People who are at high risk — and the loved ones who fear passing along the virus to them — are speaking out about being left behind as society drops pandemic safeguards.
This article was published on Tuesday, February 22, 2022 in Kaiser Health News.
Iesha White is so fed up with the U.S. response to COVID-19 that she's seriously considering moving to Europe.
"I'm that disgusted. The lack of care for each other, to me, it's too much," said White, 30, of Los Angeles. She has multiple sclerosis and takes a medicine that suppresses her immune system. "As a Black disabled person, I feel like nobody gives a [expletive] about me or my safety."
The Centers for Disease Control and Prevention has a strict definition of who is considered moderately or severely immunocompromised, such as cancer patients undergoing active treatment and organ transplant recipients. Still, millions of other people are living with chronic illnesses or disabilities that also make them especially susceptible to the disease. Though vulnerability differs based on each person and their health condition — and can depend on circumstances — catching COVID is a risk they cannot take.
As a result, these Americans who are at high risk — and the loved ones who fear passing along the virus to them — are speaking out about being left behind as the rest of society drops pandemic safeguards such as masking and physical distancing.
Their fears were amplified this month as several Democratic governors, including the leaders of California and New York — places that were out front in implementing mask mandates early on — moved to lift such safety requirements. To many people, the step signaled that "normal" life was returning. But for people considered immunocompromised or who face high risks from COVID because of other conditions, it upped the level of anxiety.
"I know my normal is never going to be normal," said Chris Neblett, 44, of Indiana, Pennsylvania, a kidney transplant recipient who takes immunosuppressive drugs to prevent his body from rejecting his transplanted organ. "I'm still going to be wearing a mask in public. I'm still probably going to go to the grocery store late at night or early in the morning to avoid other people."
He is especially concerned because his wife and young daughter recently tested positive for COVID.
Even though he's fully vaccinated, he's not sure he is protected from the virus's worst outcomes. Neblett participates in a Johns Hopkins University School of Medicine study tracking transplant recipients' immune response to the vaccine, so he knows his body produced only a low amount of antibodies after the third dose and is waiting on the results of the fourth. For now, he's isolating himself from his wife and two kids for 10 days by staying in his second garage.
"I told my wife when COVID first happened, 'I have to make it to the vaccine,'" he said. But learning the vaccine hasn't triggered an adequate immune-system response so far is crushing. "Your world really changes. You start wondering, 'Am I going to be a statistic? Am I going to be a number to people that don't seem to care?'"
Scientists estimate that almost 3% of Americans meet the strict definition of having weakened immune systems, but researchers acknowledge that many more chronically ill and disabled Americans could be severely affected if they catch COVID.
By summer 2021, scientific evidence indicated that immunocompromised people would likely benefit from a third shot, but it took federal agencies time to update their guidance. Even then, only certain groups of immunocompromised people were eligible, leaving others out.
In October, the CDC again quietly revised its vaccine guidance to allow immunocompromised people to receive a fourth COVID vaccine dose, though a recent KHN story revealed that pharmacists unaware of this change were still turning away eligible people in January.
People with weakened immune systems or other high-risk conditions argue that now is the time, as the omicron surge subsides, to double down on policies that protect vulnerable Americans like them.
"The pandemic isn't over," said Matthew Cortland, a senior fellow working on disability and healthcare for Data for Progress, who is chronically ill and immunocompromised. "There is no reason to believe that another variant won't emerge. … Now is the time, as this omicron wave begins to recede, to pursue policies and interventions that protect chronically ill, disabled, and immunocompromised people so that we aren't left behind."
Several people interviewed by KHN who are part of this community said that, instead, the opposite is taking place, pointing to a January comment by CDC Director Dr. Rochelle Walensky that implied it was "encouraging news" that the majority of people dying of COVID were already sick.
"The overwhelming number of deaths, over 75%, occurred in people who had at least four comorbidities, so really these are people who were unwell to begin with," said Walensky, when discussing a study during a television interview that showed the level of protection vaccinated people had against severe illness from COVID. "And yes, really encouraging news in the context of omicron."
Although the CDC later said Walensky's remarks were taken out of context, Kendall Ciesemier, a 29-year-old multimedia producer living in Brooklyn, New York, said she was disturbed by the comments.
Walensky's statement "sent shock waves through the disability community and the chronic illness community," said Ciesemier, who has had two liver transplants.
"It was saying the quiet part out loud," she added, noting that though it was likely a gaffe, the strong reaction to it "stemmed from this holistic feeling that these communities have not been prioritized during the pandemic and it feels like our lives are acceptable losses."
When asked by a KHN reporter at the Feb. 9 White House COVID press briefing what she wanted to convey to people who feel they are being left behind, Walensky didn't offer a clear answer.
"We, of course, have to make recommendations that are, you know, relevant for New York City and rural Montana," she said, adding that they have to be "relevant for the public, but also for the public who is immunocompromised and disabled. And so, that — all of those considerations are taken into account as we work on our guidance."
Although the CDC currently recommends that vaccinated people continue to wear masks indoors if they are in a place with high or substantial COVID transmission — which includes most of the U.S. — federal officials have indicated this guidance may be updated soon.
"We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen," said Walensky during a Feb. 16 White House COVID briefing, when discussing whether CDC's COVID prevention policies would be altered soon.
But there's no mask break in sight for Dennis Boen, a 67-year-old retiree who has had three kidney transplants. Because his community of Wooster, Ohio, already lacks a mask mandate and few residents voluntarily wear masks, he hasn't felt comfortable returning to many of the social events that he enjoys.
"I quit going to my Rotary Club that I've been a part of for decades," Boen said. "I went once in the summer to a picnic outside and it was like the people who didn't believe [in COVID] or didn't care weren't wearing masks and they weren't giving me any space. Therefore, it was just easier to not go."
Charis Hill, a 35-year-old disability activist in Sacramento, California, has postponed two surgeries, a hysterectomy, and an umbilical hernia repair for over a year because Hill didn't feel safe. Delaying has meant Hill has had to take additional medications and eat only certain foods. The surgeries are scheduled for March 21, but now that California's mask mandate has lifted, Hill is thinking about delaying the procedures again.
"I feel disposable. As if my life doesn't have value," said Hill, who is living with axial spondyloarthritis, a chronic inflammatory disease, and takes immune-suppressing medication. "I am tired of constantly being told that I should just stay home and let the rest of the world move on."
Late one night in January, Jonathan Coffino, 78, turned to his wife as they sat in bed. "I don't know how much longer I can do this," he said, glumly.
Navigating Aging focuses on medical issues and advice associated with aging and end-of-life care, helping America's 45 million seniors and their families navigate the healthcare system.
Coffino was referring to the caution that's come to define his life during the COVID-19 pandemic. After two years of mostly staying at home and avoiding people, his patience is frayed and his distress is growing.
"There's a terrible fear that I'll never get back my normal life," Coffino told me, describing feelings he tries to keep at bay. "And there's an awful sense of purposelessness."
Despite recent signals that COVID's grip on the country may be easing, many older adults are struggling with persistent malaise, heightened by the spread of the highly contagious omicron variant. Even those who adapted well initially are saying their fortitude is waning or wearing thin.
