With his company's health costs soaring and his workers struggling with high blood pressure and other medical conditions, Winston Griffin, CEO of Laurel Grocery Co., knew his company had to do something.
So the London, Kentucky, wholesaler opened a health clinic.
"Our margins are tiny, so every expense is important," Griffin said. The clinic, he said, has helped lower the company's health costs and reduce employee sick leave.
Large employers have run clinics for decades. At Laurel Grocery's in-house clinic, workers can get checkups, blood tests, and other primary care needs fulfilled free, without leaving the workplace. But Griffin's move is notable because of his company's size: only about 250 employees.
Nationwide, a modest number of small- and medium-size employers have set up their own health clinics at or near their workplaces, according to surveys and interviews with corporate vendors and consulting firms that help employers open such facilities.
Improving employee health and lowering health costs are among the main advantages employers cite for running clinics. But some companies also say they're helping to blunt the nation's shortage of primary care doctors and eliminate the hassle of finding and getting care.
"Why did we do this? So my employees would not drop dead on the floor," Griffin said. "We had such an unhealthy workforce, and drastic times called for drastic measures."
KFF's annual survey of workplace benefits this year found that about 20% of employers who offer health insurance and have 200 to 999 workers provide on-site or near-site clinics. That compares with 30% or better for employers with 1,000 or more workers.
Those figures have been relatively steady in recent years, surveys show.
And U.S. employers reported the biggest increase this year in annual family premiums for their sponsored health plans in a decade — an average jump of 7% to nearly $24,000, according to the KFF survey, released Oct. 18. That spike may intensify interest among business leaders in curbing underlying health costs, including by exploring delivering care at workplaces.
Employers don't require their workers to use their clinics but typically provide incentives such as free or reduced copayments. Griffin offered employees $150 to get a physical at the clinic; 90% took advantage of the deal, he said.
Employer clinics could alleviate the rising demand for primary care. A far lower proportion of U.S. doctors are generalists than in other advanced economies, according to data compiled by the Peterson Center on Healthcare and KFF.
For patients, frustrating wait times are one result. A recent survey by a physician staffing firm found it now takes an average of three weeks to get in to see a family doctor.
In 2022, Franklin International, a manufacturer of adhesives in Columbus, Ohio, began offering its 450 workers the option to use local primary care clinics managed by Marathon Health, one of about a dozen companies that set up on-site or near-site health centers for employers.
Franklin employees pay nothing at the clinics compared with a $50 copayment to see an outside doctor in their insurance network. So far about 30% of its workers use the Marathon clinics, said Doug Reys, Franklin's manager of compensation benefits.
"We heard about the difficulty employees had to get in to a doctor," he said. They would call providers who said they were accepting new patients but would still wait months for an appointment, he added.
At the Marathon clinics — which are shared by other employers — workers now can see a provider within a day, he said.
That's good for employees — and for the company's recruiting efforts. "It is a good benefit to say you can get free primary care," Reys said.
Not all employers that have explored opening their own clinics have seen the value. In 2020, the agency that oversees health benefits for Wisconsin state employees opted against the on-site model after a review of experiences by similar agencies in Indiana and Kentucky found it didn't save money or constrain health insurance premiums.
Kara Speer, national practice leader for consulting firm WTW, said potential cost savings from employer-run clinics can take years to accrue as employees shift from pricier hospital emergency rooms and urgent care clinics. And it can be difficult to measure whether clinics control costs by improving workers' health through preventive screenings and checkups, she said.
Kathy Vicars, a senior vice president at Marathon Health, said about 25% of its 250 clients are firms with fewer than 500 people. She said Marathon's clinics help drive down costs and help employees get easier access to doctors who spend more time with them during appointments. Her company helps employers manage workers with chronic diseases better and redirects care from urgent care centers and ERs, she said.
Hospitals have also sought to get into the business of running on-site clinics for employers, but some potential clients question whether those health systems have incentives to funnel workers to their own hospitals and specialists.
At Laurel Grocery, Griffin said he knows many of his employees don't regularly exercise and have poor diets — a reflection of the overall population in the region. Health screenings performed by a local hospital over the years found many residents with high cholesterol and high blood pressure. "Nothing tended to change," he said.
Laurel Grocery contracts with a local hospital for about $100,000 a year to manage its clinic, including having a physician assistant on-site three days a week. Laurel Grocery does not have access to any employee health records.
He said the clinic has saved money by reducing unnecessary ER use and reducing hospitalizations. "It's been way more successful than I thought it would" be, he said.
The clinic is about a three-minute walk from Kip Faulhaber's office. Faulhaber, a senior vice president at Laurel Grocer who is 73, said he goes in every week for a vitamin B12 shot to treat a deficiency. He also turns to the clinic for an annual physical, vaccinations, and when he has a sinus infection but doesn't want to wait several days to see his regular physician.
For the first time, people worried about their risk of Alzheimer's disease can go online, order a blood test, and receive results in the privacy of their homes.
This might seem appealing on the surface, but the development has Alzheimer's researchers and clinicians up in arms.
The Quest Diagnostics blood test, AD-Detect, measures elevated levels of amyloid-beta proteins, a signature characteristic of Alzheimer's. Introduced in late July, the test is targeted primarily at people 50 and older who suspect their memory and thinking might be impaired and people with a family history of Alzheimer's or genetic risks for the condition.
Given Alzheimer's is among the most feared of all medical conditions, along with cancer, this could be a sizable market, indeed. Nearly 7 million older adults in the U.S. have Alzheimer's, and that number is expected to double by 2060 if medical breakthroughs don't occur.
But Alzheimer's researchers and clinicians aren't convinced the Quest test is backed by sound scientific research. The possibility of false-positive results is high, as is the likelihood that older adults won't understand the significance of their results, they say. The test should be taken only under a physician's supervision, if at all, they advise. And, priced originally at $399 (recently discounted to $299) and not covered by insurance, it isn't cheap.
Though blood tests for Alzheimer's are likely to become common in the years ahead, the Alzheimer's Association said it's premature to offer a test of this kind directly to consumers.
For its part, Quest, which also sells direct-to-consumer tests for sexually transmitted diseases and various other conditions, suggests older adults can be trusted to respond responsibly to AD-Detect results. The test is not meant to diagnose Alzheimer's, the company stressed; instead, it's meant to help assess an individual's risk of developing the condition. But under a new, proposed biological definition of Alzheimer's, excess amyloid could automatically trigger a diagnosis of "preclinical" Alzheimer's.
