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

Thousands of people have rushed to receive infusions of powerful antibody cocktails shown to reduce hospitalizations by 70% when given promptly to high-risk patients.

This article was published on Wednesday, August 25, 2021 in Kaiser Health News.

By JoNel Aleccia  

For months, Joelle Ruppert was among the millions of Americans who are COVID vaccine holdouts. Her reluctance, she said, was not so much that she opposed the new vaccines but that she never felt "compelled" by the evidence supporting their experimental use.

Nonetheless, after she fell ill with COVID last month, Ruppert, a Florida preschool teacher, found herself desperate to try an experimental product that promised to ease her symptoms: infusion with a potent laboratory-produced treatment known as monoclonal antibody therapy.

"I was in bed; I was feeling so badly, like the longest flu I ever had in my life," said Ruppert, 54, of Gainesville. "I was, like, whatever, give me whatever."

Ruppert and her husband, Michael, 61, who also contracted COVID-19, are among thousands of people in the U.S. who in recent weeks have rushed to receive infusions of the powerful antibody cocktails shown to reduce hospitalizations by 70% when given promptly to high-risk patients.

The rush has been fueled in no small part by governors in Southern states, where vaccinations lag and hospitalizations are soaring with delta-variant infections. Republican Govs. Ron DeSantis of Florida and Greg Abbott of Texas are among leaders touting the antibody treatments even as they downplay vaccination and other measures that health officials say can prevent illness in the first place.

Together, they have opened dozens of state-sponsored sites where monoclonal antibody therapy is offered, holding regular news conferences to endorse the potentially lifesaving benefits, while continuing to resist wider public health measures such as mask mandates and vaccine passports.

"Anyone that has a better-than-average risk with COVID, if you do get infected, this is something you can do early and potentially really make a difference," DeSantis said Saturday at the opening of a monoclonal antibody infusion site in Manatee County.

Since mid-July, delivery of the antibody cocktail made by Regeneron Pharmaceuticals has soared from 25,000 doses to 125,000 doses per week, with about half shipped to four states: Florida, Texas, Mississippi and Alabama, said Alexandra Bowie, a company spokesperson. The treatments use laboratory-produced molecules to replace, enhance or mimic the body's natural antibodies that fight infection.

The sudden spotlight on the antibody treatments has whipsawed some public health experts, who have struggled for months to create and sustain sites capable of offering the therapy. The treatment is delivered primarily through a one-dose intravenous infusion that takes about 25 minutes, followed by an hour of observation for reactions.

Antibody cocktails, which must be given within 10 days of COVID infection or exposure, are effective for many patients, but "this is not a substitute for vaccine, by any means," said Dr. Christian Ramers, chief of population health and an infectious disease specialist at Family Health Centers of San Diego.

"It's a backwards strategy," said Ramers. "It's so much better to prevent a disease than to use an expensive, cumbersome and difficult-to-use therapy. It does not make any medical sense to lean into monoclonals to the detriment of vaccines. It's like playing defense with no offense."

The cost of Regeneron infusions: about $1,250 a dose. For now, the federal government is covering the cost.

The federal government is also covering the costs of COVID vaccination, at about $20 a dose.

Hospitals and infusion centers also charge for the time- and resource-intensive administration of monoclonal antibody treatment. Medicare has agreed to pay providers between $310 and $450 for performing it in healthcare settings — and $750 for treatment in a patient's home.

Some patients who receive the treatment may be charged similar amounts for copays and administration fees, depending on what a hospital charges and what their insurance covers. DeSantis has emphasized that the treatment is provided at no cost to patients at Florida's state-run sites.

The Food and Drug Administration authorized two monoclonal antibody treatments for emergency use for COVID in November, weeks after President Donald Trump credited Regeneron's product for curing his infection. Since then, use of a cocktail made by Eli Lilly has been halted because it wasn't effective against some COVID variants. In May, sotrovimab, a monoclonal antibody made by the pharmaceutical firm GlaxoSmithKline, also received emergency authorization.

The treatment is authorized for people newly infected with COVID at high risk of hospitalization and for high-risk patients who have been exposed to the virus. Those eligible include a wide swath of the American public: people who are overweight or obese; those who have diabetes, heart disease or other illnesses; and those with compromised immune systems.

The COVID vaccines also were authorized under emergency-use protocol. This week, the Pfizer-BioNTech vaccine was granted full approval for use in people 16 and older.

