Knowing it may be met with some skepticism, the Trump administration Thursday announced a sweeping plan that officials say will transform health care in rural America.
Even before the coronavirus pandemic reached into the nation’s less-populated regions, rural Americans were sicker, poorer and older than the rest of the country. Hospitals are shuttering at record rates, and health care experts have long called for changes.
The new plan, released by Health and Human Services Secretary Alex Azar, acknowledges the gaps in health care and other problems facing rural America. It lists a litany of projects and directives, with many already underway or announced within federal agencies.
“We cannot just tinker around the edges of a rural healthcare system that has struggled for too long,” Azar said in a prepared statement.
Yet, that is exactly what experts say the administration continues to do.
“They tinker around the edges,” said Tommy Barnhart, former president of the National Rural Health Association. And, he added, “there’s a lot of political hype” that has happened under President Donald Trump, as well as previous presidents.
In the past few months, rural health care has increasingly become a focus for Trump, whose polling numbers are souring as COVID-19 kills hundreds of Americans every day, drives down restaurant demand for some farm products and spreads through meatpacking plants. Rural states including Iowa and the Dakotas are reporting the latest surges in cases.
This announcement comes in response to Trump’s executive order last month calling for improved rural health and telehealth access. Earlier this week, three federal agencies also announced they would team up to address gaps in rural broadband service — a key need as large portions of the plan seek to expand telehealth.
The plan is more than 70 pages long and the word “telehealth” appears more than 90 times, with a focus on projects across HHS, including the Health Resources and Services Administration and the Centers for Medicare & Medicaid Services.
Barnhart said CMS has passed some public health emergency waivers since the beginning of the pandemic that helped rural facilities get more funding, including one that specifically was designed to provide additional money for telehealth services. However, those waivers are set to expire when the coronavirus emergency ends. Officials have not yet set a date for when the federal emergency will end.
Andrew Jay Schwartzman, senior counselor to the Benton Institute for Broadband & Society, a private foundation that works to ensure greater internet access, said there are multiple challenges with implementing telehealth across the nation. Many initiatives for robust telehealth programs need fast bandwidth, yet getting the money and setting up the necessary infrastructure is very difficult, he said.
“It will be a long time before this kind of technology will be readily available to much of the country,” he said.
Ge Bai, associate professor of accounting and health policy at Johns Hopkins University in Baltimore, noted that telehealth was short on funding in the HHS initiative. However, she said, the focus on telehealth, as well as a proposed shift in payment for small rural hospitals and changing workforce licensing requirements, had good potential.
“We are so close to the election that this is probably more of a messaging issue to cater to rural residents,” Bai said. “But it doesn’t matter who will be president. This report will give the next administration useful guidance.”
The American Hospital Association, representing 5,000 hospitals nationwide, sent a letter to Trump last week recommending a host of steps the administration could take. As of late Thursday, AHA was still reviewing the HHS plan but said it was “encouraged by the increased attention on rural health care.”
Buried within the HHS announcement are technical initiatives, such as a contract to help clinics and hospitals integrate care, and detailed efforts to address gaps in care, including a proposal to increase funding for school-based mental health programs in the president’s 2021 budget.
A senior HHS official said that while some actions have been taken in recent months to improve rural health — such as the $11 billion provided to rural hospitals through coronavirus relief funding — more is needed.
“We’re putting our stake in the ground that the time for talk is over,” he said. “We’re going to move forward.”
SACRAMENTO, Calif. — California lawmakers convened this year with big plans to tackle soaring health care costs, expand health insurance coverage and improve treatment for mental health and addiction.
But the pandemic abruptly reoriented their priorities, forcing them to grasp for legislative solutions to the virus ripping through the state.
Legislative deliberations this year were defined by quarantined lawmakers, emergency recesses and chaotic video voting — plus a late-night partisan dust-up that led to the death of dozens of bills by the time lawmakers gaveled out early Tuesday morning. Nonetheless, legislators managed to send Gov. Gavin Newsom nearly 430 bills, roughly 40% of the number they’d send in a typical year, according to Sacramento lobbyist Chris Micheli.
Among them were about two dozen COVID-related bills that addressed a range of challenges, including dire shortages of protective gear, sick leave for workers and the administration of a hoped-for COVID-19 vaccine. The measures broadly fit into three categories: dealing with the current crisis, protecting workers and consumers, and preparing for future pandemics.
Newsom has until Sept. 30 to sign the bills into law or veto them.
“In a year that couldn’t be business as usual, this session we were still able to get important business done for the people of California who are facing so many challenges,” said Senate President Pro Tem Toni Atkins. “This year’s session may be over, but this pandemic is not, and neither is our work.”
Just as important as the measures that made it to Newsom’s desk were the ones that didn’t. For instance, bills that would have limited the use of sensitive personal information in contact tracing investigations died, as did a proposal to help rebuild and fund public health infrastructure across California.
“It leaves us with the status quo,” said Michelle Gibbons, executive director of the County Health Executives Association of California, which lobbies on behalf of the state’s county health directors. “If we had sufficient staffing of public health all along, and stronger resources, it would have helped.”
Immediate Action
Narrowly focused bills that targeted real-time COVID-related problems — and avoided big price tags — were among those easily winning approval.
AB-685, by Assembly member Eloise Gómez Reyes (D-San Bernardino), would require employers to notify their workers of COVID-19 infections at work — and would mandate the reporting of infection data to state and local public health authorities.
A different measure, AB-2164, would require Medi-Cal, California’s Medicaid program, to cover more telehealth visits in underserved areas by eliminating an existing requirement for patients and providers to establish an in-person relationship first.
But this wouldn’t be a permanent change: If signed, the law would sunset 180 days after the official COVID-19 state of emergency is over. Rivas said he had to scale back the cost of the measure by applying it only to the pandemic to get it passed.
“Had we not done that, it was very likely this bill would have been held in the Senate Appropriations Committee,” said Assembly member Robert Rivas (D-Hollister), who introduced the bill.
Another bill written with near missile-guided precision is AB-1710, which would allow pharmacists to administer a COVID vaccine once one is approved by the Food and Drug Administration.
“We want to make sure we can gear up as quickly as possible,” said Assembly member Jim Wood (D-Santa Rosa), who authored the bill.
Wood also authored AB-2644, which would require nursing homes to have a full-time “infection preventionist,” and to report deaths from communicable diseases to the state during an emergency. Wood said the bill was written after he “watched with horror” as COVID-19 killed thousands of nursing home residents in the spring.
Consumer and Worker Protections
Lawmakers took on powerful business interests to boost protections for essential workers.
A bill introduced by Sen. Jerry Hill (D-San Mateo) would make it easier for some employees infected with COVID-19 to file a workers’ compensation insurance claim until January 2023.
Should Newsom sign SB-1159, for instance, state law would presume that certain front-line workers — from health care workers in hospitals to firefighters who go into people’s homes — were infected on the job unless their employers prove otherwise.
The California Chamber of Commerce, which opposed the measure, questioned whether an employee’s illness could be traced to their job when the virus is so widespread. By varying degrees, at least 14 states have extended workers’ compensation to include COVID-related scenarios, according to the National Conference of State Legislatures.
