In an effort to raise his approval rating on an issue on which he trails Democrat Joe Biden in most polls, Trump on Thursday unveiled his "America First Healthcare Plan."
This article was published on Monday, September 28, 2020 in Kaiser Health News.
When it comes to healthcare, President Donald Trump has promised far more than he has delivered. But that doesn't mean his administration has had no impact on health issues — including the operation of the Affordable Care Act, prescription drug prices and women's access to reproductive health services.
In a last-ditch effort to raise his approval rating on an issue on which he trails Democrat Joe Biden in most polls, Trump on Thursday unveiled his "America First Healthcare Plan," which includes a number of promises with no details and pumps some minor achievements into what the administration calls "monumental steps to improve the efficiency and quality of healthcare in the United States."
As the election nears, here is a brief breakdown of what Trump has done — and has not done — on some key health issues.
Affordable Care Act
Trump has not managed to repeal and replace the Affordable Care Act, despite his claims that the law is dead.
But his administration, and Republicans in Congress, have made changes to weaken the law while not dramatically affecting enrollment in marketplace plans.
Congress failed to rewrite the law in summer 2017, but Republicans who controlled both the House and Senate at the time included in their year-end tax cut bill a provision that reduced the penalty for failing to have health insurance to zero. That change eliminated what was by far the most unpopular provision of the law.
It also sparked a lawsuit by Republican state attorneys general and governors arguing that the tax change undercuts the law and thus should invalidate it. The case is set to be heard by the Supreme Court the week after the Nov. 3 election. The Trump administration is formally supporting the GOP plaintiffs in that suit.
The administration also used executive and regulatory action to chip away at the law's efficacy. Trump ended disputed cost-sharing subsidies to help insurers lower out-of-pocket costs for policyholders with low incomes. And the administration shortened the open enrollment period by half and slashed the budget for promoting the plans and paying people to help others navigate the often-confusing process of signing up.
Administration officials have complained that plans sold on the ACA marketplaces are not affordable, so they set new rules that allowed companies to sell competing "short-term" policies that were less expensive than ACA-sanctioned plans. But those plans are not required to provide comprehensive benefits or cover preexisting conditions.
Now, weeks before the election, federal officials are taking credit for premiums coming down, slightly, on ACA plans. "Premiums have gone down across all of our programs, including in healthcare.gov, which had been previously seeing double-digit rate increases," Seema Verma, who runs Medicare, Medicaid and the ACA exchanges, told reporters in a Sept. 24 conference call.
Premiums have come down this past year, confirmed Sabrina Corlette, who tracks the ACA as co-director of the Center on Health Insurance Reforms at Georgetown University, but only after many of the Trump administration's changes had driven them even higher. Insurers were spooked by the uncertainty — particularly in 2017, about whether the law would be repealed — and Trump's cutoff of federal funding for subsidies.
"The bottom line is, rates have gone up under Trump," Corlette said.
Women's Reproductive Health
Before he was elected, Trump pledged his allegiance to anti-abortion activists, who in turn urged their supporters to vote for him. But unlike many previous GOP presidents who called themselves "pro-life" but pushed the issue to the back burner, Trump has delivered on many of his promises to abortion foes.
Foremost, Trump has nominated two justices to the Supreme Court who were supported by anti-abortion advocates. With the help of the GOP Senate, Trump has also placed 200 conservative judges on federal district and appeals courts.
While many of the policy proposals advanced by the Trump administration are tied up in court, the sheer volume of activity has been notable, outstripping in less than four years efforts by Presidents Ronald Reagan and George W. Bush over each of their two-term presidencies.
Among those actions is a re-implementation and broadening of the "Mexico City Policy" that restricts foreign aid funding to organizations that "perform or promote" abortion. The administration has also moved to push Planned Parenthood out of the federal family planning program and Medicaid program. In addition, it has moved to make private insurance that covers abortion harder to purchase under the Affordable Care Act.
Trump's efforts on women's reproductive health reach beyond abortion to birth control. New rules would make it easier for employers with a "moral or religious objection" to decline to offer birth control as a health insurance benefit. Other rules would make it easier for health workers to decline to participate in any procedure to which they personally object.
COVID-19
Trump often claims that his decision in February to stop most travel from China was a critical factor in keeping the coronavirus pandemic in the U.S. from being worse than it has been. But the "travel ban" not only failed to stop many people from entering the U.S. from China anyway, scientists would later determine that the virus that spread widely in New York and other cities on the East Coast most likely came from Europe.
Although the White House has a coronavirus task force, the administration primarily has allowed states and localities to determine their own restrictions and timetables for closing and opening. The administration also had difficulty distributing medical supplies from a stockpile established for exactly this purpose. The president's son-in-law and White House adviser, Jared Kushner, said at one point that the purpose of the stockpile was to supplement state supplies, not provide them.
Testing was also a problem. An early test developed by the Centers for Disease Control and Prevention turned out to be faulty, and despite continued promises by administration officials, testing remains less available six months into the pandemic than most experts recommend. Meanwhile, Trump has claimed repeatedly — and falsely — that if the U.S. did less testing there would be fewer cases of the virus.
But many public health observers say the administration's biggest failing during the pandemic has been the lack of a single national message about the coronavirus and the best ways to prevent its spread.
More than 200,000 people in this country have died. Although the United States has only 4% of the world's population, it has recorded 21% of the fatalities around the globe.
Prescription Drug Costs
Trump pledged to attack high drug costs as one of his main campaign themes in 2016 and again this year. But he has not had the success he hoped for.
In one of the administration's biggest moves, the Department of Health and Human Services approved a rule last week that allows states to set up programs to import drugs from Canada, where they are cheaper because the Canadian government limits prices. Yet, it's unclear if the program will get off the ground, given drug industry opposition and resistance from the Canadian government.
In his healthcare policy speech Thursday, Trump promised to send each Medicare beneficiary a $200 discount card over the next several months to help them buy prescription drugs. The initiative is being done under a specific innovation program and must not add to the deficit. Administration officials Friday could not answer where they will get the nearly $7 billion to pay for what is perceived by many observers as a last-ditch stunt to win votes from older Americans.
The president previously signed an executive order that seeks to tie the price Medicare pays for drugs to a lower international reference price. The administration, however, hasn't released formal regulations to implement the policy, which could take years, and the policy is expected to be challenged in court by the drug industry.
In addition, Medicare will cap the price of insulin at $35 per prescription starting in 2021 for people getting coverage through some drug plans. More than 3 million Medicare beneficiaries use insulin to control their diabetes.
Trump also signed a law banning gag clauses used by health plans and pharmacy benefit managers to bar pharmacists from telling consumers about lower-priced drug options.
The administration's plan to require drug companies to provide prices in pharmaceutical advertising has been beaten back in court.
The administration points to the increased number of generic drugs that have been approved since Trump was elected, but many of those drugs are not on the market. That's because generic companies sometimes make deals with brand-name manufacturers to delay introducing lower-cost versions of their medicines.
At the same time, several bills the president supported to lower prices have stalled in Congress because of partisan differences and industry opposition.
"I don't think there has been any meaningful action that has had meaningful effect on drug prices," said Katie Gudiksen, a senior health policy researcher at The Source on Healthcare Price and Competition, a project of UC Hastings College of the Law in San Francisco.
