Kaiser Health News
Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail.
Fred Schulte, KFF Health News
Tue, 10 Oct 2023 09:00:00 +0000
Ron Irby expected the artificial knee implanted in his right leg in September 2018 would last two decades — perhaps longer.
Yet in just three years, the Optetrak implant manufactured by Exactech in Gainesville, Florida, had worn out and had to be replaced — a painful and debilitating operation.
“The surgery was a huge debt of pain paid over months,” said Irby, 71, a Gainesville resident and retired medical technologist with the Department of Veterans Affairs.
Irby is one of more than 1,100 patients suing Exactech after it began recalling artificial knees, hips, and ankles, starting in August 2021. A letter Exactech sent to surgeons blamed a packaging defect dating back as far as 2004 for possibly causing the plastic in a knee component to wear out prematurely in about 140,000 implants. Many patients argue in hundreds of lawsuits that they have suffered through, or could soon face, challenging and risky operations to replace defective implants that failed.
Although Exactech does not offer an express warranty on its products, the company stresses the durability of its implants in advertising, even suggesting they likely will outlive their human recipients.
Exactech, which grew over three decades from a mom-and-pop device manufacturer into a global entity that sold for $737 million in 2018, declined comment, citing the “ongoing litigation,” said company spokesperson Tom Johnson. In court filings, Exactech has argued that its products are not defective and have “an excellent history.”
A KFF Health News review of thousands of pages of court filings in patient lawsuits, a pending whistleblower lawsuit, and other government records shows that the company is being accused of downplaying or concealing evidence of product failures from patients and federal regulators for years. In hundreds of instances, according to government records, the company took years to report adverse events to a federal database that tracks device failures.
In his suit, Irby alleges that Exactech “knew or should have known” that the Optetrak “had an unacceptable failure and complication rate.” He said Exactech used packaging materials of “an inferior grade or quality.”
“I think they were cutting corners to improve their bottom line,” Irby told KFF Health News.
Exactech denied the allegations in a legal filing in Irby’s suit, in which it described the Optetrak device as “safe and effective.”
A Family Affair
Surgeon William “Bill” Petty chaired the orthopedics department at the University of Florida in Gainesville, when he, his wife, Betty, and Gary Miller, a biomedical engineer and fellow faculty member, formed Exactech in November 1985. The Pettys served in corporate roles until retiring in early 2020. Their first hire was their son David in 1988, who remains on Exactech’s board of directors.
Exactech’s fortunes started to take off in 1994, when it inked a major deal to license and market the Optetrak knee implant based on designs by surgeons and engineers at the prestigious Hospital for Special Surgery in New York City. That alliance won Exactech instant credibility in the fiercely competitive device industry.
So did its pedigree as a “surgeon-focused” business with a family-run vibe, small enough that surgeons considering its wares could meet the owners and tour its Florida plant.
Building on that goodwill, Exactech’s sales shot past $124 million in 2007, about half generated by the Optetrak knee system.
“It’s not just a road we’re on, it’s a trail we’re blazing,” the company boasted in sales literature aimed at surgeons.
Exactech’s corporate confidence belies years of warnings and doubts about the durability of the Optetrak, according to whistleblowers — one whistleblower called it an “open secret” inside the company. Notably, there were concerns about the fragility of a finned tibial tray, one of the four pieces of the knee replacement that fits into the shin bone, according to the whistleblower lawsuit.
For starters, several surgeons complained that the knee implants loosened prematurely, causing patients pain and limiting their ability to move around, court records allege.
While 95% of artificial knees should last at least a decade, surgeons had to pull out and replace many Optetrak components — a complex operation known as revision surgery — much sooner, according to allegations in patient lawsuits.
Christopher Hutchins, a Connecticut orthopedic surgeon who relied on the Optetrak finned devices for more than 350 knee surgeries, said in a court deposition that some loosened in as little as two to three years. He called that “awfully premature” and “extraordinary.”
Hutchins vented his frustrations in a brief meeting with Exactech co-founder Bill Petty at a Rhode Island hospital in either 2006 or 2007, according to his deposition. Petty told him at the meeting he “realized that it was a problem” with the device, according to Hutchins.
“I was somewhat struck that if they knew there was a problem why it wasn’t being addressed and why the product wasn’t being pulled from the market,” Hutchins testified in the November 2021 deposition.
“There was no disclosure or transparency.”
Older patients not only suffered physical pain, but also felt an “emotional burden” from facing revision surgery in which results often are “not as good as the first go around,” Hutchins explained during his deposition testimony.“I’m in the business to try to make people better, and when things fail, I take it to heart.”