Frustrated with outbreaks at meatpacking plants, lawmakers also advanced legislation calling on food-processing companies with at least 500 workers to provide two weeks of paid sick leave to those exposed to COVID-19 or advised to quarantine.
The measure, AB-1867, spearheaded by Assembly member Phil Ting (D-San Francisco), also would close a loophole in the federal emergency paid sick leave benefit that Congress authorized this spring, which excluded health care workers and emergency responders. If Newsom signs the bill, they too would qualify for two weeks of paid sick time.
And in what would be the biggest expansion to the state’s family leave program since it began in 2004, lawmakers voted to extend job protections to more workers who wish to take time off to care for a new baby or a sick relative.
California’s family leave program currently exempts small-business workers from the job protections, leaving millions of workers without the benefit. For example, an employee who works for a company with 20 or fewer employees does not qualify for job protection to bond with an infant. Employers with 50 or fewer workers aren’t required to guarantee someone’s job if they leave to care for a sick parent or other family member.
In both cases, that would change to employers with five or more workers if the governor signs SB-1383, introduced by Sen. Hannah-Beth Jackson (D-Santa Barbara).
“In the time of COVID, we are relying on families, grandparents, children to take care of each other when they get sick,” Jackson said. “We should be able to protect ourselves, to take responsibility for ourselves, to be able to protect ourselves without fear of losing our jobs.”
Lessons Learned
Inadequate personal protective gear emerged early on as one of the biggest impediments to California’s coronavirus response — and measures advanced by the legislature could prepare the state for future threats.
“We can be more prepared to protect our state in the next health crisis,” said Assembly Speaker Anthony Rendon.
California lawmakers approved a pair of high-profile bills to address protective equipment shortages. The more ambitious proposal, authored by Assembly member Freddie Rodriguez (D-Pomona), would require hospitals to stockpile a three-month supply by April 2021.
“We’ve already lost far too many members to COVID-19,” said Stephanie Roberson, lead lobbyist for the California Nurses Association, which sponsored AB-2537.
“It’s something that could have been prevented,” Roberson said, adding that “it’s the responsibility of employers to protect their workers.”
Newsom also must decide whether the state government should maintain a supply of protective gear for essential workers. SB-275, from Sen. Richard Pan (D-Sacramento) and sponsored by the Service Employees International Union California, would mandate the California Department of Public Health within one year to establish a PPE stockpile for health and other essential workers to last 90 days during a pandemic.
It also would require major employers of health care workers — such as dialysis clinics, nursing homes and hospitals — to establish by 2023 or later an additional 45-day stockpile of PPE.
An August report from the University of California-Berkeley found that at least 20,860 California cases of COVID-19 among essential workers could have been avoided, as well as dozens of deaths, if the state had had a sufficient supply of protective gear.
The powerful California Hospital Association fought both measures, saying the goals are laudable yet unworkable. “We agree that bolstering the supply and reliability of PPE for health care and other essential workers is a top priority,” said spokesperson Jan Emerson-Shea.
“It is critically important to remember, however, that we are still in the midst of a pandemic and there are still significant challenges with the global supply chain of PPE.”
The number of new cases in Los Angeles County, despite daily bounces up and down, has trended sharply lower in recent weeks — from peaks well above 4,000 in July to figures well under 2,000 by late August.
This article was published on Thursday, September 3, 2020 in Kaiser Health News.
In Los Angeles County, California’s main COVID-19 hot spot since early in the pandemic, key indicators of the disease have taken an encouraging turn recently.
New cases, hospitalizations, deaths and the rate of positive test results have all been dropping.
But because of the surge of infections after the lifting of restrictions in May, followed by a spike after Memorial Day — and another one after July Fourth — health officials and other experts are wary of loosening restrictions too quickly this time. The approaching Labor Day holiday weekend, when people traditionally gather in groups, reinforces their caution.
The daily number of new cases in the county, despite bounces in each direction, has trended sharply lower in recent weeks — from peaks well above 4,000 in July to numbers well under 2,000 by late August.
The seven-day average of daily coronavirus deaths has dropped steadily, from 44 in late July to 19 as of Aug. 25. And the seven-day average rate of positive COVID tests, another widely watched measure, fell from over 9% in early July to about 5% as of Monday.
Barbara Ferrer, L.A. County’s top public health official, expressed guarded optimism but urged caution with regard to any further loosening of restrictions on business or recreation.
“Please, let’s not let down our guard,” she said at a news conference last week. “We did have a surge after each of the other large holidays, so it would not be a good idea to move with haste on reopening plans until we can make sure that we get through Labor Day with people acting appropriately.”
The recent data is “very encouraging,” said Dr. Ravi Kavasery, medical director of quality and population health at AltaMed, one of the nation’s largest community clinic chains. But “it is very clear we are making this progress because we have made these changes to our behavior, and it provides all the more reason for us to stay the course.”
Indeed, a new plan for reopening businesses and other activities, unveiled Friday by California Gov. Gavin Newsom, shows L.A. County has a long way to go before it is out of the woods.
The new plan replaces the state’s previous county “watchlist” with a four-tier, color-coded system that ranks counties by their risk, based on how prevalent the coronavirus is.
Counties with more than 7 new daily cases per 100,000 people, or positive COVID test rates of more than 8%, are defined as highest-risk, with the danger of infection deemed “widespread” (purple). Three lower tiers are defined as counties of “substantial” (red), “moderate” (orange) and “minimal” risk (yellow).
L.A. County is in the “widespread” tier, as are 38 of the 57 other California counties. The state blueprint prohibits many nonessential businesses from operating indoors in these counties, though hair salons and barbershops can open indoors, and retail — including shopping centers — can operate while limited to a maximum of 25% capacity.
Counties must remain in each tier for at least three weeks before advancing to a less risky one. If a county’s indicators worsen for two consecutive weeks, it will be moved to a more restrictive tier.
L.A. County got some welcome news last week when another widely monitored indicator, the 14-day average COVID case rate, dropped below 200 per 100,000 residents — the state’s threshold under which elementary schools can apply for waivers to reopen for in-person classes.
“We are grateful to see this number come down,” Ferrer said, noting that just a few weeks ago the county was at 400 cases per 100,000 residents.
On Wednesday, the county health department announced that K-12 schools can reopen in a limited way to provide services for “small cohorts” of students with special needs, such as individualized education plans and instruction in English as a second language. Schools won’t fully reopen yet for general instruction, the department said.
It’s not certain the county’s case rate will hold under 200, Ferrer said last week, and for all its progress “we are still considered one of the hot spots.”
Hence, her pre-Labor Day message to the public: “Whether you are traveling or staying at home, you need to be mindful of the fact that we all have to reduce our transmission, and the way to do that is to reduce our exposure to other people. So please, always wear that face covering, always keep your distance, always be washing your hands, and make sure you’re avoiding those crowded situations.”
As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center.
This article was published on Thursday, September 3, 2020 in Kaiser Health News.
Dozens of major hospitals across the U.S. are grappling with whether to ignore a federal decision allowing broader emergency use of blood plasma from recovered COVID patients to treat the disease in favor of dedicating their resources to a gold-standard clinical trial that could help settle the science for good.
As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center, said principal investigator Dr. Todd Rice.
