About 39% of U.S. hospitals had announced vaccine mandates.

This article was published on Tuesday, August 31, 2021 in Kaiser Health News.

By Lauren Weber 

In the rural northeastern corner of Missouri, Scotland County Hospital has been so low on staff that it sometimes had to turn away patients amid a surge in COVID-19 cases.

The national COVID staffing crunch means CEO Dr. Randy Tobler has hired more travel nurses to fill the gaps. And the prices are steep — what he called "crazy" rates of $200 an hour or more, which Tobler said his small rural hospital cannot afford.

A little over 60% of his staff is fully vaccinated. Even as COVID cases rise, though, a vaccine mandate is out of the question.

"If that becomes our differential advantage, we probably won't have one until we're forced to have one," Tobler said. "Maybe that's the thing that will keep nurses here."

As of Thursday, about 39% of U.S. hospitals had announced vaccine mandates, said Colin Milligan, a spokesperson for the American Hospital Association. Across Missouri and the nation, hospitals are weighing more than patient and caregiver health in deciding whether to mandate COVID vaccines for staffers.

The market for healthcare labor, strained by more than a year and a half of coping with the pandemic, continues to be pinched. While urban hospitals with deeper pockets for shoring up staff have implemented vaccine mandates, and may even use them as a selling point to recruit staffers and patients, their rural and regional counterparts are left with hard choices as cases surge again.

"Obviously, it's going to be a real challenge for these small, rural hospitals to mandate a vaccine when they're already facing such significant workforce shortages," said Alan Morgan, head of the National Rural Health Association.

Without vaccine mandates, this could lead to a desperate cycle: Areas with fewer vaccinated residents likely have fewer vaccinated hospital workers, too, making them more likely to be hard hit by the delta variant sweeping America. In the short term, mandates might drive away some workers. But the surge could also squeeze the hospital workforce further as patients flood in and staffers take sick days.

Rural COVID mortality rates were almost 70% higher on average than urban ones for the week ending Aug. 15, according to the Rural Policy Research Institute.

Despite the scientific knowledge that COVID vaccinations sharply lower the risk of infection, hospitalization and death, the lack of a vaccine mandate can serve as a hospital recruiting tool. In Nebraska, the state veterans affairs' agency prominently displays the lack of a vaccine requirement for nurses on its job site, The Associated Press reported.

It all comes back to workforce shortages, especially in more vaccine-hesitant communities, said Jacy Warrell, executive director of the Rural Health Association of Tennessee. She pointed out that some regional healthcare systems don't qualify for staffing assistance from the National Guard as they have fewer than 200 beds. A potential vaccine mandate further endangers their staffing numbers, she said.

"They're going to have to think twice about it," Warrell said. "They're going to have to weigh the risk and benefit there."

The mandates are having ripple effects throughout the healthcare industry. The federal government has mandated that all nursing homes require COVID vaccinations or risk losing Medicare and Medicaid reimbursements, and industry groups have warned that workers may jump to other healthcare settings. Meanwhile, Montana has banned vaccine mandates altogether, and the Montana Hospital Association has gotten one call from a healthcare worker interested in working in the state because of it, said spokesperson Katy Peterson.

It's not just nurses at stake with vaccine mandates. Respiratory techs, nursing assistants, food service employees, billing staff and other healthcare workers are already in short supply. According to the latest KFF/The Washington Post Frontline Healthcare Workers Survey, released in April, at least one-third of healthcare workers who assist with patient care and administrative tasks have considered leaving the workforce.

The combination of burnout and added stress of people leaving their jobs has worn down the healthcare workers the public often forgets about, said interventional radiology tech Joseph Brown, who works at Sutter Roseville Medical Center outside Sacramento, California.

This has a domino effect, Brown said: More of his co-workers are going on stress and medical leave as their numbers dwindle and while hospitals run out of beds. He said nurses' aides already doing backbreaking work are suddenly forced to care for more patients.

"Explain to me how you get 15 people up to a toilet, do the vitals, change the beds, provide the care you're supposed to provide for 15 people in an eight-hour shift and not injure yourself," he said.