Hutchins was not the only surgeon alarmed by what he says were early failures of the Optetrak devices and the company’s tepid response.
‘Popping Out’
In August 2005, Maine orthopedic surgeon Wayne Moody told company officials that Optetrak had loosened and needed to be revised in 25 out of 385 operations he had performed over the previous four years, according to meeting minutes filed in court.
One knee implant gave out in just nine months, Moody told the group, according to the minutes.
In a deposition, Robert Farley, a former Exactech sales agent who filed a whistleblower lawsuit in 2018 alleging fraud by the company, alleged that he heard two colleagues joke about Moody’s tribulations at a national sales conference.
Moody “probably had 50-something revisions. … They’re just popping out right and left,” the sales agent said, according to Farley’s suit.
Fellow whistleblower Manuel Fuentes, a former Exactech senior product manager, testified in a deposition that pulling the product off the market around 2008 “would have been the ethical and moral thing to do.”
At a meeting in early 2008 attended by the company’s top brass, including Bill Petty, the company’s marketing director at the time, Charley Rye, floated the idea of a recall, Fuentes said. Company executives shot that down as “financially detrimental,” Fuentes testified in a sworn declaration filed with the court.
Asked about the meeting during a December 2021 deposition, Petty replied, “I don’t recall that anyone suggested a recall.”
‘Silent Recall’
Exactech discussed the loosening problem in an internal memo that said between 2006 and 2009 the company “began to get some negative feedback” about the Optetrak “that was at times confounding and difficult to process,” court records show.
The discouraging reports ranged from complaints of early revisions from at least 10 U.S. surgeons and surgery practices in several of the more than 30 countries where Exactech sold the implant, court records show.
The results did little to dim Exactech’s prospects. From 1994 through April 2022, Exactech sold 58,763 Optetrak devices with finned trays for use by 514 surgeons nationwide, according to an affidavit by a company official.
Many lawsuits argue that instead of warning patients and surgeons about the loosening problem, Exactech replaced the finned tray component in its newest products, a strategy device industry critics refer to as a “silent recall.” Exactech denies that and said in a court filing that design changes it made were part of a “natural evolution” of the Optetrak.
Even as Exactech rolled out newer generations of the Optetrak, the company faced lawsuits and other criticism alleging it had failed to come clean about unusually high surgical revision rates.
Late Notices
The Food and Drug Administration runs a massive, public, searchable databank called MAUDE to warn the public of dangers linked to medical devices and drugs.
Manufacturers must advise the FDA when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm.Those reports must be submitted within 30 days unless a special exemption is granted.
But court and government records show that reports of adverse reactions tied to Exactech’s implant sometimes took years to show up in the government database — if they were reported at all.
Exactech failed to advise the FDA of dozens of Optetrak early revision complaints lodged by orthopedic surgeons Moody and Hutchins, a company representative acknowledged in a court filing.
KFF Health News downloaded the FDA data and found about 400 examples in which Exactech reported adverse events to the MAUDE database two years or more after learning of them.
FDA inspectors who combed through Exactech’s internal files in 2017 cited the company for failing to undertake an “adequate investigation” of complaints, according to FDA records cited in court filings.
In court filings, Exactech steadfastly denied Optetrak has any defects. Instead, it blamed the loosening problem on surgeons, saying they had failed to cement the knee implants into place correctly or misaligned them.
The company said it had no obligation to report poor outcomes tied to mistakes by surgeons — even though the FDA requires companies to report injuries involving “user error.” In 2022, a federal judge in the whistleblower case, in denying a motion to dismiss, found that Exactech was “hard-pressed” to claim it was not obligated to report the adverse events.
The three whistleblowers are accusing Exactech of fraud for allegedly selling defective products to Medicare and other federal health care programs. The case is pending in federal court in Alabama and Exactech has denied any wrongdoing. Exactech in mid-August filed a motion to dismiss the case.
Lawyers for more than 300 injured patients suing in Alachua County Circuit Court in Florida are pressing for full disclosure of 2,435 complaints to the company alleging deficiencies with Exactech knee products, which the company admits receiving as of the end of April.
In other pending lawsuits, patients argue the company pointedly ignored evidence of chronic safety issues to fuel profits.
Keith Nuzzo, of Litchfield, Maine, is one. He alleged that Exactech “cut corners, utilized inferior manufacturing practices … [and] only disclosed information or took corrective action if contacted by regulatory authorities.”
Nuzzo had a right knee replacement done by orthopedic surgeon Moody in February 2012 and a left knee implanted a week afterward.
His right knee became painful and wobbly about four years later and a second surgeon replaced it in August 2016. The left knee gave out in November 2020, also requiring replacement, according to the suit.
