Americans, already weary of a pandemic nearly two years long, were dealt a new blow during the long Thanksgiving weekend: the announcement that a new coronavirus variant had emerged.
The omicron variant, officially known as B.1.1.529, surfaced in November in several southern African nations. It set off alarm bells worldwide when public health officials in South Africa saw it beginning to outcompete the previous reigning variant, delta. This suggested that omicron could eventually spread widely. Indeed, omicron has since been reported on multiple continents, likely due to international travel by people unknowingly infected.
After the emergence of omicron was announced, several nations imposed travel bans hoping to contain the virus. Whether those bans will effectively slow the spread remains unknown. “Travel bans don’t help once the horse is already out of the barn, as we’ve seen before and are seeing now,” said Tara Smith, a Kent State University epidemiologist.
Scientists caution that it’s still too early to say whether omicron will prove as dangerous as delta. Other variants that initially seemed worrisome have flamed out.
For now, here’s what we know, and don’t know, about the omicron variant.
What Is a Variant?
A variant of a virus is one that has mutated in a way that bolsters its spread or severity compared with the original strain that emerged in Wuhan, China. “RNA viruses like the coronavirus can mutate when they replicate, especially when circulating at high rates,” said Dr. Monica Gandhi, professor of medicine at the University of California-San Francisco.
Coronaviruses do not mutate as readily as influenza viruses do, but they do mutate over time. The variants generally produce the same range of symptoms as the original strain of the coronavirus. But the mutations may help the virus spread more effectively from person to person, or have an advantage in sneaking past either natural or vaccine immunity.
What Variants Were Already Circulating in the United States?
To date, public health officials have noted five “variants of concern,” plus two “variants of interest” not yet considered as worrisome. So far, no variants have emerged that fit the most worrisome of the three official categories — “variants of high consequence.”
The World Health Organization decided early this year to name the variants after Greek letters, both to simplify the discussion and to limit the stigma of having a variant named for a country.
The first four “variants of concern” — alpha, beta, gamma and delta — have been circulating in the United States for most of this year. But the most dominant variant has been delta, due to its ability to spread from person to person more quickly than other variants. For months, delta has accounted for more than 99% of coronavirus infections in the U.S.
There were no confirmed cases of omicron in the United States as of midday Nov. 29, but experts warn it’s just a matter of time. It could be in the U.S. already, merely undetected.
How Did Omicron Emerge?
Though scientists aren’t sure precisely where omicron first surfaced, it was most likely in a southern African nation.
Experts say low vaccination rates in that part of the world probably played a role in creating a favorable environment for the mutations that produced omicron. (It can be pronounced either AH-mi-crahn or OH-mi-crahn.)
“Many countries in Africa have populations with very low immunity — about 30% in South Africa are vaccinated,” Smith said. “In a largely non-immune population, the virus can sweep through, and each new person infected is a chance for the virus to mutate.”
Why Did Public Health Officials React So Urgently to Omicron?
The concern stems from the scope and nature of the new variant’s mutations. South African health officials noted 50 notable mutations, 30 of which are on the spike protein, a key structure in the virus, New York magazine reported. That’s more than previous variants have had.
“If we were looking out for mutations that do affect transmissibility, it’s got all of them,” University of Oxford evolutionary biologist Aris Katzourakis told Science magazine.
Still, what’s uncertain at this point is how effectively those mutations will work together in creating a variant that can consistently outcompete delta.
What Do We Know About Omicron’s Degree of Infectiousness?
The omicron variant is so new that scientists are just beginning to learn about its characteristics. Because of this, experts urge caution in drawing conclusions, especially from anecdotal evidence.
That said, scientists say they would not be shocked if omicron becomes as easily transmissible as delta.
“The answer is uncertain, of course, but it looks as though it will be at least as infectious as delta,” said Dr. William Schaffner, a professor of preventive medicine at Vanderbilt University School of Medicine.
One complicating factor, Schaffner said, is that the initial areas of fastest spread have been in areas of Johannesburg populated by young adults and college students, who tend to have lower vaccination rates. The vulnerability of these groups to infection may be exaggerating how rapidly omicron seems to be spreading.
What Do We Know About Whether Omicron Makes Patients Sicker?
The early evidence is somewhat conflicting, but there are signs that symptoms from omicron may not be more severe than previous variants. Dr. Angelique Coetzee, who chairs the South African Medical Association, has said that the early cases being seen among the unvaccinated are mild.
It remains to be seen, however, whether older and unhealthier patients will also see milder symptoms. Another caveat is that it may be too early in omicron’s spread to see cases that have seriously progressed.
Will Existing Vaccines Be Effective Against the Omicron Variant?
Scientists are cautiously optimistic that existing vaccines will also be effective against omicron, just as they have been against delta, at least in being able to prevent illness severe enough to require hospitalization.
Gandhi added that the immunity-providing B cells produced by the vaccines have been shown to produce antibodies against variants, and that T-cell immunity, which protects against severe disease, is robust and should not be at risk from the mutations being seen in omicron. The vaccines also produce polyclonal antibodies that work against multiple parts of the spike protein, she said. Finally, booster shots have been shown to be effective in strengthening immunity quickly.
“Most scientists believe we should still have protection against severe disease with vaccinations, and vaccination remains the mainstay of control,” Gandhi said.
Bottom line: If you haven’t been vaccinated, and especially if you haven’t had the disease yet, get vaccinated. And if you’ve already been vaccinated, get a booster.
How Long Will It Be Before We Have a Better Handle on the Threat From Omicron?
Other questions — including whether omicron makes you sicker, and whether it’s more transmissible — will take longer to answer because they require careful contact tracing and accurate diagnoses of those infected.
To better answer those questions, Smith said, “I think, at a minimum, it will take a month to get some preliminary data, and quite possibly longer to really know the fuller picture. We also won’t know about real-world experience in vaccine breakthroughs until that time.”
Can We Expect a Specific New Booster to be Developed for Omicron?
It’s unknown whether the omicron variant will require a reformulated booster. A newly formulated booster wasn’t necessary for delta, because researchers determined that the existing formulation was still effective.
That said, vaccine makers can jump in with a new booster quickly if they have to.
In the event that such a variant emerges, Pfizer and BioNTech “expect to be able to develop and produce a tailor-made vaccine against that variant” within 100 days, pending regulatory approval, a Pfizer spokesperson told The Washington Post.
Dr. Matthew Laurens, a specialist in pediatric infectious diseases at the University of Maryland School of Medicine, said he’s confident boosters could be developed and tested quickly if needed, “likely within a few months.”
What Happened to the Other Variants?
Between May 2021, when delta was named a variant of concern, and November 2021, when omicron was given the same label, two other variants were elevated to the lower “variant of interest” status: lambda from Peru and mu from Colombia. Other variants, such as one discovered in Nepal called “delta-plus,” attracted notice during that period as well. But none of these managed to outcompete delta in a consistent way, so they were never elevated to “variant of concern.”
This is the most hopeful outcome for omicron. The other variants “all had similar concerns around them, but they didn’t expand to any significant degree after the initial reporting,” Gandhi said.
Is It Reasonable to Think the U.S. Is in a Better Position to Handle Omicron Than It Was for Delta?
Experts generally agreed that the United States should be better prepared to battle omicron than it was when delta emerged earlier this year.
“We are in a much better position since we have higher rates of vaccination, the availability of boosters for everyone over 18 and vaccine eligibility down to 5 years old,” Gandhi said. “We also have higher rates of natural immunity in this country due to the delta variant’s spread since July 2021. And we have oral antiviral therapeutics on the horizon. So we have the tools to fight this new variant.”
