Observers offer 'an unequivocal yes,' to the question of whether Biden has met his campaign promise.
This article was published on Wednesday, January 18 in Kaiser Health News.
By Julie Appleby
In a speech on Nov. 2, 2020, then-presidential candidate Joe Biden promised, "I'll not only restore Obamacare; I'll build on it."
Two years and counting since then, how is he doing in meeting that promise?
KHN has teamed up with our partners at PolitiFact to monitor 100 key promises — including this one — made by Biden during the 2020 presidential campaign. The pledges touch on issues related to improving the economy, responding to calls for racial justice, and combating climate change. On healthcare, they range from getting COVID-19 under control and improving veterans' healthcare to codifying Roe v. Wade. KHN has recently done progress checks on the administration's pledges to lower the costs of prescription drugs and to reduce the nation's maternal mortality rate.
Eight days into his tenure as president, Biden signed an executive order aimed at strengthening Medicaid and the Affordable Care Act, or Obamacare. A couple of months later, he signed his first major piece of legislation, the American Rescue Plan, which included provisions expanding eligibility for subsidies and increasing premium tax credits available to help low- and moderate-income Americans purchase ACA coverage.
That legislation also offered financial incentives to encourage the 12 states that had declined to expand Medicaid eligibility to do so.
The consumer subsidies were originally set to expire this year but were extended by the Inflation Reduction Act, which Biden signed into law Aug. 16, after much debate and without any Republican votes. The expanded eligibility for subsidies was also continued by this measure.
In October, the Biden administration addressed another issue in the ACA, the so-called family glitch, which prevented some people with job-based insurance from qualifying for subsidies.
Those items alone prompt "an unequivocal yes," to the question of whether Biden has met his campaign promise, said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University.
Joe Antos, a senior fellow at the American Enterprise Institute think tank, offered a different perspective — that the actions taken on the glitch can't count toward Biden's promise to "restore" the ACA. Antos said that's because it wasn't a glitch at all, but rather an intentional element of the original ACA put there to save the government money, and help win its passage in Congress.
"Biden was vice president when the bill was signed into law, and he supposedly supported it," Antos said.
Corlette touted other Biden administration changes, including increased funding for consumer assistance programs that help people sign up for ACA coverage and streamlined some of the paperwork required for enrollment.
The White House issued an official recap of other actions taken as a result of the executive order, including extending the annual open enrollment period to bring in more policyholders, and allowing low-income Americans to sign up anytime.
Last year, a record 14.5 million Americans selected an ACA plan. This year's sign-up period ended Jan. 15 in most states and, based on preliminary numbers, enrollment in 2023 will continue the upward trend.
The boost in enrollment is due, in part, to the enhanced subsidies, which lowered premiums to $10 or less a month for some low-income consumers, and eliminated a cutoff threshold, allowing some higher-income families to qualify for at least some subsidy, said Corlette.
Antos agreed that the administration has made changes that "clearly built on Obamacare and expanded spending and probably did cover more people."
What happened with the financial incentives meant to get states to expand their Medicaid programs to include more low-income adults, particularly those at or below the poverty level who have no children? Those incentives are still there for the taking, but, so far, no states have done so.
South Dakota expanded after the rescue plan's passage, but that was because voters approved a ballot measure, not because of the financial incentives.
"That was part of Biden's goal, to close the coverage gap," said Joan Alker, executive director of the Center for Children and Families at Georgetown. "We still have 11 states resisting Medicaid expansion, and that leaves a big, gaping hole in coverage in those states. But that's not for lack of trying by the Biden administration."
Because enrollment is up, subsidies are more available, more people are helping consumers enroll, and there are additional enticements to get states to expand Medicaid, we rate this as a Promise Kept.
Our sources:
Telephone interview with Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University, Dec. 20, 2022
Telephone interview with Joseph Antos, senior fellow at the American Enterprise Institute, Jan. 5, 2023
Telephone interview with Joan Alker, executive director of the Center for Children and Families at Georgetown University, Jan. 10, 2023
SAN FRANCISCO — healthcare's business class returned to its San Francisco sanctuary last week for JPMorgan's annual healthcare confab, at the gilded Westin St. Francis hotel on Union Square. After a two-year pandemic pause, the mood among the executives, bankers, and startup founders in attendance had the aura of a reunion — as they gossiped about promotions, work-from-home routines, who's getting what investments. Dressed in their capitalist best — ranging from brilliant-blue or pastel-purple blazers to puffy-coat chic — they thronged to big parties, housed in art galleries or restaurants.
But the party was tinged with new anxiety: Would the big money invested in healthcare due to COVID-19 continue to flow? Would investors ask to see results — meaning profits — rather than just cool ideas?
The buzzy conference had just as many words about profits as about patients. The mostly maskless crowd spoke English, French, Japanese — and, of course, money.
Besides the corporate and investment types, attendees routinely saw surprising characters — like celebrity doctor Mehmet Oz, fresh off a Senate run, holding court in the lobby on Jan. 10.
If the vibe in the hotel's congested halls was upbeat — or, at least, cheery — underneath there was a frisson of anxiety as all were aware that the healthcare business bonanza looked to be slowing down.
The conference started with a sidewalk protest of pharmaceutical company Gilead Sciences, whose drugs combating HIV and hepatitis C are fabulously effective — and fabulously expensive. During the pandemic, Congress for the first time has set up a plan to allow Medicare to negotiate U.S. drug prices, which are by far the highest in the world. In a statement, company spokesperson Catherine Cantone said Gilead is the largest private funder of HIV programs in the U.S., adding, "Gilead's role in ending the HIV and hepatitis epidemics is to discover, develop, and ensure access to our life-saving medicines."
Then there's the economic environment, which is turning treacherous. Journalists at financial publication Bloomberg diagnosed a lack of exciting deals. Startup executives — who previously found millions of dollars in investments easy to come by — seemed obligated to show results in their impromptu pitches in bars and coffee shops. Business executives of all stripes promised they either currently made profits or were about to, soon.
"I think this is a tricky year," said Hemant Taneja, CEO of the venture capital firm General Catalyst, during one panel. He suggested that large swaths of health tech startups were overvalued and that their clients will be more interested in whether they're actually providing useful services.
The new message from potential investors was clear. "The idea you could grow and not be profitable is dead, gone," said Dr. Jon Cohen, CEO of the mental health startup Talkspace, in an interview.
There was some cognitive dissonance at the conference. Take, for example, BioNTech, the vaccine developer whose mRNA vaccine, created with Pfizer, provides powerful protection for COVID. Company co-founder Uğur Şahin was interrupted by applause during a presentation recounting its role in fighting the pandemic — and that's before he touted his company's role in reducing infectious disease, saving lives, and meeting global health needs for tuberculosis and malaria.
The conversation later turned to the pricing of his company's flagship vaccine — which it's jockeying to set at more than $100 a dose, up from an average government purchase price of $20.69. It was a fair price considering the "health economics," BioNTech's chief strategy officer, Ryan Richardson, explained: the hospitalizations and serious outcomes averted.
