Tag: Health Industry

The Court Case That Could Upend Access To Free Birth Control

A lawsuit winding its way through the courts could undermine the power of federal agencies to mandate the services health insurance providers must cover. And that could threaten access to free birth control for millions of Americans.

The case is called Braidwood Management Inc. v. Becerra, and it was brought by plaintiffs looking to strike down Obamacare’s requirements that private insurers cover certain kinds of preventive care without cost sharing. (Think everything from no-cost cancer screenings to free IUDs.)

Studies have shown the requirements to cover preventive care have increased consumers’ use of short- and long-term birth control methods.

Without those nationwide standards, the United States would return to a “wild West” dynamic “in which insurers and employers pick and choose which services they want to cover or which services they want to charge for,” said Zachary Baron, a health policy researcher at Georgetown Law.

The plaintiffs, a group of individuals and Christian-owned businesses, argue the three groups that set coverage standards — including an independent advisory panel to the Health Resources and Services Administration — haven’t been properly appointed by Congress.

In June, the U.S. Court of Appeals for the 5th Circuit issued a self-described “mixed bag” of an opinion. It agreed that one body hadn’t been properly appointed, making its recommendations since the Affordable Care Act became law unconstitutional. But the court said only the plaintiffs get to ignore its standards.

The appeals court sent questions about the other two groups — including the advisory panel to HRSA that makes recommendations on contraception — back to a lower court to consider.

The case is likely headed back to U.S. District Judge Reed O’Connor. O’Connor’s previous ruling that one body hadn’t been properly appointed was supported by the appeals court. His remedy — blocking its mandates nationwide — wasn’t.

O’Connor is notoriously hostile to the ACA — he struck down the law in 2018. The Supreme Court later overturned that ruling.

And that makes reproductive rights advocates nervous.

O’Connor “is someone who is willing to impose remedies where he takes access to care away from everybody in the country,” said Gretchen Borchelt, vice president of reproductive rights and health at the National Women’s Law Center.

A lack of federal requirements for birth control coverage would leave it up to the states to mandate what insurers have to provide. Fourteen states and D.C. currently protect the right to contraception.

But states can go only so far with those rules, because of a federal law that prevents them from regulating employer-funded health plans, which cover about 65 percent of workers.

“If the plaintiffs win here, it would leave significant gaps in coverage that states would be unable to fill,” Baron said.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

How to Find a Good, Well-Staffed Nursing Home

Few people want to go into a nursing home, but doing so can be the right choice if you or a loved one is physically or cognitively disabled or recovering from surgery. Unfortunately, homes vary greatly in quality, and many don’t have enough nurses and aides to give residents the care they need.

Q: How do I find nursing homes worth considering?

Start with Medicare’s online comparison tool, which you can search by city, state, ZIP code, or home name. Ask for advice from people designated by your state to help people who are older or have disabilities search for a nursing home. Every state has a “no wrong door” contact for such inquiries.

You can also reach out to your local area agency on aging, a public or nonprofit resource, and your local long-term care ombudsman, who helps residents resolve problems with their nursing home.

Find your area agency on aging and ombudsman through the federal government’s Eldercare Locator website or by calling 1-800-677-1116. Identify your ombudsman through the National Consumer Voice for Quality Long-Term Care, an advocacy group. Some people use private placement agencies, but they may refer you only to homes that pay them a referral fee.

Q: What should I find out before visiting a home?

Search online for news coverage and for reviews posted by residents or their families.

Call the home to make sure beds are available. Well-regarded homes can have long waiting lists.

Figure out how you will pay for your stay. Most nursing home residents rely primarily on private long-term care insurance, Medicare (for rehabilitation stays) or Medicaid (for long-term stays if you have few assets). In some cases, the resident pays entirely out-of-pocket. If you’re likely to run out of money or insurance coverage during your stay, make sure the home accepts Medicaid. Some won’t admit Medicaid enrollees unless they start out paying for the care themselves.

If the person needing care has dementia, make sure the home has a locked memory-care unit to ensure residents don’t wander off.

Q: How can I tell if a home has adequate staffing?

Medicare’s comparison tool gives each home a rating of one to five stars based on staffing, health inspection results, and measurements of resident care such as how many residents had pressure sores that worsened during their stay. Five is the highest rating. Below that overall rating is one specifically for staffing.

Be sure to study the annual staff turnover rate, at the bottom of the staffing page. Anything higher than the national rate — an appalling 52% — should give you pause.

You should also pay attention to the inspection star rating. The “quality” star rating is less reliable because homes self-report many of the results and have incentives to put a glossy spin on their performance.

Q: Does a home with three, four, or five stars provide good care?

Not necessarily. Medicare’s ratings compare the staffing of a home against that of other homes, not against an independent standard. The industry isn’t as well staffed as many experts think it needs to be: About 80% of homes, even some with four and five stars, are staffed below the standards the Biden administration will be requiring homes to meet in the next five years.

Q: How many workers are enough?

There’s no straightforward answer; it depends on how frail and sick a nursing home’s residents are. Medicare requires homes to prominently post their staffing each day. The notices should show the number of residents, registered nurses, licensed vocational nurses, and nurse aides. RNs are the most skilled and manage the care. LVNs provide care for wounds and catheters and handle basic medical tasks. Nurse aides help residents eat, dress, and get to the bathroom.

Expert opinions vary on the ideal ratios of staffing. Sherry Perry, a Tennessee nursing assistant who is the chair of her profession’s national association, said that preferably a nursing assistant should care for eight or fewer residents.

Charlene Harrington, an emerita professor of nursing at the University of California-San Francisco, recommends that on the day shift there be one nurse aide for every seven residents who need help with physical functioning or have behavioral issues; one RN for every 28 residents; and one LVN for every 38 residents. Patients with complex medical needs will need higher staffing levels.

Staffing can be lower at night because most residents are sleeping, Harrington said.

Nursing home industry officials say that there’s no one-size-fits-all ratio and that a study the federal government published last year found quality improved with higher staffing but didn’t recommend a particular level.

Q: What should I look for when I visit a home?

Watch to see if residents are engaged in activities or if they are alone in their rooms or slumped over in wheelchairs in hallways. Are they still in sleeping gowns during the day? Do nurses and aides know the residents by name? Is food available only at mealtimes, or can residents get snacks when hungry? Watch a meal to see whether people are getting the help they need. You might visit at night or on weekends or holidays, when staffing is thinnest.

Q: What should I ask residents and families in the home?

Are residents cared for by the same people or by a rotating cast of strangers? How long do they have to wait for help bathing or getting out of bed? Do they get their medications, physical therapy, and meals on time? Do aides come quickly if they turn on their call light? Delays are strong signs of understaffing.