The challenge, Schaffner said, will be to make sure Americans continue to get vaccinated and boosted, and to make use of testing and maintain safe behavior in public.
“All these tools are available,” he said. “The big question is how inclined the general public is to use these tools.”
Is the Coronavirus Going to Be Around Permanently, Like the Flu?
Experts now believe it’s unlikely that the coronavirus will either be eradicated from the globe, like smallpox has been, or even eliminated in the United States, as polio was following near-universal vaccination. The combination of rapid mutations and too-low vaccination rates make it likely that covid-19 won’t follow smallpox and polio into submission.
“This will more likely be the influenza model, where we have to track mutations annually and alter the boosters accordingly,” Schaffner said. In fact, he said, efforts to create combined coronavirus-flu shots are already underway.
A growing body of research into PTSD and service animals paved the way for President Joe Biden to sign into law the Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act.
This article was published on Tuesday, November 30, 2021 in Kaiser Health News.
It was supper time in the Whittier, California, home of Air Force veteran Danyelle Clark-Gutierrez, and eagerly awaiting a bowl of kibble and canned dog food was Lisa, a 3-year-old yellow Labrador retriever.
Her nails clicking on the kitchen floor as she danced about, Lisa looked more like an exuberant puppy than the highly trained service animal that helps Clark-Gutierrez manage the symptoms of post-traumatic stress disorder.
“Having her now, it’s like I can go anywhere,” Clark-Gutierrez said. “And, yes, if somebody did come at me, I’d have warning — I could run.”
A growing body of research into PTSD and service animals paved the way for President Joe Biden to sign into law the Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act. The legislation, enacted in August, requires the Department of Veterans Affairs to open its service dog referral program to veterans with PTSD and to launch a five-year pilot program in which veterans with PTSD train service dogs for other veterans.
Clark-Gutierrez, 33, is among the 25 percent of female veterans who have reported experiencing military sexual trauma while serving in the U.S. armed services.
Military sexual trauma, combat violence and brain injuries are some of the experiences that increase the risk that service members will develop PTSD. Symptoms include flashbacks to the traumatic event, severe anxiety, nightmares and hypervigilance — all normal reactions to experiencing or witnessing violence, according to psychologists. Someone receives a PTSD diagnosis when symptoms worsen or remain for months or years.
That’s what Clark-Gutierrez said happened to her after ongoing sexual harassment by a fellow airman escalated to a physical attack about a decade ago. A lawyer with three children, she said that to feel safe leaving her home she needed her husband by her side. After diagnosing Clark-Gutierrez with PTSD, doctors at VA hospitals prescribed a cascade of medications for her. At one point, Clark-Gutierrez said, her prescriptions added up to more than a dozen pills a day.
“I had medication, and then I had medication for the two or three side effects for each medication,” she said. “And every time they gave me a new med, they had to give me three more. I just couldn’t do it anymore. I was just getting so tired. So we started looking at other therapies.”
And that’s how she got her service dog, Lisa. Clark-Gutierrez’s husband, also an Air Force veteran, discovered the nonprofit group K9s for Warriors, which rescues dogs — many from kill shelters — and trains them to be service animals for veterans with PTSD. Lisa is one of about 700 dogs the group has paired with veterans dealing with symptoms caused by traumatic experiences.
“Now with Lisa we take bike rides, we go down to the park, we go to Home Depot,” said Clark-Gutierrez. “I go grocery shopping — normal-people things that I get to do that I didn’t get to do before Lisa.”
That comes as no surprise to Maggie O’Haire, an associate professor of human-animal interaction at Purdue University. Her research suggests that while service dogs aren’t necessarily a cure for PTSD, they do ease its symptoms. Among her published studies is one showing that veterans partnered with these dogs experience less anger and anxiety and get better sleep than those without a service dog. Another of her studies suggests that service dogs lower cortisol levels in veterans who have been traumatized.
“We actually saw patterns of that stress hormone that were more similar to healthy adults who don’t have post-traumatic stress disorder,” O’Haire said.
A congressionally mandated VA study that focuses on service dogs’ impact on veterans with PTSD and was published this year suggests that those partnered with the animals experience less suicidal ideation and more improvement to their symptoms than those without them.
Until now, the federal dog referral program — which relies on nonprofit service dog organizations to pay for the dogs and to provide them to veterans for free — required that participating veterans have a physical mobility issue, such as a lost limb, paralysis or blindness. Veterans like Clark-Gutierrez who have PTSD but no physical disability were on their own in arranging for a service dog.
The pilot program created by the new federal law will give veterans with PTSD the chance to train mental health service dogs for other veterans. It’s modeled on a program at the VA hospital in Palo Alto, California, and will be offered at five VA medical centers nationwide in partnership with accredited service dog training organizations.
“This bill is really about therapeutic, on-the-job training, or ‘training the trainer,’” said Adam Webb, a spokesperson for Sen. Thom Tillis (R-N.C.), who introduced the legislation in the Senate. “We don’t anticipate VA will start prescribing PTSD service dogs, but the data we generate from this pilot program will likely be useful in making that case in the future.”
The Congressional Budget Office estimates the pilot program will cost the VA about $19 million. The law stops short of requiring the VA to pay for the dogs. Instead, the agency will partner with accredited service dog organizations that use private money to cover the cost of adopting, training and pairing the dogs with veterans.
Still, the law represents a welcome about-face in VA policy, said Rory Diamond, CEO of K9s for Warriors.
“For the last 10 years, the VA has essentially told us that they don’t recognize service dogs as helping a veteran with post-traumatic stress,” Diamond said.
PTSD service dogs are often confused with emotional support dogs, Diamond said. The latter provide companionship and are not trained to support someone with a disability. PTSD service dogs cost about $25,000 to adopt and train, he said.
Diamond explained that the command “cover” means “the dog will sit next to the warrior, look behind them and alert them if someone comes up from behind.” The command “block” means the dog will “stand perpendicular and give them some space from whatever’s in front of them.”
Retired Army Master Sgt. David Crenshaw of Kearny, New Jersey, said his service dog, Doc, has changed his life.
“We teach in the military to have a battle buddy,” Crenshaw said. “And these service animals act as a battle buddy.”
A few months ago, Crenshaw experienced this firsthand. He had generally avoided large gatherings because persistent hypervigilance is one symptom of his combat-caused PTSD. But this summer, Doc, a pointer and Labrador mix, helped Crenshaw navigate the crowds at Disney World — a significant first for Crenshaw and his family of five.
“I was not agitated. I was not anxious. I was not upset,” said Crenshaw, 39. “It was truly, truly amazing and so much so that I didn’t even have to even stop to think about it in the moment. It just happened naturally.”
Thanks to Doc, Crenshaw said, he no longer takes PTSD drugs or self-medicates with alcohol. Clark-Gutierrez said Lisa, too, has helped her quit using alcohol and stop taking VA-prescribed medications for panic attacks, nightmares and periods of disassociation.
The dogs actually save the VA money over time, Diamond said. “Our warriors are far less likely to be on expensive prescription drugs, are far less likely to use other VA services and far more likely to go to school or go to work. So it’s a win-win-win across the board.”
Long waits for mental health treatment are a nationwide problem, with reports of patients waiting an average of five or six weeks for care in community clinics, at Department of Veterans Affairs facilities and in private offices from Maryland to Los Angeles County.
This article was published on Monday, November 29, 2021 in Kaiser Health News.
When Greta Christina fell into a deep depression five years ago, she called up her therapist in San Francisco. She’d had a great connection with the provider when she needed therapy in the past. She was delighted to learn that he was now “in network” with her insurance company, meaning she wouldn’t have to pay out-of-pocket anymore to see him.
