Education

In search of real autonomy for fertility patients

Since 1980, the number of twin births in the United States has increased 76% (Martin et al., 2012) and the number of triplets or higher-order multiples has increased over 400% (Dickey, 2007). While part of these increases is due to older maternal age, the primary reason is the increased use of two kinds of fertility treatment: controlled ovarian stimulation (COS), in which a woman is medically stimulated to produce eggs and then either has timed intercourse or receives sperm through intrauterine insemination, and in vitro fertilization (IVF), where embryos are created in a laboratory and transferred to a woman’s uterus (Schieve et al., 2009).

Multiple pregnancies and births are a public health concern because they are associated with a number of increased risks for women and babies over singleton pregnancies and births, including preterm and very preterm birth. More than half of twins are born preterm, defined as less than 37 weeks of gestation.

Eleven percent of twins, 36% of triplets, and 67% of quadruplets and higher are born very preterm (<32 weeks of gestation), compared with <2% of singletons. Preterm birth places babies at increased risk for death, health problems including long-term neurological disabilities, and extended time in the hospital (Hvidtjørn et al., 2006; MacKay et al., 2006; Gleicher and Barad, 2008; Glinianaia et al., 2011; Sazonova et al., 2012).

The high rates of multiple births associated with fertility treatment in the United States are due in part to the fact that many patients, even those with private health insurance, are constrained in their decision making by financial concerns and the policies of states, insurers and clinics. Expanding insurance coverage for fertility treatment in the United States would create incentives for patients to select protocols that would reduce multiple birth rates while maintaining patient autonomy.

Fertility treatment options

COS is particularly indicated for women who do not ovulate, but it is also used in other conditions, including cases of unexplained infertility. Under most COS protocols, the patient initially takes an oral medication, but if this is not successful in establishing ovulation or pregnancy, patients may be prescribed injectable medications called gonadotropins.

IVF is a more complex and invasive treatment than COS. Clinicians stimulate a woman’s ovaries to recruit many more mature eggs than she would produce in a normal monthly cycle, using the same medication (injectable gonadotropins) used in some COS protocols, but usually at higher doses.

The eggs are then surgically retrieved and fertilized in the embryology laboratory. If fertilization is successful, the embryos are kept in culture in the laboratory incubators for between two and six days. On the day of the embryo transfer, the physician and the embryologist select one or more embryos that appear viable for transfer.

Selection of embryo(s) to transfer is generally based on an empirical scoring model consisting of analysis of the embryo’s morphology, including the number of cells at specific days of in vitro development and the overall appearance of the embryo (cell symmetry, presence of fragments or vacuoles). The embryo that gets the best score is assumed to be the best quality embryo.

Some embryos are tested using pre-implantation genetic diagnosis and screening to rule out chromosomal errors or genetic disorders (like cystic fibrosis), however these techniques involve embryo biopsy and are not yet recommended as a way to improve live-birth rates (American Society for Reproductive Medicine, 2014). Newer noninvasive technologies for assessing embryo viability, including analysis of by-products of the metabolism of the embryo taken from the culture medium and the use of time lapse photography to assess the lag between cell divisions, are currently being developed and evaluated for their effectiveness in many IVF clinics (Yang et al., 2012; Forman et al., 2013; Montag et al.,2013).

Transfer of one embryo is known as single embryo transfer (SET) and transfer of two is called double embryo transfer (DET). Any viable embryos not transferred can be frozen for subsequent use. In 2011, American clinicians transferred an average of 2.0 embryos in patients under 35 undergoing a fresh IVF cycle using their own eggs and an average of between 2.0 and 2.7 in patients in older age brackets (CDC, 2013).

All IVF clinics in the country must annually provide the US Centers for Disease Control and Prevention (CDC) with data on all procedures they performed. CDC, in turn, is required to use that data to calculate and publish national as well as clinicspecific ‘pregnancy success rates’ (Fertility Clinic Success Rate and Certification Act). Very little, by comparison, is known about the use of COS for non-IVF treatments in the United States. In an article published in 2009, CDC researchers used historical data on multiple births combined with existing data on births resulting from IVF to estimate the number of babies, including multiples, born following COS treatments (Schieve et al., 2009).

They concluded that 22.8% of all multiples born in the US in 2005 (31,902 infants) were likely conceived in COS cycles, which is more than the proportion of the nation’s multiples conceived using IVF. An earlier study asking similar questions had estimated that 36.9% of triplets and 62.4% of quadruplets or higher born in the United States result from COS (Dickey, 2007). Together, the data on IVF births and the research on COS births suggest that ~40,000 twins, triplets or higher are born each year in the United States as a result of IVF and COS fertility treatments combined.

