for testicular failure | Only mandated for HMOs | Ohio Rev. Code Ann §1751.01 (A) [7] | 1991 |
| RI | None | – | R.I. Gen. Laws §27-18-30, §27-19-23, §27-20-20 and §27-41-33 | 1989, 2007 |
| TX | None | – | Tex. Insurance Code Ann. §1366.001 et seq. | 1987, 2003 |
| WV | Undefined “infertility services” as a basic health care service | Only mandated for HMOs | W. Va. Code §33-25A-2 | 1995 |
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