Michael Racke, Quest's medical director of neurology, said individuals who test positive might be inspired to talk to their physicians about cognitive symptoms and seek comprehensive evaluations from dementia specialists. Others may just want to adopt behaviors associated with brain health, such as exercising more and maintaining healthy blood pressure, blood sugar, and cholesterol levels.
"People who do consumer-initiated testing are often very motivated to figure out what they can do to help reduce the risk of disease," he said.
To get the test, a person first needs to go to the AD-Detect test's website and report that they're experiencing mild cognitive decline and have at least one other risk factor. (Self-reported complaints of this kind are often unreliable, experts note.) The order then goes automatically to a doctor paid by Quest, who will order a blood test to be drawn at a Quest laboratory.
Results classifying a person as low, medium, or high risk will be provided on a secure patient portal. Post-test counseling isn't mandatory, but individuals can speak to a physician paid by Quest, if they like. (There is a separate $13 "physician service fee.")
A new poll from the University of Michigan confirms that older adults will take results seriously: Ninety-seven percent of seniors said they would take steps to improve brain health upon receiving a positive result from a blood test, while 77% said they would consider changes to financial or end-of-life plans.
But research scientists and clinicians worry that Quest hasn't published any peer-reviewed studies documenting the test's validity. The company's preliminary data released at the 2022 Alzheimer's Association International Conference in San Diego suggests there's a relatively high chance of false-positive results, said Suzanne Schindler, an associate professor of neurology at Washington University School of Medicine in St. Louis.
That's a significant problem because telling someone they have biological changes associated with Alzheimer's disease is a "big deal and you want to be as accurate as possible," Schindler noted.
Racke said at least three scientific studies giving more details about the AD-Detect test have been submitted to medical journals and might be published by the end of this year.
Experts also question the usefulness of the test since a positive result (indicating abnormal levels of amyloid in the blood) doesn't mean an individual will definitely develop Alzheimer's disease. Amyloid in the brain accumulates slowly over the course of decades, typically beginning in middle age, and becomes more common as people age.
"This test gives you a fuzzy answer. We don't know whether you're going to get dementia, or when symptoms might begin, or, really, how high the risk is for any individual," said Meera Sheffrin, medical director of the Senior Care clinic at Stanford Healthcare.
Also, cognitive symptoms that prompt someone to take the test might be due to a wide variety of other causes, including mini-strokes, sleep apnea, thyroid problems, vitamin B12 deficiency, or medication interactions. If an older adult becomes anxious, depressed, or hopeless upon learning they're at risk for Alzheimer's — another source of concern — "they may not go for further evaluation and seek appropriate care," said Rebecca Edelmayer, senior director of scientific engagement at the Alzheimer's Association.
The University of Michigan poll confirms the potential for misunderstanding. Upon receiving a positive result from a blood test, 74% of seniors said they would believe they were likely to develop Alzheimer's and 64% said they would be likely to experience significant distress.
Because the science behind blood tests for Alzheimer's is still developing and because "patients may not really understand the uncertainty of test results," Edelmayer said, the Alzheimer's Association "does not endorse the use of the AD-Detect test by consumers."
Quest's blood test is one of several developments altering the landscape of Alzheimer's care in the United States. In early July, the FDA granted full approval to Leqembi, an anti-amyloid therapy that slightly slows cognitive decline in people with mild cognitive impairment and early-stage Alzheimer's. Early detection of cognitive symptoms and diagnosis of cognitive dysfunction have assumed greater importance now that this disease-modifying drug is available.
Also in July, a work group convened by the National Institute on Aging and the Alzheimer's Association proposed a new definition of Alzheimer's disease to be used in clinical practice.
Previously, Alzheimer's could be diagnosed only when there was evidence of underlying brain pathology (amyloid plaques and tau tangles) as well as cognitive symptoms (memory loss, poor judgment, disorientation, among others) and accompanying impairments (difficulty with managing finances, wandering, problems with self-care, and more). Under the new definition, Alzheimer's would be defined purely on a biological basis, as a "continuum that is first evident with the appearance of brain pathologic changes" including amyloid accumulation, according to a draft of the work group's report.
That would mean "you can get a positive result from the Quest test and be diagnosed with Alzheimer's disease if these guidelines are adopted, even if you're cognitively normal," cautioned Eric Widera, a professor of medicine at the University of California-San Francisco.
Demand for follow-up evaluations by dementia specialists is likely to be high and contribute to already-long waits for care, he suggested.
Additional concerns about the test relate to safeguarding privacy and the potential for discrimination. No federal laws protect people who receive Alzheimer's biomarker results from discriminatory practices, such as employment discrimination or the denial of life, disability, or long-term care insurance. (The Genetic Information Nondiscrimination Act applies only to genetic tests.) And "laws that normally protect the privacy of health information do not apply in this space," said Emily Largent, an assistant professor of medical ethics and health policy at the University of Pennsylvania's Perelman School of Medicine.
Notably, HIPAA, the Health Insurance Portability and Accountability Act, doesn't extend to laboratory tests marketed directly to consumers.
The bottom line: Before taking a test, "older adults need to ask themselves, ‘Why do I want to know this? What will I do with the information? How will I react? What would I change in the future?'" said C. Munro Cullum, a neuropsychologist and distinguished professor of clinical psychology at the University of Texas Southwestern Medical Center. "This test needs to be used very cautiously and with great forethought."
We're eager to hear from readers about questions you'd like answered, problems you've been having with your care, and advice you need in dealing with the health care system. Visit kffhealthnews.org/columnists to submit your requests or tips.
SACRAMENTO, Calif. — California continues to burnish its reputation as a progressive state for health policy as Gov. Gavin Newsom signed bills expanding paid sick leave, adding bereavement leave for miscarriages, and boosting wages for health workers.
Newsom blessed a rare agreement between labor and the health industry to gradually phase in a nation-leading $25-an-hour statewide minimum wage for health workers. Estimates based on earlier versions of the bill found it would increase healthcare costs by billions of dollars each year and put pressure on the state's Medicaid program to raise reimbursement rates for long-term care to maintain patients' access to services. Other new laws aim to strengthen reproductive rights, as well as patient protections against errant doctors and pharmacists and surprise ambulance bills.
Still, in a possible sign of his national ambitions and experience as a businessperson and father, the Democrat tempered the bill-signing season by vetoing free condoms in schools and possession of psychedelic mushrooms.