In Missouri, Tobler said his wife, Heliene, is training to be a volunteer certified medical assistant to help fill the gap in the hospital's rural health clinic.

Tobler is waiting to see if the larger St. Louis hospitals lose staff in the coming weeks as their vaccine mandates go into effect, and what impact that could have throughout the state.

In the hard-hit southwestern corner of Missouri, CoxHealth president and CEO Steve Edwards said his health system headquartered in Springfield is upping its minimum wage to $15.25 an hour to compete for workers.

While the estimated $25 million price tag of such a salary boost will take away about half the hospital system's bottom line, Edwards said, the investment is necessary to keep up with the competitive labor market and cushion the blow of the potential loss of staffers to the hospital's upcoming Oct. 15 vaccine mandate.

"We're asking people to take bedpans and work all night and do really difficult work and maybe put themselves in harm's way," he said. "It seems like a much harder job than some of these 9-to-5 jobs in an Amazon distribution center."

Two of his employees died from COVID. In July alone, Edwards said 500 staffers were out, predominantly due to the virus. The vaccine mandate could keep that from happening, Edwards said.

"You may have the finest neurosurgeon, but if you don't have a registration person everything stops," he said. "We're all interdependent on each other."

But California's Brown, who is vaccinated, said he worries about his colleagues who may lose their jobs because they are unwilling to comply with vaccine mandates.

California has mandated that healthcare workers complete their COVID vaccination shots by the end of September. The state is already seeing traveling nurses turn down assignments there because they do not want to be vaccinated, CalMatters reported.

Since the mandate applies statewide, workers cannot go work at another hospital without vaccine requirements nearby. Brown is frustrated that hospital administrators and lawmakers, who have "zero COVID exposure," are the ones making those decisions.

"Hospitals across the country posted signs that said 'Healthcare heroes work here.' Where is the reward for our heroes?" he asked. "Right now, the hospitals are telling us the reward for the heroes: 'If you don't get the vaccine, you're fired.'"

Lauren Weber: LaurenW@kff.org, @LaurenWeberHP

The problems reflect the decentralized nature of the health program, funded largely by the federal government but managed by the states.

This article was published on Friday, August 27, 2021 in Kaiser Health News.

By Phil Galewitz  

Medicaid enrollees are getting vaccinated against COVID-19 at far lower rates than the general population as states search for the best strategies to improve access to the shots and persuade those who remain hesitant.

Efforts by state Medicaid agencies and the private health plans that most states pay to cover their low-income residents has been scattershot and hampered by a lack of access to state data about which members are immunized. The problems reflect the decentralized nature of the health program, funded largely by the federal government but managed by the states.

It also points to the difficulty in getting the message to Medicaid populations about the importance of the COVID vaccines and challenges they face getting care.

"These are some of the hardest-to-reach populations and those often last in line for medical care," said Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group. Medicaid enrollees often face hurdles accessing vaccines, including worries about taking time off work or finding transportation, he said.

In California, 49% of enrollees age 12 and older in Medi-Cal (the name of Medicaid in California) are at least partly vaccinated, compared with 74% for Californians overall.

Unlike some other large states, such as Texas and Pennsylvania, California provides its Medicaid plans with information from vaccine registries, which can help them target unvaccinated enrollees. But still, the rate of immunizations lags far behind that of the general population.

According to detailed reports showing vaccination rates by county and by health plan, rates around the state vary dramatically. In Silicon Valley's Santa Clara County, 63% of Medi-Cal members have been vaccinated, versus 38% in neighboring Stanislaus County. California health plans are working with community groups to knock on doors in neighborhoods with low vaccination rates and providing shots on the spot.

This fall, California — which has the nation's largest Medicaid program, with nearly 14 million people — will offer its Medi-Cal health plans $250 million in incentives to vaccinate members. The state is also putting up $100 million for gift cards limited to $50 for each enrollee.

