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.]
In a recent campaign video, former President Donald Trump blasted President Joe Biden for "a catastrophic increase" in drug shortages.
"It's a mess," Trump said in the video, adding that new drug shortages were up last year by 30%, with "295 active drug shortages" by the end of 2022.
The continued availability of lifesaving drugs is a concern in this country. Reports of shortages of medicines on which many Americans rely — from widely used cancer medications like cisplatin to over-the-counter painkillers such as Children's Tylenol — have been widespread in recent years. The shortages have caused treatment delays or forced clinicians to substitute alternatives in place of preferred therapies.
But is Biden responsible, or is Trump's claim an oversimplification?
We contacted the Trump campaign for answers, but got no reply. So, we poked around on our own. What we found didn't align with Trump's claims. By some measures, drug shortages increased more on Trump's watch than on Biden's.
Where to Place the Blame?
Trump's statistics were in the ballpark. According to a March report by the Senate Committee on Homeland Security and Governmental Affairs, cited in the video's footnotes, the number of active drug shortages in 2022 did hit 295 at the end of 2022. The count was 246 at the end of 2021, according to the American Society of Health-System Pharmacists.
But our calculations suggest the report's math was off. The report stated an increase of "approximately 30%," but it was closer to 20%. Likewise, new drug shortages grew from 114 to 160 in 2022, a 40% increase, not the "nearly 30%" cited in an earlier version of the report, which Trump apparently relied on.
The Senate panel's report is based on data from the FDA and the society. The pharmacy group works with the University of Utah Health's Drug Information Service to track drug shortages.
The society's shortage information derives from pharmacists' and patients' reports of supply issues that affect how pharmacies prepare or dispense drugs, or influence patient care, often locally. The FDA, with its national scope, declares a drug shortage when demand or projected demand exceeds supply, as projected by drug manufacturers. So, the FDA's shortage tallies are bound to be different from the society's. For instance, the FDA reported that new and active drug shortages grew from 124 in 2021 to 135 in 2022, a 9% increase.
But Biden isn't the only president whose administration has contended with rising drug shortages. And his numbers to date aren't the worst.
Active drug shortages grew from 195 in 2016 to 264 in 2019 — when Trump was president. That's a 35% increase, according to the society's figures. During Biden's first 3½ years in office, that same category of shortages increased 12%, from 276 to 309.
New drug shortages peaked at 267, in 2011, during the Obama administration, the society reported. Some experts credit an executive order that Obama signed that year directing the FDA to broaden its shortage reporting as a turning point. Since that 2011 high, the U.S. recorded the next-largest number of new drug shortages — 186 — in 2018, when Trump was president.
The point isn't that Trump managed drug shortages badly then or that Biden is handling them badly now, experts said.
"I don't think you can tie this to any administration or specific person," said Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists.
Many factors — from natural disasters and manufacturing problems to slim profit margins on generic drugs — can contribute to shortages. Lingering drug shortages from before the pandemic, "compounded with shortages due to covid and poor quality at U.S.-based companies like Akorn pharmaceuticals, have really contributed to the very large numbers of shortages we have right now," said Erin Fox, associate chief pharmacy officer at University of Utah Health.
The Complexity of Medication Supplies
For decades, the U.S. has suffered periodic drug and medical device shortages. Disruptions at any point in the complex supply chain involving people, production, technologies, and policy decisions can ripple throughout the system, causing scarcities that may last years.
A Health Affairs article published this past January described the current system's complexity. More than 20,000 prescription drugs and more than 13,000 facilities worldwide are registered to make drugs or their active ingredients. More than three-quarters of active pharmaceutical ingredients are made outside the United States, the authors said.
Experts acknowledge that relying on overseas drug manufacturers can lead to quality control and oversight problems, because it's harder for the FDA to inspect plants overseas. For example, after an FDA inspection last December that found numerous manufacturing problems, Intas Pharmaceuticals in India voluntarily suspended production and distribution of its products that were destined for the United States. The company was allowed to distribute some drugs, including critical cancer drugs, that are in short supply, with strict third-party oversight. In the video, Trump also zeroed in on this concern. He pledged — with an emphasis on minimizing China's role in the production of medications — to return manufacturing of all essential medicines to the United States, "where they belong."
But the United States experiences manufacturing problems and weather emergencies, just as everywhere else in the world does. For example, Lake Forest, Illinois-based drugmaker Akorn filed for bankruptcy this year and stopped making more than 70 generic drugs. After a tornado hit its Rocky Mount, North Carolina, plant in July, Pfizer temporarily shuttered the facility. The company said Sept. 25 that it had restarted production at the plant.