Yet, she said, it's possible Trump's harsh criticism of the industry has had a chilling effect that led to lower prices.
Still, out-of-pocket costs for many individuals continue to climb as private and government insurance shifts more responsibility to the patient via higher cost sharing. Good Rx, an online site that tracks drug prices, noted this month that prescription drug prices have increased by 33% since 2014, faster than any other medical service or product.
Medicaid
The Trump administration has tried — but largely failed — to make many major changes to the state-federal health insurance program that covers more than 70 million low-income Americans.
Efforts by Republicans to repeal the Affordable Care Act would have ended the federal funding for the District of Columbia and the38 states that expanded their programs for everyone with incomes under 138% of the federal poverty level, or about $17,609 for an individual. About 15 million people have gained coverage through the expansion.
Trump administration officials have argued that Medicaid should be reserved for the most vulnerable Americans, including traditional enrollees such as children, pregnant women and the disabled, and not used for non-disabled adults who gained coverage under the ACA's expansion. Since Trump took office, seven states have expanded Medicaid — Idaho, Maine, Missouri, Oklahoma, Nebraska, Utah and Virginia.
In 2018, federal officials allowed states for the first time to require some enrollees to work as a condition for Medicaid coverage. The effort resulted in more than 18,000 Medicaid enrollees losing coverage in Arkansas before a federal judge halted implementation in that state and several others. The case has been appealed to the Supreme Court.
The administration also backed a move in Congress to change the way the federal government funds Medicaid. Since Medicaid's inception in 1966, federal funding has increased with enrollment and health costs. Republicans would like to instead offer states annual block grants that critics say would dramatically reduce state funding but that proponents say would give states more flexibility to meet their needs.
When the congressional attempt to establish block grants failed, the administration tried through executive action to implement a process allowing states to opt into a block grant. Yet only one state — Oklahoma — applied for a waiver to move to block-grant funding, and it withdrew its request in August, two weeks after voters there narrowly passed a ballot initiative to expand Medicaid to 200,000 residents.
Medicaid enrollment fell from 75 million in January 2017 to about 71 million in March 2018. Then the pandemic took hold and caused millions of people to lose jobs and their health coverage. As of May, Medicaid enrollment nationally was 73.5 million.
The administration's decision to expand the "public charge" rule, which would allow federal immigration officials to more easily deny permanent residency status to those who depend on certain public benefits, such as Medicaid, has discouraged many people from applying for Medicaid, said Judith Solomon, senior fellow with the Center on Budget and Policy Priorities, a research group based in Washington, D.C.
Medicare
Seniors were among Trump's most loyal voters in 2016, and he has promised repeatedly to protect the popular Medicare program. But not all his proposals would help the seniors who depend on it.
For example, invalidating the Affordable Care Act would eliminate new preventive benefits for Medicare enrollees and reopen the notorious "doughnut hole" that subjects many seniors to large out-of-pocket costs for prescription drugs, even if they have insurance.
Trump also signed several pieces of legislation that accelerate the depletion of the Medicare trust fund by cutting taxes that support the program. And his budget for fiscal 2021 proposed Medicare cuts totaling $450 billion.
At the same time, however, the administration implemented policies dramatically expanding payment fortelehealth services as well as a kidney care initiative for the millions of patients who qualify for Medicare as a result of advanced kidney disease.
Surprise Billing
Trump in May 2019 promised to end surprise billing, which leaves patients on the hook for often-exorbitant bills from hospitals, doctors and other professionals who provide service not covered by insurance.
The problem typically occurs when patients receive care at health facilities that are part of their insurance network but are treated by practitioners who are not. Other sources of surprise billing include ambulance companies and emergency room physicians and anesthesiologists, among other specialties.
An effort to end the practice stalled in Congress as some industry groups pushed back against legislative proposals.
"The administration was supportive of the pretty consumer-friendly approaches, but obviously it doesn't have any results to speak of," said Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy in Los Angeles.
"At the end of the day, plenty of people in Congress did not really want to get something done," he said.
Taking a different route, the administration finalized a rule last November that requires hospitals to provide price information to consumers. The rule will take effect Jan. 1. A federal judge shot down an attempt by hospitals to block the rule, although appeals are expected.
Brian Blase, a former Trump adviser, said this effort could soon help consumers. "Arguably, the No. 1 problem with surprise bills is that people have no idea what prices are before they receive care," he said.
But Adler said the rule would have a "very minor effect" because most consumers don't look at prices before deciding where to seek care — especially during emergencies.
Public Health/Opioids
Obesity and the opioid addiction epidemic were two of the nation's biggest public health threats until the coronavirus pandemic hit this year.
The number of opioid deaths has shown a modest decline after a dramatic increase over the past decade. Overall, overdose death rates fell by 4% from 2017 to 2018 in the United States. New CDC data shows that, over the same period, death rates involving heroin also decreased by 4% and overdose death rates involving prescription drugs decreased by 13.5%.
The administration increased funding to expand treatment programs for people using heroin and expanded access to naloxone, a medication that can reverse an overdose, said Dr. Georges Benjamin, executive director of the American Public Health Association.
Meanwhile, the nation's obesity epidemic is worsening. Obesity, a risk factor for severe effects of COVID-19, continues to become more common, according to the CDC.
Twelve states — Alabama, Arkansas, Indiana, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Oklahoma, South Carolina, Tennessee and West Virginia — have a self-reported adult obesity prevalence of 35% or more, up from nine states in 2018 and six in 2017.
Benjamin said some of the administration's other policies, such as reducing access to food stamps and undermining clean air and water regulations, have made improving public health more difficult.
But the pandemic has been the major public health issue this administration has faced.
"We were doing a reasonable job addressing the opioid epidemic until COVID hit," Benjamin said. "This shows the fragility of our health system, that we cannot manage these three epidemics at the same time."
Protecting people with preexisting medical conditions is an issue that has followed President Donald Trump his entire first term. Now, Trump has signed an executive order that he says locks in coverage regardless of anyone's health history. "Any healthcare reform legislation that comes to my desk from Congress must protect the preexisting conditions or I won't sign it," Trump said at a Sept. 24 signing event.
With the executive order, Trump said, "This is affirmed, signed and done, so we can put that to rest."
Health law and health policy experts say Trump has put nothing to rest.
"It has been and will continue to be the policy of the United States to give Americans seeking healthcare more choice, lower costs, and better care and to ensure that Americans with pre-existing conditions can obtain the insurance of their choice at affordable rates."
Joe Antos with the American Enterprise Institute, a market-oriented think tank, said the order "has no technical content."
"All it really is, is a statement that he wants one or more of his departments to come up with a plan. And he doesn't give any guidance or the vaguest outline of what that plan should be."
It takes more than a bill title to actually deliver guaranteed coverage. A Republican measure in the Senate is a good example. It's called the Protect Act, but it has loopholes that would allow insurance companies to drop coverage of certain expensive diseases from all their policies.
So far, Republican proposals have not matched what the Affordable Care Act already provides. And University of Pennsylvania law professor Allison Hoffman said Trump's executive order doesn't change that.
