Advanced Reproductive Technology is Here. But Who Decides Who Gets Access?

In November 2017, a baby named Emma Gibson was born in the state of Tennessee. Her birth, to a 25-year-old woman, was fairly typical, but one aspect made her story unique: she was conceived 24 years prior from anonymous donors, when Emma’s mother was just a year old. The embryo had been frozen for more than two decades before it was implanted into her mother’s uterus and grew into the baby who would be named Emma.

Most media coverage hailed Emma’s birth as a medical marvel, an example of just how far reproductive technology has come in allowing people with fertility issues to start a family.

Yet, the news held a small detail that gave others pause. The organization that provided baby Emma’s embryo to her parents, the National Embryo Donation Center (NEDC), has policies that state they will only provide embryos to married, heterosexual couples, in addition to several health requirements. Single women and non-heterosexual couples are not eligible.

In other industries, this policy would effectively be labeled as discriminatory. But for reproductive procedures in the United States, such a policy is completely legal. Because insurers do not consider reproductive procedures to be medically necessary, the U.S. is one of the few developed nations without formal regulations or ethical requirements for fertility medicine. This loose legal climate also gives providers the power to provide or deny reproductive services at will.

The future of reproductive technology has many excited about its potential to allow biological birth for those who might not otherwise have been capable of it. Experiments going on today, such as testing functional 3D-printed ovaries and incubating animal fetuses in artificial wombs, seem to suggest that future is well on its way, that fertility medicine has already entered the realm of what was once science fiction.

Yet, who will have access to these advances? Current trends seem to suggest that this will depend on the actions of regulators and insurance agencies, rather than the people who are affected the most.

Barriers to Reproduction in the “Lawless West”

Americans looking to procreate increasingly rely on reproductive technology to do so. About 12 percent of Americans between the ages of 15 and 44 have difficulty getting pregnant or carrying a pregnancy to full term, according to the Centers for Disease Control and Prevention (CDC). The CDC also finds that nearly 9 percent of men between 25 and 44 have reported that they or their partner have seen a doctor for some form of infertility management.

At present, if one of those individuals or couples wants to conceive, they have a few options. A person can buy sperm or eggs, depending on what they need; they can also do as Emma Gibson’s parents did and buy fertilized embryos, which are often donated by parents who have undergone in vitro fertilization (IVF) and do not require the extra gametes created in the process. These sex cells can then be implanted into the uterus via IVF, alongside a cocktail of hormones to prepare the body for pregnancy. A couple can also pay for a surrogate to carry the baby, or adopt a child. A handful of individuals have even undergone experimental procedures to bear a child via a uterus transplant, donated and implanted much like a kidney or liver might be.

A sperm fertilizing an egg. Image Credit: Wikimedia Commons

Yet regulatory and financial barriers make these options different for individuals in the U.S. than those in other countries. Experts say that the U.S. has long lagged behind the developed world in protecting individuals’ reproductive rights — access to abortion and even basic birth control continue to be a hot-button issue, as does research involving any form of human gametes. These controversies have meant that the government has always been hesitant to regulate reproduction.

“Reproductive medicine has existed in this country in an almost wholly unregulated state,” Megan Allyse, a bioethicist with the Mayo Clinic specializing in reproductive and genetic ethics, told Futurism. There’s no history of regulating this form of medicine, and it’s politically very tricky, Allyse explained; “And so efforts to regulate it run into this very complicated nexus.”

In this space collide proponents and opponents of abortion, pro-natalism, and reproductive autonomy, as well as reproductive rights advocates who want to keep regulation out altogether due to concerns it will be misused. (Compare this to the U.K., where there is an entire government agency — The Human Fertilisation and Embryology Authority — dedicated to regulating fertility treatments and research involving embryos.)

In reaction to this environment, most insurance companies in the U.S., including the few federally-funded public insurance options, don’t cover even basic fertility treatments, such as hormone therapy or IVF. That’s because insurance companies usually don’t consider fertility procedures and medications to be “medically necessary,” defined by Medicare.gov as: “Health care services or supplies needed to diagnose or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine.”

IVF, for example, is not medically necessary. A single IVF treatment can cost $10,000 or more; the first implantation often fails, necessitating multiple treatments and even higher costs. Most Americans have to pay these out of pocket, though fertility treatment is covered by universal healthcare in many places abroad. This high cost in the U.S. makes IVF unattainable for the average American. Though few official statistics exist, it’s likely that thousands of people in the U.S. are unable to achieve their dreams of having children simply because it is financially prohibitive.

“There is no question that, in America, you have no right to reproduce,” Antonio Gargiulo, an obstetrician-gynecologist (OBGYN) and the director of robotic surgery at the Brigham and Women’s Hospital in Boston, told Futurism. “There is no equality of access; rich people reproduce better than poor people.”

“There is no question that, in America, you have no right to reproduce.”

