The Biden administration announced on Monday it would enforce civil rights protections under Obamacare to prohibit discrimination in health care against patients for being LGBTQ, reversing policy during the Trump years excluding transgender status as a protected characteristic under the law.
The Department of Health & Human Services declared it would enforce Section 1557 of the Affordable Care Act, which prohibits discrimination in health care on the basis of sex, and begin to take up cases of discrimination based on sexual orientation and gender identity.
HHS Secretary Xavier Becerra said in a statement the Supreme Court has “made clear that people have a right not to be discriminated against on the basis of sex and receive equal treatment under the law, no matter their gender identity or sexual orientation.”
“Fear of discrimination can lead individuals to forgo care, which can have serious negative health consequences,” Becerra said. “It is the position of the Department of Health and Human Services that everyone — including LGBTQ people — should be able to access health care, free from discrimination or interference, period.”
The move is consistent with the executive order President Biden signed on his first day in office directing federal agencies to implement the U.S. Supreme Court’s decision last year in Bostock v. Clayton County to the furthest extent possible. Federal agencies were directed to comply within 100 days of the executive order, which is about now and a short time after Biden’s first 100 days in office.
The announcement with respect to Section 1557 comes on the same day as the hearing took place this morning in Bagly v. HHS, a case before a federal court in Massachusetts challenging Trump’s undoing of transgender protections under the law. An attorney with the U.S. Justice Department announced a new notice of proposed rule-making is coming with respect to Section 1557.
Sharita Gruberg, vice president for the LGBTQ Research and Communications Project at the Center for American Progress, said in a statement the change “assures LGBTQ people that their rights will be upheld at the doctor’s office, vaccine sites, and everywhere else they seek health care and coverage.”
“The administration’s announcement that it will enforce these protections are a critical step toward addressing vaccine hesitancy among LGBTQ people, a population that has been disproportionately impacted by the pandemic and seriously harmed by the previous administration’s attempts to permit discrimination against LGBTQ patients, Gruberg added.
The past three administrations have instituted policy on LGBTQ protections based on their interpretation of Section 1557. Each move had varying implications and directions for LGBTQ patients.
The Obama administration issued a rule in 2016 interpreting Section 1557 to apply to cases of anti-transgender discrimination and discrimination against women who have had abortions, which was consistent with court rulings at the time. However, that move was enjoined by a nationwide court order in Texas as a result of litigation filed by Texas Attorney General Ken Paxton.
The Trump administration, shortly after the Supreme Court’s ruling in Bostock, made final a regulation proposed last year rescinding the Obama administration’s transgender protections under Section 1557. Faced with criticism, the Trump administration defended itself by saying its move was consistent with the court order in Texas, although it seemed to ignore the decision from the higher court.
The new rule from HHS goes above and the beyond the Obama administration by instituting protections based on both sexual orientation and gender identity. It wasn’t immediately clear whether the proposed rule would be a new regulation entirely, or seek to modify the changes that were made in the two previous administrations. The Blade has placed a request seeking comment with HHS.
Susan Bailey, president of the American Medical Association, said in a statement the new HHS rule is a welcome change after the Trump administration rescinded protections for transgender patients.
“It’s unfortunate that such an obvious step had to be taken; the AMA welcomes this common-sense understanding of the law,” Bailey said. “This move is a victory for health equity and ends a dismal chapter in which a federal agency sought to remove civil rights protections.”
Discrimination in health care is an experience transgender people commonly report. The U.S. Transgender Survey in 2015 found one-third of responders said they had at least one negative experience in health care related to being transgender. Further, 23 percent of responders said they didn’t seek health care because they feared being mistreated and one-third said they didn’t go to a provider because they couldn’t afford it.
A Center for American Progress survey from 2018 had similar findings with respect to transgender people and patients with being gay, lesbian and bisexual or queer. Eight percent of responders said a doctor refused to see them because of their perceived or actual sexual orientation, while 28 percent of providers said a doctor refused to see them because of their actual or perceived sexual orientation.
Hospitals, especially religiously affiliated providers, refusing to provide transition-related care, including gender assignment surgery, is another frequently reported incident for transgender patients. The American Civil Liberties Union, for example, has filed litigation against hospitals under Section 1557 for refusing to perform the procedure.
Rachel Levine, assistant secretary of health and the first openly transgender presidential appointee to obtain Senate confirmation, hailed the HHS rule change in a statement.
“The mission of our Department is to enhance the health and well-being of all Americans, no matter their gender identity or sexual orientation. All people need access to healthcare services to fix a broken bone, protect their heart health, and screen for cancer risk,” Levine said. “No one should be discriminated against when seeking medical services because of who they are.”
