Crystal Joseph pays for two telemedicine video services to ensure that her small therapy practice in Silver Spring, Maryland, can always connect with its clients.
She's been burned before. During one hours-long service outage of SimplePractice in late May, PsycYourMind, which offers mental health counseling and group sessions for Black patients, lost about $600 because of missed appointments. Livid, Joseph requested a small credit from the telemedicine service, which costs $432 monthly for her team of clinicians and trainees. SimplePractice refused, she said.
"What they offer is phenomenal, especially being founded by a therapist," said Joseph, a licensed clinical professional counselor. "But with a private practice, if you don't get paid, you don't eat." For some sessions, she was able to hop onto her backup, VSee, which costs her $49 each month. Some of her peers use Zoom. But even though Joseph keeps links to both her SimplePractice and VSee accounts in her email signature, a last-minute switch-up can feel messy for clients, and she never charges a no-show fee when it's an "act of God."
Major health systems, clinics and private practices alike pivoted swiftly to telemedicine when the COVID-19 pandemic forced the nation to shelter in place and patients could no longer safely venture into healthcare settings. But the video services were not equally prepared for the titanic influx in users, said Kapil Chalil Madathil, an engineering professor at Clemson University who has researched how easy — or difficult — telemedicine platforms are to use.
Videoconferencing vendors, including Zoom, tech giants like Microsoft and Cisco, and a host of telemedicine startups absorbed an explosion of demand over the past pandemic months. PitchBook estimates that revenue from the global telehealth market will hit $312.3 billion in 2026, up from $65.5 billion in 2019. But beyond connectivity issues, some services seemed designed for dissatisfaction. They required patients to download a desktop application or made them click through multiple steps to log in. "On an iPhone, I can click one button to see my grandkids," Madathil said. "Can we not make telemedicine systems as easy as that?"
Providers often were locked in with telemedicine options from services they were already using — or what they could afford. Joseph was already paying SimplePractice to house her practice's electronic health records, so moving to another platform would have been time-consuming and costly, she said.
Practitioners have depended on telemedicine to keep their businesses afloat in the pandemic, and Joseph plans to keep a portion of her sessions virtual. A one-stop shop for private practice clinicians, SimplePractice offers scheduling, an electronic medical records system and insurance claims filing along with its video services. The company said it hosted 17 million telehealth appointments last year.
"The expectations are rising," said Diana Stepner, a SimplePractice vice president. "Individuals want screen sharing, they want grid views, so we've added new capabilities since the pandemic began and will continue to do so."
Zoom became an overnight poster child for staying connected as employees in every line of business across the country worked from home. Its revenue jumped 326% in the fiscal year that ended on Jan. 31, 2021, over the previous year's. Even before the pandemic, the Silicon Valley company offered a service tailored for healthcare practitioners that complied with the Health Insurance Portability and Accountability Act, which protects patient privacy, and could be synced with Epic Systems electronic medical records.
"It was 'all bets are off' once the pandemic hit," said Heidi West, who heads the healthcare division at Zoom. West pointed to the CARES Act and the loosening of telehealth regulations, which allowed doctors to be reimbursed for telemedicine at the same rate as for in-office visits.
UCSF Health, which had contracted with Zoom for virtual visits since 2016, gave every doctor and clinician a personal link for its videoconference line and a separate virtual waiting room. Telemedicine calls for outpatient care within the San Francisco academic medical system spiked from 2% of visits in February 2020 to more than 60% by that April. Doctors were seeing patients — who often used their cellphones — in their homes, in parked cars and in one case on skyscraper scaffolding, where a construction worker stepped away for a quick doctor's visit, said Linda Branagan, director of telehealth at UCSF Health.
Zoom is not immune to glitches, Branagan said, but it seems to bounce back faster than many other vendors and "recovers quite gracefully."
UCSF surveyed its patients and found they were more satisfied with their video visits than their in-person ones. More than a year later, almost one-third of outpatient visits are still conducted virtually.
Elsewhere, the initial transition was rockier. Dr. James McElligott, who runs Medical University of South Carolina's Center for Telehealth, said the hospital could not afford to upgrade its Vidyo conferencing system, so he opted for Doxy.me, which the center already used for research and had an easy-to-use interface.
"We were able to get clever, and many doctors really liked it," McElligott said. The software has a waiting room from which patients can be transferred into virtual rooms with providers. The health system sent patients a text with a direct link for their appointments so that they didn't lose time.
"But we couldn't control quality or solve connectivity issues ourselves," he said. "We did have a lot of patients who, despite it just being a link, were uncomfortable waiting." That led to some patients abandoning visits, he added.
Doxy.me employed just eight people when the video telemedicine service saw an unwieldy increase in users in March 2020. For two weeks straight, the company signed up 20,000 new healthcare providers a day, said founder and CEO Brandon Welch, amassing a backlog of customer service inquiries. One day, Welch recalled, there was a 30-second queue for the website to load because so many people were logging on simultaneously.
"We hired anyone who could walk and chew gum at the same time," joked Welch, noting that many of those early pandemic hires, largely tackling customer service, had been recently laid off from other industries, like restaurants.
Doxy.me automated the sign-up process as quickly as possible. The service ballooned from 80,000 users to 850,000 as it assembled a team of 120 employees. And it is still hiring. Doctors and clinicians can sign up for the basic HIPAA-compliant service — which includes audio, video and a patient waiting room — at no charge. But for enhanced options, like screen sharing or shared rooms, there's a price tag of at least $29 a month.
For many doctors and clinicians, the move to virtual visits may be permanent, even with all the technical hiccups. A survey conducted by SimplePractice of over 2,400 clinicians in February found that 88% expected to continue offering a telehealth option.
Jessica Ehrman, a Santa Monica, California, therapist who plans to keep her practice fully remote, finds telemedicine much easier for scheduling, particularly for kids who have short windows of availability. Still, connectivity issues during that small time frame can tarnish the whole session.
"If you're talking about deep childhood trauma — having your connection time out then? It's really frustrating when we're paying for a service," said Ehrman, who has been suddenly dropped from sessions, experienced lags and even once saw back-end coding pop up in her provider portal. Like Joseph in Maryland, she uses SimplePractice through her agency and personally pays for Zoom's HIPAA-compliant option to head off technical difficulties.
Despite the problems, few healthcare providers want to forsake the technology. "Video visits are cemented," said Branagan. "I will never again have to have a conversation with a physician to convince them that you can do healthcare via video."
Despite the ACA's guarantees of free contraception coverage, even for women whose health plans are subject to the law's requirements, obtaining the right product at no cost can be onerous.
For Stephanie Force, finding a birth control method that she likes and can get without paying out-of-pocket has been a struggle, despite the Affordable Care Act's promise of free contraceptives for women and adolescent girls in most health plans.
The 27-year-old physician recruiter in Roanoke, Virginia, was perfectly happy with the NuvaRing, a flexible vaginal ring that women insert monthly to release hormones to prevent pregnancy. But her insurer, Anthem, stopped covering the branded product and switched her to a generic version in early 2020. Force said the new product left her with headaches and feeling irritable and short-tempered.
