FORT SCOTT, Kan. — A slight drizzle had begun in the gray December sky outside Community Christian Church as Reta Baker, president of the local hospital, stepped through the doors to join a weekly morning coffee organized by Fort Scott's chamber of commerce.
The town manager was there, along with the franchisee of the local McDonald's, an insurance agency owner and the receptionist from the big auto sales lot. Baker, who grew up on a farm south of town, knew them all.
Still, she paused in the doorway with her chin up to take in the scene. Then, lowering her voice, she admitted: "Nobody talked to me after the announcement."
Just a few months before, Baker — joining with the hospital's owner, St. Louis-based Mercy — announced the 132-year-old hospital would close. Baker carefully orchestrated face-to-face meetings with doctors, nurses, city leaders and staff members in the final days of September and on Oct. 1. Afterward, she sent written notices to the staff and local newspaper.
For the 7,800 people of Fort Scott, about 90 miles south of Kansas City, the hospital's closure was a loss they never imagined possible, sparking anger and fear.
"Babies are going to be dying," said longtime resident Darlene Doherty, who was at the coffee. "This is a disaster."
Bourbon County Sheriff Bill Martin stopped before leaving the gathering to say the closure has "a dark side." And Dusty Drake, the lead minister at Community Christian Church, diplomatically said people have "lots of questions," adding that members of his congregation will lose their jobs.
Yet, even as this town deals with the trauma of losing a beloved institution, deeper national questions underlie the struggle: Do small communities like this one need a traditional hospital at all? And, if not, what health care do they need?
Sisters of Mercy nuns first opened Fort Scott's 10-bed frontier hospital in 1886 — a time when traveling 30 miles to see a doctor was unfathomable and when most medical treatments were so primitive they could be dispensed almost anywhere.
Now, driving the four-lane highway north to Kansas City or crossing the state line to Joplin, Mo., is a day trip that includes shopping and a stop at your favorite restaurant. The bigger hospitals there offer the latest sophisticated treatments and equipment.
And when patients here get sick, many simply go elsewhere. An average of nine patients stayed in Mercy Hospital Fort Scott's more than 40 beds each day from July 2017 through June 2018. And these numbers are not uncommon: Forty-five Kansas hospitals report an average daily census of fewer than two patients.
James Cosgrove, who directed a recent U.S. Government Accountability Officestudy about rural hospital closures, said the nation needs a better understanding of what the closures mean to the health of people in rural America, where the burden of disease — from diabetes to cancer — is often greater than in urban areas.
What happens when a 70-year-old grandfather falls on ice and must choose between staying home and driving to the closest emergency department, 30 miles away? Where does the sheriff's deputy who picks up an injured suspect take his charge for medical clearance before going to jail? And how does a young mother whose toddler fell against the coffee table and now has a gaping head wound cope?
There is also the economic question of how the hospital closure will affect the town's demographic makeup since, as is often the case in rural America, Fort Scott's hospital is a primary source of well-paying jobs and attracts professionals to the community.
The GAO plans to complete a follow-up study later this year on the fallout from rural hospital closures. "We want to know more," Cosgrove said. The report was originally requested in 2017 by then-Sen. Claire McCaskill (D-Mo.) and then-Rep. Tim Walz (D-Minn.), and has been picked up by Sen. Gary Peters (D-Mich.). Here in Fort Scott, the questions are being answered — painfully — in real time.
At the end of December, Mercy closed Fort Scott's hospital but decided to keep the building open to lease portions to house an emergency department, outpatient clinic and other services.
Mercy Hospital Fort Scott joined a growing list of more than 100rural hospitals that have closed nationwide since 2010, according to data from the University of North Carolina's Cecil G. Sheps Center for Health Services Research. How the town copes is a window into what comes next.
'We Were Naive'
Over time, Mercy became so much a part of the community that parents expected to see the hospital's ambulance standing guard at the high school's Friday night football games.
Mercy's name was seemingly everywhere, actively promoting population health initiatives by working with the school district to lower children's obesity rates as well as local employers on diabetes prevention and healthy eating programs — worthy but, often, not revenue generators for the hospital.
"You cannot take for granted that your hospital is as committed to your community as you are," said Fort Scott City Manager Dave Martin. "We were naive."
Indeed, in 2002 when Mercy decided to build the then-69-bed hospital, residents raised $1 million out of their own pockets for construction. Another million was given by residents to the hospital's foundation for upgrading and replacing the hospital's equipment.
"Nobody donated to Mercy just for it to be Mercy's," said Bill Brittain, a former city and county commissioner. The point was to have a hospital for Fort Scott.
Today Mercy is a major health care conglomerate, with more than 40 acute care and specialty hospitals, as well as 900 physician practices and outpatient facilities. Fort Scott is the second Kansas hospital Mercy has closed.
Tom Mathews, vice president of finance for Mercy's southwestern Missouri and Kansas region, said Fort Scott's steady decline in patients, combined with lack of reimbursement — as well as the increasing cost of expenses such as drugs and salaries — "created an unsustainable situation for the ministry."
But Fort Scott is a place that needs health care: One out of every four children in Bourbon County live in poverty. People die much younger here than the rest of the state and rates for teen births, adult smoking, unemployment and violent crime are all higher in Bourbon County than the state average, according todata collected by the Kansas Health Institute and the Robert Wood Johnson Foundation. Ten percent of Bourbon County's more than 14,000 residents, about half of whom live in Fort Scott, lack health insurance. Kansas is one of 14 states that have not expanded Medicaid under the Affordable Care Act and, while many factors cause a rural closing, the GAO report found states that had expanded Medicaid had fewer closures.
The GAO report also found that residents of rural areas generally have lower household incomes than their counterparts in bigger cities, and are more likely to have limitations because of chronic health conditions, like high blood pressure, diabetes or obesity, that affect their daily activities.
The county's premature birth rate is also higherthan the 9.9% nationwide, a number that worries Dr. Katrina Burke, a local family care doctor who also delivers babies. "Some of my patients don't have cars," she said, "or they have one car and their husband or boyfriend is out working with the car."
By nearly any social and economic measure, southeastern Kansas is "arguably the most troubled part of the entire state," said Dr. Gianfranco Pezzino, senior fellow at the Kansas Health Institute. While the health needs are great, it's not clear how to pay for them.
Health Care's 'Very Startling' Evolution
Reta Baker describes the farm she grew up on, south of town, as "a little wide place in the road." She applied to the Mercy school of nursing in 1974, left after getting married and came back in 1981 to take a job as staff nurse at the hospital. She has "been here ever since," 37 years — the past decade as the hospital president.
It has been "very startling" to watch the way health care has evolved, Baker said. Patients once stayed in the hospital for weeks after surgery and now, she said, "they come in and they have their gallbladder out and go home the same day."
With that, payments and reimbursement practices from government and health insurers changed too, valuing procedures rather than time spent in the hospital. Rural hospitals nationwide have struggled under that formula, the GAO report found.
Acknowledging the challenge, the federal government established some programs to help hospitals that serve poorer populations survive: Through a program called 340B, some hospitals get reduced prices on expensive drugs. Rural hospitals that qualified for a "critical access" designation because of their remote locations got higher payments for some long stays. About 3,000 hospitals nationwide get federal "disproportionate share payments" to reflect the fact that their patients tend to have poor or no insurance.
