Health insurers and medical providers are battling over who should supply high-cost infusion drugs for patients, with the tussle over profits now spilling into statehouses across the country.
The issue is that some insurers are bypassing hospital pharmacies and physician offices and instead sending more complex drugs through third-party pharmacies. Those pharmacies then send the medications directly to the medical provider or facility for outpatient infusing, which is called "white bagging," or, more rarely, to patients, in what is called "brown bagging." That shifts who gets to buy and bill for these complex medications, including pricey chemotherapy drugs.
Insurers say the policies are needed because hospital markups are too high. But hospitals argue that adding an intermediary results in unnecessary risks and delays, and they say some insurers have their own or affiliated pharmacy companies, creating financial motives for controlling the source of the medications. The patients, meanwhile, are left to deal with the red tape.
Paula Bruton Shepard in Bolivar, Missouri, is among those caught in the middle. Flares of lupus, an autoimmune disease, rob Shepard of her mobility by attacking her joints. She relies on monthly infusions to treat her symptoms. But at times, she said, her treatments were delayed due to UnitedHealthcare's white bagging infusion policy. And interruptions to her treatments exacerbated her symptoms.
"I once had to use a toilet lift and it was kind of demoralizing to say, ‘I'm a 50-year-old woman and I have to use a toilet lift,'" Shepard said of the medication delays.
This is a tug of war over profits between insurers and medical providers, said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. While insurers claim the arrangement reduces costs, she said, that doesn't mean insurers pass along savings to patients.
"I don't think we should have more sympathy toward one party or the other," Bai said. "Nobody is better than the other. They're all trying to make money."
The savings from white bagging can be significant for expensive infusion drugs, according to a report from the Massachusetts Health Policy Commission. For example, Remicade, used to treat a variety of inflammatory diseases, including Crohn's, cost on average $1,106 per unit in 2015 under hospitals' traditional buy-and-bill system, the commission found in its review of state claims data. That same drug cost an average of $975 per unit under white bagging, a 12% savings.
But the report also found patients, on average, faced higher cost sharing — what they are responsible for paying — for Remicade and other drugs when white bagging was used. While some patients had only modest increases to their costs under the policy, such as $12 more for a medication, the review found it could mean much greater cost sharing for some patients, such as those on Medicare.
At Citizens Memorial Hospital in rural Bolivar, more than 1 in 4 patients who receive regular infusions are being forced to use an outside pharmacy, said Mariah Hollabaugh, the hospital's pharmacy director. Shepard was among them.
Even if the hospital has the exact drug on the shelf, patients must wait for a separate shipment, Hollabaugh said, potentially interrupting care. Their shipped drugs may sometimes be unusable when the doctor needs to change the dosage. Or the medicine comes in a nondescript package that doesn't get immediately flagged for the pharmacy, potentially subjecting the drugs to damaging temperature fluctuations. For patients, that can mean delays in care.
"They're in pain, they're uncomfortable," Hollabaugh said. "They may be having symptoms that don't allow them to go to work."
Siteman Cancer Center, led by physicians from Washington University School of Medicine in St. Louis, has confronted the same issue. But the cancer center's size has helped it largely avoid such insurer policies.
John DiPersio, a Siteman oncologist and researcher who led the university's oncology division for more than two decades, said Siteman reluctantly allows white bagging for simple injectables but refuses to accept it for complicated chemotherapies. It does not accept brown bagging. Occasionally, he said, that means turning patients away.
"You're talking about cancer patients that are getting life-threatening treatments," DiPersio said, referring to the dangers of chemo drugs, which he said can be fatal if used improperly. "It doesn't make any sense to me. It's all stupid. It's all lunacy."
At least 21 states, including Missouri, introduced some form of white or brown bagging legislation during the most recent legislative session, according to the American Society of Health-System Pharmacists. And in the past two years, the trade group said, at least 13 states have already enacted restrictions on white bagging, including Arkansas, Louisiana, and Virginia.
ASHP has created model legislation to limit insurers from requiring the practices as a condition of coverage.
"This is a major issue," said Tom Kraus, a vice president at the trade group. "We see this as central to our ability to coordinate patient care."
At the heart of the tension is an often-litigated federal program that allows certain hospitals and the clinics they own to purchase drugs at deep discounts. The 340B program, named for a section of the law that created it, allows hospitals to buy certain drugs for much less — sometimes for a total cost of a single penny — than what they are later paid for those drugs. Hospitals are not required to pass along 340B savings to patients.
The program was intended to help hospitals spread scarce resources further to treat patients in poor and vulnerable communities, but it has morphed into a means of enriching hospitals and their affiliated clinics, researchers said in a 2014 Health Affairs report. Hollabaugh said many rural facilities such as Citizens rely on the revenue generated from the 340B drugs to subsidize infusions that have no profit margin.
The number of participating hospitals and their affiliated outpatient clinics has increased significantly since the 340B program was created in 1992. More than 2,600 of the nation's roughly 6,100 hospitals were participating in the 340B program as of January 2023. That gives them access to discounts that can knock off as much as 50% of a drug's cost, according to the Health Resources & Services Administration, which oversees the program.
The insurance industry argues that hospital markups, especially when made on top of those discounts, have gotten out of control.
"The fact is, people got greedy," Shannon Cooper, a lobbyist for Blue Cross and Blue Shield of Kansas City, said during a Missouri state Senate hearing in March.
Markups are not unique to 340B hospitals, said Sean Dickson, who helps lead pharmaceutical policy for AHIP, a trade group formerly known as America's Health Insurance Plans. The markups thrusted on commercial plans are "widely out of line" with what Medicare will pay, he said, and that is driving up costs without providing additional value.
Legislation that targets white bagging hinders an insurer's ability to rein in such costs, Dickson said, especially when an area lacks competition.
"What we're really trying to focus on here is putting pressure on those markups that are not related to cost or safety," Dickson said.
Anthem Blue Cross and Blue Shield lobbyist David Smith testified during the March hearing in Missouri that even the idea of white bagging elicited a quick response and that almost every major hospital system in the state said they would drop their prices and come back to the negotiation table.
For now, Citizens Memorial Hospital and other Missouri medical facilities will have to continue to tango with the insurers: Legislation to limit white and brown bagging did not pass during the Missouri General Assembly's recent session.
Shepard, though, won't need such legislation.
UnitedHealthcare had been sending her lupus infusion through other pharmacies on and off since 2021, unwilling to cover the drugs if they came from Citizens' in-house pharmacy. Shepard had to authorize each shipment before it was sent. If she missed the monthly call, she said, it was a "bureaucratic mess" trying to get the medication shipped.
"We are driving unnecessary costs out of the health care system to help make care more affordable, while also maintaining drug safety, effectiveness and quality of care," UnitedHealthcare spokesperson Tony Marusic wrote.
But after KFF Health News inquired about Shepard's case, Marusic said UnitedHealthcare stopped white bagging Shepard's medication to "prevent potential delays in shipping." And during her latest infusion in June, her hospital was again able to supply Shepard's medication directly.
"I'm just so relieved," Shepard said. "I don't have to take phone calls. I don't have to reply to emails. I just show up."
Lucia Agajanian, a 25-year-old freelance film producer in Chicago, doesn't have a specific primary care doctor, preferring the convenience of visiting a local clinic for flu shots or going online for video visits. "You say what you need, and there's a 15-minute wait time," she said, explaining how her appointments usually work. "I really liked that."
But Olga Lucia Torres, a 52-year-old who teaches narrative medicine classes at Columbia University in New York, misses her longtime primary care doctor, who kept tabs for two decades on her conditions, including lupus and rheumatoid arthritis, and made sure she was up to date on vaccines and screening tests. Two years ago, Torres received a letter informing her that he was changing to a "boutique practice" and would charge a retainer fee of $10,000 for her to stay on as a patient.