"The language itself guarantees nothing near the protections in the Affordable Care Act, and such sweeping protections are only possible by congressional action, not regulation," Hoffman said.
Trump and other Republicans on the campaign trail have faced repeated questioning about what will happen if the U.S. Supreme Court invalidates the Affordable Care Act. The White House is strongly behind a legal case to declare it unconstitutional. Oral arguments before the court are scheduled for Nov. 10.
Indiana University health law professor David Gamage said the executive order is no stopgap should the White House win that argument.
"Were the court to hold the Affordable Care Act unconstitutional, the executive order would still do nothing, because it has no enforcement power," Gamage said.
Larry Levitt, head of health policy at KFF, a widely used source of neutral healthcare data, called Trump's order "a pinky promise to protect people with preexisting conditions."
Trump's critics have said the order runs counter to the administration's goal of undoing the Affordable Care Act. But as Levittand others point out, there are other ways to guarantee coverage to everyone.
Lanhee Chen at Stanford University's Hoover Institution said high-risk pools remain a popular idea in conservative circles.
"Most conservative analysts, for example, have supported a system of well-funded high-risk pools at the state level to provide protections for the impacted population," Chen said.
High-risk pools have been around for decades. With them, the government, rather than a private insurance company, pays for a person's care. But as with everything in healthcare, you don't get something for nothing. State high-risk pools in the past lacked enough money to cover the large number of people with needs.
Hoffman said some high-risk pools charged very high premiums, making them unaffordable to many people.
Coverage for preexisting conditions is a persistent issue because so many Americans have them or fear having them in the future.
KFF estimates that 54 million Americans have a preexisting condition that would have led to a denial of coverage in the individual insurance market before the Affordable Care Act took effect.
STERLING, Colo. — Tonja Jimenez is far from the only person driving an RV down Colorado's rural highways. But unlike the other rigs, her 34-foot-long motor home is equipped as an addiction treatment clinic on wheels, bringing lifesaving treatment to the northeastern corner of the state, where patients with substance use disorders are often left to fend for themselves.
As in many states, access to addiction treatment remains a challenge in Colorado, so a new state program has transformed six RVs into mobile clinics to reach isolated farming communities and remote mountain hamlets. And, in recent months, they've become more crucial: During the coronavirus pandemic, even as brick-and-mortar addiction clinics have closed or stopped taking new patients, these six-wheeled clinics have kept going, except for a pit stop this summer for air conditioning repair.
Their health teams perform in-person testing and counseling. And as broadband access isn't always a given in these rural spots, the RVs also provide a telehealth bridge to the medical providers back in the big cities. Working from afar, these providers can prescribe medicine to fight addiction and the ever-present risk of overdose, an especially looming concern amid the isolation and stress of the pandemic.
Mobile health clinics have been around for years, bringing vision tests, asthma treatment and dentistry to places without adequate care. But using healthcare on wheels to treat addiction isn't as common. Nor is equipping such motor homes with telehealth capability that expands the reach of prescribing providers to treat hard-to-reach patients in these hard-to-reach rural areas.
"We really believe we bring treatment to our patients and we meet them where they're at," said Donna Goldstrom, clinical director for Front Range Clinic, a Fort Collins, Colorado, practice that operates four of the RVs. "So meeting them where they're at physically is not a long leap from meeting them where they're at motivationally and psychologically."
Each RV has a nurse, a counselor and a peer specialist who has personal experience with addiction — and all had to be trained to drive a vehicle that size.
"I never thought when I went to nursing school that I'd be doing this," Christi Couron, a licensed practical nurse, said as she pumped 52 gallons of diesel fuel into the motor home she works on with Jimenez.
The crew has driven their RV more than 30,000 miles since January, much of it viewed through a cracked windshield courtesy of a summer afternoon hailstorm. Four days a week, they ply the roads from Greeley to the smaller towns near the Nebraska border, as the view goes from mile-high to miles-wide.
Don a Mask, Pee in a Cup
On a dusty lot outside a halfway house in Sterling, Jimenez, the peer specialist, activates the leveling jacks to balance the RV, and the team readies the unit for the day's slate of patients. The passenger-side captain's chair flips around to face a table where Jimenez will check in patients. The tabletop is crowded with a printer, a scanner, a laptop and a label-maker. Underneath lie a box of specimen cups and a gallon of windshield washer fluid. The vehicle now has plenty of masks and cleaning supplies on hand, too.
After patients check in, they go to the RV's snug bathroom to provide a urine sample. With test strips built into the sides of the cup, results show instantly whether any of 13 categories of drugs — from opiates to antidepressants — are in the urine. The sample is later dropped off at a lab to confirm the results and determine which specific drug is involved. The results help the team understand how best to treat the patients and make sure they use the prescriptions they're given.
Patients then head to a small exam room in the back, where they connect via video to a nurse practitioner or physician assistant in a brick-and-mortar clinic.
If all goes well, the provider will send over a prescription for Suboxone (a combination medicine containing buprenorphine, which reduces cravings for opioids) or for Vivitrol (a monthly injectable version of naltrexone, which blocks opioid receptors). Once the staffers have the prescription in hand, the RV nurse can give those Vivitrol shots directly and distributeNarcan, a medication that will reverse an opioid overdose. Suboxone prescriptions must be called into a local pharmacy.
Patients also can drop used needles into a sharps container for disposal, but the staffers are not allowed to distribute clean needles. Some patients will talk with counselor Nicky McLean in a room just large enough to fit a table and two chairs.
Within minutes, a couple, who asked not to be identified by name because of the stigma surrounding addiction, arrive early for their appointments. They've brought the staff homemade chicken enchiladas. They had been spending $8,000 a month buying OxyContin on the street, and their lives and finances were a wreck. He lost his house. She needs clean urine tests to see her son. The couple started their addiction treatment only three weeks earlier, after he learned about the RV clinic from a friend.
They no longer have a car, so they walked a half-hour to get to their appointment.
"We would've done anything to get our drugs," she said. "Walking 30 minutes to get better, it's worth it."
Even before they've finished, another patient is at the door. Spencer Nash, 29, has been using opioids since he was 18. Nine years ago, when his wife got pregnant, the couple decided to get clean, driving two hours each way, six days a week, to a methadone clinic in Fort Collins. Now, he walks to the RV, outside the halfway house where he lives, to get his Suboxone prescription.
Filling the Gaps
A few years ago, Robert Werthwein, director of Colorado's Office of Behavioral Health, heard about a project using RVs for addiction treatment in rural upstate New York. He thought it would work in his state, too. The agency crunched the numbers to see which regions recorded the highest levels of opioid prescriptions and overdoses but lacked addiction treatment.
"We hear too often that in rural Colorado and the mountain regions of Colorado they don't have the same access to services as the Denver metro and the Front Range regions," Werthwein said. The state secured a $10 million federal grant for the program. His team brought in healthcare providers, such as Front Range Clinic, to staff and operate the RVs.
Once the RVs were ready, the staff had to be trained to drive them, which necessitated "a couple of repairs," Werthwein said. The vehicles first started rolling out in December, eventually serving six regions — and in a seventh area, a place where narrow mountain roads precluded a large RV, one of Werthwein's teams travels by SUV.