Fort Scott took part in the 340B discount drug program as well as the disproportionate share payments. But, though Baker tried, it could not gain critical access status.
When Medicare reimbursement dropped 2% because of sequestration after the Budget Control Act of 2011, it proved traumatic, since the federal insurer was a major source of income and, for many rural hospitals, the best payer.
Then, in 2013, when the federal government began financially penalizing most hospitals for having too many patients returning within 30 days, hospitals like Fort Scott's lost thousands of dollars in one year. It contributed to Fort Scott's "financial fall," Baker said.
Baker did her best to set things right. To reduce the number of bounce-back admissions, patients would get a call from the physician's office within 72 hours of their hospital stay to schedule an office visit within two weeks. "We worked really, really hard," Baker said. Five years ago, the number of patients returning to Fort Scott's hospital was 21%; in 2018 it was 5.5%.
Meanwhile, patients were also "out-migrating" and choosing to go to Ascension Via Christi in Pittsburg — which is two times larger than Fort Scott — because it offered cardiology and orthopedic services, Baker said. Patients also frequently drove 90 miles north to the Kansas City area for specialty care and the children's hospital.
"Anybody who is having a big surgery done, a bowel resection or a mastectomy, they want to go where people do it all the time," Baker said. Mercy's Fort Scott hospital had no cardiologists and only two surgeons doing less complicated procedures, such as hernia repair or removing an appendix.
Last year, only 13% of the people in Bourbon County and the surrounding area who needed hospital care chose to stay in Fort Scott, according to industry data shared by Baker.
There were no patients in the hospital's beds during one weekend in December, Baker said, adding: "I look at the report every day. It bounces between zero and seven." The hospital employed 500 to 600 people a decade ago, but by the time the closure was announced fewer than 300 were left.
That logic — the financial need — for the closing didn't sit well with residents, and Mercy executives knew it. They knew in June they would be closing Fort Scott but waited until October to announce it to the staff and the city. City Manager Martin responded by quickly assembling a health task force, insisting it was "critical" to send the right message about the closure.
Relations between Mercy and the city grew so tense that attorneys were needed just to talk to Mercy. In all, Fort Scott had spent more than $7,500 on Mercy Closure Project legal fees by the end of 2018, according to city records.
Will Fort Scott Sink With No Mercy?
When Darlene Doherty graduated from Fort Scott High School in 1962, there were two things to do in town: "Work at Mercy or work at Western Insurance." The insurance company, though, was sold in the 1980s, and the employer disappeared, along with nearly a thousand jobs.
Yet, even as the community's population slowly declined, Martin and other community leaders have kept Fort Scott vibrant. There's the new Smallville CrossFit studio, which Martin attends; a new microbrewery; two new gas stations; a Sleep Inn hotel, an assisted living center; and a Dairy Queen franchise. And the McDonald's that opened in 2012 just completed renovation.
The town's largest employer, Peerless Architectural Windows and Doors, which provides about 400 jobs, bought 25 more acres and plans to expand. There's state money promised to expand local highways, and Fort Scott has applied for federal grants to expand its airport.
Baker and some of the physicians on Mercy's staff have been busy trying to ensure that essential health care services survive, too.
Baker found buyers for the hospital's hospice, home health services and primary care clinics so they could continue operating.
Burke, the family care doctor, signed on to be part of the Community Health Center of Southeast Kansas, a federally qualified nonprofit that is taking over four health clinics operated by Mercy Hospital Fort Scott. She will have to deliver babies in Pittsburg, which is nearly 30 miles away on a mostly two-lane highway that has construction workers slowing traffic as they work to expand it to four lanes.
Burke said her practice is full, and she wants her patients to be taken care of: "If we don't do it, who's going to?"
Mercy donated its ambulances and transferred emergency medical staff to the county and city.
And, in a tense, last-minute save, Baker negotiated a two-year deal with Ascension Via Christi hospital in Pittsburg to operate the emergency department — which was closed for two weeks in February before reopening under the new management.
But she knows that too may be just a patch. If no buyer is found, Mercy will close the building by 2021.
This is the first installment in KHN's year-long series, No Mercy, which follows how the closure of one beloved rural hospital disrupts a community's health care, economy and equilibrium.
The healthcare debate has Democrats on Capitol Hill and the presidential campaign trail facing renewed pressure to make clear where they stand: Are they for "Medicare for All"? Or will they take up the push to protect the Affordable Care Act?
Obamacare advocates have found a powerful ally in House Speaker Nancy Pelosi, who in a recent "60 Minutes" appearancesaid that concentrating on the health law is preferable to Medicare for All. She argued that since the ACA's "benefits are better" than those of the existing Medicare program, implementing Medicare for All would mean changing major provisions of current Medicare, which covers people 65 and up as well as those with disabilities.
This talking point — one Pelosi has used before — seems tailor-made for the party's establishment. It's politically palatable among moderates who believe that defending the ACA's popular provisions, such as protecting coverage for those with preexisting conditions, fueled the Democrats' House takeover in 2018.
Progressive Democrats argue that the time has come to advance a far more disruptive policy, one that guarantees healthcare to all Americans. Those dynamicswere on full display on Capitol Hill, as recently as an April 30 Medicare for All hearing.
But this binary view — Medicare (and, for argument's sake, Medicare for All) versus Obamacare — oversimplifies the issues and distracts from the policy proposals.
"It's sort of a silly argument," said Robert Berenson, a health policy analyst at the Urban Institute, of Pelosi's talking point. "She's trying to argue the Affordable Care Act needs to be defended, and Medicare for All is a diversion."
As the debate continues, one point should be clear: Medicare for All would not look like the ACA or like Medicare today. Instead, it — or any other single-payer system — would drastically change how Americans get healthcare.
Medicare for All is complicated, analysts noted, and the phrase is often deployed to mean different things, depending on who is speaking.
What's clear is that the "Medicare" described in Sen. Bernie Sanders' (I-Vt.) legislation — the flagship Medicare for All proposal — would create a health program far more generous than traditional Medicare's current benefit, or even the vast majority of health plans made available through the ACA.
Sanders relied heavily on this concept during his 2016 Democratic presidential primary run and recently introduced an updated version in the Senate.
To be fair, though, Sanders also sometimes blurs the lines between the programs. In a May 5 appearanceon ABC's "This Week with George Stephanopoulos," he used existing Medicare as part of his sales pitch: "Medicare right now is the most popular health insurance program in the country," he said. "But it only applies to people 65 years of age or older. All that I want to do is expand Medicare over a four-year period to cover every man, woman and child in this country."
As counterintuitive as it sounds, understanding Medicare as it works today isn't helpful in envisioning a Medicare for All plan. Unlike with existing Medicare, the proposed health plan would cover things like nursing home care, vision care and dental services. It would get rid of cost sharing — meaning no premiums, deductibles or copays. (Sanders has acknowledged that financing the program would mean raising taxes.)
"It's not Medicare. It's something different," said Ellen Meara, a health economist at the Dartmouth Institute for Health Policy and Clinical Practice.
But voters may not grasp the differences between the existing Medicare program for seniors and the hypothetical one being discussed. Pelosi's comments may add to that confusion. Pelosi's office did not respond to a request for comment.