In other states — such as Kentucky and Ohio — health plans are giving $100 gift cards to members when they get vaccinated.

While more than 202 million Americans are at least partly vaccinated against COVID, nearly 30% of people 12 and older remain unvaccinated. Surveys show poor people are less likely to get a shot.

More than two-thirds of Medicaid beneficiaries across the country are covered by a private health plan. States pay a monthly fee to the plan for each member to handle medical needs and preventive care.

Nationally, about 70% of Medicaid enrollees are at least 12 years old and eligible for the vaccines, according to a KFF analysis.

State Medicaid programs that can track their progress show modest results:

• In Florida, 34% of Medicaid recipients are at least partly vaccinated, compared with 67% for all residents 12 and older.
   
• In Utah, 43% of Medicaid recipients are at least partly vaccinated, compared with 68% statewide.
   
• In Louisiana, 26% of Medicaid enrollees are at least partly vaccinated, compared with 59% for the state population.
   
• In Washington, D.C., 41% of Medicaid enrollees are at least partly vaccinated, compared with 76% of all residents.

"We know how we are doing, and it's not great," said Dr. Pamela Riley, medical director of the D.C. Department of Healthcare Finance, which oversees Medicaid.

Hemi Tewarson, executive director of the National Academy for State Health Policy, said she "had hoped there would not be this much of a disparity, but clearly there is."

Medicaid agencies in several states, including Pennsylvania, Missouri, New Jersey and Texas, said they lack complete data on vaccination rates and don't have access to state registries showing who has been immunized. Health experts say that, without that data, the Medicaid vaccine campaigns are virtually flying blind.

"Having data is step one in knowing who to reach out to and who to call and who to have doctors and pediatricians help out with," said Julia Raifman, assistant professor of health law, policy and management at Boston University.

For years, Medicaid programs have worked with providers to improve vaccination rates among children and adults. But now, Medicaid officials need more direction from the federal government to set up "a more clear and focused and effective approach" to control COVID, Raifman said.

Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, said the federal government is giving extra funding to state Medicaid programs to encourage COVID vaccinations. "We're also encouraging states to remind people enrolled in their state Medicaid plans that vaccines are free, safe, and effective," she said in a statement to KHN. Kennedy, of Medicaid Health Plans of America, said the job of getting shots to Medicaid enrollees is harder when states don't share immunization data.

"We need access to the state immunization registries so we can make informed decisions to get those unvaccinated people vaccinated and identify those doing a great job, but it all starts with data sharing," he said.

Medicaid agencies' claims data doesn't account for the many enrollees who get vaccinated at federal immunization sites and other places that don't require insurance information.

California Medicaid officials said they can track enrollee vaccination by linking to the state Department of Public Health's immunization registry, which captures residents' inoculations regardless of where they occur in the state.

Data as of Aug. 8 shows rural Lassen County in northeastern California with the lowest vaccination rate among Medi-Cal enrollees, at 21%, and San Francisco with the highest, at 67%.

Medicaid enrollees' vaccination rates fall short even compared with those of other people in the same county. In San Diego County, for example, 91% of residents are at least partially vaccinated, compared with 51% of Medicaid recipients.

Jana Eubank, executive director of the Texas Association of Community Health Centers, said her clinics would be grateful to know which Medicaid recipients are vaccinated to better target immunization campaigns. Having the data would also help providers make sure people get an additional dose, often called a booster, being recommended this fall.

"We have a pretty good sense, but it would be great to have more detail, as that would allow us to be more focused with our finite resources," Eubank said.

Pennsylvania's Department of Human Services, which oversees Medicaid, said it requested vaccine registry data from the state health department in the spring but hasn't received it. A health department spokesperson said her agency was working through legal issues to safeguard the registry's personal health data.

"Getting accurate, comprehensive vaccination data for our Medicaid recipients is a priority, but we cannot do so based off claims and ad hoc data alone," said Ali Fogarty, a Pennsylvania Medicaid spokesperson.

Dr. David Kelley, chief medical officer of the state's Medicaid program, said the lack of immunization data hasn't slowed the agency's vaccination work: "We are continuing full steam ahead to get folks immunized."

