Medical School on Cherokee Reservation Will Soon Send Doctors to Tribal, Rural Areas

KFF Health News, November 1, 2023

Rural residents make up about 14% of the U.S. population but fewer than 5% of incoming medical students.

This article was published on Wednesday, November 1, 2023 in Kaiser Health News.

By Arielle Zionts

TAHLEQUAH, OK — Ashton Glover Gatewood decided to give medical school a second try after learning about a new campus designed for Indigenous students like herself.

Gatewood is now set to be part of the first graduating class at Oklahoma State University's College of Osteopathic Medicine at the Cherokee Nation. Leaders say the physician training program is the only one on a Native American reservation and affiliated with a tribal government.

"This is the school that is everything that I need to be successful," said Gatewood, a member of the Choctaw Nation who also has Cherokee and Chickasaw ancestry. "Literally, the campus, the curriculum, the staff — everything was built and hired and prepared and planned for you."

The program in Tahlequah, the capital of the Cherokee Nation, aims to increase the number of Cherokee and other Indigenous physicians. It's also focused on expanding the number of doctors from all backgrounds who serve rural or tribal communities.

Natasha Bray, an osteopathic physician and dean of the program, said most medical schools teach about barriers that can make it difficult for rural or Indigenous patients to get care and improve their health.

But she said students in Tahlequah get to see these barriers firsthand by studying on the Cherokee Reservation and doing rotations in tiny communities and within facilities run by the federal Indian Health Service.

"Unless you are living in that community, you're part of that community, you're seeing patients from that community — you can't begin to understand what those barriers to care are," said Bray, who is not Native American.

For example, Bray knows that one town on the reservation is a 50-minute drive to the nearest delivery room, and that some patients trying to eat healthier live far from supermarkets and settle for convenience store food.

Rural America has a shortage of health care providers. The Indian Health Service, which serves Indigenous patients in mostly rural areas, has also struggled to recruit and retain staff.

Rural residents make up about 14% of the U.S. population but fewer than 5% of incoming medical students, according to a study of 2017 data. Native Americans are 3% of the population but represented only 0.2% of those accepted to medical school for the 2018-19 school year, according to the Association of American Medical Colleges.

Gatewood, 34, who grew up in a city between the Chickasaw Reservation and Oklahoma City, first attended medical school at the University of Missouri. She said it was a great program, but it didn't match her learning style. And with few Native American students, it left her feeling disconnected from her culture.

She ended up leaving after three semesters. Gatewood went on to become a nurse and earned a master's degree in public health.

Then, in 2019, six years after dropping out of the Missouri medical school, Gatewood learned about Oklahoma State's new campus in Tahlequah. She decided to once more pursue her dream of becoming a doctor. After taking classes in Oklahoma, she's now getting hands-on experience through a family medicine rotation in Baltimore.

Half the 202 medical students in Tahlequah are from rural areas, and nearly a quarter are Native American. Most of the Indigenous students are from Oklahoma tribes. Others come from tribes outside the state, including from Alaska and New Mexico.

Tahlequah has about 16,800 residents. It's more than an hour east of Tulsa, home to Oklahoma State's other osteopathic medicine campus.

Osteopathic physicians, or DOs, attend separate medical schools from allopathic doctors, or MDs. The schools have similar curricula, but osteopathic colleges also teach how to ease patient discomfort through physical manipulation of muscles and bones. Osteopathic schools graduate more students who decide to work in primary care and in rural areas.

The Cherokee Reservation spreads across roughly 7,000 square miles in eastern Oklahoma. It's home to about 150,000 Cherokee citizens, most of whom live in rural areas, said Principal Chief Chuck Hoskin Jr. Hoskin grew up in a small town that was once served by a doctor who traveled across the reservation, treating patients in a recreational vehicle.

The Cherokee Nation now operates 10 hospitals and clinics to ensure that all citizens live within a 30-minute drive of care. Hoskin said this means the reservation has better access to health care than much of rural America.

"There are not many communities in this country in which you would see that sort of investment," he said.

Still, access to care remains challenging for some rural residents on the reservation, Bray said. The reservation has significant poverty, and some people lack cars or cell or internet service. Cherokee residents have high rates of diabetes, obesity, addiction, and heart disease, Bray said.

The Cherokee Nation spent $40 million of its own revenue — including from casinos and federal contracts — to construct the college building on its medical campus, which includes a hospital and outpatient center. The tribe is responsible for maintenance, while Oklahoma State pays for the faculty and equipment.

The college building features large windows, Cherokee symbols etched into concrete, and orange accents — a shoutout to the university's colors. Inside, signs are written in both English and Cherokee.

On a recent afternoon, students practiced osteopathic manipulative therapy on one another inside a classroom. Down the hall in a simulation center, lifelike patient models lay with their mouths agape on hospital beds.

Next door at the hospital, medical student Mackenzie Hattabaugh checked on Chyna Chupco, who was recovering after giving birth to her first baby. Hattabaugh asked Chupco questions to make sure she was reaching recovery milestones and not showing signs of complications. She also felt Chupco's uterus to make sure it was healing properly.

Hattabaugh, who is not Native American, grew up in Muldrow, a town of about 3,300 on the reservation. The 24-year-old said the town sometimes had a doctor but never a hospital or urgent care clinic.

"I would like to go back to around my hometown and perhaps be a staple in my community, to become a physician and provide people health care who usually have to drive 30 minutes or more to get it," said Hattabaugh, a first-generation college student.

Students said studying at the Tahlequah campus prepares them to work in tribal and rural areas in ways that might not be possible at other medical schools.

Charlee Dawson, a 27-year-old medical student and citizen of the Cherokee Nation, said rotations within the Indian Health Service help students understand how the system's care and complex billing procedures differ from those of other health facilities.

The program helps students understand what health problems are more common among Native Americans, Gatewood said. She said her previous medical school taught students about the high rate of diabetes among Black patients, but not the rate for Native Americans, which is the highest of all U.S. racial groups.

The students also said they've learned to ask Indigenous patients not just what pharmaceutical drugs and supplements they're taking, but also whether they're using traditional medications or working with a healer.

Native Americans have long received inadequate, discriminatory, and unethical health care. Children died of infectious disease outbreaks during the boarding school era. The Indian Health Service sterilized thousands of women in the 1960s and '70s. Today, the agency remains chronically underfunded.

This has led some Indigenous people to mistrust the health care system. But several of the Tahlequah students said they've bonded with patients who share similar backgrounds.

"It really comforts patients to know that someone like them is taking care of them," said Caitlin Cosby, a member of the Choctaw Nation.

Cosby, 24, said she once had a patient who asked, "‘Are you Native?' And I said, ‘I am!'"

The patient told Cosby he was proud of her.

Arielle Zionts: azionts@kff.org, @Ajzionts

Enrollment Begins Nov. 1 for Most Obamacare Insurance Plans

KFF Health News, October 31, 2023

In most states, open enrollment lasts through Jan. 15, although some states have different time periods.

This article was published on Tuesday, October 31, 2023 in KFF Health News.

By Julie Appleby

For millions of Americans who buy their own health insurance through the Affordable Care Act marketplace, the end of the year brings a day of reckoning: It's time to compare benefits and prices and change to a new plan or enroll for the first time.

Open enrollment starts Nov. 1 for the ACA's federal and state exchanges. Consumers can go online, call, or seek help from a broker or other assister to learn their 2024 coverage options, calculate their potential subsidies, or change plans.

In most states, open enrollment lasts through Jan. 15, although some states have different time periods. California's, for example, is longer, open until Jan. 31, but Idaho's runs from Oct. 15 to Dec. 15. In most states enrollment must occur by Dec. 15 to get coverage that begins Jan. 1.