Prioritizing efforts to bolster the ACA based on Medicare's current benefit package "is convenient and not necessarily compelling," Berenson said, adding: "No one is proposing the Medicare benefit package would be taken and applied nationally."
That said, many of the presidential candidates have advanced far less sweeping healthcare options that would lower the Medicare age to 55 or allow people to buy in to the current Medicare program — an approach often referred to as a "public option." Those would keep the program essentially structured as it is today.
Every analyst interviewed for this story floated some kind of concern regarding a Medicare for All system. There's the issue of how people would respond to losing the option of private insurance — a likely consequence of Sanders' proposal — and the question of what level of tax hikes would be necessary to finance such a system, particularly if it covers a big-ticket item such as long-term care. There are also concerns about the financial impact for hospitals, often large employers in a community, or for the private insurance industry jobs that would likely disappear.
Focusing on current Medicare benefits misses the point, suggested Sherry Glied, a health economist and dean at New York University. When debating the merits of the ACA versus Medicare for All, Medicare's current generosity is kind of a red herring, she said.
Plus, making Obamacare or Medicare for All an either-or debate ignores a sizable political bloc: Democrats who say they support the ACA and see single-payer as a next step. That tension is at play with presidential candidates like Kamala Harris, who frame Medicare for All as an ultimate goal, while also backing incremental reforms.
The problem is that both Medicare and Obamacare are vast programs. Depending on your income, health needs and the version you sign up for, either one could prove the better choice.
"It's impossible to say the ACA as a concept has more or less generous benefits," Berenson said.
Broadly, the ACA has protections in place that traditional Medicare doesn't. It caps how much patients pay out-of-pocket, and it has more generous coverage of mental healthcare and substance abuse treatment. But, in practice, those benefits have proved elusive for many since Medicare generally has a more robust network of participating physicians than many of the ACA's cheaper plans, which restrict patients to a narrower coverage network.
Also, most beneficiaries don't solely have traditional Medicare.
About a third use Medicare Advantage, in which private insurance companies construct Medicare plans with benefits and protections based on factors like company, tier and geography. They, too, are often restricted to narrower networks.
More than 1 in 5 traditional Medicare beneficiaries also receive Medicaid coverage, according to figures kept by the Kaiser Family Foundation, and about a third of them buy so-called Medigap plans, which are sold by private insurance and are meant to supplement gaps in coverage.
The ACA also encompasses an array of coverage options. Which plans are available in an area and whether earnings qualify a consumer for a government subsidy— a tax break meant to make an ACA plan more affordable — make a significant difference in evaluating whether Medicare or an ACA plan offers better benefits for a particular person or family.
Suggesting that one is clearly better than the other, Meara said, is a "gross oversimplification."
But that kind of oversimplification may be hard to avoid, especially in a primary season where healthcare is a top issue.
"The Affordable Care Act is also not one thing, the way Medicare is not one thing," said Katherine Baicker, dean of the Harris School of Public Policy at the University of Chicago. "So much of healthcare is more complicated than we can explain in a sound bite."
The 50-something man with a shaved head and brown eyes was unresponsive when the paramedics wheeled him into the emergency room. His pockets were empty: no wallet, no cellphone, not a single scrap of paper that might reveal his identity to the nurses and doctors working to save his life. His body lacked any distinguishing scars or tattoos.
Almost two years after he was hit by a car on busy Santa Monica Boulevard in January 2017 and transported to Los Angeles County+USC Medical Center with a devastating brain injury, no one had come looking for him or reported him missing. The man died in the hospital, still a John Doe.
Hospital staffs sometimes must play detective when an unidentified patient arrives for care. Establishing identity helps avoid the treatment risks that come with not knowing a patient's medical history. And they strive to find next of kin to help make medical decisions.
"We're looking for a surrogate decision-maker, a person who can help us," said Jan Crary, supervising clinical social worker at L.A. County+USC, whose team is frequently called on to identify unidentified patients.
The hospital also needs a name to collect payment from private insurance or government health programs such as Medicaid or Medicare.
But federal privacy laws can make uncovering a patient's identity challenging for staff members at hospitals nationwide.
At L.A. County+USC, social workers pick through personal bags and clothing, scroll through cellphones that are not password-protected for names and numbers of family or friends, and scour receipts or crumpled pieces of paper for any trace of a patient's identity. They quiz the paramedics who brought in the patient or the dispatchers who took the call.
They also make note of any tattoos and piercings, and even try to track down dental records. It's more difficult to check fingerprints, because that's done through law enforcement, which will get involved only if the case has a criminal aspect, Crary said.
Unidentified patients are often pedestrians or cyclists who left their IDs at home and were struck by vehicles, said Crary. They might also be people with severe cognitive impairment, such as Alzheimer's, patients in a psychotic state or drug users who have overdosed. The hardest patients to identify are ones who are socially isolated, including homeless people — whose admissions to hospitals have grown sharply in recent years.
In the past three years, the number of patients who arrived unidentified at L.A. County+USC ticked up from 1,131 in 2016 to 1,176 in 2018, according to data provided by the hospital.
If a patient remains unidentified for too long, the staff at the hospital will make up an ID, usually beginning with the letter "M" or "F" for gender, followed by a number and a random name, Crary said.
Other hospitals resort to similar tactics to ease billing and treatment. In Nevada, hospitals have an electronic system that assigns unidentified patients a "trauma alias," said Christopher Lake, executive director of community resilience at the Nevada Hospital Association.
The deadly mass shooting at a Las Vegas concert in October 2017 presented a challenge for local hospitals who sought to identify the victims. Most concertgoers were wearing wristbands with scannable chips that contained their names and credit card numbers so they could buy beer and souvenirs. On the night of the shooting, the final day of a three-day event, many patrons were so comfortable with the wristbands that they carried no wallets or purses.
More than 800 people were injured that night and rushed to numerous hospitals, none of which were equipped with the devices to scan the wristbands. Staff at the hospitals worked to identify patients by their tattoos, scars or other distinguishing features, as well as photographs on social media, said Lake. But it was a struggle, especially for smaller hospitals, he said.
The Health Insurance Portability and Accountability Act, a federal law intended to ensure the privacy of personal medical data, can sometimes make an identification more arduous because a hospital may not want to release information on unidentified patients to people inquiring about missing persons.
In 2016, a man with Alzheimer's disease was admitted to a New York hospital through the emergency department as an unidentified patient and assigned the name "Trauma XXX."
Police and family members inquired about him at the hospital several times but were told he was not there. After a week — during which hundreds of friends, family members and law enforcement officials searched for the man — a doctor who worked at the hospital saw a news story about him on television and realized he was the unidentified patient.
Hospital officials later told the man's son that because he had not explicitly asked for "Trauma XXX," they could not give him information that might have helped him identify his father.
Prompted by that mix-up, the New York State Missing Persons Clearinghouse drafted a set of guidelines for hospital administrators who receive information requests about missing persons from police or family members. The guidelines include about two dozen steps for hospitals to follow, including notifying the front desk, entering detailed physical descriptions into a database, taking DNA samples and monitoring emails and faxes about missing persons.
California guidelines stipulate that if a patient is unidentified and cognitively incapacitated, "the hospital may disclose only the minimum necessary information that is directly relevant to locating a patient's next-of-kin, if doing so is in the best interest of the patient."
At L.A. County+USC, most John Does are quickly identified: They either regain consciousness or, as in a majority of cases, friends or relatives call asking about them, Crary said.
