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Good morning! Today’s newsletter top draws from a sweeping report by my colleagues Lenny Bernstein and Yeganeh Torbati. And for a lighter side of Washington, check out <a href="https://www.washingtonpost.com/style/2024/04/28/biden-trump-white-house-correspondents-dinner-2024/">The Post’s recap</a> of Saturday’s White House correspondents’ dinner. Not a subscriber? <a href="https://www.washingtonpost.com/newsletters/the-health-202/">Sign up here.</a>

Today’s edition: The Biden administration is finalizing new federal protections for LGBTQ+ Americans and others seeking health-care services. Why some researchers are skeptical about the data supporting an application for federal approval of the psychedelic drug MDMA. But first …

Inside the opaque world of IVF, where errors are rarely made public

Hannah Yoon

When a storage tank at a <a href="https://www.washingtonpost.com/national/health-science/fertility-clinic-informs-hundreds-of-patients-their-eggs-may-be-damaged/2018/03/11/b605ea82-2536-11e8-b79d-f3d931db7f68_story.html?itid=lk_inline_manual_2">San Francisco fertility center imploded</a>, 4,000 human eggs and embryos were damaged or destroyed. A subsequent jury ruling attributed much of the disaster to a manufacturing flaw while also implicating the center itself.

A closer look: The lab director had unplugged a malfunctioning computer, muting 128 alarms that warned of trouble. Lab personnel didn’t transfer the tank’s contents to a backup vessel after the computer failed.&nbsp;

The missteps came to light in a lawsuit and civil trial in 2021, offering a rare glimpse into the insular world of U.S. fertility care. Experts say errors and accidents often go unreported in the <a href="https://www.washingtonpost.com/wellness/2022/11/10/ivf-infertility-success-failure-struggles/?itid=lk_inline_manual_3">burgeoning industry</a>, which is <a href="https://www.washingtonpost.com/business/2024/03/07/alabama-ivf-sex-selection-ethics/?itid=lk_inline_manual_3">largely self-policed</a>. Despite a code of ethics mandating practitioners to promptly inform patients of lost or damaged genetic material, there is no requirement to report such incidents to any governing body, professional organization or the public.&nbsp;

The opaque system is under scrutiny again after the Alabama Supreme Court ruled this year that <a href="https://www.washingtonpost.com/nation/2024/02/20/ivf-treatment-alabama-embryo-ruling/?itid=lk_inline_manual_5">frozen embryos are children</a>. That case involved a patient who accidentally dropped and destroyed embryos belonging to three couples at a fertility clinic.

In vitro fertilization (IVF), a process in which an egg is fertilized in a laboratory and later implanted in the uterus, is the most common form of assisted reproduction.

The demand for IVF services in the United States has surged, with 167,689 cycles for freezing eggs and embryos recorded in 2021, nearly doubling since 2017. This heightened demand has strained IVF clinics, exacerbating the shortage of trained lab workers.

The industry insists the error rate is low. Sean Tipton, chief advocacy and policy officer for the American Society for Reproductive Medicine, which represents fertility practitioners, disputed the idea that they are more lightly regulated than other medical disciplines: “For the most part reproductive medicine and infertility care are regulated the same way as other areas of medicine.”

If all else fails, he said, patients have access to the courts to redress wrongdoing. But attorneys say many cases result in settlements with nondisclosure provisions before lawsuits are filed, reinforcing the secrecy that surrounds the industry.

Without data on errors, experts say it’s impossible to measure the quality of U.S. reproductive care.&nbsp;

While states license clinics and professional bodies oversee practitioners, inspection and accreditation of labs primarily fall to private, voluntary organizations. Many inspectors are lab directors themselves who review one another’s work looking for systemic problems, not lost reproductive material, according to the College of American Pathologists.&nbsp;

Several federal organizations play limited roles in overseeing the field. The Centers for Disease Control and Prevention <a href="https://urldefense.com/v3/__https://www.cdc.gov/art/artdata/index.html__;!!M9LbjjnYNg9jBDflsQ!HrxCYewFA8yxCG5hXrv0QodHPh2vgFd07B8oy9-tHJygIqpKNa3hFLrWuWGsx8BZnqxOCdYfDxIWTzZ3p6DRQg$">collects data on success rates</a> from more than 450 clinics, while the Food and Drug Administration inspects equipment and tissue to prevent disease transmission. The Centers for Medicare and Medicaid Services, which administers laboratory laws, also exerts some oversight.&nbsp;

However, the federal government generally stays out of fertility clinics because of the fraught politics, for both Democrats and Republicans, of regulating the creation and destruction of embryos.