In some communities, the local doctors and others have been less than thrilled, feeling the RVs would attract drug users to their town.
"We're hoping to address stigma, not just from a public standpoint, but we're hoping to show providers 'there is a demand in your community for medication-assisted treatment,'" Werthwein said.
Once the federal grant runs out in September 2022, Front Range Clinic and the other mobile unit operators will inherit and continue to operate the RVs, billing Medicaid and private insurance as they do now for the appointments.
As the RV crew's 1 p.m. departure time in Sterling approached, one patient remained. The woman, who asked that her name not be published because she didn't want to be publicly identified as a drug user, arrived at the mobile clinic without an appointment. But they couldn't take her as a new patient without a urine sample. For two hours, she was in and out of the bathroom, drinking bottles of water, but unable to fill the little plastic cup. Through the bathroom door, the staffers could hear her crying and cursing at herself.
With the battery power on the RV winding down, they coaxed her out of the bathroom. Perhaps tomorrow would work better, they told her. She could continue to rehydrate through the night and then meet the mobile unit at its next stop, Fort Morgan, some 45 minutes away.
The next day, she was still unable to produce a urine sample, whether because of dehydration from her substance use or simply nerves. They asked her to come back again when the RV returned to Sterling the next week, but she never showed up.
There is a small chance that Pfizer's vaccine trial will yield results by Nov. 3. But it could still take weeks for FDA review. Here's everything that has to happen and how to tell a political stunt from a real vaccine.
This article was published on September, September 26, 2020 in ProPublica.
Despite President Donald Trump’s promises of a vaccine next month and pundits’ speculation about how an “October surprise” could upend the presidential campaign, any potential vaccine would have to clear a slew of scientific and bureaucratic hurdles in record time.
In short, it would take a miracle.
We talked to companies, regulators, scientific advisers and analysts and reviewed hundreds of pages of transcripts and study protocols to understand all the steps needed for a coronavirus vaccine to be scientifically validated and cleared for public use. As you’ll see, it’s a long shot in 38 days.
There are three key milestones that must be met:
A clinical trial would need to observe enough infections to demonstrate that the vaccine is better than a placebo. Right now, Pfizer’s trial is the furthest along. Pfizer has said it expects results by the end of October, but analysts who follow the company aren’t so sure it’ll be that soon or whether the results will be conclusive.
Pfizer would have to turn its trial data into an application to the Food and Drug Administration. The company could either apply for full approval — a very high bar for proving the vaccine is safe, effective and able to be reliably manufactured by the millions of doses — or for an emergency use authorization, which is more flexible. Pfizer has said it could submit its application almost immediately.
The FDA has to review the data and decide whether the vaccine is ready to go to market. That could take several weeks to a month, said Dr. Mark McClellan, who led the FDA from 2002 to 2004.
“All of this put together makes it more likely that it’ll be a late 2020 availability,” McClellan said.
None of this is to say that Trump couldn’t suddenly call a White House press conference to try to grab headlines and declare victory. But knowing all the steps that would have to come first can help the public discern between a true, scientifically validated vaccine and a mere political stunt.
Yes, Pfizer could have trial results by the end of October.
Results from ongoing trials are closely guarded so that researchers (and investors) have no opportunity to mess with them. Under strict trial rules that vaccine makers and the FDA set up in advance, there are only a few predetermined times when a data monitoring board is scheduled to look at the data. The purpose of those check-ins (known as “interim analyses”) is to see if there’s already enough evidence to conclude that the vaccine either works or doesn’t.
According to the trial rules that Pfizer released last week, it has four of these check-ins before the final analysis. The first one occurs when 32 people in the trial get sick with COVID-19.
Yes, that is a tiny number in a study designed to enroll 30,000 participants. But it could be enough to show that the vaccine works if far more of the infections occur in people who took the placebo than in those who got the vaccine, so much so that it’s probably not random.
The vaccine “would have to be way, way better to meet an interim stopping boundary,” said Frank Harrell Jr., professor of biostatistics at Vanderbilt University.
If six or fewer of the first 32 cases are people who got the vaccine, that suggests the vaccine reduced COVID-19 cases by 76%. Under Pfizer’s trial rules, the company can then conclude that its vaccine is effective enough to submit its application to the FDA. If, on the other hand, 15 or more of the first 32 infections are people who got the vaccine, it would mean the vaccine doesn’t work and the study ends.
The better the vaccine works, the longer it would take to reach 32 cases, because fewer vaccinated people would get sick and more of the infections would have to occur in the placebo group.
So when exactly will Pfizer get to 32 cases?
Analysts at JPMorgan estimate that this first readout would occur on Oct. 31 if the vaccine is 70% effective, or on Nov. 2 if the vaccine is 80%. Their model also estimates that Pfizer is more than twice as likely to be able to file for approval at 80% effectiveness vs 70% effectiveness.
The JPMorgan analysts’ prediction is roughly in line with official public statements from Pfizer, though the company has projected even more confidence. “We have a good chance that we will know if the product works by the end of October,” CEO Albert Bourla said Sept. 13 on CBS’ “Face the Nation.”
The key thing we don’t know is how fast people in Pfizer’s trial are getting sick. The trial doesn’t intentionally expose people to the virus; it waits to see who catches it on their own. Even though the pandemic is far from under control, the coronavirus is not spreading as fast as it was a few months ago. The study started with a baseline assumption that just 1.3% of participants would be infected over the course of a year.
It’s possible that the thousands of people who signed up for Pfizer’s study could be getting sick faster or slower than that, depending on how bad the outbreak is where they are. If Pfizer’s trial infection rate is 1.5 to 2 times faster than publicly reported case counts, then Pfizer’s first readout could be Oct. 12-19 with a 70% effective vaccine, or Oct. 14-22 with 80% efficacy, according to JPMorgan’s model.
“When the trials started there were a lot more cases in the U.S. at that time,” said Dr. Vamil Divan, an analyst at the bank Mizuho. “That’s a key unknown. How many of these participants are enrolled in hotter areas versus New York or Boston?”
To protect the integrity of trials like this, the drugmakers running them aren’t supposed to know what the data is showing as it comes in. And yet, company executives have led some observers to believe they know how many people have tested positive for COVID-19.
“They’re making projections based on how rapidly they’re accruing data, and they probably know the total number of events,” said Susan Ellenberg, professor of biostatistics at the University of Pennsylvania.
“When they say things like that, first of all, it does some wonders for their stock prices,” she added.
In a statement, Pfizer said that it expects results “as early as the end of October” based on current infection rates. The trial, the company said, “was designed to evaluate the safety and efficacy of the vaccine candidate as fast as possible.”
“Having said that,” the company added, “neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial.”
It’s highly unlikely that the next front-runner, Moderna, could have results before the election. The JPMorgan analysts’ model suggests that infection rates would have to be four times the publicly reported rate for Moderna to be able to report results before Nov. 3.
Dr. Tal Zaks, Moderna’s chief medical officer, told investors on Sept. 17 that “some time in November is sort of a reasonable base case” for the first look at Moderna’s results. (ProPublica’s board chairman, Paul Sagan, is a member of Moderna’s board and a company stockholder.)