Or take drugstore giant CVS — which is steadily expanding beyond its retail roots into health insurance and primary care. CVS Health CEO Karen Lynch said that as part of its health business the company is looking at all the factors that underlie being well. "Health isn't just about the engagement with the provider; it's about all the other factors — including housing and nutrition," she said. Left unaddressed was the sight often greeting CVS customers upon entering a store: candy, chips, and other processed foods.
For critics, it was a mind-bending comment. "The last I heard, CVS was a for-profit company, not a social welfare agency," said Marion Nestle, a researcher who is a longtime critic of the food industry. "It sells junk foods that make people sick and drugs to treat those illnesses. How's that for a nifty business model!"
CVS spokesperson Ethan Slavin offered a very different vision, one in which CVS is seeking to be a premier health and wellness destination. "We're always evolving our food and beverage assortment to provide healthier, on-trend products." It is also supporting programs to bolster food availability in underserved areas, he added.
Some techies encountered new skepticism about "artificial intelligence." Ginkgo Bioworks co-founder Jason Kelly noted during his presentation that people at the conference heard so much about artificial intelligence during the meetings, "they want to stop hearing it." (Ginkgo's AI, used to support pharmaceutical and biotech research, he said, was different than the rest.)
One surgeon, Dr. Rajesh Aggarwal, found conversations with financiers about the stealth startup he founded, which focuses on metabolic health, were focused on silver bullets. "Tell me if I invest in this, I'll 10x" the outlay, he said, paraphrasing the bankers. Many, he said, wanted to "do some good as well" for patients.
Aggarwal felt the investors were looking for simple solutions to health problems. And one item fit that bill: a new class of drugs — GLP-1 agonists, a type of medication that aids in weight loss but will likely have to be taken for long periods. Some analysts are projecting these drugs will be worth $50 billion. The bankers, Aggarwal felt, aren't "thinking about healthcare," they're "thinking about the dollars attached to the pill."
Along with social isolation came the rapid introduction of remote access to everything from work to workouts.
This article was published on Tuesday, January 17, 2023 in Kaiser Health News.
By Christina Saint Louis
MALMO, Minn. — Eight women, all 73 or older, paced the fellowship hall at Malmo Evangelical Free Church to a rendition of Daniel O'Donnell's "Rivers of Babylon" as they warmed up for an hourlong fitness class.
The women, who live near or on the eastern shore of Mille Lacs Lake, had a variety of reasons for showing up despite fresh snow and slippery roads. One came to reduce the effects of osteoporosis; another, to maintain mobility after a stroke.
Most brought hand and ankle weights, which they would use in a later portion of the program focused on preventing falls, known as Stay Active and Independent for Life, or SAIL. The class meets twice a week in Malmo, a township of about 300 residents. It is run by Juniper, a statewide network of providers of health promotion classes.
A few years ago, older adults who were interested in taking an evidence-based class like SAIL — meaning a class proved by research to promote health — had only one option: attend in person, if one was offered nearby.
But then the COVID-19 pandemic and physical distancing happened. Along with social isolation came the rapid introduction of remote access to everything from work to workouts.
After widespread lockdowns began in March 2020, agencies serving seniors across the U.S. reworked health classes to include virtual options. Isolation has long since ended, but virtual classes remain. For older adults in rural communities who have difficulty getting to exercise facilities, those virtual classes offer opportunities for supervised physical activity that were rare before the pandemic.
And advocates say online classes are here to stay.
"Virtually the whole field knows that offering in-person and remote programming — a full range of programming — is a great way to reach more older adults, to increase access and equity," said Jennifer Tripken, associate director of the Center of Healthy Aging at the National Council on Aging. "This is where we need to move together."
Since April 2020, the National Council on Aging has organized monthly conference calls for service providers to discuss how to improve virtual programs or begin offering them.
"We found that remote programming, particularly for rural areas, expanded the reach of programs, offering opportunities for those who have traditionally not participated in in-person programs to now have the ability to tune in, to leverage technology to participate and receive the benefits," Tripken said.
In 2022, at least 1,547 seniors participated in an online fitness program through Juniper, part of a Minnesota Area Agency on Aging initiative. More than half were from rural areas.
Because of grant funding, participants pay little or nothing.
Juniper's virtual classes have become a regular activity both for people who live far from class locations and others who because of medical needs can't attend. Carmen Nomann, 73, frequented in-person exercise classes near her home in Rochester before the pandemic. After suffering a rare allergic reaction to a COVID vaccine, she's had to forgo boosters and limit in-person socializing.
Virtual classes have been "really a great lifeline for keeping me in condition and having interaction," she said.
Since 2020, Nomann has participated in online tai chi and SAIL, at one point logging on four days a week.
"Now, we would never go away from our online classes," said Julie Roles, Juniper's vice president of communications. "We've learned from so many people, particularly rural people, that that allows them to participate on a regular basis — and they don't have to drive 50 miles to get to a class."
When seniors drive a long way to attend a class with people from outside their communities, "it's harder to build that sense of ‘I'm supported right here at home,'" she said.
Roles said both virtual and in-person exercise programs address social isolation, which older adults in rural areas are prone to.
Dr. Yvonne Hanley has been teaching an online SAIL class for Juniper since 2021 from her home near Fergus Falls. She had recently retired from dentistry and was looking for a way to help people build strength and maintain their health.
At first, Hanley was skeptical that students in her class would bond, but over time, they did. "I say ‘Good morning' to each person as they check in," she said. "And then during class, I try to make it fun."
AgeOptions, an Illinois agency serving seniors, has seen similar benefits since introducing virtual fitness programs. Officials at the agency said last year that their operations "may have changed forever" in favor of a hybrid model of virtual and in-person classes.
That model allows AgeOptions to maintain exercise programs through Illinois' brutal winters. Organizers previously limited winter activities to keep older adults from traveling in snow and ice, but now AgeOptions leans on remote classes instead.
"If the pandemic didn't happen, and we didn't pivot these programs to virtual, we wouldn't be able to do that," said Kathryn Zahm, a manager at AgeOptions. "We would just potentially spend months limiting our programming or limiting the types of programming that we offered. So now we can still continue to offer fall-prevention programs throughout the year because we can offer it in a safe way."
But the new approach has challenges.
AgeOptions has identified increasing access to technology as a funding priority for the next few years, to ensure seniors can sign on.
The agency found that for many "folks in rural communities it was a challenge not only for them to have the device but to have the bandwidth to be able to do video conference calls," Zahm said.
Tripken said providers and participants need guidance and support to facilitate access to virtual classes.
"For older adults in particular, that includes ensuring those with vision loss, those with hearing loss, those with low English proficiency" can participate in virtual classes, she said.
Some programs have created accommodations to ease the technology barrier.
