R e p ro d u c t i v e H e a l t h C a re Deliver y Mark C. Lindgren, MD, Lawrence S. Ross, MD* KEYWORDS  Reproductive health  Health care  Insurance  Delivery

KEY POINTS  Most patients in the United States with reproductive health disorders are not covered by their health insurance for these problems.  Health insurance plans consider reproductive care as a lifestyle choice, not as a disease.  If coverage is provided it is, most often, directed to female factor infertility and advanced reproductive techniques, ignoring male factor reproductive disorders.  This article reviews the history of reproductive health care delivery and its present state, and considers its possible future direction.

With the passage of the Affordable Care Act (ACA) and the affirmative ruling on it by the Supreme Court, the United States is undergoing a major change in health care delivery.1 This process is likely to evolve over several years and will lead to substantive changes in reimbursement models for health care providers and patients. The ACA includes a variety of concepts and buzzwords such as global payments and accountable care organizations, and suggests the end of fee-for-service medicine. What the final product will look like is not clear, but as health care costs continue to escalate at unsustainable rates it is inevitable that significant changes lie ahead. Over the past 35 years important scientific advances have occurred in the understanding and treatment of reproductive disorders. The delivery of, and access to, reproductive health care has remained largely outside the models for most other diseases, in large measure because of the failure of federal and third-party health insurers to recognize infertility as a disease, instead characterizing

reproduction as a lifestyle choice. In 2008, the American Society of Reproductive Medicine (ASRM) Practice Committee published its definition of infertility as a disease in its journal Fertility and Sterility.2 This article reviews the present state of the extant models for reproductive health care delivery, the expanding recognition of infertility as a product of common global health concerns, and the disparities in access to and reimbursement for reproductive health care.

WHAT CONSTITUTES REPRODUCTIVE HEALTH CARE? The traditional concept of reproductive health focused on the female and included diagnosis of pregnancy, checkups throughout pregnancy, and a safe delivery for both mother and baby. Female reproductive health extends back to antiquity with professional midwives assisting deliveries in ancient Greece and Egypt.3 In modern times, many women seek medical care before becoming pregnant, either for concerns related to fertility or

Disclosures: None. Department of Urology, University of Illinois at Chicago, 820 South Wood Street, Chicago, IL 60612, USA * Corresponding author. E-mail address: [email protected] Urol Clin N Am 41 (2014) 205–211 http://dx.doi.org/10.1016/j.ucl.2013.08.011 0094-0143/14/$ – see front matter Ó 2014 Elsevier Inc. All rights reserved.




Lindgren & Ross simply to optimize their health before the stresses of pregnancy. This optimization could include addressing a variety of diseases, not only those that directly affect the reproductive tract but also diseases that indirectly affect a woman’s ability to either become pregnant or to have a safe pregnancy. All of these aspects of health care are included in the concept of reproductive health. In addition, sexual health for women of reproductive age, which includes sexual dysfunction, sexually transmitted diseases (STDs), and prevention of pregnancy, are an integral part of reproductive health. Obstetrician-gynecologists (Ob/Gyns) in the United States diagnose and treat such a broad spectrum of illnesses outside the reproductive tract that traditional primary-care concerns have become a part of Ob/Gyn training and board exams. More than one-third of a private Ob/Gyn’s nonpregnant, reproductive-aged patients use their Ob/Gyn as their primary care physician.4 Not all health concerns of these patients are included under the title of reproductive health, but the concept of reproductive health in women, which dates back to ancient times, has broadened through the years. In men, reproductive health care is a more modern concept. The mature sperm cell was first discovered in 1677 by Leeuwenhoek in Holland, and, for centuries, the only science available in male reproductive health was the microscopic analysis of semen. Through time, semen analysis progressed from the simple identification of the presence of sperm to numerous quantifiable parameters (discussed elsewhere in this issue). The absence of sperm in the ejaculate is sometimes the desired result because sterilization is another aspect of male reproductive health. Vasectomy is a safe and effective form of contraception and the most commonly performed urologic surgical procedure in the United States.5,6 The first vasectomy was performed by Cooper in the United Kingdom in the 1820s on a dog. Although human vasectomies were performed shortly thereafter, it was not until the 1940s that the vasectomy gained widespread acceptance as a form of contraception.7 Of the approximately 500,000 vasectomies performed annually in the United States in modern times, up to 7% to 10% of these vasectomized men eventually seek reversal.6,8 Reconstruction of the male reproductive tract for obstructive azoospermia remains an important aspect of male reproductive health. Male reproductive health includes the other aspects of sexual health, namely STDs and sexual/erectile dysfunction (ED). Modern male reproductive health has expanded greatly as understanding of the many risk factors and concomitant disease states that