Although the Biden administration’s announcement is a welcome move for LGBTQ advocacy groups, the change is not without critics.
John Banzhaf, a law professor at George Washington University who declares himself a supporter of transgender rights, said the policy could have unintended consequences, which he said has become evident in the British health system.
“[Transgender] individuals with a penis but no vagina are being asked to have medical tests on their non-existent cervices, while [transgender] persons with a vagina and cervix will not be asked, under new guidelines which appear to place lives at risk and encourage a physically impossible medical exam on organs which simply do not exist,” Banzhaf said. “And, carrying this absurdity to its totally illogical conclusion, a patient with a penis and a full beard was offered a cervical test because, despite his clearly masculine appearance and style of dress, he registered himself as being gender neutral.”
Transgender immigrant activists march to White House
Marchers demanded end to ICE detention of trans, HIV-positive people
More than 100 people marched to the White House on Wednesday to demand the Biden administration end the detention of transgender people and people with HIV/AIDS in U.S. Immigration and Customs Enforcement facilities.
Casa Ruby CEO Ruby Corado and other marchers left National City Christian Church in Thomas Circle after organizers held a “funeral” for three trans women — Roxsana Hernández, Victoria Arellano and Johana “Joa” Medina Leon — who died while in ICE custody or immediately after the agency released them.
Hernández, a trans woman with HIV from Honduras, died in a hospital in Albuquerque, N.M., on May 25, 2018, while in ICE custody. Arellano, a trans woman with HIV from Mexico, passed away at a hospital in San Pedro, Calif., while in ICE custody.
ICE released Medina, a trans woman with HIV from El Salvador, from its custody on May 28, 2019, the same day it transferred her to a hospital in El Paso, Texas. Medina died three days later.
Hernández’s family has filed a lawsuit against the federal government and the five private companies that were responsible for her care.
Isa Noyola, deputy director of Mijente, one of the immigrant advocacy groups that organized the march, emceed the “funeral.” Noyola played a message that Hernández’s nephew in Honduras recorded.
“The state does not recognize our humanity,” said Noyola, who became emotional at several points during the service.
A press release that announced the events said 25 trans women who had previously been in ICE custody participated. They, along with other participants, blocked traffic at the intersection of 16th and H Streets, N.W., near Black Lives Matter Plaza for several minutes before they marched into Lafayette Square.
March participants also carried three pink coffins that represented Hernández, Arellano and Medina. They propped them up on a security fence along Pennsylvania Avenue before they staged a die-in.
The march took place a week after Mijente and seven other immigrant advocacy groups in a letter to Homeland Security Secretary Alejandro Mayorkas and acting ICE Director Tae Johnson demanded the release of all trans people and people with HIV who are in immigrant detention facilities.
The White House on Tuesday announced asylum seekers who saw their cases closed under the previous administration’s “Remain in Mexico” policy will be allowed to enter the U.S. in order to pursue them. Vice President Kamala Harris, who traveled to Guatemala earlier this month, has also acknowledged anti-LGBTQ violence is one of the “root causes” of migration from Central America’s Northern Triangle.
‘Our only crime is to seek opportunities, to seek refuge’
Li An “Estrella” Sánchez, a trans woman from Mexico’s Veracruz state who the U.S. has granted asylum, is among those who participated in the march.
She told the Washington Blade during an interview in Lafayette Square after the march that she spent 13 months in ICE custody at three Georgia detention centers — the Atlanta City Detention Center, the Irwin County Detention Center and the Stewart Detention Center — before her release in 2013. Sánchez, who founded Community Estrella, an Atlanta-based organization that advocates for ICE detainees who identify as LGBTQ, said she and other trans ICE detainees face inadequate access to health and solitary confinement, among other things.
“I know first hand what they felt,” said Sánchez, referring to the three trans women who died in ICE custody or immediately after their release. “I wouldn’t wish it upon my worst enemy to be in a jail.”
“Our only crime is to seek opportunities, to seek refuge, to seek protection, to seek security,” she added.
Sánchez also had a message for President Biden.
“Listen, because the people are continuing the fight,” said Sánchez. “You have promised to support the LGBT community and you are really forgetting the immigrant community.”
VA to start process of covering gender reassignment surgery for trans veterans
Coverage was rejected even during Obama years
The Department of Veterans Affairs has become the latest federal government health program to affirm it would begin covering gender reassignment surgery — an option for transgender veterans that was even rejected during the Obama administration.
Randal Noller, a VA spokesperson, said in response to an email inquiry from the Blade the department this summer “will initiate steps to modify rules published in the Code of Federal Regulations (also known as the CFR), to expand VA’s care to transgender Veterans and include gender-affirming surgery.”