Like younger people, they're beset by uncertainty about what the future may bring. But added to that is an especially painful feeling that opportunities that will never come again are being squandered, time is running out, and death is drawing ever nearer.
"Folks are becoming more anxious and angry and stressed and agitated because this has gone on for so long," said Katherine Cook, chief operating officer of Monadnock Family Services in Keene, New Hampshire, which operates a community mental health center that serves older adults.
"I've never seen so many people who say they're hopeless and have nothing to look forward to," said Henry Kimmel, a clinical psychologist in Sherman Oaks, California, who focuses on older adults.
Older adults have suffered more illness and death from COVID-19 than any other group. How are they faring as the pandemic enters its third year? KHN and The John A. Hartford Foundation will explore that question in depth in a 90-minute interactive web event beginning at Noon ET on Wednesday, Feb. 23.
To be sure, older adults have cause for concern. Throughout the pandemic, they've been at much higher risk of becoming seriously ill and dying than other age groups. Even seniors who are fully vaccinated and boosted remain vulnerable: More than two-thirds of vaccinated people hospitalized from June through September with breakthrough infections were 65 or older.
The constant stress of wondering "Am I going to be OK?" and "What's the future going to look like?" has been hard for Kathleen Tate, 74, a retired nurse in Mount Vernon, Washington. She has late-onset post-polio syndrome and severe osteoarthritis.
"I guess I had the expectation that once we were vaccinated the world would open up again," said Tate, who lives alone. Although that happened for a while last summer, she largely stopped going out as first the delta and then the omicron variants swept through her area. Now, she said she feels "a quiet desperation."
This isn't something that Tate talks about with friends, though she's hungry for human connection. "I see everybody dealing with extraordinary stresses in their lives, and I don't want to add to that by complaining or asking to be comforted," she said.
Tate described a feeling of "flatness" and "being worn out" that saps her motivation. "It's almost too much effort to reach out to people and try to pull myself out of that place," she said, admitting she's watching too much TV and drinking too much alcohol. "It's just like I want to mellow out and go numb, instead of bucking up and trying to pull myself together."
Beth Spencer, 73, a recently retired social worker who lives in Ann Arbor, Michigan, with her 90-year-old husband, is grappling with similar feelings during this typically challenging Midwestern winter. "The weather here is gray, the sky is gray, and my psyche is gray," she told me. "I typically am an upbeat person, but I'm struggling to stay motivated."
"I can't sort out whether what I'm going through is due to retirement or caregiver stress or COVID," Spencer said, explaining that her husband was recently diagnosed with congestive heart failure. "I find myself asking 'What's the meaning of my life right now?' and I don't have an answer."
Bonnie Olsen, a clinical psychologist at the University of Southern California's Keck School of Medicine, works extensively with older adults. "At the beginning of the pandemic, many older adults hunkered down and used a lifetime of coping skills to get through this," she said. "Now, as people face this current surge, it's as if their well of emotional reserves is being depleted."
Most at risk are older adults who are isolated and frail, who were vulnerable to depression and anxiety even before the pandemic, or who have suffered serious losses and acute grief. Watch for signs that they are withdrawing from social contact or shutting down emotionally, Olsen said. "When people start to avoid being in touch, then I become more worried," she said.
Fred Axelrod, 66, of Los Angeles, who's disabled by ankylosing spondylitis, a serious form of arthritis, lost three close friends during the pandemic: Two died of cancer and one of complications related to diabetes. "You can't go out and replace friends like that at my age," he told me.
Now, the only person Axelrod talks to on a regular basis is Kimmel, his therapist. "I don't do anything. There's nothing to do, nowhere to go," he complained. "There's a lot of times I feel I'm just letting the clock run out. You start thinking, 'How much more time do I have left?'"
"Older adults are thinking about mortality more than ever and asking, 'How will we ever get out of this nightmare,'" Kimmel said. "I tell them we all have to stay in the present moment and do our best to keep ourselves occupied and connect with other people."
Loss has also been a defining feature of the pandemic for Bud Carraway, 79, of Midvale, Utah, whose wife, Virginia, died a year ago. She was a stroke survivor who had chronic obstructive pulmonary disease and atrial fibrillation, an abnormal heartbeat. The couple, who met in the Marines, had been married 55 years.
"I became depressed. Anxiety kept me awake at night. I couldn't turn my mind off," Carraway told me. Those feelings and a sense of being trapped throughout the pandemic "brought me pretty far down," he said.
Help came from an eight-week grief support program offered online through the University of Utah. One of the assignments was to come up with a list of strategies for cultivating well-being, which Carraway keeps on his front door. Among the items listed: "Walk the mall. Eat with friends. Do some volunteer work. Join a bowling league. Go to a movie. Check out senior centers."
"I'd circle them as I accomplished each one of them. I knew I had to get up and get out and live again," Carraway said. "This program, it just made a world of difference."
Kathie Supiano, an associate professor at the University of Utah College of Nursing who oversees the COVID grief groups, said older adults' ability to bounce back from setbacks shouldn't be discounted. "This isn't their first rodeo. Many people remember polio and the AIDs epidemic. They've been through a lot and know how to put things in perspective."
Alissa Ballot, 66, realized recently she can trust herself to find a way forward. After becoming extremely isolated early in the pandemic, Ballot moved last November from Chicago to New York City. There, she found a community of new friends online at Central Synagogue in Manhattan and her loneliness evaporated as she began attending events in person.
With omicron's rise in December, Ballot briefly became fearful that she'd end up alone again. But, this time, something clicked as she pondered some of her rabbi's spiritual teachings.
"I felt paused on a precipice looking into the unknown and suddenly I thought, 'So, we don't know what's going to happen next, stop worrying.' And I relaxed. Now I'm like, this is a blip, and I'll get through it."
We're eager to hear from readers about questions you'd like answered, problems you've been having with your care and advice you need in dealing with the healthcare system. Visit khn.org/columnists to submit your requests or tips.
For a national look at Medicare penalties, read Jordan Rau's "Healthcare Paradox: Medicare Penalizes Dozens of Hospitals It Also Gives Five Stars"
This broadcast was released on Saturday, February 19, 2022 in Kaiser Health News.
Samantha Young, a political correspondent for California Healthline, on Feb. 15 discussed how Medi-Cal patients struggle to get their prescription drugs on KCRW's "Press Play."
Interim Southern bureau editor Andy Miller discussed Medicare penalties for hospitals in Georgia on Georgia Public Broadcasting's "Lawmakers" on Feb. 10.
For some counties and cities that share a public health agency with other local governments, differences over mask mandates, business restrictions, and other COVID preventive measures have strained those partnerships. At least two have been pushed past the breaking point.
A county in Colorado and a small city in Southern California are splitting from their longtime public health agencies to set up their own local departments. Both Douglas County, Colorado, and West Covina, California, plan to contract some of their health services to private entities.
In Douglas County, Colorado, which is just south of Denver and has one of the nation's highest median household incomes, many residents had opposed mask mandate guidance from the Tri-County Health Department, a partnership among Adams, Arapahoe, and Douglas counties. Tri-County issued a mask order for the counties' school districts in September 2021 and, within days, conservative Douglas County announced its commissioners had voted unanimously to form its own health department.