Still, the hospital does not always succeed. From 2016 to 2018, 10 John and Jane Does remained unidentified during their stays at L.A. County+USC. Some died at the hospital; others went to nursing homes with made-up names.
But Crary said she and her team pursue every avenue in search of an identity.
Once, an unidentified and distinguished-looking older man with a neatly trimmed beard was rushed into the emergency room, delirious with what was later diagnosed as encephalitis and unable to speak.
Acting on a gut instinct that the well-groomed man must have a loved one who had reported him missing, Crary checked with police stations in the area. She learned instead that this John Doe was wanted in several states for sexual assault.
"He was done in by a mosquito," Crary mused.
"It is a case that I will never forget," she added. "The truth is that I am more elated when we are able to identify a patient and locate family for a beautiful reunification rather than finding a felon."
President Donald Trump called on Republicans and Democrats to pass legislation this year to end surprise medical bills, in remarks made in the White House's Roosevelt Room on Thursday. "We're determined to end surprise medical billing for American patients," Trump said.
Bills like those have been featured in the NPR-Kaiser Health News series launched in February 2018. Two patients whose medical bills were part of the series attended the event.
Austin, Texas, teacher Drew Calver talked about the six-figure bill he received after having a heart attack. "I felt like I was exploited at the most vulnerable time in my life," he said. His bill was reduced to $332 after the NPR-KHN story was published.
A bipartisan group of senators has been working to come up with a plan for the past several months. They said Thursday that they hope to have a bill to the president by July.
But will bipartisanship be enough? Even political will might not overcome divisions within the health industry.
Specifically, lawmakers aim to address the often-exorbitant amounts patients are asked to pay out-of-pocket when they receive care at health facilities that are part of their insurance network but are treated by out-of-network practitioners. Legislators are also looking to address bills for emergency care at a facility that doesn't have a contract with patients' insurers.
"We're getting really close to an approach that we'll be able to unveil pretty soon," Sen. Maggie Hassan (D-N.H.) told reporters on a conference call Thursday with Sen. Bill Cassidy (R-La.).
And it's not just politicians and patients: Out-of-network doctors, insurance companies and hospital groups say they want the problem for consumers fixed, too.
Despite that broad agreement, a hurdle remains. Insurers and healthcare providers each oppose the other side's preferred solution to end surprise bills. That conflict makes it almost impossible for lawmakers to come up with a fix that won't leave one of the influential groups unhappy.
"It's a different axis than the partisan [conflicts] we're used to," said Loren Adler, who has been studying the surprise-bill problem for the USC-Brookings Schaeffer Initiative for Health Policy. The fight over how to fix it is less likely "to break down between Republicans and Democrats and more likely to break down to where the money is" and which group will have to take less of it.
"I don't see a coalescence around a solution," said Chip Kahn, president and CEO of the Federation of American Hospitals, which represents for-profit facilities.
The divide is wide, despite the overall interest in protecting consumers.
"What we'd most like to see is clarity for the patients," said Bob Kneeley, a senior vice president for Envision Healthcare, which employs physicians to staff a variety of hospital departments, such as emergency rooms, neonatal units and anesthesiology. "This is a system that's just not working well for the patient, and we need to establish some appropriate guardrails."
"We want this to be solved. We know it needs federal legislation," agreed Molly Smith, a vice president at the American Hospital Association. She said hospitals believe that patients should "not have to be involved in any process if there's a dispute between the payer and the provider."
States have been working on the problem for several years. Nine now have programs aimed at protecting patients from surprise bills. But state laws cannot reach those with employer-provided insurance — more than half of all Americans — because those plans are regulated by a federal law called the Employee Retirement Income Security Act, or ERISA. That means only Congress can fix it for everyone.
Patients and groups that represent them say the problem is more urgent than ever.
"We are talking about situations in which families — despite enrolling in health insurance, paying premiums, doing their homework and trying to work within the system — are being left with completely unanticipated and sometimes financially devastating bills," Frederick Isasi, executive director of the consumer group Families USA, told a House Education and Labor subcommittee hearing in April. "This is inexcusable behavior on the part of hospitals, doctors and insurers. They each know — or should know — that patients have no real way to understand the financial trap they have just walked into."
Dr. Paul Davis, whose daughter received a bill for a $17,850 for a urine test after back surgery, also spoke at the White House on Thursday: "The situation is terrible. It is a national disgrace, and I think a lot of people would support me on that," Davis told a reporter. Their story was the first featured in the "Bill of the Month" project.
Still, it's not clear where compromise might be found.
By and large, doctors favor some sort of negotiated-fee system when there is a dispute about a bill, such as binding arbitration, in which an independent third party makes the ultimate payment decision.
"That's consistent with what's working in some states," said Envision's Kneeley.
Among those frequently cited by doctors' groups is New York, which has one of thestrongest state lawson surprise billing. There patients are not required to pay more than they would for an in-network doctor or hospital. For the remaining bill, an independent arbitrator settles any dispute between the provider and insurer.
But the insurance industry worries about that approach. "Our larger concern with arbitration is that it still relies on bill charges," said Adam Beck, a vice president for America's Health Insurance Plans, an insurance industry trade group. And insurers think those charges are too high.
A senior administration official also said on Thursday that the administration does not favor the arbitration approach, either.
Insurers — and many consumer groups — "believe if you have a clear benchmark pegged to reasonable rates, that will really solve this problem," Beck said, because insurers would be more likely to cover charges they found more in line with what they consider reasonable.
A "benchmark" payment might correspond to what Medicare pays for the same service, for instance.
But doctors don't like that idea one bit. "Even if [the benchmark] is on the high side, it's still rate-setting," said Kneeley.
Hospitals don't like it, either.
"We can't get behind any sort of rate-setting in statute," said Smith of the AHA. "We have too many concerns about getting that wrong." For example, she said, if the rate is set too low, hospitals might have trouble finding doctors willing to provide care.
Meanwhile, insurers and hospitals want to ban out-of-network providers from billing patients for whatever part of the charge the insurer won't cover, a practice called "balance billing."
Such bans are anathema to doctors, who instead believe insurers bear responsibility for doctors not being in their networks because they "don't have an incentive to offer fair rates," said Kneeley. Although insurers often feel they must contract with specific high-profile hospitals, he explained, the doctors who work there are often "invisible providers."
Addressing the underlying causes of high health costs, however, will be difficult, said Adler of USC-Brookings.
Doctors want to be paid more than insurers typically offer, he said, which is why some do not join insurance networks. And insurers "want the problems [with surprise bills to patients] to go away." The question for them, he said, is, "How much are insurers willing to pay to have their patients not get surprise bills?"
In the end, a settlement that eliminates surprise bills but builds the excess into everyone's premiums doesn't truly address healthcare's spending problem.
"I think there's a good chance it gets solved," Adler said, and that lawmakers will eventually agree on a plan. "But I'm pessimistic it gets solved in a way" that deals with healthcare's high costs.
KHN senior correspondent Fred Schulte contributed to this report.
The four proposed bills share a common goal: avoiding some of the thorny issues around drug pricing and instead getting at the ways branded drug manufacturers use patents and other tools to keep lower-priced generic competitors from reaching patients.