Despite the revisions, Nuzzo lives with “daily knee pain and discomfort,” which limits his “activities of daily living and recreation,” according to the suit. The case is pending. As of mid-September, Exactech had not filed an answer.
No Guarantees
In advertising directed at surgeons, Exactech boasts about the long life of its implants.
One sales brochure states that the Optetrak “demonstrated 91-99 percent implant survival rates” over just under a decade. That is consistent with, if not superior to, industry standards, though as a rule of thumb many surgeons expect implants to last 15 to 20 years, sometimes longer.
The mounting legal claims allege many Exactech knee and hip implants have worn out well before their time.
The KFF Health News analysis of more than 300 pending cases in Alachua County found that surgeons removed about 200 implants after less than seven years. Some people in the sample, whose surgeries spanned more than two dozen states, were awaiting revision procedures. In the federal court sample, patients alleged that half of the 400 implants that were removed lasted less than six years.
Advertising materials aside, Exactech is circumspect in describing the reliability of its implants when it speaks to courts. In a 2021 filing, the company noted that the Optetrak comes with no express warranty.
How long it lasts “depends on a multitude of factors, including those pertaining to surgical technique and the particular patient,” the company said.
Promoting the Products
Exactech’s focus on its surgeon customers includes paying handsome consulting fees to some orthopedists who have used the company’s implants in the operating room or promoted them in advertising.
Exactech paid surgeon consultants $23.2 million combined from the start of 2013 through the end of 2022, the most recent year available, according to a government database called Open Payments.
In promoting the Optetrak in sales materials, Exactech touted “excellent results” achieved by orthopedic surgeon Raymond Robinson. Left unsaid: Exactech paid Robinson more than $900,000 in consulting fees and other payments from 2013 through 2022. In a court filing, Exactech denied any consultants “were compensated in exchange for product promotion.” Robinson could not be reached for comment.
Exactech’s sales brochures also boast that surgeons “around the world have documented excellent results with the Optetrak knee system.”
Yet Exactech bottled up a succession of sharply negative reports from other countries, while working to discredit others, according to internal company records filed in court by the whistleblowers.
One surgery group in France concluded in 2012 that nine of 110 Optetrak procedures required revision due to loosening in under three years, for instance. Exactech disputed the findings in a published response, and in a court filing said the conclusions were “based on incorrect information and a flawed understanding of the true causes.”
A hospital in Buenos Aires, Argentina, reported that 25% to 30% of Optetrak knees required revisions in under two years, according to whistleblower Fuentes.
The Australian implant registry criticized Optetrak’s reliability as early as 2007 and in several later years. In response, Exactech executives said in depositions and court filings that they traced many of the poor results to a single hospital and three surgeons who failed to align the implants correctly.
The Australian registry pegged Exactech’s revision rate at 19.4% at seven years and 22% at 10 years, the worst of any knee implant on the market, which led the government health system to stop purchasing it, court records allege. Exactech denied the allegations in a court filing.
James Brooks, a retired Texas orthopedic surgeon, said in a court affidavit that he believed Exactech had an obligation to tell surgeons about the poor outcomes overseas rather than touting rosy results tied to doctors on its payroll.
In the 2021 affidavit, Brooks recalled implanting the Optetrak knee in a Dallas man in 2011, only to confirm from X-rays that it was failing in 2017 and needed to be replaced two years later. Brooks said he would have steered clear of Optetrak had he known of its “much higher failure rate than comparable products.”
Clicking Sounds
Laura Grandis is suing Ohio orthopedic surgeon and Exactech consultant Ian Gradisar, who received $132,720 from the company, including research payments, from 2013 through 2022, according to government records.
Gradisar’s father, Ivan, also an orthopedic surgeon, served on the original Optetrak design team. In 2008, Ian Gradisar helped his father with an audit of “patient outcomes” commissioned by Exactech. The audit showed that 12 of 47 Optetrak patients operated on over the course of 15 months required revisions, giving the son “first-hand knowledge of the failing and defective Optetrak,” Grandis alleges in her suit.
Ian Gradisar put an Exactech implant in Grandis’ left knee in Akron, Ohio, in November 2020.
In early 2021, she had “severe” pain in her knee and needed a cane or a walker to get around, according to the suit.
Gradisar told her the knee had failed, which he said was “very rare and only happened 5% of the time,” according to the suit.
Grandis had revision surgery in July 2021 with an Optetrak implant. Some seven months later, she felt pain that worsened throughout the day. She tried ice and rest, but that did not work. Her knee hurt when she put weight on it and started making a clicking sound when she moved, according to the suit.
In June 2022, Grandis received a “Dear Patient” form letter from the hospital where her surgery was performed notifying her of the Exactech recall.