Medicare requires homes to allow residents and families to form councils to address common issues. If there’s a council, ask to speak to its president or an officer.

Ask what proportion of nurses and aides is on staff or from temporary staffing agencies; temp workers won’t know the residents’ needs and likes as well. A home that relies heavily on temporary staff most likely has trouble recruiting and keeping employees.

Q: What do I need to know about a home’s leadership?

Turnover at the top is a sign of trouble. Ask how long the home’s administrator has been on the job; ideally it should be at least a year. (You can look up administrator turnover on the Medicare comparison tool: It’s on the staffing page beneath staff turnover. But be aware the information may not be up to date.) You should also ask about the tenure of the director of nursing, the top clinical supervisor in a home.

During your tour, observe how admissions staff members treat the person who would be living there. “If you walk in to visit with your mom and they greeted you and didn’t greet your mom or focused all their attention on you, go somewhere else,” advised Carol Silver Elliott, president of the Jewish Home Family, a nonprofit in Rockleigh, New Jersey.

Q: Does it matter who owns the home?

It often does. Generally, nonprofit nursing homes provide better care because they can reinvest revenue back into the home rather than paying some of it to owners and investors.

But there are some very good for-profit homes and some lousy nonprofits. Since most homes in this country are for-profit, you may not have a choice in your area. As a rule of thumb, the more local and present the owner, the more likely the home will be well run. Many owners live out of state and hide behind corporate shell companies to insulate themselves from accountability. If nursing home representatives can’t give you a clear answer when you ask who owns it, think twice.

Finally, ask if the home’s ownership has changed in the past year or so or if a sale is pending. Stable, well-run nursing homes aren’t usually the ones owners are trying to get rid of.

States Set Minimum Staffing Levels for Nursing Homes. Residents Suffer When Rules Are Ignored or Waived.

For hours, John Pernorio repeatedly mashed the call button at his bedside in the Heritage Hills nursing home in Rhode Island. A retired truck driver, he had injured his spine in a fall on the job decades earlier and could no longer walk. The antibiotics he was taking made him need to go to the bathroom frequently. But he could get there only if someone helped him into his wheelchair.

By the time an aide finally responded, he’d been lying in soiled briefs for hours, he said. It happened time and again.

“It was degrading,” said Pernorio, 79. “I spent 21 hours a day in bed.”

Payroll records show that during his stay at Heritage Hills, daily aide staffing levels were 25% below the minimums under state law. The nursing home said it provided high-quality care to all residents. Regardless, it wasn’t in trouble with the state, because Rhode Island does not enforce its staffing rule.

An acute shortage of nurses and aides in the nation’s nearly 15,000 nursing homes is at the root of many of the most disturbing shortfalls in care for the 1.2 million Americans who live in them, including many of the nation’s frailest old people.

They get festering bedsores because they aren’t turned. They lie in feces because no one comes to attend to them. They have devastating falls because no one helps them get around. They are subjected to chemical and physical restraints to sedate and pacify them.

California, Florida, Massachusetts, New York, and Rhode Island have sought to improve nursing home quality by mandating the highest minimum hours of care per resident among states. But an examination of records in those states revealed that putting a law on the books was no guarantee of better staffing. Instead, many nursing homes operated with fewer workers than required, often with the permission of regulators or with no consequences at all.

“Just setting a number doesn’t mean anything if you’re not going to enforce it,” said Mark Miller, former president of the national organization of long-term care ombudsmen, advocates in each state who help residents resolve problems in their nursing homes. “What’s the point?”

Now the Biden administration is trying to guarantee adequate staffing the same way states have, unsuccessfully, for years: with tougher standards. Federal rules issued in April are expected to require 4 out of 5 homes to boost staffing.

The administration’s plan also has some of the same weaknesses that have hampered states. It relies on underfunded health inspectors for enforcement, lacks explicit penalties for violations, and offers broad exemptions for nursing homes in areas with labor shortages. And the administration isn’t providing more money for homes that can’t afford additional employees.

Serious health violations have become more widespread since covid-19 swept through nursing homes, killing more than 170,000 residents and driving employees out the door.

A man with gray hair and black-rimmed glasses poses for a portrait, sitting in a chair in front of a piano
Jason Travers says his 87-year-old father, George, who lived in a Rhode Island nursing home, fell on the way to the bathroom because no one answered his call button.(Josephine Sittenfeld for KFF Health News)

Pay remains so low — nursing assistants earn $19 an hour on average — that homes frequently lose workers to retail stores and fast-food restaurants that pay as well or better and offer jobs that are far less grueling. Average turnover in nursing homes is extraordinarily high: Federal records show half of employees leave their jobs each year.

Even the most passionate nurses and aides are burning out in short-staffed homes because they are stretched too thin to provide the quality care they believe residents deserve. “It was impossible,” said Shirley Lomba, a medication aide from Providence, Rhode Island. She left her job at a nursing home that paid $18.50 an hour for one at an assisted living facility that paid $4 more per hour and involved residents with fewer needs.

The mostly for-profit nursing home industry argues that staffing problems stem from low rates of reimbursement by Medicaid, the program funded by states and the federal government that covers most people in nursing homes. Yet a growing body of research and court evidence shows that owners and investors often extract hefty profits that could be used for care.

Nursing home trade groups have complained about the tougher state standards and have sued to block the new federal standards, which they say are unworkable given how much trouble nursing homes already have filling jobs. “It’s a really tough business right now,” said Mark Parkinson, president and chief executive of one trade group, the American Health Care Association.

And federal enforcement of those rules is still years off. Nursing homes have as long as five years to comply with the new regulations; for some, that means enforcement would fully kick in only at the tail end of a second Biden administration, if the president wins reelection. Former President Donald Trump’s campaign declined to comment on what Trump would do if elected.

A man holds a photo of and older man with white hair wearing a collared shirt looking straight at the camera
“I think the lunch crew finally came in and saw him on the floor and put him in the bed,” Travers says. His father died in April 2023, four months after he entered the home. (Josephine Sittenfeld for KFF Health News)

Persistent Shortages

Nursing home payroll records submitted to the federal government for the most recent quarter available, October to December 2023, and state regulatory records show that homes in states with tougher standards frequently did not meet them.

In more than two-thirds of nursing homes in New York and more than half of those in Massachusetts, staffing was below the state’s required minimums. Even California, which passed the nation’s first minimum staffing law two decades ago, has not achieved universal compliance with its requirements: at least 3½ hours of care for the average resident each day, including two hours and 24 minutes of care from nursing assistants, who help residents eat and get to the bathroom.

During inspections since 2021, state regulators cited a third of California homes — more than 400 of them — for inadequate staffing. Regulators also granted waivers to 236 homes that said workforce shortages prevented them from recruiting enough nurse aides to meet the state minimum, exempting them from fines as high as $50,000.