Other developers are further behind. AstraZeneca’s trial is paused in the U.S. while the company investigates what happened with a participant who had a bad reaction. Johnson & Johnson is just beginning its large-scale, end-stage trial, months behind the other three.
So Pfizer is the only company with a shot at results before the election. And if the company has results to share, it’s unlikely to let political implications get in the way. The company has an ethical obligation not to delay a product that is ready to save lives, despite the risk that a vaccine announced on the eve of a contentious election could stoke partisan perceptions.
“Once you have signs of a vaccine’s effectiveness, it’s very difficult to argue anything is ethical other than making it available to those most at risk,” Dr. Mani Foroohar, an analyst with the investment bank SVB Leerink, said. “But it’s also very difficult to make the argument that you should do anything that undermines public trust. That’s one of the problems when you introduce powerful political pressures into what is meant to be a boring, dry, unemotional process.”
Once Pfizer gets results, it’s poised to seek the FDA’s go-ahead swiftly.
As soon as Pfizer has conclusive data, it will submit an application to the FDA. The application will include data from all previous trials as well as proof that the company can consistently manufacture millions of vaccine doses.
Pfizer’s CEO has indicated that the company is ready to turn around its application in a flash, if not on the same day it has results. “We will try to be able to be ready to submit with the speed of light, once we have the results ready,” Bourla said at an investor presentation on Sept. 16.
Pfizer has two options when submitting its FDA application. It can apply for an EUA or a full approval, known as a biologics license application, or BLA. An EUA would only allow Pfizer to market its vaccine for the pandemic’s duration — during the declared “emergency” period that we are currently in. If the company receives full licensure, on the other hand, its product can remain on the market forever. In its statement, Pfizer said it plans to continue its study after a possible EUA to collect more long-term data.
The bar for an EUA is lower than for full approval. By law, an EUA can be issued so long as “the product may be effective in diagnosing, treating, or preventing” the disease and “the known and potential benefits of the product … outweigh the known and potential risks.” In contrast, the standard for a full approval requires a drugmaker to prove not only that the product is safe and effective, but also that the product is pure and can be consistently made, because vaccines are biological products made from living materials.
For the COVID-19 vaccine, the FDA has said that it is going to raise the bar for an EUA, going beyond the usual requirements. Previously, the FDA has said a vaccine should be at least 50% effective. The FDA is reportedly close to announcing new standards to include at least two months of monitoring the health of trial participants after they receive their second shot. That could end up being the biggest hurdle to authorizing a vaccine before the election. Trump said on Wednesday that he might reject the new guidelines, but companies and FDA officials might still choose to observe them.
In a statement, the FDA said that “for a vaccine for which there is adequate manufacturing information,” an EUA “may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or the FDA has completed its formal review of the biologics license application.”
Pfizer said in a statement that it anticipates providing the agency safety data, including the median of two months safety information after the second dose, on a rolling basis. The trial has enrolled more than 31,000 participants, and 19,000 have received the second dose so far, the company said.
“The standards FDA is reportedly considering for a covid vaccine EUA represent appropriate balance between speed and safety in a crisis,” Dr. Scott Gottlieb, who led the FDA earlier in the Trump administration and serves on Pfizer’s board, tweeted on Thursday. “Even under EUA; you want higher assurance of safety and benefit for vaccine given to healthy people vs. drug given to those already sick.”
“Any political effort to shortcut [the] process or degrade reasonable standards will be [a] Pyrrhic victory if people lack confidence in a vaccine,” Gottlieb added.
The FDA will thoroughly review the application, and that’ll take a while.
Once the FDA receives a company’s submission, the agency’s review process consists of several steps which, put together, could take weeks to complete.
The FDA is the only health regulator in the world that asks drugmakers for raw data files and does its own analysis, said Dr. Joshua Sharfstein, the FDA’s former principal deputy commissioner from 2009 to 2011. “Now would not be the moment to stop” that practice, he said, despite the urgent need for a vaccine.
Besides reviewing clinical trial data, the FDA also inspects vaccine developers’ manufacturing capabilities to ensure that every vaccine batch can be made consistently and that the process is squeaky clean, so that no impurities can make their way into a vial of product. This process involves a lot of paperwork sent from the companies to the agency and also, usually, on-site inspections at manufacturing plants. The agency declined to comment on whether it had already completed on-site inspections for Pfizer and Moderna.
After the FDA finishes its assessment of the company’s application, it typically presents the data to an external advisory committee in a public meeting. Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, has said that the agency is committed to holding advisory committee meetings to review individual vaccine candidates.
Those meetings will take time to schedule, but it’s an essential step, according to experts both inside and outside the agency.
“How will [the public] know that we’re not, like, holding something in and sweeping something under the rug? Well, the way they’re going to know that is because any vaccine that we issue an emergency use authorization for will go to a public advisory committee meeting,” Marks said in a Sept. 10 webinar hosted by the Duke Margolis Center for Health Policy. “It’ll be critical for people to see what’s in the briefing packages, they’ll be able to see the discussion among an impartial group of advisers, they’ll see the committee recommendation and they’ll see the public dialogue that will take place at that committee.”
Advisory committee members vote on whether they recommend product approval. While the FDA does not have to follow the committee’s recommendations, the votes are public.
“It protects against political interference — it’s important,” Sharfstein said.
We contacted every advisory committee member and interviewed six of them about how they would evaluate an EUA application for a COVID-19 vaccine. These members (speaking for themselves, not for the FDA) indicated they would expect to see a level of evidence that could be tough to meet in the next 38 days.
One factor in their caution is that a premature EUA could make it harder to definitively evaluate an effective vaccine, because subjects in ongoing trials may drop out and new enrollments in trials with placebos would no longer be feasible.
“If an EUA came too soon where we don’t have sufficient clinical efficacy data, it would make it very hard to actually complete the study as written,” Dr. Paul Spearman, director of infectious diseases at Cincinnati Children’s Hospital, said. “You would want to have enough clinical efficacy data by the time of an EUA to be pretty darn certain.”
Another committee member is Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine. She also expressed caution about basing a hugely consequential decision on such a small number of cases, like the 32 in Pfizer’s first look.
“It’s hard for me to say with these small numbers will we have meaningful data to make a decision on,” Chatterjee said. “I have not made up my mind on any of this because I need to see and discuss with colleagues what the data are and what the implications might be.”
One option would be for the FDA to grant an EUA for a specific group of people, such as health care workers or the elderly, who are more vulnerable to COVID-19.
The data would have to support a specific vaccine use that aligns with a recognized unmet medical need, said Dr. Michael Kurilla, an advisory committee member and the director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, part of the National Institutes of Health. For example, it’s possible a vaccine could work well in young people but not so well in older people. In that case, it might not be that beneficial, because older people are much more vulnerable to serious disease.
“It’s not simply a matter of saying we will EUA this product,” Kurilla said. “We have to be very careful to define what it is we’re trying to address.”
Dr. Paul Offit, director of the vaccine education center at the Children’s Hospital of Philadelphia, said he would like to see robust safety data, to make sure there are no neurological side effects, from Pfizer and Moderna. Both companies are developing so-called mRNA vaccines, a type of vaccine technology that has never been approved before. He noted that most people who get vaccines are healthy, so the bar for letting a vaccine go to market is necessarily much higher than for treatments intended for severely ill COVID-19 patients.