Douglas County, which in 1966 joined what was then called the Tri-County District Health Department, is phasing out of the partnership, with plans to exit entirely by the end of this year. It has already taken over many of its own COVID relief efforts from Tri-County.
It is contracting things like COVID case investigation, contact tracing, and isolation and quarantine guidance to a private consultant, Jogan Health Solutions, founded in early 2021. The contract is reportedly worth $1.5 million.
"We believe the greatest challenges are behind us … those associated with being one of three counties with differing and competing public health demands, on a limited budget," Douglas County spokesperson Wendy Manitta Holmes said in a statement.
Daniel Dietrich, Jogan Health's president, declined a request for an interview. "All of the data that Jogan Health is collecting is being relayed directly to Douglas County so that public policy aligns with real-time data to keep the residents of Douglas County safe," Jogan Health spokesperson Sam Shaheen said in a prepared statement.
A similar situation is playing out east of Los Angeles, in West Covina, California. Its City Council has voted to terminate its relationship with the Los Angeles County Department of Public Health over disagreements about COVID shutdowns.
West Covina officials have criticized the county health department's COVID restrictions as a one-size-fits-all approach that may work for the second-largest city in the U.S., but not their suburb of about 109,500 people. West Covina plans to join Long Beach, Pasadena, and Berkeley as one of a small number of California cities with its own health agency. A date for the separation has not been set.
As in Douglas County, West Covina plans to contract some services to a private consultant, Transtech Engineers, that works mainly on city engineering projects and federal contracts, according to its website. Transtech officials did not respond to requests for comment.
West Covina Councilman Tony Wu and area family physician Dr. Basil Vassantachart are leading efforts to form the city's own department. They hope L.A. County's oversight of about 10 million people — "bigger than some states," as Vassantachart noted — can be broken up into regional departments.
Amitabh Chandra, who directs health policy research at the Harvard Kennedy School of Government, said the private sector won't necessarily have better answers to a public health problem. "It might be the case that they're good at delivering on some parts of what needs to be done, but other parts still have to be done in-house," Chandra said.
Jeffrey Levi, a professor of health policy and management at the George Washington University, suggests there are too many local health departments in the U.S. and there should be more regionalization, rather than splitting into smaller departments.
"It's very hard to effectively spend money and build the foundational capabilities that are associated with a meaningful public health department," Levi said. "Doing this just because of anger at something like a mask ordinance is really unfortunate."
Levi noted that public health departments are responsible for everything from restaurant and septic system inspections to administering the Special Supplemental Nutrition Program for Women, Infants, and Children, or WIC, a federal food assistance program. If a department is not adequately resourced or prepared, residents could see lapses in food or water safety efforts in their community, Levi said.
"L.A. County Public Health Department is one of the most sophisticated, and one of the most robust health departments in the country," Levi said. "You are losing access to just a wide, wide range of both expertise and services that will never be replicable at the local level. Never."
"The public will be hurt in ways that are not instantly measurable," he added.
The most recent major private-sector takeover of public health was a flop. A private nonprofit, the Institute for Population Health, took over Detroit's public health functions in 2012 as the city was approaching bankruptcy.
The experiment failed, leaving a private entity unable to properly oversee public funding and public health concerns placed on the back burner amid the city's economic woes. Residents also didn't have a say in where the money went, and the staff on the city's side was stripped down and couldn't properly monitor the nonprofit's use of the funds. By 2015, most services transferred back to the city as Detroit emerged from bankruptcy in 2014.
"That private institute thought it was going to issue governmental orders until it was informed it had no power," said Denise Chrysler, who directs the Network for Public Health Law's Mid-States Region at the University of Michigan School of Public Health.
In Colorado, Tri-County's deputy director, Jennifer Ludwig, expressed concerns about Douglas County creating non-COVID programs essential to the functioning of a public health department.
"We have programs and services that many single-county health departments are not able to do just because of the resources that we can tap into," Ludwig said. "Building that from scratch is a huge feat and will take many, many, many years."
There are also practical benefits. A larger health department, according to Ludwig, is more competitive in securing grant funding, can attract and retain high-quality expertise like a data team, and can buy supplies in bulk.
But West Covina's Wu accepts that the city will not be able to build its department overnight. "You have to start small," he said.
Douglas County and West Covina face another key snag: hiring amid a national public health worker shortage. Douglas County officials say they are conducting a national search for an executive director who will determine the new health department's staffing needs.
The drug industry, patient advocates, and congressional Republicans have all attacked federal officials' decision to decline routine Medicare coverage for a controversial Alzheimer's drug. They've gone as far as to accuse them of tacit racism, ageism, and discrimination against the disabled — and hinted at a lawsuit — over the decision to pay only for patients taking the drug in a clinical trial.
The drug, Aduhelm, with a listed price tag of $28,500 a year, has had few takers in the medical world. Brain doctors are leery of administering the intravenous drug because it appears dangerous and largely ineffective. Many of the nation's most prestigious hospitals — such as the Cleveland Clinic, Johns Hopkins Hospital, and Massachusetts General in Boston — have declined to offer it to patients.
While groups representing the pharmaceutical industry and patients press to undo Medicare's decision, industry critics applaud the Centers for Medicare & Medicaid Services for throwing obstacles in the way of a drug they think the FDA should never have approved in the first place.
For the industry, the campaign has a broader existential target: to prevent CMS from using its payment decisions to keep FDA-approved drugs off the market. In recent years, FDA programs to speed approval of new drugs have led to a rash of entries with often minimal scientifically sound evidence to prove they work, critics say.
The FDA's own expert panel recommended against approving Aduhelm for that reason. Last June, the agency approved it anyway.
CMS then announced Medicare would pay only when the drug was used in further clinical trials to assess its true benefit. That Jan. 11 announcement has drawn more than 9,000 comments to the agency's website — a tsunami compared with most approval decisions. The remarks are roughly divided among pros and cons, and many appear to be organized by groups on the pro side of the debate (such as the Alzheimer's Association) or those opposed (such as the nonprofit More Perfect Union). The agency could change or even reverse its decision, though experts believe the latter is unlikely.
"If the FDA were doing its job, CMS wouldn't have had to step in. But good for the CMS, they are helping to protect the public from drugs whose harms outweigh benefits," said Dr. Adriane Fugh-Berman, a Georgetown University professor of pharmacology who directs PharmedOut, a group that publicizes what it sees as poor industry practices.
Aduhelm is the first FDA approval for a class of laboratory-made antibodies designed to clear away so-called amyloid plaques, which gradually accumulate in the brains of people with Alzheimer's disease.
In clinical trials, Aduhelm did well dissolving the plaques, but its impact on the functioning of patients in earlier stages of Alzheimer's was so meager that an expert panel voted 10-0 (an 11th panelist was uncertain) in November 2020 to advise FDA to reject it. The science is unclear about whether the presence of such plaques — a so-called surrogate marker — correlates with the mental functioning of patients.
As such, the FDA gave "provisional approval" to Biogen, the maker of Aduhelm, allowing it nine years to provide evidence that the drug slows the progression of Alzheimer's. In that period, Biogen would make far more money than if the application had been rejected. Even under the CMS decision, it would reap Medicare payments from whatever is used in clinical trials, which would need to include thousands of participants to assess the drug's performance.