But her excitement was short-lived. Over time, Christina’s appointments with the therapist went from every two weeks, to every four weeks, to every five or six.
“To tell somebody with serious, chronic, disabling depression that they can only see their therapist every five or six weeks is like telling somebody with a broken leg that they can only see their physical therapist every five or six weeks,” she said. “It’s not enough. It’s not even close to enough.”
Then, this summer, Christina was diagnosed with breast cancer. Everything related to her cancer care — her mammogram, biopsy, surgery appointments — happened promptly (like a “well-oiled machine,” she said), while her depression care stumbled along.
“It is a hot mess,” she said. “I need to be in therapy — I have cancer! And still nothing has changed.”
A new law signed by Gov. Gavin Newsom in October aims to fix this problem for Californians. Senate Bill 221, which passed the state legislature with a nearly unanimous vote, requires health insurers across the state to reduce wait times for mental health care to no more than 10 business days. Six other states — including Colorado, Maryland and Texas — have similar laws limiting wait times.
At Kaiser Permanente, the state’s largest insurance company, 87% of therapists said weekly appointments were not available to patients who needed them, according to a 2020 survey by the National Union of Healthcare Workers, which represents KP therapists — and was the main sponsor of the California wait times legislation.
“It just feels so unethical,” said triage therapist Brandi Plumley, referring to the typical two-month wait time she sees at Kaiser Permanente’s mental health clinic in Vallejo, east of San Francisco.
Every day, she takes multiple crisis calls from patients who have therapists assigned to them but can’t get in to see them, she said, describing the providers’ caseloads as “enormous.”
“It’s heartbreaking. And it eats on me day after day after day,” Plumley said. “What Kaiser simply needs to do is hire more clinicians.”
Kaiser Permanente says there just aren’t enough therapists out there to hire. KP is an integrated system — it is a health provider and insurance company under one umbrella — and has struggled to fill 300 job vacancies in clinical behavioral health, according to a statement from Yener Balan, the insurer’s Northern California vice president of behavioral health.
Hiring more clinicians won’t solve the problem, said Balan, who suggested that sustaining one-on-one therapy for all who want it in the future wouldn’t be possible in the current system: “We all must reimagine our approach to the existing national model of care.”
Kaiser Permanente lodged concerns about the wait times bill when it was introduced. And the trade group representing insurers in the state, the California Association of Health Plans, opposed it, saying the shortage of therapists would make meeting the two-week mandate too difficult.
“The COVID-19 pandemic has only exacerbated this workforce shortage, and demand for these services significantly increased,” said Jedd Hampton, a lobbyist for the California Association of Health Plans, in testimony during a state Senate hearing for the bill in the spring.
“Simply put, mandating increased frequency of appointments without addressing the underlying workforce shortage will not lead to increased quality of care,” Hampton said.
Lawmakers pushed back. State Sen. Scott Wiener (D-San Francisco), who authored the bill, accused insurers of overstating the shortage. State Sen. Connie Leyva (D-Chino) said that the therapeutic providers are out there but that insurers are responsible for recruiting them into their networks by paying higher rates and reducing administrative burdens.
If insurers want more young people to enter the mental health care profession, they must improve salaries and working conditions now, said state Sen. Richard Pan (D-Sacramento). (A 2016 KQED investigation uncovered multiple ways that insurers save money by keeping provider networks artificially small.)
As bipartisan support for the bill grew in Sacramento, insurers withdrew their formal opposition.
But whether other states have the political will, or the resources, to legislate a similar solution is unclear, said Hemi Tewarson, executive director of the nonpartisan National Academy for State Health Policy in Washington, D.C. Although California may be able to force insurers to hire more therapists, she said, places like New Mexico, Montana, Wyoming, and parts of the South don’t have enough therapists at any price.
“They don’t have the providers, so you could fine the insurers as much as you want, you’re not going to be able to, in the short term, make up those wait times if they already exist,” she said.
The new California law is a solid step toward improving access to mental health care, with communities of color standing to benefit the most, said Lonnie Snowden, a professor of health policy and management at the University of California-Berkeley. African Americans, Asian Americans and Latinos face the most barriers getting into care, Snowden said, and when people of color do come in for treatment, they are more likely to drop out.
Oversight and enforcement are needed for the new rules to work, said Keith Humphreys, a psychiatry professor at Stanford University. Kaiser Permanente has data systems that can track the time between appointments, but other insurers set up contracts with therapists in private practice, who manage their own caseloads and schedules.
“Who would keep track of whether people who’ve been seen once were seen again in 10 days, when it’s hard enough just to keep track of how many providers we have and who they are seeing?” he asked.
Questions like that one will fall to state regulators, primarily the California Department of Managed Health Care. The department has fined insurers $6.9 million since 2013 for violating state standards, including a $4 million penalty against Kaiser Permanente for excessive wait times for mental health care. Previous state law required insurers to provide initial mental health care appointments within 10 days, and the new law clarifies that they must do the same for follow-up appointments.
Greta Christina, who gets her care at a Kaiser Permanente facility, said she is desperate for the new law to start working. It takes effect on July 1, 2022. Christina thought about paying out-of-pocket in the meantime, to find a therapist she could see more often. But in a cancer crisis, she said, starting over with someone new would be too hard. So she’s waiting.
“Knowing that this bill is on the horizon has been helping me hang on,” she said.
This story is part of a partnership that includes KQED, NPR and KHN.
Inspired by their own experiences, plus those of their parents and grandparents, Black entrepreneurs are launching startups that aim to close the cultural gap in health care with technology.
This article was published on Monday, November 29, 2021 in Kaiser Health News.
When Ashlee Wisdom launched an early version of her health and wellness website, more than 34,000 users — most of them Black — visited the platform in the first two weeks.
“It wasn’t the most fully functioning platform,” recalled Wisdom, 31. “It was not sexy.”
But the launch was successful. Now, more than a year later, Wisdom’s company, Health in Her Hue, connects Black women and other women of color to culturally sensitive doctors, doulas, nurses and therapists nationally.
As more patients seek culturally competent care — the acknowledgment of a patient’s heritage, beliefs and values during treatment — a new wave of Black tech founders like Wisdom want to help. In the same way Uber Eats and Grubhub revolutionized food delivery, Black tech health startups across the United States want to change how people exercise, how they eat and how they communicate with doctors.
Inspired by their own experiences, plus those of their parents and grandparents, Black entrepreneurs are launching startups that aim to close the cultural gap in health care with technology — and create profitable businesses at the same time.
“One of the most exciting growth opportunities across health innovation is to back underrepresented founders building health companies focusing on underserved markets,” said Unity Stoakes, president and co-founder of StartUp Health, a company headquartered in San Francisco that has invested in a number of health companies led by people of color. He said those leaders have “an essential and powerful understanding of how to solve some of the biggest challenges in health care.”
Platforms created by Black founders for Black people and communities of color continue to blossom because those entrepreneurs often see problems and solutions others might miss. Without diverse voices, entire categories and products simply would not exist in critical areas like health care, business experts say.
“We’re really speaking to a need,” said Kevin Dedner, 45, founder of the mental health startup Hurdle. “Mission alone is not enough. You have to solve a problem.”
Dedner’s company, headquartered in Washington, D.C., pairs patients with therapists who “honor culture instead of ignoring it,” he said. He started the company three years ago, but more people turned to Hurdle after the killing of George Floyd.
In Memphis, Tennessee, Erica Plybeah, 33, is focused on providing transportation. Her company, MedHaul, works with providers and patients to secure low-cost rides to get people to and from their medical appointments. Caregivers, patients or providers fill out a form on MedHaul’s website, then Plybeah’s team helps them schedule a ride.
