Mental Health ERISA Law for Dummies

My son is an ERISA attorney whose present work requires him to make sure that large group insurance plans offered by companies comply with various federal statutes, such as the various regulations surrounding the PPACA (i.e. ObamaCare). In one of our recent discussions about healthcare access, he made me aware of some federal laws regarding the provision of mental health benefits, which I was heretofore completely ignorant. In my practice, I have frequently been frustrated by trying to get mental health care for some of my patients, some of whom appeared to have reasonable health insurance, which turned out to have rather minimal mental health coverage, a condition ERISA nerds refer to as lack of coverage parity between mental health benefits and covered medical and surgical benefits. This is thankfully changing. Without getting into the tedious minutia of ERISA law (and it is very tedious), let me take you on an abbreviated tour of these mental healthcare federal statutes.

Prior to 1996, coverage for mental health care was unambiguously less generous than for physical illness. In 1996, the Mental Health Parity Act (MHPA) passed, which required parity of annual and aggregate lifetime limits compared to med/surg benefits. The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) expanded parity to include treatment limitations, financial issues such as co-pays, and in- and out-of-network coverage. However, and this was and continues to be a major “however”, neither of these federal statutes mandated any specific mental health coverage but simply required insurers who chose to provide mental health coverage to do so with parity with other medical and surgical benefits. I like to think of this like Title IX established parity between the sexes, MHPA and MHPAEA tried to establish parity for mental health with other medical coverage. If you want to get into the minutia, begin HERE and HERE.

With passage of the PPACA in 2010, both MHPA and MHPAEA suddenly developed some teeth. The PPACA mandated coverage of certain mental health and substance abuse disorders. Now the benefits for those covered services must have parity with other medical and surgical benefits. For a deeper dive, see HERE. But oddly, the sharpness of MHPA’s and MHPAEA’s new teeth varies by state. For technical reasons that only an ERISA attorney may understand, there remain variations in state-by-state interpretations of the coverage minimums of the PPACA 10 ‘required’ Essential Health Benefits (EHB), so see HERE for more details (particularly chart at bottom of linked article listing benefits by state).

Nonetheless, armed with these statutes, mental health advocates are demanding their parity. Recently, the 2nd US Circuit Court of Appeals allowed an ERISA lawsuit to proceed against a large health plan group administrator for their alleged reduction in mental health benefits for services provided to patients. Whether this encourages other legal challenges for more parity, time will tell.

What does foregoing mean from a bioethics standpoint? This blog has frequently discussed the problems of healthcare access for some our most vulnerable members of society, many of these related to mental health struggles. While I am no fan of the PPACA in general, this is one result that I applaud. More work needs to be done to determine exactly what mental health issues get covered and perhaps who gets to decide. Until we all behave like the Good Samaritan toward all of our neighbors, it may take statutes like these to nudge us along the way.

How paranoid should I be about my personal health care data privacy?

A recent Wall Street Journal article by Twila Brase suggests that anonymous medical data may not be so anonymous. This piqued my paranoia antenna. Her concern focuses on the new 21st Century Cures Act, which not only significantly increased funding for cancer research and opioid treatment programs, but also created “an ‘information commons’: a government-regulated pool of data accessible to all health researchers, regardless of background, training or motive.” The new law does not give patients any method for opting out of this data-sharing. It specifically prohibits what is called “information blocking” by health care providers, forcing hospitals and doctors to share information with government researchers.

But this is America – I thought anyone could opt-out of anything!

Granted, all of this information is anonymized so in theory no one can figure out that a particular unique kink in some strand of DNA is your unique kink. But as my favorite ESPN sportscaster, Lee Corso, says every weekend: “Not so fast my friend!” Big Data and the analysis of the same may have taught us (and is continuing to teach us) how to reverse the anonymization process. Latanya Sweeny and colleagues at Harvard were able to identify a majority of individuals in the Personal Genome Project by name, using limited demographics. MIT geneticist Yaniv Erlich and undergraduate student Melissa Gymreck were able to identify 50 people whose DNA was available online in free-access databases. Now granted, both of these groups of people are extremely intelligent, likely way smarter than your average computer hacker intent on just stealing and then selling your credit card numbers. Right?

