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Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail.

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Fred Schulte, KFF 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.

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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 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.

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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 Affair

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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.

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“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.

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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.”

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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.

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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.”

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At a meeting in early 2008 attended by the company's top brass, 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.

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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.

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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 .

Manufacturers must advise the FDA when they learn their device may have caused or contributed to a 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.

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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.

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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 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.

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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.

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No Guarantees

In advertising directed at surgeons, Exactech boasts about the long 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.

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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

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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.”

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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.

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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 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

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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.

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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 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.

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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

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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.

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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.

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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/

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Newsom Boosted California’s Public Health Budget During Covid. Now He Wants To Cut It.

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Angela Hart
Mon, 20 May 2024 09:00:00 +0000

When a doctor in Pasadena, California, reported in October that a hospital patient was exhibiting classic symptoms of dengue fever, such as vomiting, a rash, and bone and joint pain, local disease investigators snapped into action.

The mosquito-borne virus is common in places like Southeast Asia, East Africa, and Latin America, and when Americans contract the disease it is usually while traveling. But in this case, the patient hadn't left California.

Epidemiologists and public health nurses 175 households to conduct blood draws and local pest control workers began fumigating the patient's neighborhood. In the , they discovered a second infected person who hadn't traveled.

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Both recovered, and in that neighborhood nearly 65% of the carrier mosquitoes, part of a genus called Aedes, were eradicated within seven days, said Matthew Feaster, an epidemiologist with the Pasadena Public Health Department.

The swift and intensive response was funded largely by a new bucket of money in the budget for public health and preparedness across California, said Manuel Carmona, Pasadena's deputy director of public health.

In the midst of the covid-19 pandemic, and facing pleas from public health who said they didn't have enough resources to track and contain the disease, California Gov. Gavin Newsom had agreed to allocate $300 million each year for the state's chronically underfunded public health system.

Two years after the money started to flow, and facing a $45 billion deficit, the second-term Democratic governor proposes to slash the entirely.

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“This is a huge step backwards,” said Kat DeBurgh, executive director of the Health Association of California. “We can't go back to where we were before the pandemic. That future looks very scary.”

Michelle Gibbons, executive director of the County Health Executives Association of California, said about 900 public health workers have already been hired with the new funding — some of Pasadena's disease investigators — positions that are at risk should Newsom prevail.

The governor unveiled his updated budget plan for the 2024-25 fiscal year on May 10, saying it pained him to push such deep cuts to health and human services but that the state needed to make “difficult decisions” to balance its budget. Unlike the federal government, it cannot operate on a deficit.

Tense budget negotiations are underway between Newsom and the leaders of the state Senate and Assembly, who must reach an agreement on the state's estimated $288 billion budget by June 15.

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“We have a shortfall. We have to be sober about the reality, what our priorities are,” Newsom said after unveiling his suggested cuts. “This is a program that we wish we could continue to absorb and afford.”

Public health officials lobbied Newsom hard in 2020 and 2021 to get more resources, and secured additional annual funding of $100 million for the state Department of Public Health and $200 million for the 61 local health departments that form the backbone of California's public health system.

Now they are fighting to preserve their funding — just as cities and counties had begun using it to bolster California's public health defenses.

Some of the workers hired with the money are battling homelessness, fighting climate change, or surveying farmworkers to identify their health and social needs, but most are communicable disease specialists such as epidemiologists and public health nurses charged with investigating threats and outbreaks.

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Measles infections are breaking out in Davis, San Diego, Humboldt County, and elsewhere. Long Beach declared a public health emergency early this month over an outbreak of tuberculosis, which spreads through the air when an infected person coughs, speaks, or sneezes. Los Angeles public health authorities are investigating a spate of hepatitis A infections among homeless people.

And around the United States, the spread of bird flu from animals to humans is causing widespread concern.

“The more time this virus is out there transferring between cows and birds, the more chance it has to evolve and spread human to human,” DeBurgh said. She argues that public health agencies must have enough funding to hire workers who can halt threats as they emerge — like they did in Pasadena.

“That dengue outbreak was stopped because we had more ability to hire, and that was a huge public health ,” she said.

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Pasadena public health authorities teamed up with the local mosquito control agency to spray pesticides and deployed 29 staffers to test residents for dengue.

“We put our best people on that case,” Carmona said, adding that four of the disease investigators were funded with about $1 million in new state money the department receives each year. “Without it, we wouldn't have a timely response and we probably would have identified dengue as Nile or some other type of viral virus.”