“Gender-affirming procedures have been proven effective at mitigating serious health conditions, including suicidality, substance abuse, and dysphoria,” Noller said. “Updating this policy would allow VA to provide transgender and gender diverse Veterans with coordinated, medically necessary, transition-related surgical procedures.”
Noller added the change “would enable a safe, coordinated continuum of care that is Veteran-centric and consistent with VA values of equity and respect for all veterans.” The entire process for implementation, Noller said, can take about two years and includes a period of public comment.
VA Secretary Denis McDonough first announced the policy change in a speech in Orlando marking the five-year anniversary of the mass shooting at the Pulse nightclub.
Once implemented, the VA would join other federal health care systems in offering coverage for gender reassignment surgery, which previously has included Medicare, Medicaid (other some states, like Iowa, are dubiously claiming exemptions), the Federal Employee Health Benefits programs and the U.S. military health care system as a result of the Biden administration reversing the transgender military ban.
The idea of the VA offering coverage for gender reassignment surgery was first raised during the Obama administration. However, in the lame duck session after former President Trump was elected, the then-Secretary of Veterans Affairs scrapped the idea, citing concerns about appropriate funding.
According to the National Center for Transgender Equality, the estimated number of U.S. veterans who are transgender is more than 134,000, and more than 15,000 transgender people are serving in the military today.
Mara Keisling, executive director of the National Center for Transgender Equality, hailed the change in a statement on Saturday as “another step in the Biden administration’s effort to fight discrimination against transgender people, including our transgender veterans.”
“Every veteran deserves to have access to the health care that they need, and the VA is working to make sure that includes transgender veterans as well,” Keisling said.
HIV research sped development of COVID vaccine
Top NIH official says success in coronavirus will boost AIDS work
Since 1996, Carl W. Dieffenbach, who holds a Ph.D. in biophysics from John Hopkins University, has served as director of the Division of AIDS at the National Institute of Allergies and Infectious Diseases, which is an arm of the U.S. National Institutes of Health or NIH.
In a June 10 interview with the Washington Blade, Dieffenbach gave an update on the extensive, ongoing research into the development of an HIV/AIDS vaccine that he has helped to coordinate for many years, including current human trials for a prospective AIDS vaccine taking place in the U.S., South America, and Africa.
One thing he feels passionate about is a development not widely reported in the media reports about the successful development of the COVID-19 vaccine. According to Dieffenbach, the extensive research into an AIDS vaccine in recent and past years, while not yet successful in yielding an effective AIDS vaccine, helped lay the groundwork for the rapid development of the different versions of a COVID vaccine.
“Because my division runs the largest clinical trials program in the word, we jumped in with both feet to help with coronavirus disease for both vaccines and drugs and things like that,” he said. “And the platforms that were used – the way they are making the coronavirus vaccines – the RNA vaccines with Moderna – were first piloted by NIH and Moderna to try to make an HIV vaccine,” Dieffenbach says.
“So, in many ways, the work for the past 25 years that we’ve done in HIV vaccines sped the development of coronavirus vaccines,” he told the Blade. “And now it’s time to take what we’ve learned from coronavirus and take it back to HIV and start afresh or continue with what we have and build upon from what we have learned.”
Dieffenbach says one reason the development of a COVID vaccine came about before an AIDS vaccine, despite more than 20 years of AIDS vaccine research, is that the HIV virus is far more complex than the coronavirus, especially its ability to infect and remain embedded in the infected person for life.
“Back in 2007 we had the first hint that an AIDS vaccine might be possible with a study called RV144,” Dieffenbach says. “We spent 10 years trying to replicate that, and we just completed that study – a study called HVTN702. And it showed no efficacy,” he said, meaning it did not work.
“So that was a big disappointment to us,” he says “But in the meantime, we had pushed forward with the J&J [Johnson and Johnson pharmaceutical company] vaccine and are pretty far along. We’ll see what happens. We should know in the next several months whether the N26 version of an AIDS vaccine, and HIV vaccine works or not,” he says. “We’re very close to an answer.”
Washington Blade: Where do things stand in the development of an HIV/AIDS vaccine in light of Dr. Fauci’s statement a few weeks ago that the development of a COVID-19 vaccine could provide a boost to developing an AIDS vaccine?
Carl Dieffenbach: Sure. So, maybe I can start by introducing myself to you as a way of putting this into a context.
So, I’m the director of the Division of AIDS, which is the largest funder of HIV research in the world. And I report directly to Dr. Fauci. So, I’m responsible for all AIDS, all the time. And that is my passion and purpose in life. Part of that is working toward a safe, effective, and durable HIV vaccine, which has been one of the two most challenging questions left in science today. The other is a cure. They are connected in some ways.