Congress isn't making much headway in finding a solution to the problem of soaring prescription drug prices, but lawmakers from both parties are tinkering on the edges with legislation that aims to increase competition among drugmakers.
A comprehensive piece of drug-pricing legislation is a high priority for Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Sen. Ron Wyden (D-Ore.). And it could be introduced by mid-June, according to congressional staff.
But while that is hashed out, a slate of options to reform drug patents is working its way through the Senate Judiciary Committee, which had a hearing Tuesday featuring academics, patient advocates and a representative from the pharmaceutical industry. Their mission: to increase competition without decreasing innovation in the industry.
"I think we're dangerously close to building a bipartisanship consensus around change," Sen. Dick Durbin (D-Ill.) said during the hearing.
The four proposed bills share a common goal: avoiding some of the thorny issues around drug pricing, like whether the government will set drug prices or negotiate with manufacturers on what federal programs will pay. Instead, the patent reform proposals get at the ways branded drug manufacturers use patents, and the legal monopolies that are granted with patents, to keep lower-priced generic competitors from reaching patients.
"A package of patent reforms are important because they fix systemic problems that allow prices to go up and keep them high," testified David Mitchell, the president of Patients for Affordable Drugs, a Washington, D.C.-based advocacy group focused on lowering prescription drug prices.
Sen. John Cornyn (R-Texas) offered specific examples of drugs that have benefited from system issues, including Humira, an expensive drug for arthritis and psoriasis that is protected by 136 patents.
That's called a "patent thicket," because it prevents a generic alternative from entering the market for more years—in this case, until 2023 for a drug first approved for use in the United States in 2002. "Is there anyone on the panel who'd like to defend the status quo?" he asked.
"There is no way a biosimilar can deal with a hundred patents," testified Michael Carrier, a professor at Rutgers Law School. "This is an abuse of the system."
Among the proposed bills, the Stop STALLING ("Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics") Act—the bipartisan brainchild of Sen. Amy Klobuchar (D-Minn.) and Grassley—is supposed to put a stop to "sham" citizen petitions to the FDA. Critics say these petitions are often introduced by drugmakers under the guise of patient advocacy to slow FDA approval of new generic medicines. "Nearly every one of these citizen petitions is brought by a brand company. None are filed by individuals. I love the legislation. I would go even stronger," Carrier said.
Grassley is also the lead sponsor on the bipartisan Prescription Pricing for the People Act of 2019. It directs the Federal Trade Commission to investigate mergers of pharmacy benefit managers, the middlemen that negotiate between drugmakers and health plans.
Klobuchar and Grassley teamed up again on another measure, the Preserve Access to Affordable Generics and Biosimilars Act, which they say would end "anti-competitive behavior"—specifically, deals struck between branded companies and generic companies to keep a generic, or a biosimilar, off the market. Klobuchar, a Democratic presidential candidate, has frequently discussed her opposition to this practice on the campaign trail.
James Stansel—the executive vice president and general counsel of the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, and the lone voice of the pharmaceutical industry on the panel—cautioned against moving too aggressively on this point. "We want to make sure we don't do something that's anti-competitive in the hopes it would be pro-competitive," he said.
There's also the CREATES ("Creating and Restoring Equal Access to Equivalent Samples") Act, introduced by Sen. Patrick Leahy (D-Vt.) with 31 bipartisan co-sponsors and endorsed by nearly every witness on Tuesday's panel. It's supposed to crack down on branded companies that refuse to sell samples of their drugs to generic companies, a necessary step to increasing the number of generics on the market.
Versions of all four of those bills have also been introduced in the House and advanced out of the House Judiciary Committee.
"The American people are being played for chumps," said Sen. John Kennedy (R-La.). "Just chumps. And it's got to stop."
It was early morning in an operating theater at Providence Hospital in Portland, Ore. A middle-aged woman lay on the operating table, wrapped in blankets. Surgeons were about to cut out a cancerous growth in her stomach.
But first, an anesthesiologist—Dr. Brian Chesebro—put her under by placing a mask over her face.
"Now I'm breathing for her with this mask," he said. "And I'm delivering sevoflurane to her through this breathing circuit."
Sevoflurane is one of the most commonly used anesthesiology gases. The other big one is desflurane. There are others too, like nitrous oxide, commonly known as laughing gas.
Whichever gas a patient gets is inhaled, but only about 5% is metabolized. The rest is exhaled. And to make sure the gas doesn't knock out anyone else in the operating room, it's sucked into a ventilation system.
And then? It's vented up and out through the roof, to mingle with other greenhouse gases.
The two frequently used gases are fairly similar medically; sevoflurane needs to be more carefully monitored and meted out in some patients, but that's not difficult, Chesebro said.
Generally, unless there's a reason in a particular case to use one over the other, anesthesiologists simply tend to pick one of the two gases and stick with it. Few understand that one—desflurane—is much worse for the environment.
And that bothered Chesebro. He grew up on a ranch in Montana that focused on sustainability.
"Part of growing up on a ranch is taking care of the land and being a good steward," he said.
Now he lives in the city with his three kids and has gradually started to worry about their environmental future.
"When I look around and I see the stewardship on display today, it's discouraging," he said.
"I got depressed for a while, and so I hit the pause button on myself and said, 'Well, what's the very best that I can do?'"
He spent hours of his own time researching anesthesiology gases. And he learned desflurane is 20 times more powerful than sevoflurane in trapping heat in the Earth's atmosphere. It also lasts for 14 years in the atmosphere, whereas sevoflurane breaks down in just one year.
Opening a big, black notebook filled with diagrams and tiny writing, he showed how he computed the amount of each gas the doctors in his group practice used. Then he shared their carbon footprint with them.
"All I'm doing is showing them their data," Chesebro said. "It's not really combative. It's demonstrative."
One of the doctors he shared his analysis with was Dr. Michael Hartmeyer, who works at the Oregon Anesthesiology Group with Chesebro.
"I wish I had known earlier," Hartmeyer said. "I would have changed my practice a long time ago."
Hartmeyer said he was stunned when Chesebro explained that his use of desflurane was the greenhouse-gas equivalent of driving a fleet of 12 Hummers for the duration of each surgical procedure. It's "only" half a Hummer if he uses sevoflurane. Hartmeyer noted that outside the operating room he drives a Prius, a hybrid electric car.
"You try to be good," he said. "You take shorter showers or [don't] leave lights on, or whatever else. But you know there's always more that we could probably do. But this was, far and away, a relatively easy thing that I could do that made a huge impact."
The anesthesiology carts that get brought into operating theaters tend to have a row of gases to choose from. Hartmeyer was able to switch pretty much overnight.
Other anesthesiologists made the switch, too. And it didn't hurt that sevoflurane is considerably cheaper.
Hartmeyer's change saved his hospital $13,000 a year.
When Chesebro shared his findings with the anesthesia departments at all eight Providence Health hospitals in Oregon, they prioritized the use of sevoflurane. They now save about $500,000 a year.
She said several hospitals around the country have tried to make this shift, but with mixed results. Some just gave anesthesiologists the information and not much changed. Other hospitals took desflurane away, but that left many anesthesiologists feeling disrespected and angry.
Chesebro succeeded, she said, because he chose to persuade his colleagues—using data. He showed doctors their choice of gas plotted against their greenhouse impact. And it helped that he showed them over and over, so doctors could compare their progress to their peers.