Rob Oldham, the interim public health officer and director of Health and Human Services for Placer County, said he's weighing the “devastating” cuts he'd have to make if Newsom's proposal passes. The county has hired 11 full-time and six part-time workers using about $1.8 million in new annual state funding, he said.

“This money was just starting to take hold,” he said. “Honestly, we're scrambling, just as we're responding to another measles case.”

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Legislative leaders were reluctant to say whether they would try to safeguard the funding, as they face deep cuts in nearly every sector of state government, including early childhood education, public safety, energy, and transportation.

“We're knee-deep in budget negotiations but we're working like hell to protect the progress we've made,” said state Senate leader Mike McGuire, a Northern California Democrat.

Public health officials warned the state would be vulnerable to health and economic disasters should they lose the hard-won funding.

“It's tempting to go back to what we had before, because when we do our jobs, we are invisible. Crises are averted,” Gibbons said. “But it's devastating to think of going back to this boom-and-bust cycle of public health funding that goes neglect, panic, repeat.”

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

——————————
By: Angela Hart
Title: Newsom Boosted California's Public Health Budget During Covid. Now He Wants To Cut It.
Sourced From: kffhealthnews.org/news/article/gavin-newsom-california-public-health-budget-cuts/
Published Date: Mon, 20 May 2024 09:00:00 +0000

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Medicaid Unwinding Deals Blow to Tenuous System of Care for Native Americans

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Jazmin Orozco Rodriguez
Mon, 20 May 2024 09:00:00 +0000

About a year into the process of redetermining Medicaid eligibility after the public health emergency, more than 20 million people have been kicked off the joint federal-state program for low-income families.

A chorus of stories recount the ways the unwinding has upended people's lives, but Native Americans are proving particularly vulnerable to losing coverage and face greater obstacles to reenrolling in Medicaid or finding other coverage.

“From my perspective, it did not work how it should,” said Kristin Melli, a pediatric nurse practitioner in rural Kalispell, Montana, who also provides telehealth services to tribal members on the Fort Peck Reservation.

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The redetermination process has compounded long-existing problems people on the reservation face when seeking care, she said. She saw several patients who were still eligible for benefits disenrolled. And a rise in uninsured tribal members undercuts their health systems, threatening the already tenuous access to care in Native communities.

One teenager, Melli recalled, lost coverage while seeking lifesaving care. Routine lab work raised flags, and in follow-ups Melli discovered the girl had a condition that could have killed her if untreated. Melli did not disclose details, to protect the patient's privacy.

Melli said she spent weeks working with tribal nurses to coordinate lab monitoring and consultations with specialists for her patient. It wasn't until the teen went to a specialist that Melli received a call saying she had been dropped from Medicaid coverage.

The girl's parents told Melli they had reapplied to Medicaid a month earlier but hadn't heard back. Melli's patient eventually got the medication she needed with from a pharmacist. The unwinding presented an unnecessary and burdensome obstacle to care.

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Pat Flowers, Montana Democratic Senate minority leader, said during a political event in early April that 13,000 tribal members had been disenrolled in the state.

Native American and Alaska Native adults are enrolled in Medicaid at higher rates than their white counterparts, yet some tribal still didn't know exactly how many of their members had been disenrolled as of a survey conducted in February and March. The Tribal Self-Governance Advisory Committee of the Indian Health Service conducted and published the survey. Respondents included tribal leaders from Alaska, Arizona, Idaho, Montana, and New Mexico, among other states.

Tribal leaders reported many challenges related to the redetermination, including a lack of timely information provided to tribal members, patients unaware of the process or their disenrollment, long processing times, lack of staffing at the tribal level, lack of communication from their states, concerns with obtaining accurate tribal data, and in cases in which states have shared data, difficulties interpreting it.

Research and policy experts initially feared that vulnerable populations, including rural Indigenous communities and families of color, would experience greater and unique obstacles to renewing their health coverage and would be disproportionately harmed.

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“They have a lot at stake and a lot to lose in this process,” said Joan Alker, executive director of the Georgetown Center for Children and Families and a research professor at the McCourt School of Public Policy. “I fear that that prediction is coming true.”

Cammie DuPuis-Pablo, tribal health communications director for the Confederated Salish and Kootenai Tribes in Montana, said the tribes don't have an exact number of their members disenrolled since the redetermination began, but know some who lost coverage as far back as July still haven't been reenrolled.

The tribes hosted their first outreach event in late April as part of their effort to help members through the process. The health care resource division is meeting people at home, making calls, and planning more events.