Drug companies and pharma investors have responded to CMS' ruling with special alarm because they have spent decades improving their relationships with the FDA, only to have CMS seemingly pull the rug out by exerting its own power over an expensive drug.
"The drug companies are worried that this could be a precedent for other drugs. And it should be," Fugh-Berman said. "This isn't just about money; it's about protecting the public."
This "accelerated approval" employed for Aduhelm got its start in 1992 and is aimed at moving promising new classes of drugs to the public faster. Companies whose drugs go through the process — more than 250 drugs or vaccines have been approved so far — are supposed to quickly gather evidence that the products likely improve health once they're on the market. But such follow-up studies often lag or are never performed. For example, the makers of the Duchenne muscular dystrophy drug eteplirsen, approved in 2016, didn't start recruiting patients into a post-marketing trial until 2020 and don't expect results until 2026.
Biogen originally said it would get confirmatory results for Aduhelm within seven years of approval. In response to the Medicare decision, it promised to trim that to four years. The company also hinted that it might sue the agency, calling its decision "arbitrary and capricious."
In the meantime, patients eager to get access to the drug are furious about the coverage decision. Jim Taylor, a New Yorker whose wife, Geri, says she improved on Aduhelm during a clinical trial, said Medicare had made an "unconscionable decision" that puts Alzheimer's patients "on a dark roller coaster."
Many patients' groups are organized or at least funded and fueled by drugmakers, providing sympathetic stories that buttress a manufacturer's commercial interests. Advocacy groups also receive large donations from the makers of certain drugs. A 2020 report by UsAgainstAlzheimer's shows at least $900,000 in donations from monoclonal antibody producers. The Alzheimer's Association's top corporate donors — Biogen, Lilly, Eisai, and Genentech — all have monoclonal antibody candidates and have provided the group $1.6 million in fiscal year 2021.
These donations are a tiny part of the group's funding, its policy director, Robert Egge, told KHN, and any alignment of its position with industry is "coincidental, because of what we and our constituents believe is right."
The Taylors appeared at an online news event with activists from UsAgainstAlzheimer's and the National Minority Quality Forum, a group focused on health inequities, who argued that the decision discriminated against Black and Hispanic patients, who are more likely to suffer from Alzheimer's and less likely to join clinical trials. In fact, CMS demanded that evidence for Aduhelm be collected more extensively from minority patients. Biogen's two major trials of the drug included only 19 Black patients out of a total of 3,285.
Groups representing people with Down syndrome wrote more than 1,000 letters to CMS because its decision requires that confirmatory trials exclude people who have additional neurological conditions. Rep. Cathy McMorris Rodgers, a top drug industry cash recipient and the leading Republican on the House Energy and Commerce Committee with significant sway over pharma issues, said at a hearing last week that it was "extremely concerning and unacceptable" that Down syndrome patients would be ineligible.
But neither Biogen nor any other drug company has recruited Down syndrome patients for a major trial of a monoclonal antibody treatment. AC Immune, a Swiss company, conducted a safety study last year on 16 people with Down syndrome.
It's not surprising that groups representing those suffering from Alzheimer's placed high hopes on the monoclonal antibody drugs, which have seemed like a ray in the darkness for the estimated 2 million Americans with early Alzheimer's symptoms.
When asked why his group is so gung-ho about a product in which the medical profession shows such little confidence, Egge said the drug seems to have some benefits and that its risks — especially to patients who lack other means to slow a miserable, deadly disease — may be exaggerated. He acknowledged that 40% of patients in the biggest Aduhelm trial experienced brain swelling or bleeding, but Biogen's research showed these resolved with no apparent harm in most cases.
That said, the sluggish purchases of the drug — which earned a modest $1 million in the last quarter of 2021 — signal the market is responding to its deficiencies.
In response to the lackluster response, Biogen halved its initial $56,000 price to $28,500. If CMS had granted full approval, that would have been followed by "marketing, marketing, marketing," said Dr. Joseph Ross, a public health professor at Yale University. Hospitals that wanted to attract patient business for a lucrative infusion — patients receiving the drug also require brain scans and other tests and monitoring — could advertise their willingness to give Aduhelm.
The agency's decision "is a little inelegant" because it puts the brakes on an FDA approval, said former CMS chief medical officer Dr. Sean Tunis, now a consultant and senior fellow at Tufts Medical Center, but "it seems completely justifiable since the evidence of benefit is pretty weak and the evidence of harm is pretty strong."
Before any Tennessee physicians could be reprimanded for spreading falsehoods about COVID-19 vaccines or treatments, Republican lawmakers threatened to disband the medical board.
This article was published on Tuesday, February 15, 2022 inKaiser Health News.
Tennessee's Board of Medical Examiners unanimously adopted in September a statement that said doctors spreading COVID misinformation — such as suggesting that vaccines contain microchips — could jeopardize their license to practice.
"I'm very glad that we're taking this step," Dr. Stephen Loyd, the panel's vice president, said at the time. "If you're spreading this willful misinformation, for me it's going to be really hard to do anything other than put you on probation or take your license for a year. There has to be a message sent for this. It's not OK."
The board's statement was posted on a government website.
But before any physicians could be reprimanded for spreading falsehoods about COVID-19 vaccines or treatments, Republican lawmakers threatened to disband the medical board.
The growing tension in Tennessee between conservative lawmakers and the state's medical board may be the most prominent example in the country. But the Federation of State Medical Boards, which created the language adopted by at least 15 state boards, is tracking legislation introduced by Republicans in at least 14 states that would restrict a medical board's authority to discipline doctors for their advice on COVID.
Dr. Humayun Chaudhry, the federation's CEO, called it "an unwelcome trend." The nonprofit association, based in Euless, Texas, says the statement is merely a COVID-specific restatement of an existing rule: that doctors who engage in behavior that puts patients at risk could face disciplinary action.
Although doctors have leeway to decide which treatments to provide, the medical boards that oversee them have broad authority over licensing. Often, doctors are investigated for violating guidelines on prescribing high-powered drugs. But physicians are sometimes punished for other "unprofessional conduct." In 2013, Tennessee's board fined U.S. Rep. Scott DesJarlais for separately having sexual relations with two female patients more than a decade earlier.
Still, stopping doctors from sharing unsound medical advice has proved challenging. Even defining misinformation has been difficult. And during the pandemic, resistance from some state legislatures is complicating the effort.
A relatively small group of physicians peddle COVID misinformation, but many of them associate with America's Frontline Doctors. Its founder, Dr. Simone Gold, has claimed patients are dying from COVID treatments, not the virus itself. Dr. Sherri Tenpenny said in a legislative hearing in Ohio that the COVID vaccine could magnetize patients. Dr. Stella Immanuel has pushed hydroxychloroquine as a COVID cure in Texas, although clinical trials showed that it had no benefit. None of them agreed to requests for comment.
The Texas Medical Board fined Immanuel $500 for not informing a patient of the risks associated with using hydroxychloroquine as an off-label COVID treatment.