Health policy experts and brokers recommend all ACA policyholders at least look at next year's options, because prices — and the doctors and hospitals in plans' networks — may have changed.

It Could Be Another Record Year

ACA plans are now well entrenched — an estimated 16.3 million people signed up during open enrollment last year. This year may see even larger numbers. Enhanced subsidies first approved during the height of the covid pandemic remain available, and some states have boosted financial help in other ways.

In addition, millions of people nationwide are losing Medicaid coverage as states reassess their eligibility for the first time since early in the pandemic. Many of those ousted could be eligible for an ACA plan. They can sign up as soon as they know they're losing Medicaid coverage — even outside of the open enrollment season.

Another important caution: Don't wait until the last minute, especially if you are seeking help from a broker. Consumers this year will be asked to certify that they voluntarily agreed to brokers' assistance and that their income and other information provided by brokers is accurate.

It's a good protection for both parties, said broker Joshua Brooker, founder of PA Health Advocates in Pennsylvania. But brokers are concerned the requirement could cause delays, especially if clients wait until right before the end of open enrollment to apply.

"Brokers will need to stop what they are doing right at the end before they click 'submit' and wait for the consumer to sign a statement saying they reviewed the policy," Brooker said.

Premiums Are Changing

While some health plans are lowering premiums for next year, many are increasing them, often by 2% to 10%, according to a Peterson-KFF Health System Tracker initial review of rate requests. The median increase, based on a weighted average across its plans for each insurer, was 6%. 

Premiums, and whether they go up or down, vary widely by region and insurer. 

Experts say that's a big reason to log on to the federal website, healthcare.gov, in the 32 states that use it, or on to the insurance marketplace for one of the 18 states and the District of Columbia that run their own. Changing insurers might mean a lower premium.

"It's very localized," said Sabrina Corlette, research professor and co-director of the Center on Health Insurance Reforms at Georgetown University. "People should shop to maximize their premium tax credit, although that might require not only changing to a new insurance plan, but potentially also a new network of providers."

Most people buying their own coverage qualify for the tax credit, which is a subsidy to offset some, or even all, of their monthly premium. Subsidies are based partly on the premium of the second-lowest-priced silver-level plan in a region. When those go up or down, possibly from a new insurer entering the market with low initial rates, it affects the subsidy amount.

Household income is also a factor. Subsidies are on a sliding scale based on income.

Subsidies were enhanced during the pandemic, both to increase the amount enrollees could receive and to allow more families to qualify. Those enhancements were extended through 2025 by President Joe Biden's Inflation Reduction Act, passed last year.

Online calculators, including one at healthcare.gov, can provide subsidy estimates.

You May Qualify for Lower Deductibles and Copays

In addition to the premium subsidies, most ACA enrollees qualify for reduced deductibles, copayments, and other types of cost sharing if their income is no more than 2.5 times the federal poverty level, or about $75,000 for a family of four or $36,450 for a single-person household.

ACA plans are grouped into colored tiers — bronze, silver, gold, and platinum — based largely on how much cost sharing they require. Bronze plans offer the lowest premiums but usually the highest copayments and deductibles. Platinum plans carry the highest premiums but the lowest out-of-pocket expenses for care.

Cost-sharing reductions are available only in silver-level plans and are more generous for those on the lower end of the income scale. New this year: To help more people qualify, the federal marketplace will automatically switch eligible people to a silver plan for next year if they are currently enrolled in a bronze plan, as long as the enrollee has not made an adjustment in coverage themselves.

There are safeguards built in, said insurance expert and broker Louise Norris, so that people are auto-enrolled in a plan with the same network of medical providers and a similar or lower premium. Additionally, nine of the states that run their own marketplaces — California, Colorado, Connecticut, Maryland, Massachusetts, New Jersey, New Mexico, Vermont, and Washington — have enhanced their cost-sharing reduction programs by extending eligibility or increasing benefits.

Some 26-Year-Olds Will Get to Stay on Parents' Plans Longer

Happy birthday! Existing federal marketplace rules allowing adult children to stay on their parents' plans though the calendar year in which they turn 26, rather than lose coverage on their 26th birthday, were codified into regulation.

States that run their own markets can set similar rules, and some already allow for longer periods on a parent's plan.

Networks May Still Be Small

Insurance plans often try to reduce premiums by partnering with a limited set of doctors, hospitals, and other providers. Those can change year to year, which is why insurance experts like Norris say enrollees should always check their plans during open enrollment to ensure their preferred physicians and medical centers are included in the network.

It's also a good idea, Norris said, to look closely for changes in prescription drug coverage or copayments.

"The general message is, don't assume anything and make sure you check to see who is in the network," Norris said.

Last year, the Biden administration set rules requiring health plans to have enough in-network providers to meet specific driving time and distance standards. A proposal to limit how long patients wait for a routine appointment has been delayed until 2025.

What We Still Don't Know

A few things remain uncertain as the end of the year approaches. For example, the Biden administration proposed this summer to reverse a Trump-era rule that allowed short-term insurance plans to be sold for coverage periods of up to a year.

Short-term plans are not ACA-compliant, and many have fewer benefits and can set restrictions on coverage, including barring people with health conditions from purchasing them. As a result, they are far less expensive than ACA plans. The Biden proposal would restrict them to coverage periods of four months, but the rule isn't final.

Also pending: a final rule that would allow people to sign up for ACA coverage if they were brought to the U.S. as children by parents lacking permanent legal status — a group known as "Dreamers."

Julie Appleby: jappleby@kff.org, @Julie_appleby

When That Supposedly Free Annual Physical Generates a Bill

KFF Health News, October 30, 2023

Depression screening is covered as preventive care for adults, including when they're pregnant or in the postpartum phase.

This article was published on Monday, October 30, 2023 in KFF Health News.

By Julie Appleby

Christine Rogers of Wake Forest, North Carolina, didn't hesitate when she was asked to fill out a routine mental health questionnaire during a checkup last November.

Her answers on the form led her primary care doctor to ask about depression and her mood, and Rogers said she answered honestly.

"It was a horrible year. I lost my mom," Rogers said she told her physician.

After what Rogers estimates was a five-minute conversation about depression, the visit wrapped up. She said her doctor did not recommend treatment nor refer her for counseling.

"It's not like anything I told her triggered, ‘Oh my goodness, I'm going to prescribe you medication,'" she said.

Then the bill came.

The Patient: Christine Rogers, 60, a public relations/communications worker who is insured by Cigna Healthcare through her job.

Medical Services: An annual wellness visit, which included typical blood tests, as well as a depression screening and discussion with a physician.

Service Provider: WakeMed Physician Practices, part of WakeMed Health & Hospitals, a Raleigh-based, tax-exempt system with three acute care hospitals, outpatient centers, and hundreds of physicians across a range of specialties.

Total Bill: $487, which included a $331 wellness visit and a separate $156 charge for what was billed as a 20- to 29-minute consultation with her physician. Her insurer paid $419.93, leaving Rogers with a $67.07 charge related to the consultation.

What Gives: Rogers said the bill came as a surprise because she knows annual wellness checks are typically covered without patient cost sharing as preventive care under the Affordable Care Act. And as part of an annual physical, patients routinely fill out a health questionnaire, which may cover mental health topics.

But there is a catch: Not all care that may be provided during a wellness visit counts as no-cost preventive care under federal guidelines. If a health issue arises during a checkup that prompts discussion or treatment — say, an unusual mole or heart palpitations — that consult can be billed separately, and the patient may owe a copayment or deductible charge for that part of the visit.

In Rogers' case, a brief chat with her doctor about mental health triggered an additional visit charge — and a bill she was expected to pay.