In New York, Gov. Kathy Hochul declared an acute labor shortage, which allows homes to petition for reduced or waived fines. The state health department said it had cited more than 400 of the state’s 600-odd homes for understaffing but declined to say how many of them had appealed for leniency.

In Florida, Gov. Ron DeSantis signed legislation in 2022 to loosen the staffing rules for all homes. The law allows homes to count almost any employee who engages with residents, instead of just nurses and aides, toward their overall staffing. Florida also reduced the daily minimum of nurse aide time for each resident by 30 minutes, to two hours.

Now only 1 in 20 Florida nursing homes are staffed below the minimum — but if the former, more rigorous rules were still in place, 4 in 5 homes would not meet them, an analysis of payroll records shows.

“Staffing is the most important part of providing high-quality nursing home care,” said David Stevenson, chair of the health policy department at Vanderbilt University School of Medicine. “It comes down to political will to enforce staffing.”

A blue awning covers the entrance to Linn Health & Rehabilitation in East Providence, Rhode Island
Linn Health & Rehabilitation, a well-regarded nonprofit nursing home in East Providence, Rhode Island, closed this summer because its Medicaid payments did not cover its costs. It has been converted into an assisted living facility.(Josephine Sittenfeld for KFF Health News)

The Human Toll

There is a yawning gap between law and practice in Rhode Island. In the last three months of 2023, only 12 of 74 homes met the state’s minimum of three hours and 49 minutes of care per resident, including at least two hours and 36 minutes of care from certified nursing assistants, payroll records show. One of the homes below the minimum was Heritage Hills Rehabilitation & Healthcare Center in Smithfield, where Pernorio, president of the Rhode Island Alliance for Retired Americans, went last October after a stint in a hospital.

“From the minute the ambulance took me in there, it was downhill,” he said in an interview.

Sometimes, after waiting an hour, he would telephone the home’s main office for help. A nurse would come, turn off his call light, and walk right back out, and he would push the button again, Pernorio reported in his weekly e-newsletter.

While he praised some workers’ dedication, he said others frequently did not show up for their shifts. He said staff members told him they could earn more flipping hamburgers at McDonald’s than they could cleaning soiled patients in a nursing home.

In a written statement, Heritage Hills did not dispute that its staffing, while higher than that of many homes, was below the minimum under state law.

Heritage Hills said that after Pernorio complained, state inspectors visited the home and did not cite it for violations. “We take every resident concern seriously,” it said in the statement. Pernorio said inspectors never interviewed him after he called in his complaint.

In interviews, residents of other nursing homes in the state and their relatives reported neglect by overwhelmed nurses and aides.

Jason Travers said his 87-year-old father, George, fell on the way to the bathroom because no one answered his call button.

“I think the lunch crew finally came in and saw him on the floor and put him in the bed,” Travers said. His father died in April 2023, four months after he entered the home.

Two women, both with dark hair, sit straight-faced on a red plaid couch, and one holds a stuffed animal dog
Lori DiBiasio (right) found her mother, Mary, who had a hip fracture, sitting on the toilet unattended at her nursing home, hanging onto the grab bar. Mary’s granddaughter Keri Rossi-D’entremont (left) was her health care power of attorney.(Josephine Sittenfeld for KFF Health News)

Relatives of Mary DiBiasio, 92, who had a hip fracture, said they once found her sitting on the toilet unattended, hanging on to the grab bar with both hands. “I don’t need to be a medical professional to know you don’t leave somebody hanging off the toilet with a hip fracture,” said her granddaughter Keri Rossi-D’entremont.

When DiBiasio died in January 2022, Rhode Island was preparing to enact a law with nurse and aide staffing requirements higher than anywhere else in the country except Washington, D.C. But Gov. Daniel McKee suspended enforcement, saying the industry was in poor financial shape and nursing homes couldn’t even fill existing jobs. The governor’s executive order noted that several homes had closed because of problems finding workers.

Yet Rhode Island inspectors continue to find serious problems with care. Since January 2023, regulators have found deficiencies of the highest severity, known as immediate jeopardy, at 23 of the state’s 74 nursing homes.

A woman with gold-painted nails holds a photo of a young woman and older woman together at a restaurant
“I don’t need to be a medical professional to know you don’t leave somebody hanging off the toilet with a hip fracture,” Rossi-D’entremont says.(Josephine Sittenfeld for KFF Health News)

Homes have been cited for failing to get a dialysis patient to treatment and for giving one resident a roommate’s methadone, causing an overdose. They have also been cited for violent behavior by unsupervised residents, including one who shoved pillow stuffing into a resident’s mouth and another who turned a roommate’s oxygen off because it was too noisy. Both the resident who was attacked and the one who lost oxygen died.

Bottom Lines

Even some of the nonprofit nursing homes, which don’t have to pay investors, are having trouble meeting the state minimums — or simply staying open.

Rick Gamache, chief executive of the nonprofit Aldersbridge Communities, which owns Linn Health & Rehabilitation in East Providence, said Rhode Island’s Medicaid program paid too little for the home to keep operating — about $292 per bed, when the daily cost was $411. Aldersbridge closed Linn this summer and converted it into an assisted living facility.

“We’re seeing the collapse of post-acute care in America,” Gamache said.

A woman holding a walker smiles at a man in a suit jacket as they stand in a residential room of a nursing home
Rick Gamache, chief executive of the nonprofit that owned Linn Health & Rehabilitation, visits with a resident, Elsie Linde, when the nursing home was still in operation. (Josephine Sittenfeld for KFF Health News)

Many nursing homes are owned by for-profit chains, and some researchers, lawyers, and state authorities argue that they could reinvest more of the money they make into their facilities.

Bannister Center, a Providence nursing home that payroll records show is staffed 10% below the state minimum, is part of Centers Health Care, a New York-based private chain that owns or operates 31 skilled nursing homes, according to Medicare records. Bannister lost $430,524 in 2021, according to a financial statement it filed with Rhode Island regulators.

Last year, the New York attorney general sued the chain’s owners and investors and their relatives, accusing them of improperly siphoning $83 million in Medicaid funds out of their New York nursing homes by paying salaries for “no-show” jobs, profits above what state law allowed, and inflated rents and fees to other companies they owned. For instance, one of those companies, which purported to provide staff to the homes, paid $5 million to the wife of Kenny Rozenberg, the chain’s chief executive, from 2019 to 2021, the lawsuit said.

The defendants argued in court papers that the payments to investors and owners were legal and that the state could not prove they were Medicaid funds. They have asked for much of the lawsuit to be dismissed.

Jeff Jacomowitz, a Centers Health Care spokesperson, declined to answer questions about Bannister, Centers’ operations, or the chain’s owners.