"I felt really sad and abandoned," Torres said. "This was my PCP. I was like, 'Dude, I thought we were in this together!'"
The two women reflect an ongoing reality: The primary care landscape is changing in ways that could shape patients' access and quality of care now and for decades to come. A solid and enduring relationship with a primary care doctor — who knows a patient's history and can monitor new problems — has long been regarded as the bedrock of a quality healthcare system. But investment in primary care in the U.S. lags that of other high-income countries, and America has a smaller share of primary care physicians than most of its European counterparts.
An estimated one-third of all physicians in the U.S. are primary care doctors — who include family medicine physicians, general internists, and pediatricians — according to the Robert Graham Center, a research and analysis organization that studies primary care. Other researchers say the numbers are lower, with the Peterson-KFF Health System Tracker reporting only 12% of U.S. doctors are generalists, compared with 23% in Germany and as many as 45% in the Netherlands.
That means it's often hard to find a doctor and make an appointment that's not weeks or months away.
"This is a problem that has been simmering and now beginning to erupt in some communities at a boil. It's hard to find that front door of the health system," said Ann Greiner, president and CEO of the Primary Care Collaborative, a nonprofit membership organization.
Today, a smaller percentage of physicians are entering the field than are practicing, suggesting that shortages will worsen over time.
Interest has waned partly because, in the U.S., primary care yields lower salaries than other medical and surgical specialties.
Some doctors now in practice also say they are burned out, facing cumbersome electronic health record systems and limits on appointment times, making it harder to get to know a patient and establish a relationship.
Others are retiring or selling their practices. Hospitals, insurers like Aetna-CVS Health, and other corporate entities like Amazon are on a buying spree, snapping up primary care practices, furthering a move away from the "Marcus Welby, M.D."-style neighborhood doctor. About 48% of primary care physicians currently work in practices they do not own. Two-thirds of those doctors don't work for other physicians but are employed by private equity investors or other corporate entities, according to data in the "Primary Care Chartbook," which is collected and published by the Graham Center.
Patients who seek care at these offices may not be seen by the same doctor at every visit. Indeed, they may not be seen by a doctor at all but by a paraprofessional — a nurse practitioner or a physician assistant, for instance — who works under the doctor's license. That trend has been accelerated by new state laws — as well as changes in Medicare policy — that loosen the requirements for physician supervisors and billing. And these jobs are expected to be among the decade's fastest-growing in the health sector.
Overall, demand for primary care is up, spurred partly by record enrollment in Affordable Care Act plans. All those new patients, combined with the low supply of doctors, are contributing to a years-long downward trend in the number of people reporting they have a usual source of care, be it an individual doctor or a specific clinic or practice.
Researchers say that raises questions, including whether people can't find a primary care doctor, can't afford one, or simply no longer want an established relationship.
"Is it poor access or problems with the supply of providers? Does it reflect a societal disconnection, a go-it-alone phenomenon?" asked Christopher Koller, president of the Milbank Memorial Fund, a foundation whose nonpartisan analyses focus on state health policy.
For patients, frustrating wait times are one result. A recent survey by a physician staffing firm found it now takes an average of 21 days just to get in to see a doctor of family medicine, defined as a subgroup of primary care, which includes general internists and pediatricians. Those physicians are many patients' first stop for healthcare. That runs counter to the trend in other countries, where patients complain of months- or years-long waits for elective procedures like hip replacements but generally experience short waits for primary care visits.
Another complication: All these factors are adding urgency to ongoing concerns about attracting new primary care physicians to the specialty.
When she was in medical school, Natalie A. Cameron said, she specifically chose primary care because she enjoyed forming relationships with patients and because "I'm specifically interested in prevention and women's health, and you do a lot of that in primary care." The 33-year-old is currently an instructor of medicine at Northwestern University, where she also sees patients at a primary care practice.
Still, she understands why many of her colleagues chose something else. For some, it's the pay differential. For others, it's because of primary care's reputation for involving "a lot of care and paperwork and coordinating a lot of issues that may not just be medical," Cameron said.
The million-dollar question, then, is how much does having a usual source of care influence medical outcomes and cost? And for which kinds of patients is having a close relationship with a doctor important? While studies show that many young people value the convenience of visiting urgent care — especially when it takes so long to see a primary care doctor — will their long-term health suffer because of that strategy?
Many patients — particularly the young and generally healthy ones — shrug at the new normal, embracing alternatives that require less waiting. These options are particularly attractive to millennials, who tell focus groups that the convenience of a one-off video call or visit to a big-box store clinic trumps a long-standing relationship with a doctor, especially if they have to wait days, weeks, or longer for a traditional appointment.
"The doctor I have is a family friend, but definitely I would take access and ease over a relationship," said Matt Degn, 24, who says it can take two to three months to book a routine appointment in Salt Lake City, where he lives.
Patients are increasingly turning to what are dubbed "retail clinics," such as CVS' Minute Clinics, which tout "in-person and virtual care 7 days a week." CVS Health's more than 1,000 clinics inside stores across the U.S. treated more than 5 million people last year, Creagh Milford, a physician and the company's senior vice president of retail health, said in a written statement. He cited a recent study by a data products firm showing the use of retail clinics has grown 200% over the past five years.
Health policy experts say increased access to alternatives can be good, but forgoing an ongoing relationship to a regular provider is not, especially as people get older and are more likely to develop chronic conditions or other medical problems.
"There's a lot of data that show communities with a lot of primary care have better health," said Koller.
People with a regular primary care doctor or practice are more likely to get preventive care, such as cancer screenings or flu shots, studies show, and are less likely to die if they do suffer a heart attack.
Physicians who see patients regularly are better able to spot patterns of seemingly minor concerns that could add up to a serious health issue.
"What happens when you go to four different providers on four platforms for urinary tract infections because, well, they are just UTIs," posed Yalda Jabbarpour, a family physician practicing in Washington, D.C., and the director of the Robert Graham Center for Policy Studies. "But actually, you have a large kidney stone that's causing your UTI or have some sort of immune deficiency like diabetes that's causing frequent UTIs. But no one tested you."
Most experts agree that figuring out how to coordinate care amid this changing landscape and make it more accessible without undermining quality — even when different doctors, locations, health systems, and electronic health records are involved — will be as complex as the pressures causing long waits and less interest in today's primary care market.
And experiences sometimes lead patients to change their minds.
There's something to be said for establishing a relationship, said Agajanian, in Chicago. She's rethinking her decision to cobble together care, rather than have a specific primary care doctor or clinic, following an injury at work last year that led to shoulder surgery.
"As I'm getting older, even though I'm still young," she said, "I have all these problems with my body, and it would be nice to have a consistent person who knows all my problems to talk with."
KFF Health News' Colleen DeGuzman contributed to this report.
This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Federal regulators want most patients to see a healthcare provider in person before receiving prescriptions for potentially addictive medicines through telehealth — something that hasn't been required in more than three years.
During the COVID-19 public health emergency, the Drug Enforcement Administration allowed doctors and other healthcare providers to prescribe controlled medicine during telehealth appointments without examining the patient in person. The emergency declaration ended May 13, and in February, the agency proposed new rules that would require providers to see patients at least once in person before prescribing many of those drugs during telehealth visits.
Controlled medications include many stimulants, sedatives, opioid painkillers, and anabolic steroids.
Regulators said they decided to extend the current regulations — which don't require an in-person appointment — until November 11 after receiving more than 38,000 comments on the proposed changes, a record amount of feedback. They also said patients who receive controlled medications from prescribers they've never met in person will have until November 11, 2024, to come into compliance with the agency's future rules.
The public comments discuss the potential effects on a variety of patients, including people being treated for mental health disorders, opioid addiction, or attention-deficit/hyperactivity disorder. Thousands of commenters also mentioned possible impacts on rural patients.
