Seeking to Grow Market Share?

Get a FREE assessment of your CDH products —
a $3,000 value.

Subscribe to Kaiser Health News:Health Industry feed Kaiser Health News:Health Industry
Updated: 2 hours 59 min ago

Hep C’s Number Comes Up: Can Biden’s 5-Year Plan Eliminate the Longtime Scourge?

September 20, 2023

Rick Jaenisch went through treatment six times before his hepatitis C was cured in 2017. Each time his doctors recommended a different combination of drugs, his insurer denied the initial request before eventually approving it. This sometimes delayed his care for months, even after he developed end-stage liver disease and was awaiting a liver transplant.

“At that point, treatment should be very easy to access,” said Jaenisch, now 37 and the director of outreach and education at Open Biopharma Research and Training Institute, a nonprofit group in Carlsbad, California. “I’m the person that treatment should be ideal for.”

But it was never easy. Jaenisch was diagnosed in 1999 at age 12, after his dad took him to a San Diego hospital because Jaenisch showed him that his urine was brown, a sign there was blood in it. Doctors determined that he likely got the disease at birth from his mom, a former dental surgical assistant who learned she had the virus only after her son’s diagnosis.

People infected with the viral disease, which is typically passed through blood contact, are often outwardly fine for years. An estimated 40% of the more than 2 million people in the U.S. who are infected don’t even know they have it, while the virus may quietly be damaging their liver, causing scarring, liver failure, or liver cancer.

With several highly effective, lower-cost treatments now on the market, one might expect that nearly everyone who knows they have hepatitis C would get cured. But a study from the Centers for Disease Control and Prevention published in June found that is far from the case. A proposal by the Biden administration to eliminate the disease in five years aims to change that.

Overall, the agency’s analysis found, during the decade after the introduction of the new antiviral treatments, only about a third of the people with an initial hepatitis C diagnosis cleared the virus, either through treatment or the virus resolving on its own. Most infected people had health insurance of some kind, whether Medicare, Medicaid, or commercial coverage. But even among commercially insured patients, who were most likely to receive treatment, only half of those age 60 or older had viral clearance by the end of the study period in 2022.

“Unlike HIV, where you have it for the rest of your life, with hepatitis C it’s a very short time frame, just eight to 12 weeks, and you’re cured,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “So why aren’t we doing a better job?”

Experts point to several roadblocks that infected people encounter. When the new treatments were introduced, cost was a huge factor. Private plans and state Medicaid programs limited spending on the pricey drugs by making them tougher to get, imposing prior authorization requirements, restricting access to people whose livers were already damaged, or requiring patients to abstain from drug use to qualify, among other restrictions.

By the time Jaenisch’s case was cured at age 31, the landscape of hepatitis C treatment had changed dramatically. A groundbreaking, once-a-day pill was introduced in 2013, replacing a grueling regimen of weekly interferon injections that had uncertain success rates and punishing side effects. The first of these “direct-acting antivirals” treated the disease in eight to 12 weeks, with few side effects and cure rates exceeding 95%. As more drugs were approved, the initial eye-popping $84,000 price tag for a course of treatment has gradually dropped to about $20,000.

As drug prices have declined, and under pressure from advocates and public health experts, many states have eliminated some of those barriers that have made it difficult to get approved for treatment.

Still more barriers exist that have little to do with the price of the drug.

Ronni Marks, a former hepatitis C patient, advocates for patients who often fall through the cracks. These include rural residents and those who are uninsured, transgender people, or injection drug users. An estimated 13% of people who pass through U.S. jails and prisons each year have a chronic hepatitis C infection, but access to care there is scant.

Marks said that many disadvantaged people need help getting services. “In many cases they have no way to travel, or they’re not in a situation where they can get to testing,” she said.

Unlike the federal Ryan White HIV/AIDS Program, which for more than 30 years has provided grants to cities, states, and community-based groups to provide medication, treatment, and follow-up care for people with HIV, there’s no coordinated, comprehensive program for patients with hepatitis C.

“In a perfect world, that would have been a good model to replicate,” said Sonia Canzater, the senior project director of the infectious diseases initiative at Georgetown’s O’Neill Institute for National and Global Health Law. “That’s probably never going to happen. The closest thing we can hope for is this national plan, to systemically provide access so that people aren’t beholden to the policies in their states.”

The national plan Canzater is referring to is a $12.3 billion, five-year initiative to eliminate hepatitis C that was included in President Joe Biden’s fiscal year 2024 budget proposal. Former National Institutes of Health director Francis Collins is spearheading the initiative for the Biden administration.

The program would:

  • Speed up the approval of point-of-care diagnostic tests, allowing patients to be screened and begin treatment in a single visit, rather than the current multistep process.
  • Improve access to medications for vulnerable groups such as people who are uninsured, incarcerated, part of the Medicaid program, or members of American Indian and Alaska Native populations by using a subscription model. Known as the Netflix model, this approach enables the government to negotiate a set fee with drug companies that would cover treatment for all the individuals in those groups that need it.
  • Build the public health infrastructure to educate, identify, and treat people who have hepatitis C, including supporting universal screening; expanded testing, provider training, and additional support for care coordination; and linking people to services.

“This is both about compassion and good financial sense,” Collins said, pointing to an analysis by Harvard researchers projecting that the program would avert 24,000 deaths and save $18.1 billion in health spending over 10 years.

Collins said legislation to implement the Biden plan, currently in draft form, was expected to be introduced now that Congress has reconvened after its summer recess. The Congressional Budget Office has not yet estimated its cost.

Until covid-19 burst on the scene in 2020, hepatitis C had the dubious distinction of killing more Americans annually — nearly 20,000 — than any other infectious disease. Advocates are pleased that the virus is finally getting the attention they believe it deserves. Still, they are not confident that Congress will support providing more than $5 billion in new funding for it. The rest would come in the form of savings from existing programs. But, they said, it’s a step in the right direction.

“I’m thrilled” that there is a federal proposal to end hepatitis C, said Lorren Sandt, executive director of the Caring Ambassadors, a nonprofit in Oregon City, Oregon, that helps people manage chronic diseases such as hepatitis C. “I’ve cried so many times in joy since that came out.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

With Its Two Doctors Planning to Retire, an Alabama Town Patches Together Health Care Options

September 19, 2023

LaFAYETTE, Ala. — Charity Hodge had mixed feelings when she spotted a Facebook post announcing that her longtime primary care doctor was ready to retire after decades of serving their rural community.

“I was like, ‘Oh my gosh, no!’” Hodge recalled while sitting in an exam room on a July afternoon, waiting to see the physician, Terry Vester. “Well, I’m happy for the retirement part, but that’s my favorite doctor, so I’m crying on the inside.”

Hodge, a 29-year-old customer service representative, has been seeing Vester for nine years. She had come to check in on her diabetes management and to ask for anti-nausea medication in preparation for a cruise.

LaFayette — pronounced “luh-FAY-it” by most residents — and surrounding Chambers County face high rates of disease and chronic illness. Yet Terry Vester and her husband, Al, are the only primary care doctors in the town of 2,700 residents, surrounded by farms and other small communities.

The Vesters are in their late 60s and would like to retire soon. Terry Vester wants to spend more time with her grandson and aging parents. But she can’t imagine abandoning her patients, some of whom she has cared for since they were born.

“There are people here that still need in-town doctors,” said Vester, who sometimes visits patients in their homes. “So we want to stay here to take care of them until someone else is here to take care of them.”

Terry Vester’s worry — leaving her town with no doctors — is already reality across much of rural America, where many residents have health problems but few health care professionals to turn to.

LaFayette, in east-central Alabama near the border with Georgia, is a 30-minute drive to the nearest sizable city, the college town of Auburn. Its lush, wooded neighborhoods include elegant, restored homes with wraparound porches and massive lawns. But the town also has formerly grand houses that have fallen into disrepair, plus mobile homes and public housing.

The town’s median household income is much lower than the state’s and country’s. Black residents — who make up 70% of the population — are much more likely to live in poverty than white residents. They are also more likely to attend the public high school, whose student body is 90% Black and which is scheduled to close and consolidate with a majority-white school in another community.

The Vesters have worked in LaFayette since the early 1980s and saw the local hospital close in 1988. The nearest emergency room is now in another town 20 minutes away along a rolling road. So are the nearest urgent care clinic and pediatrician’s office.

To fill that void, residents turn to the one place in LaFayette where medical professionals are always on the clock: the city fire department, staffed with full-time firefighters and emergency medics.

Fire Chief Jim Doody worked for 13 years as the fire chief at Bagram Airfield in Afghanistan. He arrived in LaFayette in 2020, just as the county was about to be hit by one of the worst covid-19 outbreaks in Alabama.

Doody said most of the station’s ambulance runs are for nonemergency situations. Other calls involve urgent issues that could have been headed off if patients had better access to preventive care.

People from LaFayette regularly walk or drive themselves to the fire station to ask for help, Doody said. The station has a makeshift exam area within its small entryway, containing a bench, defibrillator machine, and cabinet filled with medical supplies.

Firefighter Tanner Hill said people often arrive with concerns about fatigue, blood sugar levels, breathing difficulties, or heart trouble. He recalled helping a man who walked into the station after getting hit by a car.

“He was just like, ‘Hey, I just got run over.’ And I was like, ‘Oh, OK, well, let me check you out.’ And sure enough, he got run over,” Hill said.

Hill determined the man’s leg was broken and sent him by ambulance to the nearest hospital.

This de facto walk-in clinic option isn’t available in most other rural areas, where emergency medical services are often run by volunteers who aren’t posted at a station all day, Doody said. But he’s noticed fewer LaFayette residents relying on the fire department since a new telehealth service arrived in town.

Rickey Whitlow was recently driving in LaFayette when he saw a sign touting the new option.

The 61-year-old was intrigued. He parked his car and walked into a new health center that also houses an OnMed Care Station, a large booth stocked with a video screen and high-tech health monitoring equipment.

Whitlow was scheduled for his monthly diabetes checkup with physician Al Vester in a few weeks. But his feet felt like they were burning, and he needed relief now.

Whitlow stepped into the telehealth kiosk, pressed a button, and saw a nurse practitioner appear on a large vertical video screen positioned at eye level. After consulting with the provider, he left the free appointment with a prescription for a cream to relieve his foot pain.

OnMed patients use an automated blood pressure cuff and other devices to collect their vital signs, and the data is sent to the provider treating them from a distance. Patients can also hold a stethoscope to their chest to transmit the sounds of their heart and lungs. A special camera captures internal temperatures, which can be used to diagnose infections. A hand-held camera lets providers examine problems such as rashes, irritated eyes, and swollen throats. In some states, the stations can dispense medications.

OnMed, a Florida-based company, has another kiosk in rural Texas and hopes to open several dozen more in various states next year. The company wants to keep its services free for patients, with funding from universities, health systems, nonprofits, and insurance companies.

The kiosks can stay open on evenings and weekends and are much cheaper to operate than brick-and-mortar doctor’s offices, said CEO Tom Vanderheyden. They also make telehealth available to rural residents whose home internet connections are too weak for video appointments.

LaFayette’s OnMed kiosk is part of a new health center inside a building that has seen several medical facilities come and go.

The Chambers County Community Health and Wellness Center is operated by Auburn University, whose students and faculty travel there to host vaccination and diagnostic clinics, such as speech and hearing exams. They also offer health education events on topics such as healthy eating and maternal health.

The university plans to bring similar centers and OnMed kiosks to other rural Alabama towns.

Vester, the longtime primary care physician, is excited about the new health care resources in LaFayette. But she said it’s still important to have doctors in town.

“You know everyone, or you have a connection with someone,” Vester said.

Vester’s statement rang true during recent appointments as she asked about her patients’ lives and relatives.

“Deep breath,” Vester instructed as she placed a stethoscope on Hodge’s chest.  “Are you still at home with your mother? Is she doing good?”

“Yes, she’s doing very well,” Hodge said.

Earlier that day, Vester treated a patient who had throat pain and difficultly speaking after surviving a choking incident. During the appointment, the patient mentioned an upcoming funeral.

Vester knew about the funeral. It was for a woman she once treated.

“I see her daughters and then their children, and they have children — so that’s four generations right there,” Vester said. “And so, you sort of know the whole story, you know the context.”

Vester plans to reach out to Alabama medical schools to let them know she’s looking for doctors to take over for her and her husband. But she said not everyone wants to live in rural areas like LaFayette.

The doctor hopes some of the Auburn students will want to serve in LaFayette after seeing what it’s like working at the new health center. She said it’s nice to live in a small, quiet town that’s relatively close to larger cities, and to run an independent clinic rather than work for a larger health system.

Vester said the charm of LaFayette and its residents is also a selling point.

“All they have to do is pretty much come here and spend a day and go through what we do, and I think they would enjoy it,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Save Billions or Stick With Humira? Drug Brokers Steer Americans to the Costly Choice

September 19, 2023

Tennessee last year spent $48 million on a single drug, Humira — about $62,000 for each of the 775 patients who were covered by its employee health insurance program and receiving the treatment. So when nine Humira knockoffs, known as biosimilars, hit the market for as little as $995 a month, the opportunity for savings appeared ample and immediate.

But it isn’t here yet. Makers of biosimilars must still work within a health care system in which basic economics rarely seems to hold sway.

For real competition to take hold, the big pharmacy benefit managers, or PBMs, the companies that negotiate prices and set the prescription drug menu for 80% of insured patients in the United States, would have to position the new drugs favorably in health plans.

They haven’t, though the logic for doing so seems plain.

Humira has enjoyed high-priced U.S. exclusivity for 20 years. Its challengers could save the health care system $9 billion and herald savings from the whole class of drugs called biosimilars — a windfall akin to the hundreds of billions saved each year through the purchase of generic drugs.

The biosimilars work the same way as Humira, an injectable treatment for rheumatoid arthritis and other autoimmune diseases. And countries such as the United Kingdom, Denmark, and Poland have moved more than 90% of their Humira patients to the rival drugs since they launched in Europe in 2018. Kaiser Permanente, which oversees medical care for 12 million people in eight U.S. states, switched most of its patients to a biosimilar in February and expects to save $300 million this year alone.

Biologics — both the brand-name drugs and their imitators, or biosimilars — are made with living cells, such as yeast or bacteria. With dozens of biologics nearing the end of their patent protection in the next two decades, biosimilars could generate much higher savings than generics, said Paul Holmes, a partner at Williams Barber Morel who works with self-insured health plans. That’s because biologics are much more expensive than pills and other formulations made through simpler chemical processes.

For example, after the first generics for the blockbuster anti-reflux drug Nexium hit the market in 2015, they cost around $10 a month, compared with Nexium’s $100 price tag. Coherus BioSciences launched its Humira biosimilar, Yusimry, in July at $995 per two-syringe carton, compared with Humira’s $6,600 list price for a nearly identical product.

“The percentage savings might be similar, but the total dollar savings are much bigger,” Holmes said, “as long as the plan sponsors, the employers, realize the opportunity.”

That’s a big if.

While a manufacturer may need to spend a few million dollars to get a generic pill ready to market, makers of biosimilars say their development can require up to eight years and $200 million. The business won’t work unless they gain significant market share, they say.

The biggest hitch seems to be the PBMs. Express Scripts and Optum Rx, two of the three giant PBMs, have put biosimilars on their formularies, but at the same price as Humira. That gives doctors and patients little incentive to switch. So Humira remains dominant for now.

“We’re not seeing a lot of takeup of the biosimilar,” said Keith Athow, pharmacy director for Tennessee’s group insurance program, which covers 292,000 state and local employees and their dependents.

The ongoing saga of Humira — its peculiar appeal to drug middlemen and insurers, the patients who’ve benefited, the patients who’ve suffered as its list price jumped sixfold since 2003 — exemplifies the convoluted U.S. health care system, whose prescription drug coverage can be spotty and expenditures far more unequal than in other advanced economies.