So, with that as background, when coronavirus disease came along – because my division runs the largest clinical trials program in the world – we jumped in with both feet to help with coronavirus disease for both vaccines and drugs and things like that. And the platforms that were used – the way they are making the coronavirus vaccines – the RNA vaccines with Moderna were first piloted by NIH and Moderna to try to make an HIV vaccine. So, we’ve being working on that platform with Moderna for several years.
The leadership at Pfizer used to be part of a group at Penn, where we were also working with them. The J&J vaccine – we currently have in two Phase III clinical trials for HIV, one in sub-Saharan Africa, specifically in young women and the other one in the Americas in men who have sex with men and transgender individuals. Both of those Phase IIIs are moving along. The women’s study is fully enrolled. The men’s study was hit hard by COVID, but we worked through and will be fully enrolled by September.
One other vaccine just to talk about is the Oxford vaccine, the AstraZeneca vaccine. That is also using a platform at Oxford University, which has been used for HIV. So, in many ways, the work for the past 25 years that we’ve done in HIV vaccines sped the development of coronavirus vaccines. And now it’s time to take what we’ve learned from coronavirus and take it back to HIV and start afresh or continue with what we have and build upon from where we have learned.
Blade: That’s very interesting. But can we assume, then, from the clinical trials that have taken place for an HIV vaccine that they did not succeed in providing the immunity needed for an effective vaccine?
Dieffenbach: So, that’s exactly the problem we have. Back in 2007 we had the first hint that an AIDS vaccine might be possible with a study called RV144. We spent 10 years trying to replicate that, and we just completed that study – a study called HVTN702. And it showed no efficacy. So, that was a big disappointment to us. But in the meantime, we had pushed forward with the J&J vaccine and are pretty far along. We’ll see what happens. We should know in the next several months whether the N26 version of an AIDS vaccine, and HIV vaccine works or not. We’re very close to an answer.
Blade: So, the human trials are ongoing.
Dieffenbach: Oh, again – the study in young women in sub-Sahara Africa is fully enrolled. The men’s study will be fully enrolled in September. So, we have fought through the coronavirus epidemic to maintain, to nurse these trials along to make sure with the $100 million or so we’ve invested, that we didn’t want them to go down the drain literally because we lost too many people for follow-up. So, this was a herculean effort that has gone on all the time trying to do the vaccine studies for coronavirus disease, which we were also incredibly successful in.
Blade: Can we assume all of the people participating in the studies were HIV negative?
Dieffenbach: Yes, they’re HIV negative. They are people who are at risk. And also, in South America, for example, the major countries we’re in are Peru and Brazil. And they’ve had a strong research culture with us, going back more than a decade. For example, both of those countries played big roles in our studies of pre-exposure prophylaxis. A study called I-PREX that demonstrated that in men who have sex with men that [a PrEP drug] works well to prevent HIV acquisition in seronegative men who have sex with men.
So, we’ve been there. This is a really good setup for the countries, for the citizens that are in those countries that want to avail themselves to the research that has benefited everybody.
Blade: Among those who are participating in these ongoing AIDS vaccine trials, can we assume they cannot be taking the PrEP anti-retroviral drugs that have been shown to be highly effective in preventing HIV infection?
Dieffenbach: So, what we’ve done is we – everything is by conversation. So, when somebody who is interested in the study comes in, we talk to them. What is your chief interest in being in this study? And a lot of people want to be in the study because then they can access PrEP. They want to make it easier to get a hold of pre-exposure prophylaxis. They feel that is the best way that they can protect themselves.
So, in that situation, what we do is we take those people and link them to PrEP services where they can easily get PrEP in their community. So, first it’s taking care of those people. Then there are people who really have no interest in PrEP. And we actually counsel them every time they come in for a study. Are you sure you don’t want to access PrEP? And those are the people we then say, if you’re not interested in PrEP, what do you think about participating in a vaccine trial?
Because they’re the ones who have the most freedom of thought. They don’t have an opinion about the vaccine or about PrEP. So, those are the people we’ve been focusing on and enrolling. So, we’ve been very careful to make sure that if people wanted PrEP they not only have access, but they didn’t feel like somehow having to trade something in order to get it. The freedom to join a study should be a free choice. And it shouldn’t be a coercive thing to get PrEP. So, we just took that off the table and said if you’re truly interested in PrEP we can get you PrEP and make sure that was available.
Blade: So, in that case, if they choose PrEP they would not be in the vaccine trial?