Who would buy this information anyway?

Maybe your employer? Let me introduce you to the Preserving Employee Wellness Programs Act (perhaps appropriately known as PEWPA), an act making its way through the House of Representatives, that will side-step the privacy protections in the Genetic Information Nondiscrimination Act (GINA) by making genetic tests that are part of workplace wellness programs exempt from GINA’s privacy protections (future headline “PEWPA poo-poos GINA?” – sorry, couldn’t resist). While meant to reduce healthcare costs, individual employees could face thousands in healthcare costs if they refuse to share their DNA in company sponsored wellness programs.

So my healthcare may cost me more if I don’t share my private genetic information with my employer even though reassured the data will be stored anonymously? What could possibly go wrong?

If you have never watched the movie “Gattaca”, please turn off your computer right now and go watch it. It provides at least one example of what could possibly go wrong. Then come back and tell me why I should not be just a little paranoid about the way things are heading.

CRISPR and Identity

Dr. Joel Reynolds, a postdoctoral fellow at The Hastings Center recently wrote a very poignant essay in Time magazine arguing that our increasing ability to edit our own genetic code risks eventually eliminating the very genetic code that results in people like his younger brother Jason, who was born with muscle-eye-brain disease, resulting in muscular dystrophy, hydrocephalus, cerebral palsy, severe nearsightedness and intellectual disability. In answering his question – “What, precisely, are we editing for?” – he makes the case that editing the code that resulted in Jason effectively eliminates Jason. I encourage you to read the short article, as any further summary on my part does not do it justice.

How much change of my genetic code would alter my identity? This is an important ethical question as scientists seek to use our growing genetic knowledge to alter our genetic code. Using preimplantation genetic diagnosis (PGD) to eliminate diseased segments of genetic code also eliminates the rest of the genome since a completely disease-free human embryo is selected for implantation and the disease-carrying embryo is destroyed/killed. Obviously, the identity of the implanted embryo is completely different from the destroyed embryo. No identity preservation here.

CRISPR-Cas9 (CRISPR) is held out as the beginning of future techniques to successfully remove and replace sections of our human genetic code. Diseases that are caused by point mutations would seem to be ideal challenges for CRISPR, where removing a single nucleotide effectively cures the individual of the disease, and, at least on cursory consideration, leaves the identity of the individual intact (after all, we would only be changing one nucleotide in the individual’s 3.2 billion nucleotide sequence in their unique genetic code).

Color blindness is one such example, one that I “suffer” from. If my parents had the ability to change my genetic code just after conception to eliminate my color blindness, it seems that I would be the same man I am today, absent the need to have my wife select my ties and socks. However, other life experiences could have been available were my color vision intact, such as F-14 fighter pilot and/or completion of the NASA astronaut selection program, both requiring normal color vision. Likely, I would have been someone with the same identity but certainly with very different life experiences.

At the more serious end of diseases with point mutations is Tay-Sachs disease, where a defective enzyme fails to prevent the build up of toxic fatty deposits in the brain and spinal cord, and, in the infantile form, results in mental impairment, severe sensory pain and pre-mature death. If I had the infantile form of Tay-Sachs disease and my parents changed my genetic code, is my identity different? Am I just the same “me” experiencing a tremendously different life experience or am I a different “me”? If I am a different “me”, is it just because we hold cognitive ability/behavior/function critical to one’s identity? One can lose the function of the nerves in one’s leg and not consider this a challenge to one’s identity. Sustain an injury to one’s brain and the challenge to one’s identity is stronger. Dr Reynold’s makes a similar case in describing his brother Jason as he actually was, compared to how he could have been had the prayers for healing been answered or genetic editing been available. To paraphrase, a “corrected” Jason is no longer Jason.

None of the forgoing discussion considers the human soul as it relates to identity or whether alterations in the human genome affects the human soul (or vice versa?). Those issues will have to wait for another blog post. For now my question is this: How much of my genetic code can I change and still be me?