Opponents wrote that healthcare providers, not a law enforcement agency, should decide which patients need in-person appointments. They said the rules would make it difficult for some patients to receive care.
Other commenters called for exemptions for specific medications and conditions.
Supporters wrote that the proposal would balance the goals of increasing access to healthcare and helping prevent medication misuse.
Zola Coogan, 85, lives in Washington, Maine, a town of about 1,600 residents northeast of Portland. Coogan has volunteered with hospice patients and said it's important for very sick and terminally ill people in rural areas to have access to opioids to ease their pain. But she said it can be hard to see a doctor in person if they lack transportation or are too debilitated to travel.
Coogan said she supports the DEA's proposed rules because of a provision that could help patients who can't travel to meet their telehealth prescriber. Instead, they could visit a local healthcare provider, who then could write a special referral to the telehealth prescriber. But she said accessing controlled medications would still be difficult for some rural residents.
"It could end up being a very sticky wicket" for some patients to access care, she said. "It's not going to be easy, but it sounds like it's doable."
Some healthcare providers may hesitate to offer those referrals, said Stefan Kertesz, a physician and professor at the University of Alabama at Birmingham whose expertise includes addiction treatment. Kertesz said the proposed referral process is confusing and would require burdensome record-keeping.
Ateev Mehrotra, a physician and Harvard professor who has studied telehealth in rural areas, said different controlled drugs come with different risks. But overall, he finds the proposed rules too restrictive. He's worried people who started receiving telehealth prescriptions during the pandemic would be cut off from medicine that helps them.
Mehrotra said he hasn't seen clear evidence that every patient needs an in-person appointment before receiving controlled medicine through telehealth. He said it's also not clear whether providers are less likely to write inappropriate prescriptions after in-person appointments than after telehealth ones.
Mehrotra described the proposed rules as "a situation where there's not a clear benefit, but there are substantial harms for at least some patients," including many in rural areas.
Beverly Jordan, a family practice doctor in Alabama and a member of the state medical board, supports the proposed rule, as well as a new Alabama law that requires annual in-person appointments for patients who receive controlled medications. Jordan prescribes such medications, including to rural patients who travel to her clinic in the small city of Enterprise.
"I think that once-a-year hurdle is probably not too big for anybody to be able to overcome, and is really a good part of patient safety," Jordan said.
Jordan said it's important for healthcare practitioners to physically examine patients to see if the exam matches how the patients describe their symptoms and whether they need any other kind of treatment.
Jordan said that, at the beginning of the pandemic, she couldn't even view most telehealth patients on her computer. Three-fourths of her appointments were over the phone, because many rural patients have poor internet service that doesn't support online video.
The proposed federal rules also have a special allowance for buprenorphine, which is used to treat opioid use disorder, and for most categories of non-narcotic controlled substances, such as testosterone, ketamine, and Xanax.
Providers could prescribe 30 days' worth of these medications after telehealth appointments before requiring patients to have an in-person appointment to extend the prescription. Tribal healthcare practitioners would be exempt from the proposed regulations, as would Department of Veterans Affairs providers in emergency situations.
Many people who work in healthcare were surprised by the proposed rules, Kertesz said. He said they expected the DEA to let prescribers apply for special permission to provide controlled medicine without in-person appointments. Congress ordered the agency to create such a program in 2008, but it has not done so.
Agency officials said they considered creating a version of that program for rural patients but decided against it.
Denise Holiman disagrees with the proposed regulations. Holiman, who lives on a farm outside Centralia, Missouri, used to experience postmenopausal symptoms, including forgetfulness and insomnia. The 50-year-old now feels back to normal after being prescribed estrogen and testosterone by a Florida-based telehealth provider. Holiman said she doesn't think she should have to go see her telehealth provider in person to maintain her prescriptions.
"I would have to get on a plane to go to Florida. I'm not going to do that," she said. "If the government forces me to do that, that's wrong."
Holiman said her primary care doctor doesn't prescribe injectable hormones and that she shouldn't have to find another in-person prescriber to make a referral to her Florida provider.
Holiman is one of thousands of patients who shared their opinions with the DEA. The agency also received comments from advocacy, healthcare, and professional groups, such as the American Medical Association.
The physicians' organization said the in-person rule should be eliminated for most categories of controlled medication. Even telehealth prescriptions for drugs with a higher risk of misuse, such as Adderall and oxycodone, should be exempt when medically necessary, the group said.
Some states already have laws that are stricter than the DEA's proposed rules. Amelia Burgess said Alabama's annual exam requirement, which went into effect last summer, burdened some patients. The Minnesota doctor works at Bicycle Health, a telehealth company that prescribes buprenorphine.
Burgess said hundreds of the company's patients in Alabama couldn't switch to in-state prescribers because many weren't taking new patients, were too far away, or were more expensive than the telehealth service. So Burgess and her co-workers flew to Alabama and set up a clinic at a hotel in Birmingham. About 250 patients showed up, with some rural patients driving from five hours away.
Critics of the federal proposal are lobbying for exemptions for medications that can be difficult to obtain due to a lack of specialists in rural areas.
Many of the public comments focus on the importance of telehealth-based buprenorphine treatment in rural areas, including in jails and prisons.
Rural areas also have shortages of mental health providers who can prescribe controlled substances for anxiety, depression, and ADHD. Patients across the country who use opioids for chronic pain have trouble finding prescribers.
It also can be difficult to find rural providers who prescribe testosterone, a controlled drug often taken by transgender men and people with various medical conditions, such as menopause. Controlled medications are also used to treat seizures, sleep disorders, and other conditions.
Angela Reynolds knew her mother's memory was slipping, but she didn't realize how bad things had gotten until she started to untangle her mom's finances: unpaid bills, unusual cash withdrawals, and the discovery that, oddly, the mortgage on the family home had been refinanced at a higher interest rate.
Looking back, Reynolds realizes her mother was in the early stages of Alzheimer's disease: "By the time we caught on, it was too late."
Reynolds and her mother are among a large group of Americans grappling with the financial consequences of cognitive decline.
A growing bodyof research shows money problems are a possible warning sign — rather than only a product — of certain neurological disorders. This includes a 2020 study from Johns Hopkins University of more than 81,000 Medicare beneficiaries that found people with Alzheimer's and related dementias became more likely to miss bill payments up to six years before a formal diagnosis.
The reach of these conditions is enormous. One recent study found nearly 10% of people over age 65 have dementia; more than twice as many are living with mild cognitive impairment.
Missing the Signs of Declining Cognition
One weekday in the spring of 2018, Reynolds sat next to her 77-year-old mother, Jonnie Lewis-Thorpe, in a courtroom in downtown New Haven, Connecticut. She listened in discomfort as strangers revealed intimate details of their own finances in a room full of people waiting their turn to come before the judge.
Then it hit her: "Wait a second. We're going to have to go up there, and someone's going to be listening to us."
That's because the family home was in foreclosure. The daughter hoped if she explained to the judge that her mother had Alzheimer's disease, which had caused a series of financial missteps, she could stop the seizure of the property.
Reynolds can't pinpoint when Alzheimer's crept into her mother's life. A widow, Lewis-Thorpe had lived alone for several years and had made arrangements for her aging, including naming Reynolds her power-of-attorney agent. But Reynolds lived a 450-mile drive away from New Haven, in Pittsburgh, and wasn't there to see her mom's incremental decline.
It wasn't until Reynolds began reviewing her mother's bank statements that she realized Lewis-Thorpe — once a hospital administrator — had long been in the grip of the disease.
Financial problems are a common reason family members bring their loved ones to the office of Robin Hilsabeck, a neuropsychologist at the University of Texas at Austin Dell Medical School who specializes in cognitive issues.