Dieffenbach: You know, it’s interesting that you ask it in that way. Because you have relationships with your community, many of the investigators have reported that people will say, you know I tried PrEP and it wasn’t for me. It made me gaseous. It upset my stomach. I wasn’t myself. I tried it. I couldn’t make it work for me. I want to stop PrEP. Am I still eligible for the [vaccine] study? And the answer is of course. Many people are very happy on PrEP and they come in for visits occasionally and say this is working for me and just have the relationship with the doctors there, so it works. So, again, it’s about maintaining contact with your communities.
Blade: Can you tell a little about what happens next after people become part of an HIV vaccine trial. Do you have to keep in touch with these people, and do they have to get an HIV test periodically?
Dieffenbach: Exactly. So, the vaccine consists of a series of injections. It’s a mixture of vector systems that delivers a series of encoded HIV genes that are specifically designed to induce very broad immunity. There’s a whole computer-based process to design those components of the vaccine to make sure that it has sequence similarities with all the different versions of HIV circulating in the globe. And then at the end there is a protein boost. And we carry this out.
So, about every three to four months people come in. They get a shot. They fill out questionnaires. They give a blood sample. And they’re tested for HIV and are given a boost or a placebo. And they stay in touch with the clinic. They come in and out of the clinic. And the retention is quite high in these situations because people really like having the attention of the clinic available to them. It’s part of the community.
Blade: So, they go to a clinic for all of this?
Dieffenbach: It’s a research clinic. It’s not like a state-run health clinic. It’s a research clinic. Clinic is just a term for where people are seen.
Blade: Are any of these AIDS vaccine trials that are going on taking place in the United States?
Dieffenbach: Yes. So, the study is called Mosaico. And it’s HVTN706. And we have sites throughout the United States as well as South America. But that study is limited to men who have sex with men – the one in the United States.
Blade: Is it broader than just men who have sex with men in other countries?
Dieffenbach: No, so we decided to really focus on specific at-risk populations. So, in the Americas we chose to focus on men who have sex with men and transgender individuals. And sub-Saharan Africa we focused on young women because that is the target of the study population. So, 705 is all women in sub-Saharan Africa. And in the Americas in North and South America it is all men who have sex with men and transgender individuals.
Blade: Can we assume that the researchers that are doing these studies have a sensitivity of LGBTQ people? Is there still an issue where people worry about being outed as being gay or transgender?
Dieffenbach: So, many of the sites that we work with have been part of our system for over 20 years. And so, they are trusted members of the LGBTQ community within their cities and states. And ‘states’ is a literal term where it’s a state in Colombia or Peru or Brazil. And so, it is part of the fabric of the gay community in these places. Just like in San Francisco the San Francisco health clinic and the DCF clinics are part and parcel of everything the community does there.
And so, the lead physician in San Francisco is Susan Buchbinder. She has been a leader in health in this population for over 25 years or actually closer to 30 years at this point. We’re all getting old. Do you know that? So, we have been at this a very long time. And really have tried to build structures that are durable and therefore are reliable to the community. And that’s where we go back to the same groups time after time.
Blade: Have the locations of the vaccine testing sites been released publicly?
Dieffenbach: Yes, all of that is publicly available on clinicaltrials.gov. If you go into clinicaltrials.gov and search HVTN705 or HVTN706 you will get a version of the protocol, all the times it’s been modified, where we are – the protocol. All of that is public knowledge and available to you. HVTN705 is the women’s study. HVTN706 is the men’s study.
Blade: Is there a timeframe for when these latest vaccine studies might be completed?
Dieffenbach: I think within the next several months. We will get an answer out of the women’s study and then the men’s study is probably a year away. We were slowed a little bit because of COVID. We actually had to pause enrollment for several months. But we’re back on track.
Blade: Isn’t there a parallel research effort for an HIV/AIDS cure?
Dieffenbach: Yes, we have a very large program in cure research. It is a lot earlier in the discovery process and so it’s still very ‘researchy.’ And we have a very large program called the Martin Delany Collaboratories for Cure Research. Martin Delany was an activist who really pushed NIH in so many wonderful ways to really take the need for a cure seriously. His argument was a cure is the next logical step after effective anti-retroviral therapy. You cannot stop with one pill once a day. You’ve got to keep going. And he was pretty persistent. And unfortunately, he died several years go and we just thought the best way to honor him, and his memory was to name a program after him.
Editor’s note: Next week, in the second and final installment of his interview with the Blade, Dr. Dieffenbach discusses the progress in research and studies into an HIV/AIDS cure and explains from a scientific standpoint why an HIV vaccine is taking longer to develop than a COVID vaccine.
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