Rogers said she didn't broach the subject of depression during her checkup. She was asked when she checked in to fill out the questionnaire, she said — and then the doctor brought it up during her exam.

The Affordable Care Act requires insurers to cover a variety of preventive services without a patient paying out-of-pocket, with the idea that such care might prevent problems or find them early, when they are more treatable and less costly.

The federal government lists dozens of services that are classified as no-cost-sharing preventive care for adults and children, such as cancer screenings, certain vaccinations, and other services recommended by either of two federal agencies or the U.S. Preventive Services Task Force, an independent group of experts in disease prevention.

Depression screening is covered as preventive care for adults, including when they're pregnant or in the postpartum phase.

Rogers requested an itemized bill from her doctor's practice, which is part of WakeMed Physician Practices. It showed a charge for the wellness visit (free for her), as well as a separate charge for a 20- to 29-minute office visit. Earlier, Rogers said, she had discussed the initial bill with the office manager at her doctor's office, who told her the separate charge, roughly $67, was for discussing her questionnaire results with her doctor.

For Rogers, it wasn't so much about the $67 she owed for the visit, as it was a matter of principle. The separate change, she said, was "disingenuous" because she was specifically asked about her mental health.

Also, annual physicals are intended to nip health problems in the bud, which sometimes requires a few more minutes of attention — whether to discuss symptoms of depression or palpate an abdomen for digestive issues.

Sabrina Corlette, a research professor and co-director of the Center on Health Insurance Reforms at Georgetown University, agrees the charge seemed a bit over-the-top: Depression screening "is now a recommended part of the annual physical," she said. "Implicit in that is someone looks at answers and makes an assessment, and you should not be charged for that."

Beyond the confusion of being charged for what she thought would be free preventive care, Rogers wondered how the bill was calculated: Her conversation with her doctor about depression did not last that long, she said.

A 20- to 29-minute-visit billing code is commonly used in primary care, reflecting not just the time spent, but also the complexity of the condition or diagnosis, said Yalda Jabbarpour, a family physician in Washington, D.C. She also directs the Robert Graham Center for Policy Studies, which researches primary care in the U.S.

Billing codes exist for other, shorter time frames, though those are rarely used except for the most minimal of services, such as a quick question about a test result, she said.

Physicians said Rogers did the right thing, emphasizing that patients should be honest with their doctors during preventive visits — and not keep silent about issues because they are concerned about potential cost sharing.

"If you have a condition like depression, not only does it affect mental health, but it can have significant impact on your medical health overall," said Stephen Gillaspy, senior director for health and health care financing at the American Psychological Association.

The Resolution: Confused by getting billed for a visit she thought would have no charge, Rogers initially called her doctor's office and spoke with the office manager, who told her the claim submitted to her insurer was coded correctly for her visit. She then called her insurer to question whether a mistake had been made. She said her insurer said no, agreeing that the physician had billed properly.

Rogers paid the bill.

After being contacted by KFF Health News, and with Rogers' permission, the WakeMed health system investigated the bill and said it was handled correctly.

"We do split bills when a service is provided that is above and beyond the preventive components of a physical — in this case, beyond a positive screening for depression," WakeMed spokesperson Kristin Kelly said in an email.

By contrast, Cigna Healthcare, Rogers' insurer, sent her a new explanation of benefits statement after being contacted by KFF Health News. The EOB showed Cigna had zeroed out any cost to Rogers associated with the visit.

Cigna spokesperson Meaghan MacDonald, in a written statement, said the "wellness visit was initially billed incorrectly with two separate visit codes, and has now been resubmitted correctly so there is no cost-share for Ms. Rogers. We are working with the physician to ensure she is refunded appropriately."

The insurer's website says Cigna covers a variety of preventive services without copayment and encourages doctors to counsel patients about depression.

Not long after receiving the new EOB, Rogers said she received a refund of $67.07 from WakeMed.

The Takeaway: While many preventive services are covered under the ACA, the nuances of when a patient pays can be complicated and open to interpretation. So, it is not uncommon for medical practices to narrowly interpret the term "preventive service."

That creates a billing minefield for patients. If you respond on a questionnaire that you sometimes experience heartburn or headaches, most physicians will inquire about your responses to assess the need for treatment. But should that come with an extra charge? Other patients have written to KFF Health News and NPR expressing frustration over being billed for conversations during a checkup.

Additional time spent during a wellness exam discussing or diagnosing a condition or prescribing medication can be considered beyond preventive care and result in separate charges. But if you receive a bill for a preventive service that you expected would be free, request an itemized bill with billing codes. If something seems off, ask the physician's office.

If you're billed for time spent on extra consultation, question it. You know how long the provider spent discussing your health issue better than a billing representative does. Next, reach out to your insurer to protest.

Most important, be honest with your primary care provider during your annual physical.

Stephanie O'Neill reported the audio story.

Bill of the Month is a crowdsourced investigation by KFF Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Julie Appleby: jappleby@kff.org, @Julie_appleby

Analysis: A New Era of Vaccines Leaves Old Questions About Prices Unanswered

KFF Health News, October 27, 2023

Using novel vaccines wisely — directing them to the people who need them at a price they can afford — will be key.

This analysis was published on Friday, October 27,2023 in KFF Health News.

By Elisabeth Rosenthal

The world is entering a new era of vaccines. Following the success of COVID-19 mRNA shots, scientists have a far greater capacity to tailor shots to a virus's structure, putting a host of new vaccines on the horizon.

The most recent arrivals — as anyone on the airwaves or social media knows — are several new immunizations against respiratory syncytial virus, or RSV.

These shots are welcome since RSV can be dangerous, even deadly, in the very old and very young. But the shots are also expensive — about $300 for those directed at adults, and up to $1,000 for one of the shots, a monoclonal antibody rather than a traditional vaccine, intended for babies. Many older vaccines cost pennies.

So their advent is forcing the United States to face anew questions it has long sidestepped: How much should an immunization that will possibly be given — maybe yearly — to millions of Americans cost to be truly valuable? Also, given the U.S. is one of two countries that permit direct advertising to consumers: How can we ensure the shots get into the arms of people who will truly benefit and not be given, at great expense, to those who will not?

Already, ads on televisions and social media show active retirees playing pickleball or going to art galleries whose lives are "cut short by RSV." This explains the lines for the shot at my local pharmacy.

But indiscriminate use of expensive shots could strain both public and private insurers' already tight budgets.

Other developed countries have deliberate strategies for deciding which vulnerable groups need a particular vaccine and how much to pay for it. The U.S. does not, and as specialized vaccines proliferate, public programs and private insurers will need to grapple with how to use and finance shots that can be hugely beneficial for some but will waste precious health dollars if taken by all.

A seasonal viral illness, RSV can cause hospitalization or, in rare cases, death in babies and in people age 75 or older, as well as those with serious underlying medical conditions such as heart disease or cancer. For most people who get RSV, it plays out as a cold; you've likely had RSV without knowing it.

But RSV puts about 2% of babies under age 1 in the hospital and kills between 100 and 300 of those under 6 months, because their immune systems are immature and their airways too narrow to tolerate the inflammation. Merely having a bad case of RSV in young childhood increases the risk of long-term asthma.

That's why Barney Graham, the scientist who spent decades at the government's National Institutes for Health perfecting the basic science that led to the current shots, said: "The most obvious use is in infants," not adults.

That's also why European countries trying to figure out how best to use these vaccines without breaking the bank focused first on babies and determining a sensible price. Though more of the very old may die of RSV, the years of life lost are much greater for the very young. (Babies can get the monoclonal antibody shot or gain protection through a traditional vaccine given to the mother near the end of pregnancy, conferring immunity through the womb.)