You can read Lenny and Yeganeh’s full report <a href="https://www.washingtonpost.com/health/2024/04/28/ivf-errors-fertility-clinics-regulation/">here</a>.&nbsp;

Biden administration reinstates LGBTQ+ protections in health care

Carolyn Kaster

The Biden administration is <a href="https://www.washingtonpost.com/health/2024/04/26/biden-lgbtq-health-care-protections/">reinstating federal protections</a> for LGBTQ+ people seeking health care that had been unraveled during the Trump administration, my colleagues Fenit Nirappil and Dan Diamond report.&nbsp;

The details: Under <a href="https://public-inspection.federalregister.gov/2024-08711.pdf">sweeping rules</a> finalized Friday by the Department of Health and Human Services, government health officials, federally funded organizations and health insurers operating through government plans must abide by the nondiscrimination standards.

The rules also contain more broadly applicable provisions, such as requiring health providers and other recipients of federal money to inform patients about free services offering accessibility and language assistance.&nbsp;

Key context: The move follows years of legal disputes and pressure from activists to protect patients <a href="https://www.washingtonpost.com/health/interactive/2023/transgender-health-care/?itid=lk_inline_manual_2">undergoing gender-affirming treatment</a> or who received abortions from being denied other forms of health care.&nbsp;

Conservatives oppose the rules prohibiting discrimination, arguing they could force providers to offer services against their religious beliefs. However, federal officials say the rules preserve religious exemptions, emphasizing that the policy aims to prevent discrimination against patients rather than compelling providers to perform procedures.&nbsp;

On our radar: The debate over discrimination in health care is poised to continue, as conservatives have signaled plans to resist the Biden administration’s attempt to cement protections.&nbsp;

Sarah Kate Ellis, president and CEO of the advocacy group GLAAD:

The administration is again <a href="https://www.washingtonpost.com/health/2024/04/26/menthol-cigarette-ban-delayed-biden-administration/">delaying a ban on menthol cigarettes</a> amid election-year pushback, Dan reports.

“It’s clear that there are still more conversations to have, and that will take significantly more time,” HHS Secretary Xavier Becerra said in a statement Friday, citing an “immense amount of feedback” on the policy.&nbsp;

The bigger picture: Public health experts and civil rights groups have repeatedly urged <a href="https://www.washingtonpost.com/elections/candidates/joe-biden-2024/" target="_blank" class="contextual_link">President Biden</a> to finalize the ban, which was originally anticipated last summer but has been <a href="https://www.altria.com/en/about-altria/federal-regulation-of-tobacco/menthol-in-cigarettes-and-cigar-characterizing-flavors">fiercely opposed by the tobacco industry</a>. Political advisers <a href="https://www.washingtonpost.com/health/2024/01/10/menthol-cigarette-ban-white-house-decision/">have warned</a> that the president could lose support by banning products popular in the Black community, jeopardizing votes in what is expected to be a close election in November.

The FDA, which developed the ban, has said it remains committed to implementing the rules, pending White House approval. Outside advocates have said there is no proof the ban would harm Biden’s reelection prospects — and clear evidence for its public health benefits.

Agony over ecstasy: FDA bid shows it’s hard to test psychedelics

Travis Dove

The first attempt to win government approval of a psychedelic drug for mental health treatment is <a href="https://www.washingtonpost.com/health/2024/04/27/mdma-ecstasy-therapy-fda-psychedelic/">facing skepticism</a> about its clinical trials, The Post’s David Ovalle and Daniel Gilbert report.&nbsp;

A recent independent analysis questioned the integrity of patient studies being used to support an <a href="https://www.washingtonpost.com/business/2023/12/12/mdma-therapy-fda-maps/?itid=lk_inline_manual_4">FDA application for MDMA</a> to treat post-traumatic stress disorder, citing several issues.&nbsp;

Among the most difficult to overcome: Subjects in the placebo arm of the trials knew they didn’t get the real drug because they didn’t experience distortions in consciousness, according to the <a href="https://icer.org/wp-content/uploads/2024/03/PTSD_Draft-Report_For-Publication_03262024.pdf">draft report</a> by the nonprofit Institute for Clinical and Economic Review (ICER). In other words, the trial was not “blinded” for purposes of comparing the drug’s effect, which undermines the results.

Why it matters: ICER’s report underscores the FDA’s complex decision and its implications for insurers, who rely on such assessments for coverage choices. While some PTSD patients experienced “substantial benefit,” the nonprofit found the trial evidence too murky to determine a net benefit or a fair price.&nbsp;

The view from the industry: “We stand behind the design and results of our clinical trials,” a spokesperson for Lykos Therapeutics, the company seeking the drug approval, said in a statement. The company emphasized that PTSD symptoms were assessed by staff unaware of whether participants received the drug or placebo, aiming to maintain neutrality.&nbsp;

Lykos expects an FDA decision on MDMA-assisted therapy by August, with the agency having <a href="https://www.washingtonpost.com/national/health-science/ecstasy-could-be-breakthrough-therapy-for-soldiers-others-suffering-from-ptsd/2017/08/26/009314ca-842f-11e7-b359-15a3617c767b_story.html?itid=lk_inline_manual_64">fast-tracked</a> its approval process.&nbsp;

The FDA announced <a href="https://www.fda.gov/food/alerts-advisories-safety-information/updates-highly-pathogenic-avian-influenza-hpai">that initial test results</a> of fertilized eggs — the “gold standard” method used to detect active virus — didn’t find any live, infectious H5N1 in the commercial milk supply. This reaffirmed the agency’s assessment that the commercial milk supply is safe, the FDA said Friday.