After talking to her OB-GYN, Force tried an IUD. But that made her feel worse: She had bad cramps, gained 10 pounds and developed severe hormonal acne. Plus, she was charged $248 for an ultrasound her provider used to guide the insertion of the device, a charge she successfully fought.
Force also considered a couple of birth control products approved in recent years: a non-hormonal vaginal gel called Phexxi and a vaginal ring called Annovera that can be used for a year. But Phexxi isn't covered by her employer health plan, and she would owe a $45 copayment for Annovera.
Despite the ACA's guarantees of free contraception coverage, Force's experience illustrates that even for women whose health plans are subject to the law's requirements, obtaining the right product at no cost can be onerous. New types of contraceptives aren't automatically incorporated into the federal list of required methods that insurers use to guide coverage decisions. In addition, some health plans continue to discourage use of even long-established methods like IUDs by requiring providers to get approval from the plan before prescribing them.
Consumer advocates who have studied the issue say a process is spelled out in federal rules for women to get the contraceptive they need, but far too few people know that is an option.
Ultimately, Force went back to the generic version of the NuvaRing, despite the side effects she continues to experience. She'd prefer to be on the branded NuvaRing, which didn't give her problems, and the ping-ponging from method to method has left her exhausted and furious.
"I cannot believe what hoops I have had to jump through between September 2020 and June 2021," Force said, "between switching from the generic NuvaRing to the IUD and then back, fighting my insurance and OB-GYN's office on the ultrasound charge."
In a statement, Anthem said, "Anthem health plans cover 222 contraceptive products at $0 cost share on our ACA Preventive List. We cover at least one product" in each of 18 categories of contraception methods approved by the FDA.
Contraception is a very personal choice, and what meets one woman's needs may not meet another's. If avoiding pregnancy is a woman's top priority, a virtually fail-safe method like an IUD may be the right solution. But for someone who's considering getting pregnant soon, a readily reversible method like a birth control pill might be the best option. Side effects are important to consider as well, since women respond differently to the hormones in various birth control products.
Before the ACA required no-cost birth control coverage, researchers estimate, up to 44% of women's out-of-pocket healthcare spending went toward contraceptives. The ACA required most commercial health plans to cover a comprehensive list of FDA-approved methods without charging women anything. Church plans and religious nonprofits as well as employers and schools that object to contraception are exempt from the coverage requirements. Plans that were grandfathered under the law are also exempt. Uninsured women don't benefit from the mandate either.
But the federal rules do not require health plans to cover every contraceptive. After the ACA passed in 2010, the federal Health Resources & Services Administration developed guidelines for women's preventive services. Those guidelines say women should have access without cost sharing to a list that covers the 18 FDA-approved methods, including oral contraceptives, vaginal rings and cervical caps, IUDs, implantable rods and sterilization. Under federal rules, health plans must cover at least one product in each category.
But neither the HRSA guidelines nor a birth control chart published by the FDA addresses newer methods, including the gel Phexxi, which regulates vaginal acidity to reduce the odds a sperm reaches an egg. It was approved by the FDA last year.
"There's a real need for new guidance that keeps up with new methods," said Mara Gandal-Powers, director of birth control access at the National Women's Law Center.
Many insurers have balked at covering Phexxi, said Rameshwari Gupta, director of strategic markets for Evofem Biosciences, which markets Phexxi. A box of 12 single-use applicators — consumers use one before having sex — costs $267.50 without insurance, she said.
"When I started talking to payers, they all said, 'Where are you on this FDA chart?'" she said.
According to an FDA spokesperson, the birth control chart is for consumer education purposes only and "was not created with the intent of driving coverage decisions." The agency is in the process of updating it.
In a statement, HRSA said it is reviewing the evidence on contraceptives and expects to complete its review late this year. If it opts to make revisions, it will publish draft recommendations to update the women's preventive services guidelines. These will be finalized after a public comment period and become effective a year later.
At this point, health plans consider Phexxi a spermicide and are required to cover only one type of spermicide without cost sharing, said Kristine Grow, a senior vice president at AHIP, a health insurance trade organization.
"If Phexxi is indeed considered a new 'method' of contraception, both the FDA and HRSA would need to make this clear," she added.
The vaginal ring Annovera, approved by the FDA in 2018, is typically covered by health plans, according to Grow, though it may not be available without cost sharing. The average retail price is $2,457 a year, according to GoodRx.
One way plans have made it difficult for women to access certain contraceptives, even those on the list of approved methods, is by requiring that their providers get approval from the insurer first, often by providing documentation that the product is medically necessary.
Under UnitedHealthcare's coverage policy for Phexxi, for example, before coverage will be authorized, members must have documented reasons that they are unable to use eight other contraceptive methods, including oral contraceptives, the contraceptive patch, a vaginal ring, injections and spermicides. Providers also must attest that they have counseled patients that Phexxi is less effective at preventing pregnancy than some other methods.
In a statement, UHC said it covers "a broad array" of generic and brand-name options, and it follows scientific evidence to develop its list.
Yet consumers have a way to get the specific drug that is most appropriate for them, according to a report by the National Women's Law Center.
Under federal rules, if a doctor or other healthcare provider determines that a patient needs a particular contraceptive, even if it's not on the list of approved products for the patient's plan, the insurer is required to have an expedient process for the patient to seek a waiver.
"It's not up to the insurance company whether to cover that method; it's up to the provider," said Adam Sonfield, executive editor for policy analysis at the Guttmacher Institute, a research and advocacy organization focused on women's reproductive health.
But according to the National Women's Law Center report, many insurers, patients and their providers aren't aware of the requirement, and state agencies don't enforce these so-called exceptions policies.
If patients run into trouble getting the method they want, "we typically recommend filing an appeal with their insurance provider," said Gretchen Borchelt, vice president for reproductive rights and health at the National Women's Law Center.
Stephanie Force said she was unaware of any process she could have used to get the NuvaRing covered without cost sharing. Neither her healthcare provider nor the insurer mentioned the possibility.
She recently had an appointment with a new provider, who she hopes will be a better advocate for her.
More than 18 months after Sutter Health agreed to a tentative settlement in a closely watched antitrust case joined by the California Attorney General's Office, the judge presiding over the case indicated she would sign off on the terms, pending agreement on attorney fees. The nonprofit healthcare giant, based in Sacramento, stood accused of violating California's antitrust laws by using its market dominance to drive up prices.
The settlement is expected to have nationwide implications on how hospital systems negotiate prices with insurers.
"These plaintiffs are among the first, but will not be the last, to successfully challenge dominant healthcare systems who undertake land grabs to mark up prices at the expense of patients and employers," Leemore Dafny, a Harvard Business School professor who studies the industry, wrote in an email. "This settlement has provided a marker for the rest of the nation."
The settlement, which includes $575 million in damages, was announced on a preliminary basis in December 2019. It marked a dramatic turn in a long-running legal battle initiated in 2014 as a class-action lawsuit filed by the United Food and Commercial Workers International Union & Employers Benefit Trust, representing employers, unions and local governments whose workers use Sutter services. Then-Attorney General Xavier Becerra joined the case in 2018.