Gradisar’s office told her the surgeon could not see her until October 2022 “as he was inundated with phone calls from patients about the Exactech recall,” according to the suit.
In response to the suit, Exactech denied the allegations, including that its knee implants had “increased failure rates.” The case is pending. Gradisar and his lawyer did not respond to requests for comment.
But in a court filing, Gradisar denied any defects in the implant and said he “provided quality care and treatment” to Grandis.
In December 2022, Grandis ended up having a second revision operation that kept her hobbling around on crutches for six weeks, according to her suit.
Total Recall
Two years after the initial recall, Exactech and its owners — past and present — face a rush of lawsuits demanding accountability for alleged patient injuries.
Most of the suits in the Alachua County group name Bill, Betty, and David Petty and Miller as defendants for their roles at Exactech. Their attorney did not respond to requests for comment, but in May, the defendants jointly filed a motion to dismiss, arguing that the suits fail “to allege sufficient facts to impose liability.”
Many suits in the federal court cluster also name as a defendant TPG Capital, a Texas-based private equity firm that paid $737 million to acquire Exactech in February 2018. TPG declined to comment but has filed a motion to dismiss the cases.
In one recall letter sent to surgeons, Exactech acknowledged that the data from the Australian registry confirmed that Optetrak had “statistically significant” higher rates of revisions than knee implants made by other companies — a conclusion it had previously disputed.
The letter adds that Exactech is “uncertain” if the packaging defect is the “root cause” of Optetrak’s poor performance. An FDA “safety communication” issued in March said the agency is working with Exactech to assess whether other implants packaged in the defective bags pose similar risks.
Exactech lawyers say the company may not be to blame for every implant that wears out unexpectedly.
In a November 2022 hearing, Exactech attorney Michael Kanute said wear of polyethylene implant components is a “known risk no matter who makes them.” He said the patient’s size and activity level as well as the technique of the surgeons could also be factors.
“So every case is different,” he said.
KFF Health News data editor Holly K. Hacker and reporter Megan Kalata contributed to this report.
——————————
By: Fred Schulte, KFF Health News
Title: Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail.
Sourced From: kffhealthnews.org/news/article/exactech-hip-knee-replacement-implant-lawsuit/
Published Date: Tue, 10 Oct 2023 09:00:00 +0000
Did you miss our previous article…
https://www.biloxinewsevents.com/epidemic-bodies-remember-what-was-done-to-them/
Kaiser Health News
Dual Threats From Trump and GOP Imperil Nursing Homes and Their Foreign-Born Workers
In a top-rated nursing home in Alexandria, Virginia, the Rev. Donald Goodness is cared for by nurses and aides from various parts of Africa. One of them, Jackline Conteh, a naturalized citizen and nurse assistant from Sierra Leone, bathes and helps dress him most days and vigilantly intercepts any meal headed his way that contains gluten, as Goodness has celiac disease.
“We are full of people who come from other countries,” Goodness, 92, said about Goodwin House Alexandria’s staff. Without them, the retired Episcopal priest said, “I would be, and my building would be, desolate.”
The long-term health care industry is facing a double whammy from President Donald Trump’s crackdown on immigrants and the GOP’s proposals to reduce Medicaid spending. The industry is highly dependent on foreign workers: More than 800,000 immigrants and naturalized citizens comprise 28% of direct care employees at home care agencies, nursing homes, assisted living facilities, and other long-term care companies.
But in January, the Trump administration rescinded former President Joe Biden’s 2021 policy that protected health care facilities from Immigration and Customs Enforcement raids. The administration’s broad immigration crackdown threatens to drastically reduce the number of current and future workers for the industry. “People may be here on a green card, and they are afraid ICE is going to show up,” said Katie Smith Sloan, president of LeadingAge, an association of nonprofits that care for older adults.
Existing staffing shortages and quality-of-care problems would be compounded by other policies pushed by Trump and the Republican-led Congress, according to nursing home officials, resident advocates, and academic experts. Federal spending cuts under negotiation may strip nursing homes of some of their largest revenue sources by limiting ways states leverage Medicaid money and making it harder for new nursing home residents to retroactively qualify for Medicaid. Care for 6 in 10 residents is paid for by Medicaid, the state-federal health program for poor or disabled Americans.
“We are facing the collision of two policies here that could further erode staffing in nursing homes and present health outcome challenges,” said Eric Roberts, an associate professor of internal medicine at the University of Pennsylvania.