can affect a man’s ability to reproduce has grown through time.

CHANGES IN REPRODUCTIVE HEALTH CARE THROUGH TIME The first oral contraceptive pill (OCP) was approved by the US Food and Drug Administration for contraception in 1960, but had already been available since 1957 for menstrual disorders and an estimated half a million American women had already used it.9 Although more than a million women had used the pill by the following year, OCPs were not legally available in all states to married women until 1965, and to unmarried women in 1972 after those rights were decided on in the United States Supreme Court.10,11 The availability of OCPs allowed women to control their own fertility in a reliable manner and prevent or delay pregnancy as they saw fit. The ability of women to control their fertility was especially useful during a time when women were increasingly entering the professional world. Delay of childbirth became a more common practice that continues today as women choose to better establish their careers or increase their financial position before starting a family. The US Centers for Disease Control and Prevention report that the average age of first childbirth among women born in 1930 was 20.8 years, in 1960 it was 22.7 years, and today it is 25.4 years. The rate at which women are having their first child at more than the age of 30 years has increased from 9.7% in 1995 to 13.6% in 2006 to 2010, and the first child at more than the age of 35 years from 1.7% to 2.8%.12 This trend increases the need for reproductive health care as female fecundity decreases with age, particularly after 35 years of age.13 Another important change in reproductive health care has been the introduction of advanced reproductive technologies (ART) including in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). The first human birth via IVF occurred in 1978, for which Robert G. Edwards was awarded the Nobel Prize in Physiology or Medicine in 2010.14 IVF has allowed many couples with female and/or male factor infertility to successfully achieve pregnancy and birth, with more than 4 million babies to date worldwide.15 ICSI, first successfully performed in 1992,16 has further increased the ability for couples to achieve pregnancy despite the availability of few sperm obtained from retrieval techniques. Clinical pregnancy rates of more than 40% have been reported with ICSI, which has seen widespread use through the years.17

Reproductive Health Care Delivery MODELS OF REPRODUCTIVE HEALTH CARE DELIVERY Fee For Service The use of ART is expensive. The ASRM reports the average cost for a cycle of IVF in the United States is $12,400.18 The average cost per delivery using IVF in the United States is estimated to be more than $56,000.19 Although payment for care during pregnancy and delivery has traditionally been included in many forms of health care coverage, payment for ART and treatments related to infertility including procedures for men have largely been an out-of-pocket expense to the patient.20 Over time, third-party health insurance companies began to offer coverage for infertility services. Each insurer offers different packages of coverage to different groups or employers, which makes data gathering difficult. Many coverage packages offer infertility services as a separate option to the individual, and some more robust packages include these services to all with varying levels of copay.