Is Involuntary Temporary Reversible Sterilization Always Wrong?

Ever since Janie Valentine’s blog post last week I have been thinking about the problem of repeat drug offenders and their children. My home state is also Tennessee so I read Judge Sam Benningfield’s order (to reduce prison sentences by 30 days for any drug offender willing to “consent” to voluntary temporary sterilization) with particular local and regional interest.

My office practice is on a street with more than one suboxone treatment clinic (a synthetic opioid designed to be used to assist in narcotic withdraw or as a substitute for pain management with less potential for abuse). It is not uncommon for me to see the parking lots of these clinics full of cars, with unsupervised children playing with other unsupervised children in the parking lot while their parents are inside the clinic receiving their treatment. No doubt some of these patients are opioid dependent and not necessarily opioid impaired. My point here is simply to point out the sheer volume of the opioid problem and also to highlight that this represents the families that are doing well. The children are still with their parents and the parents are not (obviously) under the jurisdiction of the court system.

One partner in my practice and his wife are foster parents and have opened their home to children of repeat drug offenders. These children have often been ordered by child protective services to be temporarily removed from their homes because of their parent’s incarceration related to a drug offense or court ordered treatment. The usual placement is a group of 2 or 3 siblings, often with one of the foster children a newborn baby in the throngs of opioid withdrawal. After seeing several iterations of this pattern, I can certainly sympathize with the judge’s moral outrage and frustration at seeing multiple children, often within the same family, born with opioid withdrawal, though I must agree with Janie Valentine and Steve Phillips that in the case of the judge’s court order (now rescinded), such consent is, at best, coerced given the incarceration.

This brings me to the point of today’s blog. Can there be any condition in which it is right to prevent repeat opioid drug offenders from conceiving a child while impaired by opioid addiction? No one will claim that conceiving a child while addicted to opioid drugs results in a desirable outcome for the parent or child. Choosing to avoid conception requires the very planning that opioid addiction frequently impairs. The current epidemic of opioid-addicted newborns proves that expecting voluntary conception avoidance by the opioid impaired is a non-starter. Voluntary reversible forms of sterilization (none are 100% successful at preventing conception) are available but have non-zero barriers (access/cost/side-effects/compliance/efficacy). Reducing the barriers for those willing to choose temporary sterilization seems reasonable. But what about individuals not willing to voluntarily avoid conception while opioid impaired? Does society have any right to temporarily (reversibly) prevent conception for some time frame in someone impaired by opioids? Should this happen after the first birth of an opioid-addicted newborn? Can it happen after the fourth such serial opioid-addicted newborn birth? At what point should autonomy of the opioid impaired yield to avoiding maleficence to a child?

Let me additionally be clear about what I am not asking or claiming. I am not making some eugenics claim that opioid impairment is genetically determined such that eliminating offspring of individuals suffering from opioid impairment somehow reduces the future risk of opioid dependency within the larger population. I am also not claiming that individuals who are currently opioid impaired will always be opioid impaired. I am not claiming that opioid impaired individuals are necessarily permanently bad parents; when not opioid addicted, they may in fact be wonderful parents. Finally, I am not asking that the sterilization be permanent, as I do not think that opioid impairment is permanent.

Again: Can there be any condition that makes it permissible to involuntarily temporarily reversibly sterilize repeat opioid drug offenders to avoid conceiving a child while opioid impaired?

The Prognosis for Whole Brain Death is…

Recent court proceedings bring the case of Jahi McMath back into the bioethical news. As you will recall, she had medical complications following a surgical procedure in 2013 and was declared brain dead. The family argued for continued life support, which the hospital denied (since she met the criteria for whole brain death). After much legal wrangling, she was transferred to New Jersey, where she remains alive on ventilator and nutritional support. This case has been reviewed in this blog (here and here). Professor Thaddeus Pope has followed this case from a medicolegalethical standpoint on his Medical Futility Blog, which is generally where I keep up with the case. His catalogue of the legal proceedings is complete, and while I disagree with many of his bioethical positions, I appreciate his rational discussion of those issues. For the remainder of this blog, I wish to focus upon the issue of brain death in the case of Jahi McMath and specifically our ability to accurately determine it.

