4 Vital Health Issues — Not Tied to Covid — That Congress Addressed in Massive Spending Bill

KFF Health News, January 28, 2021

While the $900 billion that lawmakers included for urgent pandemic relief got most of the attention, some even bigger changes for healthcare were buried in the other parts of that huge legislative package.

This article was published on Thursday, January 28, 2021 in Kaiser Health News.

By Emmarie Huetteman  Late last month, before President Joe Biden took office and proposed his pandemic relief plan, Congress passed a nearly 5,600-page legislative package that provided some pandemic relief along with its more general allocations to fund the government in 2021.

While the $900 billion that lawmakers included for urgent pandemic relief got most of the attention, some even bigger changes for healthcare were buried in the other parts of that huge legislative package.

The bundle included a ban on surprise medical bills, for example — a problem that key lawmakers had been wrestling with for two years. Starting in 2022, because of the new law, patients generally will not pay more for out-of-network care in emergencies and at otherwise in-network facilities.

But surprise bills weren't the only healthcare issue Congress addressed as it ended a tumultuous year. Lawmakers also answered pleas from strained health facilities in rural areas, agreed to cover the cost of training more new doctors, sought to strengthen efforts to equalize mental health coverage with that of physical medicine and instructed the federal government to collect data that could be used to rein in high medical bills.

Here are some details about those big changes Congress made in December.

Rural Hospitals Get a Boost

Throwing a lifeline to struggling rural health systems — and, it appears, a bone to an outgoing congressional committee chairman — lawmakers gave rural hospitals a way to get paid by Medicare for their services regardless of whether they have patients in beds.

The law creates a new category of provider, known as a "rural emergency hospital." Starting in 2023, some hospitals will qualify for this designation by maintaining full-time emergency departments, among other criteria, without being required to provide in-patient care. The Department of Health and Human Services will determine how the program is implemented and which services are eligible.

Medicare, the federal insurance program that covers more than 61 million Americans 65 and older or with certain disabilities, currently does not reimburse hospitals for emergency or hospital outpatient services unless the hospital also offers in-patient care.

That requirement has exacerbated financial problems for rural hospitals, many of which balance serving communities with fewer patients — and less need for full in-patient services — with the need for emergency and outpatient services. One study last year found 120 rural hospital facilities had closed in the past 10 years, with more at risk.

Hospital groups have praised the change, which was introduced by Sen. Chuck Grassley (R-Iowa), who has championed rural health issues and ended his term as chairman of the Senate Finance Committee this month. "I worked to ensure rural America would not go overlooked," he said in a statement.

Medicare Invests in More Doctors

Hoping to address a national shortage of doctors that has reached critical levels during the pandemic, Congress created an additional 1,000 residency positions over the next five years.

Medicare will fund the positions, which involve supervised training to medical school graduates going into specialties like emergency medicine and are distributed among hospitals most in need of personnel, including rural hospitals.

Critics like The Wall Street Journal's editorial board have noted this is Congress' attempt to fix a problem it created in the late 1990s, when lawmakers capped the number of Medicare-funded residency positions in the United States, fearing too many doctors would inflate the cost of Medicare.

While Medicare is not the only source of educational funding and hospitals may add their own residency slots as needed, Medicare generally will reimburse hospitals for the number of residents they had at the end of 1996. Among other consequences of that 1996 cap, most Medicare-funded residencies are clumped at Northeastern hospitals, a 2014 study showed.

In contrast to the 1,000 positions created as part of the stimulus package, one bipartisan proposal in 2019 that was never enacted would have added up to 15,000 positions over five years.

Strengthening Mental Health Parity

The legislative package strengthens protections for mental health coverage, requiring federal officials to study the limitations insurance companies place on coverage for mental health and substance use disorder treatments.

In 1996 Congress passed the first law barring health insurers from passing along more of the cost for mental healthcare to patients than they would for medical or surgical care. The Affordable Care Act, building on earlier laws, made mental health and substance use disorder treatments an "essential health benefit" — in other words, it required most health insurance plans to cover mental healthcare.

But enforcing that standard has been a challenge, in part because violations can be hard to spot and the system has often relied on patients to notice — and report — them.

In December, lawmakers approved a measure requiring insurers to analyze their coverage and provide their findings to state and federal officials upon request.

They also instructed federal officials to request the findings from at least 20 plans per year that may have violated mental health parity laws and tell insurers how to correct any problems they find — under penalty of having insurer violations reported to their customers if they do not comply.

The law requires federal officials to publish an annual report summarizing the analyses they collect.

More Transparency in Cost and Quality

Americans often do not know how much they will be expected to pay when they enter a doctor's office, an ambulance or an emergency room.

Taking another modest step toward transparency, Congress banned so-called gag clauses in contracts between health insurers and providers.

Among other things, these sorts of "gag" restrictions previously have prevented insurers and group health plans from sharing with patients and others — such as employers — information about a provider's prices or quality. The December legislation also prohibited insurers from agreeing to contracts that prevent them from getting access electronically to claims and other information from providers on behalf of the insurer's enrollees.

In 2018, Congress banned gag clauses in contracts between pharmacies and insurers or pharmacy benefit managers. Those gag clauses had prevented pharmacists from sharing cost information with patients, like whether they could pay a lower price for a prescription by paying out-of-pocket rather than using their insurance coverage.

The proposal approved in December's legislation came from a big, bipartisan package of healthcare cost fixes passed in 2019 by the Senate Health, Education, Labor and Pensions Committee, but not by the rest of Congress. The committee's Republican chairman, Sen. Lamar Alexander of Tennessee, retired from Congress this month. His Democratic partner on that package, Sen. Patty Murray of Washington, will take over the chairmanship as Democrats assume control of the Senate and has vowed to focus on healthcare affordability.

Consumers First, a health consumer-focused alliance of health professionals, labor unions and others, led by Families USA, praised the ban. The change is "a significant step forward" to stop "the abusive practices from hospitals and health systems and other segments of the healthcare sector that are driving up healthcare costs and making healthcare unaffordable for our nation's families, workers, and employers," it said in a statement.

KHN senior correspondent Sarah Jane Tribble contributed to this report.

Emmarie Huetteman: ehuetteman@kff.org, @emmarieDC

If I Have Cancer, Dementia or MS, Should I Get the Covid Vaccine?

KFF Health News, January 27, 2021

Experts’ advice may be helpful since states are beginning to offer vaccines to adults over age 65, 70 or 75, including those with serious underlying medical conditions.

This article was published on Wednesday, January 27, 2021 in Kaiser Health News. This story also ran on CNN.

By Judith Graham

As public demand grows for limited supplies of covid-19 vaccines, questions remain about the vaccines’ appropriateness for older adults with various illnesses. Among them are cancer patients receiving active treatment, dementia patients near the end of their lives and people with autoimmune conditions.

Recently, a number of readers have asked me whether older relatives with these conditions should be immunized. This is a matter for medical experts, and I solicited advice from several. All strongly suggested that people with questions contact their doctors and discuss their individual medical circumstances.

Experts’ advice may be helpful since states are beginning to offer vaccines to adults over age 65, 70 or 75, including those with serious underlying medical conditions. Twenty-eight states are doing so, according to the latest survey by The New York Times.

Q: My 80-year-old mother has chronic lymphocytic leukemia. For weeks, her oncologist would not tell her “yes” or “no” about the vaccine. After much pressure, he finally responded: “It won’t work for you, your immune system is too compromised to make antibodies.” She asked if she can take the vaccine anyway, just in case it might offer a little protection, and he told her he was done discussing it with her.

First, some basics. Older adults, in general, responded extremely well to the two covid-19 vaccines that have received special authorization from the Food and Drug Administration. In large clinical trials sponsored by drugmakers Pfizer and Moderna, the vaccines achieved substantial protection against significant illness, with efficacy for older adults ranging from 87% to 94%.

But people 65 and older undergoing cancer treatment were not included in these studies. As a result, it’s not known what degree of protection they might derive.

Dr. Tobias Hohl, chief of the infectious diseases service at Memorial Sloan Kettering Cancer Center in New York City, suggested that three factors should influence patients’ decisions: Are vaccines safe, will they be effective, and what is my risk of becoming severely ill from covid-19? Regarding risk, he noted that older adults are the people most likely to become severely ill and perish from covid, accounting for about 80% of deaths to date — a compelling argument for vaccination.

Regarding safety, there is no evidence at this time that cancer patients are more likely to experience side effects from the Pfizer-BioNTech and Moderna vaccines than other people. Generally, “we are confident that these vaccines are safe for [cancer] patients,” including older patients, said Dr. Armin Shahrokni, a Memorial Sloan Kettering geriatrician and oncologist.

The exception, which applies to everyone, not just cancer patients: people who are allergic to covid-19 vaccine components or who experience severe allergic responses after getting a first shot shouldn’t get covid-19 vaccines.