Numerous twists and turns have slowed the court's approval of the settlement in the months since.
San Francisco Superior Court Judge Anne-Christine Massullo had been expected to issue a preliminary approval of the terms in August 2020, but rejected the independent monitor the parties had chosen to oversee the rollout of the agreement. The monitor chosen was neither a woman nor a person of color, and Massullo said the parties' selection process did not properly take into account the court's emphasis on diversity, equity and inclusion.
More months passed as Sutter argued for further delays and suggested it would push to alter the settlement in light of the potentially dramatic effects of the COVID-19 pandemic on the healthcare system's finances and operations.
Preliminary approval was eventually granted, but most recently, final approval was postponed because of a dispute between UEBT and their lawyers over attorney fees. The parties had agreed at the outset to plaintiffs' attorneys, led by Richard Grossman of Pillsbury & Coleman, getting 30% of the settlement amount. Given the size of the settlement, that comes to $172.5 million in attorney fees, a figure UEBT argues is unreasonably high.
An additional 2% in fees will go to the Attorney General's Office. UEBT expects to receive about $15 million, and what is left of the $575 million will be distributed among the rest of the class, made up of other unions and employers who purchase health insurance for their workers.
Thursday's hearing was largely devoted to a tense back-and-forth over the attorney fees. Ultimately, the hearing concluded without resolution on the issue. But Massullo indicated she would approve the terms of the settlement in a written order once the fees had been sorted out. The timing of that final order was left unclear.
Sutter has 23 hospitals, 33 surgery centers and 12,000 physicians across Northern California, with $13 billion in operating revenue in 2020. Among other allegations, the state's lawsuit argued Sutter has aggressively bought up hospitals and physician practices throughout the Bay Area and the rest of Northern California, and exploited that market dominance for profit.
Healthcare costs in Northern California are 20% to 30% higher than in Southern California, even after adjusting for the cost of living, according to a 2018 study from the Nicholas C. Petris Center at the University of California-Berkeley that was cited in the complaint.
Among other terms, the settlement requires Sutter to:
Limit what it charges patients for out-of-network services.
Increase transparency by allowing insurers and employers to give patients pricing information.
Cease bundling services and products, and instead offer stand-alone pricing.
In agreeing to the settlement, Sutter did not admit wrongdoing. Throughout the proceedings, it has maintained that its integrated health system offers tangible benefits for patients, including affordable rates and consistent high-quality care. Sutter spokesperson Amy Thoma Tan said in an email that the settlement would not reduce the quality of patient care.
"Our commitment to providing high-quality care to our patients is unwavering, and independent data shows that our quality yields better health outcomes and a lower total cost of care," she wrote. "Sutter's quality of care is nationally recognized, with the majority of our hospitals and facilities outperforming state and national averages in nearly every measure of quality."
Still, under the terms of the settlement, Sutter agreed to end a host of practices that Becerra, who now heads the U.S. Department of Health and Human Services, alleged unfairly stifled competition. Among other conditions, the settlement also requires Sutter to limit what it charges patients for out-of-network services and end its all-or-nothing contracting deals with payers, which demanded that an insurer that wanted to include any one of the Sutter hospitals or clinics in its network must include all of them.
Sutter has earned an average 42% annual profit margin over the past decade from medical treatments paid for by commercial insurers like the plaintiff companies, according to a recent analysis by Glenn Melnick, a healthcare economist at the University of Southern California.
Sutter also faces a second federal class-action lawsuit alleging anti-competitive behavior. But while Sutter remains in the crosshairs, its practices are not unique. Experts say negotiating tactics including all-or-nothing contracts and anti-tiering provisions have become widespread among hospital systems nationwide.
"Any system could change their practices tomorrow. If we have to wait for the courts to force them to not use anti-competitive practices, that's really disappointing," said Elizabeth Mitchell, CEO of the Purchaser Business Group on Health, which represents employers that buy insurance coverage for their workers.
"What the Sutter case proves is that the people who pay for and receive care can achieve accountability from the healthcare system. But it shouldn't be that hard."
The drugmaker is running an educational campaign directed at the consumer, one who is already worried about whether those lost keys or a hard-to-recall name is a sign of something grave.
This article was published on Friday, July 23, 2021 in Kaiser Health News.
Do you sometimes lose your train of thought or feel a bit more anxious than is typical for you?
Those are two of the six questions in a quiz on a website co-sponsored by the makers of Aduhelm, a controversial new Alzheimer's drug. But even when all responses to the frequency of those experiences are "never," the quiz issues a "talk to your doctor" recommendation about the potential need for additional cognitive testing.
Facing a host of challenges, Aduhelm's makers Biogen and its partner Eisai are taking a page right out of a classic marketing playbook: Run an educational campaign directed at the consumer, one who is already worried about whether those lost keys or a hard-to-recall name is a sign of something grave.
"It's particularly egregious because they are trying to convince people with either normal memories or normal age-related decline that they are ill and they need a drug," said Dr. Adriane Fugh-Berman, a pharmacology professor at Georgetown University Medical Center, who wrote about the website in an opinion piece.
The website's "symptoms quiz" asks about several common concerns, such as how often a person feels depressed, struggles to come up with a word, asks the same questions over and over, or gets lost. Readers can answer "never," "almost never," "fairly often" or "often." No matter the answers, however, it directs quiz takers to talk with their doctors about their concerns and whether additional testing is needed.
While some of those concerns can be symptoms of dementia or cognitive impairment, "this clearly does overly medicalize very common events that most adults experience in the course of daily life: Who hasn't lost one's train of thought or the thread of a conversation, book or movie? Who hasn't had trouble finding the right word for something?" said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School who has been sharply critical of the approval.
Aduhelm was approved in June by the Food and Drug Administration, but that came after an FDA advisory panel recommended against it, citing a lack of definitive evidence that it works to slow the progression of the disease. The FDA, however, granted what is called "accelerated approval," based on the drug's ability to reduce a type of amyloid plaque in the brain. That plaque has been associated with Alzheimer's patients, but its role in the disease is still being studied.
News reports also have raised questions about FDA officials' efforts to help Biogen get Aduhelm approved. And consumer advocates have decried the $56,000-a-year price tag that Biogen has set for the drug.
On the day it was approved, Patrizia Cavazzoni, the FDA's director of the Center for Drug Evaluation and Research, said the trial results showed it substantially reduced amyloid plaques and "is reasonably likely to result in clinical benefit."
Describing the website as part of a "disease awareness educational program," Biogen spokesperson Allison Parks said in an email that it is aimed at "cognitive health and the importance of early detection." She noted that the campaign does not mention the drug by name.
Earlier Thursday, in "an open letter to the Alzheimer's disease community," Biogen's head of research, Dr. Alfred Sandrock, noted the drug is the first one approved for the condition since 2003 and said it has been the subject of "extensive misinformation and misunderstanding." Sandrock stressed a need to offer it quickly to those who have only just begun to experience symptoms so they can be treated before the disease moves "beyond the stages at which Aduhelm should be initiated."