While adoption is often recommended to those unable to afford IVF and other fertility treatments, the legal and screening fees incurred by adoption can also be high — according to Adopt US Kids, a project of the U.S. Children’s Bureau and the Adoption Exchange Association, adoption costs for healthy newborns start around $5,000 and can go as high as $40,000 (adoptions of older children from foster care are free).

“Essentially, those who are more socioeconomically advantaged have a much better chance of fulfilling their reproductive goals,” said Allyse.

Regulators could require insurers to cover the cost of reproductive care, or provide subsidies to help make it more affordable. But that doesn’t happen. Although 15 U.S. states have laws that mandate some form of fertility coverage, these laws can be very narrow. They can exclude certain forms of treatment, as several do with IVF; require that people seeking fertility treatments demonstrate specific medical conditions that prevent pregnancy; require a couple to demonstrate they have tried unsuccessfully to become pregnant “naturally” over a specific period of time (a law that excludes homosexual couples by definition); require that a person’s eggs be fertilized only with the spouse’s sperm; offer religious exemptions; or hand the decision of whether to cover treatments over to employers.

According to Allyse, the U.S. has become internationally known as “the lawless west” when it comes to reproductive medicine.

“If you can’t get something in Singapore, Israel, England, you go to the U.S., where you can get anything you’re willing to pay for,” Allyse said.

She cited the case of the “Octo-mom,” who, in 2008, received an IVF treatment that implanted ten embryos simultaneously, allowing her to give birth to octuplets. By ethical standards, transferring so many embryos alone is, arguably, irresponsible. The American Society for Reproductive Medicine (ASRM) recommends transferring a single embryo at a time, since multiple embryos have been associated with increased rates of prematurity, infant death, and complications for both the parent and child. In some European countries, single embryo transfer is even mandated. But no U.S. laws require a single embryo to be implanted at once. And until there are, some doctors will be willing to implant multiple embryos as long as a patient is willing to pay.

Governing the Ungoverned

A lack of government oversight means U.S. providers of fertility treatment are free to make decisions about who receives care in ways that might be considered unethical or even illegal in other fields. This leaves the U.S. at a paradoxical nexus: Pretty much any fertility treatment is available if you can pay for it, yet you can still be refused if a clinician does not agree with your lifestyle.

For example: NEDC, the source of Emma Gibson’s embryo, determines patient qualifications for those eligible to receive embryos from a “Judeo-Christian viewpoint,” according to Jeffrey Keenan, the center’s medical director.

“[Our policy is] looking at the biological reality of a family and how God created conception,” Keenan said in an interview with Futurism. “As much as you see gay people having children, you have noticed that none of them do it on their own. It is physically and scientifically impossible for gay people to have a child. So why just because we can have someone act as a surrogate, or because we can donate into a [gay] woman, why does that make it right? It doesn’t, not in and of itself.”

Naturally, the LGBT and civil rights communities vehemently oppose such views — and increasingly, so do the courts.

“Medical care available to some people should be available to all, not based on sexual orientation or other factors,” Jenny Pizer, an attorney with Lambda Legal, an organization that provides free advocacy and legal representation to LGBT and HIV-positive people, told Futurism. In 2008, Pizer was the lead attorney in the California Supreme Court case Benitez v. North Coast Women’s Care Medical Group, brought by a lesbian woman, Guadalupe Benitez, who had been refused IVF due to her sexuality. After a series of court battles lasting over seven years, the Supreme Court ruled in favor of Benitez.

“This isn’t just a win for me personally and for other lesbian women,” Benitez told the San Francisco Gate after the ruling. (Futurism requested an interview with Benitez, but she is no longer speaking to the media about this case.) “Anyone could be the next target if doctors are allowed to pick and choose their patients based on religious views about other groups of people.”

An egg being fertilized during IVF. Image Credit: ZEISS Microscopy/Flickr

Pizer added: “LGBT people are people, just like everyone else. And for some people the desire to form a lifelong bond with another adult, and have a family together, and share a family life is as deeply personal and profoundly important as anything else in life. For a great many people it’s more important in life.”

Several other cases have been brought to the courts, including several ongoing in Florida and New Jersey. California and Maryland have had to update the language of their fertility coverage mandates to specifically forbid discrimination by sexual orientation. Yet any state Supreme Court rulings only have effects on the state level.

There was some hope that the Affordable Care Act (ACA) might address the issue, and indeed, the act prohibits discrimination on the basis of sex, including sexual orientation and gender identity, from any program or facility that gets federal funding. But because private facilities that exclusively provide reproductive services — such as the NEDC, which is a non-profit — do not receive federal funding, that rule doesn’t apply.

“Anyone could be the next target if doctors are allowed to pick and choose their patients based on religious views about other groups of people.”