State-mandated Coverage One of the significant changes that has occurred in reproductive health care reimbursement has been state-mandated insurance coverage of

infertility treatment. At the time of this writing, only 15 states have such laws and 3 of these only mandate that the specified insurers offer coverage as an option (Table 1).20 The scope of these laws and types of infertility treatments covered varies widely among these states, but is typically narrow in focus. These laws either mandate all insurers or some combination of insurers for groups, individuals, employers, and/or health maintenance organizations to include the specified coverage for infertility treatments. The mandated coverage varies from vague statements that infertility services should be offered to specific requirements such as Maryland’s mandate of up to 3 rounds of IVF per live birth with a lifetime maximum coverage of $100,000. Several states have restrictive limits, such as Hawaii, which mandates that 1 cycle of IVF must be covered, or Arkansas, which has a $15,000 lifetime maximum of coverage. Most of the states that do not have vague laws specifically mandate coverage for IVF and female-related diagnostic tests, procedures, and treatments with little or no mention regarding male factor infertility. Four states make mention of men by specifying that only the spouse’s sperm be used to fertilize the egg, thereby prohibiting the use of donor sperm. Only 7 states include language regarding male factor infertility. Many of

Table 1 State-mandated insurance coverage of infertility treatment


Required Coverage

Maximum Lifetime Coverage

Spouse’s Sperm Only

Male Factor Infertility or Treatment Mentioned





California Connecticut Hawaii

No Yes Yes

NA 2 cycles IVF 1 cycle IVF

No No Yes

Illinois Louisiana Maryland

Yes No Yes

6 cycles IVF NA $100,000

No No Yes

Massachusetts Montana New Jersey

Yes Yes Yes

No limit No limit 4 cycles IVF

No No No

New York Ohio Rhode Island Texas West Virginia

Yes Yes Yes No Yes

No limit IVF optional, no limit $100,000 NA No limit

No No No Yes No

Abnormal male factors contributing to infertility No No Abnormal male factors contributing to infertility No No Abnormal male factors contributing to infertility Sperm procurement and banking No Surgery, including microsurgical sperm aspiration Testis biopsy and semen analysis Testicular failure No No No

Abbreviation: NA, not applicable.



Lindgren & Ross the state laws have various restrictions including an upper limit for the female’s age (from 40– 46 years) and excluding those who had previously undergone voluntary sterilization. RESOLVE, the National Infertility Association, has developed a state fertility scorecard that ranks and grades the states based on the insurance mandates discussed earlier, legislation introduced in the past year, the number of fertility clinics per capita, and the number of their own RESOLVE support groups (see ref.21 for state fertility scorecard web address). These laws impose a minimum amount of coverage on the insurers that are specified, which can be exceeded if an employer or group negotiates more coverage in their contract.

Winfertility: A Private, Bundled Model A company started in 2000, Winfertility represents a new model of reproductive health care delivery. By partnering with reproductive endocrinology (RE) practices, laboratories, and medication suppliers across the United States, Winfertility is able to provide discounted infertility services. Each couple is evaluated and presented with a bundle of services depending on the diagnostic category into which the female partner is classified. The company is also able to incorporate any insurance benefits available to the couple, which provides them with a single, all-inclusive fee that may, for example, result in a cycle of IVF. At present, Winfertility has not partnered with any urology practices. When the male partner has an abnormal semen analysis and is referred for further evaluation and treatment, these costs, as well as subsequent diagnostic and/or surgical procedures required in the male, may be negotiated separately with the referring RE practice. For many couples that are either paying out of pocket or are faced with a significant copay for their infertility workup and treatment, this bundled approach offered by Winfertility can facilitate the process by providing discounted services.22

Reproductive Endocrinologist Group Risksharing Model Some groups of reproductive endocrinologists have developed various risk-sharing models to potentially give couples a more enticing option than simple fee-for-service payment. One such program guarantees either the live birth of a normal infant or a refund for the program fee of $25,000.23 Eligible women, 35 years of age or younger, were carefully selected with pre-IVF testing to mitigate the practice’s risk. The fee covers 1 cycle of IVF but does not cover the expensive folliclestimulating hormone medications. The patient will

pay a large amount if they have a successful live birth after a single cycle of IVF, but, as mentioned earlier, an average live birth can cost much more, because often multiple IVF cycles are required. Thus, this program may provide a financial incentive to certain couples. These types of programs have been criticized for subjecting patients to unnecessary pre-IVF testing and also for being exploitative and questionable on ethical grounds.24