"The brain is really a network, and there are certain parts of the brain that are more involved with certain functions," said Hilsabeck. "You can have a failure in something like financial abilities for lots of reasons caused by different parts of the brain."
Some of the reasons are due to normal aging, as Reynolds had assumed about her mother. But when a person's cognition begins to decline, the problems can grow exponentially.
Dementia's Causes — And Sometimes Ruthless Impact
Dementia is a syndrome involving the loss of cognitive abilities: The cause can be one of several neurological illnesses, like Alzheimer's or Parkinson's, or brain damage from a stroke or head injury.
In most cases, an older adult's dementia is progressive. The first signs are often memory slips and changes in high-level cognitive skills related to organization, impulse control, and the ability to plan — all critical for money management. And because the causes of dementia vary, so do the financial woes it can create, said Hilsabeck.
For example, with Alzheimer's comes a progressive shrinking of the hippocampus. That's the catalyst for memory loss that, early in the course of the disease, can cause a person to forget to pay their bills.
Lewy body dementia is marked by fluctuating cognition: A person veers from very sharp to extremely confused, often within short passages of time. Those with frontotemporal dementia can struggle with impulse control and problem-solving, which can lead to large, spontaneous purchases.
And people with vascular dementia often run into issues with planning, processing, and judgment, making them easier to defraud. "They answer the phone, and they talk to the scammers," said Hilsabeck. "The alarm doesn't go off in their head that this doesn't make sense."
For many people older than 65, mild cognitive impairment, or MCI, can be a precursor to dementia. But even people with MCI who don't develop dementia are vulnerable.
"Financial decision-making is very challenging cognitively," said Jason Karlawish, a specialist in geriatrics and memory care at the University of Pennsylvania's Penn Memory Center. "If you have even mild cognitive impairment, you can make mistakes with finances, even though you're otherwise doing generally OK in your daily life."
Some mistakes are irreversible. Despite Reynolds' best efforts on behalf of her mother, the bank foreclosed on the family home in the fall of 2018.
Property records show that Lewis-Thorpe and her husband bought the two-bedroom Cape Cod for $20,000 in 1966. Theirs was one of the first Black families in their New Haven neighborhood. Lewis-Thorpe had planned to pass this piece of generational wealth on to her daughters.
Instead, U.S. Bank now owns the property. A 2021 tax assessment lists its value as $203,900.
Financial Protections Are Slow to Come
Though she can't prove it, Reynolds suspects someone had been financially exploiting her mom. At the same time, she feels guilty for what happened to Lewis-Thorpe, who now lives with her: "There's always that part of me that's going to say, ‘At what point did it turn, where I could have had a different outcome?'"
Karlawish often sees patients who are navigating financial disasters. What he doesn't see are changes in banking practices or regulations that would mitigate the risks that come with aging and dementia.
"A thoughtful country would begin to say we've got to come up with the regulatory structures and business models that can work for all," he said, "not just for the 30-year-old."
But the risk-averse financial industry is hesitant to act — partly out of fear of getting sued by clients.
2018's Senior Safe Act , the most recent major federal legislation to address elder wealth management, attempts to address this reticence. It gives immunity to financial institutions in civil and administrative proceedings stemming from employees reporting possible exploitation of a senior — provided the bank or investment firm has trained its staff to identify exploitative activity.
It's a lackluster law, said Naomi Karp, an expert on aging and elder finances who spent eight years as a senior analyst at the Consumer Financial Protection Bureau's Office for Older Americans. That's because the act makes training staff optional, and it lacks government oversight. "There's no federal agency that's charged with covering it or setting standards for what that training has to look like," Karp said. "There's nothing in the statute about that."
One corner of the financial industry that has made modest progress is the brokerage sector, which concerns the buying and selling of securities, such as stocks and bonds. Since 2018, the Financial Industry Regulatory Authority — a nongovernmental organization that writes and enforces rules for brokerage firms — has required agents to make a reasonable effort to get clients to name a "trusted contact."
A trusted contact is similar to the emergency contact health care providers request. They're notified by a financial institution of concerning activity on a client's account, then receive a basic explanation of the situation. Ron Long, a former head of Aging Client Services at Wells Fargo, gave the hypothetical of someone whose banking activity suddenly shows regular, unusual transfers to someone in Belarus. A trusted emergency contact could then be notified of that concerning activity.
But the trusted contact has no authority. The hope is that, once notified, the named relative or friend will talk to the account holder and prevent further harm. It's a start, but a small one. The low-stakes effort is limited to the brokerage side of operations at Wells Fargo and most other large institutions. The same protection is not extended to clients' credit card, checking, or savings accounts.
A Financial Industry Reluctant to Help
When she was at the Consumer Financial Protection Bureau, Karp and her colleagues put out a set of recommendations for companies to better protect the wealth of seniors. The 2016 report included proposals on employee training and changes to fraud detection systems to better detect warning signs, such as atypical ATM use and the addition of a new owner's name to an existing checking account. "We would have meetings repeatedly with some of the largest banks, and they gave a lot of lip service to these issues," Karp said. "Change is very, very slow."
Karp has seen some smaller community banks and credit unions take proactive steps to protect older customers — such as instituting comprehensive staff training and improvements to fraud detection software. But there's a hesitancy throughout the industry to act more decisively, which seems to stem in part from fears about liability, she said. Banks are concerned they might get sued — or at least lose business — if they intervene when no financial abuse has occurred, or a customer's transactions were benign.
Policy solutions that address financial vulnerability also present logistical challenges. Expanding something as straightforward as use of trusted contacts isn't like flipping a light switch, said Long, the former Wells Fargo executive: "You have to solve all the technology issues: Where do you house it? How do you house it? How do you engage the customer to even consider it?"
Still, a trusted contact might have alerted Reynolds much sooner that her mom was developing dementia and needed help.
"I fully believe that they noticed signs," Reynolds said of her mother's bank. "There are many withdrawals that came out of her account where we can't account for the money. … Like, I can see the withdrawals. I can see the bills not getting paid. So where did the money go?"
This article is from a partnership that includes WESA, NPR, and KFF Health News.
On Nov. 22, three FDA inspectors arrived at the sprawling Intas Pharmaceuticals plant south of Ahmedabad, India, and found hundreds of trash bags full of shredded documents tossed into a garbage truck. Over the next 10 days, the inspectors assessed what looked like a systematic effort to conceal quality problems at the plant, which provided more than half of the U.S. supply of generic cisplatin and carboplatin, two cheap drugs used to treat as many as 500,000 new cancer cases every year.
Seven months later, doctors and their patients are facing the unimaginable: In California, Virginia, and everywhere in between, they are being forced into grim contemplation of untested rationing plans for breast, cervical, bladder, ovarian, lung, testicular, and other cancers. Their decisions are likely to result in preventable deaths.
Cisplatin and carboplatin are among scores of drugs in shortage, including 12 other cancer drugs, attention-deficit/hyperactivity disorder pills, blood thinners, and antibiotics. Covid-hangover supply chain issues and limited FDA oversight are part of the problem, but the main cause, experts agree, is the underlying weakness of the generic drug industry. Made mostly overseas, these old but crucial drugs are often sold at a loss or for little profit. Domestic manufacturers have little interest in making them, setting their sights instead on high-priced drugs with plump profit margins.
The problem isn't new, and that's particularly infuriating to many clinicians. President Joe Biden, whose son Beau died of an aggressive brain cancer, has focused his Cancer Moonshot on discovering cures — undoubtedly expensive ones. Indeed, existing brand-name cancer drugs often cost tens of thousands of dollars a year.
But what about the thousands of patients today who can't get a drug like cisplatin, approved by the FDA in 1978 and costing as little as $6 a dose?
"It's just insane," said Mark Ratain, a cancer doctor and pharmacologist at the University of Chicago. "Your roof is caving in, but you want to build a basketball court in the backyard because your wife is pregnant with twin boys and you want them to be NBA stars when they grow up?"