A consortium of European experts led by Philippe Beutels, a professor in health economics at the University of Antwerp in Belgium, calculated that the shots would only be “worth it” in terms of the lives saved and hospitalizations averted in infants if the price were under about $80, he said in a phone interview. That's because almost all babies make it through RSV with supportive care.

The calculation will be used by countries such as Belgium, England, Denmark, Finland, and the Netherlands to negotiate a set price for the two infant shots, followed by decisions on which version should be offered, depending partly on which is more affordable.

They have not yet considered how to distribute the vaccines to adults — considered less pressing — because studies show that RSV rarely causes severe disease in adults who live outside of care settings, such as a nursing home.

Why did the United States and Europe approach the problem from opposite directions?

In the U.S., there was a financial incentive: Roughly 3.7 million babies are born each year, while there are about 75 million Americans age 60 and older — the group for whom the two adult vaccines were approved. And about half of children get their vaccines through the Vaccines for Children program, which negotiates discounted prices.

Also, babies can get vaccinated only by their clinicians. Adults can walk into pharmacies for vaccinations, and pharmacies are only too happy to have the business.

But which older adults truly benefit from the shot? The two manufacturers of the adult vaccines, GSK and Pfizer, conducted their studies presented to the FDA for approval in a population of generally healthy people 60 and older, so that's the group to whom they may be marketed. And marketed they are, even though the studies didn't show the shots staved off hospitalization or death in people ages 60 to 75.

That led to what some have called a "narrow" endorsement from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices for people 60 to 75: Patients in that age range could get the shot after "shared clinical decision-making" with a health provider.

It is likely that because of this fuzzy recommendation, some Americans 60 and over with commercial insurance are finding that their insurers won't cover it. Under Obamacare, insurers are generally required to cover at no cost vaccines that are recommended by the ACIP; however, if a provider recommends vaccination, then it must be covered by insurance.

(In late September, the ACIP recommended immunization of all babies with either the antibody or the maternal vaccine. Insurers have a year to commence coverage and many have been dragging their feet because of the high price.)

There are better and more equitable ways to steer the shots into the arms of those who need it, rather than simply administering it to those who have the “right” insurance or, swayed by advertising, can pay. For example, insurers, including Medicare, could be required to cover only those ages 60 to 75 who have a prescription from a doctor, indicating shared decision-making has occurred.

Finally, during the pandemic emergency, the federal government purchased all COVID-19 vaccines in bulk at a negotiated price, initially below $20 a shot, and distributed them nationally. If, to protect public health, we want vaccines to get into the arms of all who benefit, that's a more cohesive strategy than the patchwork one used now.

Vaccines are miraculous, and it's great news that they now exist to prevent serious illness and death from RSV. But using such novel vaccines wisely — directing them to the people who need them at a price they can afford — will be key. Otherwise, the cost to the health system, and to patients, could undermine this big medical win.

Elisabeth Rosenthal: erosenthal@kff.org, @RosenthalHealth

Smaller Employers Weigh a Big-Company Fix for Scarce Primary Care: Their Own Clinics

KFF Health News, October 27, 2023

About 20% of employers who offer health insurance and have 200 to 999 workers provide on-site or near-site clinics.

This article was published on Friday, October 27, 2023 in KFF Health News.

By Phil Galewitz

With his company's health costs soaring and his workers struggling with high blood pressure and other medical conditions, Winston Griffin, CEO of Laurel Grocery Co., knew his company had to do something.

So the London, Kentucky, wholesaler opened a health clinic.

"Our margins are tiny, so every expense is important," Griffin said. The clinic, he said, has helped lower the company's health costs and reduce employee sick leave.

Large employers have run clinics for decades. At Laurel Grocery's in-house clinic, workers can get checkups, blood tests, and other primary care needs fulfilled free, without leaving the workplace. But Griffin's move is notable because of his company's size: only about 250 employees.

Nationwide, a modest number of small- and medium-size employers have set up their own health clinics at or near their workplaces, according to surveys and interviews with corporate vendors and consulting firms that help employers open such facilities.

Improving employee health and lowering health costs are among the main advantages employers cite for running clinics. But some companies also say they're helping to blunt the nation's shortage of primary care doctors and eliminate the hassle of finding and getting care.

"Why did we do this? So my employees would not drop dead on the floor," Griffin said. "We had such an unhealthy workforce, and drastic times called for drastic measures."

KFF's annual survey of workplace benefits this year found that about 20% of employers who offer health insurance and have 200 to 999 workers provide on-site or near-site clinics. That compares with 30% or better for employers with 1,000 or more workers.

Those figures have been relatively steady in recent years, surveys show.

And U.S. employers reported the biggest increase this year in annual family premiums for their sponsored health plans in a decade — an average jump of 7% to nearly $24,000, according to the KFF survey, released Oct. 18. That spike may intensify interest among business leaders in curbing underlying health costs, including by exploring delivering care at workplaces.

Employers don't require their workers to use their clinics but typically provide incentives such as free or reduced copayments. Griffin offered employees $150 to get a physical at the clinic; 90% took advantage of the deal, he said.

Employer clinics could alleviate the rising demand for primary care. A far lower proportion of U.S. doctors are generalists than in other advanced economies, according to data compiled by the Peterson Center on Healthcare and KFF.

For patients, frustrating wait times are one result. A recent survey by a physician staffing firm found it now takes an average of three weeks to get in to see a family doctor.

In 2022, Franklin International, a manufacturer of adhesives in Columbus, Ohio, began offering its 450 workers the option to use local primary care clinics managed by Marathon Health, one of about a dozen companies that set up on-site or near-site health centers for employers.

Franklin employees pay nothing at the clinics compared with a $50 copayment to see an outside doctor in their insurance network. So far about 30% of its workers use the Marathon clinics, said Doug Reys, Franklin's manager of compensation benefits.

"We heard about the difficulty employees had to get in to a doctor," he said. They would call providers who said they were accepting new patients but would still wait months for an appointment, he added.

At the Marathon clinics — which are shared by other employers — workers now can see a provider within a day, he said.

That's good for employees — and for the company's recruiting efforts. "It is a good benefit to say you can get free primary care," Reys said.

Not all employers that have explored opening their own clinics have seen the value. In 2020, the agency that oversees health benefits for Wisconsin state employees opted against the on-site model after a review of experiences by similar agencies in Indiana and Kentucky found it didn't save money or constrain health insurance premiums.

Kara Speer, national practice leader for consulting firm WTW, said potential cost savings from employer-run clinics can take years to accrue as employees shift from pricier hospital emergency rooms and urgent care clinics. And it can be difficult to measure whether clinics control costs by improving workers' health through preventive screenings and checkups, she said.

Kathy Vicars, a senior vice president at Marathon Health, said about 25% of its 250 clients are firms with fewer than 500 people. She said Marathon's clinics help drive down costs and help employees get easier access to doctors who spend more time with them during appointments. Her company helps employers manage workers with chronic diseases better and redirects care from urgent care centers and ERs, she said.

Hospitals have also sought to get into the business of running on-site clinics for employers, but some potential clients question whether those health systems have incentives to funnel workers to their own hospitals and specialists.

At Laurel Grocery, Griffin said he knows many of his employees don't regularly exercise and have poor diets — a reflection of the overall population in the region. Health screenings performed by a local hospital over the years found many residents with high cholesterol and high blood pressure. "Nothing tended to change," he said.

Laurel Grocery contracts with a local hospital for about $100,000 a year to manage its clinic, including having a physician assistant on-site three days a week. Laurel Grocery does not have access to any employee health records.

He said the clinic has saved money by reducing unnecessary ER use and reducing hospitalizations. "It's been way more successful than I thought it would" be, he said.