Finally, the FDA considers the committee’s advice and makes its final decision on whether it will greenlight the product. Normally, the FDA aims to review applications for full approval within 10 months for standard reviews and six months for priority reviews.
It’s unclear exactly how quickly an EUA review can be completed for the COVID-19 vaccine. The only other vaccine that has ever received an EUA was an anthrax vaccine, but it’s not a useful comparison because the vaccine was already in use and the 2005 authorization was granted to allow the US. Department of Defense to resume giving the shots to military personnel after the mandatory vaccination program had been suspended.
Some steps could potentially be skipped when doing a review for an EUA as compared with a full approval, according to McClellan, the former FDA commissioner. For example, any vaccines needed for this pandemic won’t need long-term storage, because they’ll all be used quickly, so companies won’t need to run tests and demonstrate to the agency that their vaccines can be stored for months on end. But to receive full approval, the agency might require that.
Still, McClellan estimated, the agency’s review process from the time it receives an application to issuing an EUA could take up to a month.
All of this is just to get to yes on a vaccine. Getting shots in millions of people’s arms is another story. The two vaccine front-runners from Pfizer and Moderna pose additional logistical challenges because they have to be kept frozen.
What could go wrong?
Having read through all these steps, you can start to see the points where the process could break down and how the public might find out about it.
If a company lowers the bar for efficacy. The first four vaccine contenders have all released their clinical trial rules (Pfizer, Moderna, AstraZeneca and Johnson & Johnson), so the public should be able to assess whether the shots have met the companies’ own standards to prove it works. If they unexpectedly change their schedules or the standards, that’s concerning.
If the FDA backtracks on its commitment to consult the independent advisory board, or if the agency’s leaders reject the committee’s advice, it would be a sign that they’re acting under political pressure without scientific support.
If FDA career scientists get overruled by political appointees, that would also be a major sign of political pressure. The decision on whether or not to authorize a vaccine will fall on Marks, head of the biologics division. FDA Commissioner Stephen Hahn, however, has authority to overrule Marks’ decision, and Secretary Alex Azar of the Department of Health and Human Services has the right to further overturn Hahn’s call.
If FDA officials quit. Marks has said he’d resign if the agency authorizes an unproven or unsafe vaccine.
Ultimately, the FDA and everyone involved in vaccine development are seeking the perfect balance between speed and caution: Faced with a deadly virus that’s taken the lives of more than 200,000 Americans and upended life, devastating the economy and tearing away the livelihoods of so many, of course there is an imperative not to waste any time and an urgent desire for a vaccine.
Yet a bad vaccine could do more harm than good, and even the perception of a vaccine that is not thoroughly vetted could be just as bad, if the public doesn’t feel confident in taking it.
“A vaccine only works if it’s safe, effective and administered,” meaning people have to be willing to take it, said Bruce Mehlman, a political adviser to companies at the lobbying firm Mehlman Castagnetti Rosen & Thomas. (He doesn’t represent any pharmaceutical clients.) “If it becomes another culture war football like masks, it will not help us get past the virus and return to normal.”
It’s unlikely we’ll see a vaccine authorized in October, but to ensure the shot is safe, effective, pure and trustworthy, waiting a little longer with the knowledge that no steps have been skipped may be well worth it.
In Los Angeles, more than 35% of households report serious problems with paying credit cards, loans or other bills, while the same percentage report having depleted all or most of their savings.
This article was published on Friday, September 25, 2020 in Kaiser Health News.
Working as a fast-food cashier in Los Angeles, Juan Quezada spends a lot of his time these days telling customers how to wear a mask.
“They cover their mouth but not their nose,” he said. “And we’re like, ‘You gotta put your mask on right.'”
Quezada didn’t expect to be enforcing mask-wearing. Six months ago, he was a restaurant manager, making $30 an hour, working full time and saving for retirement. But when Los Angeles County health officials shut down most restaurants in March because of the spreading pandemic, Quezada lost his job. The only work he could find pays a lot less and is part time.
“I only work three hours and four hours rather than eight or 10 or 12 like I used to work,” he said.
Quezada doesn’t know anyone who has gotten COVID-19, but the pandemic has affected nearly every aspect of his life. “I am just draining my savings — draining and draining and draining,” he said. “I have to sell my car. Uber is a luxury.” Mostly, he now bikes or rides the bus to his part-time job.
Quezada is one of hundreds of people who responded in a newly published poll by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health. Among other things, the poll, which surveyed people from July 1 to Aug. 3, found that a whopping 71% of Latino households in Los Angeles County have experienced serious financial problems during the pandemic, compared overall with 52% of Black households there and 37% of whites. (Latinos can be of any race or combination of races.)
Like Quezada, many are burning through their savings and are having a hard time paying for necessities such as food. Quezada estimated he has about six months of savings left.
In Los Angeles, more than 35% of households report serious problems with paying credit cards, loans or other bills, while the same percentage report having depleted all or most of their savings. Eleven percent of Angelenos polled said they didn’t have any savings at the start of the outbreak.
Nationally, the picture is similar. In results released last week, the poll found that 72% of Latino households around the country reported they’re facing serious financial problems, double the share of whites who said so. And 46% of Latino households reported they have used up all or most of their savings during the pandemic.
How Poverty Differs for Latinos
Nationally, the poll found that 63% of Latinos reported loss of household income either through reduced hours or wages, furloughs or job loss since the start of the pandemic.
But Latinos have kept working through the crisis, said David Hayes-Bautista, a professor of medicine and public health at UCLA.
“In Washington, the idea is you’re poor because you don’t work. That’s not the issue with Latinos,” he said. “Latinos work. But they’re poor. The problem is, we don’t pay them.”
Latinos have the highest rate of labor force participation of any group in California. In March, when state and local officials shut down many businesses, Latinos lost jobs like everyone else. But Latinos got back to work faster.
“In April, the Latino [labor force participation] rate bounced right back up and actually has continued to increase slowly, whereas the non-Latino rate is dropping,” Hayes-Bautista said. “The reward that Latinos have for their high work ethic is a high rate of poverty.”
That work ethic has also contributed to a much higher rate of COVID-19. Hayes-Bautista pointed out that in California, as in some other regions in the U.S., Latinos tend to hold many of the jobs that have been deemed essential, and that’s made them highly susceptible to the coronavirus. Latinos now account for 60% of COVID-19 cases in California, even though they’re about 40% of the population.
“These are workers usually in their prime years — peak earning power and everything else,” Hayes-Bautista said. “Latinos between 50 and 69, those are the ones that are being hit the hardest. That’s pretty worrying.”
Exposed — And Often Without Health Insurance
Nationally, according to the poll, 1 in 4 Latino households report serious problems affording medical care during the pandemic.
Many of the essential jobs that Latinos are more likely to perform — farmworker or nursing home aide or other contract work, for example — lack benefits. That means some Latinos are more exposed to the coronavirus and less likely to have health insurance because they don’t get coverage through an employer.