The industry hasn’t recovered from covid-19, which killed more than 200,000 long-term care facility residents and workers and led to massive staff attrition and turnover. Nursing homes have struggled to replace licensed nurses, who can find better-paying jobs at hospitals and doctors’ offices, as well as nursing assistants, who can earn more working at big-box stores or fast-food joints. Quality issues that preceded the pandemic have expanded: The percentage of nursing homes that federal health inspectors cited for putting residents in jeopardy of immediate harm or death has risen alarmingly from 17% in 2015 to 28% in 2024.
In addition to seeking to reduce Medicaid spending, congressional Republicans have proposed shelving the biggest nursing home reform in decades: a Biden-era rule mandating minimum staffing levels that would require most of the nation’s nearly 15,000 nursing homes to hire more workers.
The long-term care industry expects demand for direct care workers to burgeon with an influx of aging baby boomers needing professional care. The Census Bureau has projected the number of people 65 and older would grow from 63 million this year to 82 million in 2050.
In an email, Vianca Rodriguez Feliciano, a spokesperson for the Department of Health and Human Services, said the agency “is committed to supporting a strong, stable long-term care workforce” and “continues to work with states and providers to ensure quality care for older adults and individuals with disabilities.” In a separate email, Tricia McLaughlin, a Department of Homeland Security spokesperson, said foreigners wanting to work as caregivers “need to do that by coming here the legal way” but did not address the effect on the long-term care workforce of deportations of classes of authorized immigrants.
Goodwin Living, a faith-based nonprofit, runs three retirement communities in northern Virginia for people who live independently, need a little assistance each day, have memory issues, or require the availability of around-the-clock nurses. It also operates a retirement community in Washington, D.C. Medicare rates Goodwin House Alexandria as one of the best-staffed nursing homes in the country. Forty percent of the organization’s 1,450 employees are foreign-born and are either seeking citizenship or are already naturalized, according to Lindsay Hutter, a Goodwin spokesperson.
“As an employer, we see they stay on with us, they have longer tenure, they are more committed to the organization,” said Rob Liebreich, Goodwin’s president and CEO.
Jackline Conteh spent much of her youth shuttling between Sierra Leone, Liberia, and Ghana to avoid wars and tribal conflicts. Her mother was killed by a stray bullet in her home country of Liberia, Conteh said. “She was sitting outside,” Conteh, 56, recalled in an interview.
Conteh was working as a nurse in a hospital in Sierra Leone in 2009 when she learned of a lottery for visas to come to the United States. She won, though she couldn’t afford to bring her husband and two children along at the time. After she got a nursing assistant certification, Goodwin hired her in 2012.
Conteh said taking care of elders is embedded in the culture of African families. When she was 9, she helped feed and dress her grandmother, a job that rotated among her and her sisters. She washed her father when he was dying of prostate cancer. Her husband joined her in the United States in 2017; she cares for him because he has heart failure.
“Nearly every one of us from Africa, we know how to care for older adults,” she said.
Her daughter is now in the United States, while her son is still in Africa. Conteh said she sends money to him, her mother-in-law, and one of her sisters.
In the nursing home where Goodness and 89 other residents live, Conteh helps with daily tasks like dressing and eating, checks residents’ skin for signs of swelling or sores, and tries to help them avoid falling or getting disoriented. Of 102 employees in the building, broken up into eight residential wings called “small houses” and a wing for memory care, at least 72 were born abroad, Hutter said.
Donald Goodness grew up in Rochester, New York, and spent 25 years as rector of The Church of the Ascension in New York City, retiring in 1997. He and his late wife moved to Alexandria to be closer to their daughter, and in 2011 they moved into independent living at the Goodwin House. In 2023 he moved into one of the skilled nursing small houses, where Conteh started caring for him.
“I have a bad leg and I can’t stand on it very much, or I’d fall over,” he said. “She’s in there at 7:30 in the morning, and she helps me bathe.” Goodness said Conteh is exacting about cleanliness and will tell the housekeepers if his room is not kept properly.
Conteh said Goodness was withdrawn when he first arrived. “He don’t want to come out, he want to eat in his room,” she said. “He don’t want to be with the other people in the dining room, so I start making friends with him.”
She showed him a photo of Sierra Leone on her phone and told him of the weather there. He told her about his work at the church and how his wife did laundry for the choir. The breakthrough, she said, came one day when he agreed to lunch with her in the dining room. Long out of his shell, Goodness now sits on the community’s resident council and enjoys distributing the mail to other residents on his floor.
“The people that work in my building become so important to us,” Goodness said.
While Trump’s 2024 election campaign focused on foreigners here without authorization, his administration has broadened to target those legally here, including refugees who fled countries beset by wars or natural disasters. This month, the Department of Homeland Security revoked the work permits for migrants and refugees from Cuba, Haiti, Nicaragua, and Venezuela who arrived under a Biden-era program.