No one, and as far as I can tell I mean absolutely no one, denies that Jahi met the criteria for whole brain death by late 2013. Her EEG was isoelectric (flatline – no brain electrical activity), radioisotope cranial blood flow studies showed no cortical blood flow (which normally results in cell ischemia, and, if not immediately corrected, brain cell death), brainstem auditory evoked responses (BAERs) were absent (usually indicating future inability to receive auditory input even if there were an otherwise healthy brain ready to receive that input) and somatosensory evoked potentials (SSEPs) were absent above the neck (usually indicating inability to receive sensory input from the body). As a result, she met the criteria for whole brain death in California and was issued a death certificate. Since that declaration, she has shown signs of entering puberty (which requires a minimally functioning portion of the brain called the hypothalamus), her heart rate has been noted to change when she hears her mother’s voice (which should not be possible given her BAER results) and she has moved her right arm to verbal command (an act that would require the ability to receive the auditory input, left hemisphere cortical brain processing of that input, signal transfer within the left hemisphere of the brain to the motor area that controls the right arm, and finally signal transfer down through the brainstem to the portion of the spinal cord that controls the right arm). If any of those are true, Jahi McMath fails to satisfy the criteria for whole brain death. Here is the testimony of Dr D.Alan Shewmon, emeritus professor of pediatric neurology at UCLA and an expert in pediatric brain death. His 26-page testimony provides an excellent discussion of the problems of determining whole brain death, particularly in the case of Jahi McMath.

The problem of potential reversibility after a determination of whole brain death hits home professionally for me. I have cared for patients in an inpatient rehabilitation hospital setting who suffered severe head injuries, as well as consulted on several more who never made it our rehabilitation hospital because of brain death. This included assisting in the discussion of whether to discontinue ventilator, nutrition and hydration support following a proper determination of whole brain death. And, while I think similar discussions are reasonable in individuals sustaining injuries leaving them in a persistent vegetative state (PVS, i.e. having brain function that only acts reflexively without awareness or capability for any cognition, perhaps a better description of Jahi McMath’s current status), no such discussion should happen until brain recovery has reached its maximal endpoint. With whole brain death, those discussions can happen immediately because that endpoint has been reached. Dead brains, by definition, do not recover.

Until now?

The initial determination of whole brain death in Jahi McMath appeared proper.

If the reports of her responsiveness are true, Jahi McMath clearly no longer meets the criterion for whole brain death. The very fact that she has remained alive over three years after the determination of whole brain death argues against whole brain death. Artificial life support has advanced but not to the degree that we can mimic all of the routine vegetative functions controlled by the brain necessary to keep the body alive. It is “easier” to keep an individual in PVS alive because the brain is still doing a large part of its bodily maintenance/regulation work.

At the very least, even if none of the above observations of Jahi McMath are true, the prognosis for whole brain death, while still very, very, very poor, is no longer zero.

Healthcare Insurance vs. Healthcare coverage?

Kimberly Strassel wrote an interesting piece in the WSJ entitled “The Simplicity of a Health Deal” (Link here – subscription required). I don’t think she was saying that crafting legislation to resolve all of America’a healthcare issues was easy, she was making the political point to Senate Republicans that, like it or not, no future legislation will be possible unless they agree to continue the ObamaCare provision of eliminating insurance proscriptions for pre-existing conditions. She cited a YouGov poll that showed 77% supported protections for those with pre-existing conditions as an example of the public support for this provision.

The problem with pre-existing conditions is that they cost more money to insure than not-yet-existing conditions. This fact is the primary reason for the unpopular provision of Obamacare – The Mandate (or tax, if you like). If you delay buying insurance until your not-yet-existing condition becomes an exiting condition, what exactly are you insuring? This “gaming the system” is illegal and for good reason. Without the mandate (that everyone buy some minimal level of insurance), insuring pre-existing conditions is very expensive. Insuring pre-existing conditions has turned out to be more expensive than anticipated, even with the weak mandate/tax, and insurance providers have been and are continuing to leave Obamacare, further reducing insurance options in many states. Failure to make significant changes in the present law (i.e. leaving Obamacare as is) would likely result in further reduction in the number of insurers and the cost of their products.