Participants in Bingocize — a fall-prevention program licensed by Western Kentucky University that combines exercise and health education with bingo — can use a printed copy of the game card mailed to them by AgeOptions if they lack the proficiency to play on the game's app. Either way, they're required to participate on video.
The mail option emerged after Bingocize fielded requests from many senior service organizations trying to figure out how to offer it remotely, said Jason Crandall, the creator and international director of Bingocize.
Crandall designed Bingocize as a face-to-face program and later added the online application to use during in-person classes. Then COVID hit.
"All of a sudden, all of these Area Agencies on Aging are scrambling, and they were scrambling trying to figure out, ‘How do we do these evidence-based programs remotely?'" Crandall said.
He said Bingocize was one of the few programs at the time that could quickly pivot to strictly remote programming, though it had never done so before.
"From when the pandemic began to now, we've come light-years on how that is done," he said, "and everybody's getting more comfortable with it."
[Correction: This article was revised at 11 a.m. ET on Jan. 17, 2023, to correct the spelling of the name of the creator of the Bingocize program.]
Using smartphones as diagnostic tools is a work in progress.
This article was published on Tuesday, January 17, 2023 in Kaiser Health News.
By Hannah Norman
The same devices used to take selfies and type out tweets are being repurposed and commercialized for quick access to information needed for monitoring a patient's health. A fingertip pressed against a phone's camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones' built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
"It's very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection," said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning-based medical devices is still being adjusted to reflect software's adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from healthcare providers. And many tools still need fine-tuning, said Dr. Eugene Yang, a professor of medicine at the University of Washington. Currently, Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient's face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot "compare apples to apples" with medical industry standards, Yang said. Failure to build in such assurances undermines the technology's ultimate goals of easing costs and access because a doctor still must verify results.
"False positives and false negatives lead to more testing and more cost to the healthcare system," he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
"If you took the sensor out of the phone and out of a clinical device, they are probably the same thing," said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google's research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient's blood pressure, Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
With the microphone, Canary Speech uses the same underlying technology as Amazon's Alexa to analyze patients' voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O'Connell, the company's CEO.
Australia-based ResApp Health got FDA clearance last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
Brightlamp's Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad's or iPhone's camera, the mobile app measures how a person's pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to healthcare providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone — rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple's new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
"We're not there yet," Yang said. "That's the bottom line."
The U.S. health system benefits from potentially more than $5 billion in free volunteer labor annually.
This article was published on Tuesday, January 10, 2023 in Kaiser Health News.
By Lauren Sausser, Kaiser Health News
MOUNT PLEASANT, S.C. — Most of the 30 volunteers who work at the 130-bed, for-profit East Cooper Medical Center spend their days assisting surgical patients — the scope of their duties extending far beyond those of candy stripers, baby cuddlers, and gift shop clerks.
In fact, one-third of the volunteers at the Tenet Healthcare-owned hospital are retired nurses who check people in for surgery or escort patients to a preoperative room, said Jan Ledbetter, president of the hospital's nonprofit Volunteer Services Organization. Others relay important information from hospital staffers to expectant families. "They're kept extremely busy," Ledbetter said. "We need to have four of those volunteers a day."
At hospitals across the U.S., volunteers play an integral role. So much so that when volunteers were barred from East Cooper at the beginning of the COVID-19 pandemic, staff nurses assumed the volunteers' duties in the surgical waiting room. Like paid employees, hospital volunteers typically face mandatory vaccine requirements, background checks, and patient privacy training. And their duties often entail working in regular shifts.
At HCA Healthcare, the world's largest for-profit hospital system, volunteers include aspiring medical providers who work in patient rooms, in labs, and in wound care units, according to the company's magazine.
Over centuries, leaning on volunteers in medicine has become so embedded in hospital culture that studies show they yield meaningful cost savings and can improve patient satisfaction — seemingly a win-win for hospital systems and the public.
Except, there's a catch.
The U.S. health system benefits from potentially more than $5 billion in free volunteer labor annually, a KHN analysis of data from the Bureau of Labor Statistics and the Independent Sector found. Yet some labor experts argue that using hospital volunteers, particularly at for-profit institutions, provides an opportunity for facilities to run afoul of federal rules, create exploitative arrangements, and deprive employees of paid work amid a larger fight for fair wages.
The federal government instructs that any person performing a task of "consequential economic benefit" for a for-profit entity is entitled to wages and overtime pay. That means profit-generating businesses, like banks and grocery stores, must pay for labor. A Chick-fil-A franchise in North Carolina was recently found guilty of violating minimum wage laws after paying people in meal vouchers instead of wages to direct traffic, according to a Department of Labor citation.
Still, volunteer labor at for-profit hospitals is commonplace and unchecked.
"The rules are pretty clear, and yet it happens all the time," said Marcia McCormick, a lawyer who co-directs the Wefel Center for Employment Law at Saint Louis University. "It's a confusing state of affairs."
In a statement, HCA spokesperson Harlow Sumerford said coordinators oversee hospital volunteers to ensure they are participating in appropriate activities, such as greeting and assisting visitors. Tenet Health spokesperson Valerie Burrow did not respond to a question about how the company ensures that its volunteer activities comply with federal labor laws.
Ben Teicher, a spokesperson for the American Hospital Association, whose members include more than 6,000 nonprofit, for-profit, and government hospitals, did not respond to a question about whether the organization offers guidance to hospitals regarding the legal uses of volunteers.
Meanwhile, the pandemic made the importance of hospital volunteers more apparent. In March 2020, volunteer programs nationwide were largely disbanded, and the volunteers' roles were filled by staff members — or left unfilled — when hospitals closed their doors to everyone except employees, patients, and a few visitors. Volunteers were welcomed back once vaccines became widely available, but many didn't return.
"We've lost so many volunteers," said Ledbetter, who runs the volunteer group at East Cooper Medical Center. "They found something else to do."
On South Carolina's Hilton Head Island, Vicki Gorbett, president of the island's hospital auxiliary, estimated 60% of the group's volunteers who left during the pandemic haven't returned. Much larger hospital systems, some of which boast hundreds or thousands of volunteers, have been affected, too.
"We're building back from the absolute bottom," said Kelly Hedges, who manages volunteers at the Medical University of South Carolina.
Hedges was furloughed for the better part of six months when hospital volunteers were sent home in March 2020. She estimates there are about 600 volunteers at MUSC's hospital campus in Charleston now, down from 700 before the pandemic.
"During a labor crisis, this is a department you want in operation," she said.
While hospital volunteer programs reboot across the country, labor experts say using volunteers may expose some medical facilities to liability.
The Fair Labor Standards Act prohibits "employees" — defined broadly as people an employer "requires or allows" to work — from volunteering their time to for-profit private employers. The same law also requires these employees to be paid no less than the federal minimum wage.
These regulations make it "very, very difficult" for a volunteer to donate time to a for-profit hospital, explained Jenna Bedsole, an employment attorney in Birmingham, Alabama.