Others, such as Mariel Alvarez, lack health insurance because of citizenship restrictions. She lives with her parents and sisters in Los Angeles County’s San Fernando Valley. Alvarez lost her sales job and her employer-sponsored health insurance when the pandemic hit in March, she said. Then she got sick.
Eventually, her whole family was ill. Alvarez had to pay out-of-pocket to go to a CVS clinic near her home. But after a couple of $50 visits, it got too expensive.
“I just couldn’t afford to continue to go to the doctor,” she said. She suspected it was COVID-19 but was unable to get tested.
Now that she’s recovered, getting a job with health insurance is crucial because she doesn’t qualify for any state or federal support. Alvarez is undocumented and was brought to the U.S. by her parents as a child from Bolivia. She’s one of roughly 640,000 immigrants who has a permit allowing her to work and defer deportation under the Deferred Action for Childhood Arrivals program, or DACA.
“I don’t want to jeopardize that,” Alvarez said. “You’re not supposed to use any of the government assistance when you’re on that. You’re only supposed to work, and that’s it.”
The pandemic has created a big need for one job: contact tracers. So Alvarez completed a free certificate online in the hope it will give her an edge. She’s going through the application process; if she gets hired, she hopes to have benefits again.
In the meantime, she’ll do her best not to get sick.
Jackie Fortiér is a health reporter for KPCC and LAist.com.
This story is part of a partnership that includes KPCC, NPR and KHN.
The final plan clears the way for states to implement a program bringing medications across the border despite the strong objections of drugmakers and the Canadian government.
This article was published on Friday, September 25, 2020 in Kaiser Health News.
President Donald Trump, outlining his "America First Health Plan" Thursday, announced that his administration will allow the importation of prescription drugs from Canada.
The final plan clears the way for Florida and other states to implement a program bringing medications across the border despite the strong objections of drugmakers and the Canadian government.
Florida, the biggest swing state in the presidential election, is one of six states to pass laws seeking federal approval to import drugs. Trump's announcement came the same day counties in Florida began sending out vote-by-mail ballots.
Florida Gov. Ron DeSantis, a close ally of the president, is a strong advocate of importing drugs. His administration has already advertised for a contractor to run the state program and is expected to announce Tuesday which companies have bid for the three-year, $30 million state contract.
Congress has allowed drug importation since 2000 but only if the secretary of the Department of Health and Human Services certified it is safe. That has never occurred until Secretary Alex Azar did it Wednesday, according to a letter he wrote to congressional leaders.
Implementation under the administration's final rule "poses no additional risk to the public's health and safety and will result in a significant reduction in the cost of covered products to the American consumer," Azar said in the letter KHN obtained Thursday.
The rule noted, however, that HHS is unable to make any estimates about savings because it doesn't know which drugs will be imported.
Prices are cheaper north of the border because Canada limits how much drugmakers can charge for medicines. The United States lets free market dictate drug prices.
The pharmaceutical industry has long fought efforts on importation, arguing that it would disrupt the nation's supply chain and make it easier for unsafe or counterfeit medications to enter the market.
"We are reviewing the final rule and guidance that were released; however, we continue to have grave concerns with drug importation that exposes Americans unnecessarily to the dangers of counterfeit or adulterated drugs," said a spokesperson for the Pharmaceutical Research and Manufacturers of America, an industry trade group. "It is alarming that the administration chose to pursue a policy that threatens public health at the same time that we are fighting a global pandemic."
Drugmakers have suggested in the past that they might try to stop such a policy through a lawsuit.
Trump has dangled his drug importation plan in campaign speeches over the past year — and again on Thursday in North Carolina during a speech that provided a litany of his promises on health care.
"We will finally allow the safe and legal importation of drugs from Canada," Trump said. States "can go to Canada and buy your drugs for a fraction of the price" in the U.S.
"This will be a game changer for American seniors," Trump said. "We're doing it very, very quickly."
The administration proposed the regulation in December. The final rule says it takes effect in 60 days.
But individuals will not be allowed to import drugs on their own, Azar said in his letter. Instead, they will have to rely on programs run by states.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the internet or using storefronts that connect them to foreign pharmacies. Though the practice is illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import medicines for personal use each year, and about 20 million say they or someone in their household has done so because prices are much lower in other countries, according to surveys.
The practice has been especially common in retiree-rich Florida, where more than a dozen stores help consumers make the purchases and where numerous cities, counties and school districts assist employees with the transactions.
The administration envisions a system in which a Canadian-licensed wholesaler buys from a manufacturer of drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida's legislation — approved in 2019 — would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the program to save the state about $150 million annually.
The second program would be geared to the broader state population.
The HHS final rule said the government will "in the future" allow pharmacists to import drugs from Canada, a provision that matches the law approved by Florida in 2019.
But pharmacists in Florida and across the country oppose drug importation, saying they don't think it will ensure that counterfeit drugs are kept out of the U.S. market.
The Canadian government told HHS last spring that the country doesn't have enough drugs to spare and the Trump plan would only worsen shortages of medicines there.
The final rule said state importation programs will have flexibility to decide which drugs to import and in what quantities.
The rule also makes clear that drug manufacturers will have to provide to importers documentation guaranteeing the medications are the same drugs as those already sold in the United States. HHS could set up regulations that require drugmakers to comply. Importers will have to send drugs to labs to certify their authenticity.
In addition to Florida, the other states seeking federal permission to buy drugs from Canada are Colorado, Maine, New Hampshire, New Mexico and Vermont.
Update: This story was updated on Friday 8:50 a.m. ET to add more information on the issue of savings.
Matthew Fentress was just 25 when he passed out while stuffing cannolis as a cook for a senior living community six years ago. Doctors diagnosed him with viral cardiomyopathy, heart disease that developed after a bout of the flu.
Three years later, the Kentucky man’s condition had worsened, and doctors placed him in a medically induced coma and inserted a pacemaker and defibrillator. Despite having insurance, he couldn’t pay what he owed the hospital. So Baptist Health Louisville sued him and he wound up declaring bankruptcy in his 20s.
“The curse of being sick in America is a lifetime of debt, which means you live a less-than-opportune life,” said Fentress, who still works for the senior facility, providing an essential service throughout the coronavirus pandemic. “The biggest crime you can commit in America is being sick.”
Financial fears reignited this year when his cardiologist suggested he undergo an ablation procedure to restore a normal heart rhythm. He said hospital officials assured him he wouldn’t be on the hook for more than $7,000, a huge stretch on his $30,000 annual salary. But if the procedure could curb the frequent extra heartbeats that filled him with anxiety, he figured the price was worth it.
He had the outpatient procedure in late January and it went well.
Afterward, “I didn’t have the fear I’m gonna drop dead every minute,” he said. “I felt a lot better.”
Then the bill came.
Patient: Matthew Fentress is a 31-year-old cook at Atria Senior Living who lives in Taylor Mill, Kentucky. Through his job, he has UnitedHealthcare insurance with an out-of-pocket maximum of $7,900 — close to the maximum allowed by law.
Total Bill: Fentress owed a balance of $10,092.13 for cardiology, echocardiography and family medicine visits on various dates in 2019 and 2020. UnitedHealthcare had paid $28,920.52 total, including $27,561.37 for the care he received on the day of his procedure.
Service Provider: Baptist Health Louisville, part of the nonprofit system Baptist Health.