“I’ve just spent my morning firing good, honest people because the federal government told us that we had to,” Rachel Blumberg, president of the Toby & Leon Cooperman Sinai Residences of Boca Raton, a Florida retirement community, said in a video posted on LinkedIn. “I am so sick of people saying that we are deporting people because they are criminals. Let me tell you, they are not all criminals.”
At Goodwin House, Conteh is fearful for her fellow immigrants. Foreign workers at Goodwin rarely talk about their backgrounds. “They’re scared,” she said. “Nobody trusts anybody.” Her neighbors in her apartment complex fled the U.S. in December and returned to Sierra Leone after Trump won the election, leaving their children with relatives.
“If all these people leave the United States, they go back to Africa or to their various countries, what will become of our residents?” Conteh asked. “What will become of our old people that we’re taking care of?”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
This article first appeared on KFF Health News and is republished here under a Creative Commons license.
The post Dual Threats From Trump and GOP Imperil Nursing Homes and Their Foreign-Born Workers appeared first on kffhealthnews.org
Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.
Political Bias Rating: Center-Left
This content primarily highlights concerns about the impact of restrictive immigration policies and Medicaid spending cuts proposed by the Trump administration and Republican lawmakers on the long-term care industry. It emphasizes the importance of immigrant workers in healthcare, the challenges that staffing shortages pose to patient care, and the potential negative effects of GOP policy proposals. The tone is critical of these policies while sympathetic toward immigrant workers and advocates for maintaining or increasing government support for healthcare funding. The framing aligns with a center-left perspective, focusing on social welfare, immigrant rights, and concern about the consequences of conservative economic and immigration policies without descending into partisan rhetoric.
Kaiser Health News
California’s Much-Touted IVF Law May Be Delayed Until 2026, Leaving Many in the Lurch
California lawmakers are poised to delay the state’s much-ballyhooed new law mandating in vitro fertilization insurance coverage for millions, set to take effect July 1. Gov. Gavin Newsom has asked lawmakers to push the implementation date to January 2026, leaving patients, insurers, and employers in limbo.
The law, SB 729, requires state-regulated health plans offered by large employers to cover infertility diagnosis and treatment, including IVF. Nine million people will qualify for coverage under the law. Advocates have praised the law as “a major win for Californians,” especially in making same-sex couples and aspiring single parents eligible, though cost concerns limited the mandate’s breadth.
People who had been planning fertility care based on the original timeline are now “left in a holding pattern facing more uncertainty, financial strain, and emotional distress,” Alise Powell, a director at Resolve: The National Infertility Association, said in a statement.
During IVF, a patient’s eggs are retrieved, combined with sperm in a lab, and then transferred to a person’s uterus. A single cycle can total around $25,000, out of reach for many. The California law requires insurers to cover up to three egg retrievals and an unlimited number of embryo transfers.
Not everyone’s coverage would be affected by the delay. Even if the law took effect July 1, it wouldn’t require IVF coverage to start until the month an employer’s contract renews with its insurer. Rachel Arrezola, a spokesperson for the California Department of Managed Health Care, said most of the employers subject to the law renew their contracts in January, so their employees would not be affected by a delay.
She declined to provide data on the percentage of eligible contracts that renew in July or later, which would mean those enrollees wouldn’t get IVF coverage until at least a full year from now, in July 2026 or later.
The proposed new implementation date comes amid heightened national attention on fertility coverage. California is now one of 15 states with an IVF mandate, and in February, President Donald Trump signed an executive order seeking policy recommendations to expand IVF access.
It’s the second time Newsom has asked lawmakers to delay the law. When the Democratic governor signed the bill in September, he asked the legislature to consider delaying implementation by six months. The reason, Newsom said then, was to allow time to reconcile differences between the bill and a broader effort by state regulators to include IVF and other fertility services as an essential health benefit, which would require the marketplace and other individual and small-group plans to provide the coverage.
Newsom spokesperson Elana Ross said the state needs more time to provide guidance to insurers on specific services not addressed in the law to ensure adequate and uniform coverage. Arrezola said embryo storage and donor eggs and sperm were examples of services requiring more guidance.
State Sen. Caroline Menjivar, a Democrat who authored the original IVF mandate, acknowledged a delay could frustrate people yearning to expand their families, but requested patience “a little longer so we can roll this out right.”
Sean Tipton, a lobbyist for the American Society for Reproductive Medicine, contended that the few remaining questions on the mandate did not warrant a long delay.