While MedHaul is for everyone, Plybeah knows people of color, anyone with a low income and residents of rural areas are more likely to face transportation hurdles. She founded the company in 2017 after years of watching her mother take care of her grandmother, who had lost two limbs to Type 2 diabetes. They lived in the Mississippi Delta, where transportation options were scarce.
“For years, my family struggled with our transportation because my mom was her primary transporter,” Plybeah said. “Trying to schedule all of her doctor’s appointments around her work schedule was just a nightmare.”
Plybeah’s company recently received funding from Citi, the banking giant.
“I’m more than proud of her,” said Plybeah’s mother, Annie Steele. “Every step amazes me. What she is doing is going to help people for many years to come.”
Health in Her Hue launched in 2018 with just six doctors on the roster. Two years later, users can download the app at no cost and then scroll through roughly 1,000 providers.
“People are constantly talking about Black women’s poor health outcomes, and that’s where the conversation stops,” said Wisdom, who lives in New York City. “I didn’t see anyone building anything to empower us.”
As her business continues to grow, Wisdom draws inspiration from friends such as Nathan Pelzer, 37, another Black tech founder, who has launched a company in Chicago. Clinify Health works with community health centers and independent clinics in underserved communities. The company analyzes medical and social data to help doctors identify their most at-risk patients and those they haven’t seen in awhile. By focusing on getting those patients preventive care, the medical providers can help them improve their health and avoid trips to the emergency room.
“You can think of Clinify Health as a company that supports triage outside of the emergency room,” Pelzer said.
Pelzer said he started the company by printing out online slideshows he’d made and throwing them in the trunk of his car. “I was driving around the South Side of Chicago, knocking on doors, saying, ‘Hey, this is my idea,’” he said.
Wisdom got her app idea from being so stressed while working a job during grad school that she broke out in hives.
“It was really bad,” Wisdom recalled. “My hand would just swell up, and I couldn’t figure out what it was.”
The breakouts also baffled her allergist, a white woman, who told Wisdom to take two Allegra every day to manage the discomfort. “I remember thinking if she was a Black woman, I might have shared a bit more about what was going on in my life,” Wisdom said.
The moment inspired her to build an online community. Her idea started off small. She found health content in academic journals, searched for eye-catching photos that would complement the text and then posted the information on Instagram.
Things took off from there. This fall, Health in Her Hue launched “care squads” for users who want to discuss their health with doctors or with other women interested in the same topics.
“The last thing you want to do when you go into the doctor’s office is feel like you have to put on an armor and feel like you have to fight the person or, like, you know, be at odds with the person who’s supposed to be helping you on your health journey,” Wisdom said. “And that’s oftentimes the position that Black people, and largely also Black women, are having to deal with as they’re navigating health care. And it just should not be the case.”
As Black tech founders, Wisdom, Dedner, Pelzer and Plybeah look for ways to support one another by trading advice, chatting about funding and looking for ways to come together. Pelzer and Wisdom met a few years ago as participants in a competition sponsored by Johnson & Johnson. They reconnected at a different event for Black founders of technology companies and decided to help each other.
“We’re each other’s therapists,” Pelzer said. “It can get lonely out here as a Black founder.”
In the future, Plybeah wants to offer transportation services and additional assistance to people caring for aging family members. She also hopes to expand the service to include dropping off customers for grocery and pharmacy runs, workouts at gyms and other basic errands.
Pelzer wants Clinify Health to make tracking health care more fun — possibly with incentives to keep users engaged. He is developing plans and wants to tap into the same competitive energy that fitness companies do.
Wisdom wants to support physicians who seek to improve their relationships with patients of color. The company plans to build a library of resources that professionals could use as a guide.
“We’re not the first people to try to solve these problems,” Dedner said. Yet he and the other three feel the pressure to succeed for more than just themselves and those who came before them.
“I feel like, if I fail, that’s potentially going to shut the door for other Black women who are trying to build in this space,” Wisdom said. “But I try not to think about that too much.”
Sen. Rick Scott (R-Fla.) issued a press release Nov. 16 suggesting that rising general inflation was behind the large increase in next year’s standard premiums for Medicare Part B.
This article was published on Wednesday, November 24, 2021 in Kaiser Health News.
An increase in Medicare Part B premiums means “America’s Seniors Are Paying the Price for Biden’s Inflation Crisis.” — The headline of a press release from Sen. Rick Scott (R-Fla.)
Republicans blame President Joe Biden for this year’s historic surge in inflation, reflected in higher prices for almost everything — from cars and gas to food and housing. They see last month’s 6.2% annual inflation rate — the highest in decades and mostly driven by an increase in consumer spending and supply issues related to the covid-19 pandemic — as a ticket to taking back control of Congress in next year’s midterm elections.
A key voting bloc will be older Americans, and the GOP aims to illustrate how much worse life has grown for them under the Biden administration.
Sen. Rick Scott (R-Fla.) issued a press release Nov. 16 suggesting that rising general inflation was behind the large increase in next year’s standard premiums for Medicare Part B, which covers physician and some drug costs and other outpatient services.
“Sen. Rick Scott: America’s Seniors Are Paying the Price for Biden’s Inflation Crisis” was the headline. The senator’s statement within that press release said, “We need to be LOWERING health care and drug prices and strengthening this vital program for seniors and future generations, not crippling the system and leaving families to pay the cost.” The press release from Scott says he is “slamming Biden’s inaction to address the inflation crisis he and Washington Democrats have created with reckless spending and socialist policies, which is expected to cause significant price increases on [senior] citizens and Medicare recipients.” Scott’s statement in that same press release also says the administration’s “reckless spending” will leave U.S. seniors “paying HUNDREDS more for the care they need.”
We wondered whether these points were true. Was the climbing annual inflation rate over the past several months to blame for the increase in Medicare Part B premiums?
We reached out to Scott’s office for more detail but received no reply. Upon further investigation, we found there is little, if any, connection between general inflation in the past few months and the increase in Medicare Part B premiums.
What’s the Status of Medicare Premiums?
Medicare Part B premiums have been growing steadily for decades to keep up with rising health spending.
The U.S. inflation rate, for years held at bay, has been above 4% since April, hitting 6.2% in October, the highest rate in decades.
On Nov. 12, the Centers for Medicare & Medicaid Services announced that the standard monthly premium for Medicare Part B would rise to $170.10 in 2022, from $148.50 this year. The 14.5% increase is the largest one-year increase in the program’s history.
Scott’s press release refers to the CMS report.
CMS cited three main factors for the increase: rising health care costs, a move by Congress last year that held the premium increase to just $3 a month because of the pandemic, and the need to raise money for a possible unprecedented surge in drug costs. Inflation was not on that list.
In fact, half of the premium increase was due to making sure the program was ready in case Medicare next year decides to start covering Aduhelm, a new Alzheimer’s drug priced at $56,000 per year, per patient. It’s been estimated that total Medicare spending for the drug for one year alone would be nearly $29 billion, far more than any other drug.
How Big a Hit Will Seniors Feel?
The Part B premium is typically subtracted automatically from enrollees’ Social Security checks. Because Social Security recipients will receive a 5.9% cost-of-living increase next year — about $91 monthly for the average beneficiary — they’ll still see a net gain, though a chunk will be eaten away by the hike in Medicare premiums.
About 70% of Medicare beneficiaries won’t face a 14.5% increase, anyway, because a “hold-harmless” provision in federal law protects them from premium increases that exceed Social Security’s cost-of-living increase, said Gretchen Jacobson, a vice president of the nonpartisan Commonwealth Fund. So their increase will be limited to 5.9%.