I find it odd that we continue to refer to ObamaCare or whatever the new Republican iteration will be as health insurance. Wikipedia describes insurance as a form of risk management primarily used to hedge against the risk of a contingent, uncertain loss. Life insurance and car insurance are good examples. Premiums charged for these types of insurance policies are based upon one’s risk or lack thereof, as well as how much risk an individual wished to mitigate. Essentially, these are catastrophic risks we are taking about. Healthcare insurance has morphed into healthcare coverage. We expect our health insurance to pay for everything that has to do with accessing a healthcare provider: routine office visits, medications, emergency/trauma care and end-of-life support, to name but a few. That would akin to asking our car insurance to not only handle major accidents but also gas and oil purchases.Of course, taking the car insurance analogy to its logical conclusion suggests that just as there are some people that have such a terrible driving history that they simply are not insurable, there are similar people who are not insurable based upon their terrible health history. Eliminating pre-existing condition proscriptions effectively turns the insurance model on its head as a means for risk mitigation.

If we are going to eliminate pre-existing conditions, we are essentially agreeing healthcare insurance isn’t the way to pay for healthcare, at least the essential aspects, whatever those are. We are also agreeing that those essential aspects are basic rights, without an open and honest agreement on exactly how to pay for those rights. We need to have the discussion of what exactly constitutes basic or minimal healthcare rights and then we need to have the discussion about how to obligate those providing those rights (required as part of licensure, reforming malpractice, adjusting reimbursement, etc..).

My “Happy Fourth of July” daydream is that Congress would have such a debate, aided perhaps by many bioethicists from many persuasions. Tomorrow, I will wake up and go back to work.

Voltaire and Alternative Definitions

“If you wish to converse with me,” said Voltaire, “define your terms.” How many a debate would have been deflated into a paragraph if the disputants had dared to define their terms! This is the alpha and omega of logic, the heart and soul of it, that every important term in serious discourse shall be subjected to strictest scrutiny and definition. It is difficult, and ruthlessly tests the mind; but once done it is half of any task. (Will Durant, The Story of Philosophy, New York, Garden City Publishing Co., Inc., 1926, page 67)

My reach for Voltaire was caused by a June 14, 2017 Perspective in the New England Journal of Medicine by R. Alta Charo, JD, Professor of Law and Bioethics at the University of Wisconsin Law School. In the article, she is concerned that many new executive branch appointees are purveyors of alternative science, “rife with alternative definitions of well-understood medical conditions and characterized by rejection of the scientific method as the standard for generating and evaluating the evidence.” For the remainder of the blog, I wish to focus on the latter half of her article regarding pregnancy, contraception, and abortion (and abortifacients). I will make the case that Professor Charo is wounded by her own sword.

Her concern is that those physicians, nurses and pharmacists claiming “conscious clause” refusals to “prescribe or provide hormonal contraceptives, emergency contraceptives, and IUDs because they oppose abortion” are wrong because, according to her, none of these can cause an abortion. Per Charo, a pregnancy is defined as the time from implantation of the zygote in the uterus until birth. Abortion is the termination of a pregnancy. Therefore, the term “abortion” can only be used to discuss the time from zygote implantation until birth, and, though conceding that IUDs “can also prevent implantation”, states these methods “do not interrupt pregnancy, and a drug or device that prevents fertilization or implantation is a contraceptive, not an abortifacient.”