Biologics like Humira occupy a growing share of U.S. health care spending, with their costs increasing 12.5% annually over the past five years. The drugs are increasingly important in treating cancers and autoimmune diseases, such as rheumatoid arthritis and inflammatory bowel disease, that afflict about 1 in 10 Americans.

Humira’s $200 billion in global sales make it the best-selling drug in history. Its manufacturer, AbbVie, has aggressively defended the drug, filing more than 240 patents and deploying legal threats and tweaks to the product to keep patent protections and competitors at bay.

The company’s fight for Humira didn’t stop when the biosimilars finally appeared. The drugmaker has told investors it doesn’t expect to lose much market share through 2024. “We are competing very effectively with the various biosimilar offerings,” AbbVie CEO Richard Gonzalez said during an earnings call.

How AbbVie Maintains Market Share

One of AbbVie’s strategies was to warn health plans that if they recommended biosimilars over Humira they would lose rebates on purchases of Skyrizi and Rinvoq, two drugs with no generic imitators that are each listed at about $120,000 a year, according to PBM officials. In other words, dropping one AbbVie drug would lead to higher costs for others.

Industry sources also say the PBMs persuaded AbbVie to increase its Humira rebates — the end-of-the-year payments, based on total use of the drug, which are mostly passed along by the PBMs to the health plan sponsors. Although rebate numbers are kept secret and vary widely, some reportedly jumped this year by 40% to 60% of the drug’s list price.

The leading PBMs — Express Scripts, Optum, and CVS Caremark — are powerful players, each part of a giant health conglomerate that includes a leading insurer, specialty pharmacies, doctors’ offices, and other businesses, some of them based overseas for tax advantages.

Yet challenges to PBM practices are mounting. The Federal Trade Commission began a major probe of the companies last year. Kroger canceled its pharmacy contract with Express Scripts last fall, saying it had no bargaining power in the arrangement, and, on Aug. 17, the insurer Blue Shield of California announced it was severing most of its business with CVS Caremark for similar reasons.

Critics of the top PBMs see the Humira biosimilars as a potential turning point for the secretive business processes that have contributed to stunningly high drug prices.

Although list prices for Humira are many times higher than those of the new biosimilars, discounts and rebates offered by AbbVie make its drug more competitive. But even if health plans were paying only, say, half of the net amount they pay for Humira now — and if several biosimilar makers charged as little as a sixth of the gross price — the costs could fall by around $30,000 a year per patient, said Greg Baker, CEO of AffirmedRx, a smaller PBM that is challenging the big companies.

Multiplied by the 313,000 patients currently prescribed Humira, that comes to about $9 billion in annual savings — a not inconsequential 1.4% of total national spending on pharmaceuticals in 2022.

The launch of the biosimilar Yusimry, which is being sold through Mark Cuban’s Cost Plus Drugs pharmacy and elsewhere, “should send off alarms to the employers,” said Juliana Reed, executive director of the Biosimilars Forum, an industry group. “They are going to ask, ‘Time out, why are you charging me 85% more, Mr. PBM, than what Mark Cuban is offering? What is going on in this system?’”

Cheaper drugs could make it easier for patients to pay for their drugs and presumably make them healthier. A KFF survey in 2022 found that nearly a fifth of adults reported not filling a prescription because of the cost. Reports of Humira patients quitting the drug for its cost are rife.

Convenience, Inertia, and Fear

When Sue Lee of suburban Louisville, Kentucky, retired as an insurance claims reviewer and went on Medicare in 2017, she learned that her monthly copay for Humira, which she took to treat painful plaque psoriasis, was rising from $60 to $8,000 a year.

It was a particularly bitter experience for Lee, now 81, because AbbVie had paid her for the previous three years to proselytize for the drug by chatting up dermatology nurses at fancy AbbVie-sponsored dinners. Casting about for a way to stay on the drug, Lee asked the company for help, but her income at the time was too high to qualify her for its assistance program.

“They were done with me,” she said. Lee went off the drug, and within a few weeks the psoriasis came back with a vengeance. Sores covered her calves, torso, and even the tips of her ears. Months later she got relief by entering a clinical trial for another drug.

Health plans are motivated to keep Humira as a preferred choice out of convenience, inertia, and fear. While such data is secret, one Midwestern firm with 2,500 employees told KFF Health News that AbbVie had effectively lowered Humira’s net cost to the company by 40% after July 1, the day most of the biosimilars launched.

One of the top three PBMs, CVS Caremark, announced in August that it was creating a partnership with drugmaker Sandoz to market its own cut-rate version of Humira, called Hyrimoz, in 2024. But Caremark didn’t appear to be fully embracing even its own biosimilar. Officials from the PBM notified customers that Hyrimoz will be on the same tier as Humira to “maximize rebates” from AbbVie, Tennessee’s Athow said.

Most of the rebates are passed along to health plans, the PBMs say. But if the state of Tennessee received a check for, say, $20 million at the end of last year, it was merely getting back some of the $48 million it already spent.

“It’s a devil’s bargain,” said Michael Thompson, president and CEO of the National Alliance of Healthcare Purchaser Coalitions. “The happiest day of a benefit executive’s year is walking into the CFO’s office with a several-million-dollar check and saying, ‘Look what I got you!’”

Executives from the leading PBMs have said their clients prefer high-priced, high-rebate drugs, but that’s not the whole story. Some of the fees and other payments that PBMs, distributors, consultants, and wholesalers earn are calculated based on a drug’s price, which gives them equally misplaced incentives, said Antonio Ciaccia, CEO of 46Brooklyn, a nonprofit that researches the drug supply chain.

“The large intermediaries are wedded to inflated sticker prices,” said Ciaccia.

AbbVie has warned some PBMs that if Humira isn’t offered on the same tier as biosimilars it will stop paying rebates for the drug, according to Alex Jung, a forensic accountant who consults with the Midwest Business Group on Health.

AbbVie did not respond to requests for comment.

One of the low-cost Humira biosimilars, Organon’s Hadlima, has made it onto several formularies, the ranked lists of drugs that health plans offer patients, since launching in February, but “access alone does not guarantee success” and doesn’t mean patients will get the product, Kevin Ali, Organon’s CEO, said in an earnings call in August.

If the biosimilars are priced no lower than Humira on health plan formularies, rheumatologists will lack an incentive to prescribe them. When PBMs put drugs on the same “tier” on a formulary, the patient’s copay is generally the same.

In an emailed statement, Optum Rx said that by adding several biosimilars to its formularies at the same price as Humira, “we are fostering competition while ensuring the broadest possible choice and access for those we serve.”

Switching a patient involves administrative costs for the patient, health plan, pharmacy, and doctor, said Marcus Snow, chair of the American College of Rheumatology’s Committee on Rheumatologic Care.

Doctors’ Inertia Is Powerful

Doctors seem reluctant to move patients off Humira. After years of struggling with insurance, the biggest concern of the patient and the rheumatologist, Snow said, is “forced switching by the insurer. If the patient is doing well, any change is concerning to them.” Still, the American College of Rheumatology recently distributed a video informing patients of the availability of biosimilars, and “the data is there that there’s virtually no difference,” Snow said. “We know the cost of health care is exploding. But at the same time, my job is to make my patient better. That trumps everything.”

“All things being equal, I like to keep the patient on the same drug,” said Madelaine Feldman, a New Orleans rheumatologist.

Gastrointestinal specialists, who often prescribe Humira for inflammatory bowel disease, seem similarly conflicted. American Gastroenterological Association spokesperson Rachel Shubert said the group’s policy guidance “opposes nonmedical switching” by an insurer, unless the decision is shared by provider and patient. But Siddharth Singh, chair of the group’s clinical guidelines committee, said he would not hesitate to switch a new patient to a biosimilar, although “these decisions are largely insurance-driven.”

HealthTrust, a company that procures drugs for about 2 million people, has had only five patients switch from Humira this year, said Cora Opsahl, director of the Service Employees International Union’s 32BJ Health Fund, a New York state plan that procures drugs through HealthTrust.

But the biosimilar companies hope to slowly gain market footholds. Companies like Coherus will have a niche and “they might be on the front end of a wave,” said Ciaccia, given employers’ growing demands for change in the system.

The $2,000 out-of-pocket cap on Medicare drug spending that goes into effect in 2025 under the Inflation Reduction Act could spur more interest in biosimilars. With insurers on the hook for more of a drug’s cost, they should be looking for cheaper options.

For Kaiser Permanente, the move to biosimilars was obvious once the company determined they were safe and effective, said Mary Beth Lang, KP’s chief pharmacy officer. The first Humira biosimilar, Amjevita, was 55% cheaper than the original drug, and she indicated that KP was paying even less since more drastically discounted biosimilars launched. Switched patients pay less for their medication than before, she said, and very few have tried to get back on Humira.

Prescryptive, a small PBM that promises transparent policies, switched 100% of its patients after most of the other biosimilars entered the market July 1 “with absolutely no interruption of therapy, no complaints, and no changes,” said Rich Lieblich, the company’s vice president for clinical services and industry relations.

AbbVie declined to respond to him with a competitive price, he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Health Workers Warn Loosening Mask Advice in Hospitals Would Harm Patients and Providers

September 18, 2023

Nurses, researchers, and workplace safety officers worry new guidelines from the Centers for Disease Control and Prevention might reduce protection against the coronavirus and other airborne pathogens in hospitals.

A CDC advisory committee has been updating its 2007 standards for infection control in hospitals this year. Many health care professionals and scientists expressed outrage after the group released a draft of its proposals in June.

The draft controversially concluded that N95 face masks are equivalent to looser, surgical face masks in certain settings — and that doctors and nurses need to wear only surgical masks when treating patients infected by “common, endemic” viruses, like those that cause the seasonal flu.

The committee was slated to vote on the changes on Aug. 22, but it postponed action until November. Once the advice is final, the CDC begins a process of turning the committee’s assessment into guidelines that hospitals throughout the United States typically follow. After the meeting, members of the public expressed concern about where the CDC was headed, especially as covid-19 cases rise. Nationwide, hospital admissions and deaths due to covid have been increasing for several consecutive weeks.

“Health care facilities are where some of the most vulnerable people in our population have to frequent or stay,” said Gwendolyn Hill, a research intern at Cedars-Sinai Medical Center in Los Angeles, after the committee’s presentation. She said N95 masks, ventilation, and air-purifying technology can lower rates of covid transmission within hospital walls and “help ensure that people are not leaving sicker than they came.”

“We are very happy to receive feedback,” Alexander Kallen, chief of the Prevention and Response Branch in the CDC’s Division of Healthcare Quality Promotion, told KFF Health News. “It is our goal to develop a guideline that is protective of patients, visitors, and health workers.” He added that the draft guidelines are far from final.

In June, members of the CDC’s group — the Healthcare Infection Control Practices Advisory Committee — presented a draft of their report, citing studies that found no difference in infection rates among health providers who wore N95 masks versus surgical masks in the clinic. They noted flaws in the data. For example, many health workers who got covid in the trials were not infected while wearing their masks at work. But still, they concluded the masks were equivalent.

Their conclusion runs contrary to the CDC’s 2022 report, which found that an N95 mask cuts the odds of testing positive for the coronavirus by 83%, compared with 66% for surgical masks and 56% for cloth masks. It also excludes a large clinical trial published in 2017 finding that N95 masks were far superior to surgical masks in protecting health workers from influenza infections. And it contradicts an extensive evaluation by the Royal Society, the United Kingdom’s national academy of sciences, finding that N95 masks, also called N95 respirators, were more effective against covid than surgical masks in health care settings around the world.

“It’s shocking to suggest that we need more studies to know whether N95 respirators are effective against an airborne pathogen,” said Kaitlin Sundling, a physician and pathologist at the University of Wisconsin-Madison, in a comment following the June meeting. “The science of N95 respirators is well established and based on physical properties, engineered filtered materials, and our scientific understanding of how airborne transmission works.”

Her assertion is backed by the California occupational safety agency, Cal/OSHA, whose rules on protecting at-risk workers from infections might be at odds with the CDC’s if the proposals are adopted. “The CDC must not undermine respiratory protection regulation by making the false and misleading claim that there is no difference in protection” between N95 masks and surgical masks, commented Deborah Gold, an industrial hygienist at Cal/OSHA, at the August meeting.

Researchers and occupational safety experts were also perplexed by how the committee categorized airborne pathogens. A surgical mask, rather than an N95, was suggested as protection for a category they created for “common, endemic” viruses that spread over short distances, and “for which individuals and communities are expected to have some immunity.” Three committee representatives, researchers Hilary Babcock, Erica Shenoy, and Sharon Wright, were among the authors of a June editorial arguing that hospitals should no longer require all health care workers, patients, and visitors to wear masks in hospitals. “The time has come to deimplement policies that are not appropriate for an endemic pathogen,” they wrote.

However, in a call with KFF Health News, Kallen clarified that the committee put coronaviruses that cause colds in that category, but not yet the coronavirus causing covid.

The committee’s next tier consisted of viruses in a “pandemic-phase,” when the pathogen is new and little immunity through infection or vaccination exists. It recommended that health workers wear an N95 mask when treating patients infected by bugs in this category. Its third, highest tier of protection was reserved for pathogens like those causing measles and tuberculosis, which, they claimed, can spread further than lower-tier threats and require an N95.

Virologists said the committee’s categories hold little water, biologically speaking. A pathogen’s mode of spreading isn’t affected by how common it is; common viruses can still harm vulnerable populations; and many viruses, including SARS-CoV-2, can travel significant distances on microscopic droplets suspended in the air.

“Large COVID outbreaks in prisons and long-term health care facilities have demonstrated that the behavior of infectious aerosols is not easily classified, and these aerosols are not easily confined,” wrote the deputy chief of health at Cal/OSHA, Eric Berg, in a letter of concern to the CDC committee, obtained by KFF Health News.

The committee pitted its assessment of N95 masks against their drawbacks. Its draft cites a study from Singapore in which nearly a third of health care personnel, mostly nurses, said wearing such masks negatively affected their work, causing acne and other problems exacerbated by hot and humid conditions and prolonged shifts. Rather than discard the masks, the authors of that study recommend better-fitting masks and rest breaks.

Noha Aboelata, a doctor and the CEO of Roots Community Health Center in Oakland, California, agrees. “There are other strategies to bring to bear, like improved mask design and better testing,” she said, “if we decide it’s unacceptable to give a patient covid when they go to the hospital.”

Aboelata is one of hundreds of doctors, researchers, and others who signed a letter to CDC Director Mandy Cohen in July, expressing concern that the CDC committee will weaken protections in hospitals. They also warned that scaling back on N95 masks could have repercussions on emergency stockpiles, rendering doctors and nurses as vulnerable as they were in 2020 when mask shortages fueled infections. More than 3,600 health workers died in the first year of the pandemic in the United States, according to a joint investigation by KFF Health News and The Guardian.

The concerned clinicians hope the committee will reconsider its report in light of additional studies and perspectives before November. Referring to the draft, Rocelyn de Leon-Minch, an industrial hygienist for National Nurses United, said, “If they end up codifying these standards of care, it will have a disastrous impact on patient safety and impact our ability to respond to future health crises.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

California Lawmakers Approve Nation-Leading $25 Minimum Wage for Health Workers

September 15, 2023

SACRAMENTO, Calif. — A sweeping agreement between labor and the health industry would gradually raise the minimum wage for hundreds of thousands of health workers in California to a nation-leading $25 an hour while ending a years-long battle over dialysis clinics.