Lawmakers appear poised to advance the delay to a vote by both houses of the legislature, likely before the end of June. If a delay is approved and signed by the governor, the law would immediately be paused. If this does not happen before July 1, Arrezola said, the Department of Managed Health Care would enforce the mandate as it exists. All plans were required to submit compliance filings to the agency by March. Arrezola was unable to explain what would happen to IVF patients whose coverage had already begun if the delay passes after July 1.
The California Association of Health Plans, which opposed the mandate, declined to comment on where implementation efforts stand, although the group agrees that insurers need more guidance, spokesperson Mary Ellen Grant said.
Kaiser Permanente, the state’s largest insurer, has already sent employers information they can provide to their employees about the new benefit, company spokesperson Kathleen Chambers said. She added that eligible members whose plans renew on or after July 1 would have IVF coverage if implementation of the law is not delayed.
Employers and some fertility care providers appear to be grappling over the uncertainty of the law’s start date. Amy Donovan, a lawyer at insurance brokerage and consulting firm Keenan & Associates, said the firm has fielded many questions from employers about the possibility of delay. Reproductive Science Center and Shady Grove Fertility, major clinics serving different areas of California, posted on their websites that the IVF mandate had been delayed until January 2026, which is not yet the case. They did not respond to requests for comment.
Some infertility patients confused over whether and when they will be covered have run out of patience. Ana Rios and her wife, who live in the Central Valley, had been trying to have a baby for six years, dipping into savings for each failed treatment. Although she was “freaking thrilled” to learn about the new law last fall, Rios could not get clarity from her employer or health plan on whether she was eligible for the coverage and when it would go into effect, she said. The couple decided to go to Mexico to pursue cheaper treatment options.
“You think you finally have a helping hand,” Rios said of learning about the law and then, later, the requested delay. “You reach out, and they take it back.”
This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
This article first appeared on KFF Health News and is republished here under a Creative Commons license.
The post California’s Much-Touted IVF Law May Be Delayed Until 2026, Leaving Many in the Lurch appeared first on kffhealthnews.org
Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.
Political Bias Rating: Center-Left
This content is presented in a factual, balanced manner typical of center-left public policy reporting. It focuses on a progressive healthcare issue (mandated IVF insurance coverage) favorably highlighting benefits for diverse family structures and individuals, including same-sex couples and single parents, which often aligns with center-left values. At the same time, it includes perspectives from government officials, industry representatives, opponents, and patients, offering a nuanced view without overt ideological framing or partisan rhetoric. The emphasis on healthcare access, social equity, and patient impact situates the coverage within a center-left orientation.
Kaiser Health News
Push To Move OB-GYN Exam Out of Texas Is Piece of AGs’ Broader Reproductive Rights Campaign
Democratic state attorneys general led by those from California, New York, and Massachusetts are pressuring medical professional groups to defend reproductive rights, including medication abortion, emergency abortions, and travel between states for health care in response to recent increases in the number of abortion bans.
The American Medical Association adopted a formal position June 9 recommending that medical certification exams be moved out of states with restrictive abortion policies or made virtual, after 20 attorneys general petitioned to protect physicians who fear legal repercussions because of their work. The petition focused on the American Board of Obstetrics and Gynecology’s certification exams in Dallas, and the subsequent AMA recommendation was hailed as a win for Democrats trying to regain ground after the fall of Roe v. Wade.
“It seems incremental, but there are so many things that go into expanding and maintaining access to care,” said Arneta Rogers, executive director of the Center on Reproductive Rights and Justice at the University of California-Berkeley’s law school. “We see AGs banding together, governors banding together, as advocates work on the ground. That feels somewhat more hopeful — that people are thinking about a coordinated strategy.”
Since the Supreme Court eliminated the constitutional right to an abortion in 2022, 16 states, including Texas, have implemented laws banning abortion almost entirely, and many of them impose criminal penalties on providers as well as options to sue doctors. More than 25 states restrict access to gender-affirming care for trans people, and six of them make it a felony to provide such care to youth.
That’s raised concern among some physicians who fear being charged if they go to those states, even if their home state offers protection to provide reproductive and gender-affirming health care.
Pointing to the recent fining and indictment of a physician in New York who allegedly provided abortion pills to a woman in Texas and a teen in Louisiana, a coalition of physicians wrote in a letter to the American Board of Obstetrics and Gynecology that “the limits of shield laws are tenuous” and that “Texas laws can affect physicians practicing outside of the state as well.”
The campaign was launched by several Democratic attorneys general, including Rob Bonta of California, Andrea Joy Campbell of Massachusetts, and Letitia James of New York, who each have established a reproductive rights unit as a bulwark for their state following the Dobbs decision.
“Reproductive health care and gender-affirming care providers should not have to risk their safety or freedom just to advance in their medical careers,” James said in a statement. “Forcing providers to travel to states that have declared war on reproductive freedom and LGBTQ+ rights is as unnecessary as it is dangerous.”