While the drug has critics, it is also welcomed by some patients, who see it as a glimmer of hope. The Alzheimer's Association pushed for the approval so that patients would have a new option for treatment, although the group has objected to Biogen's pricing and the fact that it has nine years to submit follow-up effectiveness studies.
"We applaud the FDA's decision," said Maria Carrillo, chief science officer for the association. "There's a benefit to having access to it now" because it is aimed at those in the early stages of dementia. Those patients want even a modest slowdown in disease progression so they have more time to do the things they want to accomplish, she said.
The drug is given by infusion every four weeks. It also requires expensive associated care. About 40% of the patients in the trials experienced brain swelling or bleeds, so regular brain imaging scans are also required, according to clinical trial results and the drug's label. In addition, patients will likely need to be checked for amyloid protein, which is done with expensive PET scans or invasive spinal taps, according to Alzheimer's experts.
Instead, the advertisements and websites focus on what is called mild cognitive impairment, including a warning that 1 in 12 people over age 50 have that condition, which it describes as the earliest clinical stage of Alzheimer's.
On its website, Biogen doesn't cite where that statistic comes from. When asked for the source, Parks said Biogen's researchers made some mathematical calculations based on U.S. population data and data from a January 2018 article in the journal Neurology.
Some experts say that percentage seems high, particularly on the younger end of that spectrum.
"I can't find any evidence to support the claim that 1 in 12 Americans over age 50 have MCI due to Alzheimer's disease. I do not believe it is accurate," said Dr. Matthew S. Schrag, a vascular neurologist and assistant professor of neurology at Vanderbilt University Medical Center in Nashville, Tennessee.
While some people who have mild cognitive impairment progress to Alzheimer's — about 20% over three years — most do not, said Schrag: "It's important to tell patients that a diagnosis of MCI is not the same as a diagnosis of Alzheimer's."
Mild cognitive impairment is tricky to diagnose — and not something a simple six-question quiz can uncover, said Mary Sano, director of the Alzheimer's Disease Research Center at the Icahn School of Medicine at Mount Sinai in New York.
"The first thing to determine is whether it's a new memory problem or a long-standing poor memory," said Sano, who said a physician visit can help patients suss this out. "Is it due to some other medical condition or a lifestyle change?"
Carrillo, at the Alzheimer's Association, agreed that MCI can have many causes, including poor sleep, depression or taking certain prescription medications.
Based on a review of medical literature, her organization estimates that about 8% of people over age 65 have mild cognitive impairment due to the disease.
She declined to comment on the Biogen campaign but did say that early detection of Alzheimer's is important and that patients should seek out their physicians if they have concerns rather than rely on "a take-at-home quiz."
Schrag, however, minced no words in his opinion of the campaign, saying it "feels like an agenda to expand the diagnosis of cognitive impairment in patients because that is the group they are marketing to."
Despite resources that other industries can only dream of, most pro leagues in the U.S. are struggling to get their teams' COVID-19 vaccination rates to 85%.
This article was published on Thursday, July 22, 2021 in Kaiser Health News.
Santa Clara County, where the San Francisco 49ers train and play their NFL home games, has one of the highest COVID vaccination rates in California. As of July 11, more than 76% of its vaccine-eligible residents were fully vaccinated, partly because the county and the 49ers franchise turned Levi's Stadium into a mass inoculation site where more than 350,000 doses were administered over four months.
The 49ers themselves, however, are not so enthusiastic about the shots. In June, head coach Kyle Shanahan said only 53 of the 91 athletes on the team roster — 58% — were fully vaccinated. The team has issued no updates since.
It's a familiar story in the world of professional sports. Despite resources that other industries can only dream of, most pro leagues in the U.S. are struggling to get their teams' COVID-19 vaccination rates to 85%, a threshold considered high enough to protect the locker room or clubhouse from spread of the disease. Only the Women's National Basketball Association, at 99%, can boast a highly successful campaign to educate and vaccinate its players.
And while the public might expect sports figures, and the rich leagues they play for, to help rally the national vaccination effort, that's not happening. Although the leagues and unions have advocated for players to get the shots, the industry clearly regards vaccination as a personal decision — not a responsibility.
"It's everyone's choice whether they want to get vaccinated or not," Sam Darnold, the Carolina Panthers' quarterback and a former USC star, said in June when revealing that he had not gotten a shot. "For me, I'm staying by myself right now. I don't have a family or anything like that. There's a ton of different things that go into it."
Comments like Darnold's and those of Buffalo Bills receiver Cole Beasley, who tweeted a long rant casting the COVID vaccines as a threat to "my way of living and my values," have dominated news cycles. Meanwhile, the leagues themselves, whose overall vaccination numbers outpace those of the country at large, pad around the topic carefully.
"Push? No. Encourage," said Tony Clark, executive director of the Major League Baseball Players Association, when asked at an MLB All-Star Game news conference about the union's position on player vaccination. "We've encouraged from the beginning."
And most players have shunned the role of public health spokesperson, making the pro-vaccination campaign a largely faceless one. Few have publicly endorsed vaccination or acknowledged receiving shots, even though the league's numbers suggest large majorities are vaccinated. Most don't want to discuss it.
In May, NBA superstar LeBron James pointedly refused to answer questions about whether he'd been vaccinated, saying, "Anything of that nature is all family talk." Tampa Bay Buccaneers linebacker Shaq Barrett said he and his wife had received vaccines, but as for encouraging teammates, "it's to each their own. I don't know why people wouldn't get it, but whatever makes you comfortable, whatever helps you sleep at night, you do that."
Zachary Binney, a sports epidemiologist at Emory University in Atlanta, believes pro athletes aren't that different from the rest of us when it comes to vaccines: "A lot of them are vaccinated. A lot of them are willing to become vaccinated. Some of them have concerns. And some of them just are not going to do it — and they are never going to do it."
In fact, most of the teams are doing well by overall U.S. standards. More than 70% of NFL and NBA players are at least partially vaccinated, according to reports. That puts both leagues' rates higher than they are for young U.S. adults as a whole.
Some players may be reluctant to speak up, Binney said, because the vaccine has been so politicized that they could lose fans by taking a stand one way or another — a far cry from the 1950s, when the country embarked on the nationwide March of Dimes campaign for polio vaccination with backing from ballplayers like Joe DiMaggio and Jackie Robinson. The country was united in viewing polio as a menace, whereas many conservatives shrug off the coronavirus. Then too, COVID's risks increase with age. Professional athletes are often in peak physical condition and may seldom visit a doctor outside of the team training room.
Sports teams' lack of leadership on the issue is a crucial miss for those pushing for greater vaccination rates, and it may also depress the chances of success within their own locker rooms, Binney said.
"One of the things we've learned is that people, not just athletes, are more likely to get vaccinated if the folks around them have become vaccinated," he said. "If your locker room leaders aren't speaking up, or if they're mostly sharing concerns or misinformation, that all has an effect on the numbers."
The NFL has set heavy restrictions on unvaccinated players — they must be tested daily and wear masks at team facilities, and can't leave the hotel when they're on the road — while mostly lifting the restraints on those who've received their shots.