Miller, the District of Columbia’s long-term care ombudsman, said many nursing home owners could pay better wages if they didn’t demand such high profits. In D.C., 7 in 10 nursing homes meet minimum standards, payroll records show.

“There’s no staffing shortage — there’s a shortage of good-paying jobs,” he said. “I’ve been doing this since 1984 and they’ve been going broke all the time. If it really is that bad of an investment, there wouldn’t be any nursing homes left.”

The new federal rules call for a minimum of three hours and 29 minutes of care each day per resident, including two hours and 27 minutes from nurse aides and 33 minutes from registered nurses, and an RN on-site at all times.

Homes in areas with worker shortages can apply to be exempted from the rules. Dora Hughes, acting chief medical officer for the U.S. Centers for Medicare & Medicaid Services, said in a statement that those waivers would be “time-limited” and that having a clear national staffing minimum “will facilitate strengthened oversight and enforcement.”

David Grabowski, a health policy professor at Harvard Medical School, said federal health authorities have a “terrible” track record of policing nursing homes. “If they don’t enforce this,” he said, “I don’t imagine it’s going to really move the needle a lot.”

A hallway of a nursing home with family pictures on the wall and bright windows at the end of the hallway
Only 12 of Linn Health & Rehabilitation’s 47 residents could stay after it became an assisted living facility. The other 35 had to move to other nursing homes.(Josephine Sittenfeld for KFF Health News)

Methodology for Analysis of Nursing Home Staffing

The KFF Health News data analysis focused on five states with the most rigorous staffing requirements: California, Florida, Massachusetts, New York, and Rhode Island.

To determine staffing levels, the analysis used the daily payroll journals that each nursing home is required to submit to the federal government. These publicly available records include the number of hours each category of nursing home employee, including registered nurses and certified nursing assistants, worked each day and the number of residents in each home. We used the most recent data, which included a combined 1.3 million records covering the final three months of 2023.

We calculated staffing levels by following each state’s rules, which specify which occupations are counted and what minimums homes must meet. The analysis differed for each state. Massachusetts, for instance, has a separate requirement for the minimum number of hours of care registered nurses must provide each day.

In California, we used state enforcement action records to identify homes that had been fined for not meeting its law. We also tallied how many California homes had been granted waivers from the law because they couldn’t find enough workers to hire.

For each state and Washington, D.C., we calculated what proportion of homes complied with state or district law. We shared our conclusions with each state’s nursing home regulatory agency and gave them an opportunity to respond.

This analysis was performed by senior correspondent Jordan Rau and data editor Holly K. Hacker.

When Hospital Cyberattacks Compromise Care, Not Just Data

When hospitals are hit by cyberattacks that compromise crucial technology systems for managing patient care, the stakes are staggering.

“We’ve started to think about these as public health issues and disasters on the scale of earthquakes or hurricanes,” said Jeff Tully, a co-director of the Center for Healthcare Cybersecurity at the University of California at San Diego.

Many hospitals are unprepared for long outages, cybersecurity experts say. And the federal government has offered little in the way of required protocols or standards to protect patient safety in attacks on the health sector, which have risen precipitously in recent years.

Long-held concerns about protecting patients’ sensitive health information have been overtaken by fears of harm to patients themselves. Kate Wells and I dug into one of the latest and biggest examples for the news organization Michigan Public and KFF Health News: the ransomware attack against Ascension that for weeks locked clinicians out of electronic health records, medication systems and other technology at one of the nation’s largest health systems.

The federal government requires hospitals to protect patient data, according to cybersecurity experts. Yet there are no requirements for hospitals to have basic cybersecurity protocols in place, which could include things like multifactor authentication, email controls and basic cybersecurity training for employees. The Biden administration, however, has indicated it will soon attempt to institute some mandatory measures.

When Denise Anderson, president of the Health Information Sharing and Analysis Center, began working in the health sector, federal officials were focused mostly on data privacy and the Health Insurance Portability and Accountability Act (HIPAA), the landmark 1996 patient privacy law.

“We weren’t pairing cybersecurity and health care in the same sentence,” said Anderson, whose organization works to protect the health sector from physical and cyberthreats.

Lawmakers have taken notice. “It is clear that HHS’ current approach to healthcare cybersecurity — self-regulation and voluntary best practices — is woefully inadequate and has left the health care system vulnerable to criminals and foreign government hackers,” Sen. Ron Wyden (D-Ore.) wrote in a June 5 letter to Health and Human Services Secretary Xavier Becerra.

Clinicians working for Ascension hospitals say the cyberattack led to harrowing lapses, including delayed or lost lab results, medication errors and an absence of routine safety checks via technology to prevent potentially fatal mistakes. More than a dozen doctors and nurses who work for the sprawling health system told Michigan Public and KFF Health News that patient care at its hospitals was compromised in the fallout of the cyberattack.

Ascension declined to answer questions about claims that care has been affected by the ransomware attack. “We are confident that our care providers in our hospitals and facilities continue to provide quality medical care,” Sean Fitzpatrick, Ascension’s vice president of external communications, said last month.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA

In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

“It changed the face of cardiac medicine,” Oz said in a video.

But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

In a YouTube video posted by the Columbia University Department of Surgery several years ago, Mehmet Oz discussed the origins of MitraClip and, using a model of the heart, explained how the device is used to treat leaky mitral valves. The process involves essentially stapling the mitral valve so it works more effectively, he said. MitraClip yielded “massive improvements” in a group of people with heart failure, he said.(Screengrab of a Columbia University Department of Surgery video)

Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

In other words: They were expected.

Inspiration in Italy

When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

An image excerpted from an FDA document of the MitraClip system.
A 2019 FDA document included an illustration of the MitraClip system and explained how it works. The system, which has undergone a series of changes since it was introduced, includes a clip that is implanted into the heart’s mitral valve and equipment used to insert the clip. The document presented data on MitraClip’s safety and effectiveness and listed dozens of potential adverse effects.(Photo illustration of 2019 FDA document)

Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

“I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

Endorsed ‘With Trepidation’

Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

Selzman voted yes on the last question “with trepidation,” he said at the time.

In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

An extract from an FDA document showing the MitraClip's clip.
An image from the 2019 FDA document showing a clip implanted to hold flaps of the heart’s mitral valve together. MitraClip is deployed via a catheter threaded through a major blood vessel.(Photo illustration of 2019 FDA document)

“The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

“At least you’re trying to do something for them,” he said.

Conflicting Studies

In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

A photo of a sign with Abbott's logo outside of its headquarters.
Abbott Laboratories is headquartered in Abbott Park, Illinois.(Christopher Dilts/Bloomberg via Getty Images)

A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

“There are some people who say, ‘Oh, well, you know, these results may have been manipulated,’” he said. “But I can guarantee you that’s not the truth.”