AmeriHealth Caritas, which operates Medicaid health plans in Pennsylvania, Florida and six other states and the District of Columbia, has about 25% of its Medicaid enrollees vaccinated, said Dr. Andrea Gelzer, senior vice president of medical affairs.

AmeriHealth is working with its doctors and community organizations to support vaccine clinics. It has offered free transportation and made vaccines available to homebound enrollees.

In Louisiana, the Medicaid program has offered bonuses to five health plans to spur vaccines. But so far only one, Aetna, has qualified.

Louisiana Medicaid is paying Aetna $286,000 for improving its vaccination rates by 20 percentage points from May to August, state and health plan officials said. Aetna had at least partly vaccinated 36% of its enrollees as of Aug. 16.

John Baackes, CEO of L.A. Care Health Plan, said he remains skeptical about paying people to get their shots and said it could upset enrollees who already have been vaccinated and won't qualify for cash or a gift card. "We don't think gift cards are going to move the needle very much," he said.

As part of its strategy to increase vaccinations, the health plan has called members at high risk of COVID complications to get them into walk-up or drive-thru immunization sites and helped homebound members get shots where they live. About half the plan's eligible enrollees have received at least one dose.

Richard Sanchez, CEO of CalOptima, the Medicaid health plan in Orange County, California, said offering $25 Subway gift cards helped increase vaccinations among members living at homeless shelters.

As of mid-August, about 56% of its eligible enrollees were at least partly vaccinated. "We are not where we should be, and the nation is not where it should be," Sanchez said.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

About three months after the surgery, Ely Bair was shocked to get the large hospital bill — about $24,000 higher than he expected.

This article was published on Friday, August 27, 2021 in Kaiser Health News.

By Phil Galewitz   

For years, Ely Bair dealt with migraine headaches, jaw pain and high blood pressure, until a dentist recommended surgery to realign his jaw to get to the root of his health problems.

Do you have an exorbitant or baffling medical bill? Join the KHN and NPR 'Bill of the Month' Club and tell us about your experience. We'll feature a new one each month.

The fix would involve two surgeries over a couple of years and wearing braces on his teeth before and in between the procedures.

Bair had the first surgery, on his upper jaw, in 2018 at Swedish Medical Center, First Hill Campus in Seattle. The surgery was covered by his Premera Blue Cross plan, and Bair's out-of-pocket hospital expense was $3,000.

He changed jobs in 2019 but still had Premera health insurance. In 2020, he had the planned surgery on his lower jaw at the same hospital where he'd been treated the first time. The surgery went well, and he spent one night in the hospital before being discharged. He was healing well and beginning to see the benefits of the surgeries.

Then the bill arrived.

The Patient: Ely Bair, 35, a quality assurance analyst. He has a Premera Blue Cross health plan through his job at a biotech firm in Seattle.

Total Bill: Swedish Medical Center billed Bair $27,119 for the second surgery in July 2020. This was Bair's share of the negotiated rate, after the hospital took $14,310 off the charge. His insurer paid $5,000. Bair owed additional bills to the surgeon and the anesthesiologist.

Service Provider: Swedish First Hill Campus in Seattle, part of the largest nonprofit health system in the Seattle area, which is affiliated with Providence, a major Catholic healthcare network.

What Gives: Bair hit two maddening health system pitfalls here: He expected his new plan to behave like his previous one from the same insurer — and he expected his mouth to be treated like the rest of his body. Neither commonsense notion appears true in America's health system.

Typically, large companies, such as Bair's employers, "self insure," meaning they pay their workers' health costs but use insurance companies to maintain provider networks and handle claims. When Bair changed jobs, his insurance coverage changed even though both employers used Premera. Bair paid $3,000 for his first surgery because that was the out-of-pocket maximum under his plan from his previous employer, which covered oral and maxillofacial surgery.