In their petition, the attorneys general included a letter from Joseph Ottolenghi, medical director at Choices Women’s Medical Center in New York City, who was denied his request to take the test remotely or outside of Texas. To be certified by the American Board of Obstetrics and Gynecology, physicians need to take the in-person exam at its testing facility in Dallas. The board completed construction of its new testing facility last year.
“As a New York practitioner, I have made every effort not to violate any other state’s laws, but the outer contours of these draconian laws have not been tested or clarified by the courts,” Ottolenghi wrote.
Rachel Rebouché, the dean of Temple University’s law school and a reproductive law scholar, said “putting the heft” of the attorneys general behind this effort helps build awareness and a “public reckoning” on behalf of providers. Separately, some doctors have urged medical conferences to boycott states with abortion bans.
Anti-abortion groups, however, see the campaign as forcing providers to conform to abortion-rights views. Donna Harrison, an OB-GYN and the director of research at the American Association of Pro-Life Obstetricians and Gynecologists, described the petition as an “attack not only on pro-life states but also on life-affirming medical professionals.”
Harrison said the “OB-GYN community consists of physicians with values that are as diverse as our nation’s state abortion laws,” and that this diversity “fosters a medical environment of debate and rigorous thought leading to advancements that ultimately serve our patients.”
The AMA’s new policy urges specialty medical boards to host exams in states without restrictive abortion laws, offer the tests remotely, or provide exemptions for physicians. However, the decision to implement any changes to the administration of these exams is up to those boards. There is no deadline for a decision to be made.
The OB-GYN board did not respond to requests for comment, but after the public petition from the attorneys general criticizing it for refusing exam accommodations, the board said that in-person exams conducted at its national center in Dallas “provide the most equitable, fair, secure, and standardized assessment.”
The OB-GYN board emphasized that Texas’ laws apply to doctors licensed in Texas and to medical care within Texas, specifically. And it noted that its exam dates are kept under wraps, and that there have been “no incidents of harm to candidates or examiners across thousands of in-person examinations.”
Democratic state prosecutors, however, warned in their petition that the “web of confusing and punitive state-based restrictions creates a legal minefield for medical providers.” Texas is among the states that have banned doctors from providing gender-affirming care to transgender youth, and it has reportedly made efforts to get records from medical facilities and professionals in other states who may have provided that type of care to Texans.
The Texas attorney general’s office did not respond to requests for comment.
States such as California and New York have laws to block doctors from being extradited under other states’ laws and to prevent sharing evidence against them. But instances that require leveraging these laws could still mean lengthy legal proceedings.
“We live in a moment where we’ve seen actions by executive bodies that don’t necessarily square with what we thought the rules provided,” Rebouché said.
This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Subscribe to KFF Health News’ free Morning Briefing.
This article first appeared on KFF Health News and is republished here under a Creative Commons license.
The post Push To Move OB-GYN Exam Out of Texas Is Piece of AGs’ Broader Reproductive Rights Campaign appeared first on kffhealthnews.org
Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.
Political Bias Rating: Center-Left
The article presents a viewpoint largely aligned with progressive and Democratic positions on reproductive rights and gender-affirming care. It highlights efforts led by Democratic attorneys general and the American Medical Association to protect abortion access and transgender healthcare amid restrictive state laws, portraying these actions positively. While it includes perspectives from anti-abortion advocates, their views are presented briefly and framed as opposition to the broader pro-choice initiatives. The overall tone and framing emphasize support for reproductive freedom and healthcare protections, reflecting a center-left leaning stance typical of mainstream health policy reporting sympathetic to Democratic policy goals.
-
News from the South - Tennessee News Feed7 days ago
Thieves take thousands of dollars in equipment from Union County Soccer League
-
Mississippi Today4 days ago
Defendant in auditor’s ‘second largest’ embezzlement case in history goes free
-
News from the South - Texas News Feed6 days ago
Robert Nichols to retire from Texas Senate
-
News from the South - Louisiana News Feed6 days ago
3 lawsuits filed against CVS, Louisiana AG announces
-
News from the South - Florida News Feed6 days ago
DeSantis signs bill into law that ensures public access to Florida beaches | Florida
-
News from the South - Missouri News Feed6 days ago
Residents provide feedback in Kearney Street Corridor redevelopment meeting
-
News from the South - Alabama News Feed6 days ago
News 5 NOW at 12:30pm | June 24, 2025
-
The Conversation7 days ago
The Vera C. Rubin Observatory will help astronomers investigate dark matter, continuing the legacy of its pioneering namesake