"Providing ongoing reports to providers is the best way for this movement to catch on and grow," she said. It can reinforce over time, she added, not just what their carbon footprint is, but also what progress they're making.
Sherman said efforts such as Chesebro's are sorely needed because the U.S. health sector is responsible for about 10% of the nation's greenhouse gases.
"We clinicians are very much focused on taking care of the patient in front of us," she said. "We tend to not think about what's happening to the community health, public health—because we're so focused on the patient in front of us."
In an emailed statement, one of the largest manufacturers of both the anesthesia gases—Baxter International—said it's important to provide a range of options for patients. The company also said inhaled anesthetics have a climate impact of 0.01% of fossil fuels.
"The overall impact of anesthetic agents on global warming is low, relative to other societal contributors, especially when you consider the critical role these products have in performing safe surgical procedures," the statement reads.
It's a fair point, Chesebro said, but he has a counterargument.
"Well, if it's there, it's bad. And if I can reduce my life's footprint by a factor of six … why wouldn't you do it?'"
The surgery Chesebro was involved in that morning at Providence was a success. Chesebro estimates that by using sevoflurane on his patient, the amount of greenhouse gases produced was the same as in a 40-mile drive across the Portland region. If he'd used desflurane instead, he said, it would have been like driving the more than 1,200 miles from Seattle to San Diego.
Now Chesebro's hospital bosses are hoping other doctors will follow his lead, research their own pet peeve and maybe solve a problem no one's thinking about.
California Gov. Gavin Newsom wants the state to provide health coverage to low-income young adults who are in the country illegally, but his plan would siphon public health dollars from several counties battling surging rates of sexually transmitted diseases and, in some cases, measles outbreaks.
Public health officials describe the proposed reallocation of state dollars as a well-meaning initiative that nonetheless would have "dire consequences" to core public health services.
There have been 764 confirmed cases of measles this year through May 3 in 23 states, including California, the highest number since 1994, the Centers for Disease Control and Prevention reported Monday. State public health officials also are struggling to address record rates of sexually transmitted diseases, with more than 300,000 cases of gonorrhea, chlamydia and syphilis reported in 2017.
The reallocation of state money "would exacerbate our already limited capacity to respond to outbreaks and public health emergencies," said Jeff Brown, director of Placer County's Health and Human Services Department, which has responded to three measles cases so far this year.
California already allows eligible immigrant children up to age 19 to participate in Medi-Cal, the state's Medicaid program for low-income residents, regardless of their immigration status. The current budget sets aside $365.2 million to pay for the coverage.
In his 2019-20 budget plan, Newsom proposes expanding eligibility to unauthorized young adult immigrants from age 19 through 25.
His office estimates it would cost nearly $260 million to cover them in 2019-20. While state and federal governments usually share Medicaid costs, California would have to bear the full cost of covering this population.
To help pay for it, Newsom proposes to redirect about $63 million in state funds from 39 counties, arguing they would no longer need to provide health benefits to low-income young adults covered by the state.
"As the state takes on responsibility for providing health care to undocumented adults, counties' costs and responsibilities on indigent health care are expected to decrease," Jenny Nguyen, a budget analyst at the state Department of Finance, told lawmakers at a recent legislative hearing.
Under the governor's 2019-20 budget plan, which requires legislative approval, 35 mostly small and rural counties expect to lose about $45 million in state money that funds health services for uninsured residents, including undocumented immigrants. Those counties—which participate in something called the County Medical Services Program—aren't expected to feel an immediate financial impact because the program has a budget surplus.
But four counties—Placer, Sacramento, Santa Barbara and Stanislaus—would take big and immediate hits to their public health budgets, officials say.
The amount of money the governor wants to divert from them to cover unauthorized immigrants under Medi-Cal is far more than the counties now spend on comprehensive health services for those immigrants, local health officials said.
"The idea that these dollars would be offset is just not accurate," said Mary Ann Lee, managing director of Stanislaus County Health Services Agency, who described the governor's budget proposal as "alarming."
For example, Stanislaus County estimates it would lose $2.5 million under the governor's budget plan. When officials studied the population served by their health centers, they found only 18 individuals were young adults who might not have legal immigration status. The total cost to provide care to them: just $1,700 a year.
Sacramento County, which reported a 300% increase in syphilis cases in the past four years, would have to shutter its newly opened STD clinic if the county loses an estimated $7.5 million in state funding, Dr. Peter Beilenson, the county Health Services Director, told lawmakers.
And while Sacramento County provides primary health care to an estimated 4,000 undocumented immigrant adults, just 100 are ages 19 to 25, and they are the least expensive to cover, Beilenson said.
"We agree with the idea behind this, increasing coverage for [those who are] undocumented," Beilenson said. But losing those funds would force the county to close its STD clinic and terminate some communicable disease investigators "at a time when we now have measles cases in the region and we don't want to be shutting those services down."
The 40 confirmed cases of measles reported in California as of May 1 include three in Sacramento County.
As a result of the reduced funding, Sacramento County also would have to slash health services to its unauthorized immigrant residents—the very people Newsom aims to help—by an estimated 75%, Beilenson added.
Whether lawmakers will approve the governor's proposal is unclear.
Several already have expressed concern, including state Assemblywoman Eloise Reyes (D-Grand Terrace), who said, "I think it is clear that this would be terrible for those counties."
Officials with the Department of Finance told lawmakers at the hearing that they were aware of counties' concerns but that the "governor's budget stands as it is."
The governor is scheduled to release a revised budget proposal by May 14, before the legislature votes on it this summer.
"I hope there will be some reconsideration," said state Sen. Richard Pan (D-Sacramento), chairman of the Senate Health Committee. "There's a disconnect there."
An analysis of insurance claims from more than 350 commercial carriers found that plastic and maxillofacial surgeons billed out-of-network more frequently than any other type of specialist in an inpatient setting.
This article was first published on Monday, May 6, 2019 inKaiser Health News.
Bob Ensor didn't see the boom swinging violently toward him as he cleaned a sailboat in dry dock on a spring day two years ago. But he heard the crack as it hit him in the face.
He was transported by ambulance to an in-network hospital near his home in Middletown, N.J., where initial X-rays showed his nose was broken as were several bones of his left eye socket. The emergency physician summoned the on-call plastic surgeon, who admitted him to the hospital and scheduled him for surgery the next day.
Shortly before surgery, the doctor introduced Ensor to a second plastic surgeon who would assist in the 90-minute procedure. Entering through Ensor's nose, the physicians realigned his facial bones, temporarily sewing Ensor's left eye shut so that the lids would stay in place as the bones knitted back together.
Six weeks later, as Ensor, then 65, continued to make an uneventful recovery, a collection agency called to inquire how he and his wife planned to pay the $71,729 bill for the assistant surgeon. Ensor's company health plan had denied payment because the surgeon wasn't part of its contracted physician network.
There was more bad news. Ensor received notice that the health plan wouldn't cover the $95,885 charged by the first plastic surgeon either because he also was out-of-network.
"The hospital knew these doctors were out-of-network and didn't bother to tell us," said his wife, Linda Ensor, noting they faced more than $167,000 in charges. "We were panicked."