The clinic is about a three-minute walk from Kip Faulhaber's office. Faulhaber, a senior vice president at Laurel Grocer who is 73, said he goes in every week for a vitamin B12 shot to treat a deficiency. He also turns to the clinic for an annual physical, vaccinations, and when he has a sinus infection but doesn't want to wait several days to see his regular physician.

"This is more than convenient," he said.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

Doubts Abound About a New Alzheimer's Blood Test

KFF Health News, October 26, 2023

Alzheimer's researchers aren't convinced the Quest test is backed by sound scientific research.

This article was published on Thursday, October 26, 2023 in KFF Health News.

By Judith Graham

For the first time, people worried about their risk of Alzheimer's disease can go online, order a blood test, and receive results in the privacy of their homes.

This might seem appealing on the surface, but the development has Alzheimer's researchers and clinicians up in arms. 

The Quest Diagnostics blood test, AD-Detect, measures elevated levels of amyloid-beta proteins, a signature characteristic of Alzheimer's. Introduced in late July, the test is targeted primarily at people 50 and older who suspect their memory and thinking might be impaired and people with a family history of Alzheimer's or genetic risks for the condition.

Given Alzheimer's is among the most feared of all medical conditions, along with cancer, this could be a sizable market, indeed. Nearly 7 million older adults in the U.S. have Alzheimer's, and that number is expected to double by 2060 if medical breakthroughs don't occur.

But Alzheimer's researchers and clinicians aren't convinced the Quest test is backed by sound scientific research. The possibility of false-positive results is high, as is the likelihood that older adults won't understand the significance of their results, they say. The test should be taken only under a physician's supervision, if at all, they advise. And, priced originally at $399 (recently discounted to $299) and not covered by insurance, it isn't cheap.

Though blood tests for Alzheimer's are likely to become common in the years ahead, the Alzheimer's Association said it's premature to offer a test of this kind directly to consumers.

For its part, Quest, which also sells direct-to-consumer tests for sexually transmitted diseases and various other conditions, suggests older adults can be trusted to respond responsibly to AD-Detect results. The test is not meant to diagnose Alzheimer's, the company stressed; instead, it's meant to help assess an individual's risk of developing the condition. But under a new, proposed biological definition of Alzheimer's, excess amyloid could automatically trigger a diagnosis of "preclinical" Alzheimer's.

Michael Racke, Quest's medical director of neurology, said individuals who test positive might be inspired to talk to their physicians about cognitive symptoms and seek comprehensive evaluations from dementia specialists. Others may just want to adopt behaviors associated with brain health, such as exercising more and maintaining healthy blood pressure, blood sugar, and cholesterol levels.

"People who do consumer-initiated testing are often very motivated to figure out what they can do to help reduce the risk of disease," he said.

To get the test, a person first needs to go to the AD-Detect test's website and report that they're experiencing mild cognitive decline and have at least one other risk factor. (Self-reported complaints of this kind are often unreliable, experts note.) The order then goes automatically to a doctor paid by Quest, who will order a blood test to be drawn at a Quest laboratory.

Results classifying a person as low, medium, or high risk will be provided on a secure patient portal. Post-test counseling isn't mandatory, but individuals can speak to a physician paid by Quest, if they like. (There is a separate $13 "physician service fee.")

A new poll from the University of Michigan confirms that older adults will take results seriously: Ninety-seven percent of seniors said they would take steps to improve brain health upon receiving a positive result from a blood test, while 77% said they would consider changes to financial or end-of-life plans.

But research scientists and clinicians worry that Quest hasn't published any peer-reviewed studies documenting the test's validity. The company's preliminary data released at the 2022 Alzheimer's Association International Conference in San Diego suggests there's a relatively high chance of false-positive results, said Suzanne Schindler, an associate professor of neurology at Washington University School of Medicine in St. Louis.

That's a significant problem because telling someone they have biological changes associated with Alzheimer's disease is a "big deal and you want to be as accurate as possible," Schindler noted.

Racke said at least three scientific studies giving more details about the AD-Detect test have been submitted to medical journals and might be published by the end of this year.

Experts also question the usefulness of the test since a positive result (indicating abnormal levels of amyloid in the blood) doesn't mean an individual will definitely develop Alzheimer's disease. Amyloid in the brain accumulates slowly over the course of decades, typically beginning in middle age, and becomes more common as people age.

"This test gives you a fuzzy answer. We don't know whether you're going to get dementia, or when symptoms might begin, or, really, how high the risk is for any individual," said Meera Sheffrin, medical director of the Senior Care clinic at Stanford Healthcare.

Also, cognitive symptoms that prompt someone to take the test might be due to a wide variety of other causes, including mini-strokes, sleep apnea, thyroid problems, vitamin B12 deficiency, or medication interactions. If an older adult becomes anxious, depressed, or hopeless upon learning they're at risk for Alzheimer's — another source of concern — "they may not go for further evaluation and seek appropriate care," said Rebecca Edelmayer, senior director of scientific engagement at the Alzheimer's Association.

The University of Michigan poll confirms the potential for misunderstanding. Upon receiving a positive result from a blood test, 74% of seniors said they would believe they were likely to develop Alzheimer's and 64% said they would be likely to experience significant distress.

Because the science behind blood tests for Alzheimer's is still developing and because "patients may not really understand the uncertainty of test results," Edelmayer said, the Alzheimer's Association "does not endorse the use of the AD-Detect test by consumers."

Quest's blood test is one of several developments altering the landscape of Alzheimer's care in the United States. In early July, the FDA granted full approval to Leqembi, an anti-amyloid therapy that slightly slows cognitive decline in people with mild cognitive impairment and early-stage Alzheimer's. Early detection of cognitive symptoms and diagnosis of cognitive dysfunction have assumed greater importance now that this disease-modifying drug is available.

Also in July, a work group convened by the National Institute on Aging and the Alzheimer's Association proposed a new definition of Alzheimer's disease to be used in clinical practice.

Previously, Alzheimer's could be diagnosed only when there was evidence of underlying brain pathology (amyloid plaques and tau tangles) as well as cognitive symptoms (memory loss, poor judgment, disorientation, among others) and accompanying impairments (difficulty with managing finances, wandering, problems with self-care, and more). Under the new definition, Alzheimer's would be defined purely on a biological basis, as a "continuum that is first evident with the appearance of brain pathologic changes" including amyloid accumulation, according to a draft of the work group's report.

That would mean "you can get a positive result from the Quest test and be diagnosed with Alzheimer's disease if these guidelines are adopted, even if you're cognitively normal," cautioned Eric Widera, a professor of medicine at the University of California-San Francisco.

Demand for follow-up evaluations by dementia specialists is likely to be high and contribute to already-long waits for care, he suggested.

Additional concerns about the test relate to safeguarding privacy and the potential for discrimination. No federal laws protect people who receive Alzheimer's biomarker results from discriminatory practices, such as employment discrimination or the denial of life, disability, or long-term care insurance. (The Genetic Information Nondiscrimination Act applies only to genetic tests.) And "laws that normally protect the privacy of health information do not apply in this space," said Emily Largent, an assistant professor of medical ethics and health policy at the University of Pennsylvania's Perelman School of Medicine.

Notably, HIPAA, the Health Insurance Portability and Accountability Act, doesn't extend to laboratory tests marketed directly to consumers.

The bottom line: Before taking a test, "older adults need to ask themselves, ‘Why do I want to know this? What will I do with the information? How will I react? What would I change in the future?'" said C. Munro Cullum, a neuropsychologist and distinguished professor of clinical psychology at the University of Texas Southwestern Medical Center. "This test needs to be used very cautiously and with great forethought."