"Bringing all manufacturing back to the United States not only isn't feasible, because we don't have the raw materials, but that also creates a reliance on a single geographical area," said Soumi Saha, senior vice president of government affairs at Premier, a large group-purchasing organization for hospitals and other health providers. "What you need is global diversification."
Marta Wosińska, a health care economist at the Brookings Schaeffer Initiative on Health Policy, agreed with Saha — domestic manufacturing isn't a panacea. "Domestic production is no guarantee of having a stable supply chain," she said. "Most shortages are caused by quality problems in both the United States and overseas."
Trump also criticized Biden for "shamefully" not following through on an executive order Trump signed that directed federal agencies to identify ways to maximize domestic production of essential medicines.
The White House didn't respond to questions about the status of Trump's order. But spokesperson Kelly Scully in a statement pointed to the five executive orders Biden issued since taking office "focused on strengthening the resilience of critical supply chains," including those for pharmaceuticals.
Our Ruling
Trump said there was a "catastrophic increase" in drug shortages under Biden's watch. Trump was correct that drug shortages have ticked upward. But Trump's statements blaming Biden for those shortages are inaccurate and lack context.
Not only have significant drug shortages increased during other presidential administrations — including Trump's — experts generally agree that there are multiple, complex, and interlocking factors that cause them, meaning no one person is at fault, not even the president.
AI tools often predict a patient's date of discharge, which coincides with the date their insurer cuts off coverage, even if the patient needs further treatment.
This article was published on Thursday, October 5, 2023 in KFF Health News.
Judith Sullivan was recovering from major surgery at a Connecticut nursing home in March when she got surprising news from her Medicare Advantage plan: It would no longer pay for her care because she was well enough to go home.
At the time, she could not walk more than a few feet, even with assistance — let alone manage the stairs to her front door, she said. She still needed help using a colostomy bag following major surgery.
"How could they make a decision like that without ever coming and seeing me?" said Sullivan, 76. "I still couldn't walk without one physical therapist behind me and another next to me. Were they all coming home with me?"
UnitedHealthcare — the nation's largest health insurance company, which provides Sullivan's Medicare Advantage plan — doesn't have a crystal ball. It does have naviHealth, a care management company it bought in 2020, and one of several businesses that use computers to help insurance companies make coverage decisions.
Its proprietary "nH Predict" tool sifts through millions of medical records to match patients with similar diagnoses and characteristics, including age, preexisting health conditions, and other factors. Based on these comparisons, an algorithm anticipates what kind of care a specific patient will need and for how long.
But patients, providers, and patient advocates in several states said they have noticed a suspicious coincidence: The tool often predicts a patient's date of discharge, which coincides with the date their insurer cuts off coverage, even if the patient needs further treatment that government-run Medicare would provide.
"When an algorithm does not fully consider a patient's needs, there's a glaring mismatch," said Rajeev Kumar, a physician and the president-elect of the Society for Post-Acute and Long-Term Care Medicine, which represents long-term care practitioners. "That's where human intervention comes in."
The federal government will try to even the playing field next year, when the Centers for Medicare & Medicaid Services begins restricting how Medicare Advantage plans use predictive technology tools to make some coverage decisions.
Medicare Advantage plans, an alternative to the government-run, original Medicare program, are operated by private insurance companies. About half the people eligible for full Medicare benefits are enrolled in the private plans, attracted by their lower costs and enhanced benefits like dental care, hearing aids, and a host of nonmedical extras like transportation and home-delivered meals.
Insurers receive a monthly payment from the federal government for each enrollee, regardless of how much care they need. According to the Department of Health and Human Services' inspector general, this arrangement raises "the potential incentive for insurers to deny access to services and payment in an attempt to increase profits." Nursing home care has been among the most frequently denied services by the private plans — something original Medicare likely would cover, investigators found.
After UHC cut off her nursing home coverage, Sullivan's medical team agreed with her that she wasn't ready to go home and provided an additional 18 days of treatment. Her bill came to $10,406.36.
Beyond her mobility problems, "she also had a surgical wound that needed daily dressing changes" when UHC stopped paying for her nursing home care, said Debra Samorajczyk, a registered nurse and the administrator at the Bishop Wicke Health and Rehabilitation Center, the facility that treated Sullivan.
Sullivan's coverage denial notice and nH Predict report did not mention wound care or her inability to climb stairs. Original Medicare would have most likely covered her continued care, said Samorajczyk.