He rejected decriminalizing such hallucinogens even as he supported their therapeutic potential as "an exciting frontier." He urged lawmakers to try again next year, this time adding specific treatment guidelines including recommended doses and protections for people with underlying psychoses. The bill's lead author, state Sen. Scott Wiener of San Francisco, had introduced the proposal amid successful decriminalization efforts in Colorado, Oregon, and some cities, saying veterans and others suffering from post-traumatic stress disorder and depression should not be penalized for seeking relief.
Newsom also shot down a $35 price cap for a 30-day supply of insulin in favor of his own price-cutting efforts, touting his administration's $50 million contract to begin sourcing its own insulin as early as next year. He argued this approach would avoid indirect price hikes for consumers that could come in the form of higher premiums to cover cheaper insulin.
The governor similarly showed caution in vetoing health and safety protections for domestic workers, arguing that "private households and families cannot be regulated in the exact same manner as traditional businesses."
The new laws will take effect in 2024 unless otherwise noted:
Sick Days
California workers will be entitled to five paid sick days a year under SB 616, by state Sen. Lena Gonzalez, a Democrat from Long Beach. That's up from the three days required in California since 2014, but short of the seven days Gonzalez originally sought. Advocates say workers shouldn't have to show up sick, potentially spreading illness, because they can't afford to stay home. But the California Chamber of Commerce included the bill on its annual job killer list and said it would harm struggling small businesses.
Miscarriage and Failed Adoption Leave
Parents who experience miscarriages, stillbirths, failed adoptions, or a breakdown in a surrogate pregnancy agreement will all be entitled to bereavement leave under SB 848. The bill, by state Sen. Susan Rubio, a Democrat from the San Gabriel Valley, will include unpaid reproductive loss leave under the state's existing law allowing up to five days of bereavement leave upon the death of a family member. She called reproductive losses "one of the most traumatizing events a person can experience," noting that Illinois and Utah enacted similar laws in 2022. The bill applies to companies with five or more employees.
Abortion Protections
A year after the U.S. Supreme Court overturned Roe v. Wade, Newsom signed nine abortion-related laws, adding to the strong protections for the procedure that California lawmakers adopted a year ago. Among them is SB 345, which increases protections for medical providers who live in California but mail abortion pills or gender-related medications to states where they are illegal. The bill's lead author, state Sen. Nancy Skinner, a Democrat from Berkeley, said in a statement that the laws strengthen California's position "as the national leader for reproductive freedom." Another bill, AB 1646, by Assembly member Stephanie Nguyen, a Democrat from Elk Grove, allows doctors from other states to receive abortion training in California without having to obtain a California medical license.
Behavioral Health Funding
Voters will get a direct say in March on Proposition 1, Newsom's key behavioral health initiative. Having signed a bipartisan package of bills, Newsom will ask voters to approve billions of dollars aimed at alleviating California's seemingly incorrigible homelessness crisis. He says that represents a paradigm shift in how California addresses the dilemma, but the proposition is opposed by those worried about expanding involuntary treatment and diverting funding from existing community-based programs. He also signed SB 43, expanding the state's conservatorship law to make it easier to force people into treatment for mental illness or addiction.
Medical Licensing Fees
The Medical Board of California will be required to follow new procedures while investigating complaints, while doctors will pay higher licensing fees to help fund those investigations. SB 815, by Sen. Richard Roth, a Riverside Democrat, mandates the new complaint procedures amid criticism of the board by patient advocates, who say bad doctors often escape sanction. It will gradually boost the license renewal fee to $1,255 every two years, up from $863 currently. It also repeals AB 2098, passed last year, that said it is unprofessional conduct for doctors to spread misinformation or disinformation related to COVID-19. The law was entangled in multiple lawsuits with conflicting rulings, including one by a federal judge who called it "unconstitutionally vague."
Pharmacy Errors
Medication errors harm at least 1.5 million Americans annually and are among the most common medical errors, according to the National Academy of Medicine. In California, they are the top violation resulting in a citation. AB 1286, by Assembly member Matt Haney, a Democrat from San Francisco, imposes what he said is a first-in-the-nation requirement that retail pharmacies report every error. It also gives the pharmacist in charge at each store the authority to increase staffing and the duty to inform the store's management of dangerous conditions. The California State Board of Pharmacy can close a pharmacy if the conditions aren't improved.
Surprise Ambulance Bills
Patients who call for an ambulance can sometimes receive "surprise bills" topping $1,000, according to Health Access California. AB 716, by Assembly member Tasha Boerner, a Democrat from Encinitas, protects consumers from being charged out-of-network costs for ambulance services and uninsured Californians from being charged what she calls inflated ambulance rates. An analysis by the California Health Benefits Review Program said that would require health plans and insurers to pay more for out-of-network services.
Lifesaving Medications
AB 1651, by Assembly member Kate Sanchez, a Republican from Rancho Santa Margarita, will require schools to have emergency epinephrine auto-injectors for use by school nurses or trained volunteers to treat life-threatening anaphylactic reactions. More than 15% of children with food allergies have had a reaction at school, according to the Latino Food Allergy Network, which sought the bill.
Food Safety
By 2027, California will become the first U.S. state to ban four chemicals widely used in processed food and drinks, following the lead of the European Union and other nations. AB 418, by Democratic Assembly members Jesse Gabriel and Buffy Wicks, initially drew headlines because it would have banned titanium dioxide, which is used in Skittles, but that chemical was dropped from the bill. Opponents said the U.S. and California already have sufficient food safety and food labeling requirements. Newsom and the bill's supporters chided the Food and Drug Administration for failing to take action.
Jason Bleak runs Battle Mountain General Hospital, a small facility in a remote Nevada gold mining town that he described as "out here in the middle of nowhere."
When several representatives from private health insurance companies called on him a few years ago to offer Medicare Advantage plan contracts so their enrollees could use his hospital, Bleak sent them away.
"Come back to the table with a better offer," the chief executive recalled telling them. The representatives haven't returned.
Battle Mountain is in north-central Nevada about a three-hour drive from Reno, and four hours from Salt Lake City. Bleak suspects insurance companies simply haven't enrolled enough of the area's seniors to need his hospital in their network.
Medicare Advantage insurers are private companies that contract with the federal government to provide Medicare benefits to seniors in place of traditional Medicare. The plans have become dubious payers for many large and small hospitals, which report the insurers are often slow to pay or don't pay.
Private plans now cover more than half of all those eligible for Medicare. And while enrollment is highest in metropolitan areas, it has increased fourfold in rural areas since 2010. Meanwhile, more than 150 rural hospitals have closed since 2010, according to the Cecil G. Sheps Center for Health Services Research at the University of North Carolina. Largely rural states such as Texas, Tennessee, and Georgia have had the most closures.