The pact approved by state lawmakers on Thursday, the last day of this year’s legislative session, would phase in the wage increase for hospitals, nursing homes, and other medical and psychiatric services providers. The bill now heads to the governor’s desk. A spokesperson for Democratic Gov. Gavin Newsom, Izzy Gordon, said the governor will evaluate the bill on the merits before his Oct. 14 deadline to act on the legislation.

SB 525 would raise the hourly minimum at large health facilities and dialysis clinics to $23 next year, $24 in 2025, and $25 in 2026. It would boost hourly wages at community clinics to at least $21 in 2024, $22 in 2026, and $25 in 2027. Other health facilities would go to at least $21 an hour in 2024, $23 in 2026, and $25 by 2028.

The agreement “now strikes an important balance between supporting workers and protecting jobs and access to care in some of our most vulnerable communities,” Carmela Coyle, president and CEO of the California Hospital Association, said in a statement. “The bill creates a pathway to improving wages for our lower-wage health care workers, while also recognizing the needs of our state’s most troubled hospitals.”

The deal is a significant union victory during what has been dubbed a “hot labor summer,” with picket lines formed by Hollywood writers and actors, hotel workers, and Los Angeles city employees. Thousands of nurses could be next. Labor also won a $20 minimum wage for California fast-food workers, a significant boost from the current statewide $15.50 minimum wage.

Union leaders say lower-income health workers such as certified nursing assistants, patient aides, and food service workers — many of them racial minorities — need the additional money to keep up. “Health care in California will be more accessible and equitable because workers and healthcare providers stood together and stood up for patient care,” SEIU California Executive Director Tia Orr said of the health care deal.

The phase-in would be slower at hospitals with a high percentage of patients covered by Medicare or Medicaid, rural independent hospitals, and small county facilities. The minimum hourly wage there would go to $18 next year, then increase annually by 3.5% until it reaches $25 in 2033.

Subsequently, at all sites, the $25 minimum wage would be increased annually to keep up with inflation. However, the bill allows health care facilities to apply for a temporary pause or slower phase-in if they can show state officials that providing the required minimum wage “would raise doubts about the covered health care facility’s ability to continue as a going concern.”

State Sen. María Elena Durazo, the Los Angeles Democrat who introduced the bill, called her bill “a first in the nation historic investment in our healthcare workforce.” The measure “is a critical step to ensuring that we are addressing our healthcare workforce shortage,” she said before the bill received final passage late Thursday in the Senate.

As part of the deal, in a separate memorandum of understanding, Service Employees International Union-United Healthcare Workers West would drop its effort to impose regulations on dialysis clinics through legislation and at the ballot box. Voters defeated all three ballot initiatives, most recently last year, but the fight has cost the dialysis industry hundreds of millions of dollars.

California Dialysis Council spokesperson Jaycob Bytel said in a statement that the agreement “protects patients from the ongoing threats at the ballot and in the legislature.” It bars for four years any legislation or statewide or local ballot measures by either SEIU or the dialysis industry.

The union has pushed for wage boosts in several California cities. But the agreement bars local governments from requiring higher local minimum wages for health care workers for 10 years, until 2034. Local governments could set higher local minimum wages, but they must include all workers.

The original bill cleared the Senate in May with no votes to spare amid strident opposition from employers, who said they couldn’t afford it. The California Chamber of Commerce put the proposal on its annual “job killer” list, a designation that often is enough to kill controversial legislation. The No SB 525 coalition, which included hospitals, doctors, and business and taxpayer groups, had said the bill would cost $8 billion annually, endangering services and leading to higher premiums and higher costs for state and local governments.

Republicans who opposed the bill echoed those arguments while saying the increases will harm rural health facilities. “We’ll see hospitals go out of service and we will see rural health clinics for sure be severely impacted and probably go out of business,” warned state Sen. Brian Dahle, a Republican who represents rural Northern California.

The bill’s opponents also included the California Nurses Association, which said it could prompt employers to lower wages for registered nurses. The association helped scuttle a push for a $25 hourly minimum wage for health workers a year ago. That earlier effort failed in part because it was tied to a delay in earthquake-safety upgrades at hospitals.

The University of California-Berkeley Labor Center projected that the increase would boost wages for more than 469,000 health workers. The center estimates it would most benefit workers of color, who make up 70% of those workers, and women, who represent about three-quarters.

The bump would help about 40% of California’s health workers, earning them on average an extra $10,352 a year and reducing their reliance on Medi-Cal, saving between $181 million and $363 million in the second year of the wage increase, according to a legislative analysis. The analysis said opponents’ $8 billion cost estimate is overblown because it fails to include billions in state assistance to hospitals.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Rural Nursing Home Supporters Fear Proposed Staffing Standards Will Trigger More Closures

September 15, 2023

SYRACUSE, Neb. — Many rural communities like this one face a health care dilemma: Is it better to have a nursing home that struggles to hire workers or no nursing home at all?

The national debate over that question will heat up now that federal regulators have proposed to improve care by setting minimum staffing levels for all U.S. nursing homes.

Rural nursing homes would have five years to comply with some of the rules, versus three for their urban counterparts. Facilities also could apply for “hardship exemptions.” But industry leaders predict the rules could accelerate a wave of closures that has already claimed hundreds of rural nursing homes.

Some families that rely on the Good Samaritan Society home in Syracuse fear the regulation could hasten its demise.

The facility is the town’s lone nursing home. It is running at barely half its licensed capacity, and managers say they’ve been turning away prospective residents because they can’t find enough staff to care for more.

Lana Obermeyer, whose mother lives there, said employees take good care of residents. “Are they overworked? Probably,” she said. “Isn’t everybody these days?”

The Biden administration proposal, released Sept. 1, is intended to ensure higher-quality care by requiring a minimum number of hours of average daily staffing per resident, including 2.5 hours from certified nurse aides and 33 minutes from registered nurses.

The proposal also would require around-the-clock coverage by at least one registered nurse at every nursing home. Regulators estimate 1,358 rural nursing homes, including 58 in Nebraska, would need to add nurses to meet that standard.

Patient-safety advocates have long pressed the government to impose such standards to prevent neglect of nursing home residents. They blame the industry for letting its staffing problems fester for decades, and many hoped the federal proposal would be more stringent.

The proposal would not affect assisted living centers, which are designed to care for people with less severe health problems.

Syracuse, which has about 1,900 people, serves a farming region in southern Nebraska. Its red-brick nursing home sits near a cemetery, a hearing aid store, and a tractor dealership. It would need to hire several more aides and an overnight registered nurse to meet the requirements.

Most of the nursing home’s 46 residents are from the area. So are most employees. Staffers often care for their former teachers, coaches, and babysitters. They know each other’s families.

If the facility closed, many residents likely would be transferred to larger nursing homes in the city of Lincoln, a 40-minute drive northwest, or Omaha, which is an hour northeast. They would be placed among strangers.

“I truly think it would kill half of these people,” said Obermeyer, whose mother, Sharon Hudson, has been in the Good Samaritan home five years.

Obermeyer lives less than a block away, and she walks over to see her mom several times a week. Hudson also enjoys frequent visits from other locals, who stop by to see her after visiting their own parents in the facility.

Hudson has advanced Alzheimer’s disease. She can no longer speak many words, but she smiles and giggles often, and tries to communicate with garbled sentences. “She’s a very happy, happy person,” Obermeyer said.

Ideally, she would be served in a specialized “memory care unit,” for people with dementia. The Good Samaritan home once had one, but the unit closed several years ago for lack of staff. The wing now sits dark.

Ten Nebraska nursing homes have shut down since 2021, said Jalene Carpenter, president of the Nebraska Health Care Association. Most have been in small towns.

The state’s long-term care facilities have raised wages as much as 30% in recent years, partly because Nebraska joined most other states in substantially increasing how much its Medicaid program pays for nursing home care, Carpenter said. But many of the state’s 196 remaining nursing homes are limiting admissions because of staffing shortages, she said. “It’s unsustainable.”

Carpenter said part of the problem is that the population of seniors who need care in many rural areas outpaces the supply of working-age adults. Job seekers have plenty of choices outside of health care, many with better hours and less stress. She noted that nine rural Nebraska counties had no registered nurses in 2021.

A prominent consumer advocate scoffed at claims that rural facilities would be unable to comply with the proposed staffing rules.

“That’s always their first response: ‘We’re going to have to close,’” said Lori Smetanka, executive director of the National Consumer Voice for Quality Long-Term Care. “It’s like, ‘The sky is falling.’”

Smetanka said the industry should have improved working conditions and wages long ago, and she contends the proposed standards are too lenient.

Regulators shouldn’t offer rural nursing homes extra time to meet the staffing rule, she said. “Residents in rural facilities have the same level of needs as those in urban facilities,” she said. “Every resident deserves quality care today.”

Smetanka’s group favors offering incentives, such as pay raises and housing assistance, to employees in the long-term care industry. It also wants the government to strengthen options for care in people’s homes instead of in facilities.

Industry leaders have suggested easing immigration rules to allow more workers from other countries. Smetanka said that such workers might help ease the staffing shortage but that they shouldn’t be subjected to the poor conditions and low pay that have driven many previous employees away.

In Iowa, 27 nursing homes have closed over the past two years, according to the Iowa Health Care Association. Most were in rural areas. About 400 remain open in the state.

John Hale, an Iowa advocate for improved long-term care, said he sympathizes with rural residents who worry about facilities closing. But he said companies sometimes use staffing woes as an excuse to shutter money-losing facilities.

Hale has roamed the halls of Iowa’s Capitol for years, trying to persuade legislators to protect vulnerable seniors and people with disabilities. He said minimum staffing proposals have always been blocked by the nursing home industry, which receives millions of state and federal tax dollars from Medicaid. The industry’s message to government officials boils down to “give us more money and leave us alone,” he said.

Hale noted Iowa’s government sets minimum staffing levels for child care centers to ensure kids’ safety, but hasn’t done so for seniors in care facilities. “I just wonder what that says about our values as a government and as a people,” he said.

The longtime federal standard for nursing homes has been that they have “sufficient” staff. Hale said that vague standard is akin to replacing speed limit signs with suggestions that motorists drive “at reasonable speeds.”

Nursing homes are required to report their staffing to federal regulators, who use formulas to measure how much daily attention residents receive from various types of professionals, including registered nurses, licensed practical nurses, and certified nursing aides. Some states have set specific minimum staffing levels, but many, including Nebraska and Iowa, have not.

The Good Samaritan home in Syracuse is rated three out of five stars for overall quality on the nursing home comparison website run by Medicare. Its staffing level is rated at four stars, although its reported ratio of staff hours to residents was below national and Nebraska averages.

The Good Samaritan Society, which owns the nursing home, is one of the country’s largest nonprofit chains of care facilities. In 2021, it reported nearly $78 million in losses on nearly $1 billion in revenue. The company is owned by the giant Sanford Health system, based in South Dakota. It has closed 13 nursing homes in the past two years, mostly in rural areas.

Good Samaritan Society President Nate Schema said he fears the proposed federal staffing standards would spark more closures, forcing rural residents to seek care far from their hometowns. Family members would not be able to visit as often, he said. “Are they going to have to drive 20 or 30 or, God forbid, 100 miles?”

In a letter to federal regulators, Schema wrote that his company owns 139 nursing homes in 19 states, with nearly 1,700 open positions. At one facility in rural South Dakota, he wrote, a night-shift nursing job has been vacant for three years.

The possibility of closure is on the minds of residents and families at the Good Samaritan nursing home in Syracuse.

Resident Nellie Swale said she knows people who had to transfer to the facility from other nursing homes that closed. They were stressed and saddened by the move, she said. “Old people really depend on routines,” she said.

Certified nursing assistant Karena Cunningham tells residents she hopes the Syracuse nursing home stays open. But, she said, “we can’t make them any promises.”

Cunningham considered looking for a less stressful job, but she couldn’t leave. “It’s my family here. I love the friends I’ve made,” she said.

The facility currently has 82 employees, with 10 vacant full-time positions. The company said it spent $150,000 in the past year raising pay at the facility. The lowest starting wage for a nurse aide there has reached $18 an hour, a 30% increase from 10 months earlier.

Cunningham said that with a bigger staff, the nursing home could accept more residents, including those with complicated issues, such as addiction, mental illness, or severe obesity.

A national minimum staffing rule sounds like it would make sense, “in a perfect world,” she said.

“Bring me these people that we’re supposed to have for staff,” Cunningham said. “Where are they?”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

As More Patients Email Doctors, Health Systems Start Charging Fees

September 14, 2023

Meg Bakewell, who has cancer and cancer-related heart disease, sometimes emails her primary care physician, oncologist, and cardiologist asking them for medical advice when she experiences urgent symptoms such as pain or shortness of breath.

But she was a little surprised when, for the first time, she got a bill — a $13 copay — for an emailed consultation she had with her primary care doctor at University of Michigan Health. The health system had begun charging in 2020 for “e-visits” through its MyChart portal. Even though her out-of-pocket cost on the $37 charge was small, now she’s worried about how much she’ll have to pay for future e-visits, which help her decide whether she needs to see one of her doctors in person. Her standard copay for an office visit is $25.

“If I send a message to all three doctors, that could be three copays, or $75,” said Bakewell, a University of Michigan teaching consultant who lives in Ypsilanti, Michigan, and is on long-term disability leave. “It’s the vagueness of the whole thing. You don’t know if you’ll get into a copay or not. It just makes me hesitate.”

Spurred by the sharp rise in email messaging during the covid pandemic, a growing number of health systems around the country have started charging patients when physicians and other clinicians send replies to their messages. Health systems that have adopted billing for some e-visits include a number of the nation’s premier medical institutions: Cleveland Clinic, Mayo Clinic, San Francisco-based UCSF Health, Vanderbilt Health, St. Louis-based BJC HealthCare, Chicago-based Northwestern Medicine, and the U.S. Department of Veterans Affairs.

Billing for e-visits, however, raises knotty questions about the balance between fairly compensating providers for their time and enhancing patients’ access to care. Physicians and patient advocates fret particularly about the potential financial impact on lower-income people and those whose health conditions make it hard for them to see providers in person or talk to them on the phone or through video.

A large part of the motivation for the billing is to reduce the messaging. Soon after the pandemic hit, health systems saw a 50% increase in emails from patients, with primary care physicians facing the biggest burden, said A Jay Holmgren, an assistant professor of health informatics at UCSF, the University of California-San Francisco. System executives sought to compensate doctors and other providers for the extensive time they were spending answering emails, while prodding patients to think more carefully about whether an in-person visit might be more appropriate than a lengthy message.

After UCSF started charging in November 2021, the rate of patient messaging dipped slightly, by about 2%, Holmgren and his colleagues found.

Like UCSF, many other health systems now charge fees when doctors or other clinicians respond to patient messages that take five minutes or more of the provider’s time over a seven-day period and require medical expertise. They use three billing codes for e-visits, implemented in 2020 by the federal Centers for Medicare & Medicaid Services.

E-visits that are eligible for billing include those relating to changes in medication, new symptoms, changes or checkups related to a long-term condition, and requests to complete medical forms. There’s no charge for messages about appointment scheduling, prescription refills, or other routine matters that don’t require medical expertise.

So far, UCSF patients are being billed for only 2% to 3% of eligible e-visits, at least partly because it takes clinicians extra time and effort to figure out whether an email encounter qualifies for billing, Holmgren said.

At Cleveland Clinic, only 1.8% of eligible email visits are being billed to patients, said Eric Boose, the system’s associate chief medical information officer. There are three billing rates based on the time the clinician takes to prepare the message — five to 10 minutes, 11 to 20 minutes, and 21 minutes or more. He said patients haven’t complained about the new billing policy, which started last November, and that they’ve become “a little smarter and more succinct” in their messages, rather than sending multiple messages a week.