Bair expected that using the same hospital and the same insurance carrier would mean his costs would be similar for part two of his treatment. Bair's oral and maxillofacial surgeon — the same doctor who performed the first procedure — checked Bair's benefits through his insurer's online portal and thought it would be covered. Premera also sent his doctor confirmation agreeing that the second procedure was medically necessary.

About three months after the surgery, Bair was shocked to get the large hospital bill — about $24,000 higher than he expected.

When he called Premera, he learned his new plan had a $5,000 lifetime limit on coverage for the reconstructive jaw procedure known as orthognathic surgery, which is sometimes regarded as a dental rather than a medical intervention. His doctor said that information was not noted in Bair's benefits when the practice reviewed them through an online portal. Premera told Bair he should have known about the limit because it was listed in his detailed, hard-copy, 86-page member-benefit booklet.

The Affordable Care Act in 2014 eliminated lifetime and annual caps on insurance coverage for categories of treatment such as prescription drugs, laboratory services and mental healthcare. While the ACA lists broad categories about what is considered an "essential health benefit," each state decides which services are included in each category and the scope or duration that must be offered. Bariatric surgery, physical therapy and abortion are examples of care for which insurance coverage can vary a lot by state under this ACA provision. Orthognathic surgery is not considered an essential health benefit in Washington. It is sometimes performed for cosmetic purposes only. Also, plans sometimes regard the surgery as part of orthodontia — which frequently involves limits on coverage. But for Bair, it was a clear medical necessity.

Without an ACA requirement for orthognathic surgery, Premera and self-insured plans are allowed to provide various levels of benefits and can impose annual and lifetime caps.

Premera spokesperson Courtney Wallace said Bair transferred from a plan with his former company that did not have a lifetime maximum to a plan with a $5,000 lifetime maximum benefit.

Martine Brousse, a patient advocate and owner of AdvimedPro, which helps patients with healthcare billing disputes, said Bair acted appropriately by using a doctor and hospital in his health plan's network and checking with his doctor about his insurance coverage.

She said Swedish should have told him before the surgery — which was planned weeks ahead of time — how much he would have to pay. "That is a failure on part of the hospital," she said.

Sabrina Corlette, co-director of the Georgetown University Center on Health Insurance Reforms, said it doesn't seem fair that his first employer covered the cost of his surgery but the second employer did not. She said the $27,000 bill seemed excessive and the $5,000 lifetime limit very low. "Essential health benefits serve a really important function, and when there are gaps or holes people can really get hurt," she said.

Resolution: Bair's doctor told him the hospital charge was at least three times the amount Swedish charges uninsured patients for the same surgery. Bair said Swedish offered to let him pay the bill over two years but did not make any other concessions.

Swedish would not say why it did not verify Bair's insurance benefits before the surgery or let him know he would face an enormous bill even though he was insured.

"Hospital pricing is complex and nuanced," Swedish officials said in a statement. Bair's bill "was inclusive of all the care he received, which included specialized services and expertise, equipment and the operating room time. He had a jaw procedure that had a maximum benefit from his insurer of $5,000. He was billed the balance not covered by his insurer."

The hospital system said it also has an online tool that generates estimates tailored to patients' coverage and choice of hospital.

The online tool did not come up with anything on the term "orthognathic surgery," however.

Bair appealed three times to Premera to reconsider its decision to cover only $5,000 of the cost of his procedure. But the insurer rejected each one saying he had exhausted his lifetime orthognathic surgery benefit and he was responsible for any additional care. When Swedish wouldn't lower his cost, he filed a complaint in December 2020 with the state attorney general's office.

A few months later, Swedish reduced Bair's bill from over $27,000 to $7,164.

"Because neither the patient nor his provider was aware of this limitation in coverage prior to the procedure, the surgeon advocated on the patient's behalf to get the bill lowered," the hospital told KHN in a statement.

Bair agreed to pay the lower amount. "The bill is at least a much more manageable number than the financial ruin $27,000 would have been," he said. "I am just looking forward to closing this chapter and moving on."

His surgeon, who helped him fight the hospital bill and limited insurance coverage, reduced his bill to $5,000 from $10,000, Bair said.