The tribes a list of members' Medicaid status each month, DuPuis-Pablo said, but a list of those no longer insured by Medicaid would be more helpful.

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Because of those data deficits, it's unclear how many tribal members have been disenrolled.

“We are at the mercy of state Medicaid agencies on what they're willing to share,” said Yvonne Myers, consultant on the Affordable Care Act and Medicaid for Citizen Potawatomi Nation Health Services in Oklahoma.

In Alaska, tribal health leaders struck a data-sharing agreement with the state in July but didn't begin receiving information about their members' coverage for about a month — at which point more than 9,500 Alaskans had already been disenrolled for procedural reasons.

“We already lost those people,” said Gennifer Moreau-Johnson, senior policy adviser in the Department of Intergovernmental Affairs at the Alaska Native Tribal Health Consortium, a nonprofit organization. “That's a real impact.”

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Because federal regulations don't require states to track or report race and ethnicity data for people they disenroll, fewer than 10 states collect such information. While the data from these states does not show a higher rate of loss of coverage by race, a KFF report states that the data is limited and that a more accurate picture would require more demographic from more states.

Tribal health leaders are concerned that a high number of disenrollments among their members is financially undercutting their health systems and ability to provide care.

“Just because they've fallen off Medicaid doesn't mean we stop serving them,” said Jim Roberts, senior executive liaison in the Department of Intergovernmental Affairs of the Alaska Native Tribal Health Consortium. “It means we're more reliant on other sources of to provide that care that are already underresourced.”

Three in 10 Native American and Alaska Native people younger than 65 rely on Medicaid, compared with 15% of their white counterparts. The Indian Health Service is responsible for providing care to approximately 2.6 million of the 9.7 million Native Americans and Alaska Natives in the U.S., but services vary across regions, clinics, and health centers. The agency itself has been chronically underfunded and unable to meet the needs of the population. For fiscal year 2024, Congress approved $6.96 for IHS, far less than the $51.4 billion tribal leaders called for.

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Because of that historical deficit, tribal health systems lean on Medicaid reimbursement and other third-party payers, like Medicare, the Department of Affairs, and private insurance, to help fill the gap. Medicaid accounted for two-thirds of third-party IHS revenues as of 2021.

Some tribal health systems receive more federal funding through Medicaid than from IHS, Roberts said.

Tribal health leaders fear diminishing Medicaid dollars will exacerbate the long-standing health disparities — such as lower life expectancy, higher rates of chronic disease, and inferior access to care — that plague Native Americans.

The unwinding has become “all-consuming,” said Monique Martin, vice president of intergovernmental affairs for the Alaska Native Tribal Health Consortium.

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“The state's really having that focus be right into the minutiae of administrative tasks, like: How do we send text messages to 7,000 people?” Martin said. “We would much rather be talking about: How do we address social determinants of health?”

Melli said she has stopped hearing of tribal members on the Fort Peck Reservation losing their Medicaid coverage, but she wonders if that means disenrolled people didn't seek help.

“Those are the ones that we really worry about,” she said, “all of these silent cases. … We only know about the ones we actually see.”

——————————
By: Jazmin Orozco Rodriguez
Title: Medicaid Unwinding Deals Blow to Tenuous System of Care for Native Americans
Sourced From: kffhealthnews.org//article/medicaid-unwinding-endangers-native-american-health-care/
Published Date: Mon, 20 May 2024 09:00:00 +0000

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The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care

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Michelle Andrews
Fri, 17 May 2024 09:00:00 +0000

For many patients, seeing a nurse practitioner has become a routine part of primary care, in which these “NPs” often perform the same tasks that patients have relied on doctors for.

But NPs in specialty care? That's not routine, at least not yet. Increasingly, though, nurse practitioners and physician assistants are joining cardiology, dermatology, and other specialty practices, broadening their skills and increasing their income.

This worries some people who track the health workforce, because current trends suggest primary care, which has counted on nurse practitioners to backstop physician shortages, soon might not be able to rely on them to the same extent.

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“They're succumbing to the same challenges that we have with physicians,” said Atul Grover, executive director of the Research and Action Institute at the Association of American Medical Colleges. The rates NPs can command in a specialty practice “are quite a bit higher” than practice salaries in primary care, he said.

When nurse practitioner programs began to proliferate in the 1970s, “at first it looked great, producing all these nurse practitioners that go to work with primary care physicians,” said Yalda Jabbarpour, director of the American Academy of Physicians' Robert Graham Center for Policy Studies. “But now only 30% are going into primary care.”