The right to be paid isn't waivable, McCormick said, meaning that even those volunteers who don't consider themselves employed may be entitled to compensation. However, the U.S. Department of Labor is "stretched pretty thin" and doesn't enforce the rules that apply to for-profit companies, except in extreme circumstances, she said.
She cited a court ruling in 2017 that found people who volunteered at consignment events for Rhea Lana — a for-profit company that organizes the resale of children's clothing — were employees who should be paid.
But in most cases, McCormick said, it is difficult to determine the outcome of enforcement actions against for-profit companies.
"The Department of Labor sends a letter to the putative employer warning them that it thinks the FLSA is being violated," she said, "and it may not take any other action. And it only issues news releases for big cases."
Companies are more likely to be targeted for the inappropriate use of unpaid interns, she said.
But this isn't to say that, in some cases, individuals can't donate their time in a for-profit setting. In a for-profit nursing home, the federal government has said, people may volunteer without pay if they're attending "to the comfort of nursing home residents in a manner not otherwise provided by the facility." That might include reading to a resident, for example.
One-off charitable opportunities are also possible. A choir group could host a concert in a hospital lobby without violating the law, or a community organization could serve hospital staffers an appreciation lunch.
Beyond that, for-profit "hospitals potentially expose themselves to risk of civil liability," Bedsole said, which could add up in terms of back pay due to employees, fines, and legal fees. If hospital volunteers provide essential services, there is a danger they could be held liable, she said.
Nonprofit hospitals must follow federal labor laws, too.
At the small, nonprofit Baptist Memorial Hospital-Leake in Carthage, Mississippi, the coordinator of volunteers, Michelle McCann, can't use a volunteer in any role that matches an employee's job description. She said she's also prohibited from asking a hospital employee who is off the clock to volunteer their time for a job similar to their own.
"We'd have to pay them for the hours," said McCann, national president of the Society of Healthcare Volunteer Leaders.
Nonprofit hospitals are required to provide a benefit to their communities, such as offering charity care, in exchange for their special tax status. But when it comes to making money, the differences between for-profit and nonprofit hospitals are often negligible to the casual observer, said Femida Handy, a professor of social policy at the University of Pennsylvania.
"When you go to the hospital, do you ask for the tax status?" she asked.
Sam Fankuchen, CEO of Golden, a company that develops software used to organize volunteer labor, said the pandemic hastened a change in public opinion. "Just because an organization is nonprofit, it doesn't necessarily mean they're 100% dedicated to the greater good," he said. "Some nonprofits are better run than others."
Most volunteers are simply trying to figure out how and where they can help in the best possible way, he said.
"The consideration about the tax structure is secondary," said Fankuchen, whose software is used by hospitals and other businesses. "The big picture is that hospitals exist to deliver care. I think it's reasonable that they have volunteer programs."
Jay Johnson, support services manager at Trident Medical Center in North Charleston, South Carolina, coordinates roughly 50 volunteers who contribute an estimated 133,000 hours annually to the for-profit hospital, which is owned by HCA Healthcare.
Trident's volunteers are widely beloved by the staff, he said.
"We actually had a ceremony for them when they came back" when restrictions loosened, Johnson said. Beyond that, volunteers benefit from premium parking spaces and free lunches "to really make sure they're appreciated," he said.
Trident volunteers are required to be vaccinated and undergo a background check. Then, they are assigned to the areas that best match their interests.
Breast cancer survivor Pat LoPresti for example, volunteers in Trident's Breast Care Center. Volunteering provides a sense of purpose and an opportunity to socialize, said LoPresti, a retiree who met her husband, another volunteer, while volunteering at the hospital.
"I started volunteering there because they could use me," LoPresti said. "It's such a privilege to help people in a time when they need it."
Feds are working piecemeal to codify new rules for prescribing controlled substances.
This article was published on Tuesday, January 10, 2023 in Kaiser Health News.
By Darius Tahir, Kaiser Health News
Controlled substances became a little less controlled during the pandemic. That benefited both patients (for their health) and telehealth startups (to make money).
Some potentially addictive medications — like buprenorphine and Adderall — are now far more available online to patients because of regulatory changes. Given the scarcity of qualified doctors to treat some of the behavioral health conditions associated with these drugs, like opioid use disorder or attention-deficit/hyperactivity disorder, doctors' new ability to prescribe online or, in some cases, by telephone is a huge change. But easier access to the drugs has both upsides and downsides, since they're often dispensed without accompanying therapy that improves the odds of a patient's success.
Pre-pandemic, patients sometimes traveled several hours for addiction care, said Emily Behar, director of clinical operations for Ophelia, a New York startup serving people with opioid addictions. Or patients might be struggling with multiple jobs or a lack of child care. Such obstacles made sustaining care fraught.
"How do you reach those people?" she asked.
It's a question preoccupying much of the behavioral health sector, complicated by the reality that most patients with opioid use disorder aren't in treatment, said Dr. Neeraj Gandotra, chief medical officer of the Substance Abuse and Mental Health Services Administration.
Increased access to telehealth has started to provide an answer. Behar, the startup executive, says its patients can see expert providers at their convenience. Missed appointments are dropping, say many in the industry.
The startup has secured solid funding — nearly $68 million, according to Crunchbase, an industry database — but addiction specialists and other prescribers of controlled substances online are a mixed group. Some are nonprofits; others are large startups attracting scrutiny from the news media and law enforcement for allegedly sloppy prescription practices.
The influx of new providers is attributable to loosened requirements born of pandemic-era necessity. To help patients get access to care while maintaining physical distance, the Drug Enforcement Administration and SAMHSA waived restrictions on telehealth for controlled substances.
But whether those changes will endure is uncertain. The federal government is working piecemeal to codify new rules for prescribing controlled substances, in light of the healthcare system's pandemic experience.
On Dec. 13, SAMHSA issued a proposal to codify telehealth regulations on opioid treatment programs — but that affects only part of the sector. Left unaddressed — at least until the DEA issues rules — is the process for individual providers to register to prescribe buprenorphine. The new rules "get us at least a little bit closer to where we need to go," said Sunny Levine, a telehealth and behavioral health lawyer at the D.C.-based firm Foley & Lardner.
Congress also tweaked rules around buprenorphine, doing away with a long-standing policy to cap the number of patients each provider can prescribe to. Ultimately, however, the DEA is the main regulatory domino yet to fall for telehealth providers.
In addition, pharmacies are taking a more skeptical stance on telehealth prescriptions — especially from startups. Patients were getting accustomed to using telemedicine to fill and refill their prescriptions for medications for some controlled substances, like Adderall, primarily used to treat ADHD. A shortage of Adderall has affected access for some patients. Now, though, some pharmacies are refusing to fill those prescriptions.
Cheryl Anderson, one Pennsylvanian with ADHD, said she sought online options because of her demanding schedule.