The teams and union have informed players about the risks and benefits of the vaccines, even bringing in experts to meet with players. On a recent media call, Dr. Thom Mayer, the NFL players association's medical director, said players had contacted him with all manner of questions about the vaccines, including about reports of rare heart inflammation in young men post-mRNA vaccination, how long antibodies might last in their systems and whether the Food and Drug Administration's emergency use authorization of the vaccines meant they were less well-tested than fully licensed products.
"They are serious, thoughtful questions that deserve serious and thoughtful answers," Mayer said during the call. "I'll say what our players say: They're grown-ass men. You give them grown-ass facts and they'll make a grown-ass decision."
For the NFL, the urgency of a looming pro football season may kick vaccination rates upward. Major League Baseball, meanwhile, reported June 25 that 23 of its 30 teams had reached the 85% threshold, which triggers loosened restrictions — but acknowledged that its efforts to get more teams to that level had begun to stall despite months of advocacy.
"I can't make any assumptions about the other leagues, but baseball is such a mixture of people with differing opinions on everything," said Jerry Blevins, 37, who retired in April after a 13-year MLB career as a pitcher. Blevins got his first dose on the first day it was available to him.
But some star athletes, current and former, are taking a stand.
Detroit Tigers slugger Miguel Cabrera agreed to serve as a spokesperson for Michigan Gov. Gretchen Whitmer's effort to promote vaccination. Basketball Hall of Famer Bill Russell, 87, got vaccinated and recorded a public service announcement on behalf of the NBA, as did San Antonio Spurs coach Gregg Popovich and fellow Hall of Famer Kareem Abdul-Jabbar.
Women's basketball has been in a league of its own, vaccination-wise, notes WNBA Commissioner Cathy Engelbert. Its campaign was led by the players union, which began providing information and addressing its members' concerns during a series of video conferences in December, before vaccines were readily available.
What came out of those conversations was a better understanding by the players of the outsize risk of COVID infection and death for Black women, who make up at least 70% of league rosters. By April, stars from the league were appearing in a public service announcement urging vaccination with the slogan "Our health is worth a shot," and appealing to Black women specifically. And they were receiving the vaccine themselves.
No other league, however, appears to have discovered such a catalyst, and the numbers show it.
"It's a different decision for everybody," the 49ers' Shanahan said. Pro athletes, seldom of one mind, don't agree on this topic, either.
MISSOULA, Mont. — Missoula's new downtown library was teeming with people who might typically spend a Saturday afternoon hiking, biking or otherwise making the most of Montana's abundant outdoor recreation. One look at the soupy haze blanketing the city and it was clear why.
"We're definitely trying to stay out of the smoke," Charlie Booher said as his kids picked out books from the stacks.
Smoke from the wildfires burning through bone-dry forests and grasslands in the West has damaged air quality this week from California to the Eastern Seaboard. The polluting smoke has been thickest in the Northwest, including Montana, where over the past week Missoula, Helena, Great Falls and other cities ranked among the 10 places with the worst air quality, according to AirNow.
The smoke and unrelenting heat pummeling the state have driven people to seek refuge at libraries, movie theaters, museums and other indoor venues. In areas with low COVID-19 vaccination rates where people have largely abandoned masks and physical distancing, health officials are concerned the result will be COVID outbreaks.
Adding to that worry is the rise of the highly transmissible delta variant of the coronavirus, and research suggests that COVID cases and deaths increase during periods of intense wildfire smoke.
Missoula County has the highest vaccination rate in Montana, at 60%, but Whitney Kors was still mindful of the risks as she took her family to the library to get out of the smoke.
"My daughter and I are still masked because she's not vaccinated," Kors said.
She said that until her daughter, who's under 12 years old, becomes eligible for her shot, her family will continue to distance from others when they're out. However, health officials worry that not everyone seeking out smoke-free activities indoors this summer will take the same precautions if they are unvaccinated.
To the north in Flathead County, Joe Russell, the county health officer, said he's tracking a roughly 50% increase in COVID cases over the past two weeks, mostly from unvaccinated people catching the virus at events.
"These are activities that are happening specific to events or settings, and they are indoors," he explained.
Russell said his team is more closely investigating new clusters to see if people went inside to escape heat and smoke. About 6 of 10 county residents who are eligible for COVID vaccines have not gotten them, and Russell is worried these large clusters could get worse if more people gather indoors.
The dangers of the pandemic appear to have waned in people's minds as they gather in indoor public spaces, many of which dropped masking and physical distancing requirements earlier this year.
In Yellowstone County and Billings, Montana's largest city, the pandemic is still being felt in hospitals that have been treating younger, sicker patients than they saw earlier in the pandemic. COVID deaths also spiked there in early July.
Yellowstone County Health Officer John Felton hoped the summer would provide time to boost the county's 50% vaccination rate before cold weather sends people indoors and increases the risk of unvaccinated people transmitting COVID.
"But this year has been so hot, so dry and with so much smoke, we are concerned we're going to have increases happening a little earlier," he said.
Across Montana, about 48% of the eligible population is fully vaccinated, but Magdalena Scott with the state Department of Public Health and Human Services said county rates range from about 23% to 60%. She said that means case numbers, hospitalizations and deaths are likely to vary more widely than they did last summer, when vaccines weren't yet available. "We are concerned that it's going to be a long smoke season for sure," Scott said.
There are also worries that wildfire smoke could drive up COVID transmission not just by driving people indoors, but also by making them more susceptible to the coronavirus.
Fine particulate matter in wildfire smoke, known as PM 2.5, is so small it bypasses the body's natural defenses, building up in the bloodstream, inflaming the lungs and wearing down the immune system, according to the Centers for Disease Control and Prevention.
PM 2.5 from urban air pollution and wildfire smoke is increasingly associated with susceptibility to respiratory infections in general, but researchers have been racing to study the same possible association with the coronavirus, a respiratory virus, since last summer.
Daniel Kiser is a researcher at the Desert Research Institute in Reno, Nevada. He worked on a recently published paper about an increase in COVID cases in Reno during the wildfire season.
"What we found was that there was about an 18% increase in the rate of positive tests during the period that was most affected by wildfire smoke," Kiser said.
Other studies also have shown a correlation between increases in particulate levels and COVID deaths. Sultan Ayoub Meo with King Saud University in Saudi Arabia led a team of researchers that studied 10 California counties where levels of fine particulate matter increased on average by 220 times at the height of the state's wildfire season last year.
"We found that the COVID-19 cases and deaths increased by 57% and 148%" at the same time, Meo said.
Meo said his team now is studying infection rates among partially and fully vaccinated people during wildfire smoke events.
University of Montana researcher Erin Landguth is also expanding her past study showing intense wildfire seasons in Montana have been followed by bad flu seasons months later in the fall and winter.
"Comparing bad fire seasons to non-bad fire seasons, one would expect to see three to five times worse flu seasons," Landguth said.
Landguth is compiling particulate-matter readings across the western U.S. to examine whether the same association holds across a larger area for not only the flu, but COVID and other respiratory diseases, too.