Efficacy is a consideration for patients whose underlying cancer or treatment suppresses their immune systems. Notably, patients with blood and lymph node cancers may experience a blunted response to vaccines, along with patients undergoing chemotherapy or radiation therapy.

Even in this case, “we have every reason to believe that if their immune system is functioning at all, they will respond to the vaccine to some extent,” and that’s likely to be beneficial, said Dr. William Dale, chair of supportive care medicine and director of the Center for Cancer Aging Research at City of Hope, a comprehensive cancer center in Los Angeles County.

Balancing the timing of cancer treatment and immunization may be a consideration in some cases. For those with serious disease who “need therapy as quickly as possible, we should not delay [cancer] treatment because we want to preserve immune function and vaccinate them” against covid, said Hohl of Memorial Sloan Kettering.

One approach might be trying to time covid vaccination “in between cycles of chemotherapy, if possible,” said Dr. Catherine Liu, a professor in the vaccine and infectious disease division at Fred Hutchinson Cancer Research Center in Seattle.

In new guidelines published late last week, the National Comprehensive Cancer Network, an alliance of cancer centers, urged that patients undergoing active treatment be prioritized for vaccines as soon as possible. A notable exception:  Patients who’ve received stem cell transplants or bone marrow transplants should wait at least three months before getting vaccines, the group recommended.

The American Cancer Society’s chief medical and scientific officer, Dr. William Cance, said his organization is “strongly in favor of cancer patients and cancer survivors getting vaccinated, particularly older adults.” Given vaccine shortages, he also recommended that cancer patients who contract covid-19 get antibody therapies as soon as possible, if their oncologists believe they’re good candidates. These infusion therapies, from Eli Lilly and Co. and Regeneron Pharmaceuticals, rely on synthetic immune cells to help fight infections.

Q: Should my 97-year-old mom, in a nursing home with dementia, even get the covid vaccine?

The federal government and all 50 states recommend covid vaccines for long-term care residents, most of whom have Alzheimer’s disease or other types of cognitive impairment. This is an effort to stem the tide of covid-related illness and death that has swept through nursing homes and assisted living facilities — 37% of all covid deaths as of mid-January.

The Alzheimer’s Association also strongly encourages immunization against covid-19, “both for people [with dementia] living in long-term care and those living in the community, said Beth Kallmyer, vice president of care and support.

“What I think this question is trying to ask is ‘Will my loved one live long enough to see the benefit of being vaccinated?’” said Dr. Joshua Uy, medical director at a Philadelphia nursing home and geriatric fellowship director at the University of Pennsylvania’s Perelman School of Medicine.

Potential benefits include not becoming ill or dying from covid-19, having visits from family or friends, engaging with other residents and taking part in activities, Uy suggested. (This is a partial list.) Since these benefits could start accruing a few weeks after residents in a facility are fully immunized, “I would recommend the vaccine for a 97-year-old with significant dementia,” Uy said.

Minimizing suffering is a key consideration, said Dr. Michael Rafii, associate professor of clinical neurology at the University of Southern California’s Keck School of Medicine. “Even if a person has end-stage dementia, you want to do anything you can to reduce the risk of suffering. And this vaccine provides individuals with a good deal of protection from suffering severe covid,” he said.

“My advice is that everyone should get vaccinated, regardless of what stage of dementia they’re in,” Rafii said. That includes dementia patients at the end of their lives in hospice care, he noted.

If possible, a loved one should be at hand for reassurance since being approached by someone wearing a mask and carrying a needle can evoke anxiety in dementia patients. “Have the person administering the vaccine explain who they are, what they’re doing and why they’re wearing a mask in clear, simple language,” Rafii suggested.

Q: I’m 80 and I have Type 2 diabetes and an autoimmune disease. Should I get the vaccine?

There are two parts to this question. The first has to do with “comorbidities” — having more than one medical condition. Should older adults with comorbidities get covid vaccines?

Absolutely, because they’re at higher risk of becoming seriously ill from covid, said Dr. Abinash Virk, an infectious diseases specialist and co-chair of the Mayo Clinic’s covid-19 vaccine rollout.

“Pfizer’s and Moderna’s studies specifically looked at people who were older and had comorbidities, and they showed that vaccine response was similar to [that of] people who were younger,” she noted.

The second part has to do with autoimmune illnesses such as lupus or rheumatoid arthritis, which also put people at higher risk. The concern here is that a vaccine might trigger inflammatory responses that could exacerbate these conditions.

Philippa Marrack, chair of the department of immunology and genomic medicine at National Jewish Health in Denver, said there’s no scientifically rigorous data on how patients with autoimmune conditions respond to the Pfizer and Moderna vaccines.

So far, reasons for concern haven’t surfaced. “More than 100,000 people have gotten these vaccines now, including some who probably had autoimmune disease, and there’s been no systematic reporting of problems,” Marrack said. If patients with autoimmune disorders are really worried, they should talk with their physicians about delaying immunization until other covid vaccines with different formulations become available, she suggested.

Last week, the National Multiple Sclerosis Society recommended that most patients with multiple sclerosis — another serious autoimmune condition — get the Pfizer or Moderna covid vaccines.

“The vaccines are not likely to trigger an MS relapse or to worsen your chronic MS symptoms. The risk of getting COVID-19 far outweighs any risk of having an MS relapse from the vaccine,” it said in a statement.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

Poll: Nearly Half of American Adults Now Want the Covid Vaccine — ASAP

KFF Health News, January 27, 2021

About half of those who said they want the shot as soon as possible know someone who has already gotten a dose, a much larger share than among those who said they'll get it only if required (29%) or will refuse to get it (36%).

This article was published on Wednesday, January 27, 2021 in Kaiser Health News.

By Phil Galewitz Americans' reluctance to get vaccinated for covid-19 is waning, according to a poll released Wednesday.

Nearly half of adults surveyed in January said they have either already been vaccinated or want the vaccine as soon as they can, up from about a third of adults polled in December, according to the latest KFF survey. (KHN is an editorially independent program of KFF.)

About 20 million Americans have been vaccinated for covid since distribution of the first vaccines began in mid-December. The pace has also picked up in recent weeks, with more than a million Americans on average getting vaccinated every day. The survey found that when people know someone close to them who has been vaccinated, they are more likely to want the shots.

About half of those who said they want the shot as soon as possible know someone who has already gotten a dose, a much larger share than among those who said they'll get it only if required (29%) or will refuse to get it (36%).

Nearly half (47%) of adults said they have personally received at least one vaccine dose or know someone who has. People posting their vaccination status on social networks such as Facebook and Twitter has helped spread the word.

Racial, ethnic and economic disparities continue, however. White adults (51%) are more likely than Black (38%) or Hispanic (37%) respondents to have either been vaccinated or know someone who has, and those with annual household incomes of at least $90,000 are almost twice as likely as those with incomes under $40,000 to say so (64% vs. 34%). (Hispanics can represent any race or combination of races.)

About 3 in 10 adults said they want to wait until the vaccine "has been available for a while to see how it is working for others" before getting it themselves. About 7% of adults said they will get the vaccine only "if required to do so for work, school or other activities," and just 13% said they will "definitely not get" the vaccine, not a significant change.

The poll also found about 1 in 3 health care workers planned to wait to see how the vaccine is working or would get it only if required to.

The percentage of people who said they want the vaccine immediately is up among the racial and ethnic groups surveyed, although white (53%) adults remained more likely to say so than Black (35%) and Hispanic (42%) adults. Black (43%) and Hispanic (37%) adults were more likely than white adults (26%) to say they want to "wait and see" before getting vaccinated, according to the poll.

Democrats and independents also showed increased enthusiasm, though Republicans' views were little changed since December.

Republicans remained the least enthusiastic political group, with 32% saying they have already been vaccinated or want the vaccine as soon as they can, 33% saying they want to wait and see how it works for others, and 25% saying they will definitely not get the vaccine.

The KFF survey of 1,563 adults was conducted Jan. 11-18 and had a margin of error of +/-3 percentage points.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

Remdesivir, Given to Half of Hospitalized Covid Patients in U.S., Is Big Win for Gilead — Boosted by Taxpayers

KFF Health News, January 27, 2021

As U.S. infections climb above 24 million, doctors with no other FDA-approved treatment options are now prescribing remdesivir to half the covid patients in U.S. hospitals.

This article was published on Wednesday, January 27, 2021 in Kaiser Health News.

By Sarah Jane Tribble

It was the end of April — just as the U.S. confirmed its millionth covid-19 case and 50,000 deaths — when White House adviser Dr. Anthony Fauci announced "highly significant" news about a drug called remdesivir.

That was surprising because the antiviral drug, owned by Gilead Sciences and developed with investment from the federal government, had languished for years with no apparent commercial use. It had struck out as a treatment for hepatitis C and Ebola.