There are several problems with her choice of definitions and her consistency of definition within the article itself. Pregnancy can be defined in several ways. Most healthcare providers still use the last menstrual period (LMP) to begin the count for the determination of gestation age. In Vitro Fertilization (IVF) and Assisted Reproduction Technologies (ART) can obviously pinpoint the exact timing of fertilization, thus providing an accurate fertilization age; gestational age is then calculated as fertilization age + 14 days. Lastly, pregnancy can be defined beginning at the time of implantation of the zygote to the lining of the uterus, roughly 7-10 days after fertilization. Under this definition, according to trusty Wikipedia, “during the time between conception and implantation, the future fetus exists, but the woman is not considered pregnant.” It is this last definition that Professor Charo clings to in her argument in the latter half of her article. The problem is that she relies upon the first definition only two paragraphs earlier in arguing: “the fetus does not have the physiological (let alone the psychological) capacity to experience pain until at least 24 weeks gestation (as properly estimated from last menses).”(emphasis mine)

The problem in this particular case is what do we believe to be the moral status of the zygote between conception until implantation (during the time frame outlined in this diagram)? Professor Charo is not ignorant of this time period as she parenthetically comments: “Roughly half of all blastocysts naturally fail to implant, but getting one’s menstrual period is not having a miscarriage.” Fine, but is it something else entirely to intentionally, knowingly cause the blastocyst to unnaturally fail to implant? Does she have a definition for that?

The mechanism by which levonorgestrel (LNG, the active ingredient in Plan B) is successful when used as an emergency contraceptive (“morning after pill”) is that it prevents ovulation (release of a potentially fertilizable egg), though it was originally thought to also prevent implantation. Professor Charo cited a 2001 study that observed no change in the endometrium of surgically sterilized women who took LNG. A summary of more recent studies has continued to argue that implantation is likely not effected by LNG, but summarized that “it is not scientifically possible to definitively rule out [that mechanism]”. From the same summary paper regarding IUDs: its “very high effectiveness implies that emergency insertion of a copper IUD must be able to prevent pregnancy after fertilization” (that is before implantation).

The union of a human egg and a human sperm, whether in utero or in vitro, results in a unique new human being. That is a scientific fact regardless of one’s definition of pregnancy. As such, I believe this new human being deserves the same moral safeguards as anyone reading this blog. The fact that this unique human being does not implant in the womb for up to 9 days post conception ought not alter these moral protections. In castigating physicians, nurses and pharmacists who raise moral objections to the intentional termination of the life of any human being prior to implantation by accusing them of using “alternative definitions of well-understood medical conditions”, I believe Professor Charo is guilty of the same crime. Her definitions do nothing to improve the environment for an open and honest discussion of the moral question at hand, namely: Is it right to intentionally terminate the life of a human being after fertilization but before implantation?

Tom Garigan covered this general topic very nicely in a previous post on this blog back in September 2015, which I encourage you to (re)read. He offered a similar soft nod to Voltaire in his title.

Also, extrapolating from the definition in Wikipedia, any “future fetus” is a “right now” human being. And “right now” is the time to start defining our terms more clearly so we can have the type of conversation that Voltaire had in mind.

Bioethical Jets and Sharks

Recently, Professor Craig Klugman called on the President to set up his Presidential Bioethics Commission. He provides a nice history of Presidential Bioethics Commissions dating back to President Ford. The link to that article is HERE. Other than the usual implication that the President may not be intellectually up to the challenge, I agree with Professor Klugman that there are many pressing bioethical issues that will or ought to affect policy in the not-too-distant future, so I also join the chorus to call for the President to set up his bioethics commission.

Professor Klugman’s plea for such a commission followed an earlier one by Wesley Smith, who called for a “populist” bioethics commission. He admits to desiring a less intellectual or less philosophical commission so we are not limited to receiving only “arcane advice”, preferring instead to have “the verbal equivalent of West Side Story’s knife fight between the Jets and the Sharks.” I admit that a commission with that type of energy would be fun to follow and certainly generate more public awareness of bioethics.

This got me to wondering: What do the readers of this blog consider to be the most pressing bioethics issue? Specifically, if the President listens to Wesley Smith and appoints you to the populist Presidential Commission on Bioethics, what is the one issue you want to make sure makes the list for 2017-2020?