"My husband is frequently out of town, so I don't have someone to reliably watch the baby to go to an in-person appointment," she said. It was tough, with three kids, to find the time. Telehealth helped for about half of 2022. Previously, the DEA and state governments imposed tough rules on obtaining controlled substances from online pharmacies.
But in September, after her doctor wrote a refill prescription, she got a phone call saying her local pharmacy wouldn't dispense medications if the prescription came through telehealth. Other local pharmacies she called took the same position.
Those denials seem to reflect a broader cultural shift in attitudes. Whereas patients and politicians hailed telemedicine at the beginning of the pandemic — first for its safety but also for its increased convenience and potential to extend care to rural areas and neighborhoods without specialists — hints of skepticism are creeping in.
The telehealth boom attracted shady actors. "You had a lot of people who saw an opportunity to do things that were less than scrupulous," particularly in the behavioral health market, said Michael Yang, a managing partner at the venture capitalist firm OMERS Ventures. Skeptical media coverage has proliferated of startups that, allegedly, shotgun prescriptions for mental health conditions without monitoring patients receiving those medications. "It'll settle down."
The startups pose quandaries for local pharmacists, said Matt Morrison, owner of Gibson's Pharmacy in Dodge City, Kansas.
Pharmacists have multiple obligations related to prescriptions, he said: to make sure incoming prescriptions are from legitimate physicians and that they're connected to an actual health condition before filling the order. The sense around the industry, Morrison said, is that prescriptions from startups are tricky. They might come from a distant provider, whom the pharmacist can't contact easily.
Those qualms pose difficulties for addiction treatment. Persuading pharmacists to fill prescriptions is one of the biggest administrative tasks for Ophelia, Behar said. Still, the shift online has been helpful.
"Telehealth picks up the gaps," said Josh Luftig, a founding member of CA Bridge, a program based in Oakland, California, that helps patients in emergency departments initiate treatment for substance misuse. The supply of care providers wasn't enough to meet demand. "Across the board, there's been a lack of access to treatment in the outpatient setting. Now all they need is a phone and to get to a pharmacy."
Treatment is more efficient for patient and provider alike, providers say. "The majority of our patients prefer to have a telehealth experience," he said. "The telehealth appointments are more efficient. It increases the capacity of each person involved."
Well-established organizations also report success: Geisinger, a large mid-Atlantic health system, said 94% of participants in one maternity-focused program were compliant, spokesperson Emile Lee said.
Ophelia, which started up just before the pandemic, expected to treat patients both in-office and online. "We have an office in Philadelphia we've never used," she said. Now the company labors every few months — in anticipation of the end of state and federal public health emergencies — to make sure that the end of the associated looser rules doesn't lead to disruptions in care for their patients.
More clarity on the future of online treatment could result from permanent regulations from the DEA. What the agency's rule — which would create a registration process for providers interested in prescribing controlled substances online — will say is "anyone's guess," said Elliot Vice, an executive specializing in telehealth with the trade group Faegre Drinker. That rule has been pending for years. "To see this still not move, it is puzzling."
The agency, which declined to comment specifically for this article, pointed to previous statements praising increased access to medication-assisted treatment.
"There shouldn't be any change in the rules for telehealth," Luftig said. "It would be the most horrific thing in terms of access for our communities. It would be an unmitigated disaster."
Private equity investors have rolled up orthopedic practices in at least 12 states.
This story was published on Friday, January 6, 2023 in Kaiser Health News.
By Harris Meyer
Dr. Paul Jeffords and his colleagues at Atlanta-based Resurgens Orthopaedics were worried about their ability to survive financially, even though their independent orthopedic practice was the largest in Georgia, with nearly 100 physicians.
They nervously watched other physician practices sell out entirely to large hospital systems and health insurers. They refused to consider doing that. "It was an arms race," Jeffords said, "and we knew we had to do something different if we wanted to remain independent and strong and offer good quality of care."
So, in December 2021, Resurgens sold a 60% share in United Musculoskeletal Partners, their own management company, to Welsh, Carson, Anderson & Stowe, a large New York-based private equity firm known as Welsh Carson. Although details of the sale were not disclosed, physician-shareholders in deals like this typically each receive a multimillion-dollar cash payout, plus the potential for subsequent big payouts each time the practice is sold to another investor in future years.
Orthopedic surgeons, long seen as fiercely independent, are rapidly catching up with other specialist physicians, such as dermatologists and ophthalmologists, in selling control of their practices to private equity investment firms. They hope to grab a bigger chunk of the surging market in outpatient surgery and maintain their position as one of the highest-paid specialties in medicine — $633,620 was the average compensation for orthopedists in 2021. For older doctors, the upfront cash payout and the potential second payout when the business is flipped offers the promise of a posh retirement.
Proponents say private equity investment has the potential to reduce total spending on musculoskeletal care and improve quality by helping physicians move more procedures to cheaper outpatient surgery centers, which have less overhead. It also could help the doctors shift to value-based payment models, in which they charge fixed amounts for whole episodes of care, such as total joint replacements and spine surgeries — receiving bonuses or penalties from insurers based on cost and quality performance.
But critics warn that profit-hungry private equity ownership alternatively could result in higher prices for patients and insurers, more unnecessary surgery, and less access to care for patients on Medicaid or those who are uninsured or underinsured. A recent study found that in the two years after a sale, PE-owned practices in three other medical specialties had average charges per claim that were 20% higher than at places not owned by private equity.
Critics also worry that PE investors will put pressure on doctors to see more patients and use more non-physician providers in ways that could lead to poorer care, as KHN has reported about gastroenterology and other specialties.
"Private equity has no interest in reducing the cost of medicine," said Dr. Louis Levitt, chief medical officer of MedVanta, a Maryland orthopedic management company whose physician-owners have rejected partnering with private equity. "Their goal is to increase profitability in three to five years and sell to the next group that comes along. They can only do it by making the doctors work longer and reduce service delivery."
There are now at least 15 PE-backed management companies — called platforms — that own orthopedic practices across the country, said Gary Herschman, a New York lawyer who advises physicians in these deals. The first orthopedic deals were done in 2017, and dozens of sales have occurred since then, with the pace expected to quicken. In 2022 alone, at least 15 orthopedic practices were sold to PE-owned management companies.
Dana Jacoby, CEO of the Vector Medical Group, a strategic consultancy for physician groups, said several orthopedic platforms built by private equity investors already are on the market for resale to other investors, though she wouldn’t say which ones. The government does not require public reporting of these deals unless they exceed $101 million, a threshold that is adjusted over time.
Private equity investors have rolled up orthopedic practices in at least 12 states, with concentrations in Georgia, Texas, Florida, and Colorado.
Besides United Musculoskeletal Partners, other sizable PE-owned orthopedic platforms include Phoenix-based HOPCo, backed by Audax Group, Linden Capital Partners, and Frazier Healthcare Partners, with 305 physicians in seven states; Alpharetta, Georgia-based U.S. Orthopaedic Partners, backed by FFL Partners and Thurston Group, with 110 physicians in two states; and Fort Lauderdale, Florida-based Orthopedic Care Partners, backed by Varsity Healthcare Partners, with 120 physicians in four states.