The doctors at Cleveland Clinic, like those at most health systems that bill for e-visits, don’t personally pocket the payments. Instead, they get productivity credits, which theoretically enables them to reduce their hours seeing patients in the office.

“Most of our physicians said it’s about time we’re getting compensated for our time in messaging,” Boose said. “We’re hoping this helps them feel less stressed and burned out, and that they can get home to their families earlier.”

“It’s been a frustration for many physicians for many years that we weren’t reimbursed for our ‘pajama-time’ work,” said Sterling Ransone, the chair of the American Academy of Family Physicians’ Board of Directors. Ransone’s employer, Riverside Health System in Virginia, started billing for e-visits in 2020. “We do it because it’s the right thing for patients. But rarely do you see other professions do all this online work for free,” he said.

“We see physicians working two to four hours every evening on their patient emails after their shift is over, and that’s not sustainable,” said CT Lin, the chief medical information officer at University of Colorado Health, which has not yet adopted billing for email visits. “But we worry that patients with complex disease will stop messaging us entirely because of this copay risk.”

Many health care professionals share the fear that billing for messages will adversely affect medically and socially vulnerable patients. Even a relatively small copay could discourage patients from emailing their clinicians for medical advice in appropriate situations, said Caitlin Donovan, a senior director at the National Patient Advocate Foundation, citing studies showing the dramatic negative impact of copays on medication adherence.

Holmgren said that while patients with minor acute conditions may not mind paying for an email visit rather than coming into the office, the new billing policies could dissuade patients with serious chronic conditions from messaging their doctors. “We don’t know who is negatively affected,” he said. “Are we discouraging high-value messages that produce a lot of health gains? That is a serious concern.”

Due to this worry, Lin said, University of Colorado Health is experimenting with an alternative way of easing the time burden of e-visits on physicians. Working with Epic, the dominant electronic health record vendor, it will have an artificial intelligence chatbot draft email replies to patient messages. The chatbot’s draft message will then be edited by the provider. Several other health systems are already using the tool.

There also are questions about price transparency — whether patients can know when and how much they’ll have to pay for an email visit, especially since much depends on their health plan’s deductibles and copays.

While Medicare, Medicaid, and most private health plans cover email visits, not all do, experts say. Coverage may depend on the contract between a health system and an insurer. Ransone said Elevance Health, a Blue Cross Blue Shield carrier, recently told his health system it would no longer pay for email or telephonic visits in its commercial or Medicaid plans in Virginia. An Elevance spokesperson declined to comment.

Another price concern is that patients who are uninsured or have high-deductible plans may face the full cost of an email visit, which could run as high as $160.

At University of Michigan Health, where Bakewell receives her care, patients receive a portal alert prior to sending a message that there may be a charge; they must click a box indicating they understand, said spokesperson Mary Masson.

But Donovan said that leaves a lot of room for uncertainty. “How is the patient supposed to know whether something will take five minutes?” Donovan said. “And knowing what you’ll be charged is impossible because of health plan design. Just saying patients could be charged is not providing transparency.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Por qué los CDC recomiendan el nuevo refuerzo contra covid para todos

September 13, 2023

Un panel federal de expertos recomendó el martes 12 de septiembre que todas las personas desde los 6 meses en adelante reciban el nuevo refuerzo contra covid-19. Estiman que la vacunación universal podría prevenir 100,000 hospitalizaciones adicionales cada año, en comparación con vacunar solo a las personas de edad avanzada.

El Comité Asesor sobre Prácticas de Inmunización (ACIP) de los Centros para el Control y Prevención de Enfermedades (CDC) votó 13-1 a favor de la moción después de meses de debate sobre si limitar los refuerzos a grupos de alto riesgo.

Un día antes, la Administración de Drogas y Alimentos (FDA) aprobó la nueva dosis de refuerzo, afirmando que era segura y eficaz para proteger contra las variantes de covid-19 que circulan actualmente en los Estados Unidos.

Después de que se lanzara el refuerzo anterior en 2022, solo el 17% de la población lo recibió, en comparación con aproximadamente la mitad de la nación que recibió la primera dosis de refuerzo en el otoño de 2021.

El cansancio pandémico y la evidencia de que las vacunas no siempre evitan las infecciones por covid-19 jugaron un rol.

Sin embargo, aquellos que se vacunaron tuvieron mucho menos riesgo de enfermarse gravemente o morir, según los datos presentados en la reunión del martes.

El virus a veces causa enfermedad grave incluso en personas sin afecciones subyacentes, provocando más muertes en niños que otras enfermedades prevenibles por vacunas como la varicela, antes de que se recomendara universalmente la vacuna contra este patógeno.

Los datos de los CDC muestran que el número de pacientes hospitalizados con covid-19 ha aumentado un poco en las últimas semanas, y los expertos en enfermedades infecciosas anticipan un alza más adelante en el otoño y el invierno.

Moderna y Pfizer junto con su socio alemán, BioNTech, fabrican las dosis, que costarán hasta $130. Han lanzado campañas de marketing nacionales para fomentar la vacunación. El comité asesor pospuso una decisión sobre una tercera dosis de refuerzo, producida por Novavax, porque la FDA aún no la ha aprobado.

Esto es lo que hay que saber:

¿Quién debe recibir la dosis de refuerzo contra covid-19?

Los CDC aconsejan que todos, desde los 6 meses, la reciban, por el beneficio común. Aquellos con mayor riesgo de enfermedad grave incluyen a bebés y niños pequeños, adultos mayores, mujeres embarazadas y personas con afecciones de salud crónicas, incluyendo la obesidad.

Los riesgos son menores, aunque no nulos, para todos los demás. Se sabe que las vacunas tienden a prevenir la infección en la mayoría de las personas solo durante unos meses. Pero hacen un buen trabajo al prevenir la hospitalización y la muerte, y, disminuyendo las infecciones, pueden frenar la propagación de la enfermedad entre los más vulnerables, cuyos sistemas inmunes pueden ser demasiado débiles para generar una buena respuesta a la vacuna.

Pablo Sánchez, profesor de pediatría en la Universidad Estatal de Ohio y el único disidente en el panel de los CDC, dijo que le preocupaba que las dosis de refuerzo no se hubieran probado lo suficiente, especialmente en niños.

La cepa de la vacuna en las nuevas dosis de refuerzo se aprobó solo en junio, por lo que casi todas las pruebas se hicieron en ratones o monos. Sin embargo, vacunas casi idénticas se han administrado de manera segura a miles de millones de personas en todo el mundo.

¿Cuándo deberías recibirlo?

Los fabricantes de la vacuna dicen que comenzarán a distribuirla la semana del 11 de septiembre. Si estás en un grupo de alto riesgo y no has sido vacunado o has tenido covid en los últimos dos meses, podrías recibirlo de inmediato, según John Moore, experto en inmunología de la Facultad de Medicina Weill Cornell.

Si planeas viajar en esta temporada de vacaciones, Moore sugiere que esperes hasta finales de octubre o principios de noviembre para maximizar el período en el que la protección inducida por la vacuna sigue siendo alta.

¿Quién pagará por las dosis?

Cuando el ACIP recomienda una vacuna para niños, el gobierno está legalmente obligado a garantizar la cobertura gratuita para los niños, y lo mismo se aplica a la cobertura de seguros comerciales para vacunas de adultos.

Para los 25 a 30 millones de adultos sin seguro, el gobierno federal creó el Bridge Access Program,  que pagará por las dosis en centros de salud rurales y comunitarios, así como en Walgreens, CVS y algunas farmacias independientes

Los fabricantes acordaron donar algunas de las dosis, según funcionarios de los CDC.

¿Funcionará esta nueva dosis de refuerzo contra las variantes actuales de covid-19?

Debería. Más del 90% de las cepas que circulan actualmente están estrechamente relacionadas con la variante seleccionada para la dosis de refuerzo a principios de este año, y los estudios mostraron que las vacunas producían suficientes anticuerpos contra la mayoría de ellas.

Las dosis también parecieron generar una buena respuesta inmune contra una cepa divergente que inicialmente preocupaba a las personas, llamada BA.2.86. En la actualidad, esa cepa representa menos del 1% de los casos.

¿Por qué algunos médicos no están entusiasmados con la dosis de refuerzo?

La experiencia con las vacunas contra covid-19 ha demostrado que su protección contra la hospitalización y la muerte dura más que su protección contra la enfermedad, que disminuye relativamente rápido, y esto ha generado escepticismo.

La mayoría de las personas en el país han tenido covid y la mayoría se vacunó al menos una vez, lo que en conjunto suele ser suficiente para prevenir enfermedades graves, si no infecciones, en la mayoría de las personas.

Además, muchos médicos creen que el enfoque debería estar en vacunar a quienes realmente están en riesgo.

Con la nueva dosis de refuerzo, más las vacunas contra la gripe y el virus respiratorio sincitial (VRS), ¿cuántas dosis debo esperar recibir este otoño?

Las personas tienden a enfermarse a finales del otoño porque pasan más tiempo en interiores y pueden viajar y reunirse en grupos familiares grandes. Este otoño, por primera vez, hay una vacuna contra el VRS para adultos mayores.

Kathryn Edwards, pediatra de 75 años de la Universidad de Vanderbilt, planea recibir las tres dosis, pero “probablemente no todas juntas”, dijo.

Covid-19 “puede tener un impacto” y algunas de las vacunas contra el VRS y la gripe recomendadas para mayores de 65 años también pueden causar dolor en el brazo y, a veces, fiebre u otros síntomas.

Un dato reciente que surgió de un análisis reveló que las personas que recibieron las vacunas contra la gripe y covid-19 juntas podrían tener un riesgo ligeramente mayor de accidente cerebrovascular. Esa conexión parece haber desaparecido después de un estudio posterior, pero aún podría ser más seguro no recibirlas juntas.

Pfizer y Moderna están probando vacunas combinadas, con la primera vacuna contra la gripe y covid-19 disponible a partir del próximo año.

¿Se ha utilizado esta versión de la dosis de refuerzo en otras partes del mundo?

No, aunque la vacuna de Pfizer ha sido aprobada en la Unión Europea, Japón y Corea del Sur, y Moderna ha obtenido la aprobación en Japón y Canadá. Los lanzamientos comenzarán en Estados Unidos y otros países esta semana.

A diferencia de períodos anteriores de la pandemia, es poco probable que haya mandatos para la dosis de refuerzo. Pero “es importante que las personas tengan acceso a la vacuna si la quieren”, dijo Beth Bell, miembro del panel y profesora de salud pública en la Universidad de Washington. “Dicho esto, está claro que el riesgo no es igual, y el mensaje debe aclarar que muchas personas mayores y personas con afecciones subyacentes están muriendo y realmente necesitan una dosis de refuerzo”, dijo.

Sarah Long, miembro del ACIP y pediatra en el Hospital Infantil de Philadelphia, votó a favor de una recomendación universal pero dijo que le preocupaba que no fuera suficiente. “Creo que la recomendaremos y nadie la recibirá”, dijo. “Las personas que más la necesitan no la recibirán”.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Why the CDC Has Recommended New Covid Boosters for All

September 13, 2023

Everyone over the age of 6 months should get the latest covid-19 booster, a federal expert panel recommended Tuesday after hearing an estimate that universal vaccination could prevent 100,000 more hospitalizations each year than if only the elderly were vaccinated.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 for the motion after months of debate about whether to limit its recommendation to high-risk groups. A day earlier, the FDA approved the new booster, stating it was safe and effective at protecting against the covid variants currently circulating in the U.S.

After the last booster was released, in 2022, only 17% of the U.S. population got it — compared with the roughly half of the nation who got the first booster after it became available in fall 2021. Broader uptake was hurt by pandemic weariness and evidence the shots don’t always prevent covid infections. But those who did get the shot were far less likely to get very sick or die, according to data presented at Tuesday’s meeting.

The virus sometimes causes severe illness even in those without underlying conditions, causing more deaths in children than other vaccine-preventable diseases, as chickenpox did before vaccines against those pathogens were universally recommended.

The number of hospitalized patients with covid has ticked up modestly in recent weeks, CDC data shows, and infectious disease experts anticipate a surge in the late fall and winter.

The shots are made by Moderna and by Pfizer and its German partner, BioNTech, which have decided to charge up to $130 a shot. They have launched national marketing campaigns to encourage vaccination. The advisory committee deferred a decision on a third booster, produced by Novavax, because the FDA hasn’t yet approved it. Here’s what to know:

Who should get the covid booster?

The CDC advises that everyone over 6 months old should, for the broader benefit of all. Those at highest risk of serious disease include babies and toddlers, the elderly, pregnant women, and people with chronic health conditions including obesity. The risks are lower — though not zero — for everyone else. The vaccines, we’ve learned, tend to prevent infection in most people for only a few months. But they do a good job of preventing hospitalization and death, and by at least diminishing infections they may slow spread of the disease to the vulnerable, whose immune systems may be too weak to generate a good response to the vaccine.

Pablo Sánchez, a pediatrics professor at The Ohio State University who was the lone dissenter on the CDC panel, said he was worried the boosters hadn’t been tested enough, especially in kids. The vaccine strain in the new boosters was approved only in June, so nearly all the tests were done in mice or monkeys. However, nearly identical vaccines have been given safely to billions of people worldwide.

When should you get it?

The vaccine makers say they’ll begin rolling out the vaccine this week. If you’re in a high-risk group and haven’t been vaccinated or been sick with covid in the past two months, you could get it right away, says John Moore, an immunology expert at Weill Cornell Medical College. If you plan to travel this holiday season, as he does, Moore said, it would make sense to push your shot to late October or early November, to maximize the period in which protection induced by the vaccine is still high.

Who will pay for it?

When the ACIP recommends a vaccine for children, the government is legally obligated to guarantee kids free coverage, and the same holds for commercial insurance coverage of adult vaccines. For the 25 to 30 million uninsured adults, the federal government created the Bridge Access Program. It will pay for rural and community health centers, as well as Walgreens, CVS, and some independent pharmacies, to provide covid shots for free. Manufacturers have agreed to donate some of the doses, CDC officials said.

Will this new booster work against the current variants of covid?

It should. More than 90% of currently circulating strains are closely related to the variant selected for the booster earlier this year, and studies showed the vaccines produced ample antibodies against most of them. The shots also appeared to produce a good immune response against a divergent strain that initially worried people, called BA.2.86. That strain represents fewer than 1% of cases currently. Moore calls it a “nothingburger.”

Why are some doctors not gung-ho about the booster?

Experience with the covid vaccines has shown that their protection against hospitalization and death lasts longer than their protection against illness, which wanes relatively quickly, and this has created widespread skepticism. Most people in the U.S. have been ill with covid and most have been vaccinated at least once, which together are generally enough to prevent grave illness, if not infection — in most people. Many doctors think the focus should be on vaccinating those truly at risk.

With new covid boosters, plus flu and RSV vaccines, how many shots should I expect to get this fall?

People tend to get sick in the late fall because they’re inside more and may be traveling and gathering in large family groups. This fall, for the first time, there’s a vaccine — for older adults — against respiratory syncytial virus. Kathryn Edwards, a 75-year-old Vanderbilt University pediatrician, plans to get all three shots but “probably won’t get them all together,” she said. Covid “can have a punch” and some of the RSV vaccines and the flu shot that’s recommended for people 65 and older also can cause sore arms and, sometimes, fever or other symptoms. A hint emerged from data earlier this year that people who got flu and covid shots together might be at slightly higher risk of stroke. That linkage seems to have faded after further study, but it still might be safer not to get them together.

Pfizer and Moderna are both testing combination vaccines, with the first flu-covid shot to be available as early as next year.

Has this booster version been used elsewhere in the world?

Nope, although Pfizer’s shot has been approved in the European Union, Japan, and South Korea, and Moderna has won approval in Japan and Canada. Rollouts will start in the U.S. and other countries this week.