For me, I favor a robust re-examination of what we as a country will permit or proscribe in embryological research, particularly within the first 28 days of the life of the embryo. Within this blog, Jon Holmlund has outlined nicely the technological advances outpacing bioethical consensus in the area of Synthetic Human Entities with Embryo-like Features (see SHEEFs Part 1 and Part 2) and Steve Phillips recently highlighted similar issues in the field of IVF (HERE) just to name a few.

So what is the number one bioethical issue on your list?

And remember, if Wesley Smith’s description of the potential energy in those future debates is accurate: You may want to bring more than a knife to the fight (verbal equivalently speaking, of course…)

Inner Sense and Gender Dysphoria

Steve Phillips posted on “Caring for people with gender dysphoria” almost one year ago. In his post, he referenced a talk at a previous CBHD Summer Conference by Prof. Robert George, where Dr. George posited that the concept that the belief that one’s gender is based one’s innate or inner sense rather than one’s biological/physical sex is rooted in the Gnostic idea that human beings consist of a personal mind that lives in a non-personal body and that this stands in contrast to the longstanding Christian understanding of unity of non-material soul/spirit and material body making up the whole person. I did not attend that talk but offer a recent paper by Dr. George which covers the same ground as backdrop to this post.

The reason for the discussion of Gnosticism related to an earlier point in that same blog referencing the opinion of Dr. Paul McHugh, retired psychiatrist at Johns Hopkins University, who has over the past few years published comments arguing that gender dysphoria is a result of disordered thinking, that is, a mental disorder, requiring treatment, not surgery to complete a gender transition. Dr. McHugh has made much of the fact that Johns Hopkins, despite being an early leader in gender transition surgery, decided very early on that gender transition surgery was not sufficiently efficacious and discontinued the practice.

What a difference a year can make. Johns Hopkins has recently decided to resume what they are calling gender-affirming surgery and specifically point out that when “individuals associated with Johns Hopkins exercise the right of expression, they do not speak on behalf of the institution.”

Johns Hopkins is not alone. A very recent Perspective in the New England Journal of Medicine called “The Future of Transgender Coverage” by Kellan Baker commented that there has been “a rapid increase in insurance coverage for health care services related to gender transition.” Baker offered three reasons to account for this increase: “a growing expert consensus on the medical necessity of gender transition, new legal interpretations prohibiting insurance discrimination against transgender people, and mounting evidence that transgender-inclusive coverage is cost-effective.”

For the sake of the remainder of this blog entry, I want to focus on the first claim: Is there a growing expert consensus on the medical necessity of gender transition?

Gender dysphoria is the term used in the Diagnostic and Statistical Manual of Mental Disorders to describe the clinically significant stress that can occur in a transgender person, one who experiences a discrepancy between one’s innate sense of gender identity and one’s birth sex. Baker says the current standard of care for treating gender dysphoria is gender transition, “which may include mental health counseling, hormone therapy, and reconstructive surgeries affecting primary and secondary sex characteristics.” The source provided for the standard of care claim is a 2012 article in the International Journal of Transgenderism (see here for abstract link – full article requires subscription). Baker supported the growing expert consensus claim by providing a list maintained by Lambda Legal of several major US medical associations consensus statements insisting on health insurance coverage in general for treatment of gender dysphoria, a smaller portion specifically stipulating that coverage include gender transition.

What data is being used to determine whether gender transition is medically necessary to treat gender dysphoria? Available research articles or meta-analyses of these research articles on the long-term outcomes of gender transition is actually less definitive. Most studies are too small to have statistical power, not surprising given the small number of transgender people. Another problem with most studies is lack of a control group. The ideal control group would be a group of transgender people who requested but did not receive gender transition. A third problem is the lack of bias-limiting randomization (though how could one ever ethically design a study where sex-reassignment was done randomly to some patients but not to others?) A summary of the recent research and meta-analysis may be found in a 2016 review article by Lawrence Mayer and Paul McHugh in “Sexuality and Gender” in The New Atlantis (see pages 108-113). Mayer and McHugh conclude their summary by stating they remain skeptical of the efficacy of gender transition in treating gender dysphoria, which has resulted in largely negative and some frankly ad hominem attacks. I was surprised by that response, as the summary includes the meta-analysis by Mayo Clinic researchers Murad et. al., which was arguably pro gender transition regarding self-reported measures reporting some improvement in gender dysphoria, and the large study by Dhejne and colleagues at the Karolinska Institute and Gothenburg University, though showing high suicide rates in sex-reassigned persons (though not suggesting the high suicide rate was caused by the gender transition surgery), went so far as to comment that “things might have been even worse without sex reassignment”. Their study specifically did not address the question of whether gender reassignment alters gender dysphoria.