Those not covered by the hold-harmless provision are mainly high-income beneficiaries (people with incomes over $91,000 for individuals), those newly enrolled in Medicare Part B, people who receive both Medicaid and Medicare, and enrollees not receiving Social Security because they are still working.
What Role Does Inflation Play?
Several Medicare experts said the spike in the general inflation rate has little or nothing to do with the Medicare premium increase. In fact, Medicare is largely immune from inflation, because the program sets prices for hospitals and doctors.
“This is so false that it is annoying,” Paul Ginsburg, a professor of health policy at the Sol Price School of Public Policy at the University of Southern California, said of Scott’s claim that general inflation is behind the premium increase. “The effect of the inflation spike so far on prices is zero because Medicare controls prices.”
Medicare Part B premiums, he said, reflect changes in the amount of health services delivered and a more expensive mix of drugs. “Premiums are tracking spending, only a portion of which reflects prices,” Ginsburg said. “I can’t see that the administration really had any discretion” in setting the premium increase due to the need to build a reserve to pay for the Alzheimer’s drug and make up for the reduced increase last year, he said.
Stephen Zuckerman, co-director of the Urban Institute’s health policy center, said a rise in wages caused by inflation could spur a small boost in Medicare spending because wages help determine how much the program pays providers. But, he said, such an increase would have to occur for more than a few months to affect premiums. Continued soaring inflation could influence 2023 Medicare premiums, not those for 2022. “The claim that premium increases are due to inflation in the last couple of months doesn’t make sense,” Zuckerman said.
CMS faced the challenge of trying to estimate costs for an expensive drug not yet covered by Medicare. “It is a very difficult projection to make, and they want to have enough contingency reserved,” said Jacobson, of the Commonwealth Fund.
Still, the 5.9% jump that will hit most enrollees is a relatively large premium increase, she added. Those beneficiaries will see an $8.76 monthly increase in premiums, or about $105 more for all of 2022.
Our Ruling
Scott said in a press release about the 2022 increase in Medicare Part B premiums that “America’s seniors are paying the price for Biden’s inflation crisis.”
Though his statement contains a sliver of truth, Scott’s assertion ignores critical facts that create a different impression.
For instance, Medicare policy experts said, current general inflation has little, if anything, to do with the increase in premiums. CMS said the increase was needed to put away money in case Medicare starts paying for an Alzheimer’s drug that could add tens of billions in costs in one year and to make up for congressional action last year that held down premiums.
And most seniors will not pay hundreds of dollars more for premiums because of the hold-harmless provision. About 30% of Medicare enrollees — those with high incomes and those who do not receive Social Security — will have to pay the full $21.60 a month, or about $259 for 2022, a 14.5% increase. People in this category either have higher incomes or are not yet receiving Social Security because they are still working.
The other 70% of enrollees will face a 5.9%, or $8.76 a month, increase. This means most Medicare enrollees will see a $105 increase in premiums for all of 2022, not hundreds of dollars.
We rate the claim Mostly False.
SOURCES:
Telephone interview with Stephen Zuckerman, co-director of the Health Policy Center at the Urban Institute, Nov. 19, 2021.
Telephone interview with Paul Ginsburg, professor of health policy at the Sol Price School of Public Policy at the University of Southern California, Nov. 18, 2021.
Telephone interview with Gretchen Jacobson, vice president of the Medicare program at the Commonwealth Fund, Nov. 18, 2021.
Telephone interview with Joe Antos, senior fellow with American Enterprise Institute, Nov. 18, 2021.
The decisions have been gut-wrenching. Should she try another round of chemotherapy, even though she barely tolerated the last one? Should she continue eating, although it’s getting difficult? Should she take more painkillers, even if she ends up heavily sedated?
Dr. Susan Massad, 83, has been making these choices with a group of close friends and family — a “health team” she created in 2014 after learning her breast cancer had metastasized to her spine. Since then, doctors have found cancer in her colon and pancreas, too.
Now, as Massad lies dying at home in New York City, the team is focused on how she wants to live through her final weeks. It’s understood this is a mutual concern, not hers alone. Or, as Massad told me, “Health is about more than the individual. It’s something that people do together.”
Originally, five of Massad’s team members lived with her in a Greenwich Village brownstone she bought with friends in 1993. They are in their 60s or 70s and have known one another a long time. Earlier this year, Massad’s two daughters and four other close friends joined the team when she was considering another round of chemotherapy.
Massad ended up saying “no” to that option in September after weighing the team’s input and consulting with a physician who researches treatments on her behalf. Several weeks ago, she stopped eating — a decision she also made with the group. A hospice nurse visits weekly, and an aide comes five hours a day.
Anyone with a question or concern is free to raise it with the team, which meets now “as needed.” The group does not exist just for Massad, explained Kate Henselmans, her partner, “it’s about our collective well-being.” And it’s not just about team members’ medical conditions; it’s about “wellness” much more broadly defined.
Massad, a primary care physician, first embraced the concept of a “health team” in the mid-1980s, when a college professor she knew was diagnosed with metastatic cancer. Massad was deeply involved in community organizing in New York City, and this professor was part of those circles. A self-professed loner, the professor said she wanted deeper connections to other people during the last stage of her life.
Massad joined with the woman’s social therapist and two of her close friends to provide assistance. (Social therapy is a form of group therapy.) Over the next three years, they helped manage the woman’s physical and emotional symptoms, accompanied her to doctors’ visits and mobilized friends to make sure she was rarely alone.
As word got out about this “let’s do this together” model, dozens of Massad’s friends and colleagues formed health teams lasting from a few months to a few years. Each is unique, but they all revolve around the belief that illness is a communal experience and that significant emotional growth remains possible for all involved.
“Most health teams have been organized around people who have fairly serious illness, and their overarching goal is to help people live the most fulfilling life, the most giving life, the most social life they can, given that reality,” Massad told me. An emphasis on collaborative decision-making distinguishes them from support groups.
Emilie Knoerzer, 68, who lives next door to Massad and Henselmans and is a member of the health team, gives an example from a couple of years ago. She and her partner, Sandy Friedman, were fighting often and “that was bad for the health of the whole house,” she told me. “So, the whole house brought us together and said, ‘‘This isn’t going well, let’s help you work on this.’ And if we started getting into something, we’d go ask someone for help. And it’s much better for us now.”
Mary Fridley, 67, a close friend of Massad’s and another health team member, offered another example. After experiencing serious problems with her digestive system this past year, she pulled together a health team to help her make sense of her experiences with the medical system. None of the many doctors Fridley consulted could tell her what was wrong, and she felt enormous stress as a result.
“My team asked me to journal and to keep track of what I was eating and how I was responding. That was helpful,” Fridley told me. “We worked on my not being so defensive and humiliated every time I went to the doctor. At some point, I said, ‘All I want to do is cry,’ and we cried together for a long time. And it wasn’t just me. Other people shared what was going on for them as well.”
Dr. Hugh Polk, a psychiatrist who’s known Massad for 40 years, calls her a “health pioneer” who practiced patient-centered care long before it became a buzzword. “She would tell patients, ‘We’re going to work together as partners in creating your health. I have expertise as a doctor, but I want to hear from you. I want you to tell me how you feel, what your symptoms are, what your life is like,’” he said.
As Massad’s end has drawn near, the hardest but most satisfying part of her teamwork is “sharing emotionally what I’m going through and allowing other people to share with me. And asking for help. Those aren’t things that come easy,” she told me by phone conversation.
“It’s very challenging to watch her dying,” said her daughter Jessica Massad, 54. “I don’t know how people do this on their own.”