Private equity funds, with a reported $1.8 trillion to invest in health care, are attracted to the size of the orthopedic care market. Annual patient spending is nearly $50 billion alone for treating back pain. The soaring demand of aging Americans for joint replacements, the high rates insurers pay for musculoskeletal procedures — such as nearly $50,000 for a knee replacement — and the lucrative array of orthopedic service lines and ancillary businesses, including ambulatory surgery centers, physical therapy, diagnostic imaging, pain management, and sports medicine, make this a tantalizing line of business.
The standard playbook of private equity firms is to pull profits of 20% out of their physician groups each year, then reap up to a 350% return on their cash investment when they sell the platform, say experts involved in these deals.
Orthopedic surgeons "are very excited about getting a $5 million to $7 million check," said Dr. Jack Bert, former chair of the practice management committee of the American Academy of Orthopedic Surgeons. "But some I’ve talked to say the suits come in and tell the doctors, ‘You’re not working hard enough, you’ve got to increase production by 20%.’ That can be a big problem."
Through their sale to Welsh Carson, the Resurgens orthopedists in Atlanta got a capital partner and executive expertise to help them expand by acquiring other orthopedic practices in Georgia and other markets. Soon after the deal, United Musculoskeletal Partners acquired large orthopedic practices in Dallas and Denver, and brought in a second private equity firm as an additional investor. Several other acquisitions are imminent, said Sean Traynor, a general partner at Welsh Carson.
The investment capital and the company’s growing size in major markets will sharpen the doctors’ ability to negotiate richer contracts with insurers, get better deals on equipment and supplies, build more outpatient surgery centers, and improve quality of care for patients.
The physicians, Traynor said, retain full responsibility for clinical governance, and that is protected by a permanent contract provision binding on all future owners.
"Other physicians ask what’s changed [since the sale], and I say nothing, which is great," said Dr. Irfan Ansari, one of the Resurgens orthopedists.
But some large employers, whose self-funded health plans pay for orthopedic care for their workers, view the trend toward private equity ownership warily. They fear the new owners will milk the current fee-for-service system, which financially rewards doctors for providing more — and more expensive — surgical procedures, rather than promoting less costly but effective services such as physical therapy for lower back pain.
"The worry we have is we’re not seeing private equity fulfilling the promise of value-based care," said Alan Gilbert, vice president for policy at the Purchaser Business Group on Health, which represents nearly 40 large private and public employers. "We’re seeing the same short-term financial goals you see with other private equity investments, including pressure to perform non-indicated procedures."
At least two PE-backed orthopedic groups, however, are working with insurers on cost-saving value-based care programs. U.S. Orthopaedic Partners and HOPCo tout their partnerships with insurers, boasting that they’ve built systems to deliver entire episodes of care at lower costs under fixed-payment models.
Jennifer Allen, chief financial officer at Blue Cross & Blue Shield of Mississippi, said her health plan has saved nearly 40% by collaborating with Mississippi Sports Medicine, now owned by U.S. Orthopaedic Partners, on bundled payments for hip, knee, and shoulder replacement procedures as well as several spine procedures. But Allen said the program was launched in 2016 before private equity investors bought that orthopedic group.
"We had established the protocols, the benefits, the bundle, and everything before that," she said. "I didn’t see anything that the private equity platform brought to the table."
Dr. David Jacofsky, HOPCo’s chairman, said private equity owners should be steering their orthopedic groups toward value-based care, but so far he’s not seeing that happening much. "Private equity has lofty goals of wanting to build these things, but the time frame it takes is much longer than private equity wants to stay in these deals," he said. Instead, he added, most are trying to grow bigger and demand higher payments from insurers, and "that’s not good for anyone."
Still, MedVanta’s Levitt isn’t optimistic about his orthopedic colleagues’ ability, or willingness, to resist private equity. "We’re on an island and pieces are being chipped away by piranhas in the water," he said. "I’m not sure it’s possible to remain independent."
[Correction: This article was updated at 7 p.m. ET on Jan. 6, 2023, to remove the attribution to Sean Traynor in describing the impact of Welsh Carson’s investment capital and its growing size in major markets.]
Older adults contemplating major surgery often aren't sure whether to proceed.
This article was published on Monday, January 3, 2023 in Kaiser Health News.
By Judith Graham
Larry McMahon, who turns 80 this month, is weighing whether to undergo a major surgery. Over the past five years, his back pain has intensified. Physical therapy, muscle relaxants, and injections aren't offering relief.
"It's a pain that leaves me hardly able to do anything," he said.
Should McMahon, a retired Virginia state trooper who now lives in Southport, North Carolina, try spinal fusion surgery, a procedure that can take up to six hours? (Eight years ago, he had a lumbar laminectomy, another arduous back surgery.)
"Will I recover in six months — or in a couple of years? Is it safe for a man of my age with various health issues to be put to sleep for a long period of time?" McMahon asked, relaying some of his concerns to me in a phone conversation.
Older adults contemplating major surgery often aren't sure whether to proceed. In many cases, surgery can be lifesaving or improve a senior's quality of life. But advanced age puts people at greater risk of unwanted outcomes, including difficulty with daily activities, extended hospitalizations, problems moving around, and the loss of independence.
I wrote in November about a new study that shed light on some risks seniors face when having invasive procedures. But readers wanted to know more. How does one determine if potential benefits from major surgery are worth the risks? And what questions should older adults ask as they try to figure this out? I asked several experts for their recommendations. Here's some of what they suggested.
What's the goal of this surgery? Ask your surgeon, "How is this surgery going to make things better for me?" said Margaret "Gretchen" Schwarze, an associate professor of surgery at the University of Wisconsin School of Medicine and Public Health. Will it extend your life by removing a fast-growing tumor? Will your quality of life improve by making it easier to walk? Will it prevent you from becoming disabled, akin to a hip replacement?
If your surgeon says, "We need to remove this growth or clear this blockage," ask what impact that will have on your daily life. Just because an abnormality such as a hernia has been found doesn't mean it has to be addressed, especially if you don't have bothersome symptoms and the procedure comes with complications, said Drs. Robert Becher and Thomas Gill of Yale University, authors of that recent paper on major surgery in older adults.
If things go well, what can I expect? Schwarze, a vascular surgeon, often cares for patients with abdominal aortic aneurysms, an enlargement in a major blood vessel that can be life-threatening if it bursts.
Here's how she describes a "best case" surgical scenario for that condition: "Surgery will be about four to five hours. When it's over, you'll be in the ICU with a breathing tube overnight for a day or two. Then, you'll be in the hospital for another week or so. Afterwards, you'll probably have to go to rehab to get your strength back, but I think you can get back home in three to four weeks, and it'll probably take you two to three months to feel like you did before surgery."