If anything, gatekeepers who oppose patient lifestyles seem likely to receive moregovernment protections, not fewer. The Trump administration has revealed plans to overhaul the rules governing the Health and Human Services civil rights office, which is responsible for enforcing laws that protect “fundamental rights of nondiscrimination, conscience, religious freedom, and health information privacy.” Trump’s reform will give the civil rights office a “Conscience and Religious Freedom Division” made to protect health workers who have “religious or moral objections”that would lead them to refuse treating certain people, such as transgender patients or people seeking abortions. The rule would prevent organizations from firing workers who expressed these objections, and it would punish facilities that prevented workers from expressing them.

Though HHS staffers and groups like the American Civil Liberties Union (ACLU) have expressed concerns that the new rules are blurring the line between church and state, they come from current HHS leadership and promises made by the president himself, and seem likely to go through.

Pizer says she already anticipates more legal battles as a result. “We think it’s profoundly alarming,” she said. “It’s really turning the civil rights division on its head, to be aggressively asserting protections for health workers [who] don’t want to provide care to patients. The larger dynamic here is, if the government is putting out the message that people can refuse to do their job based on religious grounds, that encourages people to refuse. It’s already likely to increase something that has been a real problem.”

Allyse also noted that discrimination can be a much more insidious and hard-to-address problem in the medical field.

“Even if [providers] don’t say, ‘I won’t provide treatment because you’re in a same-sex relationship,’ they can say lots of other things,” Allyse said. Medical ethics permit providers to turn you down as a potential patient based on their own “clinical discretion,” Allyse said, and that can mean pretty much anything. “We may be making progress in terms of overt discrimination in access, but we have no real mechanism for tracking or ameliorating more tacit and covert discrimination.”

“In Good Hands,” but Still Unaffordable

Doctors working in reproductive medicine stressed to Futurism that discrimination and biases were relatively uncommon in their field; while discrimination is certainly an issue, most fertility doctors see their work as a way of providing people of all orientations autonomy over their own bodies.

“The field of reproductive endocrinology — the infertility doctors — tend to be an open-minded group who have made a lot of strides in how LGBT people build families, or in patients with HIV/AIDS and hepatitis, how they build families safely,” said Pietro Bortoletto, an OB/GYN at Brigham and Women’s Hospital in Boston. “We do a lot of the management for people doing gender transitions. As a whole, the field tends to be really progressive. And as long as this sort of technology and these [future] procedures live within the field of infertility, it’s in good hands.”

Discriminatory practices aside, the same experts don’t anticipate that these treatments will ever become affordable unless insurance companies choose to cover them, or are forced to.

Bortoletto and Gargiulo are part of the team at Brigham and Women’s exploring the potential development of a uterine transplant program for the hospital, though they emphasize that “no formal preparations are underway at this time.” Because uterus transplants are considered experimental, they would be offered to individuals at no cost. But even once uterine transplants become a “standard” treatment for infertility, as IVF currently is — which doctors say could happen in 10-20 years — Gargiulo predicts that nobody is ever going to pay for a uterine transplant. Just as almost nobody pays for a kidney or heart transplant out-of-pocket, the costs of this surgery are simply too high. People will need to rely on insurance companies to cover these procedures if they’re going to be done at all.

Sonogram. Image Credit: Miki Yoshihito/Flickr

To Allyse, it seems unlikely that the federal government will establish the regulation needed to make insurance companies cover such procedures, at least not anytime soon.

“There’s almost no chance [of federal regulation changing],” she said. “We currently have an administration that is significantly anti-regulatory, so the idea we would create new systems in the current political climate is doubtful to me.” For three decades, the fertility industry has successfully lobbied to keep regulation to a minimum, Allyse added. For now, it doesn’t seem likely that anything, or anyone, will be able to override that power.

However, there’s more hope that individual states, in which progressive legislation moves more quickly, could make legislative changes to improve access to fertility treatments. In 2017, New York’s Governor Andrew Cuomo began requiring that insurance companies provide infertility treatments to homosexual couples and single women; the state is one of the 15 that requires coverage, but previously had rules on the book that made it impossible for single people or gay couples to prove they were eligible for treatment. In Massachusetts, fertility coverage has been standard since 1987, when it became the first state to pass a law requiring that fertility treatments be covered by insurance. The state has offered its own healthcare, MassHealth, to residents of certain income brackets who cannot access the minimum standard of health care through other means. This makes Massachusetts one of the few places where nearly anyone can access fertility treatments that would otherwise be prohibitively expensive.

If uterine transplants became a standard procedure, they could one day be free in Massachusetts, Gargiulo marveled.

To Pizer, these remaining hurdles for reproductive equality are one of the last major barriers to equality for all sexual orientations. Regardless of the quibbling around medical necessity or insurance coverage, to advocates of equality, discrimination is discrimination.

“It’s an important priority for our movement, to allow more members of this community to live full lives who they really are, openly and honestly, and bring their whole selves into those family roles,” Pizer said.

Disclaimer: the editor of this piece was a recipient of the Mayo Clinic’s 2017 journalist residency for surgery, where she met a number of the sources quoted in this piece. The residency was paid for by the Mayo Clinic; however, neither the clinic nor any of its affiliates have editorial review privileges.

Source: Futurism