Medicare Advantage growth has had an outsize impact on the finances of small, rural hospitals that Medicare has designated as "critical access." Under the designation, government-administered Medicare pays extra to those hospitals to compensate for low patient volumes. Medicare Advantage plans, on the other hand, offer negotiated rates that hospital operators say often don't match those of traditional Medicare.
"It's happening across the country," said Carrie Cochran-McClain, chief policy officer of the National Rural Health Association, whose members include small-town hospitals.
"Depending on the level of Medicare Advantage penetration in individual communities, some facilities are seeing a significant portion of their traditional Medicare patient or beneficiary move into Medicare Advantage," Cochran-McClain said.
Kelly Adams is the CEO of Mesa View Regional Hospital, another rural hospital in Nevada. He said he applauds Battle Mountain's Bleak for keeping Medicare Advantage plans out of his hospital "as long as he has."
Mesa View, which is a little more than an hour's drive east of Las Vegas, has a high percentage of patients enrolled in Medicare Advantage plans.
"Am I going to say I'm not going to take care of 40% of our patients at the hospital or the clinic?" Adams said, adding that it would be a "tough deal" to be forced to reject patients because they didn't have traditional Medicare.
Mesa View has 21 Medicare Advantage contracts with multiple insurance companies. Adams said he has trouble getting the plans to pay for care the hospital has provided. They are either "slow pay or no pay," he said.
In all, the plans owe Mesa View more than $800,000 for care already provided. Mesa View lost about $1.3 million taking care of patients, according to its most recent annual cost report.
NRHA's Cochran-McClain said the growth in the plans also narrows options for patients because "the contracting that is happening under Medicare Advantage frequently has an influence on steering patients to specific types of providers." If a hospital or provider does not contract with a Medicare Advantage plan, then a patient may have to pay for out-of-network care. That generally wouldn't happen with traditional Medicare, which is widely accepted.
At Mesa View, patients must drive to Utah to find nursing homes and rehabilitation facilities covered by their Medicare Advantage plans.
"Our local nursing homes are not taking Medicare Advantage patients because they don't get paid. But if you're straight Medicare, they'd be happy to take that patient," Adams said.
David Allen, a spokesperson for AHIP, an industry trade group formerly known as America's Health Insurance Plans, declined to respond to Bleak's and Adams' specific concerns. Instead, he said enrollees are signing on because the plans "are more efficient, more cost-effective, and deliver better value than original Medicare."
Centers for Medicare & Medicaid Services press secretary Sara Lonardo said CMS has acted to ensure "that private insurance companies are held accountable for providing quality coverage and care."
The reach of private Medicare Advantage plans varies widely in rural areas, said Keith Mueller, director of the Rural Policy Research Institute at the University of Iowa College of Public Health. If recent trends continue, enrollment could tip to 50% of all rural Medicare beneficiaries in about three years — with some regions like the Upper Midwest already higher than 50% and others lower, such as Nevada and the Mountain States, but trending upward.
In June, a bipartisan group of Congress members, led by Sen. Sherrod Brown (D-Ohio), sent a letter urging federal agencies to do more to force Medicare Advantage insurers to pay health systems what they owe for patient care.
In an August response, CMS Administrator Chiquita Brooks-LaSure wrote that a final rule issued in April made "impactful changes" to speed up care and address concerns about prior authorization — when a hospital and patient must get advance permission for care to ensure it will be covered by an insurer. Brooks-LaSure noted another proposed rule that, once finalized, could mandate that insurers provide specific reasons for denying care within seven days.
Hospital operators Adams and Bleak also want more federal action, and fast.
Bleak at Battle Mountain said he knows Medicare Advantage plans will eventually move into his area and he will have to contract with them.
"The question is," Bleak said, "how can we match the reimbursement so that we can sustain and keep our hospitals in these rural areas viable and strong?"
The way the hearing began — introducing issues and politics that are not necessarily on point — highlights how much the job of leading the NIH has changed.
This article was published on Friday, October 20, 2023 in KFF Health News.
A Senate committee finally held a hearing Wednesday on President Joe Biden's pick to lead the National Institutes of Health. But the panel's chair, Sen. Bernie Sanders (I-Vt.), was focused on drug prices — an issue over which the NIH has very little control.
After introducing the nominee, Monica Bertagnolli, at a hearing of the Health, Education, Labor and Pensions Committee, Sanders quickly pivoted to the high prices Americans pay for prescription drugs.
"Let me say a few words about my concerns," he said, using his opening statement to detail the failures of the country's "broken" health system. "Very relevant to the hearing that we are conducting right now," he said, "we spend, as a nation, the highest prices — we pay the highest prices in the world for prescription drugs, in some cases 10 times more than the people in other nations."
The way the hearing began — introducing issues and politics that are not necessarily on point — highlights how much the job of leading the NIH has changed. The agency has a budget of more than $47 billion, making it the largest funder of medical research in the world. But the responsibility of its director has, since the pandemic, taken on new layers of complexity.
It has become "an enormous job of bridging between the world of policy, the world of the public, and the world of science," said Larry Levitt, executive vice president for health policy at KFF.
"COVID turned the scientific health agencies into political footballs like never before," he said in an interview.
The nomination of Bertagnolli, a surgical oncologist and the director of the NIH's National Cancer Institute, was applauded by much of the medical research community, especially the oncology world. But after she was tapped for the role in May, progress stalled.
The confirmation of Bertagnolli's predecessor, Francis Collins, a physician and geneticist, took just four weeks in 2009, Sen. Tommy Tuberville (R-Ala.), observed. Bertagnolli's, he told her, has "faced a much different nomination process. Your nomination was held up by Chairman Sanders."
Sanders agreed to hold the hearing only after the Biden administration announced a contract with biotech company Regeneron Pharmaceuticals for a next-generation monoclonal antibody to prevent COVID-19 that required the list price of any resulting drug to be equal to or lower than the price in other major countries.
During the hearing, he returned to the issue, suggesting NIH should seek more such agreements with drugmakers that depend on the agency's research. He asked Bertagnolli if she could "commit to us that you will work to make sure that Americans do not pay higher prices for prescription drugs in this country than people around the world."
She responded noncommittally. "It would be a great honor to be able to work with you to make sure that the American people have access to the care that they need to live long and healthy lives."
As part of his criticism of Sanders, Tuberville also pointed out that the NIH has been without a confirmed director for 21 months. Tuberville, meanwhile, has for months been holding up nominations to military leadership positions over abortion policies.