‘Nationwide Scheme’

A still from an animation of the MitraClip in action.
A video posted on YouTube by Abbott illustrates the workings of the heart’s mitral valve and two types of mitral regurgitation, primary and secondary. It shows how, in a MitraClip procedure, a clip is implanted through what the company describes as “a minimally invasive transcatheter procedure.” In the video, a clip is inserted into the heart and affixed to flaps of the mitral valve.(Screengrab of an Abbott video)

A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

Reports to the FDA

As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.(Sarah Silbiger/Getty Images)

As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

MitraClip’s risks weren’t a surprise.

Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

“These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

KFF Health News audience engagement producer Tarena Lofton contributed to this report.

Falsa terapeuta engañó a cientos de pacientes en Internet, y solo se supo porque murió

Cientos de estadounidenses pueden haber recibido terapia, sin saberlo, de una impostora sin formación que se hizo pasar por terapeuta en sesiones por internet, posiblemente durante dos años. El engaño sólo se descubrió cuando murió, según registros de departamentos de salud estatales.

Peggy A. Randolph, trabajadora social con licencia en Florida y Tennessee, quien trabajaba para Brightside Health, una empresa nacional de terapia en línea, está acusada de ayudar a su esposa a hacerse pasar por ella en sesiones de internet, según el informe de una investigación del Departamento de Salud de Florida.

El informe de Florida indica que la pareja “estafaba” a los pacientes mediante un “esfuerzo coordinado”: mientras Randolph trataba a pacientes en persona, su esposa se hacía pasar por ella en sesiones de telesalud con pacientes de Brightside. El engaño se descubrió después que la esposa impostora muriera el año pasado, y un paciente se diera cuenta de que había estado hablando con la persona equivocada, según un acuerdo de conciliación del Departamento de Salud de Tennessee.

Los registros de ambos estados identifican a la esposa de Randolph sólo por sus iniciales, T.R., pero su nombre completo figura en su obituario: Tammy G. Heath-Randolph. Tradicionalmente, se espera que los terapeutas tengan al menos una maestría, pero la esposa de Randolph “no tenía licencia ni formación para prestar ningún tipo de servicios de consejería”, según revela el acuerdo de Tennessee.

Según consta en el acuerdo: “[Randolph] niega saber que T.R. estuviera utilizando sus credenciales de acceso al portal de terapeutas de Brightside Health o tratando a clientes con su cuenta. Sin embargo, [ella] recibió compensación por las sesiones realizadas”.

La presunta artimaña no había sido denunciada anteriormente y sus detalles y alcance salieron a la luz recientemente en las páginas de unos documentos públicos divulgadas por los agencias estatales.

El acuerdo de Tennessee, publicado en mayo, indica que Randolph debió haber proporcionado terapia en línea a “cientos de clientes” mientras trabajaba para Brightside Health desde enero de 2021 hasta febrero de 2023. Sin embargo, una investigación interna de Brightside descubrió que en realidad era Heath-Randolph quien “veía a todos los pacientes y lo estuvo haciendo durante mucho tiempo”, según el informe de la investigación de Florida.

Randolph declinó hacer comentarios.

Los registros de Florida y Tennessee dicen que Randolph renunció voluntariamente a sus licencias de trabajadora social en ambos estados. Esto dio lugar a que los departamentos de salud abandonaran sus investigaciones, lo que limitó los detalles del caso y los documentos disponibles en el registro público.

El informe de la investigación interna de Brightside no se ha divulgado.

Brightside Health, una empresa de San Francisco que ofrece sesiones de psiquiatría y terapia en línea en todo el país, declinó hacer ningún tipo de declaración por medio de una entrevista.

La vocera de la empresa, Hannah Changi, dijo en un correo electrónico que en cuanto Brightside se enteró de las acusaciones, hizo una auditoría de su seguridad, despidió a Randolph y la denunció ante las autoridades estatales que concede las licencias. Changi señaló que Brightside no puede decir cuántos pacientes fueron atendidos por la esposa de Randolph “debido a la naturaleza del incidente y los procedimientos legales en curso”, pero aseguró que la compañía notificó y reembolsó a todos los “pacientes potencialmente afectados”.

“Nos tomamos muy en serio la experiencia de nuestros pacientes y tenemos un elevado código ético de conducta”, dijo Changi. “Nos decepciona profundamente que uno de nuestros proveedores haya traicionado la confianza que Brightside y, más importante, sus pacientes habían depositado en ella”.

Además, Brightside se vio obligada a alertar al Departamento de Salud y Servicios Humanos de Estados Unidos, que investiga la filtración de datos que exponen información médica privada. En esta filtración, un “individuo no autorizado” accedió a la información de 767 personas, incluidos números de seguro social y diagnósticos, según la base de datos en línea de la agencia.

Ni las autoridades de salud de Florida ni las de Tennessee respondieron a las preguntas sobre el caso.

Dean Flener, vocero del Departamento de Salud de Tennessee, dijo que los detalles del caso de Randolph siguen siendo confidenciales en virtud de la ley estatal.

Jae Williams, vocero del Departamento de Salud de Florida, señaló que no se llevó a cabo una investigación completa porque Randolph renunció a su licencia, lo que tiene el mismo efecto que la revocación por parte del estado, pero le permitió conservar “la dignidad que le quedaba”.

Two Rival Hospitals Want To Join Forces. Will Patients Lose?

In Terre Haute, Ind., two rival hospitals want to merge, a move that supporters say will save patients money and help people live longer.

But similar hospital consolidations in Tennessee, Virginia and North Carolina have resulted in government reports documenting diminished care.

In more than a dozen states, certificates of public advantage (COPAs) permit deals like the one on the table in Indiana, even though the Federal Trade Commission otherwise considers them illegal because they reduce competition. As a result, the FTC has warned states to avoid COPAs and the mergers they create.

In Terre Haute, state regulators will decide whether to allow Union Hospital to purchase the surrounding county’s only other acute care facility, Terre Haute Regional Hospital. The merger would be the first deal under the state’s 2021 COPA law. Aside from the FTC’s concerns about the anti-competitive nature of these deals, there’s another, potentially bigger question: Does allowing hospitals to combine forces improve patient care?

The largest COPA-created hospital system in the country, Tennessee-based Ballad Health, has reported that the time patients spend in its ERs in Virginia and Tennessee before being hospitalized has more than tripled, reaching nearly 11 hours, in the six years since that monopoly of 20 hospitals formed.

The FTC has been closely examining the effects mergers have on prices, quality and even employee wages. In 2019, the FTC ordered multiple insurers and COPA-created health systems, including Ballad, to turn over information. The FTC declined to provide an update on the status of its findings.