Among other things people might ask their surgeon, according to a patient brochure Schwarze's team has created: What will my daily life look like right after surgery? Three months later? One year later? Will I need help, and for how long? Will tubes or drains be inserted?
If things don't go well, what can I expect? A "worst case" scenario might look like this, according to Schwarze: "You have surgery, and you go to the ICU, and you have serious complications. You have a heart attack. Three weeks after surgery, you're still in the ICU with a breathing tube, and you've lost most of your strength, and there's no chance of ever getting home again. Or, the surgery didn't work, and still you've gone through all this."
"People often think I'll just die on the operating table if things go wrong," said Dr. Emily Finlayson, director of the UCSF Center for Surgery in Older Adults in San Francisco. "But we're very good at rescuing people, and we can keep you alive for a long time. The reality is, there can be a lot of pain and suffering and interventions like feeding tubes and ventilators if things don't go the way we hope."
Given my health, age, and functional status, what's the most likely outcome? Once your surgeon has walked you through various scenarios, ask, "Do I really need to have this surgery, in your opinion?" and "What outcomes do you think are most likely for me?" Finlayson advised. Research suggests that older adults who are frail, have cognitive impairment, or other serious conditions such as heart disease have worse experiences with major surgery. Also, seniors in their 80s and 90s are at higher risk of things going wrong.
"It's important to have family or friends in the room for these conversations with high-risk patients," Finlayson said. Many seniors have some level of cognitive difficulties and may need assistance working through complex decisions.
What are the alternatives? Make sure your physician tells you what the nonsurgical options are, Finlayson said. Older men with prostate cancer, for instance, might want to consider "watchful waiting," ongoing monitoring of their symptoms, rather than risk invasive surgery. Women in their 80s who develop a small breast cancer may opt to leave it alone if removing it poses a risk, given other health factors.
Because of Larry McMahon's age and underlying medical issues (a 2021 knee replacement that hasn't healed, arthritis, high blood pressure), his neurosurgeon suggested he explore other interventions, including more injections and physical therapy, before surgery. "He told me, ‘I make my money from surgery, but that's a last resort," McMahon said.
What can I do to prepare myself? "Preparing for surgery is really vital for older adults: If patients do a few things that doctors recommend — stop smoking, lose weight, walk more, eat better — they can decrease the likelihood of complications and the number of days spent in the hospital," said Dr. Sandhya Lagoo-Deenadayalan, a leader in Duke University Medical Center's Perioperative Optimization of Senior Health program.
When older patients are recommended to POSH, they receive a comprehensive evaluation of their medications, nutritional status, mobility, preexisting conditions, ability to perform daily activities, and support at home. They leave with a "to-do" list of recommended actions, usually starting several weeks before surgery.
If your hospital doesn't have a program of this kind, ask your physician, "How can I get my body and mind ready" before having surgery, Finlayson said. Also ask: "How can I prepare my home in advance to anticipate what I'll need during recovery?"
What will recovery look like? There are three levels to consider: What will recovery in the hospital entail? Will you be transferred to a facility for rehabilitation? And what will recovery be like at home?
Ask how long you're likely to stay in the hospital. Will you have pain, or aftereffects from the anesthesia? Preserving cognition is a concern, and you might want to ask your anesthesiologist what you can do to maintain cognitive functioning following surgery. If you go to a rehab center, you'll want to know what kind of therapy you'll need and whether you can expect to return to your baseline level of functioning.
During the covid-19 pandemic, "a lot of older adults have opted to go home instead of to rehab, and it's really important to make sure they have appropriate support," said Dr. Rachelle Bernacki, director of care transformation and postoperative services at the Center for Geriatric Surgery at Brigham and Women's Hospital in Boston.
For some older adults, a loss of independence after surgery may be permanent. Be sure to inquire what your options are should that occur.
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 khn.org/columnists to submit your requests or tips.
Need medical treatment this year and want to nail down your out-of-pocket costs before you walk into the doctor's office? There's a new tool for that, at least for insured patients.
As of Jan. 1, health insurers and employers that offer health plans must provide online calculators for patients to get detailed estimates of what they will owe — taking into account deductibles and copayments — for a range of services and drugs.
It's the latest effort in an ongoing movement to make prices and upfront cost comparisons possible in a business known for its opaqueness.
Insurers must make the cost information available for 500 nonemergency services considered "shoppable," meaning patients generally have time to consider their options. The federal requirement stems from the Transparency in Coverage rule finalized in 2020.
So how will it work?
Patients, knowing they need a specific treatment, drug, or medical service, first log on to the cost estimator on a website offered through their insurer or, for some, their employer. Next, they can search for the care they need by billing code, which many patients may not have; or by a general description, like "repair of knee joint," or "MRI of abdomen." They can also enter a hospital's or physician's name or the dosage amount of a drug for which they are seeking price information.
Not all drugs or services will be available in the first year of the tools' rollout, but the required 500-item list covers a wide swath of medical services, from acne surgery to X-rays.
Once the information is entered, the calculators are supposed to produce real-time estimates of a patient's out-of-pocket cost.
Starting in 2024, the requirement on insurers expands to include all drugs and services.
These estimator-tool requirements come on top of other price information disclosures that became effective during the past two years, which require hospitals and insurers to publicly post their prices, including those negotiated between them, along with the cost for cash-paying or uninsured patients.
Still, some hospitals have not fully complied with this 2021 disclosure directive and the insurer data released in July is so voluminous that even researchers are finding it cumbersome to download and analyze.
The price estimator tools may help fill that gap.
The new estimates are personalized, computing how much of an annual deductible patients still owe and the out-of-pocket limit that applies to their coverage. The amount the insurer would pay if the service were out of network must also be shown. Patients can request to have the information delivered on paper, if they prefer that to online.
Insurers or employers who fail to provide the tool can face penalty fines of at least $100 a day for each person affected, a significant incentive to comply — if enforced.
And there are caveats: Consumers using the tools must be enrolled in the respective health plan, and there's no guarantee the final cost will be exactly as shown.
That's because "unforeseen factors during the course of treatment, which may involve additional services or providers, can result in higher actual cost sharing liability," federal regulators wrote in outlining the rules.
Insurers will not be held liable for incorrect estimates.
Because the cost estimates may well vary from the final price, either because the procedure was more complex than initially expected, or was handled by a different provider at the last minute, one risk is that "I might get a bill for $4,000 and I'm going to be upset because you told me $3,000," said Gerard Anderson, a professor of health policy and management and of international health at the Johns Hopkins University Bloomberg School of Public Health.
Many insurers have offered versions of cost-estimator tools before, but small percentages of enrollees actually use them, studies have shown.
Federal regulators defended the requirement for estimator tools, writing that even though many insurers had provided them, the new rule sets specific parameters, which may be more detailed than earlier versions.
In outlining the final rule, the Centers for Medicare & Medicaid Services pointed out that some previous calculators "on the market only offer wide-range estimates or average estimates of pricing that use historical claims data" and did not always include information about how much the patient had accumulated toward an annual deductible or out-of-pocket limit.