Sullivan appealed twice but lost. Her next appeal was heard by an administrative law judge, who holds a courtroom-style hearing usually by phone or video link, in which all sides can provide testimony. UHC declined to send a representative, but the judge nonetheless sided with the company. Sullivan is considering whether to appeal to the next level, the Medicare Appeals Council, and the last step before the case can be heard in federal court.
Sullivan's experience is not unique. In February, Ken Drost's Medicare Advantage plan, provided by Security Health Plan of Wisconsin, wanted to cut his coverage at a Wisconsin nursing home after 16 days, the same number of days naviHealth predicted was necessary. But Drost, 87, who was recovering from hip surgery, needed help getting out of bed and walking. He stayed at the nursing home for an additional week, at a cost of $2,624.
After he appealed twice and lost, his hearing on his third appeal was about to begin when his insurer agreed to pay his bill, said his lawyer, Christine Huberty, supervising attorney at the Greater Wisconsin Agency on Aging Resources Elder Law & Advocacy Center in Madison.
"Advantage plans routinely cut patients' stays short in nursing homes," she said, including Humana, Aetna, Security Health Plan, and UnitedHealthcare. "In all cases, we see their treating medical providers disagree with the denials."
UnitedHealthcare and naviHealth declined requests for interviews and did not answer detailed questions about why Sullivan's nursing home coverage was cut short over the objections of her medical team.
Aaron Albright, a naviHealth spokesperson, said in a statement that the nH Predict algorithm is not used to make coverage decisions and instead is intended "to help the member and facility develop personalized post-acute care discharge planning." Length-of-stay predictions "are estimates only."
However, naviHealth's website boasts about saving plans money by restricting care. The company's "predictive technology and decision support platform" ensures that "patients can enjoy more days at home, and healthcare providers and health plans can significantly reduce costs specific to unnecessary care and readmissions."
New federal rules for Medicare Advantage plans beginning in January will rein in their use of algorithms in coverage decisions. Insurance companies using such tools will be expected to "ensure that they are making medical necessity determinations based on the circumstances of the specific individual," the requirements say, "as opposed to using an algorithm or software that doesn't account for an individual's circumstances."
The CMS-required notices nursing home residents receive now when a plan cuts short their coverage can be oddly similar while lacking details about a particular resident. Sullivan's notice from UHC contains some identical text to the one Drost received from his Wisconsin plan. Both say, for example, that the plan's medical director reviewed their cases, without providing the director's name or medical specialty. Both omit any mention of their health conditions that make managing at home difficult, if not impossible.
The tools must still follow Medicare coverage criteria and cannot deny benefits that original Medicare covers. If insurers believe the criteria are too vague, plans can base algorithms on their own criteria, as long as they disclose the medical evidence supporting the algorithms.
And before denying coverage considered not medically necessary, another change requires that a coverage denial "must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue."
Jennifer Kochiss, a social worker at Bishop Wicke who helps residents file insurance appeals, said patients and providers have no say in whether the doctor reviewing a case has experience with the client's diagnosis. The new requirement will close "a big hole," she said.
The leading MA plans oppose the changes in comments submitted to CMS. Tim Noel, UHC's CEO for Medicare and retirement, said MA plans' ability to manage beneficiaries' care is necessary "to ensure access to high-quality safe care and maintain high member satisfaction while appropriately managing costs."
Restricting "utilization management tools would markedly deviate from Congress' intent in creating Medicare managed care because they substantially limit MA plans' ability to actually manage care," he said.
In a statement, UHC spokesperson Heather Soule said the company's current practices are "consistent" with the new rules. "Medical directors or other appropriate clinical personnel, not technology tools, make all final adverse medical necessity determinations" before coverage is denied or cut short. However, these medical professionals work for UHC and usually do not examine patients. Other insurance companies follow the same practice.
David Lipschutz, associate director of the Center for Medicare Advocacy, is concerned about how CMS will enforce the rules since it doesn't mention specific penalties for violations.
CMS' deputy administrator and director of the Medicare program, Meena Seshamani, said that the agency will conduct audits to verify compliance with the new requirements, and "will consider issuing an enforcement action, such as a civil money penalty or an enrollment suspension, for the non-compliance."
Although Sullivan stayed at Bishop Wicke after UHC stopped paying, she said another resident went home when her MA plan wouldn't pay anymore. After two days at home, the woman fell, and an ambulance took her to the hospital, Sullivan said. "She was back in the nursing home again because they put her out before she was ready."
Dollar General's pilot mobile clinic program has been touted by company officials, rural health experts, and analysts as a model that could help solve rural America's primary care shortage. But its Tennessee launch has been met with local skepticism.