Riverview Medical Center in Red Bank, N.J., where Ensor was treated, said that it "empathizes with patients who are trying to navigate the complexity of the healthcare billing system" and that transparency in billing has not always been optimal for emergency department patients
As surprise out-of-network billing becomes a politically charged issue, Americans want the federal government to take action. In an April survey, more than three-quarters of consumers said the government should protect them from such bills, according to the Kaiser Family Foundation's monthly health tracking poll. (KHN is an editorially independent program of the foundation.)
An analysis of insurance claims from more than 350 commercial carriers found that plastic and maxillofacial surgeons billed out-of-network more frequently than any other type of specialist in an inpatient setting. Examining hospital admissions in 2016, researchers at Johns Hopkins Bloomberg School of Public Health found that plastic and maxillofacial surgeons billed their services out-of-network 23% of the time, more than any of the other 50 specialties analyzed.
That leaves patients like Ensor, whose care requires plastic or maxillofacial surgery, extremely vulnerable. It also catches patients off guard: When a parent brings in a child with a cut and a triage nurse asks if they'd prefer a plastic surgeon, many reflexively answer "yes" not understanding whether there is an actual need nor anticipating the charges.
According to one survey of emergency department directors at more than 440 hospitals, 81% reported they had inadequate plastic surgery coverage, a higher percentage than reported shortages of any other type of surgical specialty.
The reasons these specialists are such frequent out-of-network billers are fairly straightforward.
Many plastic surgeons don't participate in health plans because they have flexibility other physicians may not have — their practices often focus on elective cosmetic procedures like nose reshaping and breast augmentation that patients pay for on their own.
Also, general surgeons and heart surgeons generally want to maintain good relations with the hospitals — and be on call for the ER— since the ER is a source of patient referrals and their patients often require inpatient care. In contrast, plastic surgeons often operate at outpatient centers.
"Fortunately for some plastic surgeons with alternative revenue streams, they don't need to participate with insurance companies," said Dr. Gregory Greco, the board vice president for health policy and advocacy of the American Society of Plastic Surgeons, who has a solo practice in New Jersey and Manhattan. Greco participates in the employee plans at the institutions where he has hospital privileges, but he doesn't accept other insurance plans.
The society did not respond to a request for information regarding the percentage of plastic surgeons who participate in insurance networks.
That can spell trouble in emergency care. Under the federal Emergency Medical Treatment and Labor Act (EMTALA), hospital emergency departments are required to screen and stabilize any patient who walks through the door, whether or not they can afford to pay. Hospitals often rely on a roster of on-call specialists to treat emergency patients, but studies show many specialists are reluctant to be on call, and low rates of insurance reimbursements may play a role in those decisions.
Data from a New York state program to arbitrate surprise medical bills — a 2015 state law holds patients harmless for such charges — highlights the scope of the problem with plastic surgery coverage.
Emergency care involving out-of-network plastic surgery services was by far the most common type of bill reviewed, according to figures from the state Department of Financial Services. By late 2018, there had been 543 decisions regarding such bills, compared with 335 for emergency physician care and 263 for orthopedists.
In New York, the surprise billing law has discouraged plastic surgeons from charging extremely high fees for out-of-network work, said Dr. Andrew Kleinman, a plastic surgeon in suburban New York City who is a former president of the Medical Society of the State of New York. Under the program, which uses a process called "baseball arbitration," the insurer and provider each submits a proposed dollar amount and the arbitrator picks one.
"Baseball arbitration gives the physician an incentive not to bill an outrageous rate because they're going to lose," Kleinman said. If a doctor charges $20,000 for services provided, but the insurer offers $500, "the insurer will win every time," he said.
More than two dozen states have passed laws that address surprise bills to some extent — although they do not protect the many patients covered by plans regulated by national rules. Congress is debating measures that would address surprise bills at the national level.
In the meantime, patients remain vulnerable. Dr. Meghan Candee was visiting family in Riverhead, N.Y., last summer when her daughter, who was 4 at the time, fell against a wooden bench and got a small cut underneath her left eyebrow. Candee, a pediatric neurologist in Salt Lake City, took her to the emergency department nearby, where she opted for a plastic surgeon, who put in a single stitch, without any sedation.
Candee paid the $100 copayment for the emergency department visit and took the stitch out herself five days later.
A few weeks later, Candee's insurer sent a $25,175 check to pass on to the out-of-network plastic surgeon, who had charged that amount for his work.
Assuming there was an error, Candee called the plastic surgeon's billing office but was told the amount was correct. Even though she wasn't herself on the hook, Candee was "outraged."
"This is why people have issues with physicians, and they think most of us are out there trying to get money," she said.
In New York, the average out-of-network charge at a hospital or other setting for an injury like Candee's daughter's — a simple repair of a superficial wound on the face that is 2.5 centimeters or less in length — is $438.01, according toFAIR Health, a national, independent nonprofit organization that collects and manages an extensive database of insurance claims. In the Great Neck/Port Washington area of Long Island, the area with the highest charges for that repair nationwide, the average charge is $1,067.25.
Patients should know that a plastic surgeon may not be covered in-network and is not necessary in many cases. "It's not uncommon for a family to say they would like a plastic surgeon," said Dr. William Jaquis, president-elect of the American College of Emergency Physicians. "But, in the vast majority of cases, a well-trained emergency physician can do most of the repairs." A plastic surgeon makes sense when there's extensive, deep-tissue damage and the skin is not cleanly torn, especially on the face, he said. A dog bite or an eye socket injury like Ensor's is a classic example.
Luckily for the Ensors, the sailing club stepped in to take up his case with the out-of-network plastic surgeons. Since sailing club members were required to volunteer on work projects to keep membership costs in check, the club's insurer agreed to cover the accident as a workers' compensation case. It paid 100% of the outstanding bill.
The Food and Drug Administration announced it is shutting down its controversial "alternative summary reporting" program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public.
The agency said it will open past records to the public within weeks.
A Kaiser Health News investigation in March revealed that the obscure program was vast, collecting 1.1 million reports since 2016. The program, which began about 20 years ago, was so little-known that forensic medical device experts and even a recent FDA commissioner were unaware of its existence.
Former FDA official Dr. S. Lori Brown said ending the program now is a "victory for patients and consumers."
"The No. 1 job of the FDA — it shouldn't be 'buyer beware' — is to have the information available to people so they can have information about the devices they are going to put in their body," Brown said.
FDA principal deputy commissioner Dr. Amy Abernethy and its device center director, Dr. Jeff Shuren, announced the decision to terminate the program in a statement on increasing transparency about the safety of breast implants.
The agency has for years allowed makers of breast implants to report hundreds of thousands of injuries and malfunctions out of the public eye, federal records show.
"We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events," Abernethy and Shuren said in a statement. "This is part of a larger effort to end the alternative summary reporting program for all medical devices."
FDA spokeswoman Angela Stark said the agency will also end "alternative summary reporting" exemptions still in place for makers of implantable cardiac defibrillators, pacemakers and tooth implants. The FDA has said the program was originally designed to allow for more efficient internal review of well-known risks.
The agency said it began winding down the program in mid-2017, revoking many reporting exemptions, including those for saline breast implants and for balloon pumps used inside patients' blood vessels.
At that point, the agency required device makers with ongoing exemptions to file quarterly reports in its public device-harm database known as MAUDE, short for the Manufacturer and User Facility Device Experience.
Still, FDA data provided to KHN shows that during the first nine months of 2018 the FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under the hidden "alternative summary reporting" program.