Unlike in earlier periods of the pandemic, mandates for the booster are unlikely. But “it’s important for people to have access to the vaccine if they want it,” said panel member Beth Bell, a professor of public health at the University of Washington.

“Having said that, it’s clear the risk is not equal, and the messaging needs to clarify that a lot of older people and people with underlying conditions are dying, and they really need to get a booster,” she said.

ACIP member Sarah Long, a pediatrician at Children’s Hospital of Philadelphia, voted for a universal recommendation but said she worried it was not enough. “I think we’ll recommend it and nobody will get it,” she said. “The people who need it most won’t get it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Despite Successes, Addiction Treatment Programs for Families Struggle to Stay Open

September 13, 2023

MORA, Minn. — Two playgrounds border the Recovering Hope Treatment Center for addiction that sits at the end of a gravel road in eastern Minnesota’s rural Kanabec County. A meeting room inside is furnished with rocking chairs and baby walkers. And there are strollers in the halls.

Recovering Hope is one of only five providers in the state that offer family-based residential treatment, allowing women to enter the program while pregnant or to bring one of their children younger than 5 with them for the duration of their stay. Men can receive outpatient treatment but aren’t permitted in the residential program.

It’s the only such residential program located in a rural Minnesota county and is licensed for 108 beds. It has a waitlist that can span from two to six weeks, depending on whether a woman plans to enter treatment alone or with her child.

“If you don’t provide family services, the parents run the risk of losing their kids,” said Ashley Snyder, a licensed drug and alcohol counselor at Recovering Hope.

Family-based residential treatment has been recognized by behavioral health professionals as having better outcomes for women and their children. But such programs often struggle to stay afloat because of staffing shortages and volatile funding. And because of that complexity, families in rural areas are less likely to find such a residential treatment program in their communities.

Meanwhile, maternal opioid-related diagnoses have increased nationwide. From 2010 to 2017, the rates of women with those diagnoses at delivery increased by 131% and babies born with withdrawal symptoms increased by 82%, according to the Centers for Disease Control and Prevention. The increases disproportionately affected rural areas. At Recovering Hope, opioids are among the top substances, along with alcohol and meth, that lead women to seek treatment.

“There are too few programs,” said Margaret Ratcliff, an executive vice president at Volunteers of America, which co-published a national directory of family-based residential treatment programs with Wilder Research in 2019. At that time, the directory listed 362 family-based residential treatment programs nationwide, a number that experts, including Ratcliff, say is continually in flux.

Many of the programs offer some variation of the model in place at Recovering Hope, though the maximum age of children varies.

From its own affiliations with such programs, Ratcliff said, Volunteers of America has seen that “the problem is that Medicaid does not cover the cost of a comprehensive program, and grants come and go.”

Even at Recovering Hope, which has operated since 2016 and is expanding its outpatient treatment to include teenagers and building sober houses, smaller insurance reimbursements have affected care. Women in the center’s residential program previously spent up to an average of 40 days in high-intensity care at the beginning of their treatment, but that timespan is now closer to 30 days to contain costs due to those low reimbursement rates. Most of the women in the residential treatment program are covered by Medicaid.

High-intensity care accounts for a third of the center’s treatment plan. On average, women’s full residential treatment at Recovering Hope lasts 90 to 120 days. During that time, women can enroll their children in on-site day care and bring them along to programming. The kids receive regular visits from a Head Start educator and a psychologist.

Researchers say that family-based residential treatment can improve women’s pregnancy outcomes by keeping them away from drug use during their pregnancy and strengthening their bond with their children. Experts also say the programs increase the likelihood that women will complete treatment.

Beyond the financial hurdles involved in running family treatment programs, managers face logistical constraints. Providing schooling is one of the challenges that come with operating a family-based treatment center, Snyder said. For example, she said, part of the reason the facility allows only for children younger than 5 is to not affect local school enrollment.

“The school district kind of said, ‘Hey, if you put kids in our school district, and then take them out, that’s not great for us,’” she said. “‘We don’t have enough teachers. So, if you put three kids in the classroom that’s already at max, we would technically need to hire another teacher, but they’re only here for three months.’”

In addition to the age restriction, Recovering Hope limits the women to bringing one child each.

For Lisa Thompson, who was in residential treatment there from January to April, that limit led her to leave both of her kids with their grandmother rather than split them up.

“First getting there, it was really hard seeing women with their children and not having mine,” Thompson, 40, said. “But after being there, and becoming more comfortable, it was just nice being able to have that connection with other mothers there.”

For Gabriela Cajucom, Recovering Hope’s ability to accommodate one child helped her reunite with her oldest son one month into her inpatient program, which ran from November to February. Child Protective Services had originally placed him with his grandmother but allowed him to live with Cajucom as she completed her treatment.

“He even just ran up to one of the old day care ladies, like totally remembered her and gave her a hug,” said Cajucom, 26, who since has moved to outpatient treatment and is set to graduate in October. “It was a very good community feeling.”

CPS granted her custody of her son in May.

But despite success stories from Recovering Hope and other programs, some states have found it difficult to keep such facilities running.

In neighboring North Dakota, the state Department of Health and Human Services has been trying to establish a family-based residential treatment option like Recovering Hope since 2020. The state has been without one since April 2019, when its lone provider shut down.

The department has issued three requests for proposals seeking providers to offer a treatment model that allows children to live with a parent undergoing residential treatment but didn’t receive any responses.

“It was during covid, the height of covid, and programs were really trying to maintain what they had, or they were already decreasing some of their services due to capacity or changing their practices to go to telehealth,” said Lacresha Graham, the department’s manager of addiction treatment and recovery program and policy. “I guess that caused providers to not want to look at expanding.”

In requesting proposals, the state outlined requirements, such as: The provider must have the residential capacity to serve at least 10 women and their children at once and situate the facility in a community with a neonatal intensive care unit.

Though the expectation is that providers already have experience in adult addiction treatment, they also must change their care model to accommodate both the physical and health needs of mothers and children, Graham said.

In May, Republican Gov. Doug Burgum approved a one-time $1 million allocation in the state Health and Human Services 2023-25 budget to fund family-based residential treatment, which can be used to cover construction and renovation costs. As a result, the department is working to issue another request for proposals to find a provider that offers services like those at Recovering Hope.

“Ideally, there would be multiple across the state so there’d be better access to locations for women that would need it,” Graham said. “Our priority is getting one up and running and see where we can go from there.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

‘Dr. Google’ Meets Its Match: Dr. ChatGPT

September 12, 2023

As a fourth-year ophthalmology resident at Emory University School of Medicine, Riley Lyons’ biggest responsibilities include triage: When a patient comes in with an eye-related complaint, Lyons must make an immediate assessment of its urgency.

He often finds patients have already turned to “Dr. Google.” Online, Lyons said, they are likely to find that “any number of terrible things could be going on based on the symptoms that they’re experiencing.”

So, when two of Lyons’ fellow ophthalmologists at Emory came to him and suggested evaluating the accuracy of the AI chatbot ChatGPT in diagnosing eye-related complaints, he jumped at the chance.

In June, Lyons and his colleagues reported in medRxiv, an online publisher of health science preprints, that ChatGPT compared quite well to human doctors who reviewed the same symptoms — and performed vastly better than the symptom checker on the popular health website WebMD. And despite the much-publicized “hallucination” problem known to afflict ChatGPT — its habit of occasionally making outright false statements — the Emory study reported that the most recent version of ChatGPT made zero “grossly inaccurate” statements when presented with a standard set of eye complaints.

The relative proficiency of ChatGPT, which debuted in November 2022, was a surprise to Lyons and his co-authors. The artificial intelligence engine “is definitely an improvement over just putting something into a Google search bar and seeing what you find,” said co-author Nieraj Jain, an assistant professor at the Emory Eye Center who specializes in vitreoretinal surgery and disease.

But the findings underscore a challenge facing the health care industry as it assesses the promise and pitfalls of generative AI, the type of artificial intelligence used by ChatGPT: The accuracy of chatbot-delivered medical information may represent an improvement over Dr. Google, but there are still many questions about how to integrate this new technology into health care systems with the same safeguards historically applied to the introduction of new drugs or medical devices.

The smooth syntax, authoritative tone, and dexterity of generative AI have drawn extraordinary attention from all sectors of society, with some comparing its future impact to that of the internet itself. In health care, companies are working feverishly to implement generative AI in areas such as radiology and medical records.

When it comes to consumer chatbots, though, there is still caution, even though the technology is already widely available — and better than many alternatives. Many doctors believe AI-based medical tools should undergo an approval process similar to the FDA’s regime for drugs, but that would be years away. It’s unclear how such a regime might apply to general-purpose AIs like ChatGPT.

“There’s no question we have issues with access to care, and whether or not it is a good idea to deploy ChatGPT to cover the holes or fill the gaps in access, it’s going to happen and it’s happening already,” said Jain. “People have already discovered its utility. So, we need to understand the potential advantages and the pitfalls.”

The Emory study is not alone in ratifying the relative accuracy of the new generation of AI chatbots. A report published in Nature in early July by a group led by Google computer scientists said answers generated by Med-PaLM, an AI chatbot the company built specifically for medical use, “compare favorably with answers given by clinicians.”

AI may also have better bedside manner. Another study, published in April by researchers from the University of California-San Diego and other institutions, even noted that health care professionals rated ChatGPT answers as more empathetic than responses from human doctors.

Indeed, a number of companies are exploring how chatbots could be used for mental health therapy, and some investors in the companies are betting that healthy people might also enjoy chatting and even bonding with an AI “friend.” The company behind Replika, one of the most advanced of that genre, markets its chatbot as, “The AI companion who cares. Always here to listen and talk. Always on your side.”

“We need physicians to start realizing that these new tools are here to stay and they’re offering new capabilities both to physicians and patients,” said James Benoit, an AI consultant. While a postdoctoral fellow in nursing at the University of Alberta in Canada, he published a study in February reporting that ChatGPT significantly outperformed online symptom checkers in evaluating a set of medical scenarios. “They are accurate enough at this point to start meriting some consideration,” he said.

Still, even the researchers who have demonstrated ChatGPT’s relative reliability are cautious about recommending that patients put their full trust in the current state of AI. For many medical professionals, AI chatbots are an invitation to trouble: They cite a host of issues relating to privacy, safety, bias, liability, transparency, and the current absence of regulatory oversight.

The proposition that AI should be embraced because it represents a marginal improvement over Dr. Google is unconvincing, these critics say.

“That’s a little bit of a disappointing bar to set, isn’t it?” said Mason Marks, a professor and MD who specializes in health law at Florida State University. He recently wrote an opinion piece on AI chatbots and privacy in the Journal of the American Medical Association. “I don’t know how helpful it is to say, ‘Well, let’s just throw this conversational AI on as a band-aid to make up for these deeper systemic issues,’” he said to KFF Health News.

The biggest danger, in his view, is the likelihood that market incentives will result in AI interfaces designed to steer patients to particular drugs or medical services. “Companies might want to push a particular product over another,” said Marks. “The potential for exploitation of people and the commercialization of data is unprecedented.”

OpenAI, the company that developed ChatGPT, also urged caution.

“OpenAI’s models are not fine-tuned to provide medical information,” a company spokesperson said. “You should never use our models to provide diagnostic or treatment services for serious medical conditions.”

John Ayers, a computational epidemiologist who was the lead author of the UCSD study, said that as with other medical interventions, the focus should be on patient outcomes.

“If regulators came out and said that if you want to provide patient services using a chatbot, you have to demonstrate that chatbots improve patient outcomes, then randomized controlled trials would be registered tomorrow for a host of outcomes,” Ayers said.

He would like to see a more urgent stance from regulators.

“One hundred million people have ChatGPT on their phone,” said Ayers, “and are asking questions right now. People are going to use chatbots with or without us.”

At present, though, there are few signs that rigorous testing of AIs for safety and effectiveness is imminent. In May, Robert Califf, the commissioner of the FDA, described “the regulation of large language models as critical to our future,” but aside from recommending that regulators be “nimble” in their approach, he offered few details.

In the meantime, the race is on. In July, The Wall Street Journal reported that the Mayo Clinic was partnering with Google to integrate the Med-PaLM 2 chatbot into its system. In June, WebMD announced it was partnering with a Pasadena, California-based startup, HIA Technologies Inc., to provide interactive “digital health assistants.” And the ongoing integration of AI into both Microsoft’s Bing and Google Search suggests that Dr. Google is already well on its way to being replaced by Dr. Chatbot.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

The Shrinking Number of Primary Care Physicians Is Reaching a Tipping Point

September 08, 2023

I’ve been receiving an escalating stream of panicked emails from people telling me their longtime physician was retiring, was no longer taking their insurance, or had gone concierge and would no longer see them unless they ponied up a hefty annual fee. They have said they couldn’t find another primary care doctor who could take them on or who offered a new-patient appointment sooner than months away.

Their individual stories reflect a larger reality: American physicians have been abandoning traditional primary care practice — internal and family medicine — in large numbers. Those who remain are working fewer hours. And fewer medical students are choosing a field that once attracted some of the best and brightest because of its diagnostic challenges and the emotional gratification of deep relationships with patients.

The percentage of U.S. doctors in adult primary care has been declining for years and is now about 25% — a tipping point beyond which many Americans won’t be able to find a family doctor at all.

Already, more than 100 million Americans don’t have usual access to primary care, a number that has nearly doubled since 2014. One reason our coronavirus vaccination rates were low compared with those in countries such as China, France, and Japan could be because so many of us no longer regularly see a familiar doctor we trust.

Another telling statistic: In 1980, 62% of doctor’s visits for adults 65 and older were for primary care and 38% were for specialists, according to Michael L. Barnett, a health systems researcher and primary care doctor in the Harvard Medical School system. By 2013, that ratio had exactly flipped and has likely “only gotten worse,” he said, noting sadly: “We have a specialty-driven system. Primary care is seen as a thankless, undesirable backwater.” That’s “tragic,” in his words — studies show that a strong foundation of primary care yields better health outcomes overall, greater equity in health care access, and lower per capita health costs.

One explanation for the disappearing primary care doctor is financial. The payment structure in the U.S. health system has long rewarded surgeries and procedures while shortchanging the diagnostic, prescriptive, and preventive work that is the province of primary care. Furthermore, the traditionally independent doctors in this field have little power to negotiate sustainable payments with the mammoth insurers in the U.S. market.

Faced with this situation, many independent primary care doctors have sold their practices to health systems or commercial management chains (some private equity-owned) so that, today, three-quarters of doctors are now employees of those outfits.

One of them was Bob Morrow, who practiced for decades in the Bronx. For a typical visit, he was most recently paid about $80 if the patient had Medicare, with its fixed-fee schedule. Commercial insurers paid significantly less. He just wasn’t making enough to pay the bills, which included salaries of three employees, including a nurse practitioner. “I tried not to pay too much attention to money for four or five years — to keep my eye on my patients and not the bottom line,” he said by phone from his former office, as workers carted away old charts for shredding.

He finally gave up and sold his practice last year to a company that took over scheduling, billing, and negotiations with insurers. It agreed to pay him a salary and to provide support staff as well as supplies and equipment.

The outcome: Calls to his office were routed to a call center overseas, and patients with questions or complaining of symptoms were often directed to a nearby urgent care center owned by the company — which is typically more expensive than an office visit. His office staff was replaced by a skeleton crew that didn’t include a nurse or skilled worker to take blood pressure or handle requests for prescription refills. He was booked with patients every eight to 10 minutes.

He discovered that the company was calling some patients and recommending expensive tests — such as vascular studies or an abdominal ultrasound — that he did not believe they needed.

He retired in January. “I couldn’t stand it,” he said. “It wasn’t how I was taught to practice.”