While evidence showing COVID cases and deaths have increased during wildfire events continues to emerge, more study is needed. However, Landguth said, we know enough to be concerned and to advise people to protect themselves.
Back in Missoula, county Air Quality Specialist Sarah Coefield said the best thing people can do is get vaccinated, especially if they plan to seek out public spaces to escape heat and smoke. They can also create a clean-air space at home.
With about 2.5 million acres already burned this year in the U.S., and drought worsening across the West, Coefield said, "There's nothing in the forecast to suggest it's going to end anytime soon — and it's not going to get any easier as it goes on."
Zipping heatstroke patients into ice-filled body bags works so well it could become a go-to treatment in a world increasingly altered by climate change.
This article was published on Thursday, July 22, 2021 in Kaiser Health News.
As a deadly heat wave scorched the Pacific Northwest last month, overwhelming hospital emergency rooms in a region unaccustomed to triple-digit temperatures, doctors resorted to a grim but practical tool to save lives: human body bags filled with ice and water.
Officials at hospitals in Seattle and Renton, Washington, said that as more people arrived experiencing potentially fatal heatstroke, and with cooling catheters and even ice packs in short supply, they used the novel treatment to quickly immerse and cool several elderly people.
Zipping heatstroke patients into ice-filled body bags worked so well it could become a go-to treatment in a world increasingly altered by climate change, said Dr. Alex St. John, an emergency physician at UW Medicine's Harborview Medical Center.
"I have a feeling that we're looking at many more days of extreme heat in the future, and this is likely to become more common," he said.
Despite the macabre connotation of body bags, using them is a cheap, convenient and scalable way to treat patients in mass casualty emergencies caused by excessive heat, said Dr. Grant Lipman, a Stanford University professor of emergency medicine. He co-authored a pioneering case study documenting the use for heatstroke of what doctors call "human remains pouches."
"When people are this sick, you've got to cool them down fast," Lipman said.
Heatstroke is the most dangerous type of heat illness, a medical emergency that leads to death in up to a third of hospitalized patients. It occurs when the body overheats, either because of exertion in high temperatures or because of prolonged exposure to heat with no relief. The core body temperature rises to 104 degrees Fahrenheit or higher, which can damage the brain and other organs.
Heatstroke can be particularly dangerous for children and older people, whose bodies don't regulate temperature well. Also, elderly people may take medications that impair their ability to tolerate high temperatures.
Patients typically would be treated with strategically placed ice packs or misted with water and placed in front of huge fans. Some emergency room staffers immerse patients in large tubs of water or insert cooling catheters into the body's large veins.
During emergencies, however, equipment, ice and time may all be in short supply.
St. John treated nearly two dozen heatstroke patients on June 28, the hottest period of a six-day heat wave, when temperatures in Seattle shot up to a record-breaking 108 degrees. That was more than he'd seen at one time in his decade as a doctor, including working in hospitals in the Arizona desert, he said.
Similarly, the University of Washington Valley Medical Center in Renton saw more than 70 patients with heat-related illnesses, including three who were treated using body bags, said emergency department director Dr. Cameron Buck.
"The large number who came in very quickly taxed the system," Buck said.
Overall, nearly 2,800 emergency department visits for heat illness were logged from June 25 through June 30 in a region that includes Oregon, Washington, Idaho and Alaska, including more than 1,000 on June 28 alone, according to the Centers for Disease Control and Prevention. At least 112 deaths in Washington and 115 deaths in 12 deaths in Washington and 115 deaths in Oregon have been linked to the heat wave.
Among the sickest patients St. John saw was a woman in her 70s who arrived at the Harborview ER on June 28 confused and weak, with a core body temperature of 104 degrees. A family member had discovered her ill at home. St. John said a colleague had mentioned the body bag technique just days earlier, so he gave it a try.
The treatment involves filling a body bag with a slurry of water and ice, putting the patient inside and zipping the bag just up to the armpits to allow access for medical equipment and close monitoring. The self-contained bag keeps the ice and water close to the patient's skin.
Within several minutes of being placed into the bag, the woman's temperature dropped to 100.4 degrees, just enough to "get her out of that danger zone," St. John said. She was removed from the bag, dried off and placed on a gurney, allowing her body's natural cooling abilities to take over. After being admitted to the hospital, she recovered fully, he said.
As the effects of climate change lead to hotter temperatures in more places — including historically temperate zones where air conditioning isn't in wide use — using body bags to rapidly treat heat illness is a logical solution, said Lipman, who directs Stanford's Wilderness Medicine Fellowship and runs Global Outdoor Emergency Support, or GOES, which provides medical guidance for outdoor travelers.
"Every hospital has body bags. Every hospital has ice machines," Lipman said.
He and colleagues described the treatment of an 87-year-old woman with cancer who was found unconscious in a parking lot during a heat wave in the San Francisco Bay Area, another region not accustomed to sustained high temperatures. It was July 2019, which was then designated the hottest month recorded on Earth. Using the ice-and-water-filled body bags, doctors cooled her temperature from 104 degrees to 101.1 within 10 minutes. She, too, fully recovered.
Immersing patients in cold water has long been the gold standard for treating athletes with heatstroke caused by exertion, Lipman said. It's the most efficient method, because water conducts heat away from the body about 25 times faster than air.
For now, the body bag treatment has been studied mostly in younger, healthier people, and some doctors worry about the effects of cold water on older people and whether the technique might induce shivering that actually raises body temperature. Lipman agrees further study is needed but said his experience has found "the cooling benefits will outweigh any harm of shivering."
And what about patients who might shudder at the thought of being zipped into a body bag?
Because they're generally so ill when they arrive and get treated so quickly, it's "unlikely they're aware," Lipman said, adding: "But you'd need to ask them."
Hospitals in southwestern Missouri are overflowing. As of July 19, Centers for Disease Control and Prevention data show Missouri is worst in the nation for covid case rates over the past week, and in the bottom 15 states for vaccinations against the potentially deadly virus.
This article was published on Wednesday, July 21, 2021 in Kaiser Health News.
ST. LOUIS — The day after Missouri Gov. Mike Parson finished his bicentennial bus tour to drum up tourism to the state in mid-July, Chicago issued a travel advisory warning about visiting Missouri.
Earlier this summer, as covid-19 case counts began to tick up when the highly transmissible delta variant took hold in the state, the Republican-majority legislature successfully enacted laws limiting public health powers and absolving businesses from covid legal exposure.
The state health officer post has sat vacant since Dr. Randall Williams resigned suddenly in late April — leaving Missouri without a permanent leader as the covid numbers grew. And Brian Steele, a mayor in the Springfield area, which is at the epicenter of swelling cases, faces a recall vote for his masking mandate that ended in April.
Hospitals in southwestern Missouri are overflowing. As of July 19, Centers for Disease Control and Prevention data show Missouri is worst in the nation for covid case rates over the past week, and in the bottom 15 states for vaccinations against the potentially deadly virus. Though cases are not even half of what they were during the winter spike, they continue to rise rapidly, sending a warning to other states with low vaccination rates about the havoc the coronavirus’s delta variant can bring.