In Tennessee, state lawmakers called a special legislative session in October to address COVID restrictions, and Republican Gov. Bill Lee signed a sweeping package of bills that push back against pandemic rules. One included language directed at the medical board's recent COVID policy statement, making it more difficult for the panel to investigate complaints about physicians' advice on COVID vaccines or treatments.
In November, Republican state Rep. John Ragan sent the medical board a letter demanding that the statement be deleted from the state's website. Ragan leads a legislative panel that had raised the prospect of defunding the state's health department over its promotion of COVID vaccines to teens.
Among his demands, Ragan listed 20 questions he wanted the medical board to answer in writing, including why the misinformation "policy" was proposed nearly two years into the pandemic, which scholars would determine what constitutes misinformation, and how was the "policy" not an infringement on the doctor-patient relationship.
"If you fail to act promptly, your organization will be required to appear before the Joint Government Operations Committee to explain your inaction," Ragan wrote in the letter, obtained by KHN and Nashville Public Radio.
In response to a request for comment, Ragan said that "any executive agency, including Board of Medical Examiners, that refuses to follow the law is subject to dissolution."
He set a deadline of Dec. 7.
In Florida, a Republican-sponsored bill making its way through the state legislature proposes to ban medical boards from revoking or threatening to revoke doctors' licenses for what they say unless "direct physical harm" of a patient occurred. If the publicized complaint can't be proved, the board could owe a doctor up to $1.5 million in damages.
Although Florida's medical board has not adopted the Federation of State Medical Boards' COVID misinformation statement, the panel has considered misinformation complaints against physicians, including the state's surgeon general, Dr. Joseph Ladapo.
Chaudhry said he's surprised just how many COVID-related complaints are being filed across the country. Often, boards do not publicize investigations before a violation of ethics or standards is confirmed. But in response to a survey by the federation in late 2021, two-thirds of state boards reported an increase in misinformation complaints. And the federation said 12 boards had taken action against a licensed physician.
"At the end of the day, if a physician who is licensed engages in activity that causes harm, the state medical boards are the ones that historically have been set up to look into the situation and make a judgment about what happened or didn't happen," Chaudhry said. "And if you start to chip away at that, it becomes a slippery slope."
The Georgia Composite Medical Board adopted a version of the federation's misinformation guidance in early November and has been receiving 10 to 20 complaints each month, said Dr. Debi Dalton, the chairperson. Two months in, no one had been sanctioned.
Dalton said that even putting out a misinformation policy leaves some "gray" area. Generally, physicians are expected to follow the "consensus," rather than "the newest information that pops up on social media," she said.
"We expect physicians to think ethically, professionally, and with the safety of patients in mind," Dalton said.
A few physician groups are resisting attempts to root out misinformation, including the Association of American Physicians and Surgeons, known for its stands against government regulation.
Some medical boards have opted against taking a public stand against misinformation.
The Alabama Board of Medical Examiners discussed signing on to the federation's statement, according to the minutes from an October meeting. But after debating the potential legal ramifications in a private executive session, the board opted not to act.
In Tennessee, the Board of Medical Examiners met on the day Ragan had set as the deadline and voted to remove the misinformation statement from its website to avoid being called into a legislative hearing. But then, in late January, the board decided to stick with the policy — although it did not republish the statement online immediately — and more specifically defined misinformation, calling it "content that is false, inaccurate or misleading, even if spread unintentionally."
Board members acknowledged they would likely get more pushback from lawmakers but said they wanted to protect their profession from interference.
"Doctors who are putting forth good evidence-based medicine deserve the protection of this board so they can actually say, 'Hey, I'm in line with this guideline, and this is a source of truth,'" said Dr. Melanie Blake, the board's president. "We should be a source of truth."
The medical board was looking into nearly 30 open complaints related to COVID when its misinformation statement came down from its website. As of early February, no Tennessee physician had faced disciplinary action.
The four free COVID-19 rapid tests President Joe Biden promised in December for every American household have begun arriving in earnest in mailboxes and on doorsteps.
A surge of COVID infections spurred wide demand for over-the-counter antigen tests during the holidays: Clinics were overwhelmed with people seeking tests and the few off-the-shelf brands were nearly impossible to find at pharmacies or even online via Amazon. Prices for some test kits cracked the hundred-dollar mark. And the government vowed that its purchase could provide the tests faster and cheaper so people, by simply swabbing at home, could quell the spread of COVID.
The Defense Department organized the bidding and announced in mid-January, after a limited competitive process, that three companies were awarded contracts totaling nearly $2 billion for 380 million over-the-counter antigen tests, all to be delivered by March 14.
The much-touted purchase was the latest tranche in trillions of dollars in public spending in response to the pandemic. How much is the government paying for each test? And what were the terms of the agreements? The government won't yet say, even though, by law, this information should be available.
The cost — and, more importantly, the rate per test — would help demonstrate who is getting the best deal for protection in these COVID times: the consumer or the corporation.
The reluctance to share pricing details flies against basic notions of cost control and accountability — and that's just quoting from a long-held position by the Justice Department. "The prices in government contracts should not be secret," according to its website. "Government contracts are 'public contracts,' and the taxpayers have a right to know — with very few exceptions —what the government has agreed to buy and at what prices."
Americans often pay far more than people in other developed countries for tests, drugs, and medical devices, and the pandemic has accentuated those differences. Governments abroad had been buying rapid tests in bulk for over a year, and many national health services distributed free or low-cost tests, for less than $1, to their residents. In the U.S., retailers, companies, schools, hospitals, and everyday shoppers were competing months later to buy swabs in hopes of returning to normalcy. The retail price climbed as high as $25 for a single test in some pharmacies; tales abounded of corporate and wealthy customers hoarding tests for work or holiday use.
"We don't know why that data isn't showing up in the FPDS database, as it should be visible and searchable. Army Contracting Command is looking into the issue and working to remedy it as quickly as possible," spokesperson Jessica R. Maxwell said in an email in January. This month, she declined to provide more information about the contracts and referred all questions about the pricing to the Department of Health and Human Services.
Only vague information is available in DOD press releases, dated Jan. 13 and Jan. 14, that note the overall awards in the fixed-price contracts: iHealth Labs for $1.275 billion, Roche Diagnostics for $340 million, and Abbott Rapid Dx North America for $306 million. There were no specifics regarding contract standards or terms of completion — including how many test kits would be provided by each company.
Without knowing the price or how many tests each company agreed to supply, it is impossible to determine whether the U.S. government overpaid or to calculate if more tests could have been provided faster. As variants of the deadly virus continue to emerge, it is unclear if the government will re-up these contracts and under what terms.
To put forth a bid to fill an "urgent" national need, companies had to provide answers to the Defense Department by Dec. 24 about their capacity to scale up manufacturing to produce 500,000 or more tests a week in three months. Among the questions: Had a company already been granted "emergency use authorization" for the test kits, and did a company have "fully manufactured unallocated stock on hand to ship within two weeks of a contract award?"
Based on responses from about 60 companies, the Defense Department said it sent "requests for proposals" directly to the manufacturers. Twenty companies bid. Defense would not release the names of interested companies.
Emails to the three chosen companies to query the terms of the contracts went unanswered by iHealth and Abbott. Roche spokesperson Michelle A. Johnson responded in an email that she was "unable to provide that information to you. We do not share customer contract information." The customers — listed as the Defense Department and the Army command — did not provide answers about the contract terms.