This article was published on Wednesday, October 4, 2023 in KFF Health News.
CLARKSVILLE, Tenn. — On a hot July morning, customers at the Dollar General along a two-lane highway northwest of Nashville didn't seem to notice signs of the chain store's foray into mobile healthcare, particularly in rural America.
A woman lifted a child from the back of an SUV and walked into the store. A dog barked from a black pickup truck before its owner returned with cases of soda. Another woman checked her hair in a convertible's rearview mirror before shopping.
Each went right by a sign exclaiming "Quick, Easy Health Visits," with an image of a mobile clinic.
Just after 10 a.m., registered nurse Kimberly French arrived to work at the DocGo mobile clinic parked in the store's lot. She checked her schedule.
"We don't have any appointments so far today, but that could change," French said. "Last night we didn't have any appointments and three or four people showed up all at one time."
Dollar General, the nation's largest retailer by number of stores, with more than 19,000, partnered with New York-based mobile medical services company DocGo to test whether they could draw more customers and tackle persistent health inequities.
Deploying mobile clinics to fill care gaps in underserved areas isn't a new idea. But pairing them with Dollar General's ubiquitous small-town presence has been heralded by investment analysts and some rural health experts as a way to ease the healthcare drought in rural America.
Dollar General's latest annual report notes that about 80% of the company's stores are in towns with populations of fewer than 20,000 — precisely where medical professionals are scarce.
Catering to those who want urgent or primary care, the mobile clinics take private insurance as well as Medicaid and Medicare. The company's website says DocGo's self-pay rates start at $69 for patients without insurance or who are out of network. DocGo officials said Tennessee patients may be charged different rates but declined to provide details.
On the ground in Tennessee, primary care doctors and patients are skeptical.
"Honestly, they don't really grasp, I don't think, what they're getting into," said Brent Staton, a family medicine doctor and the leader of the Cumberland Center for Healthcare Innovation, a statewide organization that helps small-town family care doctors coordinate care and negotiate with insurers, including Medicare.
Michelle Green manages the popular Sweet Charlotte grill about 10 miles south of Dollar General's most rural test site. Green, who was handing out hamburgers and hand-cut fries during a Saturday rush, said she hadn't heard of the mobile clinic. She said with a shrug that Dollar General and healthcare clinics "don't go together."
"I wouldn't want to go to a healthcare clinic in a parking lot; that's just me," Green said, adding that someone might go if "you're sick and you can't go anywhere else."
Bumps in the Road
The Clarksville-area pilot, which launched last fall, is in a federally designated primary care shortage area for low-income residents.
About 1,000 patients have been seen in the company's clinics, either at Dollar General sites or community pop-up events, and some became repeat visitors, according to DocGo. Payment is taken outside on a mobile device and, once inside, patients meet with an on-site staff member, like French, and connect via telehealth on an iPad screen with a physician assistant or nurse practitioner.
The clinic rotates between three Dollar General pilot sites each week. The stores are in the Clarksville area and, early this summer, the van stopped going to the most rural site, near Cumberland Furnace, because of low utilization, according to company leaders. DocGo moved that location's time slot to busy Fort Campbell Boulevard in Clarksville.
"We do try for months in a given area to see where it makes sense and where it doesn't," former DocGo CEO Anthony Capone said in a July interview. "Our goal is to align the supply we have with the demand of the local community."
Capone, though, said he thought the pilot would work in rural areas when insurers are signed on to refer their members to the mobile clinic. DocGo recently announced a deal with Blue Cross Blue Shield of Tennessee.
Capone abruptly resigned on Sept. 15 after the Albany Times Union reported he lied about having a graduate degree.
Dollar General stores have a "tremendous opportunity" to have "a major impact on health there and really bond themselves as a member of the community," said Tom Campanella, the healthcare executive-in-residence at Baldwin Wallace University, who has managed mobile clinics in rural places.
Near tiny Cumberland Furnace, south of Clarksville, William "Bubba" Murphy stopped on his way into a Dollar General, paused to wave and holler hello to friends getting out of their cars, and shared that multiple family members — his sister-in-law, nephew, and niece's boyfriend — used and liked "the little clinic on wheels."
"We don't have to go to town and fight all that traffic," he said. "They come to us. That's a wonderful thing. It helps a lot of people."
Over on busy Fort Campbell Boulevard in Clarksville, Marina Woolever, a mother of three, said she might use the clinic if she didn't have insurance. Natural health professional Nichole Clemmer glanced toward the clinic and called it a "ploy" to make more money.