Of course, not every practice sale ends with such unhappy results, and some work out well.

But the dispirited feeling that drives doctors away from primary care has to do with far more than money. It’s a lack of respect for nonspecialists. It’s the rising pressure to see and bill more patients: Employed doctors often coordinate the care of as many as 2,000 people, many of whom have multiple problems.

And it’s the lack of assistance. Profitable centers such as orthopedic and gastroenterology clinics usually have a phalanx of support staff. Primary care clinics run close to the bone.

“You are squeezed from all sides,” said Barnett.

Many ventures are rushing in to fill the primary care gap. There had been hope that nurse practitioners and physician assistants might help fill some holes, but data shows that they, too, increasingly favor specialty practice. Meanwhile, urgent care clinics are popping up like mushrooms. So are primary care chains such as One Medical, now owned by Amazon. Dollar General, Walmart, Target, CVS Health, and Walgreens have opened “retail clinics” in their stores.

Rapid-fire visits with a rotating cast of doctors, nurses, or physician assistants might be fine for a sprained ankle or strep throat. But they will not replace a physician who tells you to get preventive tests and keeps tabs on your blood pressure and cholesterol — the doctor who knows your health history and has the time to figure out whether the pain in your shoulder is from your basketball game, an aneurysm, or a clogged artery in your heart.

Some relatively simple solutions are available, if we care enough about supporting this foundational part of a good medical system. Hospitals and commercial groups could invest some of the money they earn by replacing hips and knees to support primary care staffing; giving these doctors more face time with their patients would be good for their customers’ health and loyalty if not (always) the bottom line.

Reimbursement for primary care visits could be increased to reflect their value — perhaps by enacting a national primary care fee schedule, so these doctors won’t have to butt heads with insurers. And policymakers could consider forgiving the medical school debt of doctors who choose primary care as a profession.

They deserve support that allows them to do what they were trained to do: diagnosing, treating, and getting to know their patients.

The United States already ranks last among wealthy countries in certain health outcomes. The average life span in America is decreasing, even as it increases in many other countries. If we fail to address the primary care shortage, our country’s health will be even worse for it.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

KFF Health News' 'What the Health?': Welcome Back, Congress. Now Get to Work. 

September 07, 2023
The Host Julie Rovner KFF Health News @jrovner Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

Congress returns from its August recess with a long list of things to do and not a lot of time to do them. The fiscal year ends Sept. 30, and it’s possible that lawmakers will fail to finish work not only on the annual appropriations bills, but also on any short-term spending bill to keep the government open.

Meanwhile, Medicare has announced the first 10 drugs whose prices will be negotiated under the Inflation Reduction Act of 2022. Exactly how the program will work remains a question, however. Even how the process will begin is uncertain, as drugmakers and other groups have filed lawsuits to stop it.

This week’s panelists are Julie Rovner of KFF Health News, Rachel Cohrs of Stat, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, and Alice Miranda Ollstein of Politico.

Panelists Rachel Cohrs Stat News @rachelcohrs Read Rachel's stories Joanne Kenen Johns Hopkins Bloomberg School of Public Health and Politico @JoanneKenen Read Joanne's stories Alice Miranda Ollstein Politico @AliceOllstein Read Alice's stories

Among the takeaways from this week’s episode:

  • Hard-line Republicans are refusing to back even a temporary government spending bill, suggesting a government shutdown looms — with repercussions for health programs. While the Senate and House have come to intra-chamber agreements on subjects like community health center funding or even have passed spending bills, Congress as a whole has been unable to broker an overarching deal.
  • A coalition of House Republicans is falsely claiming that global HIV/AIDS funding through PEPFAR promotes abortion and is battling efforts to extend the program’s funding. PEPFAR is a bipartisan effort spearheaded by then-President George W. Bush and credited with saving millions of lives.
  • The PEPFAR fight underscores the dysfunction of the current Congress, which is struggling to fund even a highly regarded, lifesaving program. Another example is the months-long blockade of military promotions by a freshman Republican senator, Alabama’s Tommy Tuberville, a member of the Senate Armed Services Committee. His objections over an abortion-related Pentagon policy have placed him at odds with top military leaders, who recently warned that his heavy-handed approach is weakening military readiness.
  • The Biden administration recently announced new staffing requirements for nursing homes, as a way to get more nurses into such facilities. But how long will compliance take, considering ongoing nursing shortages? And the drug industry is reacting to the news of which 10 drugs will be up first for Medicare negotiation, with much left to be sorted out.
  • In abortion news, a Texas effort to block patients seeking abortions from using the state’s roads is spreading town to town — and, despite being dubiously enforceable, it could still have a chilling effect.

Also this week, Rovner interviews Meena Seshamani, who leads the federal Medicare program, about the plan to start negotiating drug prices.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: JAMA Health Forum’s “Health Systems and Social Services — A Bridge Too Far?” by Sherry Glied and Thomas D’Aunno.

Alice Miranda Ollstein: The Washington Post’s “Heat’s Hidden Risk,” by Shannon Osaka, Erin Patrick O’Connor, and John Muyskens.

Rachel Cohrs: The Wall Street Journal’s “How Novartis’s CEO Learned From His Mistakes and Got Help From an Unlikely Quarter,” by Jared S. Hopkins.

Joanne Kenen: Politico’s “How to Wage War on Conspiracy Theories,” by Joanne Kenen, and “Court Revives Doctors’ Lawsuit Saying FDA Overstepped Its Authority With Anti-Ivermectin Campaign,” by Kevin McGill.

Also mentioned in this week’s episode:

Credits Francis Ying Audio producer Emmarie Huetteman Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ “What the Health?” on SpotifyApple PodcastsPocket Casts, or wherever you listen to podcasts.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Most States Have Yet to Permanently Fund 988. Call Centers Want Certainty.

September 07, 2023

Since the National Suicide Prevention Lifeline transitioned a year ago to the three-digit crisis phone number 988, there has been a 33% increase in the number of calls, chats, and texts to the hotline.

But even with that early sign of success, the program’s financial future is shaky.

Over the past two years, the federal government has provided about $1 billion from the American Rescue Plan and Bipartisan Safer Communities acts to launch the number, designed as an alternative to 911 for those experiencing a mental health crisis. After that infusion runs out, it’s up to states to foot the bill for their call centers.

“We don’t know what Congress will allocate in the future,” said Danielle Bennett, a spokesperson for the federal Substance Abuse and Mental Health Services Administration, which oversees 988. “But the hope is that there will be continued strong bipartisan support for funding 988 at the level it needs to be funded at and that states will also create funding mechanisms that make sense for their states.”

Only eight states have enacted legislation to sustain 988 through phone fees, according to the National Alliance on Mental Illness, which is tracking state funding for the system. Others have budgeted short-term funding. But many predominantly rural states, where mental health services are in short supply and suicide rates are often higher than in more urban states, have not made long-term plans to provide support.

According to a KFF analysis of Lifeline data, since last summer 988 has received almost 5 million contacts, including calls, texts, and chat messages. And state programs managed to answer a high percentage of 988 calls instead of routing them to call centers elsewhere.

Mental health advocates and state 988 operators say that to keep those in-state staffers answering phones, promises of long-term funding are critical.

In the earlier version of the National Suicide Prevention Lifeline, “call centers, basically, were not paid,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, which advocates for sustained investment in 988. “There is a growing recognition that we’re making it easier for people to contact and, therefore, we need to build more infrastructure.”

In Ohio, where data from spring 2023 shows local operators responded to 88% of calls, lawmakers recently acknowledged the need for stable funding. In July, Republican Gov. Mike DeWine approved $46.5 million for 988 in the state’s biennial budget. But that support will last only two years.

“It is still not the most secure form of funding that we would hope for,” said Brian Stroh, CEO and medical director of Netcare Access, a call center that serves four rural counties on Ohio’s eastern border. “What if we turned the tables a little bit and said we’re only going to fund 911 a little bit at a time? That’s a really hard proposition to work under.”

SAMHSA, which distributes 988 grant funding, likens the number to 911 except that it is strictly for mental health crises. The law that mandated 988’s creation, the National Suicide Hotline Designation Act of 2020, allows states to install phone surcharges to support 988 indefinitely, similar to the funding structure for 911.

Stroh said that, while he is “pretty pleased” with how the first year of 988 went for Netcare Access, with short-term funding it’s hard to reassure prospective call operators of job security or compete with rising wages in other industries.

For Kristin McCloud, executive director of Pathways of Central Ohio, a call center that also responds to rural counties in the eastern part of the state, the $573,056 her center received in 988’s first year was exactly what it needed. She had money for training staffers to answer crisis calls and supplying them with computers for remote work.

During that time, operators answered 2,316 calls — almost double the previous year’s volume.

“I really feel like, for once, we were given adequate funding,” said McCloud, who has worked in social services more than 35 years.

According to SAMHSA, before 988 grants, most call centers received minimal federal funding to answer Lifeline calls, typically between $2,500 and $5,000 annually.

Like Stroh, McCloud views Ohio’s recent allocation as positive but hopes the state installs a permanent funding plan. A bill pending in the legislature would add a surcharge to phone bills to help fund 988, as a few other states have done.

All but one of the eastern counties that Pathways of Central Ohio and Netcare Access serve are designated by the state’s Department of Health Primary Care Office as mental health professional shortage areas.

In North Dakota, where almost every county is rural and has such a designation, a single call center manages the state’s 988 program.

That center, FirstLink, has seen a significant increase in mental health crisis calls since the transition to 988. Comparing the first six months of 2023 to the first of 2022 alone, calls have increased 55%, according to Jeremy Brown, outreach director.

The demand has “helped us with sparking conversations with our state legislature about funding and support,” he said.

In May, Republican Gov. Doug Burgum approved a one-time $1.86 million appropriation to 988 in the state’s biennial budget.

Brown said the funding will not only allow FirstLink to train staff members and keep phone lines updated, but it will also help human service centers support mobile crisis units that can be dispatched to callers if necessary.

Though mobile crisis unit dispatch is an option, FirstLink prefers to deescalate crises over the phone, said Dallas Tufty, one of FirstLink’s operators.

“The only time that we’ll really call for rescue or something is if that person is in immediate, imminent danger of their life,” they said.

Tufty works 40 hours a week at FirstLink, at least six of those spent answering calls and messages to 988. Operators like Tufty also answer FirstLink’s 211 line, another program that provides health and social service assistance information to callers. It’s not an emergency line, but on occasion people in crisis call there instead of 988.

No matter which line a call comes through, Tufty said, the hard part is not knowing what happens once the call is over.

“There’s times where you don’t really know if they’re going to call back because they need to again,” they said. “Even if you make a plan, there’s only so much we can do on the phone to hold people to those plans.”

While North Dakota and Ohio fund 988 through their state budgets, not all states do. In Montana, Republican Gov. Greg Gianforte recently dedicated $300 million to the behavioral health and developmental disabilities systems that, among other uses, can fund “ opportunities for Montanans to receive integrated physical and behavioral health care,” according to the bill authorizing the money. But the state has yet to address 988 funding specifically.

In 2021, Montana lawmakers declined to advance a bill that would have established a phone fee and corresponding revenue account to fund 988 ahead of its launch.

At this point, “if it is able to be funded in the budget, without new legislation, that’s just fine with us,” said Matt Kuntz, executive director of Montana’s chapter of the National Alliance on Mental Illness. “We just want to make sure that it’s sustainably funded, because it is an important service.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Even in the Most Depressed County in America, Stigma Around Mental Illness Persists

September 06, 2023

LOGAN, W.Va. — Sitting on a bench laughing with a co-worker during a morning smoke break, Debra Orcutt quickly raises her hand when asked if she knows anyone dealing with depression.

“I am,” she tells a visitor to the roadside market where she bakes brownies and peanut butter fudge.

Orcutt, 63, has used medication to manage her depression for more than two decades since her son, Kyle, died at age 4 from a congenital illness. “There were days I couldn’t leave the house,” she said.

After a long marriage that ended in divorce, she said, she lives happily with her “hillbilly” partner near this small town in the heart of Appalachia, an hour’s drive south of the state capital, Charleston. But certain things, such as the sound of an ambulance siren or the death of her potbellied pig, can trigger lingering feelings of sadness.

Orcutt is hardly alone in this county, where almost everyone knows someone with depression — or experiences it themselves. And that’s not an exaggeration.

An estimated 32% of adults in Logan County, West Virginia, have been diagnosed with depression — the highest rate in the United States and nearly double the national rate, according to a report released in June by the Centers for Disease Control and Prevention.

The study, which provided estimates by county based on a national survey of nearly 400,000 people conducted in 2020, showed depression rates varied widely by region and even within states. Most counties with the highest rates were in a 13-state swath of Appalachia; the southern Mississippi River Valley, particularly Arkansas, Louisiana, and Tennessee; and Missouri, Oklahoma, and Washington.

The states with the lowest rates included California, Illinois, Alaska, and Hawaii.

West Virginia, which also has some of the nation’s highest rates of poverty and poor health, is home to eight of the 10 counties with the highest estimated rates of adult depression, the CDC survey found.

Overall, 18% of adults in the United States reported having been diagnosed with depression in their lifetimes, the CDC survey found.

Health experts say depression has risen to epidemic levels in the U.S. in recent decades, and the covid-19 pandemic exacerbated the problem with its isolating public health measures, threat of serious illness, lingering health effects, and sobering death toll.

With heightened awareness of rising depression rates, the Biden administration has announced plans to expand access to mental health care.

The CDC findings correlate with those from other surveys that show depression rates at alarming levels.

More than a simple case of the blues, depression is a mood disorder that causes a persistent feeling of sadness and a loss of interest in things once enjoyed. It affects eating, sleeping, and concentrating, as well as activities such as working or going to school.

“Depression is often a chronic illness, and if you stop treatment, it eventually comes back,” said Mark Miller, a psychiatry professor at West Virginia University in Morgantown.

He said his state’s combination of poor overall health, low education levels, and poverty — as well as the opioid epidemic, which has hit West Virginia particularly hard — takes a punishing toll on residents’ mental health.

In Logan County, nearly a quarter of whose 31,000 residents live in poverty, few expressed surprise in interviews with KFF Health News when told their home tops the list of most depressed counties.

“You’ve come to the right place for depression,” said Marie Tomblin as she worked the front desk of the Holiday Inn Express & Suites in Logan, noting her sister, daughter, and other family members have faced it. “I see it a whole lot, and people think it’s a normal feeling and don’t want to admit they have a problem,” she said.

Logan County is in the Appalachian coal-mining region, now a shadow of its former self, as the industry has buckled under economic and regulatory pressures, taking many jobs with it. In Logan, the county seat, the downtown has numerous closed stores and office buildings, and few people were out walking its sidewalks on a recent weekday morning.

The county’s high rates of chronic diseases like diabetes and obesity also make it a breeding ground for depression, health experts say.

While depression rates have risen nationally, Medicare claims data shows treatment for depression has increased more in West Virginia and especially in Logan County in recent years. Nationwide, 18% of enrollees in original Medicare received care related to depression in 2020, up from 16% in 2012 — despite an overall drop in care as the pandemic struck.

In Logan County, it was 28% of Medicare enrollees in 2020, up from 21% in 2012. As in the CDC study, Logan County’s numbers were among the highest in the country.

Yet, health professionals here say they are not overwhelmed by people seeking help for the condition.

Robert Perez, an internist in Logan, estimates more than half of his patients have depression. But he said few want to talk about it or accept a referral to a psychiatrist and he is limited in what he can do for them.

“It’s hard to convince people who don’t want to be helped,” he said. “I don’t have that much time to treat their depression.”

David Brash, the chief executive of Logan Regional Medical Center, which sits on a hill overlooking the town, said he’s not surprised by the area’s high depression rates.