Jabbarpour was referring to the 2024 primary care scorecard by the Milbank Memorial Fund, which found that from 2016 to 2021 the proportion of nurse practitioners who worked in primary care practices hovered between 32% and 34%, even though their numbers grew rapidly. The proportion of physician assistants, also known as physician associates, in primary care ranged from 27% to 30%, the study found.

Both nurse practitioners and physician assistants are advanced practice clinicians who, in addition to graduate degrees, must complete distinct education, , and certification steps. NPs can practice without a doctor's supervision in more than two dozen states, while PAs have similar independence in only a handful of states.

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About 88% of nurse practitioners are certified in an area of primary care, according to the American Association of Nurse Practitioners. But it is difficult to track exactly how many work in primary care or in specialty practices. Unlike physicians, they're generally not required to be endorsed by a national standard-setting body to practice in specialties like oncology or cardiology, for example. The AANP declined to answer questions about its annual workforce survey or the extent to which primary care NPs are moving toward specialties.

Though data tracking the change is sparse, specialty practices are adding these advanced practice clinicians at almost the same rate as primary care practices, according to frequently cited research published in 2018.

The clearest evidence of the shift: From 2008 to 2016, there was a 22% increase in the number of specialty practices that employed nurse practitioners and physician assistants, according to that study. The increase in the number of primary care practices that employed these professionals was 24%.

Once more, the most recent projections by the Association of American Medical Colleges predict a dearth of at least 20,200 primary care physicians by 2036. There will also be a shortfall of non-primary care specialists, a deficiency of at least 10,100 surgical physicians and up to 25,000 physicians in other specialties.

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When it to the actual work performed, the lines between primary and specialty care are often blurred, said Candice Chen, associate professor of health policy and management at George Washington University.

“You might be a nurse practitioner working in a gastroenterology clinic or cardiology clinic, but the scope of what you do is starting to overlap with primary care,” she said.

Nurse practitioners' salaries vary widely by location, type of facility, and experience. Still, according to data from recruiter AMN Healthcare Physician Solutions, formerly known as Merritt Hawkins, the total annual average starting compensation, including signing bonus, for nurse practitioners and physician assistants in specialty practice was $172,544 in the year that ended March 31, slightly higher than the $166,544 for those in primary care.

According to forecasts from the federal Bureau of Labor Statistics, nurse practitioner will increase faster than jobs in almost any other occupation in the decade leading up to 2032, growing by 123,600 jobs or 45%. (Wind turbine service technician is the only other occupation projected to grow as fast.) The growth rate for physician assistants is also much faster than average, at 27%. There are more than twice as many nurse practitioners as physician assistants, however: 323,900 versus 148,000, in 2022.

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To Grover, of the AAMC, numbers like this signal that there will probably be enough NPs, PAs, and physicians to meet primary care needs. At the same time, “expect more NPs and PAs to also flow out into other specialties,” he said.

When Pamela Ograbisz started working as a registered nurse 27 years ago, she worked in a cardiothoracic intensive care unit. After she became a family nurse practitioner a few years later, she found a job with a similar specialty practice, which trained her to take on a bigger role, first running their outpatient clinic, then working on the floor, and later in the intensive care unit.

If nurse practitioners want to specialize, often “the doctors mentor them just like they would with a physician residency,” said Ograbisz, now vice president of clinical operations at temporary placement recruiter LocumTenens.com.

If physician assistants want to specialize, they also can do so through mentoring, or they can “certificates of added qualifications” in 10 specialties to demonstrate their expertise. Most employers don't “encourage or require” these certificates, however, said Jennifer Orozco, chief medical officer at the American Academy of Physician Associates.

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There are a number of training programs for family nurse practitioners who want to develop skills in other .

Raina Hoebelheinrich, 40, a family nurse practitioner at a regional medical center in Yankton, South Dakota, recently enrolled in a three-semester post-master's endocrinology training program at Mount Marty University. She lives on a farm in nearby northeastern Nebraska with her husband and five sons.

Hoebelheinrich's new skills could be helpful in her current hospital job, in which she sees a lot of patients with acute diabetes, or in a clinic setting like the one in Sioux Falls, South Dakota, where she is doing her clinical endocrinology training.

Lack of access to endocrinology care in rural areas is a real problem, and many people may travel hundreds of miles to see a specialist.

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“There aren't a lot of options,” she said.

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By: Michelle Andrews
Title: The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care
Sourced From: kffhealthnews.org//article/nurse-practitioners-trend-primary-care-specialties/
Published Date: Fri, 17 May 2024 09:00:00 +0000

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