Jefferies lead equity analyst Corey Tarlowe, who follows discount retailers, said the clinics will help "democratize" access to healthcare and simultaneously boost traffic to Dollar General stores.
With its rapid growth in recent years, Dollar General has faced accusations that its stores kill off local grocery stores and other businesses, reduce employment, and contribute to the creation of food deserts. More recently, the U.S. Labor Department said the chain "continues to discount safety" for employees as it has piled up more than $21 million in federal fines.
Crystal Luce, senior director of public relations for Dollar General, said the company believes each new store provides "positive economic benefits," including new jobs, low-cost products, and its literacy foundation. On the federal fines, Luce said Dollar General is "committed to providing a safe work environment for its associates and shopping experience for its customers." The company declined to provide an interview.
The DocGo pilot, she wrote, is intended to "complement" the DG Wellbeing initiative, which is a corporatewide push. Dollar General wants to increase "access to basic healthcare products and, ultimately, services over time, particularly in rural America," Luce wrote.
States away, DocGo is under fire for a no-bid contract to provide housing, busing, and other services for asylum-seekers in New York. State Attorney General Letitia James is investigating complaints levied by migrants under the company's care. In August, DocGo officials said claims aired by sources in a New York Times article that first reported the problems were "not reflective of the overall scope and quality" of the services the company has provided.
The company's pilot with Dollar General is "supported with funding from the state of Tennessee," DocGo's Capone said during the company's first-quarter earnings call. The Dollar General partnership is cited in quarterly grant reports DocGo's Rapid Reliable Testing LLC submitted to the state, according to records KFF Health News obtained through public information requests.
In the grant filing, DocGo listed Dollar General along with other organizations as "trusted messengers" in building vaccine awareness.
Dollar General declined to respond to a question about its involvement in the grant. Instead, Luce stated, "We continue to test and learn through the DocGo pilot."
'Relational Care'
The goal of the $2.4 million grant, funded by the Centers for Disease Control and Prevention and distributed by the Tennessee Department of Health, is to administer COVID-19 vaccines. In a written response provided by DocGo's marketing director, Amanda Shell Jennings, the company said, "Dollar General has no involvement with the TN Department of Health grant funding or allocations."
The grant covers storage and maintenance of COVID-19 vaccines on the DocGo mobile clinics, Jennings' statement said, adding that, as of September, DocGo has held 41 vaccine events and provided 66 vaccines to rural Tennesseans.
Lulu West, 72, was visiting a friend at the Historic Cumberland Furnace Iron Museum when she stopped to consider the mobile clinic. West said she would rather go to her primary care doctor.
"When you say mobile clinic outside a Dollar General it just kind of has a connotation that you may not be comfortable with. You know what I mean?" she said.
That kind of response doesn't surprise Carlo Pike, a doctor who for years has practiced family medicine in Clarksville. He said he's not worried about the competition because providing primary care is about developing relationships.
"If I can do this relationship right," Pike said, "maybe we can keep you from getting a [blood] sugar of 500 [mg/dL] or from Grandpa climbing up a ladder and trying to fix something he has no business with and falling off and breaking his leg."
Staton said the Cumberland Center for Healthcare Innovation, his accountable care organization, has saved Medicare and Medicare Advantage companies more than $100 million by focusing on preventive care and reducing hospitalizations and emergency visits for patients.
"We're just small rural primary care docs doing our jobs with a process that works," Staton said. In another interview, Staton called it "relational care."
DocGo surveyed its patients and found that 19% of them did not have a primary care physician or hadn't seen theirs in more than a year. In the written responses Jennings provided, DocGo said it follows up with every patient after the initial visit, offers telemedicine support between visits, and provides ongoing preventive care on a regular schedule.
But despite its outreach, DocGo struggled to get a foothold in rural Cumberland Furnace.
Lottie Stokes, the president of the community center in Cumberland Furnace, said DocGo's team had "called and asked to come down here." Stokes said she would rather use the local emergency medical technicians and firefighters, who she knows are "legit."
Her father-in-law, Bobby Stokes, who's nearly 80 years old, said he used the mobile clinic before it moved locations.
His wife couldn't breathe. They pulled into the parking lot and climbed onto the van.
"We wasn't in there five minutes," he said. "They done the blood pressure test and what they need to do and put her in the car and said, ‘Get her to the hospital, to the emergency room.'"
The DocGo staff, he said, did not ask for payment: "Nothing."
"They were more concerned with her than they were with I guess getting their money," he said, adding that his wife is doing well now. "They told me to get there, and I took them at their word. My car runs fast."
KFF Health News correspondent Brett Kelman contributed to this report.