The Army's Contracting Command, based in Alabama, initially could not be reached to answer questions. An email address on the command's website for media bounced back as out-of-date. Six phone numbers listed on the command's website for public information were unmanned in late January. At the command's protocol office, the person who answered a phone in late January referred all queries to the Aberdeen Proving Ground offices in Maryland.
"Unfortunately, there is an issue with voicemail," said Ralph Williams, a representative of the protocol office. "Voicemail is down. I mean, voicemail has been down for months."
Asked about the bounced email traffic, Williams said he was surprised the address — acc.pao@us.army.mil — was listed on the ACC website. "I'm not sure when that email was last used," he said. "The army stopped using the email address about eight years ago."
Williams provided a direct phone number for Aberdeen and apologized for the confusion. "People should have their phone forwarded," he said. "But I can only do what I can do."
Joyce Cobb, an Army Contracting Command-Aberdeen Proving Ground spokesperson, reached via phone and email, referred all questions to Defense personnel. Maxwell referred more detailed questions about the contracts to HHS, and emails to HHS went unanswered.
Both the Defense and Army spokespeople, after several emails, said the contracts would have to be reviewed, citing the Freedom of Information Act that protects privacy, before release. Neither explained how knowing the price per test could be a privacy or proprietary concern.
A Defense spokesperson added that the contracts had been fast-tracked "due to the urgent and compelling need" for antigen tests. Defense obtained "approval from the Assistant Secretary of the Army for Acquisition, Logistics, & Technology to contract without providing for full and open competition."
KHN separately searched for the contracts on the sam.gov website during a phone call with a government representative who assisted with the search. During an extended phone session, the representative called in a supervisor. Neither could locate the contracts, which are updated twice a week. The representative wondered whether the numbers listed in the Defense press release were wrong and offered: "You might want to double-check that."
On Jan. 25, Defense spokesperson Maxwell, in an email, said that the Army Contracting Command "is working to prepare these contracts for public release and part of that includes proactively readying the contracts for the FOIA redaction." Three days later, she sent an email stating that "under the limited competition authority … DOD was not required to make the Request for Proposal (RFP) available to the public."
Maxwell did not respond when KHN pointed out that the contracting provision she cited does not prohibit the release of such information. In a Feb. 2 email, Maxwell said "we have nothing further to provide at this time."
On sam.gov, the COVID spreadsheets include a disclaimer that "due to the tempo of operations" in the pandemic response, the database shows only "a portion of the work that has been awarded to date."
In other words, it could not vouch for the timeliness or accuracy of its own database.
With studies showing that the fees led to fewer low-income adults signing up for coverage and fewer reenrolling, the Biden administration is moving to eliminate them.
This article was published on Thursday, February 10, 2022 in Kaiser Health News.
When Republican-led states balked at expanding Medicaid under the Affordable Care Act, President Barack Obama's administration tossed them a carrot — allowing several to charge monthly premiums to newly eligible enrollees.
Republicans pushed for the fees to give Medicaid recipients "skin in the game" — the idea they would value their coverage more — and to make the government program resemble employer-based insurance.
It will force Arkansas and Montana to phase out premiums by the end of 2022. Federal health officials have indicated they may do the same in six other states allowed to charge premiums — Arizona, Georgia, Indiana, Iowa, Michigan, and Wisconsin.
The policy flip is one of several moves the administration has made to change how states run their Medicaid programs, and it provides a stark example of how Medicaid changes depending on who has control of the White House and state capitols.
Medicaid, which has about 83 million enrollees, is a state-federal partnership that provides health coverage to people with low incomes. Washington is responsible for most of the funding and states handle operations. For decades, states have complained that the federal government sets too many rules and doesn't respond quickly enough when states want to make changes through a wide variety of waivers to improve care or control costs.
But in recent months, the power struggle has intensified around the waivers that states seek from those federal rules so they can test new approaches for delivering health services. Waivers have become an integral part of the Medicaid program, and some states have renewed theirs to last for decades.
With spending on Medicaid waivers now making up about a third of federal spending on the program, they've become a lightning rod for disputes between states and the federal government.
Such conflicts are not new, said Matthew Lawrence, an associate professor at Emory University's law school. But lately "the level of conflict is unprecedented."
"The conflicts are more consequential because there is so much more money on the table," said Josh Archambault, a senior fellow with the conservative Cicero Institute, a Texas-based think tank.
At stake for states is not merely retaining authority on how to run their Medicaid program, but often billions of dollars in federal funding. Because securing a waiver can often take years, states are dismayed the Biden administration is trying to withdraw previously approved ones before they are up for renewal, Archambault said.
Both Georgia and Texas have sued the Biden administration for revoking part of their waivers approved in the waning days of President Donald Trump's administration. The changes sought be each state varied widely.
Neither of these Republican-led states has expanded Medicaid to cover all adults with annual incomes under 138% of the federal poverty level, about $18,800, as 38 other states have done.
Georgia sued the Biden administration in January after the Centers for Medicare & Medicaid Services rejected key parts of its waiver — approved in October 2020 but never implemented by the state as it awaited a review by the Biden administration.
These provisions would have required newly eligible enrollees to pay a monthly premium and work or volunteer as part of a plan to modestly increase enrollment.
The lawsuit says the decision by CMS was an illegal and arbitrary "bait and switch of unprecedented magnitude."
The Texas lawsuit filed in May stems from the Biden administration's reversal of a 10-year waiver extension approved five days before Joe Biden was sworn in as president. That waiver allowed the Texas Medicaid program to reimburse hospitals for treating uninsured patients and included $30 billion in federal aid. The Biden administration said Texas did not appropriately seek public comments and the move was seen as a way to nudge Texas toward expanding Medicaid. A federal district judge in August sided with Texas and issued a temporary injunction.
In another example of reversing Trump's policies, CMS last year told Michigan, Wisconsin, Arkansas, and New Hampshire, which had previously received approval for work requirements for newly eligible adults, that the federal government was withdrawing that green light. The change, however, had little practical effect since the work requirements had been put on hold by federal courts.
Advocacy groups say Medicaid enrollees are caught in the middle of these political battles.
Laura Colbert, executive director of the consumer advocacy group Georgians for a Healthy Future, said the lawsuit brought by the governor and state attorney general is a waste of time and taxpayer dollars. "Federal courts have repeatedly struck down work requirements for Medicaid-eligible adults because work requirements ultimately act as a barrier to health coverage and care," she said.
Typically, CMS reserves the right to terminate or rescind a waiver as long as its decision is not considered "arbitrary or unreasonable," said MaryBeth Musumeci, associate director of KFF's Program on Medicaid and the Uninsured.
In the Texas case, in fact, the federal court said CMS was arbitrary and unreasonable in revoking the state's Medicaid waiver.
Brian Blase, a former Trump health adviser and president of Paragon Health Institute, a research firm, said having so much of the Medicaid program run through waivers is problematic because states are seldom held accountable for how the waivers work and that the program changes depending on which party is in power in Washington.
"States get whipsawed back and forth under the current structure of Medicaid," he said.