But early in 2020, when the first global cases of a new pneumonia-like viral illness emerged in China, Gilead resurfaced the compound, branded as Veklury, and shared it with scientists across the globe. From the Oval Office, Fauci, director of the National Institute of Allergy and Infectious Diseases, said remdesivir would be the "standard of care" for treating coronavirus disease.

Its emergency-use approval by the Food and Drug Administration immediately drew a storm of criticism. Clinical trials suggested it was only modestly helpful to covid patients. The World Health Organization recommended against its use. Politicians railed at its $3,120 price tag.

Yet, nine months later, it appears Fauci was right: As U.S. infections climb above 24 million, doctors with no other FDA-approved treatment options are now prescribing remdesivir to half the covid patients in U.S. hospitals.

"We want to shorten their hospital stay," said Dr. Jade Le, an infectious diseases specialist with Access Physicians in Texas, where hospitals have been at capacity for weeks. Le prescribes remdesivir on average three to five times a day, always in concert with a low-cost steroid.

This month, Gilead chief executive Daniel O'Day raised the company's profit estimates, noting that remdesivir alone would deliver about $2.8 billion in 2020 sales, bolstered by its use in U.S. and European markets. The company is proud of the role the treatment is playing during the pandemic, he said.

Still, controversies abound. Tension mounted last summer as shortages of remdesivir taxed the global medical community and raised urgent questions about how the federal government could step in. While doctors rationed the drug, politicians and advocates said U.S. taxpayers had invested enough in remdesivir's development to merit a lower price.

"The remdesivir story is actually a story that is all too common," said Zain Rizvi, law and policy researcher at the consumer advocacy group Public Citizen. Rizvi — and other advocates — say the drug would not have come to market if it wasn't for federal grants and the help of U.S. scientists.

They said the rags-to-riches story of remdesivir, a losing prospect turned blockbuster, holds lessons in how Americans end up paying more for medicine than anyone else in the world. Remdesivir used taxpayer dollars to be developed but, in a public health emergency, patients have no option but to pay whatever the pharmaceutical giant demands.

Rizvi has estimated that federal grants of "at least" $70 million supported the scientific discovery of remdesivir. He pointed to early research done, including a collaboration between Gilead and university scientists, using federal grants, to test remdesivir's antiviral compounds against coronaviruses, such as MERS and SARS. Others figure the investment could be much higher.

Kathryn Ardizzone, legal counsel for the patent rights group Knowledge Ecology International, is among those, though she agreed the amount is at least $70 million and declined to estimate the total amount of federal dollars used for remdesivir's discovery. There is no publicly available database of how much the government has spent to develop any drug, including remdesivir.

The NIH said in an emailed statement that it "did not develop remdesivir." The agency confirmed it funded research on the drug's uses as well as providing money to institutions that worked with Gilead to develop the drug.

KEI filed a Freedom of Information Act request to view the grants and clinical trials related to remdesivir. In October, the group sued the National Institutes of Health because it had failed to respond. Ardizzone said she expects the records will counter Gilead's justification of remdesivir's price: "When the government has played such a critical role at every step of the way, that argument falls apart."

Gilead, in an emailed statement, said its investment in the drug predates any government involvement and "disagrees with the premise that the government has any rights to Gilead's remdesivir intellectual property." No federal scientists are named on remdesivir's patents.

The company has defended the price of the drug, saying it invested more than $1 billion in 2020 to support clinical trials as well as to manufacture and distribute remdesivir. Gilead priced it at $3,120 for a five-day course of treatment in the U.S. market, and $2,340 for other developed countries. Some smaller U.S. government entities, like the Indian Health Service, pay the lower price as well. Noting the price for developed countries, Gilead spokesperson Arran Attridge said the drug is priced "significantly below the potential value" it delivers.

But U.S. Sen. Ron Wyden, a top-ranking Democrat from Oregon on the Senate Finance Committee, said he has been concerned about Gilead's price for a five-day course of treatment since it was announced. "My previous investigative work … has shown Gilead's willingness to put profits over patients," Wyden said. Wyden, along with Sen. Chuck Grassley (R-Iowa), released an investigation in 2015 of Gilead's hepatitis C drug prices and marketing.

At its core, remdesivir is a simple, "small molecule" drug. Generics manufacturers in India have copied the design and priced it at $53.34 per vial, or $320 for a course of treatment.

The U.S. government, so far, has not exerted its intellectual property rights. But there are signals that could change.

In late summer, California Attorney General Xavier Becerra led a group of more than 30 attorneys general calling for the federal government to license remdesivir to another manufacturer, such as a lower-cost provider from overseas. President Joe Biden nominated Becerra to lead the Department of Health and Human Services.

Another Biden pick, Dr. Rochelle Walensky, an infectious diseases specialist who has been tasked to lead the Centers for Disease Control and Prevention, co-authored a New York Times opinion piece suggesting that HHS could buy the drug from another company (including a generics maker overseas) and pay royalties to Gilead. This fall, U.S. Rep. Lloyd Doggett (D-Texas) held a news conference supporting the approach Walensky and others proposed.

Neither maneuver, however, was meant as a lever to lower its price for patients, said Adam Mossoff, a law professor at George Mason University. Mossoff doubted that either of the strategies would hold up in court and noted there are plenty of congressional proposals to lower drug prices and sometimes "people get ahead of themselves." They try to use the law to advocate for what should be a policy goal, he said.

Underlying Becerra's and Walensky's proposals is the deeper, nagging question of whether Gilead should fully own the rights to remdesivir if the U.S. funded research and its scientists worked with Gilead to discover the drug.

Doggett put it this way: "Gilead is overcharging on a drug that was saved from the scrap heap of failed drugs only because of taxpayer-funded research."

Sen. Debbie Stabenow (D-Mich.) and Rep. Carolyn Maloney (D-N.Y.) have asked the government's federal watchdog agency, the Government Accountability Office, to investigate "what legal rights do federal agencies have" in relation to remdesivir. Gilead said it is cooperating with the investigation; government officials expect the review to be completed this spring.

Gilead, in an emailed statement in response to a question about the GAO review, called the government's involvement "limited." In response to questions about the patents, Gilead said its own investments predate any government involvement and its inventors identified the drug's antiviral activity, optimized the formula and scaled up the manufacturing process.

Gilead confirmed it has eight listed patents on remdesivir, with the last expiring in 2038.

In the abstracts of two patents, filed in 2014 and 2015, the CDC and USAMRIID, the U.S. Army Medical Research Institute of Infectious Diseases, are mentioned as places studies were conducted. Each patent emphasizes its focus on treating the Ebola virus and other filoviruses that cause fatal hemorrhagic fevers.

Christopher Morten, deputy director of technology law and policy clinic at New York University School of Law, said those two patents should list government scientists as co-inventors. Referring to one patent (No. 9,724,360), Morten said its earliest filing was October 2014. "Which makes perfect sense, because the U.S. government collaboration started in 2013 with Ebola and the CDC," Morten said. While not attaching specific government investment dollars to its descriptions, Gilead confirms the collaboration, as well, saying it "worked with the U.S. government to confirm remdesivir's preclinical activity against Ebola."

Morten, who previously represented pharmaceutical companies as a patent lawyer, said he believes the question of inventorship should be raised in court, using the legal tactic proposed by CDC chief Walenksy. Morten co-authored a white paper on remdesivir with the HIV advocacy group PrEP4All.

Notably, PrEP4All also challenged Gilead's patents for the HIV drug Truvada. In 2019, the U.S. Departments of Justice and Health and Human Services sued Gilead over patent rights for Truvada. The case is ongoing.

Back on the pandemic's front lines, U.S. doctors administer remdesivir even after the World Health Organization recommended against the drug in November. The WHO's recommendation, which referenced results from an international trial called Solidarity, found remdesivir did not improve a covid patient's chance of survival.

The Food and Drug Administration gave remdesivir full regulatory approval in October, making it the only approved U.S. treatment for the deadly disease.

Dr. Rajesh Gandhi, a member of the Infectious Diseases Society of America's panel on covid-19 treatment guidelines, pointed to another clinical trial of more than 1,000 hospitalized patients run by the National Institutes of Health. The trial, called ACTT-1, showed hospital stays of about 10 days for those who received remdesivir compared with 15 days for those who did not, he said.

"Many of us believe remdesivir has a role," Gandhi said, "though we wish it had a greater effect." He noted that the trial showed one group of patients saw the biggest benefit: those who need supplemental oxygen but are not yet on a ventilator. It's clear, he said, "we need better drugs than remdesivir."

Remdesivir — along with a steroid — was enough for Shirley Lewis.

The 69-year-old Florida resident said she was sick for about a week when she found herself unable to breathe and went to the hospital.

"I'm telling you, I was like half-dead and half-alive … all I could do was pray," Lewis said. Doctors put her on supplemental oxygen and began IV bags of remdesivir paired with steroids. Lewis said she felt the difference right away.