Divisions abound in Missouri, where vaccines are widely available but only 40% of the state has been vaccinated. Public health mitigation measures to reel in the rising case counts would be wildly unpopular in a state that never had a statewide mask mandate. And the more the virus circulates, the higher the chance it could mutate further into something more transmissible or deadly, even for those already vaccinated.
Escalating political backlash to public health efforts has the state staring down the barrel of potential incoming disaster, said Kelley Vollmar, executive director of the Jefferson County Health Department.
“Missouri is the Show Me State,” Vollmar said, as the state has made headlines for its surging cases among its many unvaccinated residents. “I just wish we could do it for the right reasons.”
Kelli Jones, a spokesperson for the governor, said the national media spotlight on Missouri is misdirected. Flare-ups where vaccination rates are low are to be expected, she said, adding that hospitals in those areas may be strained, but that’s partly because a backlog of elective procedures are being performed during this iteration of the pandemic.
“When the national media catches on stuff, they don’t have all the full facts of all the details,” she said.
Jones and Lisa Cox, spokesperson for the Missouri Department of Health and Senior Services, both pointed to a $5 million multimedia campaign aimed at encouraging vaccinations. They have been heartened to see an increase in vaccine orders from vaccinators — this past week, it was more than triple the usual demand, Cox said.
Vaccines, however, take time to take effect.
Meanwhile, hot spot Springfield has requested state funding for an alternative covid care site to treat patients, saying health systems are at capacity. The Springfield-Greene County Health Department Facebook page shows the stark contrast between the vaccinated and those resisting the call, as it’s littered with warring comments, some containing vaccine misinformation.
Will Marrs, a lobbyist for the Missouri Association of Local Public Health Agencies, was born and raised in the heavily afflicted Springfield area. He’s been trying to persuade high school friends to get vaccinated but said it’s difficult to penetrate misinformation echo chambers.
Marrs blames national politics seeping into the Statehouse and the political lifeblood of Missouri, arguing state legislators are following national Republican Party trends instead of shouting from the rooftops about the importance of vaccinations. Earlier this month at the Conservative Political Action Conference in Dallas, attendees cheered over the country not hitting vaccination rates.
And the state’s Senate delegation shows the trend: Sen. Josh Hawley, a Republican eyeing higher national office, has appeared on Fox News likening a vaccine misinformation initiative from President Joe Biden to a “surveillance state” that is “out of Beijing.” His counterpart, Republican Sen. Roy Blunt, who has frequently stressed the importance of getting vaccinated, is not seeking reelection.
“We’re in a crisis not only here in Missouri but around the country and the world, and we are acting like it’s just business as usual,” Democratic state Sen. Jill Schupp said of the Republican leadership in the state. “They have chosen to take the side that says, ‘I’m going to turn a blind eye to this, to this pandemic and to this variant, and I’m going to pretend like it doesn’t exist.’”
Parson has urged Missourians to get their vaccinations to prevent covid. But he also took a public shot at the federal government, tweeting: “I have directed our health department to let the federal government know that sending government employees or agents door-to-door to compel vaccination would NOT be an effective OR a welcome strategy in Missouri!”
Local public health workers, not federal agents, have been going door to door in Springfield and elsewhere in the state to encourage vaccinations.
Jones said some of the critiques that Parson isn’t doing enough to promote vaccinations come from an ideological divide: The governor does not believe the government has the power to mandate such things, much as he doesn’t believe in mandating masks, she said.
“It comes down to some personal responsibility; the governor said that from the very beginning,” she said. “And people are just gonna have to decide to, you know, hopefully, to get vaccinated.”
Amid the uptick in cases, the White House announced it was sending a “surge response team” to help Missouri.
That “team” currently consists of one epidemiologist on the ground in southwestern Missouri and a vaccination specialist offering virtual support, numbers based on what the state said it needed. Cox said the state is requesting more resources.
But two people — one remote — are hardly enough to combat decades of underfunding and a year and a half of political vitriol, said Brian Castrucci, CEO of the de Beaumont Foundation, which advocates for public health.
“We are being forced to apply band-aids where we don’t have the resources for stitches,” he said.
Back in eastern Missouri, Vollmar’s county is inching back up the covid case chart. She suspects everyone went to tourist (and delta) hot spots in southwestern Missouri over the Fourth of July.
While she’s thrilled to have the game-changing vaccine, only roughly 30% of Jefferson County is vaccinated. Unlike last year during a similar rise in cases, she feels she doesn’t have the political buy-in from her area for mitigation measures like masking. Candidates for her local school board ran and won on the idea of eliminating mask mandates in schools.
The state health department’s advisories to hot spots say “social distancing, masking, and other precautions remain important” but do not mandate them.
Vollmar also warned about a lack of funding for contact tracers and other public health measures needed for the wave she worries is coming. Funding has been slow to reach local health departments, much as it was last year when some county commissioners around the state withheld funding for local departments, angry about lockdowns and other restrictions. Platte County in the Kansas City area paid roughly the same in pandemic relief funding to a local cruise ship company as it did to its health department, which served nearly 90,000 people.
“We all hoped that once the elections were over, that this would die down,” Vollmar said. “If you don’t have the support of your leaders, you don’t have the support of the community.”
Without a state health officer coordinating the response or getting the ear of the governor, Vollmar said, local officials like her have been interacting more with federal officials. The governor’s office said a new director will be announced Wednesday. Cox said the acting director, Robert Knodell — formerly Parson’s deputy chief of staff, who does not have a public health background — had been “very involved” in the response.
A 2020 KHN and AP investigation found Missouri’s public health spending was one of the bottom 10 in the nation at $50 per Missourian per year before the pandemic. Missouri public health staffing had fallen 8% from 2010 to 2019 with the loss of 106 full-time employees.
Williams’ departure was one of at least 10 Missouri public health leadership departures this year, according to another piece of the KHN and AP investigation. Nationally, that report found at least 248 state and local public health leaders had departed since the beginning of the pandemic — leaving nearly 1 in 6 Americans without a local public health leader for some length of time.
But Schupp asked, considering the recent legislation and political climate in Missouri, will any qualified state health officer want to come? “We’re not allowing anyone to do a good job,” she said.
Out of an estimated 16 million Medicare beneficiaries whose excess weight and risky A1c level make them eligible, only 3,600 have participated in diabetes prevention classes since Medicare began covering the two-year Medicare Diabetes Prevention Program (MDPP) in 2018.
This article was published on Wednesday, July 21, 2021 in Kaiser Health News.
Damon Diessner tried for years to slim down from his weight of more than 400 pounds, partly because his size embarrassed his wife but even more because his doctors told him he was at risk of developing Type 2 diabetes. His hemoglobin A1c level, a blood sugar marker, was 6.3%, just below the diabetes range of 6.5%.