Bair said his employer, Adaptive Biotechnologies, is looking into eliminating its $5,000 lifetime limit for the procedure when it is medically necessary.

Since the surgery, Bair said he gets far fewer migraine headaches and his high blood pressure has been reduced. "I feel way more energized," he said.

The Takeaway: When facing a planned surgery, talk to your hospital, doctor and insurer about how much of the bill you will be responsible for — and get it in writing before any procedure.

"In theory, you should be able to rely on your provider to confirm your coverage but, in practice, it is in your best interest to call your insurer yourself," Corlette said.

Even though the ACA eliminated lifetime and annual caps on coverage, that applies only to services deemed essential in a patient's state. Be aware that certain surgeries — like jaw surgery — lie in a gray area; insurers might not consider them a necessary medical intervention or even a medical procedure at all. Corlette said health plans should notify patients when they are closing in on lifetime or annual limits, but that doesn't always happen.

Also, be aware that even though your insurance carrier may stay the same after switching jobs, your benefits could be quite different.

Kudos to Bair for being a proactive patient and appealing to the state attorney general — which got him a positive result.

Stephanie O'Neill contributed the audio profile with this report.

Bill of the Month is a crowdsourced investigation by KHN 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!

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

With an increasing number of hearing aids being sold directly to consumers, advocates are eager for the FDA rules to come out.

This article was published on Thursday, August 26, 2021 in Kaiser Health News.

By Phil Galewitz

Spurred by decades of complaints about the high cost of hearing aids, Congress passed a law in 2017 to allow over-the-counter sales, with hopes it would boost competition and lower prices.

Four years later, federal regulators have yet to issue rules to implement the law. But changes in the industry are offering consumers relief.

In August 2017, President Donald Trump signed the legislation that called for the Food and Drug Administration to issue regulations by 2020 for hearing aids that could be sold in stores without a prescription or a visit to an audiologist or other hearing specialist. That hasn't happened yet, and President Joe Biden last month ordered the FDA to produce those rules for over-the-counter (OTC) purchases by mid-November. That means it will likely take at least until next summer for consumers to feel the direct effects of the law.

Despite the delay, consumers' options have expanded with more hearing devices entering the market, alternative ways to get them and lower prices, particularly for the largest segment of the population with impaired hearing — those with mild to moderate hearing loss, for whom the law was intended.

Leading consumer brands Apple and Bose are offering products and several smaller companies sell aids directly to consumers, providing hearing tests and customer service online from audiologists and other hearing specialists. Even major retailers offer hearing aids directly to consumers and provide audiology services online: Walgreens stores in five Southern and Western states sell what the chain calls "FDA-registered" Lexie hearing aids for $799 a pair — far less than half the price of typical devices.

Nationally, personal sound amplification products, or PSAPs, that are smaller and customizable are now available in stores and online. These devices, which look like hearing aids and sell for a fraction of the price, amplify sounds, but some do not address other components of hearing loss, such as distortion.

"There are many more options than there were in 2017 when Trump signed the Hearing Aid Act into law," said Nancy Williams, president of Auditory Insight, a hearing industry consulting firm in New Haven, Connecticut. "In a sense, you can say the OTC revolution is happening without the FDA, but the difficulty is it is happening more slowly than if the FDA issued its rules on time."

The price for a pair of standard hearing aids typically ranges from $2,000 to $8,000, depending on the technology. That price includes the professional fitting fees and follow-up visits. The hearing aid industry has remained largely insulated from price competition because of consolidation among manufacturers, widespread state licensing laws that mandate sales through audiologists or other hearing professionals, and the acquisition of hearing professionals' practices by device makers.

The federal law creates a category of hearing aids that would legally bypass state dispensing laws and enable consumers to buy aids in stores without consulting a hearing aid professional. Users would be expected to program the devices through a smartphone, and companies could offer service via phone or internet.