If she's confirmed, Bertagnolli would lead the NIH at a time of high scrutiny and skepticism of public health agencies. HELP Committee Ranking Member Bill Cassidy (R-La.) told her that part of her duty would be "to rebuild the relationship with Congress and the public, being a leader that represents the interests of all Americans and not just of the scientific community."
To this end, senators asked Bertagnolli about how she would lead the agency's research on maternal health and diabetes, and about how she would address both opioid addiction and mental health crises. She was pressed on how accessible NIH's data would be to the public.
Roger Marshall (R-Kan.) asked if she thought taxpayers should "fund gender reassignment experiments." She dodged the question, noting that transgender youth are some of the most vulnerable in the country.
Bertagnolli kept a cool tone throughout the hearing as she shared her vision of "making sure that American people have access and availability and can afford the healthcare that can save lives."
Senators also questioned how well-rounded Bertagnolli's experience is and whether she would favor the NCI over the agency's 26 other institutes and centers. Sen. Susan Collins (R-Maine) asked Bertagnolli if she would be able to find a balance.
She explained that, as an oncologist, she "took care of patients of all ages, all walks of life, all different health states. I am very familiar to working with colleagues in cardiology, in mental health, in opioid use disorder, in kidney disease, to take care of my patients with cancer."
The HELP Committee has scheduled a vote on Bertagnolli's nomination Oct. 25.
Heather Avant always dresses up when she goes to the emergency room.
"I've been conditioned to act and behave in a very specific way," said Avant. "I try to do my hair. I make sure I shower, have nice clothes. Sometimes I put on my University of Michigan shirt."
It's a strategy to combat discrimination the 42-year-old photographer in Mesquite, Texas, has developed over a lifetime of managing her sickle cell disease, a rare blood disorder that affects an estimated 100,000 Americans. The hereditary condition can affect a person of any race or ethnicity, but Black patients, like Avant, make up the majority of those afflicted in the U.S.
For people living with the disease, a sickle cell crisis can happen at any time. When it does, their rigid, sickle-shaped red blood cells become stuck in their blood vessels, blocking flow and causing extreme pain or breathing difficulties. A crisis can escalate into life-threatening complications such as strokes, seizures, and sepsis.
When a pain crisis can't be managed at home, patients head to the ER to get the high dosage of opioids they need, in addition to IVs to help with dehydration or even blood transfusions. Yet staffers in emergency departments — already overextended and grappling with nursing shortages — don't always have experience in treating the rare disease. Doctors, amid a still-raging opioid crisis, remain resistant to prescribing the painkillers necessary to treat sickle cell crises. So, patients say, they face long delays before receiving essential care, plus discrimination and suspicion that they are seeking drugs to get high.
"I have to look like I'm not coming in here off the street looking for medication," said Avant. "I have to put on an entire show to get you to believe that I need care."
Years of research have documented the delays. A study published in 2013 found that patients seeking care from 2003 through 2008 at an ER for their sickle cell crises waited 50% longer than patients who arrived with broken legs or arms. A study published in 2021 found that 50% of sickle cell patients reported having to wait at least two hours before their pain was treated, despite medical guidelines recommending such patients in crisis receive their first dose of pain medication no more than 60 minutes after arriving at the ER.
Medical associations such as the American Society of Hematology, the National Heart, Lung, and Blood Institute, and the Emergency Nurses Association have established guidelines for emergency department-based care of sickle cell pain. And, in 2021, the Emergency Department Sickle Cell Care Coalition, a national collaboration of hematologists, pharmacists, and nurses, helped launch a point-of-care tool to help medical professionals manage the disease in the ER.
But patients and sickle cell experts said those best practices haven't been widely adopted. A 2020 survey of nearly 250 emergency medicine providers found that 75% of them were unaware of the NHLBI's recommendations, first published in 2014, yet 98% felt confident in their ability to treat patients with sickle cell disease.
Still, ER horror stories abound among adults with sickle cell disease. For Lesly Chavez, 29, a Houston hairstylist, her worst experience occurred a few years ago. She said she spent four hours in a waiting room before getting seen.
"And when they finally got to me, they told me they could help with ‘my addiction,' but they decided that there was nothing that they could do for me," Chavez said. "They just flat-out said no and sent me home while I was in crisis."
Chavez said she has since avoided that hospital even though it's 10 minutes from her home. Now she drives to an ER 30 minutes away.
Chavez, who is Hispanic, said she confronts "doubt everywhere I go" because sickle cell disease primarily affects Black Americans. (Those who are Hispanic can be of any race.)
Paula Tanabe, a professor of nursing at Duke University who has spent decades researching ways to improve care for sickle cell patients, said a confluence of factors adds to the racial bias patients may face.
"Emergency rooms are incredibly overcrowded, at rates that we have never seen before, and that's for everyone," said Tanabe.
Legislators are trying to help. A federal bill introduced in June would allocate $8.2 million annually for five years to a program that trains doctors on best practices for caring for sickle cell patients. Another, introduced this spring, would provide funding for community organizations working to spread awareness about the condition and give student loan relief to medical providers who commit to working on the disease. Some state legislatures have established sickle cell task forces to improve physician education and care coordination.
Advocates for sickle cell patients said investment in data collection to track the disease is also important. Although the Centers for Disease Control and Prevention estimates that some 100,000 Americans have it, the true number is unknown. That's because no national system exists to collect data on sickle cell, unlike other conditions such as diabetes, cancer, and Alzheimer's.
"I'm 32 and we've been saying it's 100,000 my entire life," said Quannecia McCruse, who co-founded the Sickle Cell Association of Houston. "I know there's more. I know people are going uncounted."
Eleven state-led data collection programs currently exist and, in February, the CDC opened a new grant application for additional states. Improved data would allow funding to be allocated toward the areas with the greatest need, sickle cell patient advocates said.
Texas had an opportunity to join those efforts. This spring, the state legislature passed a bill with broad bipartisan support to create a sickle cell patient registry, but Republican Gov. Greg Abbott vetoed it, saying it would compromise patient privacy.
"That was a bad excuse," said McCruse. "We have a cancer registry already, and everyone's information is safe. That registry would have gone a long way to help."
While progress grinds slowly, patients like McCruse say they're forced to balance advocating for themselves during bouts of excruciating pain against the need not to irritate or alienate hospital staffers.
"It feels like someone is taking a Taser and shocking the crap out of me. Or when it's really bad, and it feels like shards of glass are just moving through my veins," said the mother of two. "It's very, very painful. And you're telling somebody whose body is torturing them that it's not that bad?"