Counsyl: Flat-rate Genetic Testing Another new service has recently become available that may lower the cost of genetic testing for infertile couples. The company, Counsyl, offers a comprehensive genetic screening test that includes more than 100 different potential inheritable conditions. Counsyl provides this test for a guaranteed $99 copay to any patient with insurance, regardless of the type of insurance. This single-price copay applies even if the test is denied reimbursement as long as the patient has insurance. Counsyl is basing this service on a shared-risk model with the assumption that the test will be reimbursed often enough to remain profitable. This approach to screening for numerous conditions is arguably too broad and may cause needless worry among patients. However, for couples with insurance and $198, this testing may provide either piece of mind or the opportunity to undergo genetic counseling and weigh their options if they both test positive as carriers of a potentially severe condition. The testing includes 100 common cystic fibrosis transmembrane conductance regulator mutations, which are commonly tested for among urologists treating men with congenital bilateral absence of the vas deferens.25

Federal Title X The federal government enacted the Title X Family Planning Program in 1970 as a federal grant program devoted to family planning and related preventative health services that prioritized the needs of uninsured or low-income individuals, including those not eligible for Medicaid. The services provided at reduced or no cost include access to contraceptive services, supplies, and information and assistance in determining the number and spacing of children for both positive birth outcomes and healthy families. Title X provides federal funding for approximately 4400 community-based clinics (as of 2011) with at least one clinic in 72% of US counties.26 In addition to contraceptive services and counseling, these clinics provide related preventative health services such as breast and cervical cancer screening and

Reproductive Health Care Delivery STD and HIV education, testing, and referral. The diagnosis and treatment of infertility has not been a part of the services covered by Title X funding, but recent discussion within the program has raised the question of whether infertility care, male and female, should be a part of the care provided at Title X clinics.

Federal/State: Medicaid Medicaid is a state-administered program to provide medical care for US citizens and their families with low incomes and certain disabilities. Medicaid is supported by both federal and state funding. Much like Title X, Medicaid provides coverage for family planning services including contraception and STD testing and treatment, and preventive services such as breast and cervical cancer screening. However, being a state-administered program, there is heterogeneity regarding the various services offered. Regarding permanent contraception, only 13 states cover tubal ligation and only 10 states cover vasectomies. Two states provide Medicaid coverage for vasectomy reversal. Infertility services in general are rarely covered by Medicaid, with only 3 states providing limited coverage of testing and rare coverage of infertility treatment.27

Military Personnel and Tricare Active duty military obtain their health care via the federally funded and administrated Military Health System. Spouses and dependents are similarly covered under the Tricare program. Diagnostic services regarding infertility are covered for both men and women under these plans. Although the plans state that infertility treatments and corrective surgeries are covered, there are some notable exceptions to this statement. IVF and intrauterine insemination (IUI) are not covered, but hormonal treatments are covered. Although not covered, IVF and IUI may be performed at a Military Treatment Facility, which offers discounted rates over the open market. Surgical procedures for male factor infertility are not explicitly covered, but are evaluated on a case-by-case basis and may be approved for cost sharing between the patient and the government. In addition, some infertility clinics offer discounted services to active duty military personnel.

Veterans Health Administration Infertility treatment options have traditionally been limited for US veterans as well, but this may be changing. In December 2012, the Murray Bill passed the Senate and would have lifted the ban on ART in Veterans Administration hospitals

specifically for veterans who had injuries that would have made conceiving children impossible without medical assistance such as sperm retrieval. The bill failed to reach the president’s desk, reportedly because of the manner in which the bill would be funded. Regardless, a new bill has been proposed, the Women Veterans and Other Health Care Improvements Act of 2013, which also has the same provision for ART for wounded veterans.28 Even with the restriction of ART, veterans are provided with otherwise comprehensive reproductive health care, which includes both medical and surgical contraception (male and female), all aspects of sexual health, IUI, varicocelectomy, and even vasectomy reversal at certain medical centers.

SHOULD REPRODUCTIVE HEALTH CARE BE COVERED? At the heart of the discussion regarding reproductive health care delivery is the larger philosophic question: should reproductive health care be covered? Or more to the point: should infertility services be covered by public funds or group insurance policies? It is hard to imagine people arguing against coverage for prenatal care or delivery. Coverage for the diagnosis and treatment of STDs is similarly universal and regarded as a public health matter. Contraception and surgical sterility are more controversial because they are forbidden in certain religions. However, infertility seems to be the most divisive aspect of reproductive health in that it is the least frequently covered condition. Those arguing against sharing in the expense for infertility treatment via tax dollars or insurance premiums may contend that parenthood is not a right, but rather a choice individuals make. The enormous expense that accompanies modern infertility treatments may have influenced policy makers, both in the legislative and insurance sectors, against more widespread coverage. In contrast, couples stricken with infertility argue that they have a disease affecting the reproductive system of the male, female, or both. The organs and tissues affected by this disease are as much a part of the human body as the skeletal, digestive, or cardiovascular systems. Reproduction is fundamental for human survival. Furthermore, this disease, which comes about from numerous causes, can have a serious impact on the psychosocial well-being of one or both members of a couple.29 In addition to the direct effects that infertility can have on a patient’s well-being, infertility can also be a marker of other diseases (the epidemiology of reproduction is discussed in detail elsewhere in this issue). In addition, young men undergoing



Lindgren & Ross an infertility evaluation often have other significant health concerns, such as testis cancer or diabetes.30 Another aspect of reproductive health, ED, is strongly associated with concomitant cardiovascular disease and predicts future cardiovascular events.31 ED is also associated with other public health concerns such as obesity, dyslipidemia, and diabetes.32 STDs are an additional public health concern within the realm of reproductive health. All of these aspects of reproductive health are matters of public health.

THE FUTURE OF REPRODUCTIVE HEALTH CARE The ACA is more than 2000 pages long and, despite attempts at repeal, has been the law of the land since 2010. This complex legislation has numerous provisions that become effective over a multiple year timeline, and will certainly cause important changes throughout health care in the United States. Over time, fee-for-service medicine may end as global payments and quality-based reimbursements emerge. Beginning in January 2014, the various conditions that will be covered by all types of insurance will be spelled out in documents called Essential Health Benefits. These essential benefits will not be dictated by the federal government, but rather will be decided on at the state level. In theory, there could be 50 different versions of what is considered essential coverage. Time will tell whether infertility care will be included as an essential health benefit, but, based on the existing laws, at least 15 states will probably make mention of infertility care in one form or another. Urologists engaged in all aspects of male reproductive care have several responsibilities to their patients. They need to continue to study the genetic, environmental, and developmental causes that affect reproductive disease in men. They need to continue to find the most effective therapies that provide the best outcomes for patients in the most cost-effective ways. As clinicians seek these answers, they need to provide education so that patients can lead healthier lives with regard to their reproductive potential. Patients can then be prepared to work with clinicians to educate legislators and leaders in health care reimbursement so that reproductive diseases will be treated no differently than any other disease.

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Reproductive Health Care Delivery 24. Shared-risk or refund programs in assisted reproduction. The Ethics Committee of the American Society for Reproductive Medicine. Fertil Steril 2004; 82(Suppl 1):S249–50. 25. Counsyl. 2013. Available at: www.counsyl.com. Accessed June 10, 2013. 26. Services UDoHaH. Title X Family Planning. 2013. 27. Foundation KF. State Medicaid Coverage of family planning services: summary of state survey findings 2009. Available at: kff.org/medicaid/report/ state-medicaid-coverage-of-family-planning-servicessummary-of-state-survey-findings. Accessed June 10, 2013. 28. resolve.org. Women Veterans and Other Health Care Improvements Act2013. Available at: www.resolve.





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Reproductive health care delivery.

Most patients in the United States with reproductive health disorders are not covered by their health insurance for these problems. Health insurance p...
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