To mitigate the negative effects of a monopoly, merged hospitals typically agree to conditions imposed by state regulators. Still, Tennessee has awarded Ballad top marks even when certain quality metrics, including its ER speed, fall below its established benchmarks.

Ballad Health spokesperson Molly Luton said the system’s performance has improved since statistics were collected for its 2023 fiscal year, which ended June 30, 2023, and that ER wait times have shortened.

COPA arrangements have also led to fallout in nearby North Carolina. When the state repealed its 2015 COPA law, it removed state oversight of Asheville’s Mission Health system, which was required as part of the merger. That meant the local monopoly remained but none of the COPA’s conditions applied when a subsidiary of HCA Healthcare bought the system for $1.5 billion in 2019.

Last year, government inspectors found “deficiencies” at Mission Health that contributed to four patient deaths and posed an “immediate jeopardy” to patients’ health and safety, according to the 384-page federal inspection report.

North Carolina Attorney General Joshua Stein sued HCA’s subsidiary, alleging that the ER was “significantly degraded” and that the company did not maintain certain critical services, including oncology care, a violation of a purchase agreement Stein’s office negotiated because the company acquired a nonprofit.

HCA said it promptly addressed the issues found in the inspections and denied Stein’s allegations in its response to the ongoing lawsuit, arguing that it has expanded services. HCA also contended the agreement is silent about maintaining the quality of care.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

Lack of Affordability Tops Older Americans’ List of Health Care Worries

What weighs most heavily on older adults’ minds when it comes to health care?

The cost of services and therapies, and their ability to pay.

“It’s on our minds a whole lot because of our age and because everything keeps getting more expensive,” said Connie Colyer, 68, of Pleasureville, Kentucky. She’s a retired forklift operator who has lung disease and high blood pressure. Her husband, James, 70, drives a dump truck and has a potentially dangerous irregular heart rhythm.

Tens of millions of seniors are similarly anxious about being able to afford health care because of its expense and rising costs for housing, food, and other essentials.

A new wave of research highlights the reach of these anxieties. When the University of Michigan’s National Poll on Healthy Aging asked people 50 and older about 26 health-related issues, their top three areas of concern had to do with costs: of medical care in general, of long-term care, and of prescription drugs. More than half of 3,300 people surveyed in February and March reported being “very concerned” about these issues.

In fact, five of the top 10 issues identified as very concerning were cost-related. Beyond the top three, people cited the cost of health insurance and Medicare (52%), and the cost of dental care (45%). Financial scams and fraud came in fourth place (53% very concerned). Of much less concern were issues that receive considerable attention, including social isolation, obesity, and age discrimination.

In an election year, “our poll sends a very clear message that older adults are worried about the cost of health care and will be looking to candidates to discuss what they have done or plan to do to contain those costs,” said John Ayanian, director of the University of Michigan’s Institute for Healthcare Policy and Innovation.

Older adults have good reason to worry. One in 10 seniors (about 6 million people) have incomes below the federal poverty level. About 1 in 4 rely exclusively on Social Security payments, which average $1,913 a month per person.

Even though inflation has moderated since its 2022 peak, prices haven’t come down, putting a strain on seniors living on fixed incomes.

Meanwhile, traditional Medicare doesn’t cover several services that millions of older adults need, such as dental care, vision care, or help at home from aides. While private Medicare Advantage plans offer some coverage for these services, benefits are frequently limited.

All of this contributes to a health care affordability squeeze for older adults. Recently published research from the Commonwealth Fund’s 2023 Health Care Affordability Survey found that nearly a third of people 65 or older reported difficulty paying for health care expenses, including premiums for Medicare, medications, and expenses associated with receiving medical services.

One in 7 older adults reported spending a quarter or more of their average monthly budget on health care; 44% spent between 10% and 24%. Seventeen percent said they or a family member had forgone needed care in the past year for financial reasons.

The Colyers in Pleasureville are among them. Both need new dentures and eyeglasses, but they can’t afford to pay thousands of dollars out-of-pocket, Connie said.

“As the cost of living rises for basic necessities, it’s more difficult for lower-income and middle-income Medicare beneficiaries to afford the health care they need,” said Gretchen Jacobson, vice president of the Medicare program at the Commonwealth Fund. Similarly, “when health care costs rise, it’s more difficult to afford basic necessities.”

This is especially worrisome because older adults are more prone to illness and disability than younger adults, resulting in a greater need for care and higher expenses. In 2022, seniors on Medicare spent $7,000 on medical services, compared with $4,900 for people without Medicare.

Not included in this figure is the cost of assisted living or long-term stays in nursing homes, which Medicare also doesn’t cover. According to Genworth’s latest survey, the median annual cost of a semiprivate room in a nursing home was $104,000 in 2023, while assisted living came to $64,200, and a week’s worth of services from home-health aides averaged $75,500.

Many older adults simply can’t afford to pay for these long-term care options or other major medical expenses out-of-pocket.

“Seventeen million older adults have incomes below 200% of the federal poverty level,” said Tricia Neuman, executive director of the Program on Medicare Policy for KFF. (That’s $30,120 for a single-person household in 2024; $40,880 for a two-person household.) “For people living on that income, the risk of a major expense is very scary.”

How to deal with unanticipated expenses in the future is a question that haunts Connie Colyer. Her monthly premiums for Medicare Parts B and D, and a Medigap supplemental policy come to nearly $468, or 42% of her $1,121 monthly income from Social Security.

With a home mortgage of $523 a month, and more than $150 in monthly copayments for her inhalers and her husband’s heart medications, “we wouldn’t make it if my husband wasn’t still working,” she told me. (James’ monthly Social Security payment is $1,378. His premiums are similar to Connie’s and his income fluctuates based on the weather. In the first five months of this year, it approached $10,000, Connie told me.)

The couple makes too much to qualify for programs that help older adults afford Medicare out-of-pocket costs. As many as 6 million people are eligible but not enrolled in these Medicare Savings Programs. Those with very low incomes may also qualify for dual coverage by Medicaid and Medicare or other types of assistance with household costs, such as food stamps.

Older adults can check their eligibility for these and other programs by contacting their local Area Agency on Agency, State Health Insurance Assistance Program, or benefits enrollment center. Enter your ZIP code at the Eldercare Locator and these and other organizations helping seniors locally will come up.

Persuading older adults to step forward and ask for help often isn’t easy. Angela Zeek, health and government benefits manager at Legal Aid of the Bluegrass in Kentucky, said many seniors in her area don’t want to be considered poor or unable to pay their bills, a blow to their pride. “What we try to say is, ‘You’ve worked hard all your life, you’ve paid your taxes. You’ve given back to this government so there’s nothing wrong with the government helping you out a bit.’”

And the unfortunate truth is there’s very little, if any, help available for seniors who aren’t poor but have modest financial resources. While the need for new dental, vision, and long-term care benefits for older adults is widely acknowledged, “the question is always how to pay for it,” said Neuman of KFF.