Officials at some hospitals said they are considering committing only to the clinical trial — and either avoiding or minimizing use of convalescent plasma through an emergency use authorization issued Aug. 23 by the federal Food and Drug Administration.
The response comes amid concerns that the Trump administration pressured the FDA into approving broader use of convalescent plasma, which already has been administered to more than 77,000 COVID patients in the U.S. President Donald Trump characterized the treatment as a "powerful therapy," even as government scientists called for more evidence that COVID plasma is beneficial.
A National Institutes of Health panel this week countered the FDA's decision, saying that the therapy "should not be considered the standard of care for the treatment of patients with COVID-19" and that well-designed trials are needed to determine whether the therapy is helpful. Data so far suggests the treatment could be beneficial, but it's not definitive.
"It's an important scientific question that we don't have the answer to yet," said Rice, an associate professor of medicine and director of VUMC's medical intensive care unit.
Convalescent plasma uses an antibody-rich blood product taken from people who have recovered from a viral infection and injects it into people still suffering in the hopes that the therapy will jump-start their immune systems, boosting their ability to fight the virus. The approach has been used on an experimental basis for more than a century to fight other virulent diseases, including the 1918 flu, measles, Ebola, SARS and H1N1 influenza.
Last month, NIH officials awarded $34 million to Rice's study, the Passive Immunity Trial of the Nation for COVID-19, dubbed PassItOnII, which has also received funding from country music superstar Dolly Parton. The trial, which aims to enroll 1,000 adult hospitalized patients, could meet its goals by the end of October. If it shows evidence of likely benefit to COVID patients, it could immediately change clinical practice, Rice said.
Half of the participants will receive convalescent plasma with high levels of disease-fighting antibodies from a stockpile of more than 150 units of the product already collected, Rice said. The other half will receive a placebo solution.
Though the trial launched in April, enrollment has been slow. The funding allows enlistment at more than 50 sites nationwide. That has spurred new conversations about joining the trial — and about not employing the controversial authorization issued by the FDA, said Dr. Claudia Cohn, director of the Blood Bank Laboratory at the University of Minnesota Medical School. She expected her institution to decide this week.
"I'd rather frame it as not rejecting the FDA, but simply taking the longer view," said Cohn, who is also medical director for the AABB, an international nonprofit focused on transfusion medicine and cellular therapies.
At the Ohio State University Wexner Medical Center, officials have opted to join the trial and are considering making it "the first option" for COVID patients who qualify, said Dr. Sonal Pannu, an assistant professor and pulmonologist.
"Many of the academic leaders believe we should do the trial, and we would be severely limiting" the emergency use authorization, or EUA, she said, noting that first patients could be enrolled soon. The plasma still could be used under the EUA to treat patients such as prisoners, who are unable to consent to join a clinical trial, she added.
That's the same stance adopted by the University of Washington, said Dr. Nicholas Johnson, an assistant professor of emergency medicine who's leading the trial at the Seattle site. "We're really interested in enrolling patients as the first option," he said.
The questions are similar to those raised with hydroxychloroquine, another treatment Trump touted for treating COVID-19. FDA officials issued an EUA for the drug in April, only to revoke it in June after data indicated the drug might be harmful.
"On a couple of occasions, we've allowed clinical practice to get ahead of the science," Johnson said. "We've learned that lesson a couple of times now."
FDA officials did not respond to requests for comment.
Top federal health leaders, including NIH Director Dr. Francis Collins and Dr. Anthony Fauci, the nation's leading infectious disease doctor, initially resisted the move to issue the EUA for convalescent plasma last month, telling The New York Times that the evidence for it was too weak.
Trump has criticized the FDA for moving too slowly to speed approval of treatments and vaccines for COVID-19. He announced the EUA on the eve of the Republican National Convention, calling it a "truly historic announcement."
Issuing the EUA puts the fate of clinical trials into "extreme jeopardy," said Arthur Caplan, a professor of bioethics at the New York University School of Medicine. With convalescent plasma in very short supply, it sets the stage for fights over access and makes sick patients less inclined to join a trial, where they might receive a placebo.
"If you have the EUA, it starts to damage the trials," Caplan said.
Still, given that the FDA has authorized convalescent plasma for patients ill with COVID-19, hospitals that hesitate or refuse to provide it outside a trial are sure to face questions from families.
That creates "a very interesting and delicate ethics problem," said Cohn.
"If you commit to the randomized controlled trial only, you're committing to a long-term dedication to science," she said. "The question is, is it ethically inappropriate not to provide a therapy that has been shown to be possibly beneficial?"
Johnson, at the University of Washington, said most patients have been willing — even eager — to participate in clinical trials once they understand the need for rigorous scientific results.
And Caplan, the bioethicist, applauded the decision of hospitals to minimize the EUA and focus on the trial, calling it "a pretty feisty action."
"It's sensible," he said. "It's likely to really generate an answer to the question of 'Does COVID convalescent plasma do anything?'"
A COVID-19 vaccine could be available earlier than expected if ongoing clinical trials produce overwhelmingly positive results, said Dr. Anthony Fauci, the nation’s top infectious disease official, in an interview Tuesday with KHN.
Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.
The Data and Safety Monitoring Board could say, “‘The data is so good right now that you can say it’s safe and effective,’” Fauci said. In that case, researchers would have “a moral obligation” to end the trial early and make the active vaccine available to everyone in the study, including those who had been given placebos — and accelerate the process to give the vaccine to millions.
Fauci’s comments come at a time of growing concern about whether political pressure from the Trump administration could influence federal regulators and scientists overseeing the nation’s response to the novel coronavirus pandemic, and erode shaky public confidence in vaccines. Prominent vaccine experts have said they fear Trump is pushing for an early vaccine approval to help win reelection.
Fauci, director of the National Institute of Allergy and Infectious Diseases, said he trusts the independent members of the DSMB — who are not government employees — to hold vaccines to high standards without being politically influenced. Members of the board are typically experts in vaccine science and biostatistics who teach at major medical schools.
“If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective,” Fauci said. “I’m not concerned about political pressure.”
The safety board periodically looks at data from a clinical trial to determine if it’s ethical to continue enrolling volunteers, who are randomly assigned to receive either an experimental vaccine or a placebo shot. Neither the volunteers nor the health workers who vaccinate them know which shot they’re receiving.
Manufacturers are now testing three COVID vaccines in large-scale U.S. trials. The first two studies — one led by Moderna and the National Institutes of Health and the other led by Pfizer and BioNTech — began in late July. Each study was designed to enroll 30,000 participants. Company officials have said both trials have enrolled about half that total. AstraZeneca, which has been running large-scale clinical trials in Great Britain, Brazil and South Africa, launched another large-scale vaccine study this week in the U.S., involving 30,000 volunteers. Additional vaccine trials are expected to begin this month.
In trials of this size, researchers will know if a vaccine is effective after as few as 150 to 175 infections, said Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, in a call with reporters Friday.
“It may be surprising, but the number of events that need to occur is relatively small,” Redfield said.
Right now, only the safety board has access to the trial data, said Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services. As for when trial results will be available, “we cannot determine if it will be the middle of October or December.”
Safety boards set “stopping rules” at the beginning of a study, making their criteria for ending a trial very clear, said Dr. Eric Topol, executive vice president for research at Scripps Research in San Diego and an expert on the use of data in medical research.
Although the safety board can recommend stopping a trial, the ultimate decision to halt a study is made by the scientists running the trial, Topol said.
A vaccine manufacturer could then apply to the Food and Drug Administration for an emergency use authorization, which can be granted quickly, or continue through the regular drug approval process, which requires more time and evidence.
Safety monitors also can stop a trial because of safety concerns, “if it looks like it’s actually harming people in the vaccine arm, due to a lot of adverse events,” Fauci said.
Fauci said people can trust the process, because all the data that outside monitors used to make their decisions would be made public.
“All of that has to be transparent,” Fauci said. “The only time you get concerned is if there is any pressure to terminate the trial before you have enough data on safety and efficacy.”
Topol and other scientists have sharply criticized the FDA in recent weeks, accusing Commissioner Stephen Hahn of bowing to political pressure from the Trump administration, which has pushed the agency to approve COVID treatments faster.
Stopping trials early poses a number of risks, such as making a vaccine look more effective than it really is, Topol said.
“If you stop something early, you can get an exaggerated benefit that isn’t real,” because less positive evidence only emerges later, Topol said.
Stopping the studies early also could prevent researchers from recruiting more minority volunteers. So far, only about 1 in 5 trial participants are Black or Hispanic. Given that Blacks and Hispanics have been hit harder than other groups by the pandemic, Topol said, it’s important that they make up a larger part of vaccine trials.
Ending vaccine trials early also carries safety risks, said Dr. Paul Offit, a vaccine developer who serves on an NIH advisory panel on COVID vaccines and treatments.
A smaller, shorter trial could fail to detect important vaccine side effects, which could become apparent only after millions of people have been immunized, said Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Researchers will continue to follow vaccinated volunteers for a full year to look for long-term side effects, Redfield said.
And Fauci acknowledged that cutting a trial short could undermine public confidence in COVID vaccines. One American in three is unwilling to get a COVID vaccine, according to a recent Gallup Poll.
Health departments that have been underfunded for decades say they currently lack the staff, money and tools to educate people about vaccines and then to distribute, administer and track hundreds of millions of doses.
This article was published on Wednesday, September 2, 2020 inKaiser Health News.
Millions of Americans are counting on a COVID-19 vaccine to curb the global pandemic and return life to normal.
While one or more options could be available toward the end of this year or early next, the path to delivering vaccines to 330 million people remains unclear for the local health officials expected to carry out the work.
"We haven't gotten a lot of information about how this is going to roll out," said Dr. Umair Shah, executive director of Texas' Harris County Public Health department, which includes Houston..
In a four-page memo this summer, the federal Centers for Disease Control and Prevention told health departments across the country to draft vaccination plans by Oct. 1 "to coincide with the earliest possible release of COVID-19 vaccine."
But health departments that have been underfunded for decades say they currently lack the staff, money and tools to educate people about vaccines and then to distribute, administer and track hundreds of millions of doses. Nor do they know when, or if, they'll get federal aid to do that.
Dozens of doctors, nurses and health officials interviewed by KHN and The Associated Press expressed concern about the country's readiness to conduct mass vaccinations, as well as frustration with months of inconsistent information from the federal government.
The gaps include figuring out how officials will keep track of who has gotten which doses and how they'll keep the workers who give the shots safe, with enough protective gear and syringes to do their jobs.
With only about half of Americans saying they would get vaccinated, according to a poll from AP-NORC Center for Public Affairs Research, it also will be crucial to educate people about the benefits of vaccination, said Molly Howell, who manages the North Dakota Department of Health's immunization program.
The unprecedented pace of vaccine development has left many Americans skeptical about the safety of COVID-19 immunizations; others simply don't trust the federal government.
"We're in a very deep-red state," said Ann Lewis, CEO of CareSouth Carolina, a group of community health centers that serve mostly low-income people in five rural counties in South Carolina. "The message that is coming out is not a message of trust and confidence in medical or scientific evidence."
And while states, territories and 154 large cities and counties received billions in congressional emergency funding, that money can be used for a variety of purposes, including testing and overtime pay.
An ongoing investigation by KHN and the AP has detailed how state and local public health departments across the U.S. have been starved for decades, leaving them underfunded and without adequate resources to confront the coronavirus pandemic. The investigation further found that federal coronavirus funds have been slow to reach public health departments, forcing some communities to cancel non-coronavirus vaccine clinics and other essential services.
States are allowed to use some of the federal money they've already received to prepare for immunizations. But KHN and the AP found that many health departments are so overwhelmed with the current costs of the pandemic — such as testing and contact tracing — that they can't reserve money for the vaccine work to come. Health departments will need to hire people to administer the vaccines and systems to track them, and pay for supplies such as protective medical masks, gowns and gloves, as well as warehouses and refrigerator space.
CareSouth Carolina is collaborating with the state health department on testing and the pandemic response. They used federal funding to purchase $140,000 retrofitted vans for mobile testing that they plan to continue to use to keep vaccines cold and deliver them to residents when the time comes, said Lewis.
But most vaccine costs will be new.
Pima County, Arizona, for example, is already at least $30 million short of what health officials need to fight the pandemic, let alone plan for vaccines, said Dr. Francisco Garcia, deputy county administrator and chief medical officer.
Some federal funds will expire soon. The $150 billion that states and local governments received from a fund in the CARES Act, for example, covers only expenses made through the end of the year, said Gretchen Musicant, health commissioner in Minneapolis. That’s a problem, given vaccine distribution may not have even begun.
Although public health officials say they need more money, Congress left Washington for its summer recess without passing a new pandemic relief bill that would include additional funding for vaccine distribution.
"States are anxious to receive those funds as soon as possible, so they can do what they need to be prepared," said Dr. Kelly Moore, associate director of immunization education at the Immunization Action Coalition, a national vaccine education and advocacy organization based in St. Paul, Minnesota. "We can't assume they can take existing funding and attempt the largest vaccination campaign in history."
What's the Plan?
Then there's the basic question of scale. The federally funded Vaccines for Children program immunizes 40 million children each year. In 2009 and 2010, the CDC scaled up to vaccinate 81 million people against pandemic H1N1 influenza. And last winter, the country distributed 175 million vaccines for seasonal influenza vaccine, according to the CDC.
But for the U.S. to reach herd immunity against the coronavirus, most experts say, the nation would likely need to vaccinate roughly 70% of Americans, which translates to 200 million people and — because the first vaccines will require two doses to be effective — 400 million shots.
Although the CDC has overseen immunization campaigns in the past, the Trump administration created a new program, Operation Warp Speed, to facilitate vaccine development and distribution. In August, the administration announced that McKesson Corp., which distributed H1N1 vaccines during that pandemic, will also distribute COVID-19 vaccines to doctors' offices and clinics.
"With few exceptions, our commercial distribution partners will be responsible for handling all the vaccines," Operation Warp Speed's Paul Mango said in an email.
"We're not going to have 300 million doses all at once," said Mango, deputy chief of staff for policy at the Health and Human Services Department, despite earlier government pledges to have that many doses ready by the new year. "We believe we are maximizing our probability of success of having tens of millions of doses of vaccines by January 2021, which is our goal."
Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, said it will take time for the vaccines to be widespread enough for life to return to what's considered normal. "We have to be prepared to deal with this virus in the absence of significant vaccine-induced immunity for a period of maybe a year or longer," Adalja said in August.
In preliminary guidance for state vaccine managers, the CDC said doses will be distributed free of charge from a central location. Health departments' local vaccination plans may be reviewed by both the CDC and Operation Warp Speed.
The CDC has vetted state and federal vaccination plans in five locations: North Dakota, Florida, California, Minnesota and Philadelphia. No actual vaccines were distributed during the "microplanning" sessions, which focused on how to get vaccines to people in places as different as urban Philadelphia, where pharmacies abound, and rural North Dakota, which has few chain drugstores but many clinics run by the federal Indian Health Service, said Kris Ehresmann, who directs infectious disease control at the Minnesota Department of Health.
Those planning sessions have made Ehresmann feel more confident about who's in charge of distributing vaccines. "We are getting more specific guidance from CDC on planning now," she said. "We feel better about the process, though there are still a lot of unknowns."
Outdated Technology Could Hamper Response
Still, many public health departments will struggle to adequately track who has been vaccinated and when, because a lack of funding in recent decades has left them in the technological dark ages, said Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials.
In Mississippi, for example, health officials still rely on faxes, said the state's health officer, Dr. Thomas Dobbs. "You can't manually handle 1,200 faxes a day and expect anything efficient to happen," he said.
When COVID-19 vaccines become available, health providers will need to track where and when patients receive their vaccines, said Moore, the medical director of Tennessee's immunization plan during the H1N1 influenza pandemic in 2009 and 2010. And with many different shots in the works, they will need to know exactly which one each patient got, she said.
People will need to receive their second COVID-19 dose 21 or 28 days after the first, so health providers will need to remind patients to receive their second shot, Moore said, and ensure that the second dose is the same brand as the first.
The CDC will require vaccinators to provide "dose-level accounting and reporting" for immunizations, so that the agency knows where every dose of COVID-19 vaccine is "at any point in time," Moore said. Although "the sophistication of these systems has improved dramatically" in the past decade, she said, "many states will still face major challenges meeting data tracking and reporting expectations."
The CDC is developing an app called the Vaccine Administration Monitoring System for health departments whose data systems don't meet standards for COVID-19 response, said Claire Hannan, executive director of the Association of Immunization Managers, a nonprofit based in Rockville, Maryland.
"Those standards haven't been released," Hannan said, "so health departments are waiting to invest in necessary IT enhancements." The CDC needs to release standards and data expectations as quickly as possible, she added.
Meanwhile, health departments are dealing with what Minnesota's Ehresmann described as "legacy" vaccine registries, sometimes dating to the late 1980s.
A Historic Task
Overwhelmed public health teams are already working long hours to test patients and trace their contacts, a time-consuming process that will need to continue even after vaccines become available.
When vaccines are ready, health departments will need more staffers to identify people at high risk for COVID-19, who should get the vaccine first, Moore said. Public health staff also will be needed to educate the public about the importance of vaccines and to administer shots, she said, as well as monitor patients and report serious side effects.
At an August meeting about vaccine distribution, Dr. Ngozi Ezike, director of Illinois' health department, said her state will need to recruit additional health professionals to administer the shots, including nursing students, medical students, dentists, dental hygienists and even veterinarians. Such vaccinators will need medical-grade masks, gowns and gloves to keep those workers safe as they handle needles amid the contagious coronavirus.
Many health officials say they feel burned by the country's struggle to provide hospitals with ventilators last spring, when states found themselves bidding against one another for a limited supply. Those concerns are amplified by the country's continuing difficulties providing enough testing kits; supplying health workers with personal protective equipment; allocating drugs such as remdesivir; and recruiting contact tracers — who track down everyone with whom people diagnosed with COVID-19 have been in contact.
Although Ehresmann said she's concerned Minnesota could run out of syringes, she said the CDC has assured her they will provide them.
Given that vaccines are far more complex than personal protective equipment and other medical supplies — one vaccine candidate must be stored at minus 94 degrees Fahrenheit — Plescia said people should be prepared for shortages, delays and mix-ups.
"It's probably going to be even worse than the problems with testing and PPE," Plescia said.
Associated Press writer Michelle R. Smith and KHN Midwest correspondent Lauren Weber contributed to this report.
This story is a collaboration between The Associated Press and KHN.
SACRAMENTO — After years of failed attempts and vociferous opposition, California lawmakers on Monday adopted a measure to grant nurse practitioners the ability to practice without doctor supervision — but only after making big concessions to the powerful doctors' lobby, which nonetheless remains opposed.
The bill now heads to Gov. Gavin Newsom for consideration, fenced in by amendments that would stringently limit how much independence nurse practitioners — nurses with advanced training and degrees — can have to practice medicine.
Lawmakers credit these compromises, like them or not, for finally allowing them to push the issue over the finish line, capping years of political scrapping and perhaps one day altering the delivery of healthcare in California.
"This is not an intrusion on a hallowed profession, it's a relief," said state Sen. John Moorlach (R-Costa Mesa), one of four Republican senators who voted for the bill. Moorlach said the measure would get more practitioners into underserved areas that don't have enough doctors.
"It's like the cavalry coming up over the hill to provide reinforcements to a tired army of wonderful and overworked doctors," he said.
California is behind most other states in empowering nurse practitioners. If the bill becomes law, the state would join nearly 40 others to grant some level of independence to nurse practitioners; 22 grant full independence, according to the American Association of Nurse Practitioners. California would have among the most restrictive policies on nurse practitioner independence in the country.
"I'm not going to say I regret any of these changes," said Assembly member Jim Wood (D-Santa Rosa), who chairs the Assembly Health Committee and authored the bill, AB-890.
Wood opposed previous attempts to remove supervision requirements.
"I wish it could be a little less strict, quite frankly," he said, adding that this was a reasonable compromise informed by his experiences as a dentist and what he learned from other providers.
Today, nurse practitioners must enter into a written agreement with a physician to oversee their work with patients. In exchange, physicians bill them between $5,000 and $15,000 per year, according to a report by the California Healthcare Foundation and the University of California-San Francisco. (California Healthline is an editorially independent service of the California Healthcare Foundation.)
"Where we are with the pandemic and the craziness of the world today, it highlights why there's a need for this," said Andrew Acosta, a spokesperson for the California Association for Nurse Practitioners. "The doctor shortage isn't going away anytime soon."
Under Wood's measure, nurse practitioners would be able to see patients in their own practice, but only after working under physician supervision for at least three years. The bill also contains many other restrictions.
Nurse practitioners argue that the measure, even with its limitations, would ease primary care shortages, especially in rural areas — a problem the pandemic has made more stark.
Opponents, primarily the powerful California Medical Association, which is the doctors' lobbying group, counter that stripping nurse practitioners of physician oversight would lead to a lower standard of care, and that nurse practitioners wouldn't necessarily flock to rural areas once they're free of physician supervision.
These arguments aren't new in Sacramento, but lawmakers and lobbyists say this version of the bill succeeded because there are new leaders at the helm of influential legislative committees who were willing to make changes, and because the pandemic has changed healthcare.
"I think the legislature is starting to realize decades of evidence that nurse practitioners are safe, productive providers," said Ed Hernandez, a former legislator who was termed out in 2018 and authored the last two failed bills. "I think the policy is finally overshadowing the politics" of the California Medical Association.
Still, the biggest difference this year is the bill itself. Hernandez's bills, introduced in 2013 and 2015, were "clean" bills that granted independence to nurse practitioners without many requirements.
There's nothing clean about Wood's bill, which was heavily amended in the state Senate. Instead of simply lifting the supervision requirements on nurse practitioners, the measure imposes several hoops for nurse practitioners to jump through. Before they could practice independently, nurse practitioners would have to be certified by preapproved national nursing boards, and possibly complete additional California-specific testing if accredited out of state.
Once certified, they would have to practice under physician supervision for at least three years — up to six in some cases — before they could strike out on their own. And they would have to disclose to patients that they aren't doctors.
The bill even prescribes a Spanish phrase for "nurse practitioner": enfermera especializada. (Technically, this refers to a female nurse. The bill doesn't provide the equivalent phrase for a male nurse.)
That's not even all the amendments — and the measure wouldn't take effect until 2023.
The requirements were inserted in response to criticism from the California Medical Association that nurse practitioners are not qualified to provide patient care without physician oversight, and that patients wouldn't understand that they're seeing someone with less training than a doctor, lawmakers said.
Despite the numerous amendments, the association remains opposed, saying the changes don't address their fundamental concerns.
"We've increased the training required for physicians over the last couple years and now all of a sudden we're allowing unsupervised providers to treat patients who have even less training," said association spokesperson Anthony York.
Rounds of negotiations, major concessions and hourslong Zoom calls still could not get the doctors' group on board, Wood said.
He said it was like chasing "goalposts that continue to move."
"It's very disappointing when you work with opposition and nothing is ever good enough," Wood said. "CMA will never support this bill. They'll never go neutral on it."
York said that characterization is not accurate. He pointed to a different bill — SB-1237 — that would allow certified nurse midwives to attend to low-risk pregnancies without physician supervision. The association was initially opposed, but after negotiations and amendments to the bill, it changed its position to neutral. That bill is also headed to Newsom.
"You don't have to look too far to find a case where we were willing to engage on a scope-of-practice issue," York said.
David McCuan, a political science professor at Sonoma State University, called the association's inability to kill Wood's bill a political "watershed moment" for the group.
"Their M.O. for 70 years has been about blocking, stunting and preventing change," McCuan said. "The deference toward the medical profession has changed. In that sense, it would be a momentous event if this is signed."
Though the California Association for Nurse Practitioners is celebrating legislative passage of the measure, even in its amended form, it's a different story at the national level. Sophia Thomas, president of the American Association of Nurse Practitioners, said in a statement that the bill is choked by too much red tape to provide any meaningful change.
"California's so-called 'solution,' the flawed AB-890, would establish a cascading set of new restrictions on NP practice that would maintain California's position among the most heavily regulated and restrictive in the nation," Thomas said.
State Sen. Richard Pan (D-Sacramento), a pediatrician who chairs the Senate Health Committee, said he also opposed the bill, but not simply because he is a doctor or a member of the California Medical Association.
Yet many of his objections reflect those of the association, such as concerns about training and access to care in rural areas.
He also believes independence for nurse practitioners could exacerbate inequalities in the healthcare system, as people with less means see providers with less training.
"People with more resources are going to go with the person they think is more qualified. That's just the way it tends to happen," Pan said.
California Healthline's Angela Hart contributed to this report.
Instead of being celebrated for their difficult and dangerous work, public health officials face violent threats and political attacks from those who disagree with their tactics.
This article was published on Tuesday, September 1, 2020 in Kaiser Health News.
As a veteran who served back-to-back tours in Iraq, I initially cringed when commentators compared the COVID-19 crisis to wartime — no bullets, no blood and no one volunteered for this.
But after my months of reporting on the pandemic, it has become painfully clear this is like war. People are dying every day as a result of government decisions — and indecision — and the death toll is climbing with no end in sight.
Less than six months into the pandemic, COVID-19 has already killed at least 183,000 Americans, more than triple the number who died in the Vietnam War, and far more than the wars in Iraq and Afghanistan combined.
We are all being asked to make sacrifices for the good of our country. And we're experiencing, as a nation, a deeply traumatic event. Like war, the toll will be felt for a long time.
In California, local public health officials are leading the front lines in this battle against COVID-19, dictating strategy, issuing orders and developing tactics to carry out that strategy. Every day, they make gut-wrenching calls to protect our health and livelihoods, even if those decisions may inflict initial harm on the economy or contradict politicians and popular opinion.
But instead of being celebrated for their difficult and dangerous work, as I was, they are now facing violent threats and political attacks from those who disagree with their tactics — such as requiring masks in public and ordering businesses and parks closed to prevent the spread of infection.
I can't imagine being afraid of the people I signed up to protect.
When I interview them, often late at night, I hear in their voices that familiar mix of emotions that often come with war: exhaustion, anxiety and devotion to duty.
"We've become easy scapegoats for people's fear and anxiety during COVID-19," said Dr. Gail Newel, the health officer for Santa Cruz County, who continues to face threats for issuing public health orders.
The latest — a menacing email sent to her in late July calling her a "communist bitch" — prompted local law enforcement to recommend she get a guard dog and firearm to protect herself. "That weighs very heavily," she said.
I can't imagine the burden. Although many of us serving in Iraq disagreed with the war, we remained dedicated to our mission and enjoyed broad support at home.
I joined the military as a U.S. Army reservist in 1999 and was deployed on active duty to Iraq in early 2003, when it truly was like the Wild West.
Serving first as logistics clerk and then the acting supply sergeant for a military police company out of San Jose, California, I helped ensure my military brothers and sisters had proper equipment. When the George W. Bush administration sent us to Iraq, for example, it did so without armoring our Humvees — a major failure that elevated our risk of being blown up by roadside explosives.
I returned home in July 2004 and spent years putting the battlefield behind me as I transitioned to a career in journalism. But living through COVID-19 has resurrected those feelings of being at war.
Now, just like then, there is an overall sense of fear and uncertainty because we don't know when the crisis will end. We aren't free to go about our lives as we once did and we yearn for the comforts we took for granted. We miss our loved ones we can't see.
We must remain hyper-vigilant to potential threats, and even make sure to don our "armor" when we leave our homes, except now it's masks and gloves instead of helmets and flak jackets.
There's something that happens when you're in a conflict zone — the air feels heavier. You can feel threats all around you, just waiting to strike. There's deep anxiety for what the future holds, and you wonder whether you'll be alive next week or next month.
Living through COVID-19 has resurrected those feelings of being at war.
Public health officers are shouldering the added anxiety that duty brings. For much of the pandemic, Gov. Gavin Newsom has pushed the responsibility — and blame — of reopening largely onto counties and the state's 61 local health officers, who have worked for months without days off, giving up time with their families to attack this crisis head-on.
I have interviewed dozens of them. Some have broken into tears while talking with me, and worry chokes their voices as they lament problems with testing or explain how they don't have enough supplies or contact tracers to safely reopen. They felt rushed into lifting stay-at-home restrictions in May and June, yet they had no choice in the face of pressure from politicians and suffering residents and businesses. After years of severe underfunding, public health agencies don't have the money or resources to deploy an adequate response.
They're also wrestling with the guilt and trauma that come with making decisions that affect people's lives and livelihoods.
"It has been hard on all of us," acknowledged Sacramento County's health officer, Dr. Olivia Kasirye. "We're getting phone calls daily from people saying they're going bankrupt and they can't pay their rent and they have loved ones who are dying that they can't see."
I know how that feels, having been conflicted about our long-term strategy in the Middle East and the harm we inadvertently inflicted on innocent civilians. But I can't imagine being afraid of the people I signed up to protect.
Public health officials have become targets of aggressive and personal attacks. Some have seen their photos smeared with Hitler mustaches, while others have had their personal phone numbers and home addresses circulated publicly, prompting the need for round-the-clock security.
"Imagine treating American soldiers and military families with the kind of hatred and disrespect that local health officers are facing," said Dr. Charity Dean, unprompted, a day after she left her job as one of the top public health officials in the Newsom administration. "They're the ones taking all the risk, and it makes me angry to see how they've been treated."
Mimi Hall, Newel's boss and Santa Cruz County's top public health official, told me law enforcement is investigating a threatening letter addressed to her that was allegedly signed by a far-right anti-government extremist group.
In response, Hall considered retiring early. But she didn't want to abandon her troops and wasn't going to let fear stop her from doing her job. So she had a perimeter fence and home security system installed over the weekend — and reported for work promptly Monday morning.
Yes, we are waging a life-or-death battle in which innocent people are hurt, but it's these battle-scarred public health officers who are making deeply personal sacrifices to steer us to safety.
We commemorate military leaders with medals and parades. Why not treat our public health officials with the same level of appreciation?
A bill, SB-852, opens the door for California to make its own generic drugs in the future. Gov. Gavin Newsom will have until Sept. 30 to sign or veto the measure.
This article was published on Tuesday, September 1, 2020 in Kaiser Health News.
SACRAMENTO — California is poised to become the first state to develop its own line of generic drugs, targeting soaring drug prices and stepping into a fiercely competitive drug market dominated by deep-pocketed pharmaceutical companies.
The Democratic-controlled legislature overwhelmingly approved a measure Monday that would direct the state's top health agency to partner with one or more drug companies by January to make or distribute a broad range of generic or biosimilar drugs — including the diabetes medicine insulin — that are cheaper than brand-name products.
The bill, SB-852, also opens the door for California to make its own generic drugs in the future.
Gov. Gavin Newsom will have until Sept. 30 to sign or veto the measure.
"People need these drugs, but prices are through the roof, so we're saying there's a role for the state to bring prices down," said the bill's author, state Sen. Richard Pan (D-Sacramento).
He argued the measure is more important than ever because COVID-19 has exposed "glaring gaps" in the ability of public and private entities — from major hospitals to government drug purchasers — to maintain adequate supplies of drugs, medical equipment and devices.
"This also creates a model to address drug shortages and other supply chain issues during COVID and future pandemics," he said.
Newsom, a Democrat, floated his own generic drug proposal in January as part of his broader drug agenda to reduce pharmaceutical costs, but was forced to abandon his plan in May as he and lawmakers sought to address a pandemic-induced $54 billion budget deficit.
Though it could take years to successfully bring a new California generic product to the market, the move would put the nation's most populous state in direct competition with major generic and brand-name drug manufacturers that dominate the market, and potentially allow California to use its massive purchasing power to drive down drug prices.
"Other legislative efforts in Congress and in other states have focused on government negotiating with pharmaceutical companies to lower prices on generic drugs," said Edwin Park, research professor at the Health Policy Institute at Georgetown University.
The Pharmaceutical Research and Manufacturers of America, which represents brand-name drugmakers, has taken a neutral position on the bill and declined to comment.
But Brett Michelin, lead lobbyist for the Washington, D.C.-based trade group that represents generic drugmakers, the Association for Accessible Medicines, said generic companies aren't threatened by the possibility of California entering the market — and even welcome it.
"Generic manufacturers are more than open to doing this kind of partnership," Michelin said. "I think having a fair and open process to sell drugs and compete for customers is what the generic industry is very used to and comfortable with."
Under the measure, state-developed generics would be "widely" available to public and private purchasers within California. Taxpayers would pick up the costs, roughly $1 million to $2 million in startup funding, plus ongoing staff costs estimated in the low hundreds of thousands of dollars annually, according to a state fiscal analysis.
It's unclear which drugs the state would make or procure, though it would target drugs that could produce the biggest cost savings for the state and consumers.
But the bill specifically calls for the production of "at least one form of insulin, provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in savings."
Insulin is a biologic drug, made with living cells. Once a biologic hits the market, rival copycat products that follow are called biosimilars.
Three major drug companies — Eli Lilly and Co., Sanofi and Novo Nordisk — have long controlled the lucrative insulin market in the U.S. The state of California would be the first entity to produce a biosimilar version of one of the newer, fast- and long-acting insulins on a not-for-profit basis, said Jane Horvath, a health policy consultant in Washington, D.C.
Although it would be costly and could take years, the Utah-based nonprofit drug company Civica Rx, which has consulted with Pan on his bill, is discussing partnering with California to produce generic or biosimilar drugs. It has already hammered out deals with major health systems running short on critical drugs, including the Department of Veterans Affairs, and is producing lower-cost generics for insurers, including Blue Shield of California.
"There's no doubt insulin would be a more complex and expensive drug to develop, but it's certainly possible," said Allan Coukell, the company's senior vice president of public policy. "We are watching how the biosimilar market develops."
Patients who need insulin have faced huge cost spikes. A 2019 report by the Healthcare Cost Institute concluded that average prices for insulin doubled from 2012 to 2016. And California health insurance regulators found last year that diabetes medications accounted for nine of the 25 costliest brand-name drugs sold in the state.
"It's a big deal — diabetes affects a lot of people who rely on insulin for their very lives," said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. "And insulin has probably been the poster child for unreasonable drug pricing." (Kaiser Health News, which produces California Healthline, is an editorially independent program of the foundation.)
Laura Marston, a Washington, D.C.-based lawyer and diabetic who advocates for lower insulin prices, said she's excited about California's idea.
Marston has been on the same insulin, Humalog, since 1996. At that time, the price was $21 a vial, but has since ballooned to more than $275 a vial, she said.
"If there was a lower-cost option and the price wasn't going to be raised, I would absolutely switch from Humalog," she said. "I feel held totally hostage to these pharmaceutical companies."
Marston said she'd like the federal government to do the same thing, "so it could apply to all patients."
Congressional efforts to tackle rising prices for insulin and other drugs fizzled last year in the face of opposition from the influential pharmaceutical lobby. So states have increasingly sought ways to regulate a for-profit industry in which brand-name manufacturers hold near-monopoly power.
Colorado last year becamethe first state to cap out-of-pocket insulin costs at $100 for a 30-day supply. It was followed by at least nine other states, from New Mexico to New York, whose cost-sharing caps vary.
California had already capped out-of-pocket drug costs at $250 to $500 for a 30-day supply, but a measure that would have lowered the cap for insulin to $100 a month stalled this year — a casualty of a pandemic-shortened legislative calendar.