"It's just a travesty that this is the level of health care in the United States of America right now," said Stephen Divers, an oncologist in Hot Springs, Arkansas, who in recent weeks has had to delay or change treatment for numerous bladder, breast, and ovarian cancer patients because his clinic cannot find enough cisplatin and carboplatin. Results from a survey of academic cancer centers released June 7 found 93% couldn't find enough carboplatin and 70% had cisplatin shortages.
"All day, in between patients, we hold staff meetings trying to figure this out," said Bonny Moore, an oncologist in Fredericksburg, Virginia. "It's the most nauseous I've ever felt. Our office stayed open during covid; we never had to stop treating patients. We got them vaccinated, kept them safe, and now I can't get them a $10 drug."
The 10 cancer clinicians KFF Health News interviewed for this story said that, given current shortages, they prioritize patients who can be cured over later-stage patients, in whom the drugs generally can only slow the disease, and for whom alternatives — though sometimes less effective and often with more side effects — are available. But some doctors are even rationing doses intended to cure.
Isabella McDonald, then a junior at Utah Valley University, was diagnosed in April with a rare, often fatal bone cancer, whose sole treatment for young adults includes the drug methotrexate. When Isabella's second cycle of treatment began June 5, clinicians advised that she would be getting less than the full dose because of a methotrexate shortage, said her father, Brent.
"They don't think it will have a negative impact on her treatment, but as far as I am aware, there isn't any scientific basis to make that conclusion," he said. "As you can imagine, when they gave us such low odds of her beating this cancer, it feels like we want to give it everything we can and not something short of the standard."
Brent McDonald stressed that he didn't blame the staffers at Intermountain Health who take care of Isabella. The family — his other daughter, Cate, made a TikTok video about her sister's plight — were simply stunned at such a basic flaw in the health care system.
Cate McDonald used this TikTok video to let people know about her sister's osteosarcoma, a rare and dangerous bone cancer. She wanted to raise awareness of the critical shortages of generic drugs in the United States, including methotrexate, which her sister, Isabella, desperately needs. (Cate McDonald)
At Moore's practice, in Virginia, clinicians gave 60% of the optimal dose of carboplatin to some uterine cancer patients during the week of May 16, then shifted to 80% after a small shipment came in the following week. The doctors had to omit carboplatin from normal combination treatments for patients with recurrent disease, she said.
On June 2, Moore and her colleagues were glued to their drug distributor's website, anxious as teenagers waiting for Taylor Swift tickets to go on sale — only with mortal consequences at stake.
She later emailed KFF Health News: "Carboplatin did NOT come back in stock today. Neither did cisplatin."
Doses remained at 80%, she said. Things hadn't changed 10 days later.
Generics Manufacturers Are Pulling Out
The causes of shortages are well established. Everyone wants to pay less, and the middlemen who procure and distribute generics keep driving down wholesale prices. The average net price of generic drugs fell by more than half between 2016 and 2022, according to research by Anthony Sardella, a business professor at Washington University in St. Louis.
As generics manufacturers compete to win sales contracts with the big buyers, including wholesale purchasers Vizient and Premier, their profits sink. Some are going out of business. Akorn, which made 75 common generics, went bankrupt and closed in February. Israeli generics giant Teva, which has a portfolio of 3,600 medicines, announced May 18 it was shifting to brand-name drugs and "high-value generics." Lannett Co., with about 120 generics, announced a Chapter 11 reorganization amid declining revenue. Other companies are in trouble too, said David Gaugh, interim CEO of the Association for Accessible Medicines, the leading generics trade group.
The generics industry used to lose money on about a third of the drugs it produced, but now it's more like half, Gaugh said. So when a company stops making a drug, others do not necessarily step up, he said. Officials at Fresenius Kabi and Pfizer said they have increased their carboplatin production since March, but not enough to end the shortage. On June 2, FDA Commissioner Robert Califf announced the agency had given emergency authorization for Chinese-made cisplatin to enter the U.S. market, but the impact of the move wasn't immediately clear.
Cisplatin and carboplatin are made in special production lines under sterile conditions, and expanding or changing the lines requires FDA approval. Bargain-basement prices have pushed production overseas, where it's harder for the FDA to track quality standards. The Intas plant inspection was a relative rarity in India, where the FDA in 2022 reportedly inspected only 3% of sites that make drugs for the U.S. market. Sardella, the Washington University professor, testified last month that a quarter of all U.S. drug prescriptions are filled by companies that received FDA warning letters in the past 26 months. And pharmaceutical industry product recalls are at their highest level in 18 years, reflecting fragile supply conditions.
The FDA listed 137 drugs in shortage as of June 13, including many essential medicines made by few companies.
Intas voluntarily shut down its Ahmedabad plant after the FDA inspection, and the agency posted its shocking inspection report in January. Accord Healthcare, the U.S. subsidiary of Intas, said in mid-June it had no date for restarting production.
Asked why it waited two months after its inspection to announce the cisplatin shortage, given that Intas supplied more than half the U.S. market for the drug, the FDA said via email that it doesn't list a drug in shortage until it has "confirmed that overall market demand is not being met."
Prices for carboplatin, cisplatin, and other drugs have skyrocketed on the so-called gray market, where speculators sell medicines they snapped up in anticipation of shortages. A 600-milligram bottle of carboplatin, normally available for $30, was going for $185 in early May and $345 a week later, said Richard Scanlon, the pharmacist at Moore's clinic.
"It's hard to have these conversations with patients — ‘I have your dose for this cycle, but not sure about next cycle,'" said Mark Einstein, chair of the Department of Obstetrics, Gynecology and Reproductive Health at Rutgers New Jersey Medical School.
Should Government Step In?
Despite a drug shortage task force and numerous congressional hearings, progress has been slow at best. The 2020 CARES Act gave the FDA the power to require companies to have contingency plans enabling them to respond to shortages, but the agency has not yet implemented guidance to enforce the provisions.
As a result, neither Accord nor other cisplatin makers had a response plan in place when Intas' plant was shut down, said Soumi Saha, senior vice president of government affairs for Premier, which arranges wholesale drug purchases for more than 4,400 hospitals and health systems.
Premier understood in December that the shutdown endangered the U.S. supply of cisplatin and carboplatin, but it also didn't issue an immediate alarm, she said. "It's a fine balance," she said. "You don't want to create panic-buying or hoarding."
More lasting solutions are under discussion. Sardella and others have proposed government subsidies to get U.S. generics plants running full time. Their capacity is now half-idle. If federal agencies like the Centers for Medicare & Medicaid Services paid more for more safely and efficiently produced drugs, it would promote a more stable supply chain, he said.
"At a certain point the system needs to recognize there's a high cost to low-cost drugs," said Allan Coukell, senior vice president for public policy at Civica Rx, a nonprofit funded by health systems, foundations, and the federal government that provides about 80 drugs to hospitals in its network. Civica is building a $140 million factory near Petersburg, Virginia, that will produce dozens more, Coukell said.
Ratain and his University of Chicago colleague Satyajit Kosuri recently called for the creation of a strategic inventory buffer for generic medications, something like the Strategic Petroleum Reserve, set up in 1975 in response to the OPEC oil crisis.
In fact, Ratain reckons, selling a quarter-million barrels of oil would probably generate enough cash to make and store two years' worth of carboplatin and cisplatin.
"It would almost literally be a drop in the bucket."
Human Rights Watch, the nonprofit that for decades has called attention to the victims of war, famine, and political repression around the world, is taking aim at U.S. hospitals for pushing millions of American patients into debt.
In a new report, published June 15, the group calls for stronger government action to protect Americans from aggressive billing and debt collection by nonprofit hospitals, which Human Rights Watch said are systematically undermining patients' human rights.