Blase and other conservatives want Congress to give states a defined amount of money — a block grant — for Medicaid each year and let states manage it as they see fit. Democrats have fought such proposals, saying they would limit how much money states have to help the poor, especially during difficult economic times.
The proposal to fund Medicaid through block grants is at the center of another simmering waiver feud. The Trump administration in its final days approved a new financing plan for Tennessee that would convert the state's federal Medicaid funding into a type of block grant. The Biden administration reopened the public comment period last summer. Nearly all of the 3,000 letters submitted opposed the plan.
Blase said that some Republican states expanded Medicaid only because they were allowed to implement it with work requirements and premiums. Taking away those provisions, he said, "is an affront to those states and will discourage other states from adopting the expansion."
But it's unlikely Republican-led states would turn away from the expansions they've implemented because it's politically difficult to kick people off the program.
Democrats have long opposed Medicaid premiums, so it's no surprise the Biden administration is moving away from them now that it has data to show their negative impact.
A 2021 study in Michigan found that the number of adults dropping out of Medicaid increased by nearly 12% after the state began charging them a monthly premium, which now averages about $18 a month. Disenrollment rose by nearly 1 percentage point for every dollar charged monthly, the study found.
States needed waivers because federal law prohibits charging premiums to most Medicaid enrollees.
Katharine Bradley, a senior researcher at Mathematica who recently helped evaluate premium policies in several Medicaid programs for CMS, said premiums as low as $1 a month act as a deterrent to signing up, she said.
"All the evidence points in the same direction — that premiums inhibit overall enrollment," Bradley said.
Michigan — like other states with premiums — stopped enforcing the provision during the pandemic. But even before the national health emergency, Michigan enrollees faced few consequences for not paying. If people did not pay, the state would deduct the amount from their state tax refund or any lottery winnings.
By contrast, before the pandemic, states such as Indiana, Iowa, and Montana disenrolled thousands of Medicaid enrollees who did not pay.
When asked late last year if CMS would eliminate premiums in all Medicaid waivers, CMS Administrator Chiquita Brooks-LaSure said: "We want our programs to be consistent."
By understanding hantavirus and the complex ecology that governs it, researchers hope to create a model system to better understand the ecology of other viruses, including coronaviruses.
This article was published on Thursday, February 10, 2022 in Kaiser Health News.
For the past 20 years, Amy Kuenzi has spent three days of every month traveling to a ranch near Gregson, Montana, and setting out traps that contain peanut butter and oats. Her quarry is deer mice. She takes blood samples, looks for scars and fleas, and attaches ear tags.
"Mice are fairly trap happy and easy to catch," she said. "But it can be kind of a miserable job in the winter."
Kuenzi's goal is to better understand how a type of hantavirus called Sin Nombre spreads through these mouse populations.
Kuenzi, a professor of biology at Montana Technological University, and her colleague Angie Luis, a professor of biology at the University of Montana, are among a growing number of researchers working to predict where viruses may be likely to spill over from animals to humans. Sixty percent of human diseases, including the Sin Nombre hantavirus, originate in animals, and two-thirds of those originate in wildlife.
By understanding hantavirus and the complex ecology that governs it, Kuenzi and Luis also hope to create a model system to better understand the ecology of many other viruses, including coronaviruses.
The researchers have built six large enclosures at the Bandy Ranch, a University of Montana research facility. There, they can study how deer mice behave when they're the sole occupants and then introduce the mice's main rodent competitors, voles, to see how mouse populations, mouse behavior, and disease prevalence change.
"We're asking how competitors affect the transmission of disease," Luis said of the research, recently funded with a $2.5 million National Science Foundation grant. "We are trying to understand that as we stress animals, as we add or remove competitors, how does that change the transmission?"
The role of biodiversity in zoonotic diseases is complex and can have both positive and negative effects. For example, competition from other rodents can lower deer mice numbers and reduce how often the mice interact, limiting infections. At the same time, the presence of more competitors can stress deer mice, and stress in animals has been shown to lower their immunity and greatly increase their viral load.
Climate change is also a factor. Warmer temperatures and fluctuations in rain and snow are changing habitats, which can affect infection rates. The first recognized outbreak of hantavirus in humans, in 1993, is thought to have been driven by a wet winter that provided more food for mice.
The Montana study area has only two main rodents, making it a simple system for carrying out research. Kuenzi and Luis are also gathering data in the Southwest, where Sin Nombre is far more prevalent — and complicated. "At one site in Arizona, we caught 29 species of rodent-sized small mammals," Kuenzi said. The larger number of species appears to decrease the prevalence of the disease, Luis said.
Sin Nombre, Spanish for "without a name," is one of several types of hantavirus. It is transmitted through the inhalation of airborne particles from mouse droppings. The disease is rare in humans but can be deadly. In 1993, the first known outbreak was on the Navajo Nation in the Southwest. It killed 13 people, half of those it infected.
The disease is most prevalent in rural areas, where mice and other rodents are common, and public health officials urge people to take special care when cleaning homes or buildings that have been closed for the winter or when working in areas like crawl spaces or vacant buildings where rodents may be present.
In 2012, Sin Nombre in tent cabins in Yosemite National Park killed three people. In 2004, the deputy superintendent of Glacier National Park died from the disease. From Sin Nombre's discovery in 1993 through 2019, fewer than 900 infections were reported in the U.S.
The hope for the research in Montana is that it will lead to recommendations on how to manage land in ways that don't increase the prevalence of the disease.
This is just one thread in the tapestry of disease ecology. The long list of factors that increase the possibility that pathogens will spill over from animals to humans is getting a lot of attention from researchers around the world in response to the pandemic caused by SARS-CoV-2. Viral outbreaks are a product of the ways that humans are altering the natural world, though researchers are seeking to determine precisely how.
In the big picture, research from the past 20 years shows that keeping nature intact will help minimize the risk of another pandemic. "Evidence is mounting that biodiversity dilutes out disease," Luis said. "As we lose biodiversity, we see greater disease prevalence."
When animals can move to find food when they need to and avoid humans and domestic animals, "we are not going to see spillover events," said Raina Plowright, a professor at Montana State University, who studies the disease ecology of bats.
Activities that bring people into contact with wildlife — such as farming, logging, and building homes in wild areas, all of which change the ecosystem — may amplify the risk of spillover.
It could, for example, drive the competitors of deer mice out completely. "Deer mice like disturbance," Luis said. As land is developed, species that compete with deer mice may scatter, and without competitors, deer mice increase in number. With more mice come more encounters between them and the spread of Sin Nombre.
Early studies of biodiversity and disease took place in upstate New York, where the fragmentation of forest habitat by development had led to the loss of foxes, owls, hawks, and other predators. Those changes drove a five-fold surge in the number of white-footed mice, which are potent reservoirs for the bacteria that cause Lyme disease.
But the idea that biodiversity has protective effects is more complicated than first thought. "There are lots of exceptions to this idea that biodiversity dilutes out disease," Luis said. "You can get both positive and negative effects of biodiversity at the same time. There is an overall dilution effect because competitors lower the density of deer mice," she said, but there might be amplification from stress caused by competitors.