The medical center doesn’t have psychiatrists on staff, but its primary care doctors try to treat depression as part of their practice, he said. The center recently started offering telepsychiatric consultations for its physicians to help treat patients in its emergency room.

“When you come from this area, you know what the challenges are,” Brash said. “And the economic challenges affect the depression — it’s not a new phenomenon.”

Diana Barnette, the county’s top elected official as president of the Logan County Commission, said doctors are often too quick to give patients medicine when they are feeling down. “I’m not saying we do not have a lot of depression in the area, but culturally it’s become so accepted to have a doctor give you a pill to make you feel better.”

Barnette, who owns several businesses in the county, including a movie theater, also blames the region’s rainy, cloudy weather and how its mountains limit residents’ sun exposure.

“There’s still a lot of stigma around it,” said Michael Baker, a pharmacist at Aracoma Drug Company, a pharmacy in Chapmanville, the county’s largest town after Logan.

Indeed, Chris Palmer, an assistant professor of psychiatry at Harvard Medical School, said the notion that overprescribing or cloudy weather explains high depression rates does not help the problem.

That viewpoint “strikes me as a hopeless and nihilistic attitude, that we are drowning and there is nothing we can do about it,” he said.

There are glimmers of hope here.

The pandemic is considered over by most residents; the state has leaned into its tourism motto, “Almost Heaven,” inspired by a well-known John Denver tune; and the region’s economy is slowly shifting from coal as the county markets its wooded trails to all-terrain vehicle enthusiasts.

In June, the same month the CDC released its findings, Coalfield Health Center, a federally funded clinic in the county, announced it had hired its first psychiatrist, David Lewis.

Lewis, who grew up in Logan County and taught high school math here, said he has seen about 50 patients so far and knows he has room to see more.

“People are not used to having the option of going to a psychiatrist here, and doctors still refer out to bigger institutions, which could be in Charleston,” he said.

Coalfield is struggling to overcome the stigma and other treatment obstacles around depression. In this region, Lewis said, people often view going for mental health help as being “weak in faith.”

“Only a small percentage of people who need help for depression are getting it,” said Kristin Dial, the executive director of Coalfield Health Center. “What we have found is that we can refer them to Dr. Lewis, but we have a high no-show rate.”

“We have to be here when they are ready,” she said.

Lewis said the best treatment for depression includes improving diet and exercise and avoiding drugs and alcohol. But when patients are asked how they want to manage their illness, they tend just to want pills, he said.

Coalfield also has a nurse practitioner, Elice Hinkle, who recently finished training to offer counseling at the clinic.

Because patients know Hinkle from her having treated their physical ailments, she said, they are more likely to come for counseling, and she can coordinate efforts with a patient’s other providers at the clinic.

Back at the market, Orcutt says it’s been many years since she went to counseling. These days, she copes with her depression and anxiety by keeping busy with hobbies such as sculpting and painting.

“It helps not to dwell on it,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Mississippi’s Cervical Cancer Deaths Indicate Broader Health Care Problems

September 05, 2023

Shementé Jones knew something wasn’t right. Her back hurt. She felt pain during sex.

She said she kept telling her doctor something was wrong.

Her doctor told her, “Just wash your underwear in Dreft,” Jones said, referring to a brand of detergent.

Within months of that 2016 appointment, Jones, who lives in a suburb of Jackson, Mississippi, was diagnosed with stage 3 cervical cancer. She underwent a hysterectomy then weeks of radiation therapy.

“I ended up fine,” said Jones, now 43. “But what about all the other women?”

The question is especially pertinent in Jones’ home state, which had the nation’s second-highest age-adjusted cervical cancer mortality rate, 3.4 deaths per 100,000 women and girls annually from 2016 through 2020, behind only Oklahoma, according to National Cancer Institute data. And, for non-Hispanic Black women such as Jones, the rates in the state are even higher — 3.7 deaths per 100,000 people. This all translates to about 50 avoidable deaths of Mississippi women from cervical cancer each year in this largely rural state.

Health care experts said such a high death rate from a cancer that is preventable, detectable, and successfully treatable when found early is a warning sign about the general state of health care in Mississippi.

“They desperately need help there,” said Otis Brawley, a professor of oncology at Johns Hopkins School of Medicine and an expert on health disparities. “Political leadership is incredibly important in turning this around, and in Mississippi, the political leadership don’t give a damn.”

Despite the beauty of Mississippi, from the rolling hills of the Natchez Trace to white-sand beaches on the Gulf of Mexico, and the cultural renown of its famous musicians and storytellers, the state’s reputation is marred by its high rates of poverty. People who live there are accustomed to being the butt of jokes, but it hurts.

“Often Mississippi gets represented poorly,” said Mildred Ridgway, an OB-GYN at the University of Mississippi Medical Center in Jackson.

Recently the state has reeled from crisis after crisis. As recently as March, tornadoes and other severe weather killed more than two dozen people and caused extensive damage. Last year, the water in Jackson, the state capital, was undrinkable for months because of treatment plant failures.

On just about any measure of health, Mississippi ranks near or at the bottom. Nationally, an estimated 10% of people under 65 lack health insurance, but in Mississippi it is about 14%. Deaths from cardiovascular disease, diabetes, cancer, and many other illnesses are among the highest per capita in the country.

The high rates of poverty contribute to the high cervical cancer mortality, health experts said. About 19% of Mississippians — nearly 1 in 5 — live in poverty, while nationally it is about 13%.

“If I had to pinpoint what that’s from, it’s from lack of education,” said Ridgway, referring to a lack of knowledge about regular cervical cancer screening, which the U.S. Preventive Services Task Force recommends every three years for women 21 to 65.

But it likely goes far beyond that, many health experts said. Doctors may be less likely to stress preventive care to less educated women and women of color, studies suggest.

“There’s a big difference in the quality of care,” said Rajesh Balkrishnan, a professor of public health at the University of Virginia who has extensively studied oncology care in Appalachia and other underserved areas.

In her case, Jones said, she could not get her doctor’s office to return her calls in a timely manner. She was concerned about her symptoms.

“I felt I wasn’t listened to. I called her more than she called me,” Jones said of her doctor. “I was going to my appointments, and I was ignored.”

And getting access to any care — let alone quality, culturally competent care from providers who acknowledge a patient’s heritage, beliefs, and values during treatment — may be difficult.

Most of the state’s 82 counties are rural. The average travel distance to a grocery store is 30 miles, and half the population lives in a county that is considered medically underserved, said Letitia Thompson, a vice president in Mississippi for the American Cancer Society.

Low-income rural residents often lack reliable transportation, she said, and even if they own a vehicle, they lack gas money. They often can’t find — or pay for — someone to take care of their children so they can go to the doctor. Women with low-paying jobs often lack the time to drive to a clinic in a distant town, or the ability to take off from work without losing pay.

“Women who work and take care of children often have a huge burden of responsibility,” Ridgway said. “They don’t have time or the money.”

Many also don’t have insurance. While the Affordable Care Act has lowered the uninsured rate in Mississippi, an estimated additional 88,000 Mississippians could have coverage through Medicaid if the state expanded eligibility for the federal-state insurance program for low-income Americans. But the state is one of 10 that have not agreed to expand coverage to more adults.

Mississippi Gov. Tate Reeves, a Republican up for reelection this year, is opposed to expansion. His Democratic challenger, Brandon Presley, a second cousin of the music legend Elvis, favors it. Polls show Presley lagging Reeves.

Without expansion of Medicaid, people who have low incomes are often left to decide between forgoing insurance and purchasing a policy through the Affordable Care Act marketplace if they cannot get insurance through employment. Even if they qualify for subsidized marketplace plans, they may face high deductibles or copayments for visits, health experts said. That often means going to the doctor only when sick. Preventive care becomes a luxury.

“You save your health care dollars for when you are sick or your kids are sick,” said Thompson, of the American Cancer Society.

But regular medical care can make all the difference with cervical cancer. Pap tests have long helped detect abnormal cervical cells that could turn malignant. Brawley said the test is “one of the best” cancer screening tests because of its accuracy.

In 2006, vaccines to prevent cervical cancer were first approved by the FDA. The vaccines guard against the common sexually transmitted infection called the human papillomavirus, which causes nearly all cervical cancers. The HPV vaccine is most effective when administered before a person has become sexually active; the federal recommendation is to get the shots by age 12.

Only a handful of places in the U.S. — including Hawaii, Rhode Island, Virginia, Puerto Rico, and the District of Columbia — require the vaccines to attend school. California has pending legislation that initially would have required that middle schoolers get the shots, but the bill has since been watered down to recommend them instead.

Mississippi does not require the vaccine, and the state has had the lowest share of fully vaccinated teens by a large margin for years. Fewer than 39% of teens there were up to date on HPV vaccination as of 2022, according to the CDC, compared with an estimated 63% nationally.

Thompson said she thinks many parents are hesitant to have their children vaccinated because they believe it would encourage sexual activity.

“This is an anti-cancer vaccine,” Thompson said.

Krista Guynes, director of the women’s health program at the Mississippi State Department of Health, said the state has several efforts underway to better inform women about the need for screening. It also has clinics for uninsured women. In partnership with the National Cancer Institute and University of Mississippi Medical Center, she said, the health department is conducting a study to evaluate risk and look for new biomarkers in women undergoing screening for cervical cancer.

As for Jones, she considers herself lucky to have survived stage 3 cancer.

“I would just like to say to every woman, ‘Get the vaccine.’ The vaccine will make the difference, so they won’t have to be told, ‘I’m sorry, you have cancer.’”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Biden Administration Proposes New Standards to Boost Nursing Home Staffing

September 01, 2023

The nation’s most thinly staffed nursing homes would be required to hire more workers under new rules proposed on Friday by the Biden administration, the greatest change to federal nursing home regulations in three decades.

The proposed standard was prompted by the industry’s troubled performance earlier in the coronavirus pandemic, when 200,000 nursing home residents died. But the proposal falls far short of what both the industry and patient advocates believe is needed to improve care for most of the 1.2 million Americans in nursing homes.

The proposal, by the Centers for Medicare and Medicaid Services, would require all facilities to increase staff up to certain minimum levels, but it included no money for nursing homes to pay for the new hires.

CMS estimated that three-quarters of the nation’s 15,000 homes would need to add staff members. But the increases at many of those facilities would be minor, as the average nursing home already employs nurses and aides at, or very close to, the proposed levels.

“The standards are a lot lower than what a lot of experts, including myself, have called for over the years,” said David Grabowski, a professor of health care policy at Harvard Medical School. “There are some real positives in here, but I wish the administration had gone further.”

The government said it would exempt nursing homes from punishment if they could prove that there was a local worker shortage and that the facilities had made sincere efforts to recruit employees.

“Fundamentally, this standard is wholly inadequate to meet the needs of nursing home residents,” said Richard Mollot, the executive director of the Long Term Care Community Coalition, an advocacy group based in New York.

Executives in the nursing home industry said that without extra money from Medicare or Medicaid — the two federal insurers that pay for most nursing home care — the requirement would be financially unattainable.

“It’s meaningless to mandate staffing levels that cannot be met,” Katie Smith Sloan, the president and chief executive of LeadingAge, an association that includes nonprofit nursing homes, said in a statement. “There are simply no people to hire — especially nurses. The proposed rule requires that nursing homes hire additional staff. But where are they coming from?”

The new staffing standard would require homes to have daily average nurse staffing levels amounting to at least 0.55 hours per resident. That translates to one registered nurse for every 44 residents. But that is below what the average nursing home already provides, which is 0.66 hours per resident, a 1:36 ratio, federal records show.

At least one registered nurse would have to be on duty at all times under the proposed plan — one of the biggest changes for the facilities, as they currently must have nurses for only eight consecutive hours each day.

The proposed rule also calls for 2.45 nurse aide hours per resident per day, meaning a ratio of about one aide for every 10 residents. While the federal government sets no specific staffing requirements for nurse aides, the average home already provides 2.22 nurse aide hours a day, a ratio of about 1:11.

“The federal minimum staffing standards proposed by CMS are robust yet achievable,” the agency said in a statement. “The proposal also makes clear that the numerical staffing levels are a floor — not a ceiling — for safe staffing.”

Registered nurses are at the top of the chain of command at nursing homes, overseeing assessments of residents and handling complex clinical tasks. Nurses delegate more straightforward clinical roles to licensed practical nurses.

Certified nurse assistants, often called nurse aides, are generally the most plentiful in a nursing home and help residents with basic needs like bathing, getting out of bed and eating.

On average, registered nurses make $37 an hour while licensed practical nurses earn $28 an hour, according to CMS. Aides often start at minimum wage or slightly above, earning $17 an hour on average.

“People have more choice,” said Tina Sandri, the chief executive of Forest Hills of DC, a nursing home in Washington, D.C., referring to nursing home staff. “They can go to hospitals and make more and do less than they do here in a nursing home.”

“We’ve lost staff to hospitals that had $20,000 signing bonuses,” she added, “and as a nonprofit, we can’t compete with that.”

Nursing home officials say they cannot afford to pay higher wages because state Medicaid programs reimburse them too little. Patient advocates, however, note that some for-profit homes are providing substantial returns to investors.

Medicare and Medicaid spent $95 billion on nursing home care and retirement community care in 2021, according to CMS. The agency estimated that the new standards would cost homes another $4 billion in three years, when all homes except those in rural areas would need to comply. Rural homes would have five years.

Ellen Quirk, a retired certified nurse assistant in Hayes, Virginia, recalled that sometimes she would care for all of the residents on a single floor in the nursing home, which could be 20 or more people, by herself. It’s challenging for an aide to care for more than five to seven people at a time, she said.

“If it’s more than that, then things aren’t done properly,” Quirk, 63, said. “Things are skipped over, like a bath or changing them every couple of hours or feeding them properly.”

“I’ve seen patients that roll over and fall out of bed,” she added. “Sometimes they get bed sores because beds are saturated in urine for hours and hours.”

The nursing home industry has been pressing federal and state governments to pay for a bevy of enticements to long-term care workers, including educational subsidies for those who have worked in nursing homes, loan forgiveness and career opportunities for certified nursing assistants working toward their nursing degrees.

The administration said it would offer $75 million in scholarships and tuition as part of the new proposal. The administration is accepting comments for the next 60 days before it finalizes the new standard.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

When Temps Rise, So Do Medical Risks. Should Doctors and Nurses Talk More About Heat?

September 01, 2023

An important email appeared in the inboxes of a small group of health care workers north of Boston as this summer started. It warned that local temperatures were rising into the 80s.

An 80-plus-degree day is not sizzling by Phoenix standards. Even in Boston, it wasn’t high enough to trigger an official heat warning for the wider public.

But research has shown that those temperatures, coming so early in June, would likely drive up the number of heat-related hospital visits and deaths across the Boston region.

The targeted email alert the doctors and nurses at Cambridge Health Alliance in Somerville, Massachusetts, got that day is part of a pilot project run by the nonprofit Climate Central and Harvard University’s Center for Climate, Health, and the Global Environment, known as C-CHANGE.

Medical clinicians based at 12 community-based clinics in seven states — California, Massachusetts, North Carolina, Oregon, Pennsylvania, Texas, and Wisconsin — are receiving these alerts.

At each location, the first email alert of the season was triggered when local temperatures reached the 90th percentile for that community. In a suburb of Portland, Oregon, that happened on May 14 during a springtime heat wave. In Houston, that occurred in early June.

A second email alert went out when forecasts indicated the thermometer would reach the 95th percentile. For Cambridge Health Alliance primary care physician Rebecca Rogers, that second alert arrived on July 6, when the high hit 87 degrees.

The emails remind Rogers and other clinicians to focus on patients who are particularly vulnerable to heat. That includes outdoor workers, older adults, or patients with heart disease, diabetes, or kidney disease.