Ronni Solomon, vice president and chief policy officer of the ECRI Institute, which studies device safety, said the staff uses the FDA's open data on a daily basis to look for signals that might show heightened risks with a particular device.
"We think it's really vital for the sake of transparency, for the sake of policy, for sake of science," she said. "We're really glad to see this, the sooner the better."
The agency said its forthcoming data release will be for the alternative summary reports filed before mid-2017. The FDA for years reached agreements with makers of about 100 devices, allowing them to cease public reports of certain types of problems. The agency previously said the agreements and resulting records were available only by filing a Freedom of Information Act request, a process that can take months or even years.
Going forward, device makers will be required to file individual reports describing each case of patient harm related to a medical device.
The FDA has not said it will stop allowing device makers to file other types of device-harm exemption reports that are withheld from the public, such as when there is mass litigation over a device or when a company is submitting reports from an independent device-tracking registry. Nor has a plan been announced to open those records, which contain reports of harm related to pelvic mesh and surgical robots and reports of deaths related to several cardiac devices.
The FDA had granted Covidien, now a division of Medtronic, a long-standing "alternative summary reporting" exemption for its surgical staplers, a device used to cut tissues and vessels and quickly seal them during a variety of surgeries.
In 2016, when just 84 reports of stapler-related harm were disclosed in the FDA's MAUDE database, almost 10,000 more malfunction reports were sent directly to the FDA's in-house database, the agency acknowledged.
The device has been subject to numerous lawsuits over patient deaths and grave harm.
Doris Levering alleged in court that a stapler malfunction during liver surgery caused profuse bleeding that left her husband, Mark, 62, with serious brain damage and unable to walk. She applauded the agency's decision to open the database. "It's just wonderful to know that this information is going to be out in the open and not covered up," she said. "Now doctors who need to find the information will be able to find it."
The surgeon, hospital and device maker have all denied wrongdoing in an ongoing legal case.
The FDA has announced a May 30 advisory board meeting to review the agency's oversight of surgical staplers.
The FDA will leave in place a newer summary-reporting program that allows makers of more than 5,500 types of devices to send the agency spreadsheets logging device malfunctions. Unlike the "alternative summary reporting" program, device makers will not be allowed to report serious injuries using that approach.
Over the years, the FDA has had an uneven record of disclosing its "exemption" reports to advisers who review the safety of individual devices.
In February, FDA officials presented an advisory panel on gynecological devices with data showing 476 adverse events in 2017 related to a certain type of pelvic mesh. That panel was not briefed on nearly 12,000 reports filed by eight mesh makers in 2017, under a special exemption for lawsuit-related reports, according to an agency spokeswoman and a review of public records.
FDA spokeswoman Deborah Kotz said in an email that those "litigation" summary reports did not contain enough detail for the FDA to determine whether they shed any light on the safety question at hand.
The FDA ultimately took decisive action, though, ordering makers of the type of mesh under review to stop marketing those products, which were used to support sagging pelvic organs.
In late March, after KHN's investigation landed, the FDA convened another panel to review breast implant-related injuries and a rare form of lymphoma. For that meeting, the agency did provide a full tally of previously unreported injury and malfunction reports related to breast implants.
As of Thursday, though, the agency said it would leave the textured breast implants linked to a rare lymphoma on the market.
Matt Baretich, a Denver-area biomedical engineer who advises health systems on device safety, is eager to examine the hidden reports as they're released by the FDA.
"I'm really interested to see what information has been hidden so I can go back," Baretich said. "I may have been looking for that information and not found anything and thought there was not a problem."
Most downgraded homes had payroll records that showed no RN hours at all for four days or more. The remainder failed to submit payroll records or sent data that couldn't be verified.
This article was first published on Friday, May 3, 2019, in Kaiser Health News.
The federal government accelerated its crackdown on nursing homes that go days without a registered nurse by downgrading the rankings of a tenth of the nation's homes on Medicare's consumer website, new records show.
In its update in April to Nursing Home Compare, the Centers for Medicare & Medicaid Services gave its lowest star rating for staffing — one star on its five-star scale — to 1,638 homes.
Most were downgraded because their payroll records reported no registered-nurse hours at all for four days or more, while the remainder failed to submit their payroll records or sent data that couldn't be verified through an audit.
"Once you're past four days [without registered nursing], it's probably beyond calling in sick," said David Grabowski, a health policy professor at Harvard Medical School. "It's probably a systemic problem."
It was a tougher standard than Medicare had previously applied, when it demoted nursing homes with seven or more days without a registered nurse.
"Nurse staffing has the greatest impact on the quality of care nursing homes deliver, which is why CMS analyzed the relationship between staffing levels and outcomes," the agency announced in March. "CMS found that as staffing levels increase, quality increases."
The latest batch of payroll records, released in April, shows that even more nursing homes fell short of Medicare's requirement that a registered nurse be on-site at least eight hours every day. Over the final three months of 2018, 2,633 of the nation's 15,563 nursing homes reported that for four or more days, registered nurses worked fewer than eight hours, according to a Kaiser Health News analysis. Those facilities did not meet Medicare's requirement even after counting nurses whose jobs are primarily administrative.
CMS has been alarmed at the frequency of understaffing of registered nurses — the most highly trained category of nurses in a home — since the government last year began requiring homes to submit payroll records to verify staffing levels. Before that, Nursing Home Compare relied on two-week snapshots nursing homes reported to health inspectors when they visited — a method officials worried was too easy to manipulate. The records show staffing on weekends is often particularly anemic.
CMS' demotion of ratings on staffing is not as severe as it might seem, however. More than half of those homes were given a higher rating than one star for their overall assessment after CMS weighed inspection results and the facilities' own measurement of residents' health improvements.
That overall rating is the one that garners the most attention on Nursing Home Compare and that some hospitals use when recommending where discharged patients might go. Of the 1,638 demoted nursing homes, 277 were rated as average in overall quality (three stars), 175 received four stars, and 48 received the top rating of five stars.
Still, CMS' overall changes to how the government assigns stars drew protests from nursing home groups. The American Healthcare Association, a trade group for nursing homes,calculated that 36% of homes saw a drop in their ratings while 15% received improved ratings.
"By moving the scoring 'goal posts' for two components of the Five-Star system," the association wrote, "CMS will cause more than 30 percent of nursing centers nationwide to lose one or more stars overnight — even though nothing changed in staffing levels and in quality of care, which is still being practiced and delivered every day."
The association said in an email that the payroll records might exaggerate the absence of staff through unintentional omissions that homes make when submitting the data or because of problems on the government's end. The association said it had raised concerns that salaried nurses face obstacles in recording time they worked above 40 hours a week. Also, the association added, homes must deduct a half-hour for every eight-hour shift for a meal break, even if the nurse worked through it.
"Some of our member nursing homes have told us that their data is not showing up correctly on Nursing Home Compare, making it appear that they do not have the nurses and other staff that they in fact do have on duty," LeadingAge, an association of nonprofit medical providers including nursing homes, said last year.
Kaiser Health News has updated its interactive nursing home staffing tool with the latest data. You can use the tool to see the rating Medicare assigns to each facility for its registered nurse staffing and overall staffing levels. The tool also shows KHN-calculated ratios of patients to direct-care nurses and aides on the best- and worst-staffed days.