After conducting my own non-scientific survey of readily available scholarly articles related to gender transition for adult gender dysphoria published since 2016, most of which consisted of small sample, non-randomized, mostly non-controlled studies, I am willing to concede that the majority do state that gender transition reduces gender dysphoria.

But if the gold standard for gender is an individual’s inner sense regardless of that individual’s biological sex (or any other physical/material trait), what objective measure may a researcher reliably use to determine the effect of physical gender transition on gender and gender dysphoria? Per Dr. George (emphasis his):

What is a pre-operative “male-to-female” transgender individual saying when he says he’s “really a woman” and desires surgery to confirm that fact? He’s not saying his sex is female; that’s obviously false. Nor is he saying that his gender is “woman” or “feminine,” even if we grant that gender is partly or wholly a matter of self-presentation and social presence. It is clearly false to say that this biological male is already perceived as a woman. He wants to be perceived this way. Yet the pre-operative claim that he is “really a woman” is the premise of his plea for surgery. So it has to be prior. What, then, does it refer to? The answer cannot be his inner sense. For that would still have to be an inner sense of something—but there seems to be no “something” for it to be the sense of.

It takes a Village to…make… a Child?

Depending upon your political persuasion, Hillary Clinton is either famous or infamous for popularizing the concept that it takes a village to raise a child. Taking the village’s influence back to the point of conception, Assisted Reproductive Technologies (ART), specifically a potential novel combination of human Induced Pluripotential Stem Cells (hiPSCs) and in vitro gametogenesis (IVG), just might make it possible for that same village (that is, more than two parents) to actually make the child.

Jon Holmlund has written extensively in this blog regarding both the technique and ethical considerations of hiPSC and more recently human extended pluripotential stem cells (hESCs) (e.g. see here for a recent example). Roughly, hiPSCs/hESCs create stem cells (cells that have the potential to become any other cell in the human body) from common cells such as adult skin cells. IVG is the process that has the potential to change the hiPSCs/hESCs into gametes (eggs and sperm) which then can be combined via in vitro fertilization (IVF) to make a baby. If the process can be reliably perfected in humans, there would be no physical barrier for a single individual, non-fertile heterosexual couple, homosexual couple, or frankly any number of people to have a baby that is his/her/their genetic offspring (see summary here for ethical arguments fully supportive of these techniques and here for legal arguments both pro and con). We have already crossed into the concept of group parenting with maternal spindle cell transfer used to prevent mitochondrial disease (the so-called three parent babies). With IVG, we needn’t stop at just three parents (from the Palacios-Gonzalez et. al. link):

“IVG could permit instead a much more substantive sharing of genetic kinship, through what is in essence a generational shortcut. Imagine that four people in a relationship want to parent a child while being all genetically related to her. IVG would enable the following scenario: first, two embryos would be generated from either couple through IVF with either naturally or in vitro generated gametes. hESC lines would be then established from both embryos and differentiated into IVG to be used in a second round of IVF. The resulting embryo would be genetically related to all four prospective parents, who would technically be the child’s genetic grandparents.”

There is a huge amount of ethical ground to consider with these technologies and most will be left to future blog-space. Let’s just consider one aspect. Traditionally, a heterosexual couple wasn’t really a family until they had a baby. ART is allowing (and perhaps will soon further allow) our culture’s expanding definition of what constitutes a family to have a baby that is his/her/their genetic offspring. So is ART driving an expanded definition of family, or is our expanded definition of family, in some sense, driving ART? Should we be asking a village to make a child?