Alexis Thompson, a hematologist who treats sickle cell patients at the Children's Hospital of Philadelphia, said she works with her pediatric patients to develop self-advocacy skills. But sometimes that backfires.
"The great irony is patients who are well informed and capable of self-advocating are being accused of being manipulative, because they are capable of articulating very clearly what's effective for them down to the name of the medication or the absolute dose," Thompson said.
Sickle cell experts recommend that doctors adhere to a patient's individual pain plan, if available. Thompson said those plans, which document patients' diagnoses alongside a recommended medication and dosage, can be uploaded to online portals that patients can pull up on their cellphones when visiting an ER to verify what they need.
Patients such as Avant hope such steps can help decrease their ER waits while easing their anxiety about seeking emergency care.
"I don't fear dying," said Avant, "but I do fear dying in the hospital."
Jodi Bobbitt, the school nurse at William Ramsay Elementary in Alexandria, Virginia, is always ready to see children with a wide range of injuries and illnesses. One day during the first week of school, the parade started before the first bell when a little girl walked in with red, irritated eyes.
A student fell from the monkey bars and another tripped while playing tag. Two kids hit each other's heads with lunchboxes and needed ice packs. A young boy had a stomachache. Bobbitt also saw her regular kiddos: one who has special needs and uses a wheelchair and another who has diabetes and gets his blood sugar checked daily before lunch.
"Every day, I'm seeing more and more [youngsters]," Bobbitt, who is a certified nurse practitioner, said with a smile. "I saw more today than yesterday, so we just have to wait and see what the year has in store."
As the only school nurse at this suburban Washington, D.C., elementary school, Bobbitt's responsibilities extend beyond treating scraped knees and sniffles for the school's 600 pupils. At her under-the-sea-themed clinic, she administers medications, teaches kids about health care, and conducts routine health screenings. As the school nurse, she also serves as a public health point person — tracking student vaccinations, linking parents to local health care resources, and communicating sometimes difficult messages to them, such as warnings about sexually transmitted diseases and signs of depression.
It's a full plate, but Bobbitt considers herself lucky. In a previous school nursing job, she split her time between two buildings within the same school district — some years three. What hasn't changed is that school nurses play a critical role in keeping students healthy and ready to learn, but it's an often-unrecognized field for which schools struggle to attract and retain employees.
School nurses' roles were further complicated by COVID-19. Since the pandemic took hold, they've been tasked with tracking cases and tracing exposures. An "extreme load of work was put on school nurses' shoulders during the pandemic," said Kate King, president of the NASN.
They got caught in the middle between anti-maskers and maskers and anti-vaccine and pro-vaccine parents, and were the point of contact whenever students had to quarantine. "School nurses are used to interacting with parents who are angry," said King, but because of the pandemic "that anger just got to levels we had never seen before."
In general, kids' attendance and learning can suffer when students don't have access to a school nurse. "You're going to see more absences," she said, citing a study from the Journal of School Nursing that found students with illnesses or injuries were sent home 18% of the time when evaluated by an unlicensed school employee while only 5% went home after being seen by a school nurse.
Teachers and administrators are shouldering some of the burden by learning how to handle injuries and illnesses themselves, but "it doesn't take the place of having a school nurse who can respond immediately," King said.
Though there is no federal law requiring schools to have nurses on staff, the Centers for Disease Control and Prevention recommends at least one full-time nurse for every 750 students enrolled — but most states are missing the mark by miles. School nurses in California have one of the heaviest workloads in the country with a student-to-school-nurse ratio of 2,410 students for every nurse, according to the Public Policy Institute of California.
According to research organization Child Trends, California, along with 34 other states and the District of Columbia, requires schools to employ school nurses. Of those, 12 set required nurse-to-student ratios. Seven states encourage schools to have nurses on staff. Eight states don't have mandates on the books.
Still, schools were scrambling over the summer to hire nurses.
Jessica Sawko, director of education for Children Now, a California-based nonprofit organization, said schools struggle not only to retain nurses but also encourage aspiring nurses to consider working in schools. Districts can't compete with the salaries and benefits hospitals offer. The national median salary for school nurses is nearly $55,000 a year, but a registered nurse could make nearly $30,000 more annually working at a hospital.
In some states, school nurses need special certification in addition to their nursing degrees.
The lack of school nurses is a byproduct of a larger issue: the nation's overall nursing shortage. Health organizations in general — even those that offer healthy salaries — are facing difficulties hiring and keeping nurses. Around 40% of nurses who participated in a 2023 survey by McKinsey & Co. said they were considering leaving their position.
As a nurse for junior high students, King said she is keenly aware that school nurses sometimes serve as students' only contact with a health care professional, especially at her campus.
World Language Middle School in Columbus, Ohio, where King works, has a diverse student body and takes in many students who are new to the country. "So that requires school nurses like myself to have a very broad range of knowledge of diseases and symptoms," she said.
Robin Wallin, director of school health services for Alexandria City Public Schools, said that another layer of this issue is that school nursing "is an aging cohort." The district has at least one school nurse in each of its 18 campuses — but this year it was a challenge to fill every spot. That's partly because many school nurses are aging out, starting to retire, she said. "We need to start to replenish our cohorts."
Bobbitt said the nursing students who shadow her almost never imagine themselves working in a school. "They want to work in the ER, they want to work in the hospital, they want to work in the NICU, or somewhere where they can have that adrenaline," Bobbitt said. "This is a little different," she said, adding that it is fast paced in its own way.
Robin Cogan is a clinical coordinator at Rutgers University's School Nurse Specialty Program in New Jersey, and she said one of the biggest learning curves for nurses who opt to work in school settings is that they are "often an independent practitioner," which involves juggling a lot of responsibilities.
Meanwhile, Bobbitt, working in her brightly colored clinic, stays focused on her daily mission: to address the students' needs as quickly as possible. "We don't want them to miss very much school or much class work," Bobbit said. "That's our goal, right?"
Don Smith remembers the moment he awoke in an intensive care unit after 13 days in a medically induced coma. His wife and daughter were at his bedside, and he thought it had been only a day since he arrived at the emergency room with foot pain.
Smith said his wife "slowly started filling me in" on the surgery, the coma, the ventilator. The throbbing in his foot had been a signal of a raging problem.
"When you hear someone say a person died of infection, that's sepsis," said Smith, 66, of Colorado Springs, Colorado, who went to the ER shortly before Christmas 2017. Ultimately, he spent almost two months in the hospital and a rehab center following multiple surgeries to clear the infected tissue and, later, to remove seven toes.