Then, two years ago, one of his doctors helped get him into a YMCA-run Diabetes Prevention Program not far from his home in Redmond, Washington. The group classes, at first held in person and then via Zoom during the covid-19 pandemic, were led by a lifestyle coach. He learned how to eat better, exercise more and maintain a healthier lifestyle overall. He now weighs 205 pounds, with an A1c level of 4.8%, which is in the normal range.
“This has been a life-changing program,” said Diessner, 68, an environmental consultant. “My cardiologist said you have clearly beaten diabetes. I tell everyone who has blood sugar issues or just wants to lose weight that this is the thing to do.”
Over the past decade, tens of thousands of American adults of all ages have taken these diabetes prevention classes with personalized coaching at YMCAs, hospitals, community health centers and other sites. But out of an estimated 16 million Medicare beneficiaries whose excess weight and risky A1c level make them eligible, only 3,600 have participated since Medicare began covering the two-year Medicare Diabetes Prevention Program (MDPP) in 2018, according to the federal government’s Centers for Medicare & Medicaid Services (CMS).
Researchers and people who run diabetes prevention efforts said participation is low because of the way Medicare has set up the program. It pays program providers too little: a maximum of $704 per participant, and usually much less, for dozens of classes over two years. It also imposes cumbersome billing rules, doesn’t adequately publicize the programs and requires in-person classes with no online options, except during the pandemic emergency period. Most of the private Medicare Advantage plans haven’t promoted the program to their members.
Now, CMS has proposed to address some but not all of those problems in a rule change. It predicted the changes would reduce the incidence of diabetes in the Medicare population and potentially cut federal spending to treat diabetes-related conditions.
On July 13, the agency proposed shortening the program to one year, starting in 2022, because providers complain that too few beneficiaries complete the second year. That and other changes proposed by Medicare would modestly enhance reimbursement to providers. The government is also planning to waive a one-time $599 fee that groups offering the classes must pay Medicare to be part of its program. CMS said the rule changes would make it easier and more attractive for MDPP providers, including YMCAs and other local community organizations, to participate.
While providers have welcomed the proposed revisions as marginally helpful, they criticized CMS for not letting them provide classes and counseling to Medicare beneficiaries through online methods including apps, videoconferencing and texting. Many health insurers covering people under age 65 offer similar diabetes classes online, and they claim success rates comparable to in-person classes.
“The proposed rule changes should have the intended effect on increasing access for Medicare members,” said Dr. Liz Joy, senior medical director for wellness and nutrition at Intermountain Healthcare in Salt Lake City. It offered in-person classes at many of its hospitals but switched to online classes during the pandemic. “Virtual access would improve access and reduce disparities for people who have barriers such as transportation and distance,” Joy said.
A bipartisan bill in the House and Senate, the Prevent Diabetes Act, would let virtual providers certified by the Centers for Disease Control and Prevention participate in the Medicare Diabetes Prevention Program. The bill’s sponsors say virtual programs are needed to better serve lower-income, minority and rural Americans.
The diabetes prevention initiative is just one of several programs that have been found effective in reducing or treating chronic medical conditions but have been underused due to the U.S. health care system’s lack of focus on disease prevention. For instance, Medicare’s coverage of personal nutrition counseling for people with diabetes or kidney disease is used by fewer than 1% of the 15 million beneficiaries with those conditions. Insurers, hospitals, and doctors lack adequate financial incentives to offer preventive services.
“Patients might change providers next year, so why would a company invest in prevention if they don’t know that they’ll reap the benefits?” said Maria Alva, an assistant research professor at Georgetown University who has studied the MDPP. “And doctors are paid more for prescribing diabetes drugs than taking the time to recommend the diabetes prevention program.”
CMS started paying for the diabetes prevention program in 2018, following studies showing its effectiveness in helping overweight, prediabetic beneficiaries lose nearly 5% of their body weight, which can cut the risk of developing diabetes by 71%. The agency had estimated that the program would save Medicare $182 million over 10 years by reducing diabetes. CMS had projected that 110,000 beneficiaries would enroll.
An evaluation of the program by the research group RTI International published in March found there aren’t enough enrollees to determine whether participation improves health outcomes or lowers Medicare costs. With about 200 organizations providing MDPP classes at 762 sites around the country, CMS needs to prioritize signing up more providers, RTI said. Nationwide, about 1,900 organizations are certified by the CDC to offer diabetes prevention classes, but only a small percentage choose to participate in Medicare.
A key factor limiting providers’ participation up to now is that CMS has tied a bonus payment to beneficiaries’ losing at least 5% of their body weight, which only a minority of participants achieve. But studies show that weight loss of just 2% to 3% can significantly reduce A1c levels and the associated risk of developing diabetes.
In contrast, the CDC recently updated its certification standards for Diabetes Prevention Programs to include two alternative measures for successful completion of the program — a 0.2% decrease in hemoglobin A1c levels, or a 4% weight loss combined with at least 150 minutes a week of physical activity.
But under Medicare’s new proposed rule, MDPP providers would receive up to $635 if a participant hit the 5% weight loss target and attended 13 sessions over one year, or $661 if the person lost 9% of body weight. Providers’ payments would be capped at $338 if a participant fell short of the 5% weight loss goal.
Researchers and providers say that payment model hurts organizations that serve low-income and minority groups, whose members are less likely for a variety of reasons to attend all the sessions and achieve 5% weight loss but who still can benefit from the program. Even without the penalty for not hitting the 5% target, Medicare’s payment rate doesn’t come close to covering the cost of running in-person classes, experts say.
“Five percent is a stretch goal, and 9% is laughable,” said Dr. Amanda Parsons, who previously headed the MDPP program at Montefiore Health System in New York City, which serves mostly low-income Black and Hispanic beneficiaries. “I want to know how many folks are coming anywhere close to achieving that.”
Asked to comment, CMS said CDC standards require providers to meet performance targets but did not explain why it didn’t adopt the CDC’s alternative success measures. On the issue of online classes, CMS said MDPP was originally intended to provide primarily in-person services.
Diessner, who far exceeded the 5% weight loss goal, said he was inspired to get into MDPP by watching his young grandson’s brave efforts to cope with Type 1 diabetes. Despite Diessner’s determination, his doctor had to lobby YMCA staff members over several months to get him a slot, because the few available classes were full. He was shocked when told the low number of participants nationally.
“I see lots of people out in the street who could use help with this,” he said. “The idea that so few people are taking advantage of it is a travesty.”
The drugmaker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of covid-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now — and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them last week.
This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading?
Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective”?
The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior covid shot. The booster is likely to be safe — hundreds of millions have taken the earlier shots — and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.
But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.
What if a booster is safe and effective in one sense but simply not needed — at least for now?
Reliance on the simple “safe and effective” standard — which certainly sounds reasonable — is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.
The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”
In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in covid revenue this year.
The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.
It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and Type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.
In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?
For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness — the health value of a product relative to its price — a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker — like an antibody level — a good enough stand-in for whether a drug will have a significant impact on a patient’s health?
In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the price being offered. But there’s no such automatic process in the U.S.
When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out-of-pocket, decide to get the shot.
To make any recommendation on a booster, government experts say they need more data. They could, for example, as Dr. Anthony Fauci has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.
But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.