"I said, Oh, thank God," Lewis recalled about a month after being released from the hospital. "I thought it was some kind of miracle, I really did. So don't let them say it doesn't work, because it did."

Sarah Jane Tribble: sjtribble@kff.org, @SJTribble

'We're Not Controlling It in Our Schools': Covid Safety Lapses Abound Across US

KFF Health News, January 26, 2021

A KHN analysis of OSHA data found more than 780 covid-related complaints covering more than 2,000 public and private K-12 schools.

This article was published on Tuesday, January 26, 2021 in Kaiser Health News.

By Laura Ungar

Computer science teacher Suzy Lebo saw covid-19 dangers frequently in her Indiana high school: classes with about 30 students sitting less than 18 inches apart. Students crowding teachers in hallways. Students and staff members taking off their masks around others.

“I'm concerned,” said Lebo, who teaches at Avon High School in the Indianapolis suburbs. “We're not controlling the virus in our county. We're not controlling it in our state. And we're not controlling it in our schools.”

President Joe Biden's covid response proposes $130 billion to improve school safety, offers federal guidance for making schools safer and improves workplace protections to safeguard teachers and other workers from covid.

This comes after many school districts and states holding in-person classes have ignored recommendations from public health officials or written their own questionable safety rules — creating a tinderbox where covid can sicken and kill.

A KHN analysis of federal and state Occupational Safety and Health Administration data found more than 780 covid-related complaints covering more than 2,000 public and private K-12 schools. But those pleas for help likely represent only a small portion of the problems, because a federal loophole prevents public school employees from lodging them in 24 states without their own OSHA agencies or federally approved programs for local and state employees. Still, the complaints filed provide a window into the safety lapses: Employees reported sick children coming to school, maskless students and teachers less than 6 feet apart, and administrators minimizing the dangers of the virus and punishing teachers who spoke out.

KHN also found that practices contradicting safety experts' advice are codified into the patchwork of covid rules put out by states and districts. For instance, about half of states don't require masks for all students — including 11 that have exempted schoolchildren of various ages from mandatory masks, with New Hampshire excluding all K-12 students. Districts can craft stricter rules than their states but often don't.

“The response to the virus has been politicized,” said Dr. Chandy John, an expert in pediatric infectious diseases at the Indiana University School of Medicine. “There's a willingness to ignore data and facts and go with whatever you're hearing from the internet or from political leaders who don't have any scientific knowledge.”

But even with Biden's rollout of new school safety steps, struggles over balancing the need for education with covid safety are sure to continue, since it will be months before the nationwide vaccine rollout reaches all school staff members, and the shots haven't yet been approved for kids.

Meanwhile, the scope of covid in schools remains unknown. Biden's order calls for tracking it on the federal level, which wasn't happening. States haven't collected uniform data either. The Covid Monitor, a project launched by volunteers and public health researchers, has counted more than 505,000 cases in K-12 schools — more than a quarter of them among staffers. Although kids are less likely than adults to become seriously ill, recent research suggests they can spread the virus even if asymptomatic. The American Federation of Teachers estimates covid-19 has killed at least 325 school employees, though it's unclear whether they caught it at school.

Among them was Susanne Michael, 47, a fourth grade teacher at Harrisburg Elementary School in northeastern Arkansas. As a cancer survivor with diabetes, she rarely went anywhere outside her home this past fall, according to her husband, Keith. She told him she worried about catching the coronavirus while teaching, but she “went and did it because she loved it.”

She tried her best to keep more than 20 students 6 feet apart, he said, but told him it was nearly impossible.

Though she always wore a mask, he doesn't know if every student did. According to the district's website, masks are required in grades 4-12 “when social distancing is not feasible,” and “physical distancing will be practiced to the extent practical.” District leaders did not respond to requests for comment.

Michael wound up hospitalized on a ventilator. Doctors let her husband visit in protective gear because he, too, had the virus. He held her hand as she slipped away Oct. 1.

The loss hits him hardest at night. “For 27 years, I always had somebody there next to me,” he said. “It's difficult and weighs on your mind and heart a lot when you're laying there in an empty bed and your best friend's gone.”

She left five children, ages 3 to 22, including a former student and her two siblings adopted in July.

A Litany of Lapses

Doctors said covid risks can be drastically reduced by following straightforward safety practices.

“First and foremost, mask mandate, mask mandate, mask mandate,” said Dr. Jason Newland, a pediatrics and infectious diseases professor at Washington University in St. Louis.

But school employees across the nation complain such measures don't exist or aren't enforced.

“School officials openly scoff at covid-19 and believe it is a hoax. This attitude trickles down to staff, so hardly anyone has been wearing their mask or wearing it correctly,” an unidentified employee of Hart Public Schools, in rural western Michigan, wrote in an OSHA complaint in September. The complaint also described large crowds of students sitting too close in cafeterias. The employee alleges being terminated for whistleblowing.

Hart Superintendent Mark Platt said in an email that he won't comment on personnel matters, but “takes seriously its health and safety protocols for students and staff.” The district's covid preparedness and response plan requires staffers and older students to wear masks in classrooms, common areas and buses, while K-5 students must wear them everywhere except in their own classrooms with their own class.

At the public Avon Community School Corp. in Indiana, Lebo said, problems festered since the beginning of the fall semester in July, when an OSHA complaint was lodged. In addition to crowding in the halls and difficulty keeping students 6 feet apart in classrooms, Lebo said, the school's many extracurricular activities — including football, wrestling and show choir — brought their own risks.

Avon schools spokesperson Kevin Carr wouldn't comment except to say students and staff members have tried their best to abide by the district's health and safety protocols.

Over the semester ending in December, Avon schools reported 346 covid cases among nearly 9,800 in-person students and staffers, a rate of 3.5% compared with 2.1% for 1,412 remote learners. The covid rate reached 5.5% at the high school, which went remote briefly in the fall after the number of people quarantining skyrocketed.

Like the vast majority of school OSHA complaints, the one about Avon was closed without an inspection. Across all industries, research shows, just a small percentage of pandemic-related complaints have led to inspections or fines.

A Biden executive order on worker safety calls for OSHA to bolster enforcement and work with states and local governments to ensure workers, including those in the public sector, are protected from covid.

Without strong laws, “workers are facing big challenges: Do I speak up? Do I show up to work?” said Rebecca Reindel, director of occupational safety and health for the AFL-CIO. “They're making a decision between needing a paycheck and risking bringing the virus home.”

Varied, Questionable Guidance

That decision gets even harder when potentially unsafe practices are written into official recommendations.

Missouri and Iowa, for example, advise that students exposed to covid don't need to be quarantined as long as infected and exposed children are both wearing masks correctly — which goes against Centers for Disease Control and Prevention advice to quarantine anyone who has had close contact with a person who has the virus.

Some districts in South Carolina, Tennessee, Florida and Nebraska — with green lights from the Trump administration and their states — classified teachers as “critical infrastructure workers,” allowing them to keep working after exposure if they don't develop symptoms.

A superintendent in Billings, Montana, told administrators in October to “disrupt the 15-minute timeline” required to be deemed a close contact “through movement, distancing or masking.” Following media reports, he issued a statement saying he hadn't intended to “game the system” and no one should move students to avoid quarantines.

In many communities, mask rules are lax.

In Missouri, where there's no statewide mask rule, Ozark School District requires them only “when social distancing is not an option,” according to its website, which describes spacing desks and using barriers to give people a “break” from masks.

Lakeland Joint School District in Idaho recommends masks when physical distancing isn't possible. Dacia Chaffee, parent of an eighth grader and a high school freshman in the district, said “it's almost like normal,” with few students wearing masks. Her kids don't either, she said; they don't want to stand out.

Public health experts said making schools safer will require clear, consistent data and guidance — and political will. They said governments also need to give public schools enough resources to keep more than 50 million students and 3.2 million teachers safe. A recent CDC report estimated that the cost of covid mitigation measures for the 2020-21 school year ranges from $55 per student for items such as masks, plexiglass barriers and face shields to $442 per student with added custodians and transportation, such as buses and drivers, to allow for better physical distancing.

And crucially, experts said, covid policies for schools must be rooted in science, not politics.

“Behaviors and attitudes flow from the top down,” said Dr. Mark Schleiss, a pediatrics professor at the University of Minnesota Medical School. “We have to hold people accountable. This is a life-and-death situation.”

Laura Ungar: lungar@kff.org, @laura_ungar

Big Business Boosts Vaccine Effort, but It's 'Complex Choreography' to Get Shots in Arms

KFF Health News, January 26, 2021

This backup from businesses comes as states continue to navigate uncertainty around when they'll receive doses.

This article was published on Tuesday, January 26, 2021 in Kaiser Health News.