Christina Pushaw, a DeSantis spokesperson, said criticism of efforts to promote monoclonal antibody therapy amounts to "a false choice."

"Prevention and treatment are not mutually exclusive," she said in an email. "Both monoclonals and vaccines save lives. The difference is that vaccines are preventative and cannot help someone who is already infected with COVID-19."

Some health officials welcomed the attention to monoclonal antibody therapy generated by DeSantis and others, saying the treatment has been undervalued and underused. The federal government has shipped more than 1.3 million doses of monoclonal products to nearly 6,300 sites, according to the Department of Health and Human Services. So, far, about 637,000 doses — or fewer than half — have been used.

"It's not about vaccination. It's about a treatment for COVID that can keep patients out of the hospital," said Connie Sullivan, president and chief executive of the trade group National Home Infusion Association. "This isn't about politics. This is about patients at risk."

Still, some unvaccinated people appear to view the antibody treatments as a backup plan if they get sick, several health officials said.

At Memorial Hospital Pembroke in South Florida, Chief Nursing Officer David Starnes has overseen treatment of more than 2,000 patients with antibody cocktails since December. At least 90% of the patients have been unvaccinated — and the numbers keep climbing.

"What's amazing to me is that a vaccine we've been working on for 10 years, they are deathly afraid of," Starnes said. "But this highly experimental cocktail? They're willing to run in there the minute that they're sick to get this infused into their bodies."

Even those confounded by the emphasis on monoclonals over vaccination in some states say this new attention to the treatment has helped counter a basic public relations problem: Until recently, awareness of monoclonal treatments, often called mAbs, was low, leaving patients in danger of missing the 10-day window for treatment.

Utah, where fewer than half of residents are vaccinated, is among the states hosting an intensive, coordinated effort to reach people in time. Officials at the Intermountain Healthcare system, based in Utah, pulled together a team of volunteer medical professionals, dubbed "the mAb squad," who scan lists of newly positive COVID patients and call those who meet eligibility criteria to connect them with the treatment.

Dr. Curt Andersen, a family medicine physician and an associate medical director with Intermountain Healthcare, said he's seeing lists of 70 to 80 patients every day because of the delta surge. "I talked to this one gentleman who got treated. Then his wife got treated. Then his mother, who was at very high risk," Andersen said. "On the phone, he broke down in tears because we had this resource and he was so grateful."

Ruppert, the Gainesville preschool teacher, said she, too, was grateful. She and her husband both felt better within days of being treated at UF Health Shands Hospital. The experience has caused her to rethink how to protect herself and her family from COVID.

"Now that I've been there, I have a completely different perspective on this," said Ruppert, who will be eligible for vaccination in mid-October, 90 days after the antibody infusion. "I most likely will be vaccinated."

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

The new contract – which is retroactive to July 15, when the old contract expired and expires on April 30, 2025 -- ends a month-long public spat.

Dignity Health and Anthem Blue Cross have signed a four-year contract that allows Anthem's beneficiaries in-network access to Dignity.

The new contract – which is retroactive to July 15, when the old contract expired and expires on April 30, 2025 -- ends a month-long public spat between the San Francisco-based provider and Indianapolis-based Anthem.

In posts on its website, Dignity called Anthem the "nation's largest for-profit insurance company," and noted that it recorded $1.7 billion in profits in Q1, which went to shareholders and was "not reinvested in patient care or expanded access."

In return, Anthem called Dignity "one of the more expensive health systems in California. We cannot, and will not, agree to excessive rate increases that will make care at Dignity even less affordable for those we serve."

All that appears to be water under the bridge for the two organizations, both of whom declared victory.

"We are pleased to continue working with Dignity. While we understand this wasn’t easy for consumers, it was necessary for us to stand firm as part of our efforts to help slow the sharp rise in healthcare costs," Anthem Regional Vice President John Pickett said. "Our members remained our number one priority as we worked hard and in good faith to find common ground and reach an agreement with Dignity that helps protect affordability."

Robert Quinn, MD, CEO of Dignity Health Medical Foundation called the new contract "a win for our patients."

"From the beginning, our goal in working with Anthem has always been about ensuring we can continue to meet the needs of our patients today and in the future," he said. "This agreement ensures we can continue to provide value-driven care for Anthem members."