Sepsis, the body's extreme response to an infection, affects 1.7 million adults in the United States annually. It stems from fungal, viral, or bacterial infections, similar to what struck Madonna this year, although the singer never said whether she was diagnosed with sepsis. Treatment delays of even a few hours can undermine a patient's chance of survival. Yet sepsis can be difficult to diagnose because some patients don't present with common symptoms like fever, rapid heart rate, or confusion.
A Biden administration rule, finalized in August, ups the ante for hospitals, setting specific treatment metrics that must be met for all patients with suspected sepsis, which could help save some of the 350,000 adults who die of infections annually. Children, too, are affected, with some estimates that 75,000 are treated each year for sepsis and up to 20% of them die. Hospitals that fail to meet the requirements risk losing potentially millions in Medicare reimbursement for the year.
Still, because the rule applies broadly, it has triggered pushback for its lack of flexibility.
Efforts to reduce sepsis deaths are welcome, but "where it gets controversial becomes 'Is this the best way to do it?'" said Chanu Rhee, an infectious disease physician and associate professor of population medicine at Harvard Medical School.
The approach requires that blood tests be done quickly to look for markers that may indicate sepsis. Also, the measures say antibiotics must be started within three hours of identifying a possible case. The quality measures, called the Severe Sepsis/Septic Shock Early Management Bundle, also call for certain other tests and intravenous fluids to keep blood pressure from dropping dangerously low.
In the proposed rule, which was issued in May, Medicare regulators wrote that the treatments have resulted in "significant reductions in hospital length of stay, re-admission rates and mortality," since the guidelines were initiated in 2015 under a requirement that hospitals simply report whether they were following them or not.
"These are core things that everyone should do every time they see a septic patient," said Steven Simpson, a critical-care physician, a professor of medicine at the University of Kansas, and the chairman of the Sepsis Alliance, an advocacy group backed by individual, government, and health industry funding.
The final rule builds on that earlier effort. Nationwide, an average of 57% of patients received care that met the guidelines in 2021, with the most compliant averaging 80%, according to the Biden administration.
But, starting in fall 2024, hospitals must move beyond simply reporting on the measures and meet the specific treatment benchmarks, which will be added to Medicare's Hospital Value-Based Purchasing Program.
"Before, even if you were reporting 0% compliance, you didn't lose your money. Now you actually have to do it," said Simpson.
Failing to meet those measures and other patient-safety standards could be costly: Smaller hospitals could lose "hundreds of thousands" of dollars in Medicare reimbursements annually; for large institutions, "it's in the millions-of-dollars range," said Akin Demehin, senior director of quality and patient safety policy at the American Hospital Association.
The hospital association opposed the final rule, writing in a June letter to the Centers for Medicare & Medicaid Services that the recommended treatments had not kept up with evolving science and that their focus on quick antibiotic administration for all suspected cases "has the high potential to lead to excessive use." That could fuel antibiotic resistance.
Similar concerns have been cited by other professional medical associations, including the Infectious Diseases Society of America. In a 2020 paper, it called for modifying the metrics to target only patients with septic shock, the most serious form of the condition, rather than all suspected sepsis cases. The society also argued that physicians need more flexibility.
What's more, there is debate over whether broadly implementing the treatment regimen will save lives.
Rhee raised this issue early this year in JAMA. In an opinion piece he co-authored, Rhee cited four studies, including one he led, showing broad-spectrum antibiotic use increased after the sepsis bundle was introduced eight years ago, yet there was little or no change in outcomes for patients.
"Unfortunately, we do not have good evidence that implementation of the sepsis policy has led to an improvement in sepsis mortality rates," he said.
Another study offers a different view. It showed that adhering to the treatments reduced deaths by about 5.7% among patients who received them. Medicare officials cited the study and its results in their proposal for the rule.
Rhee is unconvinced that the treatment protocols alone led to the drop.
Simpson, at the Sepsis Alliance, said there is enough evidence that the effort to follow the treatment standard resulted in improvements, and he is looking forward to more.
"It is quite clear that this works better than what was present before, which was nothing," Simpson said. If the current sepsis mortality rate could be cut "by even 5%, we could save a lot of lives."
All those involved agree that awareness is crucial, not only on the part of medical teams, but among patients, too. Crystal Waguespack, 41, a nurse in Baton Rouge, Louisiana, said she knew about sepsis but didn't apply that to her own symptoms when she began experiencing severe pain in 2018, two weeks after an operation.
"I never checked to see if I had a fever," or noticed her increased heart rate, she said.
But she did speak up. Waguespack said the severe pain, which occurred on a weekend when her regular doctor was unavailable, led her to see a physician unfamiliar with her case who told her that the pain was normal and that she was simply anxious. So she went to the emergency department.
"I did not take no for an answer, and I think that saved my life," she said.
At the hospital, doctors found she had spinal fluid leaking and a surgery-site infection. She spent 14 days in the hospital battling sepsis, meningitis, and a heart infection.
Key takeaways from her experience: Always ask, "Could this be sepsis?" said advocates. And don't wait.
Smith certainly wishes he had gone directly to a hospital instead of first seeing a foot specialist.
"I went to a foot doctor because my foot hurt," said Smith. "But a foot doctor is not an infectious disease doctor. You need to get to a place where different kinds of doctors can see you. That's called a hospital."
More than 1,100 patients have sued Exactech since it began recalling artificial knees, hips, and ankles, starting in August 2021.
This article was published on Tuesday, October 10, 2023 in KFF Health News.
By Fred Schulte
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.
The Hospital Consumer Assessment of Healthcare Providers and Systems doesn't ask about maternity care or discrimination and has low response rates among people of color.
This article was published on Friday, October 6, 2023 in KFF Health News.
When Selam Solomon Caldwell and her husband learned she was pregnant last year, the stakes for finding the right OB-GYN felt high. Caldwell, a Black woman, had heard stories from family and friends of maternity care providers who ignored their requests or pressured them into cesarean sections without clear medical justification.
As a relative newcomer to Los Angeles, the recruiter, now 31, knew few Black people who could recommend doctors who had treated them with respect. She combed review sites, including Google reviews and Healthgrades, but couldn't find how nearby physicians and hospitals might treat a Black woman like her.
"It's hard to tell if it's a fellow Black person who's giving the review," Caldwell said.
Consumer ratings sites rarely identify patient experiences by race or ethnicity and hospitals are under no obligation to reveal the racial and ethnic breakdowns of their patient satisfaction scores. Yet that information could be instrumental in holding maternity care providers and hospitals accountable for treating patients inequitably and could empower expectant mothers like Caldwell in finding quality obstetric care.