We're eager to hear from readers about questions you'd like answered, problems you've been having with your care, and advice you need in dealing with the health care system. Visit kffhealthnews.org/columnists to submit your requests or tips.

Judith Graham: khn.navigatingaging@gmail.com, @judith_graham

CA Expands Paid Sick Days and Boosts Health Worker Wages

KFF Health News, October 25, 2023

Gov. Cavin Newsom tempered the bill-signing season by vetoing free condoms in schools and possession of psychedelic mushrooms.

This article was published on Wednesday, October 25, 2023 in KFF Health News.

By Don Thompson

SACRAMENTO, Calif. — California continues to burnish its reputation as a progressive state for health policy as Gov. Gavin Newsom signed bills expanding paid sick leave, adding bereavement leave for miscarriages, and boosting wages for health workers.

Newsom blessed a rare agreement between labor and the health industry to gradually phase in a nation-leading $25-an-hour statewide minimum wage for health workers. Estimates based on earlier versions of the bill found it would increase healthcare costs by billions of dollars each year and put pressure on the state's Medicaid program to raise reimbursement rates for long-term care to maintain patients' access to services. Other new laws aim to strengthen reproductive rights, as well as patient protections against errant doctors and pharmacists and surprise ambulance bills.

Still, in a possible sign of his national ambitions and experience as a businessperson and father, the Democrat tempered the bill-signing season by vetoing free condoms in schools and possession of psychedelic mushrooms.

He rejected decriminalizing such hallucinogens even as he supported their therapeutic potential as "an exciting frontier." He urged lawmakers to try again next year, this time adding specific treatment guidelines including recommended doses and protections for people with underlying psychoses. The bill's lead author, state Sen. Scott Wiener of San Francisco, had introduced the proposal amid successful decriminalization efforts in Colorado, Oregon, and some cities, saying veterans and others suffering from post-traumatic stress disorder and depression should not be penalized for seeking relief.

Newsom also shot down a $35 price cap for a 30-day supply of insulin in favor of his own price-cutting efforts, touting his administration's $50 million contract to begin sourcing its own insulin as early as next year. He argued this approach would avoid indirect price hikes for consumers that could come in the form of higher premiums to cover cheaper insulin.

The governor similarly showed caution in vetoing health and safety protections for domestic workers, arguing that "private households and families cannot be regulated in the exact same manner as traditional businesses."

The new laws will take effect in 2024 unless otherwise noted:

Sick Days

California workers will be entitled to five paid sick days a year under SB 616, by state Sen. Lena Gonzalez, a Democrat from Long Beach. That's up from the three days required in California since 2014, but short of the seven days Gonzalez originally sought. Advocates say workers shouldn't have to show up sick, potentially spreading illness, because they can't afford to stay home. But the California Chamber of Commerce included the bill on its annual job killer list and said it would harm struggling small businesses.

Miscarriage and Failed Adoption Leave

Parents who experience miscarriages, stillbirths, failed adoptions, or a breakdown in a surrogate pregnancy agreement will all be entitled to bereavement leave under SB 848. The bill, by state Sen. Susan Rubio, a Democrat from the San Gabriel Valley, will include unpaid reproductive loss leave under the state's existing law allowing up to five days of bereavement leave upon the death of a family member. She called reproductive losses "one of the most traumatizing events a person can experience," noting that Illinois and Utah enacted similar laws in 2022. The bill applies to companies with five or more employees.

Abortion Protections

A year after the U.S. Supreme Court overturned Roe v. Wade, Newsom signed nine abortion-related laws, adding to the strong protections for the procedure that California lawmakers adopted a year ago. Among them is SB 345, which increases protections for medical providers who live in California but mail abortion pills or gender-related medications to states where they are illegal. The bill's lead author, state Sen. Nancy Skinner, a Democrat from Berkeley, said in a statement that the laws strengthen California's position "as the national leader for reproductive freedom." Another bill, AB 1646, by Assembly member Stephanie Nguyen, a Democrat from Elk Grove, allows doctors from other states to receive abortion training in California without having to obtain a California medical license.

Behavioral Health Funding

Voters will get a direct say in March on Proposition 1, Newsom's key behavioral health initiative. Having signed a bipartisan package of bills, Newsom will ask voters to approve billions of dollars aimed at alleviating California's seemingly incorrigible homelessness crisis. He says that represents a paradigm shift in how California addresses the dilemma, but the proposition is opposed by those worried about expanding involuntary treatment and diverting funding from existing community-based programs. He also signed SB 43, expanding the state's conservatorship law to make it easier to force people into treatment for mental illness or addiction.

Medical Licensing Fees

The Medical Board of California will be required to follow new procedures while investigating complaints, while doctors will pay higher licensing fees to help fund those investigations. SB 815, by Sen. Richard Roth, a Riverside Democrat, mandates the new complaint procedures amid criticism of the board by patient advocates, who say bad doctors often escape sanction. It will gradually boost the license renewal fee to $1,255 every two years, up from $863 currently. It also repeals AB 2098, passed last year, that said it is unprofessional conduct for doctors to spread misinformation or disinformation related to COVID-19. The law was entangled in multiple lawsuits with conflicting rulings, including one by a federal judge who called it "unconstitutionally vague."

Pharmacy Errors

Medication errors harm at least 1.5 million Americans annually and are among the most common medical errors, according to the National Academy of Medicine. In California, they are the top violation resulting in a citation. AB 1286, by Assembly member Matt Haney, a Democrat from San Francisco, imposes what he said is a first-in-the-nation requirement that retail pharmacies report every error. It also gives the pharmacist in charge at each store the authority to increase staffing and the duty to inform the store's management of dangerous conditions. The California State Board of Pharmacy can close a pharmacy if the conditions aren't improved.

Surprise Ambulance Bills

Patients who call for an ambulance can sometimes receive "surprise bills" topping $1,000, according to Health Access California. AB 716, by Assembly member Tasha Boerner, a Democrat from Encinitas, protects consumers from being charged out-of-network costs for ambulance services and uninsured Californians from being charged what she calls inflated ambulance rates. An analysis by the California Health Benefits Review Program said that would require health plans and insurers to pay more for out-of-network services.

Lifesaving Medications

AB 1651, by Assembly member Kate Sanchez, a Republican from Rancho Santa Margarita, will require schools to have emergency epinephrine auto-injectors for use by school nurses or trained volunteers to treat life-threatening anaphylactic reactions. More than 15% of children with food allergies have had a reaction at school, according to the Latino Food Allergy Network, which sought the bill.

Food Safety

By 2027, California will become the first U.S. state to ban four chemicals widely used in processed food and drinks, following the lead of the European Union and other nations. AB 418, by Democratic Assembly members Jesse Gabriel and Buffy Wicks, initially drew headlines because it would have banned titanium dioxide, which is used in Skittles, but that chemical was dropped from the bill. Opponents said the U.S. and California already have sufficient food safety and food labeling requirements. Newsom and the bill's supporters chided the Food and Drug Administration for failing to take action.

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

Tiny, Rural Hospitals Feel the Pinch as Medicare Advantage Plans Grow

KFF Health News, October 23, 2023

MA plans have become dubious payers for many hospitals, which report the insurers are often slow to pay or don't pay.

This article was published on Monday, October 23, 2023 in KFF Health News.

By Sarah Jane Tribble

Jason Bleak runs Battle Mountain General Hospital, a small facility in a remote Nevada gold mining town that he described as "out here in the middle of nowhere."

When several representatives from private health insurance companies called on him a few years ago to offer Medicare Advantage plan contracts so their enrollees could use his hospital, Bleak sent them away.