With an increasing number of hearing aids and PSAPs being sold directly to consumers, advocates are eager for the FDA rules to come out, because they worry about the confusion caused by the array of choices — with none having the FDA's full seal of approval.

"The FDA delaying regulations has done more harm than good, because the direct-to-consumer market is filling the void and people are doing what they want, and we don't know the quality of these devices," said Barbara Kelley, executive director of the Hearing Loss Association of America, a consumer advocacy group.

The law, sponsored by Sen. Elizabeth Warren (D-Mass.), gave the FDA until August 2020 to issue regulations. Last year, after missing that deadline, FDA officials said the COVID-19 pandemic had delayed the rule-making process.

Many in the hearing aid industry are concerned about the unchecked competition likely to come with allowing consumers to buy aids on their own without an evaluation by a hearing specialist.

Brandon Sawalich, CEO of Starkey, the largest U.S.-based hearing aid company, said consumers need expert assistance to test their hearing, buy an appropriate aid, properly fit it and fine-tune its settings.

"It's not just picking up something off the shelf at your local drugstore or ordering something online and putting it in your ear and your life is going to be reconnected and you are going to hear perfectly again," he said on a recent podcast. "It doesn't work that way, and it's not that easy."

However, by avoiding professional help, more Americans likely can get hearing assistance. "The OTC and direct-to-consumer options open up avenues for those who have no other path to get hearing aids," said Hope Lanter, a Charlotte, North Carolina, audiologist with Hear.com, a Netherlands-based online hearing aid retailer.

She expects that after the FDA issues its rules many hearing aid manufacturers will develop lower-cost, over-the-counter devices that can be obtained without an audiologist's evaluation. She said consumers with modest hearing loss may start out with those types of aids, but later, if their hearing worsens, shift to more expensive devices that require assistance from hearing aid professionals.

"In my view, there is enough pie for everyone," Lanter said, noting that millions of people with hearing loss are not getting any help today. More than 37 million American adults have trouble hearing, including nearly half of people over age 60. Only 1 in 4 adults who could benefit from a hearing aid have ever used one, federal health officials estimate.

Unlike most consumer electronics, hearing aids have remained expensive for decades, generating consumer complaints.

The price is concerning because Medicare and many insurers don't cover hearing aids, though most private Medicare Advantage plans do. Only about half of state Medicaid programs cover the devices, but benefits in those states vary widely, according to data from KFF.

Industry experts predict new over-the-counter hearing aids will be priced at less than $1,000 a pair — about 25% lower than low-cost retailer Costco sells its Kirkland aids, dispensed through a hearing aid professional.

Without federal rules in place, manufacturers have largely waited to develop devices for the OTC market.

Bose chose a different path. This spring it began selling its hearing aids, which can be purchased online without a doctor visit, hearing test or prescription. Bose gained FDA clearance in 2018 after providing data showing the effectiveness of its self-fitting aids was comparable to that of similar devices fitted by a hearing professional. The Bose aids sell for $849 a pair.

Meanwhile, Apple last year integrated hearing assistance into its popular Air Pods Pro earbuds, which can be customized using settings on an iPhone. Apple is not marketing the free benefit as a hearing aid but instead as similar to a PSAP that amplifies sound to help hearing.

Several companies such as Eargo, Lively and Lexie allow consumers to buy aids online and get help from specialists to set them up remotely. As long as companies have generous return policies that enable people to try a couple of aids to see which works best, the proliferation of online options selling high-quality aids is good news for consumers, said Williams, the Connecticut hearing consultant.

Lanter said the stigma around hearing aids will be reduced as people obtain them more easily. She predicted consumers will someday buy hearing aids much as they can buy inexpensive reading eyeglasses at the drugstore today with the option to get a prescription for higher-quality glasses or ones with a more precise fit.

Michelle Arnold, an audiologist and assistant professor at the University of South Florida, said there is no evidence consumers will be harmed buying a hearing aid without seeing an audiologist, and the benefits of getting some improvement in their hearing outweigh any risks. "Will people get the maximum benefit? Maybe not, but it's better than nothing," she said.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz