Kaiser Health News

FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men

Published

3 weeks ago

May 24, 2024

Rae Ellen Bichell
Fri, 24 May 2024 09:00:00 +0000

The federal government in 2020 and 2023 changed who it said could safely donate organs and blood, reducing the restrictions on men who have had sex with another man.

But the FDA's restrictions on donated tissue, a catchall term encompassing everything from a person's eyes to their skin and ligaments, remain in place. Advocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular, said they are frustrated the FDA hasn't heeded their calls. They want to align the guidelines for tissue donated by gay and bisexual men with those that apply to the rest of the human body.

Such groups have been asking the FDA for years to reduce the deferral period from five years to 90 days, meaning a man who has had sex with another man would be able to donate tissue as long as such sex didn't occur within three months of his death.

One of the loudest voices on lightening the restrictions is Sheryl J. Moore, who has been an advocate since her 16-year-old son's death in 2013. Alexander “AJ” Betts Jr.'s internal organs were successfully donated to seven people, but his eyes were rejected because of a single question asked by the donor network: “Is AJ gay?”

Moore and a Colorado doctor named Michael Puente Jr. started a campaign called “Legalize Gay Eyes” and together got the attention of national eye groups and lawmakers.

Puente, a pediatric ophthalmologist with the University of Colorado School of Medicine and Children's Hospital Colorado, said the current patchwork of donor guidelines is nonsensical considering advancements in the ability to test potential donors for HIV.

“A gay man can donate their entire heart for transplant, but they cannot donate just the heart valve,” said Puente, who is gay. “It's essentially a categorical ban.”

The justification for these policies, set 30 years ago as a means of preventing HIV transmission, has been undercut by the knowledge gained through scientific progress. Now, they are unnecessary and discriminatory in that they focus on specific groups of people rather than on specific behaviors known to heighten HIV risk, according to those who advocate for changing them.

Since 2022, the FDA's Center for Biologics Evaluation and Research has put changes to the tissue guidance on its agenda but has yet to act on them.

“It is simply unacceptable,” Rep. Joe Neguse (D-Colo.) said in a statement. He was one of dozens of Congress members who signed a letter in 2021 that said the current deferral policies perpetuate stigma against gay men and should be based on individualized risk assessments instead.

“FDA policy should be derived from the best available science, not historic bias and prejudice,” the letter read.

The FDA said in a statement to KFF Health News that, “while the absolute risk transmission of HIV due to ophthalmic surgical procedures appears to be remote, there are still relative risks.”

The agency routinely reviews donor screening and testing “to determine what changes, if any, are appropriate based on technological and evolving scientific knowledge,” the statement said. The FDA provided a similar response to Neguse in 2022.

In 2015, the FDA got rid of a policy dubbed the “blood ban,” which barred gay and bisexual men from donating blood, before replacing it in 2023 with a policy that treats all prospective donors the same. Anyone who, in the past three months, has had anal sex and a new sexual partner or more than one sexual partner is not allowed to donate. An FDA study found that, while men who have sex with men make up most of the nation's new HIV diagnoses, a questionnaire was enough to effectively identify low-risk versus high-risk donors.

The U.S. Public Health Service adjusted the guidelines for organ donation in 2020. Nothing prevents sexually active gay men from donating their organs, though if they've had sex with another man in the past 30 days — down from a year — the patient set to receive the organ can decide whether or not to accept it.

But Puente said gay men like him cannot donate their corneas unless they were celibate for five years prior to their death.

He found that, in one year alone, at least 360 people were rejected as cornea donors because they were men who had had sex with another man in the past five years, or in the past year in the case of Canadian donors.

Corneas are the clear domes that protect the eyes from the outside world. They have the look and consistency of a transparent jellyfish, and transplanting one can restore a person's sight. They contain no blood, nor any other bodily fluid capable of transmitting HIV. Scientists suspect that's why there are no known cases of a patient contracting HIV from a cornea transplant, even when those corneas came from donors of organs that did infect recipients.

Currently, all donors, whether of blood, organs, or tissue, are tested for HIV and two types of hepatitis. Such tests aren't perfect: There is still what scientists call a “window period” following infection during which the donor's body has not yet produced a detectable amount of virus.

But such windows are now quite narrow. Researchers with the Centers for Disease Control and Prevention found that nucleic acid tests, which are commonly used to screen donors, are unlikely to miss someone having HIV unless they acquired it in the two weeks preceding donation. Another study estimated that even if someone had sex with an HIV-positive person a couple of weeks to a month before donating, the odds are less than 1 in a million that a nucleic acid test would miss that infection.

“Very low, but not zero,” said Sridhar Basavaraju, who was one of the researchers on that study and directs the CDC's Office of Blood, Organ, and Other Tissue Safety. He said the risk of undetected hepatitis B is slightly higher “but still low.”

At least one senior FDA official has indirectly agreed. Peter Marks, who directs the FDA's Center for Biologics Evaluation and Research, co-authored a report last year that said “three months amply covers” the window period in which someone might have the virus but at levels too low for tests to pick up. Scott Haber, director of public health advocacy at the American Academy of Ophthalmology, said his group's stance is that the tissue donation guideline “should be at least roughly in alignment” with that for blood donations.

Kevin Corcoran, who leads the Eye Bank Association of America, said the five-year abstinence required of corneal donors who are gay or bisexual isn't just “badly out of date” but also impractical, requiring grieving relatives to recall five years of their loved one's sexual history.

That's the situation Moore found herself in on a July day in 2013.

Her son loved anime, show tunes, and drinking pop out of the side of his mouth. He was bad at telling jokes but good at helping people: Betts once replaced his little sister's lost birthday money with his own savings, she said, and enthusiastically chose to be an organ donor when he got his driver's license. Moore remembered telling her son to ignore the harassment by antigay bigots at school.

“The kids in show choir had told him he's going to hell for being gay, and he might as well just kill himself to save himself the time,” she recalled.

That summer, he did. At the hospital, as medical staff searched for signs of brain activity in the boy before he died, Moore found herself answering a list of questions from Iowa Donor Network, including, she recalled: “Is AJ gay?”

“I remember very vividly saying to them, ‘Well, what do you mean by, “Was he gay?” I mean, he's never had penetrative sex,'” she said. “But they said, ‘We just need to know if he was gay.' And I said, ‘Yes, he identified as gay.'”

The Iowa Donor Network said in a statement that the organization can't comment on Moore's case, but said, “We sincerely hope for a shift in FDA policy to align with the more inclusive approach seen in blood donation guidelines, enabling us to honor the decision of all individuals who want to save lives through organ and tissue donation.”

Moore said her son's organs helped save or prolong the lives of seven other people, including a boy who received his heart and a middle-aged woman who received his liver. Moore sometimes exchanges messages with her on Facebook.

She found out a year later that her son's corneas were rejected as donor tissue because of that conversation with Iowa Donor Network about her son's sexuality.

“I felt like they wasted my son's body parts,” Moore said. “I very much felt like AJ was continuing to be bullied beyond the grave.”

——————————
By: Rae Ellen Bichell
Title: FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men
Sourced From: kffhealthnews.org/news/article/tissue-donation-rules-fda-gay-bisexual-men-cornea-transplant/
Published Date: Fri, 24 May 2024 09:00:00 +0000

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Indiana Weighs Hospital Monopoly as Officials Elsewhere Scrutinize Similar Deals

Published

2 days ago

June 14, 2024

Staff Editor

Samantha Liss
Fri, 14 Jun 2024 09:00:00 +0000

TERRE HAUTE, Ind. — Locals in this city of 58,000 are used to having to wait at railroad crossings for one of the dozens of daily cargo trains to pass through.

But a proposed merger between the two hospitals on either side of the city could exacerbate the problem in emergencies if the hospitals shut down some services, such as trauma care, at one site, which the proposal cites as a possibility. Tom High, fire chief of a nearby township, said some first responders would be forced to transport critical patients farther, risking longer delays, if they become what locals call “railroaded” by a passing train.

That's just one of the fears in this community as Indiana officials review whether to allow Union Hospital, licensed as a 341-bed facility, to purchase the county's only other acute care hospital, the 278-bed Terre Haute Regional Hospital. The proposed deal also raises concerns about reduced tax revenue, worsening care, and higher prices.

Within the next few months, the Indiana Department of Health must find “clear evidence” that the proposed merger would improve health outcomes, access, and the quality of care. Those benefits must “outweigh any potential disadvantages.”

As the nation's health care industry has become more concentrated amid a steady clip of mergers in recent decades, it's common for one large system to dominate a market. In this case, the deal would be Indiana's first merger under the COPA law, short for Certificate of Public Advantage, that the state enacted in 2021. Such laws allow deals that the Federal Trade Commission otherwise considers illegal because they reduce competition and often create monopolies. To mitigate the negative effects of a monopoly, the merged hospitals typically agree to conditions imposed by state regulators.

Union Hospital leaders said it's time to move “beyond competition” for the sake of the region, which has struggled to keep jobs and raise life expectancy rates. Hospital spokesperson Neil Garrison said the merger would ultimately improve care, increase access, and cut costs. Leaders of Regional Hospital, which is owned by for-profit chain HCA Healthcare, did not respond to questions about the proposal.

One unusual implication arises, though: If the merger is approved, the surrounding county would lose tax revenue from one of its larger businesses. Union Hospital, which as a nonprofit is exempt from paying taxes, would be acquiring tax-paying Terre Haute Regional, which paid roughly $508,000 in county taxes for 2023, said Vigo County Auditor Jim Bramble. That's the equivalent of the starting salaries of about nine sheriff's deputies, per the county's $83 million 2024 budget.

Garrison said the hospital system is aware of the tax implications for the county and is “exploring opportunities” to address it.

Meanwhile, Roland Kohr, formerly a pathologist at Regional and a county coroner, frets about erasing competition that forced the hospitals to add services or match the other. “The push to introduce new technologies, to recruit more physicians, that may not happen,” he said.

The FTC has urged states to avoid COPAs, pointing to research that found they “have resulted in significant price increases and contributed to declines in quality of care.” The fallout of similar mergers has triggered federal sanctions in North Carolina and pushback from locals and legislators in Tennessee.

“A merged hospital system that faces little remaining competition after the merger usually has little incentive to follow through with its promises because patients have no other choice,” wrote Chris Garmon, a University of Missouri-Kansas City economist who has studied COPA mergers, in a warning to Indiana health officials about the proposed merger.

Indiana already has among the highest hospital prices in the country, according to a study by the Rand Corp. research organization. The Indiana Legislature spent the past year trying to rein in prices. Gloria Sachdev, CEO of Indianapolis-based Employers' Forum of Indiana, which pushed for those pricing limits on behalf of frustrated business leaders, is worried a Union-Regional merger would undo those gains and raise prices further.

Indiana's COPA restricts how much the hospital could increase charges, Garrison said.

Elsewhere, the largest COPA-created hospital system in the country, Ballad Health, has reported that the time patients spend in its ERs in Virginia and Tennessee before being hospitalized has more than tripled, reaching nearly 11 hours, in the six years since that monopoly of 20 hospitals formed. Still, Tennessee has awarded Ballad top marks even when certain quality metrics, including its ER speed, fall below established benchmarks.

Ballad Health spokesperson Molly Luton said the system's performance has improved since those statistics were gathered.

Last fall, some Tennesseans unsuccessfully urged a county board to call on the state to better regulate the hospital system. This spring, state lawmakers refused to hear testimony from residents who drove five hours to Nashville to testify for a bill that sought to limit future COPA mergers in the state — which ultimately didn't make it to a full vote.

Problems have also occurred when a COPA — and its oversight — are removed, leaving the merged hospital system as an “unregulated monopoly.” After North Carolina repealed its COPA in 2015, a subsidiary of HCA Healthcare bought Mission Health, a COPA-created monopoly in Asheville, for $1.5 billion in 2019. The monopoly in Asheville remained but none of the COPA's conditions applied to the new owner.

Last year, government inspectors found “deficiencies” at Mission Health that contributed to four patient deaths and posed an “immediate jeopardy” to patients' health and safety, according to the 384-page federal inspection report. North Carolina Attorney General Joshua Stein sued HCA's subsidiary last year, alleging the ER was “significantly degraded,” and that the company failed to maintain certain critical services, including oncology care, a violation of a purchase agreement Stein's office negotiated with it because the company acquired a nonprofit.

HCA said it promptly addressed the issues and denied Stein's allegations in its legal response to the ongoing lawsuit, arguing it has expanded services since its purchase. HCA also argued that the agreement is silent about maintaining the quality of care.

Back in Indiana, Union Hospital laid the groundwork for its merger more than three years ago when its leaders provided the language for COPA legislation to then-state Sen. Jon Ford, a Republican in Terre Haute, believing he would be “the best champion for this proposal,” according to legislative testimony from Taylor Hollenbeck, an RJL Solutions consultant on the merger. Ford, listed on the legislature's site as the bill's co-author, did not respond to requests for comment.

Union CEO Steve Holman testified in the bill's hearings that the county's public health rankings — with an average life expectancy ranking 68th out of 92 counties in the state — should be a “call to action” to do something “big and bold.”

Terre Haute Mayor Brandon Sakbun agrees the merger could help what he called the county's “abysmal” public health statistics. Last year, he was elected the city's youngest mayor at age 27 on a promise to “turn Terre Haute around.” The region's workforce has steadily declined and local leaders have pinned their hopes on a new casino and a manufacturer of battery parts for electric vehicles to reverse this trend.

Sakbun's father is an OB-GYN at Union, but the mayor said that doesn't color his opinion and that he supports the hospital merger despite the loss of the tax base. He believes it will help recruit medical and other professionals to an area that has struggled to attract top talent.

“Do I believe that this is the one that bucks the research?” Sakbun said. “I truthfully do.”

KFF Health News correspondent Brett Kelman contributed to this article.

——————————
By: Samantha Liss
Title: Indiana Weighs Hospital Monopoly as Officials Elsewhere Scrutinize Similar Deals
Sourced From: kffhealthnews.org/news/article/indiana-copa-hospital-monopoly-scrutiny/
Published Date: Fri, 14 Jun 2024 09:00:00 +0000

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Kaiser Health News

California Lawmakers Preserve Aid to Older, Disabled Immigrants

Published

2 days ago

June 14, 2024

Staff Editor

Vanessa G. Sánchez
Fri, 14 Jun 2024 09:00:00 +0000

California lawmakers on Thursday passed a 2024-25 budget that rejected Gov. Gavin Newsom's proposal to cut in-home supportive services for low-income older, blind, and disabled immigrants lacking legal residency. However, the Democratic governor has not said whether he'll use his line-item veto authority to help close the state's $45 billion deficit.

The legislature, controlled by Democrats, passed a $211 billion general fund spending plan for the fiscal year starting July 1 by drawing more from the state's rainy-day fund and reducing corporate tax deductions to prevent cuts to health and social services.

“Our legislative budget plan achieves those goals with targeted, carefully calibrated investments in safety-net programs that protect our most vulnerable,” said Assembly member Jesse Gabriel, chair of the Assembly's budget committee, following voting in Sacramento.

Newsom and lawmakers are expected to continue talks.

“What was approved today represents a two-house agreement between the Senate and the Assembly – not an agreement with the governor,” said state Department of Finance spokesperson H.D. Palmer. “We've made good progress, but there's still more work to do.”

Newsom had proposed eliminating the new in-home benefit for qualified immigrants to save nearly $95 million in the next fiscal year, with no plans to bring it back. Lawmakers not only rejected Newsom's cut to the in-home services program; they also refused the governor's proposal to slash $300 million a year from public health agencies. However, they accepted delaying food assistance to low-income older immigrants without legal residency.

The In-Home Supportive Services program helps low-income older, blind, and disabled individuals receive care in their homes, which helps keep them out of more costly nursing and residential facilities. The program works by paying $16 to $21 an hour to caregivers, many of them family members.

Advocates applauded lawmakers for rejecting the cut. They had urged the governor to adopt the legislature's budget, arguing the state could end up paying more in the long run as Medi-Cal recipients tap nursing services. The state has estimated the annual per-person cost of nursing homes is $124,189, compared with the roughly $28,000 average cost for people without legal residency in the in-home services program.

“These individuals would need to essentially go into costly hospital or nursing care,” said Ronald Coleman Baeza, managing policy director at the California Pan-Ethnic Health Network. “It's not only cruel for undocumented immigrants, but it doesn't make sense as a fiscal decision either.”

The governor has said he's trying to maintain fiscal discipline while preserving Medi-Cal benefits for immigrants. California was the first state to expand Medicaid eligibility to all qualified immigrants regardless of legal status, phasing it in over several years: children in 2016, adults ages 19-26 in 2020, people 50 and older in 2022, and all remaining adults this year.

“It's a core of I think who we are as a state, and we should be as a nation,” Newsom said in May.

As part of the Medi-Cal expansion, the state authorized nearly 3,000 older, blind, and disabled immigrants without legal residency to access paramedical services and daily care, including meal preparation, bathing, feeding, and transportation to medical appointments. Advocates estimate 17,000 immigrants qualify.

“Fixing California's deficit means making tough choices, so the Assembly came to these negotiations focused on preserving programs that matter most to Californians,” said Assembly Speaker Robert Rivas, a Central Coast Democrat, in an earlier statement.

Lawmakers did agree to Newsom's proposal to delay around $165 a month in food assistance to low-income immigrants without legal residency ages 55 and older. Lawmakers had approved the benefit two years ago, but the governor proposed delaying it by two fiscal years to 2027.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

——————————
By: Vanessa G. Sánchez
Title: California Lawmakers Preserve Aid to Older, Disabled Immigrants
Sourced From: kffhealthnews.org/news/article/california-lawmakers-aid-immigrants-in-home-services-budget-newsom/
Published Date: Fri, 14 Jun 2024 09:00:00 +0000

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Kaiser Health News

KFF Health News’ ‘What the Health?’: SCOTUS Rejects Abortion Pill Challenge — For Now

Published

3 days ago

June 13, 2024

Staff Editor

Thu, 13 Jun 2024 18:50:00 +0000

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

Julie Rovner is chief Washington correspondent and host of KFF Health News' weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

A unanimous Supreme Court turned back a challenge to the FDA's approval and rules for the abortion pill mifepristone, finding that the anti-abortion doctor group that sued lacked standing to do so. But abortion foes have other ways they intend to curtail availability of the pill, which is commonly used in medication abortions, which now make up nearly two-thirds of abortions in the U.S.

Meanwhile, the Biden administration is proposing regulations that would bar credit agencies from including medical debt on individual credit reports. And former President Donald Trump, signaling that drug prices remain a potent campaign issue, attempts to take credit for the $35-a-month cap on insulin for Medicare beneficiaries — which was backed and signed into law by Biden.

This week's panelists are Julie Rovner of KFF Health News, Anna Edney of Bloomberg News, Rachana Pradhan of KFF Health News, and Emmarie Huetteman of KFF Health News.

Panelists

Anna Edney
Bloomberg

@annaedney

Read Anna's stories.

Emmarie Huetteman
KFF Health News

@emmarieDC

Read Emmarie's stories.

Rachana Pradhan
KFF Health News

@rachanadpradhan

Read Rachana's stories.

Among the takeaways from this week's episode:

All nine Supreme Court justices on June 13 rejected a challenge to the abortion pill mifepristone, ruling the plaintiffs did not have standing to sue. But that may not be the last word: The decision leaves open the possibility that different plaintiffs — including three states already part of the case — could raise a similar challenge in the future, and that the court could then vote to block access to the pill.
As the presidential race heats up, President Joe Biden and former President Donald Trump are angling for health care voters. The Biden administration this week proposed eliminating all medical debt from Americans' credit scores, which would expand on the previous, voluntary move by the major credit agencies to erase from credit reports medical bills under $500. Meanwhile, Trump continues to court vaccine skeptics and wrongly claimed credit for Medicare's $35 monthly cap on insulin — enacted under a law backed and signed by Biden.
Problems are compounding at the pharmacy counter. Pharmacists and drugmakers are reporting the highest numbers of drug shortages in more than 20 years. And independent pharmacists in particular say they are struggling to keep drugs on the shelves, pointing to a recent Biden administration policy change that reduces costs for seniors — but also cash flow for pharmacies.
And the Southern Baptist Convention, the nation's largest branch of Protestantism, voted this week to restrict the use of in vitro fertilization. As evidenced by recent flip-flopping stances on abortion, Republican candidates are feeling pressed to satisfy a wide range of perspectives within even their own party.

Also this week, Rovner interviews KFF president and CEO Drew Altman about KFF's new “Health Policy 101” primer. You can learn more about it here.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: HuffPost's “How America's Mental Health Crisis Became This Family's Worst Nightmare,” by Jonathan Cohn.

Anna Edney: Stat News' “Four Tops Singer's Lawsuit Says He Visited ER for Chest Pain, Ended Up in Straitjacket,” by Tara Bannow.

Rachana Pradhan: The New York Times' “Abortion Groups Say Tech Companies Suppress Posts and Accounts,” by Emily Schmall and Sapna Maheshwari.

Emmarie Huetteman: CBS News' “As FDA Urges Crackdown on Bird Flu in Raw Milk, Some States Say Their Hands Are Tied,” by Alexander Tin.

Also mentioned on this week's podcast:

Bloomberg News' “Dozens of CVS Generic Drug Recalls Expose Link to Tainted Factories,” by Anna Edney and Peter Robison.
KFF Health News' “Biden Plan To Save Medicare Patients Money on Drugs Risks Empty Shelves, Pharmacists Say,” by Susan Jaffe.
KFF Health News' “More States Legalize Sales of Unpasteurized Milk, Despite Public Health Warnings,” by Tony Leys.

Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News' “What the Health?” on Spotify, Apple Podcasts, Pocket Casts, or wherever you listen to podcasts.

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Title: KFF Health News' ‘What the Health?': SCOTUS Rejects Abortion Pill Challenge — For Now
Sourced From: kffhealthnews.org/news/podcast/what-the-health-351-supreme-court-abortion-pill-mifepristone-june-13-2024/
Published Date: Thu, 13 Jun 2024 18:50:00 +0000

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