The Federal Trade Commission is <a href="https://www.ftc.gov/news-events/news/press-releases/2024/04/ftc-finalizes-changes-health-breach-notification-rule">finalizing its plan</a> to expand the scope of its Health Breach Notification Rule to include personal health information collected by digital apps and other technology not covered by existing federal health privacy laws.&nbsp;

On our radar: Mississippi Senate leaders on Friday said for the first time that they are <a href="https://abcnews.go.com/Health/wireStory/mississippi-legislative-leaders-swap-proposals-medicaid-expansion-109705138">willing to expand Medicaid</a> to the full level allowed under the Affordable Care Act, as long as there is a work requirement for recipients, Emily Wagster Pettus reports for the Associated Press.&nbsp;

📅 Welcome back, Congress! The House reconvenes today, while the Senate resumes tomorrow. Here’s what we’re watching this week:

On Tuesday: A House Energy and Commerce subcommittee <a href="https://energycommerce.house.gov/posts/chairs-rodgers-and-guthrie-announce-subcommittee-hearing-on-legislation-to-increase-medicaid-access-and-improve-program-integrity">will consider</a> 19 legislative proposals aimed at increasing Medicaid access and bolstering program integrity; a Senate Armed Services subcommittee <a href="https://www.armed-services.senate.gov/hearings/to-receive-testimony-on-the-department-of-defenses-efforts-to-ensure-servicemembers-access-to-safe-high-quality-pharmaceuticals">will examine</a> the Defense Department’s efforts to ensure service members' access to safe, high-quality pharmaceuticals.&nbsp;

On Wednesday: Peter Daszak, president of EcoHealth Alliance, <a href="https://energycommerce.house.gov/posts/eco-health-alliance-president-peter-daszak-to-appear-for-public-hearing">will testify</a> before the House select subcommittee on the <a href="https://www.washingtonpost.com/coronavirus/" target="_blank" class="contextual_link">coronavirus</a> pandemic regarding the nonprofit’s virology research and the origins of covid-19; a House Appropriations subcommittee <a href="https://appropriations.house.gov/events/hearings/budget-hearing-fiscal-year-2025-request-indian-health-service">will review</a> the president’s fiscal 2025 budget request for the Indian Health Service.&nbsp;

Across the Capitol, UnitedHealth Group CEO Andrew Witty <a href="https://www.finance.senate.gov/hearings/hacking-americas-health-care-assessing-the-change-healthcare-cyber-attack-and-whats-next">will testify</a> before the Senate Finance Committee on the <a href="https://www.washingtonpost.com/business/2024/03/03/change-health-care-hack-hospitals/">Change Healthcare cyberattack</a>.&nbsp;

On Thursday: The Senate Health, Education, Labor and Pensions Committee <a href="https://www.help.senate.gov/hearings/what-can-congress-do-to-address-the-severe-shortage-of-minority-health-care-professionals-and-the-maternal-health-crisis">will examine</a> what Congress can do to address shortages of minority health-care professionals and the maternal health crisis.

<a href="https://www.wsj.com/health/wellness/child-caregivers-caring-parents-2b956149?mod=hp_lista_pos2" target="_blank">Millions of American kids are caregivers now: ‘The hardest part is that I’m only 17’ (By Clare Ansberry | The Wall Street Journal)</a>

<a href="https://www.propublica.org/article/cigna-medical-director-doctor-patient-preapproval-denials-insurance" target="_blank">A Doctor at Cigna Said Her Bosses Pressured Her to Review Patients’ Cases Too Quickly. Cigna Threatened to Fire Her. (By Patrick Rucker | The Capitol Forum and David Armstrong | ProPublica )</a>

<a href="https://apnews.com/article/florida-lethal-restraint-police-sedation-injections-94041bb6599a88a883c4effc7afb559a" target="_blank">At least 17 people died in Florida after medics injected sedatives during encounters with police (By Ryan J. Foley and Carla K. Johnson | The Associated Press)</a>

Thanks for reading! See you tomorrow.

American University, BA in journalism

McKenzie Beard is a researcher for The Health 202, a morning newsletter and daily guide to Washington's health-care policy debate. She started at the Post as an American University practicum student on the investigative desk in 2021 and has previously reported for Voice of America and Teen Vogue.

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