"Given the high prevalence of hospital-related medical debt in the U.S., this system is clearly not working," concludes the report, which draws extensively on an ongoing investigation of medical debt by KFF Health News and NPR.
The report continues: "The U.S. model of subsidizing privately operated hospitals with tax exemptions in the hope that they will increase the accessibility of hospital care for un- and underinsured patients allows for abU.S.ive medical billing and debt collection practices and undermines human rights, including the right to health."
Nationwide, about 100 million people — or 41% of adults — have some form of healthcare debt, a KFF survey conducted for the KFF Health News-NPR project found. And while patient debt is being driven by a range of medical and dental bills, polls and studies suggest hospitals are a major contributor.
About a third of U.S. adults with healthcare debt owed money for hospitalization, KFF's polling found. Close to half of those owed at least $5,000. About a quarter owed $10,000 or more.
The scale of this crisis — which is unparalleled among wealthy nations — compelled Human Rights Watch to release the new report, said researcher Matt McConnell, its author. "Historically, Human Rights Watch has been an organization that has focused on international human rights issues," he said. "But on medical debt, the U.S. is a real outlier. What you see is a system that privileges a few but creates large barriers to people accessing basic health rights."
Hospital industry officials defend their work, citing hospitals' broader work to help the communities they serve. "As a field, hospitals provide more benefit to their communities than any other sector in healthcare," Melinda Hatton, general counsel at the American Hospital Association, wrote in a response to the Human Right Watch report.
Federal law requires private, tax-exempt hospitals — which make up more than half the nation's medical centers — to provide care at no cost or at a discount to low-income patients. But reporting by KFF Health News and others has found that many hospitals make this aid difficult for patients to get.
At the same time, thousands of medical centers — including many tax-exempt ones — engage in aggressive debt collection tactics to pursue patients, including garnishing patients' wages, placing liens on their homes, or selling their debt to third-party debt collectors.
Overall, KFF Health News found that most of the nation's approximately 5,100 hospitals serving the general public have policies to U.S.e legal action or other aggressive tactics against patients. And 1 in 5 will deny nonemergency care to people with outstanding debt.
"Medical debt is drowning many low-income and working families while hospitals continue to benefit from nonprofit tax statU.S. as they pursue families for medical debt," said Marceline White, executive director of Economic Action Maryland. The advocacy group has helped enact tighter rules to ensure Maryland hospitals make financial assistance more easily accessible and to restrict hospitals from some aggressive debt collection tactics, such as placing liens on patients' homes.
Similar efforts are underway in other states, including Colorado, New Mexico, New York, Oregon, and Washington. But many patient and consumer advocates say stronger federal action is needed to expand patient protections.
The Human Rights Watch report — titled "In Sheep's Clothing: United States' Poorly Regulated Nonprofit Hospitals Undermine Healthcare Access" — lists more than a dozen recommendations. These include:
Congress should pass legislation to ensure that hospitals provide at least the same amount of charity care as they receive in public subsidies.
The IRS should set uniform national standards on patients' eligibility for financial assistance at nonprofit hospitals. Currently, hospitals are free to set their own standards, resulting in widespread variation, which can confuse patients.
The Consumer Financial Protection Bureau, a federal watchdog agency, should crack down on debt collectors that do not ensure that patients have been screened for financial assistance before being pursued.
CMS, which administers the two mammoth public insurance programs, should penalize hospitals that do not provide adequate financial assistance to patients.
"Nonprofit hospitals are contributing to medical debt and engaging in abusive billing and debt collection practices," McConnell said. "The reason this keeps happening is the absence of clear guidelines and the federal government's inadequate enforcement of existing regulations."
About This Project
"Diagnosis: Debt" is a reporting partnership between KFF Health News and NPR exploring the scale, impact, and causes of medical debt in America.
The series draws on original polling by KFF, court records, federal data on hospital finances, contracts obtained through public records requests, data on international health systems, and a yearlong investigation into the financial assistance and collection policies of more than 500 hospitals across the country.
Additional research was conducted by the Urban Institute, which analyzed credit bureau and other demographic data on poverty, race, and health statU.S. for KFF Health News to explore where medical debt is concentrated in the U.S. and what factors are associated with high debt levels.
The JPMorgan Chase Institute analyzed records from a sampling of Chase credit card holders to look at how cU.S.tomers' balances may be affected by major medical expenses. And the CED Project, a Denver nonprofit, worked with KFF Health News on a survey of its clients to explore links between medical debt and housing instability.
KFF Health News journalists worked with KFF public opinion researchers to design and analyze the "KFF healthcare Debt Survey." The survey was conducted Feb. 25 through March 20, 2022, online and via telephone, in English and Spanish, among a nationally representative sample of 2,375 U.S. adults, including 1,292 adults with current healthcare debt and 382 adults who had healthcare debt in the past five years. The margin of sampling error is plus or minus 3 percentage points for the full sample and 3 percentage points for those with current debt. For results based on subgroups, the margin of sampling error may be higher.
Reporters from KFF Health News and NPR also conducted hundreds of interviews with patients across the country; spoke with physicians, health industry leaders, consumer advocates, debt lawyers, and researchers; and reviewed scores of studies and surveys about medical debt.
Too many Americans are losing Medicaid coverage because of red tape, and states should do more to make sure eligible people keep their health insurance, the Biden administration said Monday.
Hannah Recht June 13, 2023
More than a million Americans have lost coverage through the program for low-income and disabled Americans in the past several weeks, following the end of pandemic protections on April 1, according to the latest Medicaid renewal data from more than 20 states.
After a three-year pause, most states have now resumed checking which Medicaid recipients remain eligible and dropping those who no longer qualify or don’t complete required paperwork. About 4 in 5 people dropped so far either never returned the paperwork or omitted required documents, federal and state data show.
Xavier Becerra, secretary of the Department of Health and Human Services, decried those numbers in a letter sent to state governors on June 12.
“I am deeply concerned with the number of people unnecessarily losing coverage, especially those who appear to have lost coverage for avoidable reasons that State Medicaid offices have the power to prevent or mitigate,” he wrote.
The Biden administration outlined several optional steps states can take to ensure everyone who still qualifies for the safety-net health insurance program stays covered. For instance, states can pause the cancellations to allow more time to reach people who haven’t responded. Health insurance companies that manage Medicaid plans can help their enrollees fill out the paperwork.
Some states were already choosing to take extra time. Though Wyoming began renewals in May, the state is being “deliberately cautious” and won’t drop people for incomplete paperwork until July or August, state Health Department spokesperson Kim Deti said. Oregon won’t start those cancellations until October.
Officials in other states have demonstrated no eagerness to slow the cuts.
About 10 percent of Arkansas’ Medicaid and Children’s Health Insurance Program enrollees have already been dropped, nearly all because they didn’t complete paperwork. Arkansas is speeding through the redeterminations in just six months, while most other states are taking about a year, as HHS recommended. Despite outcry from some federal lawmakersand advocates, Medicaid officials in the state wrote on June 8 that they would continue to “swiftly disenroll” people who no longer qualify.
That could be disastrous, said Joan Alker, executive director of Georgetown University’s Center for Children and Families. “My big worry is that we could lose millions of families quickly. It’s going to be very hard to get them back.”
Becerra also wrote that he is “particularly concerned” about children losing coverage, although the administration doesn’t know exactly how many kids have been dropped. States don’t have to report numbers by age to federal authorities, said Dan Tsai, director of the Center for Medicaid and CHIP Services.
Tens of thousands of kids are losing coverage, according to data from states that shared it. In Indiana, of the 53,000 dropped in the first month, a third were kids. In South Dakota, more than half were kids. In Arkansas, nearly 55,000 kids were dropped in the first two months.