By Will Stone

As states await the promise of a renewed federal pandemic response and expand the number of Americans who qualify for a shot, some governors are trying to scale up their covid vaccine operations — and smooth out the kinks — with the help of the private sector.

In Washington state, Starbucks, Microsoft and Costco are lending logistical expertise and manpower to public health agencies that are trying to dispatch their doses of vaccines more efficiently.

Over the weekend, thousands of people filed through the Charlotte Motor Speedway in North Carolina — now serving as a mass vaccine site — run by Honeywell and other local businesses that have partnered with the state.

And on Monday, Google pledged $150 million to "promote vaccine education and equitable distribution" and to make it easier for people to find "when and where to get the vaccine."

This backup from businesses comes as states continue to navigate uncertainty around when they'll receive doses. A patchwork of vaccination eligibility rules and ways to sign up for a shot have left many Americans confused, frustrated and even frightened, as those at high risk of serious complications from the covid virus continue to wait with little news on when they'll be inoculated.

Washington Gov. Jay Inslee calls private enterprise the "arsenal" of the coronavirus vaccination campaign, comparing the partnership to the production of battleships during World War II, but even Inslee, a Democrat, did not oversell the immediate impact.

"This is not going to be an expectation of an Amazon delivery system," Inslee said while announcing his state's plan last week. "There will be times when people will not have dosages available in their community because there isn't enough being delivered."

Washington and more than half of all states have opened up vaccines to anyone 65 and older — greatly spiking demand — yet a major hang-up continues to be making use of all the delivered vaccines.

Of the approximately 41 million vaccines delivered to states, more than 19 million have not yet been given, according to data from the Centers for Disease Control and Prevention.

"It's a dance that requires a lot of complex choreography," said Alison Buttenheim, an associate professor of nursing and health policy at the University of Pennsylvania.

"We aren't always so innovative and nimble in public health and this is the moment where we need that — we need innovation and we need states trying different things."

The Washington state partnership is using Starbucks to streamline the vaccine clinics, Microsoft to provide tech support and space on its campus, and Costco to manage logistics around delivering the shots.

Every state should be looking to its businesses to fill gaps in the vaccination operations, whether around online scheduling, public messaging or the nitty-gritty details of coordinating delivery and clinics, Buttenheim said.

"There's no one corporate entity that's going to solve this, but most have something to offer," she said.

Many public health departments have struggled with making the vaccine process "customer friendly" because they don't typically provide this kind of direct service, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials (ASTHO), which represents state health directors.

"It has been challenging to scale those kinds of things up," he said. "Then you add in that public health departments have been dealing with covid for a year, with limited resources and people are tired."

In North Carolina, Atrium Health, a nonprofit health care system, is part of the business partnership with Honeywell that aims to give 1 million shots by July.

"It allows us as the health care system to focus on what we do best — getting the shots in the arms and making sure people are tolerating it and the aftercare," said Dr. Scott Rissmiller, Atrium's executive vice president.

"Our hospitals are full, and it's the same people that are working in our hospitals that we are needing to redeploy for the vaccines."

Looking Ahead

The Biden administration has pledged more transparency around the availability of doses and enlisted the Federal Emergency Management Agency to set up mass vaccination sites, as many as 100 in the next month.

While the pace of vaccination has picked up, public health experts warn the U.S. must move faster as at least one more contagious variant of the virus shows up in a growing number of states and threatens to drive another devastating surge.

A federal partnership with large pharmacies has faced criticism for not moving more quickly. Some states have gone through the majority of their doses, while others have used fewer than half of what's been delivered.

Public health can get a boost from the private sector, but there are limits to what can be outsourced, said epidemiologist Jennifer Nuzzo of Johns Hopkins University.

"This isn't just handing somebody a package; this is a clinical encounter," said Nuzzo.

Data entry involves sensitive personal information, and the actual vaccinators need to be trained and credentialed.

Nuzzo, who has studied the U.S. capacity for mass vaccination, estimates the U.S. will need anywhere from 100,000 to 184,000 people to staff vaccine clinics, of which 17,000 would have to be vaccinators, to meet the Biden administration's goal of 100 million shots in 100 days.

"I think it would be extraordinarily difficult to just find those vaccinators," she said.

The private sector may be able to contribute, but Nuzzo cautioned that any partnerships cannot appear to favor the employees of the company.

Last week, Amazon offered to assist the Biden administration on the vaccine rollout and has signaled it hopes to vaccinate its own front-line workers as soon as possible.

The shaky supply has limited the ability of some states to pursue mass vaccine sites, and many providers are still hesitant to schedule vaccines too far in advance. A hospital in Arlington, Virginia, canceled 10,000 appointments after the state changed how it allocates its supply of vaccines.

In Arizona, which has two mass vaccine sites so far, appointments are already booked through February.

Since the early days of the vaccine rollout — when the Trump administration promised 20 million doses before 2021 — the public has received confusing messages about when they'll be able to get a shot.

States still face the challenge of how to set realistic expectations. Many are ramping up their capacity for giving vaccines, even before the supply has caught up.

"The worry I have is that if we create expectations for how quickly people can get vaccinated and then don't deliver, people will become perhaps jaded or disappointed or, worse, mistrustful of vaccination efforts," she said.

More than half of unvaccinated Americans say they need more information about when or where they'll get vaccinated, according to a national survey from the Kaiser Family Foundation. (KHN is an editorially independent program of KFF.)

At his grocery store in Everett, Wash., Wil Peterson, a cashier, hears this confusion around the vaccine process from his co-workers.

"There's a lot of information that's been floating around, so I'm just trying to keep up with the latest developments," said Peterson, who's in his 50s and expects his turn to get a shot will come sometime in February.

Peterson worries about catching the virus every day he goes to work and still deals with customers who refuse to wear masks, so he's eager to get vaccinated.

But he also knows it may not go smoothly, after hearing from a friend who tried to sign up for his shot.

"But the site crashed, so I'm kind of bracing for maybe that happening when I try to do it, but I'm hoping that won't be the case," he said.

This story is part of a partnership that includes NPR and KHN.

California's Top Hospital Lobbyist Cements Influence in Covid Crisis

KFF Health News, January 26, 2021

California Hospital Association President and CEO Carmela Coyle is a power player in the state Capitol.

This article was published on Tuesday, January 26, 2021 in Kaiser Health News.

By Samantha Young

SACRAMENTO — As intensive care units filled and coronavirus cases surged over the holidays, Carmela Coyle invoked a World War II-era quote attributed to British Prime Minister Winston Churchill to rally her own troops: "If you're going through hell, keep going."

Coyle is head of the California Hospital Association, and her "troops" are the highly paid hospital executives she represents. Throughout the pandemic, as in the December memo in which she quoted Churchill, she has employed battlefield rhetoric to galvanize their massive political and financial clout.

That's because Coyle believes hospitals are quite simply "in battle conditions" — a sentiment she has impressed upon the state's top healthcare officials.

While Coyle, 60, is unknown to many Californians, she is a power player in the state Capitol, one whose profile and influence have grown in the past year. She has used her position as president and CEO of the association to lobby for the multibillion-dollar hospital industry, including asking officials to temporarily relax guidelines intended to safeguard patients and workers.

Along the way, she has been granted personal access to Gov. Gavin Newsom and other top officials, helping shape the state's response to covid-19.

"Having spent many, many hours embedded with the Governor's team in the state's Office of Emergency Services, everyone is working 18-plus hours a day," she wrote to hospital executives in March, "and the dedication to supporting what hospitals need to do their jobs is impressive."

Though she hasn't won every battle, Coyle has scored some big wins for the industry.

She successfully petitioned the Newsom administration to relax nurse-to-patient ratios and allow healthcare workers exposed to the coronavirus to continue to work — critical but contentious rule changes intended to keep hospitals staffed that were approved over union objections.

When hospitals started to fill with covid patients last summer, Newsom agreed with Coyle that hospitals could care for them while also performing moneymaking elective surgeries, which hospitals had voluntarily canceled in the spring.

Newsom invited her to a July press briefing to explain that logic to the public. At the briefing, he described Coyle as an "outstanding partner" and a leader with a "seriousness of purpose."

"I just can't thank her enough, more publicly than I have in the past, but I need to repeat it yet again," Newsom said. "We're all being put to the test, particularly our hospital system at this moment."

That Coyle, a relative newcomer to Sacramento politics, is such an influential advocate in the Capitol comes partly with the job. She represents more than 400 hospitals that provide not just critical care, but also jobs to Californians in every corner of the state.

In the first three quarters of 2019, California's hospitals earned about $101.7 billion in net patient revenue, according to financial data filed with the Office of Statewide Health Planning and Development. During the same time last year, they earned about $97.6 billion — representing a 4% decline — despite the loss of elective surgeries and a drop in emergency room visits early in pandemic.

The California Hospital Association is a healthcare heavyweight in Sacramento, along with the doctors' lobby, the dialysis industry and others. It spent nearly $5.3 million on lobbying from Jan. 1, 2019, to Sept. 30, 2020, and $4.3 million to support state and local political campaigns, according to filings with the California secretary of state's office.

In 2019, the association paid Coyle $1.4 million, it said.

"The hospitals are such a big player that you have to be working with them," especially during a public health outbreak, said David Panush, a Sacramento healthcare policy consultant who worked in state government for 35 years.

Coyle also has the ear of Mark Ghaly, secretary of the state Health and Human Services Agency. Ghaly and Coyle have corresponded often since March — sometimes multiple times a day — by phone and email about the state's response to the pandemic, according to emails obtained by California Healthline.

For instance, in March, Coyle shared a letter with Ghaly that she had sent to hospital executives, in which she warned them — and by extension, him — that "we are in battle conditions, and it's all hands on deck to turn the tide."

In other letters and emails, Coyle pressed Ghaly to allow healthcare workers exposed to the virus to continue working as long as they didn't show symptoms. Newsom later issued the rule in an executive order.

"Nurses are the heartbeat of the hospital," said Stephanie Roberson, government relations director of the California Nurses Association — whose leaders, unlike Coyle, have not been invited into the governor's state operations center since it was activated in March. "Instead, we have someone who basically represents the opposite of nursing interests standing alongside the governor discussing the importance of public health."

In a recent statement, Ghaly said the pandemic has required the state to work not only with hospitals but also with doctors, nurses, public health departments, nursing homes, laboratories and emergency services agencies to save lives.

"I am grateful to Carmela and our hospital partners for their tremendous work, particularly during this current surge when hospitals are overwhelmed with patients and intensive care units are filled," Ghaly said.

It took the administration six months to direct hospitals to test healthcare workers for covid at least once a week after requiring nursing homes to do so — a testament, critics say, to the hospital industry's political and economic impact.

"The association exists to increase profits for hospitals, increase the bottom line," said Sal Rosselli, president of the National Union of Healthcare Workers. The union lobbied for the mandatory testing rule, which took effect in December. "That's why they oppose every patient care advocacy issue, every worker issue."

Coyle countered that hospitals have no choice but to make trade-offs while they provide crisis care. She emphasized that the hospitals' requests for exemptions are temporary.

"If we don't flex some of these requirements, it means that people will not get the care they need and, worse, people may die," she said at a news conference earlier this month.

Coyle, a Minnesota native, is known for her intelligence and the expertise she has honed working on healthcare policy for more than 30 years.

As head of the Maryland Hospital Association for nine years before she took the California job in 2017, Coyle built a reputation as a consensus builder even as she looked out for her constituency. For instance, she cultivated relationships with Maryland's congressional delegation and lobbied it for federal funding in 2014 to help the state's hospitals prepare for and treat Ebola patients, most of whom were American healthcare workers who had contracted the virus in Africa.

"She really understood the old maxim that there's no such thing as permanent friends or permanent enemies. There are only permanent interests," said Stan Dorn, a senior fellow at the advocacy group Families USA, who previously served on a Maryland commission on healthcare costs with Coyle. "She understood that it's good to have good relationships with everybody because you never know, day after tomorrow, who is going to be important to your cause."

Along with her credentials comes a strong streak of determination. After Coyle graduated from Minnesota's Carleton College with degrees in economics and Spanish literature, she worked at a Washington, D.C., flower shop until the Congressional Budget Office offered her a two-year internship. She had called to check on her application every Friday for three months.

Coyle "was raised to know" such perseverance as she grew up in a working-class family, the daughter of a Colombian immigrant father.

"Kids teased me and called me names when I was a kid, my father being dark-skinned and having a heavy accent," Coyle said. "I was dark-skinned as well, and they just thought we were so strange."

Laughed at for the way her father spoke, Coyle today unabashedly harnesses the power of language to sway government officials and public opinion — and to marshal her own hospital forces to lobby "with one voice."

In the waning days of last year's legislative session, Coyle warned hospital executives of the battles before them in the Capitol: bills that would come with hefty costs to hospitals should they pass.

In the end, the industry succeeded in blocking a bill that would have made it harder for hospitals to consolidate. But they didn't get legislative approval to delay seismic retrofits at hospitals, as they had wanted. Lawmakers also passed a bill opposed by hospitals that requires them to maintain a 45-day stockpile of personal protective equipment, which Coyle had argued was unreasonable given that it has been in short supply.

"They're not all-powerful, but certainly they're influential," said state Sen. Richard Pan (D-Sacramento), who chairs the Senate Health Committee. "And during covid, they're taking care of patients. They're the ones saving the lives of people who are intubated."

When Coyle readied her troops for the legislative fights, she acknowledged they weren't going to win every battle. She borrowed another World War II quote, this time from Gen. Douglas MacArthur, to explain to hospital executives that they may need to compromise.

"In war, you win or lose, live or die," she wrote. "And the difference is just an eyelash."

California Healthline correspondent Angela Hart and KHN data editor Elizabeth Lucas contributed to this report.

Why Even Presidential Pressure Might Not Get More Vaccine to Market Faster

KFF Health News, January 26, 2021

Forcing companies to gear up production won't provide much-needed doses anytime soon. Expanding production lines takes time. Establishing lines in repurposed facilities can take months.

This article was published on Tuesday, January 26, 2021 in Kaiser Health News.

By Liz Szabo and Sarah Jane Tribble and Arthur Allen and Jay Hancock

Americans are dying of covid-19 by the thousands, but efforts to ramp up production of potentially lifesaving vaccines are hitting a brick wall.

Vaccine makers Moderna and Pfizer-BioNTech are running their factories full tilt and are under enormous pressure to expand production or collaborate with other drug companies to set up additional assembly lines. That pressure is only growing as new viral variants of the virus threaten to launch the country into a deadlier phase of the pandemic.

President Joe Biden has said he plans to invoke the Cold War-era authority of the Defense Production Act to provide more vaccines to millions of Americans. Consumer advocates — who had called for Donald Trump to use the Defense Production Act more aggressively as president — are now asking Biden to do the same.

But even forcing companies to gear up production won't provide much-needed doses anytime soon. Expanding production lines takes time. Establishing lines in repurposed facilities can take months.

"The big problem is that even if you can get the raw material and get the infrastructure set up, how do you get a company that is already producing at maximum capacity to go beyond that maximum capacity?" said Lawrence Gostin, a professor of global health law at Georgetown University.

Ordering the companies to work 24/7 "would be a naïve solution," said Dr. Nicole Lurie, a senior adviser to the CEO of the Coalition for Epidemic Preparedness Innovations, an international group that finances vaccines for emerging diseases. "They're probably already doing that to the extent they have the raw materials."

Lurie added, "If you completely wear people out, mistakes happen. You have to balance speed with quality and safety."

The technological challenges involved are daunting, and the companies haven't been forthcoming about what's needed to overcome any supply shortfalls.

"We don't know what the holdup is. Is it capacity? Raw materials? People? Glass vials? We just don't know what the bottleneck is," said Erin Fox, senior director of drug information and support services at the University of Utah Health Hospitals.

Forcing other companies to start making the vaccines might not work either, Gostin said.

"I'm not sure if Biden could require a private company to transfer its technology to another company," Gostin said. "That is highly questionable legally. … President Biden's room for maneuvering isn't as great as people think."

Drug companies define "trade secrets" broadly, Fox said. "In general, drug companies don't have to tell me who is making their product, where it's made, the location of the factory. … That's considered proprietary."

Part of the challenge relates to how these vaccines are made. The first two authorized products use lipid nanoparticles to deliver a snippet of the coronavirus's genetic material — called messenger RNA, or mRNA — into cells. The viral genes teach our cells how to make proteins that stimulate an immune response to the novel coronavirus.

Messenger RNA is fragile and breaks down easily, so it needs to be handled with care, with specific temperatures and humidity levels.

The vaccines "are not widgets," said Lurie, who served as assistant secretary for preparedness and response at the Department of Health and Human Services during the Obama administration.

Every step, experts say, to get vaccines to market has its complexities: obtaining raw materials; building facilities to precise specifications; buying single-use products, such as tubing and plastic bags to line stainless steel bioreactors; and hiring employees with the requisite training and expertise. Companies also must pass safety and quality inspections and arrange for transportation.

The Defense Production Act, for instance, would allow the government to commandeer a plant that already has a fermenter — there are plenty in the biotech industry — to expand production. But that's just the first stage in making an mRNA vaccine and, even then, it would take about a year to get going, said Dr. George Siber, a vaccine expert who is on the advisory board of CureVac, a German mRNA vaccine company.

Companies would first have to do a breathtakingly thorough cleaning to prevent cross-contamination, Siber said. Next, they would need to set up, calibrate and test equipment, and train scientists and engineers to run it. Finally, Siber said, unlike a drug, whose components can be tested for purity, there's no way to be sure a vaccine produced in a new facility is what it claims to be without testing it on animals and people.

"Making vaccines is not like making cars, and quality control is paramount," said Dr. Stanley Plotkin, a vaccine industry consultant credited with inventing the rubella vaccine. "We are expecting other vaccines in a matter of weeks, so it might be faster to bring them into use."

However, even that will require patience. Johnson & Johnson, expected to announce clinical trial results this month, has said that it won't be able to deliver as many shots as planned because of manufacturing delays. The company did not confirm a manufacturing delay and declined to respond to questions.

AstraZeneca's vaccine, also funded in part by U.S. taxpayers, is in use already in the United Kingdom and India, but the Food and Drug Administration has raised questions about its late-stage trial, so it may not be available here until the spring.

Novavax, another U.S.-funded vaccine maker, has been plagued by delays and only recently began recruiting volunteers for its big trial. Merck, the most recent company to get federal support for covid vaccines, announced Monday it was scrapping its two candidates after they failed to produce adequate immune response in early tests.

"None of the vaccine makers are manufacturing at the volume they ultimately want to be at," Lurie said. "They all have manufacturing delays."

Pfizer, which has committed 200 million doses to the U.S. government by the end of July, said last week it expected "no interruptions" in shipments from its primary U.S. covid manufacturing plant in Kalamazoo, Michigan. Pfizer spokesperson Sharon Castillo said the company has expanded manufacturing facilities and added more suppliers and contract manufacturers. Those efforts, and the company's announcement that its five-dose vials actually contain an extra dose, mean "we can potentially deliver approximately 2 billion doses worldwide by the end of 2021."

The U.S. government also has an option to acquire another 400 million doses of the Pfizer-BioNTech vaccine, though the company declined to provide details on that option when asked.

But countries around the world are competing for the same supplies and raw materials, Gostin said.

Biden could use the Defense Production Act "to force Pfizer to prioritize U.S. contracts, but that would be politically risky," given that other countries could retaliate by hoarding supplies. Although Pfizer is an American company, it has partnered with BioNTech, of Germany, to make its covid vaccine. "That would lead to a global mess."

Trying to corner the world market on vaccine ingredients or supplies would look bad, experts say, given that the United States just this week joined Covax, an international venture to source and distribute vaccines, in an effort to ensure poor countries aren't left behind.

Paradoxically, the rush to get vaccines to market may have resulted in a less efficient manufacturing process.

Vaccine companies typically spend months making their factories run as efficiently as possible, as well as finding an ideal dose and the most effective interval between doses, Lurie said. Given the urgency of the pandemic, however, they delayed parts of this process and launched straight into mass production.

Pfizer angered European countries last week when it paused vaccine production at a Belgian plant to upgrade its capacity. Pfizer said the weeklong closure would decrease vaccine deliveries to Europe for three to four weeks before boosting supplies in February. The move doesn't affect U.S. vaccine supplies.

"The U.S can't necessarily readily access stuff that's being held for vaccines in other countries," Lurie said.

And forcing other companies to make covid vaccines could jeopardize production of other important shots, such as measles, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Routine childhood immunization rates have fallen during the pandemic, raising the risk of epidemics.

Using the act to prioritize covid vaccine manufacturing has already disrupted supplies of at least one drug, Fox noted. In December, Horizon Therapeutics warned doctors and patients to expect a shortage of a drug called Tepezza, used to treat thyroid-related eye disease, because its manufacturer was ordered to prioritize covid shots.

Lawmakers and consumer advocates such as Public Citizen called on the government to use the Defense Production Act more aggressively. In a letter sent earlier this month, Sen. Elizabeth Warren (D-Mass.) and Rep. Katie Porter (D-Calif.) said Moderna should share its technique for stabilizing its vaccine at normal refrigerator temperatures, without "ultracold" freezers.

Moderna officials have said the intrinsic differences in the two companies' mRNA material make that technology hard to share. Besides, they say, Pfizer has declined to share data with Moderna. Pfizer has declined to comment on the issue.

Since Moderna's effort is federally funded, the government presumably has march-in rights and could take over production, said Mike Watson, former president of Moderna subsidiary Valera, in an email. "The reality is that however far you push production capacity, you sooner or later reach a bottleneck."

Experts say it's not as simple as demanding that glassmaker Corning step up and make glass vials, for example. Of course, the vials will need to meet rigorous requirements. But there's also this: The U.S. is facing a shortage of mined sand, the main component needed to make glass vials.

Liz Szabo: lszabo@kff.org, @LizSzabo

Sarah Jane Tribble: sjtribble@kff.org, @SJTribble

Arthur Allen: ArthurA@kff.org, @ArthurAllen202

Jay Hancock: jhancock@kff.org, @JayHancock1

Vaccine Ramp-Up Squeezes Covid Testing and Tracing

KFF Health News, January 25, 2021

Diminished testing capacity could lead to longer waits for appointments, which means infected people could potentially expose others for a longer time before learning they have the virus.

This article was published on Monday, January 25, 2021 in Kaiser Health News.

By Bernard J. Wolfson

California Gov. Gavin Newsom, under growing pressure to jump-start a faltering covid-19 vaccine rollout, jetted to Los Angeles on Jan. 15 to unveil a massive new vaccination site at Dodger Stadium that is expected eventually to inoculate 12,000 people a day.

The city-run venue had been the biggest covid testing site in the U.S., administering over 1 million tests in its nearly eight months of operation — and over 10,000 a day during the recent surge. Its redeployment to the cause of vaccination, Newsom declared, provides "an extraordinary world-class site for a world-class logistics operation."

That effort came with a trade-off: When the city of Los Angeles ended covid tests at Dodger Stadium and closed another testing site to help staff the new vaccination center, it removed, at least temporarily, about one-third of all government-run testing in Los Angeles County — the nation's largest county, with a population of 10 million, and one of the biggest covid hot spots.

Sites operated by the city, county or state account for just over one-third of all covid tests in L.A. County, said Dr. Clemens Hong, who heads the county's testing operations.

Diminished testing capacity could lead to longer waits for appointments, which means infected people could potentially expose others for a longer time before learning they have the virus.

But L.A. Mayor Eric Garcetti said that has not happened so far. In what he called an instance of "perfect timing," infection rates in L.A. County have declined since Dodger Stadium switched to vaccinations, and demand for tests has dropped by half to two-thirds, the mayor said Thursday. "We are meeting the need — actually exceeding the need."

Still, he acknowledged that converting the stadium had been a risk – one the city took because "the vaccines will prevent and heal and finally resolve this."

Many health experts agree that prioritizing vaccination over testing is the right move.

"The best way out of our current crisis is masks, few contacts per day and vaccines, so it makes sense to create lots more access points for vaccinations even if it means a bit less testing," said Dr. Bob Kocher, a senior fellow at the University of Southern California's Schaeffer Center for Health Policy & Economics and a former member of the state's COVID-19 Testing Task Force.

But with covid caseloads still high despite their recent decline from peak levels, and mutant strains of the virus threatening to fuel new outbreaks, some senior public health officials say testing remains an equally vital part of the effort to contain — and ultimately suppress — the pandemic.

And it could become even more important in the coming months, as the inoculation campaign gains steam, since the tests could prove a valuable tool for assessing how well the vaccines are working.

"It's hard to say right now, given how many people are sick with covid, that vaccine is more important," said Hong. "It's hard to balance those two against each other, because we really just need a lot of both."

Balancing vaccinations with testing and other covid-related tasks is a significant challenge for public health officials across California and the nation, because those functions draw on many of the same resources — especially the staff needed for administration and record-keeping.

At vaccination sites, keeping good records is essential for planning from day to day how many doses to pull out of the freezer. "It's got to be done right, or else you screw up when the second dose is," said Dr. George Rutherford, an epidemiologist at the University of California-San Francisco.

Sara Bosse, public health director of Madera County, noted that counties across the state have asked Newsom for $400 million in the current budget year to help defray the costs of setting up vaccination sites, including facility costs, security, data entry staffers and clinicians to give the shots and watch for adverse side effects. They are also seeking $280 million for covid testing and $440 million for contact tracing and non-group housing to protect covid-vulnerable residents.

"I think that many counties are prioritizing vaccination, and based on the resources they have, they may pull from various parts of the covid response such as contact tracing or testing," Bosse said. The funding, she said, would help county health officials avoid "those difficult decisions where we have to pull from one part of the covid response to prop up the next."

There could also be federal help on the way: President Joe Biden has announced plans to establish 100 federally supported vaccination centers and allocate $50 billion to expand testing.

In Madera County, a poor rural area of 160,000 people that stretches from the Central Valley into the Sierra Nevada, the state has largely taken over covid testing, allowing the county to focus its resources on vaccinations, Bosse said.