Every day, a few people inside or outside her house stop by to read to Massad or listen to music with her — a schedule her team is overseeing. “It is a very intimate experience, and Susan feels loved so much,” said Henselmans.
For Massad, being surrounded by this kind of support is freeing. “I don’t feel compelled to keep living just because my friends want me to,” she said. “We cry together, we feel sad together, and that can be difficult. But I feel so well taken care of, not alone at all with what I’m going through.”
Doctor groups and medical associations have lashed out at the interim final rules that HHS unveiled last month, saying they favor insurance companies in the arbitration phase.
This article was published on Tuesday, November 23, 2021 in Kaiser Health News.
Overpriced doctors and other medical providers who can’t charge a reasonable rate for their services could be put out of business when new rules against surprise medical bills take effect in January, and that’s a good thing, Health and Human Services Secretary Xavier Becerra told KHN, in defending the regulations.
The proposed rules represent the Biden administration’s plan to carry out the No Surprises Act, which Congress passed to spare patients from the shockingly high bills they get when one or more of their providers unexpectedly turn out to be outside their insurance plan’s network.
The law shields patients from those bills, requiring providers and insurers to work out how much the physicians or hospitals should be paid, first through negotiation and then, if they can’t agree, arbitration. Doctor groups and medical associations, however, have lashed out at the interim final rules that HHS unveiled last month, saying they favor insurance companies in the arbitration phase. That’s because, although the rules tell arbiters to take many factors into account, they are instructed to start with a benchmark largely determined by insurers: the median rate negotiated for similar services among in-network providers.
The doctor groups say giving the insurers the upper hand will let them drive payment rates down and potentially force doctors out of networks or even out of business, reducing access to health care.
The department has heard those concerns, Becerra said, but the bottom line is protecting patients. Medical providers who have taken advantage of a complicated system to charge exorbitant rates will have to bear their share of the cost, or close if they can’t, he said.
“I don’t think when someone is overcharging, that it’s going to hurt the overcharger to now have to [accept] a fair price,” Becerra said. “Those who are overcharging either have to tighten their belt and do it better, or they don’t last in the business.”
“It’s not fair to say that we have to let someone gouge us in order for them to be in business,” he added.
Nonetheless, Becerra said he did not foresee a wave of closures, or diminished access for consumers. Instead, he suggested that a competitive, market-driven process will find a balance, especially when consumers know better what they are paying for.
“We’re willing to pay a fair price,” he said. But he emphasized that “I’ll pay for the best, but I don’t want to have to pay for the best and then three times more on top of that and get blindsided by the bill.”
Becerra also pointed to a report on surprise medical bills that HHS released Monday and that was provided to KHN in advance, highlighting the impacts of negotiation and arbitration laws already in effect in 18 states.
The report, which aggregates previous research, found people getting hit with surprise bills averaging $1,219 for anesthesiologists, $2,633 for surgical assistants, $744 for childbirth and north of $24,000 for air ambulances.
In the states that use benchmarks similar to what doctors are suggesting HHS use, such as New York and New Jersey, the report found costs rising. New York has a “baseball-style” system in which the arbiter chooses between the offers presented by the provider and the insurer, although the arbiter is told to consider the offer closest to the 80th percentile of charges. “Since the amount providers charge is typically much higher than the actual negotiated rate, this approach risks leading to significantly higher overall costs,” the report found. In New Jersey, billed charges or “usual and customary” rates are considered.
“When the arbitration process is wide open, no boundaries, at the end of the day health care costs go up, not down,” Becerra said of the methods doctors prefer. “We want costs to go down. And so we want to set up a system that helps provide the guideposts to keep us efficient, transparent and cost-effective.”
The system chosen by the Biden administration was expected to push insurance premiums down by 0.5% to 1%, the Congressional Budget Office estimated.
“Everyone has to give a little to get to a good place,” Becerra said. “That sweet spot, I hope, is one where patients … are extracted from that food fight. And if there continues to be a food fight, the arbitration process will help settle it in a way that is efficient, but it also will lead to lower costs.”
While the administration chose a benchmark that physician and hospital groups don’t like, the law does specify that other factors should be considered, such as a provider’s experience, the market and the complexity of a case. Becerra said those factors help ensure arbitration is fair.
“What we simply did was set up a rule that says, ‘Show the evidence,’” Becerra said. “It has to be relevant, material evidence. And let the best person win in that fight in arbitration.”
The interim final rules were published Oct. 7, giving stakeholders 60 days to comment and seek changes. More than 150 members of Congress, many of them doctors, have asked HHS and other relevant federal agencies to reconsider before the law takes effect Jan. 1. The lawmakers charge that the administration is not adhering to the spirit of the compromises Congress made in passing the law.
Rules that are this far along tend to go into effect with little or no changes, but Becerra said his department was still listening. “If we think there’s a need to make any changes, we are prepared to do so,” the secretary said.
The HHS report also noted that the law requires extensive monthly and annual reporting to regulators and Congress to determine if the regulations are out of whack or have undesirable consequences like those the physicians are warning of.
Becerra said he thinks the rules strike the right balance, favoring not insurers or doctors, but the people who need medical care.
“We want it to be transparent, so we can lead to more competition, and keep costs low — not just for the payer, the insurer, not just for the provider, the hospital or doctor, but for the patients especially,” he said.
In the middle of a rainy Michigan night, 88-year-old Dian Wurdock walked out the front door of her son’s home in Grand Rapids, barefoot and coatless. Her destination was unknown even to herself.
Wurdock was several years into a dementia diagnosis that turned out to be Alzheimer’s disease. By luck, her son woke up and found her before she stepped too far down the street. As the Alzheimer’s progressed, so did her wandering and with it, her children’s anxiety.
“I was losing it,” said her daughter, Deb Weathers-Jablonski. “I needed to keep her safe, especially at night.”
Weathers-Jablonski installed a monitoring system with nine motion sensors around the house — in her mother’s bedroom, the hallway, kitchen, living room, dining room and bathroom and near three doors that led outside. They connected to an app on her phone, which sent activity alerts and provided a log of her mother’s movements.
“When I went to bed at night, I didn’t have to guess what she was doing,” Weathers-Jablonski said. “I was actually able to get some sleep.”
New monitoring technology is helping family caregivers manage the relentless task of looking out for older adults with cognitive decline. Setting up an extensive monitoring system can be expensive — Weathers-Jablonski’s system from People Power Co. costs $299 for the hardware and $40 a month for use of the app. With scores of companies selling such gear, including SentryTell and Caregiver Smart Solutions, they are readily available to people who can pay out-of-pocket.
But that’s not an option for everyone. While the technology is in line with President Joe Biden’s plan to direct billions of dollars toward helping older and disabled Americans live more independently at home, the costs of such systems aren’t always covered by private insurers and rarely by Medicare or Medicaid.
Monitoring also raises ethical questions about privacy and quality of care. Still, the systems make it possible for many older people to stay in their home, which can cost them far less than institutional care. Living at home is what most people prefer, especially in light of the toll the covid-19 pandemic took on nursing homes.
Technology could help fill a huge gap in home care for the elderly. Paid caregivers are in short supply to meet the needs of the aging population, which is expected to more than double in coming decades. The shortage is fueled by low pay, meager benefits and high rates of burnout.
And for the nearly 1 in 5 U.S adults who are caregivers to a family member or friend over age 50, the gadgets have made a hard job just a little easier.