Kevin Lafferty is an ecologist with the U.S. Geological Survey's Western Ecological Research Center in Santa Barbara, California, and studies the ecology of parasites. Focusing on the ecology of mice and hantavirus makes sense, he said: "If wild rodents … are going to become more abundant because we disturb the environment, then those particular diseases might be the kind of things we should worry about."
However, the broad notion of protecting biodiversity to prevent disease is "wishful thinking," he said. "That's a vague and ineffective way to solve human health problems," Lafferty said. Instead, he added, researchers should focus on how the viruses' hosts respond to the environment.
Luis agreed that more work needs to be done on a complicated topic. "Outbreaks that are moving from animals to humans have only become more common over the last 30 to 40 years," Luis said. "This is not the last pandemic. We need to understand how what we are doing leads to these outbreaks."
SACRAMENTO, Calif. — A month into its debut, California's new Medicaid prescription drug program is riddled with problems, leaving thousands of patients without medications — often after languishing on hold for up to eight hours on call center phone lines.
On Jan. 1, the state handed control of its Medicaid drug program, known as Medi-Cal Rx, to Magellan Health, which is administering prescription drug coverage for California's 14 million Medicaid patients, most of whom previously got their medications from about two dozen managed-care plans.
But Magellan has tripped up implementation. It didn't anticipate that calls to its help center would take so long, and a large number of its call center workers have been sickened during the omicron surge — with 100 of 220 absent during the first two weeks of January, state officials said. Magellan also didn't get some data it needed from managed-care plans.
This has left Californians from Redding to Oceanside without their medications for days, sometimes weeks.
"We've had many, many patients who are sort of in this limbo," said Dr. James Schultz, chief medical officer of Neighborhood Healthcare, which operates 17 clinics in Riverside and San Diego counties.
"Somebody is gonna die if they haven't already," added Schultz, who said some of his clinics' patients have experienced delays getting life-saving medications such as antibiotics or those used to prevent seizures and blood clots. "That's why we're fighting so hard."
Officials from the California Department of Healthcare Services, which administers Medi-Cal, California's Medicaid program for low-income people, called the problems "unacceptable." The department and Magellan Health are scrambling to find missing patient data, fix improper claim denials, add call center staffers, and provide pharmacists with codes to override prescription denials.
Handing over Medi-Cal's drug program to a single pharmacy benefit manager is one of Gov. Gavin Newsom's big healthcare initiatives. His administration estimates it will save the state $414 million in the 2022-23 budget year alone, in part by getting bigger discounts on drugs than the managed-care insurance plans did.
But the massive transfer has been rocky for many providers, pharmacists, and patients, especially patients who use medications their doctors consider medically necessary but require prior authorizations from Medi-Cal Rx and are generally not on the state's approved drug list. Magellan has received more than 95,000 prior authorization requests since it took over, state officials said.
In the months leading up to the switch, patients and doctors were told all their medications would be grandfathered into the new system for 180 days, but that hasn't always been the case.
Marilyn Bloomer of Oceanside had gone nearly a week without a specialty histamine prescription that she takes to regulate an overactive allergic response in her body, a condition known as mast cell activation syndrome, because her pharmacist and Magellan said it was no longer covered. When she finally reached someone at the Magellan call center last week — six hours after she placed the call — a supervisor gave her a code the pharmacist could use to override the denial.
But the pharmacy wouldn't accept it.
On Monday, Bloomer's health plan secured an emergency five-day supply for her, but she doesn't know what will happen when it runs out. Without the medication, called ketotifen, Bloomer gets bright red, patchy hives all over her face.
"I'm getting the runaround, and I'm getting confused," said Bloomer, 57, who said her face had been beginning to swell. "It's beyond frustrating."
State officials said Magellan representatives had answered more than 81,000 calls at the 24-hour, 7-day-a-week call center as of Feb. 1 and paid 11 million prescription claims totaling approximately $1.3 billion as of Feb. 4.
"As we sit here, clearly five weeks into operations, Magellan, our contractor, has really struggled with some service operations," Jacey Cooper, the state's Medicaid director, told lawmakers at an Assembly budget subcommittee hearing Monday.
She said that the Department of Healthcare Services is holding daily meetings with Magellan to discuss its management of the program and that the state has provided staffers to help answer calls at the Medi-Cal Rx call center. The immediate goal, Cooper added, is to ensure medications that require prior authorization are approved within 24 hours. In the meantime, she said, the state has given pharmacies the go-ahead to fill emergency prescriptions for up to two weeks. It also has removed prior authorization requirements for some medications.
Magellan referred media questions to the Department of Healthcare Services.
After the hearing, Assembly member Joaquin Arambula (D-Fresno), who chairs the Assembly budget subcommittee that oversees Medi-Cal, said he is satisfied with the administration's plan. "I believe there's a real path forward to implementing the system successfully," he told KHN.
Sharon Ng, pharmacy director at the Venice Family Clinic, isn't as optimistic. Even though state officials say they have given pharmacies authorization to use override codes and fill temporary emergency prescriptions, prescriptions continue to be denied.
"It's just chaos," Ng said. "We just kept getting rejections. It's been so frustrating because the rejection doesn't tell you what's wrong. And then if you finally go through their lines, they don't help you either. They're just guessing."
What Magellan needs, she added, is a dedicated hotline for pharmacists — like the managed-care plans had — so they don't have to compete with Medi-Cal patients.
Patients and legal advocates say they are confounded by the chaos because both the state and Magellan had plenty of time to prepare for the rollout, since the program was delayed by nearly a year after the healthcare company Centene announced plans to acquire Magellan.
Medi-Cal Rx finally launched Jan. 1 after state officials ruled in December that Magellan could independently administer the Medi-Cal drug benefit without any conflict of interest with its new owner.
"Magellan should have come into this understanding fully what the volume and the needs were going to be," said Jack Dailey, an attorney with the Legal Aid Society of San Diego, which is representing some Medi-Cal enrollees unable to get their medication. "I did not think this is where we would be a month into this process."
Shah'ada, a mother in Redding, has spent the past two weeks desperately trying to get her 16-year-old son's birth control medication approved. He is transgender and hadn't had a period in five years until last week, she said. Without the birth control, he bled for 11 days.
"Things in our household have started dissolving," said Shah'ada, who asked that her last name not be published to protect her son's privacy. "He's been depressed, unable to go to school for several days, really high anxiety. It's just very emotional and frustrating."
When Shah'ada tried to fill the prescription, the pharmacist told her that it was denied because of her son's gender.
She dialed the prescription call center every chance she got. Her managed-care plan suggested there was a glitch in the system but didn't know how to help since it no longer controls prescription drugs for its members. Her son's doctor tried to submit more paperwork to no avail, and she submitted a grievance to Medi-Cal Rx.
Over the weekend, she finally got approval for her son's birth control, but she's worried about refilling the prescription in three months.
Schultz, the San Diego County physician, said his staff is also directed to the call center to ask questions when patients are denied medications. But the appeal form they are asked to fill out is incomplete, he said, lacking a section for the previous medications a patient has tried, for instance, information Medi-Cal Rx requires for approval.
"We've got people out with COVID. We really don't have time to sit on hold for eight hours. We have dozens of patients in the same boat," Schultz said. "Theoretically, all of our staff could be tied up on hold with Magellan. We can't do it."