The big challenge on that front, she said, is having enough trained health personnel to run the vaccination sites. The county recently heard from 85 trained clinicians willing to volunteer for the vaccine effort, "which is going to be a game changer for us," Bosse said.

In Los Angeles, the city has the means to add testing capacity elsewhere and beef up mobile testing, Garcetti said. It had been considering a testing site at Pierce College in the San Fernando Valley, "which it looks like we won't need to open," the mayor said.

The city, county and state are also discussing the possibility of a partnership to expand testing at Exposition Park in South L.A.

In San Diego County, health officials expect to face a challenge due to the competition for staffing between vaccination and testing, and they are hiring to meet the need, said Sarah Sweeney, a spokesperson for the county's Health and Human Services Agency. The county hasn't yet converted testing venues to vaccination sites but expects to do so after vaccine supplies increase, she said.

San Bernardino County health officials are committed to maintaining testing at current volumes even as they ramp up vaccinations, said Corwin Porter, the director of public health. But he conceded that doing both at the same time "is a struggle" because "we don't have enough vaccine and we don't have enough staff."

The county is holding hiring events every week and working with multiple partners to find additional resources, "because we are trying not to pull anything out of testing or contact tracing," Porter said.

Beyond the resource question, another big challenge confronts health officials: "There is an issue of divided attention," said L.A. County's Hong. "Now we have two big things to deal with — three if you include contact tracing. I think we will have to be thoughtful about our strategy."

Once a broad swath of the population has been vaccinated, which could take many months, testing volume will likely drop off sharply, said UCSF's Rutherford.

"I don't see hundreds of thousands of tests a day anymore once we get well up on vaccinations," he said. "You'll be testing thousands of people to find tens of cases."

In the meantime, L.A. County will likely add questions to its testing appointment website asking people about their vaccination status, Hong said. "That way we can track what's happening in people who are vaccinated."

Ongoing covid outbreaks may require increased testing, particularly in poorer communities of color, which have been hit hardest by the pandemic — and where hesitancy to be vaccinated is likely to be more widespread, said Hong. "So the bottom line is that testing is not going away."

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Bernard J. Wolfson: bwolfson@kff.org, @bjwolfson

Amid Covid Health Worker Shortage, Foreign-Trained Professionals Sit on Sidelines

KFF Health News, January 25, 2021

The pandemic highlights licensing barriers that predate covid, but many believe it can serve as a wake-up call for state legislatures to address the issue for this crisis and beyond.

This article was published on Monday, January 25, 2021 in Kaiser Health News.

By Markian Hawryluk

As hospitals nationwide struggle with the latest covid-19 surge, it's not so much beds or ventilators in short supply. It's the people to care for the sick.

Yet a large, highly skilled workforce of foreign-educated doctors, nurses and other health practitioners is going largely untapped due to licensing and credentialing barriers. According to the Migration Policy Institute think tank in Washington, D.C., some 165,000 foreign-trained immigrants in the U.S. hold degrees in health-related fields but are unemployed or underemployed in the midst of the health crisis.

Many of these workers have invaluable experience dealing with infectious disease epidemics such as SARS, Ebola or HIV in other countries yet must sit out the covid pandemic.

The pandemic highlights licensing barriers that predate covid, but many believe it can serve as a wake-up call for state legislatures to address the issue for this crisis and beyond. Already, five states — Colorado, Massachusetts, Nevada, New Jersey and New York — have adapted their licensing guidelines to allow foreign-trained health care workers to lend their lifesaving skills amid pandemic-induced staff shortages.

"These really are the cabdrivers, the clerks, the people who walk your dog," said Jina Krause-Vilmar, CEO of Upwardly Global, a nonprofit that helps immigrant professionals enter the U.S. workforce. "They also happen to be doctors and nurses in their home countries, and they're just not able to plug and play into the system as it's set up."

That's left doctors such as Sussy Obando, a 29-year-old from Colombia, jumping through hoops to become physicians in the U.S. In 2013, she graduated after six years of medical school in Colombia, then spent a year treating patients in underserved communities. But when Obando arrived in the U.S., her credentials and experience weren't enough.

While licensure guidelines vary by state, foreign-trained doctors typically must pass a medical licensing exam costing more than $3,500, and then complete at least a year of on-the-job training, known as a residency, in the U.S. For many, including Obando, that means brushing up on their English and learning the relevant medical terminology. She also needed U.S. clinical experience to qualify for a residency, something U.S.-trained doctors achieve through rotations during medical school.

"If you don't know anyone in this field, you have to go door to door to find somebody to give you the opportunity to rotate," Obando said.

She tried emailing Hispanic doctors she found online to ask if she could complete a rotation with one of them. She ended up paying $750 to enter a psychiatry rotation at the University of Texas McGovern Medical School in Houston.

"I tried to go into internal medicine," Obando said. "But because psychiatry was less expensive, I have to go for that."

She also worked for almost a year as a volunteer at Houston's MD Anderson Cancer Center, and is now assisting with clinical trials for covid vaccines at the Texas Center for Drug Development. She's applied for a residency through a national program that matches medical school graduates with residency slots. But it's difficult for foreign-trained physicians to secure a spot, because many are earmarked for U.S. med school graduates. And many residency programs are open only to recent graduates, not those who finished medical school years ago.

"It's competitive for people who trained in the United States to get into a residency program. If you're trained outside the United States, it's even harder," said Jacki Esposito, director of U.S. policy and advocacy for World Education Services, a nonprofit that helps immigrants find jobs in the U.S. and Canada.

That's why states such as Colorado have eased the requirement for a residency during the pandemic. Early on, Colorado officials realized they couldn't license doctors and other health workers because covid lockdowns had canceled required licensing exams. Under an executive order from Democratic Gov. Jared Polis in April, state officials created a temporary licensing program allowing medical school graduates to begin practicing under supervision for six months, and then extended it through June 2021.

Officials created a similar pathway to temporary licensure for foreign medical school graduates who lacked the minimum year of residency.

Colorado also created temporary licenses for foreign-trained nurses, certified nurse's aides, physician assistants and many other health professionals. All of those licenses require supervision from a licensed professional and are valid only as long as the governor's public health emergency declaration remains in effect.

The state relaxed the scope-of-practice rules for those health workers, too, allowing them to perform any task their supervisors assign to them.

"So if you're an occupational therapist, you can give vaccinations as long as they are delegating to you and they're confident you have the skill and knowledge," said Karen McGovern, deputy director of legal affairs for the professions and occupations division at the Colorado Department of Regulatory Agencies. "You can exceed your statutory skill and practice to what needs to be done during the pandemic."

Through mid-December, the state had received 36 applications from foreign-trained doctors seeking temporary licenses, although only one applicant met all the criteria. New Jersey, on the other hand, received more than 1,100 applications for temporary medical licenses last year. (Michigan also issued an executive order allowing temporary licenses, but it was later rescinded.)

Many of the medical professionals stuck on the sidelines have unique skills and experience that would be invaluable during the pandemic. Victor Ladele, 44, finished medical school in Nigeria and treated patients during a drought in Niger in 2005, in the midst of the Darfur genocide in Sudan in 2007 and after a civil war in Liberia in 2010. His family moved to the U.S. a few years later, but Ladele was recruited to help with the Ebola outbreak in West Africa in 2014. What he thought would be a three-month stay turned into a two-year mission.

Now back in Edmond, Oklahoma, working with a U.N. program that helps new business ventures get off the ground, Ladele has found that the challenges of the covid pandemic parallel many of his past experiences. He saw how a program for Ebola contact tracing told people with a cough or fever to call a hotline, which would direct them to a care center. But as soon as the initiative went live, rumors began to spread on social media that European doctors at the care centers were harvesting organs. It took months of outreach to tribal and religious leaders to instill confidence in the system.

He's seen similar misinformation spread about covid and masks.

"If, in Oklahoma, the public health officials had done outreach to all the pastors in the churches and gained their support for masking, would there be more people using masks?" Ladele said.

Ideally, he said, he would like to spend about half his time seeing patients, but the licensing process remains a challenge.

"It's not unsurmountable," he said. But "when I think of all the hurdles to credentialing here, I'm not really sure it's worth the effort."

Upwardly Global helps health professionals navigate that unfamiliar application and credentialing system. Many foreign-trained health workers have never had to write résumés or interview for jobs.

While the pandemic has temporarily eased entry in five states, Krause-Vilmar and others believe it could be a model to address workforce shortages in underserved areas across the country. As of September, the federal Health Resources and Services Administration had designated more than 7,300 health care shortage areas, requiring an additional 15,000 health care practitioners.

"We've had a crisis in access to health care, especially in rural areas, in this country for a long time," she said. "How do we start imagining what that would look like in terms of more permanent licenses for these folks who are helping us recover and rebuild?"

Markian Hawryluk: MarkianH@kff.org, @MarkianHawryluk

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