Becerra also urged governors to work more directly with families at risk of losing coverage. State agencies should team up with schools, faith-based groups, pharmacies, and other community organizations to help enrollees better understand how to stay on Medicaid, he wrote.
In most states, people who still qualify for Medicaid but lose coverage because of state errors or incomplete paperwork have 90 days to ask for their coverage back.
Some officials view the large number of paperwork-related cancellations as no big deal because people can reapply if they still qualify. But it’s not that simple, Alker said. Many people don’t know their appeal rights, and the grace period doesn’t apply to all adults in several of the hardest-hit states.
Alker said states will temporarily save money from not having to pay for enrollees’ care. But in the meantime, people won’t be able to afford their regular medications. Some will end up in the emergency room sicker than before, she said. “There’s really nothing good that comes out of these gaps in coverage.”
Policy analysts, Democrats, and Republicans dissatisfied with the deal agree: Federal health programs have dodged a budgetary bullet in the Washington showdown over raising the nation’s debt ceiling.
Julie Rovner, KFF Health News
A compromise bill, approved late Thursday by the Senate, includes some trims and caps on health spending for the next two years.
But the deal spares health programs like Medicaid from the deep cuts approved in April by the Republican-led House. The bill suspends the debt ceiling — the federal government’s borrowing limit — until January 1, 2025, after the next presidential election.
The need for Congress to act to avoid an unprecedented debt default and its rippling economic consequences gave House Republicans leverage to extract spending concessions from Democrats. But in the end the compromise bill, negotiated primarily by House Speaker Kevin McCarthy and Biden administration officials, limits health spending only slightly.
The most conservative Republicans said they are outraged at what they see as a giveaway to Democrats. “It is a bad deal,” said Rep. Chip Roy (R-Texas), one of the bill’s most outspoken opponents, during a news conference at the Capitol. “No one sent us here to borrow an additional $4 trillion to get absolutely nothing in return.”
Besides the spending limits, the main health-related concession made by Democrats is the clawback of about $27 billion in money appropriated for covid-related programs but not yet spent.
Only a portion of the money being reclaimed from covid programs is specifically health-related; money is also being returned to the federal government from programs centered on housing and transportation, for example.
Of the unspent covid funds, according to the Congressional Budget Office, the biggest single rescission is nearly $10 billion from the Public Health and Social Services Emergency Fund. The CDC would have to give back $1.5 billion. But exempted from those health-related givebacks are “priority” efforts such as funding for research into next-generation covid vaccines; long covid research; and efforts to improve the pharmaceutical supply chain.
“The deal appears to have minimal effect on the health sector,” concluded Capital Alpha Partners, a Washington-based policy strategy firm.
That would not have been the case with the House Republicans’ “Limit, Save, Grow Act,” their first offer to raise the debt ceiling and slow — in some areas dramatically — the growth of federal spending. That bill would have reduced the federal deficit by nearly $5 trillion over the next decade, including through more than $3 trillion in cuts to domestic discretionary programs, which account for roughly 15 percent of federal spending. A part of that 15 percent goes to health programs, including the National Institutes of Health, the Centers for Disease Control and Prevention, and the FDA.
The Republican bill would also have imposed nationwide work requirements on the Medicaid health program, a proposal that was vehemently opposed by Democrats in Congress and the Biden administration.
Democrats argued that such requirements would not increase work but rather would separate eligible people from their health insurance for failing to complete required paperwork. That is already happening, according to a KFF Health News analysis, as states begin to trim rolls following the end of the covid public health emergency.
The compromise bill, however, leaves untouched the major federal health programs, Medicare and Medicaid — amounting to a political victory for Democrats, who prioritized protecting entitlement programs. The deal includes no new work requirements for Medicaid.
The bill also freezes other health spending at its current level for the coming fiscal year and allows for a 1% increase the following year. It will be up to the House and Senate Appropriations Committees to determine later exactly how to distribute the funds among the discretionary programs whose spending levels they oversee.
Advocacy groups have argued that even a funding freeze hurts programs that provide needed services to millions of Americans. The result, said Sharon Parrott, president of the liberal Center on Budget and Policy Priorities, “will still be cuts overall in key national priorities when the very real impact of inflation is taken into account.”
Even less happy, however, are conservatives who had hoped the debt ceiling fight would give them a chance to take a much bigger bite out of federal spending.
“Overall, this agreement would continue America’s trajectory towards economic destruction and expanded federal control,” Kevin Roberts, president of the conservative Heritage Foundation, said in a statement.
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People concerned about the safety of patients often compare healthcare to aviation. Why, they ask, can't hospitals learn from medical errors the way airlines learn from plane crashes?
That's the rationale behind calls to create a "National Patient Safety Board," an independent federal agency that would be loosely modeled after the National Transportation Safety Board, which is credited with increasing the safety of skies, railways, and highways by investigating why accidents occur and recommending steps to avoid future mishaps.
But as worker shortages strain the U.S. healthcare system, heightening concerns about unsafe care, one proposal to create such a board has some patient safety advocates fearing that it wouldn't provide the transparency and accountability they believe is necessary to drive improvement. One major reason: the power of the hospital industry.
Two measures are underway to create a safety board: A bill filed in the U.S. House in December by Rep. Nanette Diaz Barragán (D-Calif.), which is expected to be refiled this session, calls for the creation of a board to help federal agencies monitor safety events, identify conditions under which problems occur, and suggest preventive measures.
However, the board would need permission from healthcare organizations to probe safety events and could not identify any healthcare provider or setting in its reports. That differs from the NTSB, which can subpoena both witnesses and evidence, and publish detailed accident reports that list locations and companies.
A related measure under review by a presidential advisory council would create such a board by executive order. Its details have not been made public.
The push comes as many patients continue to get hurt, according to recent reviews of medical records. The Department of Health and Human Services' inspector general found that 13% of hospitalized Medicare patients experienced a preventable harm during a hospital stay in October 2018. A New England Journal of Medicine study of patients hospitalized in Massachusetts in 2018 showed that 7% had a preventable adverse event with 1% suffering a preventable injury that was serious, life-threatening, or fatal.
Learning about safety concerns at specific facilities remains difficult. While transportation crashes are public spectacles that make news, creating demand for public accountability, medical errors often remain confidential, sometimes even ordered into silence by court settlements. Meaningful and timely information for consumers can be challenging to find. However, patient advocates said, unsafe providers should not be shielded from reputational consequences.
"People pay vast amounts of money for healthcare," said Helen Haskell, president of South Carolina-based Mothers Against Medical Error, an advocacy group she founded because her 15-year-old son died from septic shock following elective surgery in 2000. "Providers shouldn't be able to sweep things under the rug."
Barragán's bill follows a 2014 effort to create a national patient safety board to investigate incidents and make more providers' safety records publicly available. It stemmed from the Institute of Medicine's landmark 1999 report that called medical error in hospitals a leading cause of death and recommended a nationwide mandatory reporting system for serious adverse events. That campaign never got enough traction to become a congressional bill.
Patients and their families would still like to know the rate of harm in every hospital, said Lisa McGiffert, president of the Patient Safety Action Network, a group discontented with some aspects of the current bill. "We are so far away from that now," she added.
But Karen Wolk Feinstein, president and CEO of the Jewish Healthcare Foundation, a Pittsburgh-based philanthropy that leads more than 70 groups pushing the latest safety board campaign, said during an online forum in January that public reporting would compromise data integrity by leading hospitals to scrub records to hide bad events.
"You're going to have to protect data for a while — de-identify it," she said, "so that we can do what needs to be done."
She said that a patient safety board "will not happen" without broad support, including from hospitals and medical societies. Those groups have long opposed measures to publicly identify facilities where errors occur.
That industry influence is "the elephant in the room," said McGiffert. Hospitals, nursing homes, and medical professionals pour hundreds of millions of dollars into federal political campaigns each election cycle and spent $220 million lobbying Congress last year, according to OpenSecrets, a nonprofit that tracks money in U.S. politics.