The agency says such price disclosure will help people comparison-shop and may ultimately help slow rising medical costs.
But that isn't a given.
"CMS has a lot of people who believe this will make a significant impact, but they also have a long time frame," said David Brueggeman, director of commercial health at the consulting firm Guidehouse.
In the short term, results may be harder to see.
"Most patients are not moving en masse to use these tools," said Dr. Ateev Mehrotra, a professor of healthcare policy at Harvard Medical School.
There are many reasons, he said, including little financial incentive if they face the same dollar copayment whether they go to a very expensive facility or a less expensive one. A better way to get patients to switch to lower-cost providers, he said, is to create pricing tiers, rewarding patients who seek the most cost-effective providers with lower copayments.
Mehrotra is skeptical that the cost estimator tools alone will do much to dent rising medical prices. He's more hopeful that, in time, the requirement that hospitals and insurers post all their negotiated prices will go further to slow costs by showcasing which are the most expensive providers, along with which insurers negotiate the best rates.
Still, the cost-estimator tools could be useful for the increasing number of people with high-deductible health plans who pay directly out-of-pocket for much of their healthcare before they hit that deductible. During that period, some may save substantially by shopping around.
Those deductibles add "pressure on consumers to shop on price," said Brueggeman, at Guidehouse. "Whether they are actually doing that is up for debate."
Amanda Shelley was sitting in her dentist's waiting room when she received a call from the police. A local teenage girl had been sexually assaulted and needed an exam.
Shelley, a nurse in rural Eagle County, Colorado, went to her car and called a telehealth company to arrange an appointment with a sexual assault nurse examiner, or SANE. The nurse examiners have extensive training in how to care for assault survivors and collect evidence for possible criminal prosecution.
About an hour later, Shelley met the patient at the Colorado Mountain Medical urgent care clinic in the small town of Avon. She used a tablet to connect by video with a SANE about 2,000 miles away, in New Hampshire.
The remote nurse used the video technology to speak with the patient and guide Shelley through each step of a two-hour exam. One of those steps was a colposcopy, in which Shelley used a magnifying device to closely examine the vagina and cervix. The remote nurse saw, in real time, what Shelley could see, with the help of a video camera attached to the machine.
The service, known as "teleSANE," is new at Shelley's hospital. Before, sexual assault patients faced mountains of obstacles — literally — when they had to travel to a hospital in another county for care.
"We're asking them to drive maybe over snowy passes and then [be there] three to four hours for this exam and then drive back home — it's disheartening for them," Shelley said. "They want to start the healing process and go home and shower."
To avoid this scenario, teleSANE services are expanding across the country in rural, sparsely populated areas. Researchshows SANE programs encourage psychological healing, provide comprehensive healthcare, allow for professional evidence collection, and improve the chance of a successful prosecution.
Jennifer Pierce-Weeks is CEO of the International Association of Forensic Nurses, which created the national standards and certification programs for sexual assault nurse examiners. She said every sexual assault survivor faces health consequences. Assaults can cause physical injuries, sexually transmitted infections, unwanted pregnancies, and mental health conditions that can lead to suicide attempts and drug and alcohol misuse.
"If they are cared for on the front end, all of the risks of those things can be reduced dramatically with the right intervention," Pierce-Weeks said.
Pierce-Weeks said there's no comprehensive national data on the number and location of healthcare professionals with SANE training. But she said studies show there's a nationwide shortage, especially in rural areas.
Some rural hospitals struggle to create or maintain in-person SANE programs because of staffing and funding shortfalls, Pierce-Weeks said.
Training costs money and takes time. If rural hospitals train nurses, they still might not have enough to provide round-the-clock coverage. And nurses in rural areas can't practice their skills as often as those who work in busy urban hospitals.
Some hospitals without SANE programs refer sexual assault survivors elsewhere because they don't feel qualified to help and aren't always legally required to provide comprehensive treatment and evidence collection.
Avel eCare, based in Sioux Falls, South Dakota, has been providing telehealth services since 1993. It recently added teleSANE to its offerings.
Avel provides this service to 43 mostly rural and small-town hospitals across five states and is expanding to Indian Health Service hospitals in the Great Plains. Native Americans face high rates of sexual assault and might have to travel hours for care if they live in one of the region's large, rural reservations.
Jen Canton, who oversees Avel's teleSANE program, said arriving at a local hospital and being referred elsewhere can be devastating for sexual assault survivors. "You just went through what is potentially the worst moment of your life, and then you have to travel two, three hours away to another facility," Canton said. "It takes a lot of courage to even come into the first hospital and say what happened to you and ask for help."
Patients who receive care at hospitals without SANE programs might not receive trauma-informed care, which focuses on identifying sources of trauma, determining how those experiences may affect people's health, and preventing the retraumatizing of patients. Emergency department staffers may not have experience with internal exams or evidence collection. They also might not know about patients' options for involving police.
Patients who travel to a second hospital might struggle to arrange for and afford transportation or child care. Other patients don't have the emotional bandwidth to make the trip and retell their stories.
That's why some survivors, like Ada Sapp, don't have an exam.
Sapp, a healthcare executive at Colorado Mountain Medical, was assaulted before the hospital system began its SANE program. She was shocked to learn she would need to drive 45 minutes to another county for an exam. "I didn't feel comfortable doing that by myself," Sapp said. "So, my husband would have had to come with me, or a friend. The logistics made it feel insurmountable."
Sapp's experience inspired her to help bring SANE services to Colorado Mountain Medical.
Shelley and several other of the hospital system's nurses have SANE training but appreciate having telehealth support from the remote nurses with more experience. "We are a rural community and we're not doing these every single day," Shelley said. "A lot of my nurses would get really anxious before an exam because maybe they haven't done one in a couple months."
A remote "second set of eyes" increases the confidence of the in-person nurse and is reassuring to patients, she said.
Avera St. Mary's Hospital in Pierre, South Dakota, recently began using teleSANE. Rural towns, farms, and ranches surround this capital city, home to about 14,000 people. The nearest metropolitan area is about a three-hour drive.
Taking a break from a recent busy morning in the emergency department, nurse Lindee Miller rolled out the mobile teleSANE cart and colposcope device from Avel eCare. She pulled out a thick binder of instructions and forms and opened drawers filled with swabs, evidence tags, measuring devices, and other forensic materials.
"You're never doing the same exam twice," Miller said. "It's all driven by what the patient wants to do."
She said some patients might want only medicine to prevent pregnancy and sexually transmitted infections. Other patients opt for a head-to-toe physical exam. And some might want her to collect forensic evidence.
SANE programs, including telehealth versions aimed at rural communities, are expected to continue expanding across the country.
President Joe Biden signed a bill last year that provides $30 million to expand SANE services, especially those that use telehealth and serve rural, tribal, and other underserved communities. The law also requires the Justice Department to create a website listing the locations of the programs and grant opportunities for starting them.