Insurance coverage for fertility treatment

Coverage of fertility treatment in the United States is limited, particularly for IVF. Prior to implementation of the Affordable Care Act (ACA), over 48 million Americans had no health insurance and therefore, of course, no coverage for any fertility treatment.

Medicaid, the United States’ main safety-net insurance program, provides coverage to almost 60 million Americans, including preconception care as part of family planning services, but infertility testing and treatment are rarely covered (Ranji et al., 2009). Even among those with private insurance, coverage for COS treatment is often limited, and very few have any coverage for IVF.

Those US patients with COS and IVF coverage have it largely thanks to laws passed by individual states. State mandates enacted over the last 25 years have helped to expand coverage in 15 of the 50 US states. Yet their reach is modest and not uniform, with policies variable state by state. Further, they do not apply to patients whose insurance is rovided by employers who self-insure.

In the United States, many people get their insurance as a benefit of employment. Some employers purchase insurance for their employees directly from insurance companies, and these plans are subject to state laws. But large employers often choose to ‘self-insure’, which means that the company pays directly for its employees’ claims rather than purchasing plans from an insurance company (although the employer may contract with an insurance company to administer the benefits).

These plans are covered by the Employee Retirement Income Security Act (ERISA) of 1973, a federal law focused primarily on pensions, which preempts state regulation meaning that state laws about insurance benefits do not apply to these plans. Self-insured plans cover about half of all employees with job-based health benefits in the United States.

Lessons from other jurisdictions: how regulations and incentives can reduce multiple births

Policy makers and leaders in fertility medicine in other countries have recognized the need for SET in reducing the multiple birth rates and have used a combinationof regulations and financial incentives to encourage the use of SET and to reduce the rate of multiple births. Belgium has a policy designed to encourage the use of SET by providing a strong economic incentive.

In 2003, the Belgian government adopted a policy that pays the laboratory costs for up to six IVF cycles for women younger than age 43 if they agree to single embryo transfer. The policy has significantly increased the percentage of single embryo transfers and increased the number of singleton births without reducing the overall pregnancy rate (Gordts, 2005; Ombelet et al., 2005; Van Landuyt et al., 2006).

In contrast to the incentive approach adopted by Belgium, Sweden has relied on a combination of professional guidelines and flexible regulations (Karlström and Bergh, 2007). In 2003, the National Board of Health and Welfare issued guidelines.

Single embryo transfer is recommended for women up to age 38 for the first two treatment cycles and regulations call for these guidelines to be followed unless there are exceptional circumstances (Karlström and Bergh, 2007). Between 2000 and 2004, the rate of multiple births decreased dramatically without a subsequent drop in the live birth rate. Among women under the age of 30, for example, the rate of multiple births fell from 25.3% in 2000 to 4% in 2004, but the live birth rate only dropped from 32.3% to 31% (Karlström and Bergh, 2007).

Despite the success of Sweden’s regulatory approach, Jennings and Callahan object that a strict regulation of the number of embryos transferred does not adequately respect the autonomy and that women should be the ‘final arbiters of how many embryos will be transplanted into their reproductive tracts in any given cycle’ (Jennings and Callahan, 2001). In contrast, Orentlicher argues that if restrictions like those imposed by Sweden ‘were coupled with insurance coverage of IVF they would not limit reproductive rights’ (Orentlicher, 2013).

Recently, the Canadian province of Quebec elected to both extend its citizens’ health coverage for fertility treatments and restrict how those treatments are practiced. Under the program, which is the first of its kind in Canada, the province covers all costs related to medical procedures and medication for ovarian stimulation, artificial insemination and three cycles of in vitro fertilization for all women of childbearing age.

The plan covers three full cycles of IVF and ‘implantation of each embryo, one at a time, is covered, for as many times as there are embryos’ or ‘up to 6 cycles for natural or modified in vitro fertilization cycles’ (which generally produce a single embryo). The benefit limit is reset after the birth of a child.

The plan does make provision for transfer of two and even three embryos, but these cases must be justified (Gouvernement du Québec, 2013). The Quebec program has been in place since August 2010. Data on the program’s first three months showed that of the almost 1300 cycles performed, just 50% were SET (despite the ‘exceptional circumstances’ language).

 

Author: JOSEPHINE JOHNSTON MICHAEL K. GUSMANO PASQUALE PATRIZIO

 

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