Passive surveillance systems are replacing the “I’ve fallen and I can’t get up” medical alert buttons. Using artificial intelligence, the new devices can automatically detect something is wrong and make an emergency call unasked. They also can monitor pill dispensers and kitchen appliances using motion sensors, like EllieGrid and WallFlower. Some systems include wearable watches for fall detection, such as QMedic, or can track GPS location, like SmartSole’s shoe insoles. Others are video cameras that record. People use surveillance systems like Ring inside the home.
Some caregivers may be tempted to use technology to replace care, as researchers in England found in a recent study. A participant who had visited his father every weekend began visiting less often after his dad started wearing a fall detector around his wrist. Another participant believed her father was active around the house, as evidenced by activity sensor data. She later realized the app was showing not her father’s movement, but his dog’s. The monitoring system picked up the dog’s movements in the living room and logged it as activity.
Technology isn’t a substitute for face-to-face interaction, stressed Crista Barnett Nelson, executive director of Senior Advocacy Services, a nonprofit group that helps older adults and their families in the North Bay area outside San Francisco. “You can’t tell if someone has soiled their briefs with a camera. You can’t tell if they’re in pain, or if they just need an interaction,” she said.
In some instances, people being monitored changed their habits in response to technology. Clara Berridge, a professor of social work at the University of Washington who studies the use of technology in elder care, interviewed a woman who stopped her usual practice of falling asleep on the recliner because the technology would falsely alert her family that something was wrong based on inactivity deemed abnormal by the system. Another senior reported rushing in the bathroom for fear an alert would go out if they took too long.
The technology presents another worry for those being monitored. “A caregiver is generally going to be really concerned about safety. Older adults are often very concerned about safety too, but they may also weigh privacy really heavily, or their sense of identity or dignity,” Berridge said.
Charles Vergos, 92 and living in Las Vegas, is uncomfortable with video cameras in his house and wasn’t interested in wearing gadgets. But he liked the idea that someone would know if something went wrong while he was alone. His niece, who lives in Palo Alto, California, suggested Vergos install a home sensor system so she could monitor him from afar.
“The first question I asked is, does it take pictures?” Vergos recalled. Because the sensors don’t have a video component, he was fine with them. “Actually, after you have them in the house for a while, you don’t even think about it,” Vergos said.
The sensors also have made conversations with his niece more convenient for him. She knows he likes to talk on the phone while he’s in his chair in the den, so she’ll check his activity on her iPad to determine whether it’s a good time to call.
People making audio and video recordings must abide by state privacy laws, which typically require the consent of the person being recorded. It’s not as clear, however, if consent is needed to collect the activity data that sensors gather. That falls into a gray area of the law, similar to data collected through internet browsing.
Then there is the problem of how to pay for it all. Medicaid, the federal-state health program for low-income people, does cover some passive monitoring for home care, but it’s not clear how many states have opted to pay for such service.
Some seniors also lack access to robust internet broadband, putting much of the more sophisticated technology out of reach, noted Karen Lincoln, founder of Advocates for African American Elders at the University of Southern California.
The relief monitoring devices bring caregivers may be the most compelling reason for their use. Delaine Whitehead, who lives in Orange County, California, started taking medication for anxiety about a year after her husband, Walt, was diagnosed with Alzheimer’s.
Like Weathers-Jablonski, Whitehead sought technology to help, finding peace of mind in sensors installed on the toilets in her home.
Her husband often flushed too many times, causing the toilets to overflow. Before Whitehead installed the sensors in 2019, Walt had caused $8,000 worth of water damage in their bathroom. With the sensors, Whitehead received an alert on her phone when the water got too high.
“It did ease up a lot of my stress,” she said.
Sofie Kodner is a writer with the Investigative Reporting Program at the University of California-Berkeley Graduate School of Journalism. The IRP reported this story through a grant from The SCAN Foundation.
A mile northeast of Capitol Hill in Washington, D.C., along what’s known as the H Street corridor, about half the people crowding the sidewalks are wearing masks. Perhaps it’s because they know that when they step into any business or establishment here, they will have to put one on anyway. The capital, after all, is one of the few remaining cities or states nationwide that mandate masks for public indoor spaces — at least it has, until today.
“We have a bunch of rule followers,” said Claire Bengur, the owner of Atlas Salon, which has been in the neighborhood since 2018. “I am so thankful that my salon is in D.C.” She’s been glad to have a mask requirement, she said, because it’s impossible to do clients’ hair without standing close to them.
Bengur is unsure how to feel about Mayor Muriel Bowser’s decision to roll back the mandate. As the covid-19 pandemic has worn on, many Washingtonians have come to view masking as something between a habit and a security blanket. Even when the rule was lifted for about two months starting in May, many people continued to use masks in places like grocery stores. While face coverings will still be required in select spaces, such as public transit and schools, the District of Columbia will no longer require them in private businesses like Atlas Salon. And that has triggered mixed feelings.
Bengur had been debating whether to continue to ask clients to wear masks because the district gives businesses that option. But at the same time, “there is a certain level of excitement … like I don’t want to wear masks forever.” She ultimately decided to let clients choose for themselves. Bengur and her staff feel more at ease than they did earlier in the pandemic because her salon requires proof of vaccination.
A block away at the H Street Northeast location of Solidcore, a boutique fitness chain that started in the district, CEO Bryan Myers had an it’s-about-time take. “This will be game-changing for our clients’ comfort while working out and the health of our industry,” he said.
On the whole, Washington has been especially cautious when it comes to covid, which has helped the city avoid the worst of the pandemic. Now, the mayor is moving away from ordering protective measures and instead offering recommendations based on vaccination status.
This change can partly be explained by adjustments in the district health department’s goal, which no longer is to reach zero cases. Viewing covid as more of an “endemic” disease — one regularly found in particular populations — Bowser explained her decision this way: “This does not mean that everyone needs to stop wearing their masks. But it does mean that we are shifting the government’s response to providing you risk-based information.” While she’s reserved the right to reinstate the mandate, Bowser has doubled down on her decision. “Quite frankly, I don’t expect many D.C. residents will change their current behavior,” she said Friday during an interview on a local radio show.
The shift has some residents feeling perplexed, if not nervous, especially given the timing.
Children ages 5 to 11 just became eligible for vaccination, so they are not fully immunized yet, and infections are likely to climb with the holidays coming. Cases have already increased in half the states. That neighboring Montgomery County reinstated its mask mandate over the weekend leaves some people all the more baffled. A majority of district council members are already pushing the mayor to reconsider. Meanwhile, the White House, just steps from the mayor’s office, is not lifting its mask requirement, noting that the Centers for Disease Control and Prevention recommends one given the substantial level of community transmission.
“I’m a little bit iffy about the whole thing,” said Sandra Basanti, co-owner of Pie Shop, which offers fresh pies and live music on H Street.
Basanti has two young children who are not yet fully vaccinated. She’s unsure whether she’ll require customers to wear masks but expects to — at least at first. She’s hesitant because staffers received pushback when Pie Shop became one of the first venues in town to impose a vaccine requirement. She would like to see Washington follow New York City’s example and require proof of vaccination to enter public spaces such as shopping centers, sports arenas and theaters.
“We were just kind of waiting for the city to make that call for us so that we wouldn’t have to fight people on it, and they never did,” said Basanti. “I just don’t want to make the staff feel like they now also have to be the mask police again.”
“Being the mask police sucks,” she added.
The owner of the dive bar across the street agrees. “I’m very exhausted with arguing with people about masks and all the different things,” said Tony Tomelden of the Pug, which will not require patrons to wear masks but will insist that they be vaccinated. “Once a week, at least, there’s some kind of argument with some customer.”
Tomelden worries that talk of endemic covid means leaders are moving on without addressing all the pandemic-induced needs of small businesses beyond masking. “I’m so tired of begging for a break on bills and for grants and that kind of thing, but we’re still not fully recovered,” he said.