Other at-risk groups include youth athletes and people who can’t afford air conditioning, or who don’t have stable housing. Heat has been linked to complications during a pregnancy as well.

“Heat can be dangerous to all of us,” said Caleb Dresser, director of health care solutions at C-CHANGE. “But the impacts are incredibly uneven based on who you are, where you live, and what type of resources you have.”

The pilot program aims to remind clinicians to start talking to patients about how to protect themselves on dangerously hot days, which are happening more frequently because of climate change. Heat is already the leading cause of death in the U.S. from weather-related hazards, Dresser said. Letting clinicians know when temperatures pose a particular threat to their patients could save lives.

“What we’re trying to say is, ‘You really need to go into heat mode now,'” said Andrew Pershing, vice president for science at Climate Central, with a recognition that “it’s going to be more dangerous for folks in your community who are more stressed.”

“This is not your grandmother’s heat,” said Ashley Ward, who directs the Heat Policy Innovation Hub at Duke University. “The heat regime that we are seeing now is not what we experienced 10 or 20 years ago. So we have to accept that our environment has changed. This might very well be the coolest summer for the rest of our lives.”

The alerts bumped heat to the forefront of Rogers’ conversations with patients. She made time to ask each person whether they can cool off at home and at work.

That’s how she learned that one of her patients, Luciano Gomes, works in construction.

“If you were getting too hot at work and maybe starting to feel sick, do you know some things to look out for?” Rogers asked Gomes.

“No,” said Gomes slowly, shaking his head.

Rogers told Gomes about early signs of heat exhaustion: dizziness, weakness, or profuse sweating. She handed Gomes tip sheets she’d printed out after receiving them  along with the email alerts.

They included information about how to avoid heat exhaustion and dehydration, as well as specific guidance for patients with asthma, chronic obstructive pulmonary disease (COPD), dementia, diabetes, multiple sclerosis, and mental health concerns.

Rogers pointed out a color chart that ranges from pale yellow to dark gold. It’s a sort of hydration barometer, based on the color of one’s urine.

“So if your pee is dark like this during the day when you’re at work,” she told Gomes, “it probably means you need to drink more water.”

Gomes nodded. “This is more than you were expecting to talk about when you came to the doctor today, I think,” she said with a laugh.

During this visit, an interpreter translated the visit and information into Portuguese for Gomes, who is from Brazil and quite familiar with heat. But he now had questions for Rogers about the best ways to stay hydrated.

“Because here I’ve been addicted to soda,” Gomes told Rogers through the interpreter. “I’m trying to watch out for that and change to sparkling water. But I don’t have much knowledge on how much I can take of it.”

“As long as it doesn’t have sugar, it’s totally good,” Rogers said.

Now Rogers creates heat mitigation plans with each of her high-risk patients. But she still has medical questions that the research doesn’t yet address. For example: If patients take medications that make them urinate more often, could that lead to dehydration when it’s hot? Should she reduce their doses during the warmest weeks or months? And, if so, by how much? Research has yielded no firm answers to those questions.

Deidre Alessio, a nurse practitioner at Cambridge Health Alliance, also has received the email alerts. She has patients who sleep on the streets or in tents and search for places to cool off during the day.

“Getting these alerts makes me realize that I need to do more homework on the cities and towns where my patients live,” she said, “and help them find transportation to a cooling center.”

Most clinics and hospitals don’t have heat alerts built into electronic medical records, don’t filter patients based on heat vulnerability, and don’t have systems in place to send heat warnings to some or all of their patients.

“I would love to see health care institutions get the resources to staff the appropriate outreach,” said Gaurab Basu, a Cambridge Health Alliance physician who co-directs the Center for Health Equity Advocacy and Education at Cambridge Health Alliance. “But hospital systems are still really strained by covid and staffing issues.”

This pilot program is an excellent start and could benefit by including pharmacists, said Kristie Ebi, founding director of the Center for Health and the Global Environment at the University of Washington.

Ebi has studied heat early-warning systems for 25 years. She says one problem is that too many people don’t take heat warnings seriously. In a survey of Americans who experienced heat waves in four cities, only about half of residents took precautions to avoid harm to their health.

“We need more behavioral health research,” she said, “to really understand how to motivate people who don’t perceive themselves to be at risk, to take action.”

For Ebi and other researchers, the call to action is not just to protect individual health, but to address the root cause of rising temperatures: climate change.

“We’ll be dealing with increased exposure to heat for the rest of our lives,” said Dresser. “To address the factors that put people at risk during heat waves, we have to move away from fossil fuels so that climate change doesn’t get as bad as it could.”

This article is from a partnership that includes WBUR, NPR, and KFF Health News.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

5 Things to Know About the New Drug Pricing Negotiations

August 30, 2023

The Biden administration has picked the first 10 high-priced prescription drugs subject to federal price negotiations, taking a swipe at the powerful pharmaceutical industry. It marks a major turning point in a long-fought battle to control ever-rising drug prices for seniors and, eventually, other Americans.

Under the 2022 Inflation Reduction Act, Congress gave the federal government the power to negotiate prices for certain high-cost drugs under Medicare. The list of drugs selected by the Centers for Medicare & Medicaid Services will grow over time.

The first eligible drugs treat diabetes, blood clots, blood cancers, arthritis, and heart disease — and accounted for about $50 billion in spending from June 2022 to May 2023.

The United States is clearly an outlier on drug costs, with drugmakers charging Americans many times more than residents of other countries “simply because they could,” Biden said Tuesday at the White House. “I think it’s outrageous. That’s why these negotiations matter.”

He added, “We’re going to keep standing up to Big Pharma and we’re not going to back down.”

Democratic lawmakers cheered the announcement, and the pharmaceutical industry, which has filed a raft of lawsuits against the law, condemned it.

The companies have until Oct. 2 to present data on their drugs to CMS, which will make initial price offers in February, setting off negotiations set to end next August. The prices would go into effect in January 2026.

Here are five things to know about the impact:

1. How important is this step?

Medicare has long been in control of the prices for its services, setting physician payments and hospital payments for about 65 million Medicare beneficiaries. But it was previously prohibited from involvement in pricing prescription drugs, which it started covering in 2006.

Until now the drug industry has successfully fought off price negotiations with Washington, although in most of the rest of the world governments set prices for medicines. While the first 10 drugs selected for negotiations are used by a minority of patients — 9 million — CMS plans by 2029 to have negotiated prices for 50 drugs on the market.

“There’s a symbolic impact, but also Medicare spent $50 billion on these 10 drugs in a 12-month period. That’s a lot of money,” said Juliette Cubanski, deputy director of KFF’s analysis of Medicare policy.

The long-term consequences of the new policy are unknown, said Alice Chen, vice dean for research at University of Southern California’s Sol Price School of Public Policy. The drug industry says the negotiations are essentially price controls that will stifle drug development, but the Congressional Budget Office estimated only a few drugs would not be developed each year as a result of the policy.

Biden administration officials say reining in drug prices is key to slowing the skyrocketing costs of U.S. health care.

2. How will the negotiations affect Medicare patients?

In some cases, patients may save a lot of money, but the main thrust of Medicare price negotiation policy is to provide savings to the Medicare program — and taxpayers — by lowering its overall costs.

The drugs selected by CMS range from specialized, hyper-expensive drugs like the cancer pill Imbruvica (used by about 26,000 patients in 2021 at an annual price of $121,000 per patient) to extremely common medications such as Eliquis (a blood thinner for which Medicare paid about $4,000 each for 3.1 million patients).

While the negotiations could help patients whose Medicare drug plans require them to make large copayments for drugs, the relief for patients will come from another segment of the Inflation Reduction Act that caps drug spending by Medicare recipients at $2,000 per year starting in 2025.

3. What do the Medicare price negotiations mean for those not on Medicare?

One theory is that reducing the prices drug companies can charge in Medicare will lead them to increase prices for the privately insured.

But that would be true only if companies aren’t already pricing their drugs as high as the private market will bear, said Tricia Neuman, executive director of KFF’s program on Medicare policy.

Another theory is that Medicare price negotiations will equip private health plans to drive a harder bargain. David Mitchell, president of the advocacy group Patients for Affordable Drugs, predicted that disclosure of negotiated Medicare prices “will embolden and arm private sector negotiators to seek that lower price for those they cover.”

Stacie B. Dusetzina, a professor of health policy at Vanderbilt University, said the effect on pricing outside Medicare isn’t clear.

“I’d hedge my bet that it doesn’t change,” she said.

Nonetheless, Dusetzina described one way it could: Because the government will be selecting drugs for Medicare negotiations based partly on the listed gross prices for the drugs — distinct from the net cost after rebates are taken into account — the process could give drug companies an incentive to lower the list prices and narrow the gap between gross and net. That could benefit people outside Medicare whose out-of-pocket payments are pegged to the list prices, she said.

4. What are drug companies doing to stop this?

Even though negotiated prices won’t take effect until 2026, drug companies haven’t wasted time turning to the courts to try to stop the new program in its tracks.

At least six drug companies have filed lawsuits to halt the Medicare drug negotiation program, as have the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, known as PhRMA.

The lawsuits include a variety of legal arguments. Merck & Co., Johnson & Johnson, and Bristol Myers Squibb are among the companies arguing their First Amendment rights are being violated because the program would force them to make statements on negotiated prices they believe are untrue. Lawsuits also say the program unconstitutionally coerces drugmakers into selling their products at inadequate prices.

“It is akin to the Government taking your car on terms that you would never voluntarily accept and threatening to also take your house if you do not ‘agree’ that the taking was ‘fair,’” Janssen, part of Johnson & Johnson, wrote in its lawsuit.

Nicholas Bagley, a law professor at the University of Michigan, predicted the lawsuits would fail because Medicare is a voluntary program for drug companies, and those wishing to participate must abide by its rules.

5. What if a drug suddenly gets cheaper by 2026?

In theory, it could happen. Under guidelines CMS issued this year, the agency will cancel or adjourn negotiations on any drug on its list if a cheaper copycat version enters the market and finds substantial buyers.

According to company statements this year, two biosimilar versions of Stelara, a Johnson & Johnson drug on the list, are prepared to launch in early 2025. If they succeed, it would presumably scotch CMS’ plan to demand a lower price for Stelara.

Other drugs on the list have managed to maintain exclusive rights for decades. For example, Enbrel, which the FDA first approved in 1998 and cost Medicare $1.5 billion in 2021, will not face competition until 2029 at the earliest.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

Exclusive: CMS Study Sabotages Efforts to Bolster Nursing Home Staffing, Advocates Say

August 29, 2023

The Biden administration last year promised to establish minimum staffing levels for the nation’s roughly 15,000 nursing homes. It was the centerpiece of an agenda to overhaul an industry the government said was rife with substandard care and failures to follow federal quality rules.

But a research study the Centers for Medicare & Medicaid Services commissioned to identify the appropriate level of staffing made no specific recommendations and analyzed only staffing levels lower than what the previous major federal evaluation had considered best, according to a copy of the study reviewed Monday by KFF Health News. Instead, the new study said there was no single staffing level that would guarantee quality care, although the report estimated that higher staffing levels would lead to fewer hospitalizations and emergency room visits, faster care, and fewer failures to provide care.

Patient advocates said the report was the latest sign that the administration would fall short of its pledge to establish robust staffing levels to protect the 1.2 million Americans in skilled nursing facilities. Already, the administration is six months behind its self-imposed deadline of February to propose new rules. Those proposals, which have not been released, have been under evaluation since May by the Office of Management and Budget. The study, dated June 2023, has not been formally released either, but a copy was posted on the CMS website.

“It’s honestly heartbreaking,” said Richard Mollot, executive director of the Long Term Care Community Coalition, a nonprofit that advocates for nursing home patients in New York state. “I just don’t see how this doesn’t ultimately put more residents at risk of neglect and abuse. Putting the government’s imprimatur on a standard that is patently unsafe is going to make it much more difficult for surveyors to hold facilities accountable for the harm caused by understaffing nursing homes.”

For months, the nursing home industry has been lobbying strenuously against a uniform ratio of patients to nurses and aides. “What is clear as you look across the country is every nursing home is unique and a one-size-fits-all approach does not work,” said Holly Harmon, senior vice president of quality, regulatory, and clinical services at the American Health Care Association, an industry trade group.

Nursing home groups have emphasized the widespread difficulty in finding workers willing to fill existing certified nursing assistant jobs, which are often grueling and pay less than what workers can make at retail stores. Homes say their licensed nurses are often drawn away by other jobs, such as better-paying hospital positions. “The workforce challenges are real,” said Katie Smith Sloan, president and CEO of LeadingAge, an association that represents nonprofit nursing homes.

The industry has also argued that if the government wants it to hire more workers it needs to increase the payments it makes through state Medicaid programs, which are the largest payor for nursing home care. Advocates and some researchers have argued that nursing homes, particularly for-profit ones, can afford to pay employees more and hire additional staff if they forsake some of the profits they give investors.

“Certainly, facilities haven’t put all the dollars back into direct care over the years,” said David Grabowski, a professor of health care policy at Harvard Medical School. “But for certain facilities, it’s going to be a big lift to pay for” higher staffing levels, he said in an interview last week.

The administration last week declined to discuss the status of its rule. “The Centers for Medicare & Medicaid Services (CMS) is committed to holding nursing homes accountable for protecting health and safety for all residents, and adequate staffing is critical to this effort,” CMS press secretary Sara Lonardo said in an email. “We look forward to releasing our proposals, as well as the nursing home staffing study, soon.”

The study has been widely anticipated, both because of the central role the administration said it would play in its policy and because the last major CMS study, conducted in 2001, had concluded that nursing home care improves as staffing increases up to the level of about one worker for every six residents. The formal metric for that staffing level was 4.1 staff hours per resident per day, which is calculated by dividing the number of total hours worked by nurses and aides on duty daily by the number of residents present each day.

CMS never adopted that staffing ratio and instead gave each nursing home discretion to determine a reasonable staffing level. Regulators rarely cite nursing homes for insufficient staffing, even though independent researchers have concluded low staffing is the root of many nursing home injuries. Too few nurse aides, for instance, often means immobile residents are not repositioned in bed, causing bedsores that can lead to infection. Low staffing also is often responsible for indignities residents face, such as being left in soiled bedsheets for hours.

The new research was conducted by Abt Associates, a regular contractor for CMS that also performed the 2001 study. But the report, in an implicit disagreement with its predecessor, concluded there was “no obvious plateau at which quality and safety are maximized or ‘cliff’ below which quality and safety steeply decline.” Abt did not immediately respond to requests for comment on its study.

The study evaluated four minimum staffing levels, all of which were below the 4.1 daily staff hours that the prior study had identified as ideal. The highest was 3.88 daily staff hours. At that level, the study estimated 0.6% of residents would get delayed care and 0.002% would not get needed care. It also said that staffing level would result in 12,100 fewer hospitalizations of Medicare residents and 14,800 fewer emergency room visits. The report said three-quarters of nursing homes would need to add staff to meet that level and that it would cost $5.3 billion extra each year.

The lowest staffing level the report analyzed was 3.3 daily staffing hours. At that level, the report said, 3.3% of residents would get delayed care and 0.04% would not get needed care. That level would reduce hospitalizations of Medicare residents by 5,800 and lead to 4,500 fewer emergency room visits. More than half of nursing homes would have to increase staff levels to meet that ratio, the report said, and it would cost $1.5 billion more each year.

Charlene Harrington, a professor emeritus of nursing at the University of California-San Francisco, said CMS “sabotaged” the push for sufficiently high staffing through the instructions it gave its contractor. “Every threshold they looked at was below 4.1,” she said. “How can that possibly be a decent study? It’s just unacceptable.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).