This will become an even bigger issue in the coming years because of the burgeoning aging population.

There is some relief on the horizon, however: Assistance with Medicare drug costs is available through the 2022 Inflation Reduction Act, although many older adults don’t realize it yet. The act allows Medicare to negotiate the price of prescription drugs for the first time. This year, out-of-pocket costs for medications will be limited to a maximum $3,800 for most beneficiaries. Next year, a $2,000 cap on out-of-pocket drug costs will take effect.

“We’re already seeing people who’ve had very high drug costs in the past save thousands of dollars this year,” said Frederic Riccardi, president of the Medicare Rights Center. “And next year, it’s going to get even better.”

El dolor ya no se puede medir en una escala de cero a 10

En los últimos dos años, una solicitud simple pero desconcertante ha precedido la mayoría de mis encuentros con profesionales médicos: “Califique su dolor en una escala del cero al 10”.

Me formé como médica y he hecho esta misma pregunta a los pacientes miles de veces, así que pienso mucho en cómo cuantificar la suma de caderas doloridas, muslos punzantes y el dolor adormecedor cerca de mi omóplato izquierdo. Hago una pausa y luego, generalmente de manera arbitraria, elijo un número. “¿Tres o cuatro?”, aventuro, sabiendo que la respuesta real es larga, complicada e imposible de medir de esta manera unidimensional.

El dolor es algo escurridizo. A veces es ardiente, a veces perforante, a veces oprime profundo en los músculos. El mío puede depender de mi estado de ánimo o de cuánto le preste atención, y puede “desaparecer” casi por completo si estoy concentrada en una película o tarea.

El dolor también puede ser lo suficientemente incapacitante como para cancelar vacaciones, o tan abrumador que vuelve a las personas adictas a los opioides. Incluso el dolor de 10+ puede ser soportable cuando se tolera por una buena razón, como dar a luz.

Pero, ¿cuál es el propósito de los dolores que tengo ahora, efectos persistentes de una lesión en la cabeza?

El concepto de reducir estos matices del dolor a un solo número data de la década de 1970. Pero hoy en día la escala del cero a 10 parece vetusta debido a lo que se llamó una “revolución del dolor” en los años 90, cuando la nueva forma de abordar el dolor —principalmente con opioides— se presentó como un progreso.

Los médicos de hoy tienen una comprensión más completa del tratamiento del dolor, así como de las terribles consecuencias de recetar opioides con liviandad. Lo que están aprendiendo ahora es cómo medir mejor el dolor y tratar sus muchas formas.

Hace unos 30 años, los médicos que defendían el uso de opioides dieron nueva vida a lo que había sido hasta el momento una especialidad marginal: la gestión del dolor. Comenzaron a promover la idea de que el dolor debería medirse en cada cita como un “quinto signo vital”. La Sociedad Americana del Dolor llegó a registrar la frase. Pero a diferencia de los otros signos vitales —presión arterial, temperatura, frecuencia cardíaca y frecuencia respiratoria— el dolor no tenía una escala objetiva.

¿Cómo medir lo inmensurable?

La sociedad alentó a los médicos y enfermeras a usar el sistema de calificación de cero a 10. Alrededor de esa época, la Administración de Drogas y Alimentos (FDA) aprobó OxyContin, un analgésico opioide de liberación lenta fabricado por Purdue Pharma.

El propio fabricante de medicamentos instó a los médicos a registrar y tratar el dolor de manera rutinaria, y promovió agresivamente los opioides como una solución obvia. Para ser justos, en una época en la que el dolor a menudo se ignoraba o se trataba de manera insuficiente, el sistema de calificación de cero a 10 podría considerarse un avance.

Las bombas de morfina no estaban disponibles para aquellos pacientes con cáncer que vi en los años 80, incluso aquellos con un dolor agonizante por cáncer en los huesos; los médicos consideraban el dolor como una parte inevitable de la enfermedad. En la sala de emergencias donde trabajé a principios de los 90, recetar incluso unas pocas píldoras de opioides era un inconveniente: requería pedirle a la enfermera jefe que desbloqueara un recetario especial y hacer una copia para la agencia estatal que rastreaba los patrones de prescripción.

Los reguladores (con razón) se preocupaban de que repartir narcóticos llevara a la adicción. Como resultado, algunos pacientes necesitados de alivio probablemente se quedaron sin él.

Después que los médicos del dolor y los fabricantes de opioides hicieran campaña para un uso más amplio de estas drogas — alegando que las formas más nuevas no eran adictivas, o mucho menos que las formulaciones anteriores — recetar los medicamentos se volvió mucho más fácil y se promovieron para todo tipo de dolor, ya sea una artritis de rodilla o problemas de espalda.

Como joven médica que se unía a la “revolución del dolor”, probablemente les pregunté a los pacientes miles de veces que calificaran su dolor en una escala de cero a 10 y escribí muchas recetas cada semana para medicamentos para el dolor, ya que monitorear “el quinto signo vital” se volvió rápidamente rutinario en el sistema médico.

Con el tiempo, la medición del dolor de cero a 10 se convirtió en caja necesaria para llenar en los registros médicos electrónicos. La Commission on the Accreditation of Healthcare Organizations hizo que evaluar el dolor regularmente fuera un requisito previo para que los centros médicos recibieran dólares federales de atención médica.

Los grupos médicos agregaron el tratamiento del dolor a su lista de derechos de los pacientes, y la satisfacción con el tratamiento del dolor se convirtió en un componente de las encuestas de pacientes posteriores a la cita médica. (Una mala calificación podría significar un menor reembolso por parte de algunos aseguradoras).

Pero este enfoque para la gestión del dolor tenía claros inconvenientes. Estudios revelaban que medir el dolor de los pacientes no resultaba en un mejor control del dolor. Los médicos mostraban poco interés en, o no sabían cómo responder a la respuesta registrada. Y que los pacientes estuvieran satisfechos con discutir su dolor con el médico no significaba necesariamente que recibieran un tratamiento adecuado.

Al mismo tiempo, los medicamentos estaban alimentando la creciente epidemia de opioides. La investigación mostró que se estimaba que entre el 3% y el 19% de las personas que recibían una receta de medicamentos para el dolor desarrollaban una adicción.

Sin embargo, los médicos que querían tratar el dolor tenían pocas otras opciones. “Teníamos un buen sentido de que estos medicamentos no eran la única forma de manejar el dolor”, me dijo Linda Porter, directora de la Oficina de Políticas y Planificación del Dolor de los Institutos Nacionales de Salud. “Pero no teníamos una buena comprensión de la complejidad o las alternativas”.

El entusiasmo por los narcóticos dejó muchas variedades de dolor sin explorar y sin tratar durante años.