Moreover, healthcare is the dominant employer in at least 47 states, according to Health Affairs, which means that, when legislation is in play, the industry "can always drum up local people to talk about how it affects them," McGiffert added.
Feinstein agreed that legislators always ask about the position of their local health systems. "That is the first question," she said during the January forum.
Although patient safety groups represent the interests of millions of people, they don't have the same financial firepower on hand as the healthcare industry does. McGiffert said her own organization's bank balance is $6,000. Feinstein said her foundation is using its endowment — created with proceeds from the sale of a tax-exempt hospital — to fund the patient safety board campaign, among other initiatives. The foundation reported assets of nearly $186 million in 2021.
The American Hospital Association declined to comment about the patient safety board proposal because it was still reviewing it, said spokesperson Colin Milligan. He provided a statement from the association's senior director of quality and patient safety policy, Akin Demehin, saying hospitals are "deeply committed" to safety and have urged that "publicly reported measures assess hospitals accurately and fairly while giving patients meaningful information."
The safety board campaign initially declared the NTSB as its model. However, Feinstein said, it now envisions it as "something of a hybrid" of the NTSB and the Commercial Aviation Safety Team, a lesser-known government-industry partnership that analyzes a massive amount of data to detect emerging risks.
Christopher Hart, a former NTSB chairperson who serves on the board of the Joint Commission, a healthcare accrediting body, likened the proposed patient safety board to the voluntary reporting of aviation errors and near misses, which are statutorily protected from public disclosure. Protecting such tips about non-public events has "enabled a flood of voluntarily provided information" that is "foundational to improving airline safety," Hart said.
But some consumer advocates argue that in healthcare, secrecy and voluntarism have fallen short. They point to the 2005 Patient Safety Act, which lets healthcare providers submit data confidentially to research groups called patient safety organizations. As of 2018, about 40% of hospitals reimbursed by Medicare didn't report to such organizations despite liability and public disclosure protections, and most of the organizations didn't submit data to national research databases, according to the HHS inspector general.
With safety indicators worsening during the pandemic, supporters of a patient safety board argue the current proposal would be a step forward. It could hasten adoption of surveillance technology, launch a national portal for anyone to report events, and coordinate efforts of states, federal agencies, and accrediting bodies.
Barragán will reintroduce the bill in the current term but declined to give a date, said spokesperson Kevin McGuire. "From our understanding, the stakeholders we are working with are discussing the concerns" raised by advocates, McGuire said.
Sue Sheridan, a co-founder of Patients For Patient Safety US, became a patient safety advocate after untreated jaundice left her son brain-damaged and her husband died of cancer that went untreated for months because a pathology result was not properly communicated. She now is a member of a working group for the presidential advisory council and said she expects consumer-friendly tweaks to the proposal, including putting patient representatives on the board itself — a step she said she would support. And she backs the overall effort, despite saying the plan needs to be somewhat refined.
"We will be safer with it than without it," Sheridan said.
Millions of Americans in the past few years have run into this experience: filing a healthcare insurance claim that once might have been paid immediately but instead is just as quickly denied. If the experience and the insurer's explanation often seem arbitrary and absurd, that might be because companies appear increasingly likely to employ computer algorithms or people with little relevant experience to issue rapid-fire denials of claims — sometimes bundles at a time — without reviewing the patient's medical chart. A job title at one company was "denial nurse."
It's a handy way for insurers to keep revenue high — and just the sort of thing that provisions of the Affordable Care Act were meant to prevent. Because the law prohibited insurers from deploying previously profit-protecting measures such as refusing to cover patients with preexisting conditions, the authors worried that insurers would compensate by increasing the number of denials.
And so, the law tasked the Department of Health and Human Services with monitoring denials both by health plans on the Obamacare marketplace and those offered through employers and insurers. It hasn't fulfilled that assignment. Thus, denials have become another predictable, miserable part of the patient experience, with countless Americans unjustly being forced to pay out-of-pocket or, faced with that prospect, forgoing needed medical help.
A recent KFF study of ACA plans found that even when patients received care from in-network physicians — doctors and hospitals approved by these same insurers — the companies in 2021 nonetheless denied, on average, 17% of claims. One insurer denied 49% of claims in 2021; another's turndowns hit an astonishing 80% in 2020. Despite the potentially dire impact that denials have on patients' health or finances, data shows that people appeal only once in every 500 cases.
Sometimes, the insurers' denials defy not just medical standards of care but also plain old human logic. Here is a sampling collected for the KFF Health News-NPR "Bill of the Month" joint project.
Dean Peterson of Los Angeles said he was "shocked" when payment was denied for a heart procedure to treat an arrhythmia, which had caused him to faint with a heart rate of 300 beats per minute. After all, he had the insurer's preapproval for the expensive ($143,206) intervention. More confusing still, the denial letter said the claim had been rejected because he had "asked for coverage for injections into nerves in your spine" (he hadn't) that were "not medically needed." Months later, after dozens of calls and a patient advocate's assistance, the situation is still not resolved.
An insurer's letter was sent directly to a newborn child denying coverage for his fourth day in a neonatal intensive care unit. "You are drinking from a bottle," the denial notification said, and "you are breathing on your own." If only the baby could read.
Deirdre O'Reilly's college-age son, suffering a life-threatening anaphylactic allergic reaction, was saved by epinephrine shots and steroids administered intravenously in a hospital emergency room. His mother, utterly relieved by that news, was less pleased to be informed by the family's insurer that the treatment was "not medically necessary."
As it happens, O'Reilly is an intensive-care physician at the University of Vermont. "The worst part was not the money we owed," she said of the $4,792 bill. "The worst part was that the denial letters made no sense — mostly pages of gobbledygook." She has filed two appeals, so far without success.
Some denials are, of course, well considered, and some insurers deny only 2% of claims, the KFF study found. But the increase in denials, and the often strange rationales offered, might be explained, in part, by a ProPublica investigation of Cigna — an insurance giant, with 170 million customers worldwide.
ProPublica's investigation, published in March, found that an automated system, called PXDX, allowed Cigna medical reviewers to sign off on 50 charts in 10 seconds, presumably without examining the patients' records.
Decades ago, insurers' reviews were reserved for a tiny fraction of expensive treatments to make sure providers were not ordering with an eye on profit instead of patient needs.
These reviews — and the denials — have now trickled down to the most mundane medical interventions and needs, including things such as asthma inhalers or the heart medicine that a patient has been on for months or years. What's approved or denied can be based on an insurer's shifting contracts with drug and device manufacturers rather than optimal patient treatment.
Automation makes reviews cheap and easy. A 2020 study estimated that the automated processing of claims saves U.S. insurers more than $11 billion annually.
But challenging a denial can take hours of patients' and doctors' time. Many people don't have the knowledge or stamina to take on the task, unless the bill is especially large or the treatment obviously lifesaving. And the process for larger claims is often fabulously complicated.
The Affordable Care Act clearly stated that HHS "shall" collect the data on denials from private health insurers and group health plans and is supposed to make that information publicly available. (Who would choose a plan that denied half of patients' claims?) The data is also supposed to be available to state insurance commissioners, who share with HHS the duties of oversight and trying to curb abuse.
To date, such information-gathering has been haphazard and limited to a small subset of plans, and the data isn't audited to ensure it is complete, according to Karen Pollitz, a senior fellow at KFF and one of the authors of the KFF study. Federal oversight and enforcement based on the data are, therefore, more or less nonexistent.
HHS did not respond to requests for comment for this article.
The government has the power and duty to end the fire hose of reckless denials harming patients financially and medically. Thirteen years after the passage of the ACA, perhaps it is time for the mandated investigation and enforcement to begin.