"You can't change what you don't see," said Kimberly Seals Allers, founder of Irth, an app allowing Black and brown women to find and leave reviews of maternity care providers. She's one of a few entrepreneurs developing new tools for collecting feedback from mothers of color.
A steady drip of new research over the past several years has spotlighted racial discrimination by maternity care providers and the role it may play in one of the country's most vexing health disparities: Black women experience the worst birthing outcomes, a gap not explained by income or education, according to a KFF analysis. In 2021, they were nearly three times as likely to die of pregnancy-related causes as white women.
Mothers of color, especially Black women, report that they do in fact experience discrimination. They are more likely than white women to say that their care providers ignored them, scolded them, or pressured them into treatments they didn't want. The extent to which discrimination is reported varies widely by survey, but one recently published report by the Centers for Disease Control and Prevention found roughly 30% of Black, Hispanic, and multiracial women reported mistreatment during maternity care, compared with 20% of women overall.
It's unclear how many hospitals track survey responses by race, and, even if they do, they rarely reveal that information. And the federal government requires generic reporting on how patients say they were treated, making it difficult to pin down and address incidents of bias in maternity care.
Funding and Regulations Lag
Currently, the results of the industry's standard patient experience survey, known as the Hospital Consumer Assessment of Healthcare Providers and Systems, are made publicly available by the federal government to help patients compare hospitals. They incentivize hospitals to improve care and are included in the rankings of many hospital ratings sites, such as U.S. News & World Report's Best Hospitals. But it doesn't ask about maternity careor discrimination and has low response rates, particularly among people of color.
These flaws can also make the survey inadequate for improving birth equity. "We know it's insufficient," said Amanda P. Williams, an OB-GYN and clinical innovation adviser to the nonprofit California Maternal Quality Care Collaborative. Hospitals, she said, could fill in the gaps by collecting feedback from maternity care surveys and breaking the results out by race and other demographic information; they could also talk to patients through forums such as town halls or focus groups.
Joy Lewis, senior vice president for health equity strategies at the American Hospital Association, said many hospitals do this work, both generally and in obstetrics.
However, Williams believes it isn't happening enough in maternity care.
She said there are some pockets where people are doing these activities but that they are not yet widespread. At a national conference of 200 hospital executives this year, Williams said, only a few raised their hands when asked if they break out their maternity outcomes data. "If your overall C-section rate is fine, you might think everything's hunky-dory," she said. "But if you see that your Black people are having 50% higher C-section rates than your white and Asian patients, there's very important work to be done."
Fearing retaliation and being seen as an "angry Black woman," Ta-She-Ra Manning, a maternal health program coordinator in Fresno, California, said she didn't provide any critical feedback when her OB-GYN dismissed her concerns about unusual symptoms during her 2021 pregnancy.
Meanwhile, new funding to measure disparities has been slow in coming. President Biden's 2023 budget proposed $7.4 million to develop a supplemental survey aimed at reducing maternal health disparities, among other steps. But Congress did not fund the item. Instead, an agency in the Department of Health and Human Services is developing it with its own funding and estimates the work will take less than five years, according to a statement from Caren Ginsberg, who directs the agency's surveys.
Still, the public likely won't see changes anytime soon. After a survey's measures are created, it can take several years for the results to be publicly reported or tied to payment, said Carol Sakala, senior director for maternal health at the National Partnership for Women & Families, an advocacy organization.
"This molasses level of movement contrasts acutely with all the things hitting the news about people not getting the right care and attention and respect," Sakala said.
Amid growing interest in health equity, traditional ratings sites are grappling with how much to share with the public. For its birthing hospital ratings, U.S. News & World Report recently started assessing whether hospitals tracked racial disparities in maternity outcomes measures, but it withholds actual results. Healthgrades is taking time to think through how to collect and display sensitive information publicly, said spokesperson Sarah Javors in a statement.
Black Innovators Fight for Better Data
Some Black women are trying to fill the void by creating new feedback mechanisms that could be more trusted by the community. Allers said she created Irth after a traumatic birth experience as a Black mother at a highly rated hospital left her feeling failed by mainstream ratings. On the app, verified users answer questions, from whether they felt respected by their doctor to if they experienced certain types of mistreatment such as dismissal of pain. Irth currently has 10,000 reviews of hospitals, OB-GYNs, and pediatricians nationally, according to Allers.
"Our data is for the community," said Allers. "They know their feedback has value to another mom or family."
Irth also offers analysis of the reviews to hospitals and leads campaigns to collect more reviews for them. But Allers said many hospitals have expressed little interest.
Karen Scott, an OB-GYN who created PREM-OB, a scientifically validated survey that measures racism in Black birthing experiences, said she has met hospital leaders who don't think their providers could mistreat patients or who worry that documenting responses could carry legal risk.
The American Hospital Association's Lewis declined to comment specifically on Irth and PREM-OB but acknowledged the Black community's long-standing mistrust of health care providers. She said hospitals want to hear more from patients in historically marginalized groups.
Early signs of progress are emerging in parts of the country.
California hospitals will likely report disparities in birth outcomes and patient satisfaction measures. Hospitals are expected to start posting data broken out by race and other demographics on their websites in 2026, though the state hasn't finalized the measures that will be required, said Andrew DiLuccia, a spokesperson for the state's health data agency. At least two states, Washington and New Jersey, have disclosed rates of C-sections among low-risk patients by race for individual hospitals.
Scott founded Birthing Cultural Rigor to increase uptake of her survey. The firm has partnered with birth equity groups to recruit respondents in select counties in Georgia, Michigan, Ohio, and Tennessee. Scott said results will be used to train local health professionals on how to reduce racism in maternity care.
Separately, Irth will collect and analyze reviews for three hospitals or health systems in California, said Allers. One of them, MemorialCare Miller Children's and Women's Hospital Long Beach, will work with Irth to better understand the impact of birth equity efforts such as implicit bias training.
"We'll get to see if what we're doing is actually working," said Sharilyn Kelly, executive director of the hospital's perinatal services.
Caldwell, the recruiter, eventually found a doctor she trusted and went on to have a smooth pregnancy and delivery. Her son is now 8 months old. But with so little information available on how she might be treated, she said, she felt anxious until she met her doctor, when "a lot of that stress and anxiety melted away."
Digital strategy & audience engagement editor Chaseedaw Giles contributed to this report.
[Editor's note: California Healthline is an editorially independent service of the California Health Care Foundation, which has contributed funding to PREM-OB and the birth equity nonprofit Narrative Nation, which developed Irth.]