Solo en 2018, un año en que casi 50,000 estadounidenses murieron por una sobredosis, el Congreso comenzó a financiar un programa —la Red de Investigación Clínica de la Fase Temprana del Dolor, o EPPIC-Net— diseñado para explorar tipos de dolor y encontrar mejores soluciones. La red conecta especialistas en 12 centros clínicos académicos especializados y está destinada a iniciar nuevas investigaciones en este campo y encontrar soluciones a medida para diferentes tipos de dolor.

Una escala de cero a 10 puede tener sentido en ciertas situaciones, como cuando una enfermera la usa para ajustar la dosis de medicación para un paciente hospitalizado después de una cirugía o un accidente. Y los investigadores y especialistas en dolor han intentado crear mejores herramientas de calificación — docenas, de hecho, ninguna de las cuales fue adecuada para capturar la complejidad del dolor, concluyó un panel de expertos europeos.

Por ejemplo, la Administración de Salud de Veteranos creó una que tenía preguntas adicionales e indicaciones visuales: una calificación de 5 se correlacionaba con un ceño fruncido y un nivel de dolor que “interrumpe algunas actividades”. La encuesta tardaba mucho más y producía resultados que no eran mejores que el sistema de cero a 10.

Para la década de 2010, muchas organizaciones médicas, incluida la Asociación Médica Estadounidense y la Academia Estadounidense de Médicos de Familia, estaban rechazando no solo la escala de cero a 10, sino toda la noción de que un paciente podía informar su dolor de manera numérica y significativa.

En los años en que los opioides habían dominado los remedios para el dolor, algunos medicamentos — como la gabapentina y la pregabalina para la neuropatía, y los parches y cremas de lidocaína para los dolores musculoesqueléticos — estaban disponibles.

“Había una creciente conciencia de la increíble complejidad del dolor, y de que tendrías que encontrar los medicamentos adecuados para los pacientes adecuados”, me dijo Rebecca Hommer, directora interina de EPPIC-Net.

Los investigadores ahora están buscando biomarcadores asociados con diferentes tipos de dolor para que los estudios de medicamentos puedan usar medidas más objetivas para evaluar sus efectos. Una mejor comprensión de las vías neurales y los neurotransmisores que crean diferentes tipos de dolor también podría ayudar a los investigadores a diseñar medicamentos para interrumpirlos y domesticarlos.

Es poco probable que cualquier tratamiento que surja de esta investigación sea un éxito de taquilla como los opioides; por diseño, serán útiles para menos personas. Eso también los hace prospectos menos atractivos para las compañías farmacéuticas.

Así que EPPIC-Net está ayudando a pequeños laboratorios, académicos e incluso a médicos individuales a diseñar y realizar ensayos en etapa temprana para probar la seguridad y eficacia de moléculas prometedoras para aliviar el dolor.

Esa información se entregará a las farmacéuticas para ensayos en etapa tardía, todo con el objetivo de obtener nuevos medicamentos aprobados por la FDA más rápidamente. Los primeros ensayos de EPPIC-Net están comenzando. Encontrar mejores tratamientos no será una tarea fácil, porque el sistema nervioso es un universo en gran parte inexplorado de moléculas, células y conexiones eléctricas.

El Premio Nobel de Fisiología o Medicina 2021 fue para los científicos que descubrieron los mecanismos que nos permiten sentir las sensaciones más básicas: el frío y el calor. En comparación, el dolor es una hidra, un monstruo de muchas cabezas. Un simple número puede parecer definitivo. Pero no ayuda a nadie a que el dolor desaparezca.

Fake Therapist Fooled Hundreds Online Until She Died, State Records Say

Hundreds of Americans may have unknowingly received therapy from an untrained impostor who masqueraded as an online therapist, possibly for as long as two years, and the deception crumbled only when she died, according to state health department records.

Peggy A. Randolph, a social worker who was licensed in Florida and Tennessee and formerly worked for Brightside Health, a nationwide online therapy company, is accused of helping her wife impersonate her in online sessions, according to an investigation report from the Florida Department of Health.

The Florida report says the couple “defrauded” patients through a “coordinated effort”: As Randolph treated patients in person, her wife pretended to be her in telehealth sessions with Brightside patients. The deceit was discovered after the wife died last year and a patient realized they’d been talking to the wrong person, according to a Tennessee Department of Health settlement agreement.

Records from both states identify Randolph’s wife only by her initials, T.R., but her full name is in her obituary: Tammy G. Heath-Randolph. Therapists are generally expected to have at least a master’s degree, but Randolph’s wife was “not licensed or trained to provide any sort of counseling services,” according to the Tennessee agreement.

“[Randolph] denies knowing that T.R. was using her Brightside Health Therapist Portal log-in credentials or treating clients under her account. However, [she] received compensation for the sessions conducted,” the agreement states.

The alleged ruse has not been previously reported and its details and scope were only recently glimpsed in a few pages of public documents released by the state agencies. The Tennessee settlement, released in May, states that Randolph was supposed to provide online therapy to “hundreds of clients” while working for Brightside Health from January 2021 to February 2023. However, a Brightside internal investigation found it was actually Heath-Randolph who was “seeing all her patients and had been for a long time,” according to the Florida investigation report.

Randolph declined to comment.

The Florida and Tennessee records say Randolph voluntarily surrendered her social worker’s licenses in both states. This resulted in the health departments dropping their investigations, which limited the case details and documents available in the public record. Brightside’s internal investigation report has not been made public.

Brightside Health, a San Francisco company that offers nationwide online psychiatry and therapy sessions, declined to make an official available for an interview.

Company spokesperson Hannah Changi said in an email that as soon as Brightside learned of the allegations, it audited its security, fired Randolph, and reported her to state licensing authorities. Changi said Brightside can’t say how many patients were seen by Randolph’s wife “due to the nature of the incident and ongoing legal proceedings,” but said the company notified and refunded all “potentially impacted patients.”

“We take our patient experience seriously and hold ourselves to a high ethical code of conduct,” Changi said. “We’re extremely disappointed that a single provider was willing to violate the trust that Brightside and, most importantly, her patients had placed in her.”

Brightside was also required to alert the U.S. Department of Health and Human Services, which investigates data breaches that expose private medical information. In this breach, an “unauthorized individual” accessed the info of 767 people, including Social Security numbers and diagnoses, according to the agency’s online database.

Neither Florida nor Tennessee health officials answered questions about the case.

Dean Flener, a spokesperson for the Tennessee Department of Health, said details of Randolph’s case remain confidential under state law.

Jae Williams, a Florida Department of Health spokesperson, said a full investigation was not completed because Randolph surrendered her license, which has the same effect as the state revoking it but allowed her to keep “what dignity she had left.”