"Come back to the table with a better offer," the chief executive recalled telling them. The representatives haven't returned.

Battle Mountain is in north-central Nevada about a three-hour drive from Reno, and four hours from Salt Lake City. Bleak suspects insurance companies simply haven't enrolled enough of the area's seniors to need his hospital in their network.

Medicare Advantage insurers are private companies that contract with the federal government to provide Medicare benefits to seniors in place of traditional Medicare. The plans have become dubious payers for many large and small hospitals, which report the insurers are often slow to pay or don't pay.

Private plans now cover more than half of all those eligible for Medicare. And while enrollment is highest in metropolitan areas, it has increased fourfold in rural areas since 2010. Meanwhile, more than 150 rural hospitals have closed since 2010, according to the Cecil G. Sheps Center for Health Services Research at the University of North Carolina. Largely rural states such as Texas, Tennessee, and Georgia have had the most closures.

Medicare Advantage growth has had an outsize impact on the finances of small, rural hospitals that Medicare has designated as "critical access." Under the designation, government-administered Medicare pays extra to those hospitals to compensate for low patient volumes. Medicare Advantage plans, on the other hand, offer negotiated rates that hospital operators say often don't match those of traditional Medicare.

"It's happening across the country," said Carrie Cochran-McClain, chief policy officer of the National Rural Health Association, whose members include small-town hospitals.

"Depending on the level of Medicare Advantage penetration in individual communities, some facilities are seeing a significant portion of their traditional Medicare patient or beneficiary move into Medicare Advantage," Cochran-McClain said.

Kelly Adams is the CEO of Mesa View Regional Hospital, another rural hospital in Nevada. He said he applauds Battle Mountain's Bleak for keeping Medicare Advantage plans out of his hospital "as long as he has."

Mesa View, which is a little more than an hour's drive east of Las Vegas, has a high percentage of patients enrolled in Medicare Advantage plans.

"Am I going to say I'm not going to take care of 40% of our patients at the hospital or the clinic?" Adams said, adding that it would be a "tough deal" to be forced to reject patients because they didn't have traditional Medicare.

Mesa View has 21 Medicare Advantage contracts with multiple insurance companies. Adams said he has trouble getting the plans to pay for care the hospital has provided. They are either "slow pay or no pay," he said.

In all, the plans owe Mesa View more than $800,000 for care already provided. Mesa View lost about $1.3 million taking care of patients, according to its most recent annual cost report.

NRHA's Cochran-McClain said the growth in the plans also narrows options for patients because "the contracting that is happening under Medicare Advantage frequently has an influence on steering patients to specific types of providers." If a hospital or provider does not contract with a Medicare Advantage plan, then a patient may have to pay for out-of-network care. That generally wouldn't happen with traditional Medicare, which is widely accepted.

At Mesa View, patients must drive to Utah to find nursing homes and rehabilitation facilities covered by their Medicare Advantage plans.

"Our local nursing homes are not taking Medicare Advantage patients because they don't get paid. But if you're straight Medicare, they'd be happy to take that patient," Adams said.

David Allen, a spokesperson for AHIP, an industry trade group formerly known as America's Health Insurance Plans, declined to respond to Bleak's and Adams' specific concerns. Instead, he said enrollees are signing on because the plans "are more efficient, more cost-effective, and deliver better value than original Medicare."

Centers for Medicare & Medicaid Services press secretary Sara Lonardo said CMS has acted to ensure "that private insurance companies are held accountable for providing quality coverage and care."

The reach of private Medicare Advantage plans varies widely in rural areas, said Keith Mueller, director of the Rural Policy Research Institute at the University of Iowa College of Public Health. If recent trends continue, enrollment could tip to 50% of all rural Medicare beneficiaries in about three years — with some regions like the Upper Midwest already higher than 50% and others lower, such as Nevada and the Mountain States, but trending upward.

In June, a bipartisan group of Congress members, led by Sen. Sherrod Brown (D-Ohio), sent a letter urging federal agencies to do more to force Medicare Advantage insurers to pay health systems what they owe for patient care.

In an August response, CMS Administrator Chiquita Brooks-LaSure wrote that a final rule issued in April made "impactful changes" to speed up care and address concerns about prior authorization — when a hospital and patient must get advance permission for care to ensure it will be covered by an insurer. Brooks-LaSure noted another proposed rule that, once finalized, could mandate that insurers provide specific reasons for denying care within seven days.

Hospital operators Adams and Bleak also want more federal action, and fast.

Bleak at Battle Mountain said he knows Medicare Advantage plans will eventually move into his area and he will have to contract with them.

"The question is," Bleak said, "how can we match the reimbursement so that we can sustain and keep our hospitals in these rural areas viable and strong?"

Sarah Jane Tribble: sjtribble@kff.org, @SJTribble

Biden Pick to Lead NIH Finally Has Her Day, but Still Gets Caught Up in Drug Price Debate

KFF Health News, October 20, 2023

The way the hearing began — introducing issues and politics that are not necessarily on point — highlights how much the job of leading the NIH has changed.

This article was published on Friday, October 20, 2023 in KFF Health News.

By Colleen DeGuzman

A Senate committee finally held a hearing Wednesday on President Joe Biden's pick to lead the National Institutes of Health. But the panel's chair, Sen. Bernie Sanders (I-Vt.), was focused on drug prices — an issue over which the NIH has very little control.

After introducing the nominee, Monica Bertagnolli, at a hearing of the Health, Education, Labor and Pensions Committee, Sanders quickly pivoted to the high prices Americans pay for prescription drugs.

"Let me say a few words about my concerns," he said, using his opening statement to detail the failures of the country's "broken" health system. "Very relevant to the hearing that we are conducting right now," he said, "we spend, as a nation, the highest prices — we pay the highest prices in the world for prescription drugs, in some cases 10 times more than the people in other nations."

The way the hearing began — introducing issues and politics that are not necessarily on point — highlights how much the job of leading the NIH has changed. The agency has a budget of more than $47 billion, making it the largest funder of medical research in the world. But the responsibility of its director has, since the pandemic, taken on new layers of complexity.

It has become "an enormous job of bridging between the world of policy, the world of the public, and the world of science," said Larry Levitt, executive vice president for health policy at KFF.

"COVID turned the scientific health agencies into political footballs like never before," he said in an interview.

The nomination of Bertagnolli, a surgical oncologist and the director of the NIH's National Cancer Institute, was applauded by much of the medical research community, especially the oncology world. But after she was tapped for the role in May, progress stalled.

The confirmation of Bertagnolli's predecessor, Francis Collins, a physician and geneticist, took just four weeks in 2009, Sen. Tommy Tuberville (R-Ala.), observed. Bertagnolli's, he told her, has "faced a much different nomination process. Your nomination was held up by Chairman Sanders."

Sanders agreed to hold the hearing only after the Biden administration announced a contract with biotech company Regeneron Pharmaceuticals for a next-generation monoclonal antibody to prevent COVID-19 that required the list price of any resulting drug to be equal to or lower than the price in other major countries.

During the hearing, he returned to the issue, suggesting NIH should seek more such agreements with drugmakers that depend on the agency's research. He asked Bertagnolli if she could "commit to us that you will work to make sure that Americans do not pay higher prices for prescription drugs in this country than people around the world."

She responded noncommittally. "It would be a great honor to be able to work with you to make sure that the American people have access to the care that they need to live long and healthy lives."

As part of his criticism of Sanders, Tuberville also pointed out that the NIH has been without a confirmed director for 21 months. Tuberville, meanwhile, has for months been holding up nominations to military leadership positions over abortion policies.