Newsom's office declined to comment on the generic drug legislation. But recent changes to the proposal reflect direct negotiations with the administration, Pan's office said.
Newsom spokesperson Jesse Melgar said in a statement that "the governor's goal of a sustainable system of universal coverage has not changed and making prescription drugs affordable is one more step toward that goal."
Should Newsom sign the bill into law, the state Health and Human Services Agency would have 18 months to identify a list of drugs the state could manufacture, with a report due to the legislature by July 2022. By July the following year, the state would be required to assess whether it can manufacture its own generics and biosimilars.
The bill calls for state health officials to prioritize development of generics for chronic and high-cost health conditions, and urges production of those that can be delivered through mail order.
California could emerge as a leader in the national drug debate, Levitt said.
"If California can pull it off, it would be a model for other states and federally," he said. "For it to pull this off means it can be done at scale."
The problem is most acute for medical students in their third and fourth years of study. Year three is when most medical students do their "core clinical clerkships."
This article was first published on Monday, August 31, 2020 in Kaiser Health News.
COVID-19 is disrupting just about every student’s 2020 education, but medical students have it particularly hard right now.
“It’s a nightmare scenario for the class of 2021,” said Jake Berg, a fourth-year student at the Kentucky College of Osteopathic Medicine in Pikeville. In March, students were abruptly pulled out of hospitals and medical offices, where they normally work with professionals to learn about treating patients. Over the space of less than two weeks, he said, medical students in “pretty much the entire country” transitioned from seeing patients in person to learning online.
“Everyone goes along with the idea that we’re all in the same boat together,” he said. “But, really, it’s like we’re all on the Titanic and it’s sinking.”
Megan Messinger, in her fourth year at the Western University of Health Sciences in Pomona, California, calculates she has lost about 400 hours of patient time. She worries “the class of 2021 is going to be the dumb class of interns,” said Messinger, who hopes to do a combined residency in pediatrics and psychiatry. “I feel very behind.”
The problem is most acute for medical students in their third and fourth years of study. Year three is when most medical students do their “core clinical clerkships.” These are one- or two-month stints in hospitals and clinics, through which they get the flavor of specialties such as internal medicine, pediatrics, surgery and obstetrics/gynecology.
Fourth-year students tend to spend time in more specialized options, often traveling to get experience in specialties in short supply at their own medical school’s affiliated hospitals, and also to informally “audition” at places they might like to apply to for residency. Because of the coronavirus pandemic, however, “away rotations” have been suspended, and residency interviews for next year’s graduating class will be done virtually.
Schools and hospitals are trying to restore the core clerkships but, in many areas, this is a work in progress. The uncertainty adds considerably to students’ stress levels.
“I have no idea how I will learn about the culture of the hospitals I’m applying to,” said Garrett Johnson, a fourth-year student at Harvard Medical School. On one hand, this year’s class of doctors-to-be will save a lot of money — typically, travel and housing costs for away rotations and in-person residency interviews are paid by the students. On the other hand, he said, “you don’t get to meet any of the people or get a feel for the place.”
Karissa LeClair, a fourth-year student at the Geisel School of Medicine at Dartmouth, agreed. “I was looking forward to getting to know places I had not been to previously,” she said.
LeClair, who wants to become an ear, nose and throat specialist, said clerkships she applied to in New York City, Ann Arbor, Michigan, and Boston were all canceled.
Since she was not planning to be in New Hampshire for most of this year, LeClair now has no place to live near Dartmouth. “I’m piecing together sublets and staying with friends,” she said. Unless something changes, she will spend her final year of medical school only in facilities formally affiliated with Dartmouth.
Messinger is facing similar problems in Southern California. “I’m at Cedars right now, and loving it,” she said, referring to Los Angeles’s Cedars Sinai medical center. “But you can only do one rotation there. I don’t have anything scheduled after this. My only audition rotation, at Tulane, was canceled.”
Administrators are sympathetic. “They have had major disruption,” said Dr. Alison Whelan, chief medical education officer for the Association of American Medical Colleges, which oversees M.D.-degree programs. “Medical school is stressful, and with COVID it’s even more stressful.”
“I feel for the students, they’re really in a tough position,” said Dr. Robert Cain, president and CEO of the American Association of Colleges of Osteopathic Medicine, which oversees osteopathy programs. About 1 in 4 U.S. medical students pursue a doctorate in osteopathy, which is similar to an M.D. degree but includes training in hands-on manipulative techniques and more emphasis on whole-body health.
Starting this year, M.D. and D.O. students are competing for the same residency training programs and work side by side, a change planned before the pandemic.
One hurdle is that all these students, in order to become well-rounded doctors, need to see a broad mix of patients with a diverse group of medical issues. But even at hospitals and clinics that have resumed general care, patients with ailments other than those associated with COVID-19 are not showing up, because they are afraid of catching the coronavirus. Elsewhere elective procedures have been canceled or postponed.
“That has become a challenge,” Whelan said. In areas with high COVID-19 rates, hospitals and other facilities often do not have enough personal protective equipment for even essential health personnel, so students are kept out.
The AAMC in August updated its guidance on student participation in clinical rotations. It continued to leave decisions about allowing students into patient care areas up to individual teaching hospitals and medical schools. But it also noted that while students are not technically essential in day-to-day care activities, “medical students are the essential, emerging physician workforce” whose learning is necessary to prevent future medical shortages.
“The progression of students over time for relatively on-time graduation is essential to the physician workforce,” Whelan said. Enabling students to finish their education in the COVID-19 era “is an ongoing, complex, jigsaw puzzle.”
Both the M.D. and D.O. organizations said third-year students can still complete most of their required rotations, although perhaps not in the usual order, and schools have dramatically increased their use of online teaching of diagnostics and care.
“A fair amount of what students do is observation,” she said. “So schools have created step-by-step videos.”
And some educators are confident these students will catch up — eventually. “Most learning goes on during your residency,” said Dr. Art Papier, who teaches dermatology at the University of Rochester medical school. “I think it can all be made up.”
In addition to losing in-person patient contact, medical students face obstacles in taking required national board examinations — there are several types and are not always conveniently offered near their training sites.
After having one required test canceled on short notice, student Jake Berg had to reschedule. The first open seat was three hours away and a couple of weeks later; then his canceled test was reinstated.
The exam that tests clinical skills has been postponed for all M.D. students but is expected to be rescheduled.
The comparable exam for osteopathic students, however, has been made optional. That’s partly because D.O. students must demonstrate not only clinical skills, but also proficiency in physical manipulation techniques, which means they need to work with patients under the supervision of doctors as part of their test. But the D.O. clinical skills exam is offered only in two places: Chicago and outside Philadelphia.
“If there’s a self-isolation period, who can afford to spend two weeks in a hotel in Chicago or Philadelphia?” asked Messinger, of Western University.
While the travel may be a burden, the exams are needed “to protect the public” from doctors who have not demonstrated competence, said Cain, of the osteopathic colleges’ association.
Whelan and Cain said details are being worked out and changes are possible as the COVID situation evolves.
In the end, Cain said, this crop of students may emerge from COVID as better doctors than those who didn’t face such challenges.
“Hopefully, we’ll look back and see them as the class of resilience,” he said. “That they were able to work through some very hard times.”