Like residents, public health experts are not in agreement on whether the district is acting prematurely.
“It makes sense,” Dr. Lynn Goldman, dean of the Milken Institute School of Public Health at George Washington University, said of the mayor’s decision. She reasoned that, thanks to vaccination, the district has few covid hospitalizations and deaths. “At the same time … we don’t really know how it’s going to go.”
Meanwhile, Dr. David Dowdy, an associate professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, said he generally recommends against easing restrictions at a time like this. “My expectation is that we’re likely to see something of an increase in cases over the winter,” he said, “and then this probably is going to become after that point in time something of an endemic disease.”
“We’ve come this far. It probably is not too difficult to keep our guard up for a couple more months,” he added. “But the flip side of that is we’ve been doing this for a really long time and people are very tired.”
Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, sees Washington’s experience as emblematic of what can happen when leaders do not clearly explain their response to covid or why mask mandates are imposed or withdrawn.
Part of the challenge, Osterholm said, is that the explanations are unsatisfying. “We do not understand why surges start or stop,” he said. “Why they start and stop surely can’t be tied to human mitigation strategies. What can be tied to those is how big those surges get.”
Experts say the success of the treatments would hinge on one uncertain factor: whether high-risk patients infected with covid will be able to get tested — and then treated — fast enough to make a difference.
This article was published on Monday, November 22, 2021 in Kaiser Health News.
Within a few weeks, perhaps before many Americans finish decorating for the holidays, the U.S. could have access to a new antiviral pill from Merck expected to alter the deadly trajectory of the covid-19 pandemic — with a second option from Pfizer to follow shortly after.
Now under federal review, both pills are being hailed by infectious-disease doctors not prone to superlatives.
“This is truly a game changer,” said Dr. Daniel Griffin, an expert on infectious diseases and immunology at Columbia University. “This is up there with vaccines. It’s not a substitute for vaccines; we still want to get people vaccinated. But, boy, this is just another great tool to have.”
The new regimens, which require 30 or 40 pills to be taken over five days, have been shown to dramatically reduce hospitalizations and prevent deaths in adults with mild to moderate covid who are at risk for severe disease because of age or underlying conditions. But experts say the success of the treatments would hinge on one uncertain factor: whether high-risk patients infected with covid will be able to get tested — and then treated — fast enough to make a difference.
“Early, accessible testing and access to the results in a time frame that allows us to make a decision is really going to be key to these medications,” said Dr. Erica Johnson, who chairs the Infectious Disease Board of the American Board of Internal Medicine. “It puts the onus on our public health strategy to make these available.”
In clinical trials, molnupiravir, the antiviral drug developed by Merck & Co. and Ridgeback Biotherapeutics, was given to non-hospitalized, unvaccinated, high-risk adult patients within five days of their first covid symptoms. Pfizer’s product, Paxlovid, was tested in similar patients as early as three days — just 72 hours — after symptoms emerged.
Results from the Merck trial, released last month, showed the drug reduced the risk of hospitalizations by about 50% and prevented deaths entirely. It will be considered by an advisory panel to the federal Food and Drug Administration on Nov. 30. Pfizer officials, who requested FDA emergency authorization for their drug on Nov. 16, said Paxlovid cut the risk of hospitalizations and deaths by 89%. Both drugs work by hampering the way the covid virus reproduces, though they do so at different points in the process.
But those promising results assume the drugs can be administered in the narrow window of time used in the trials, a proven challenge when getting antiviral treatments to actual patients. Similar drugs can prevent dire outcomes from influenza if given early, but research shows that only about 40% of high-risk patients during five recent flu seasons sought medical care within three days of falling ill.
“That’s just not human nature,” said Kelly Wroblewski, director of infectious disease programs for the Association of Public Health Laboratories. “If you have a sniffle, you wait to see if it gets worse.”
Even when patients do seek early care, access to covid testing has been wildly variable since the start of the pandemic. U.S. testing capacity continues to be plagued by a host of problems, including supply-chain bottlenecks, staffing shortages, intermittent spikes in demand and results that can take hours — or far longer.
PCR, or polymerase chain reaction tests, the gold standard to detect SARS-CoV-2, can require scheduled appointments at medical offices or urgent care centers, and patients often wait days to learn the results. Rapid antigen tests are faster but less accurate, and some medical providers are hesitant to rely on them. Over-the-counter tests that can be used at home provide results quickly but are hard to find in stores and remain expensive. And it’s not yet clear how those results would be confirmed and whether they would be accepted as a reason for treatment.
“Get ready,” Griffin said. “You don’t want to call someone four days later to say, ‘Ooh, you’re now outside the window,’ and the efficacy of this oral medication has been lost because of problems on our end with getting those results.”
The situation is expected to improve after a Biden administration push to invest $3 billion in rapid testing, including $650 million to ramp up manufacturing capacity for rapid tests. But it could be months before the change is apparent.
“Supplies will be getting better, but it’s going to be slow,” said Mara Aspinall, co-founder of Arizona State University’s biomedical diagnostics program, who writes a weekly newsletter monitoring national testing capacity.
If getting tests will be tough, acquiring doses of the antiviral drugs is expected to be tougher, at least at first. The federal government has agreed to purchase about 3.1 million courses of molnupiravir for $2.2 billion, which works out to about $700 per course of treatment. The Biden administration is planning to announce a deal to pay $5 billion for 10 million courses of the Pfizer drug, paying about $500 per treatment course, according to The Washington Post.
Doses of the drugs distributed by the federal government would go to states and patients at no cost. But only a fraction of the planned inventory will be available to start, said Dr. Lisa Piercey, Tennessee’s health commissioner, who has been part of a small group of state health officials working on the distribution plans.
Under one scenario, in which 100,000 courses of the Merck drug are available as early as Dec. 6, Piercey said Tennessee would receive just 2,000 patient courses even as the state is reporting more than 1,200 new cases a week on average. Deciding which sick patients receive those scarce supplies will be “an educated stab in the dark,” Piercey said.
U.S. Department of Health and Human Services officials have said the antiviral treatments will be distributed through the same state-based system adopted for monoclonal antibody treatments. The lab-made molecules, delivered via IV infusion or injection, mimic human antibodies that fight the covid virus and reduce the risk of severe disease and death. Federal officials took over distribution in September, after a covid surge in Southern states with low vaccination rates led to a run on national supplies. They’re now allotted to states based on the number of recent covid cases and hospitalizations and past use.
The antivirals will be cheaper than the monoclonal antibody treatments, which cost the government about $1,250 per dose and can carry infusion fees that leave patients with hundreds of dollars in copays. The pills are much easier to use, and pharmacies likely will be allowed to order and dispense them for home use.
Still, the antiviral pills won’t replace the antibody treatments, said Dr. Brandon Webb, an infectious-disease specialist at Intermountain Healthcare in Salt Lake City.
Questions remain about the long-term safety of the drugs in some populations. Merck’s molnupiravir works by causing mutations that prevent the virus from reproducing. The Pfizer treatment, which includes Paxlovid and a low dose of ritonavir, an HIV antiretroviral, may cause interactions with other drugs or even over-the-counter supplements, Webb said.
Consequently, the antivirals likely won’t be used in children, people with kidney or liver disease, or pregnant people. They’ll need to be administered to patients capable of taking multiple pills at once, a couple of times a day, and those patients should be monitored to make sure they complete the therapy.
“We’ll be on an interesting tightrope in which we’ll be trying to identify eligible patients early on to treat them with antivirals,” Webb said. “We’re just going to need to be nimble and ready to pivot.”