If she's confirmed, Bertagnolli would lead the NIH at a time of high scrutiny and skepticism of public health agencies. HELP Committee Ranking Member Bill Cassidy (R-La.) told her that part of her duty would be "to rebuild the relationship with Congress and the public, being a leader that represents the interests of all Americans and not just of the scientific community."

To this end, senators asked Bertagnolli about how she would lead the agency's research on maternal health and diabetes, and about how she would address both opioid addiction and mental health crises. She was pressed on how accessible NIH's data would be to the public.

Roger Marshall (R-Kan.) asked if she thought taxpayers should "fund gender reassignment experiments." She dodged the question, noting that transgender youth are some of the most vulnerable in the country.

Bertagnolli kept a cool tone throughout the hearing as she shared her vision of "making sure that American people have access and availability and can afford the healthcare that can save lives."

Senators also questioned how well-rounded Bertagnolli's experience is and whether she would favor the NCI over the agency's 26 other institutes and centers. Sen. Susan Collins (R-Maine) asked Bertagnolli if she would be able to find a balance.

She explained that, as an oncologist, she "took care of patients of all ages, all walks of life, all different health states. I am very familiar to working with colleagues in cardiology, in mental health, in opioid use disorder, in kidney disease, to take care of my patients with cancer."

The HELP Committee has scheduled a vote on Bertagnolli's nomination Oct. 25.

Colleen DeGuzman: cdeguzman@kff.org, @acolleendg

For People With Sickle Cell Disease, ERs Can Mean Life-Threatening Waits

KFF Health News, October 17, 2023

A crisis can quickly escalate into life-threatening complications such as strokes, seizures, and sepsis.

This article was published on Tuesday, October 17, 2023 in KFF Health News.

By Sara Hutchinson

Heather Avant always dresses up when she goes to the emergency room.

"I've been conditioned to act and behave in a very specific way," said Avant. "I try to do my hair. I make sure I shower, have nice clothes. Sometimes I put on my University of Michigan shirt."

It's a strategy to combat discrimination the 42-year-old photographer in Mesquite, Texas, has developed over a lifetime of managing her sickle cell disease, a rare blood disorder that affects an estimated 100,000 Americans. The hereditary condition can affect a person of any race or ethnicity, but Black patients, like Avant, make up the majority of those afflicted in the U.S.

For people living with the disease, a sickle cell crisis can happen at any time. When it does, their rigid, sickle-shaped red blood cells become stuck in their blood vessels, blocking flow and causing extreme pain or breathing difficulties. A crisis can escalate into life-threatening complications such as strokes, seizures, and sepsis.

When a pain crisis can't be managed at home, patients head to the ER to get the high dosage of opioids they need, in addition to IVs to help with dehydration or even blood transfusions. Yet staffers in emergency departments — already overextended and grappling with nursing shortages — don't always have experience in treating the rare disease. Doctors, amid a still-raging opioid crisis, remain resistant to prescribing the painkillers necessary to treat sickle cell crises. So, patients say, they face long delays before receiving essential care, plus discrimination and suspicion that they are seeking drugs to get high.

"I have to look like I'm not coming in here off the street looking for medication," said Avant. "I have to put on an entire show to get you to believe that I need care."

Years of research have documented the delays. A study published in 2013 found that patients seeking care from 2003 through 2008 at an ER for their sickle cell crises waited 50% longer than patients who arrived with broken legs or arms. A study published in 2021 found that 50% of sickle cell patients reported having to wait at least two hours before their pain was treated, despite medical guidelines recommending such patients in crisis receive their first dose of pain medication no more than 60 minutes after arriving at the ER.

Medical associations such as the American Society of Hematology, the National Heart, Lung, and Blood Institute, and the Emergency Nurses Association have established guidelines for emergency department-based care of sickle cell pain. And, in 2021, the Emergency Department Sickle Cell Care Coalition, a national collaboration of hematologists, pharmacists, and nurses, helped launch a point-of-care tool to help medical professionals manage the disease in the ER.

But patients and sickle cell experts said those best practices haven't been widely adopted. A 2020 survey of nearly 250 emergency medicine providers found that 75% of them were unaware of the NHLBI's recommendations, first published in 2014, yet 98% felt confident in their ability to treat patients with sickle cell disease.

Still, ER horror stories abound among adults with sickle cell disease. For Lesly Chavez, 29, a Houston hairstylist, her worst experience occurred a few years ago. She said she spent four hours in a waiting room before getting seen.

"And when they finally got to me, they told me they could help with ‘my addiction,' but they decided that there was nothing that they could do for me," Chavez said. "They just flat-out said no and sent me home while I was in crisis."

Chavez said she has since avoided that hospital even though it's 10 minutes from her home. Now she drives to an ER 30 minutes away.

Chavez, who is Hispanic, said she confronts "doubt everywhere I go" because sickle cell disease primarily affects Black Americans. (Those who are Hispanic can be of any race.)

Paula Tanabe, a professor of nursing at Duke University who has spent decades researching ways to improve care for sickle cell patients, said a confluence of factors adds to the racial bias patients may face.

"Emergency rooms are incredibly overcrowded, at rates that we have never seen before, and that's for everyone," said Tanabe.

Legislators are trying to help. A federal bill introduced in June would allocate $8.2 million annually for five years to a program that trains doctors on best practices for caring for sickle cell patients. Another, introduced this spring, would provide funding for community organizations working to spread awareness about the condition and give student loan relief to medical providers who commit to working on the disease. Some state legislatures have established sickle cell task forces to improve physician education and care coordination.

Advocates for sickle cell patients said investment in data collection to track the disease is also important. Although the Centers for Disease Control and Prevention estimates that some 100,000 Americans have it, the true number is unknown. That's because no national system exists to collect data on sickle cell, unlike other conditions such as diabetes, cancer, and Alzheimer's.

"I'm 32 and we've been saying it's 100,000 my entire life," said Quannecia McCruse, who co-founded the Sickle Cell Association of Houston. "I know there's more. I know people are going uncounted."

Eleven state-led data collection programs currently exist and, in February, the CDC opened a new grant application for additional states. Improved data would allow funding to be allocated toward the areas with the greatest need, sickle cell patient advocates said.

Texas had an opportunity to join those efforts. This spring, the state legislature passed a bill with broad bipartisan support to create a sickle cell patient registry, but Republican Gov. Greg Abbott vetoed it, saying it would compromise patient privacy.

"That was a bad excuse," said McCruse. "We have a cancer registry already, and everyone's information is safe. That registry would have gone a long way to help."

While progress grinds slowly, patients like McCruse say they're forced to balance advocating for themselves during bouts of excruciating pain against the need not to irritate or alienate hospital staffers.

"It feels like someone is taking a Taser and shocking the crap out of me. Or when it's really bad, and it feels like shards of glass are just moving through my veins," said the mother of two. "It's very, very painful. And you're telling somebody whose body is torturing them that it's not that bad?"

Alexis Thompson, a hematologist who treats sickle cell patients at the Children's Hospital of Philadelphia, said she works with her pediatric patients to develop self-advocacy skills. But sometimes that backfires.

"The great irony is patients who are well informed and capable of self-advocating are being accused of being manipulative, because they are capable of articulating very clearly what's effective for them down to the name of the medication or the absolute dose," Thompson said.

Sickle cell experts recommend that doctors adhere to a patient's individual pain plan, if available. Thompson said those plans, which document patients' diagnoses alongside a recommended medication and dosage, can be uploaded to online portals that patients can pull up on their cellphones when visiting an ER to verify what they need.

Patients such as Avant hope such steps can help decrease their ER waits while easing their anxiety about seeking emergency care.

"I don't fear dying," said Avant, "but I do fear dying in the hospital."

Sara Hutchinson: @peachhutchinson

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