Medical Service: Fentress underwent cardiac ablation this year on Jan. 23. The outpatient procedure involved inserting catheters into an artery in his groin that were threaded into his heart. He also had related cardiology services, testing and visits to a primary care doctor and a cardiologist before and after the procedure.
What Gives: Fentress said he always made sure to take jobs with health insurance, “so I thought I’d be all right.”
But like nearly half of privately insured Americans under age 65, he has a high-deductible health plan, a type of insurance that experts say often leaves patients in the lurch. When he uses health providers within his insurer’s network, his annual deductible is $1,500 plus coinsurance. His out-of-pocket maximum is $7,900, more than a quarter of his annual salary.
Fentress owed around $5,000 after his 2017 hospitalization and set up a monthly payment plan but said he was sent to collections after missing a $150 payment. He declared bankruptcy after the same hospital sued him.
He faced another bill about a year later, when a panic attack sent him to the emergency room, he said. That time, he received financial aid from the hospital.
When he got the bill for his ablation this spring, he figured he wouldn’t qualify for financial aid a second time. So instead of applying, he tried to set up a payment plan. But hospital representatives said he’d have to pay $500 a month, he said, which was far beyond his means and made him fear another spiral into bankruptcy.
This precarious situation makes him “functionally uninsured,” said author Dave Chase, who defines this as having an insurance deductible greater than your savings. “It’s a lot more frequent than a lot of people realize,” said Chase, founder of Health Rosetta, a firm that advises large employers on health costs. “We’re the undisputed leaders in medical bankruptcy. It’s a sad state of affairs.”
Jennifer Schultz, an economics professor and co-director of the Health Care Management program at the University of Minnesota-Duluth, said Fentress faces a difficult financial road ahead. “Once you declare bankruptcy, your credit rating is destroyed,” she said. “It will be hard for a young person to come back from that.”
A recent survey by the Commonwealth Fund found that just over a quarter of adults 19 to 64 who reported medical bill problems or debt were unable to pay for basic necessities like rent or food sometime in the past two years. Three percent had declared bankruptcy. In the first half of 2020, the survey found, 43% of U.S. adults ages 19 to 64 were inadequately insured. About half of them were underinsured, with deductibles accounting for 5% or more of their household income, or out-of-pocket health costs, excluding premiums, claiming 10% or more of household income over the past year.
In Fentress’ case, the $10,092 he owed the hospital was more than a third of what his insurer paid for his care. The majority of his debt — $8,271.56 — was coinsurance, about 20% of the bill, which he must pay after meeting his deductible. Because the bill covered services spanning two years, he owed more than his annual out-of-pocket maximum. If all his care had been provided during 2019, he would have owed much less and the insurer would have been responsible for more of the bill.
The insurer’s payment for Fentress’ care that January day — around $27,600 — falls into the typical cost range, Gurav said. Fentress is being asked to pay $9,296, meaning the hospital would get more than $36,000 for the care.
Schultz, a state representative from Minnesota’s Democratic-Farmer-Labor Party, said nonprofit hospitals could potentially waive or reduce costs for needy patients.
“They definitely have a moral responsibility to provide a community benefit,” she said.
Resolution: Charles Colvin, Baptist Health’s vice president for revenue strategy, said hospital officials quoted Fentress an estimated price for the ablation that was within a few dollars of the final amount, although his bill included other services such as tests and office visits on various dates. Colvin said there appeared to be some charges that UnitedHealthcare didn’t process correctly, which could lower his bill slightly.
Maria Gordon Shydlo, communications director for UnitedHealthcare, said Fentress is responsible for 100% of health costs up to his annual, in-network deductible, then pays a percentage of health costs in “coinsurance” until he reaches his out-of-pocket maximum. So he will owe around $7,900 on his bill, she said, and any new in-network care will be fully covered for the rest of the year.
A hospital representative suggested Fentress apply for financial assistance. She followed up by sending him a form, but it went to the wrong address because Fentress was in the process of moving.
In September, he said he was finally going to fill out the form and was optimistic he’d qualify.
The Takeaway: Insurance performs two functions for those lucky enough to have it. First, you get to take advantage of insurers’ negotiated rates. Second, the insurer pays the majority of your medical bills once you’ve met your deductible. It pays nothing before then. High-deductible plans have the lowest premiums, so they are attractive or are the only plans many patients can afford. But understand you will be asked to pay for everything except preventive care until you’ve hit that number. And your deductible may be only part of the picture: “Coinsurance” is the bulk of what Fentress owes.
Out-of-pocket maximums are regulated by federal law. In 2021, the maximum will be $8,550 for single coverage. Try to plan treatment and procedures with an eye on the calendar — people with chronic conditions and this kind of insurance could save a lot of money if they have an expensive surgery in December rather than January.
As always, if you face a big medical bill, ask about payment plans, financial aid and charity care. According to the Baptist Health system’s website, the uninsured and underinsured can get discounts. Those with incomes equivalent to 200%-400% of the federal poverty level — or $25,520-$51,040 for an individual — may be eligible for assistance.
If you don’t qualify for help, negotiate with the hospital anyway. Arm yourself with information about the going rate insurers pay for the care you received by consulting websites like Healthcare Bluebook or Fair Health.
As Fentress tries to move past his latest bill, he’s now worried about something else: racking up new bills if he contracts COVID-19 down the road as an essential worker with existing health problems and the same high-deductible insurance.
“I don’t have hope for a financially stable future,” he said. “It shouldn’t be such a struggle.”
Dan Weissmann, host of “An Arm and a Leg” podcast, reported the radio interview of this story. Joe Neel of NPR produced Sacha Pfeiffer’s interview with KHN Editor-in-Chief Elisabeth Rosenthal on “All Things Considered.”
Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!
The executive order signed by Democratic Gov. Gavin Newsom late Wednesday is a response to threats made to health officers across California during the coronavirus pandemic.
This article was published on Thursday, September 24, 2020 in Kaiser Health News.
SANTA CRUZ, Calif. — California will allow public health officials to participate in a program to keep their home addresses confidential, a protection previously reserved for victims of violence, abuse and stalking and reproductive health care workers.
The executive order signed by Democratic Gov. Gavin Newsom late Wednesday is a response to threats made to health officers across California during the coronavirus pandemic. More than a dozen public health leaders have left their jobs amid such harassment over their role in mask rules and stay-at-home orders.
A series examining how the U.S. public health front lines have been left understaffed and ill-prepared to save us from the coronavirus pandemic. The project is a collaboration between KHN and the AP.
"Our public health officers have all too often faced targeted harassment and stalking," wrote Secretary of State Alex Padilla in a statement. This "program can help provide more peace of mind to the public health officials who have been on the frontlines of California's COVID-19 response."
A community college instructor accused of stalking and threatening Santa Clara health officer Sara Cody was arrested in late August. The Santa Clara County sheriff said it believes the suspect, Alan Viarengo, has ties to the "Boogaloo" movement, a right-wing, anti-government group that promotes violence and is associated with multiple killings, including the murders of a federal security officer and a sheriff deputy in the Bay Area. Thousands of rounds of ammunition, 138 firearms and explosive materials were found in his home, the sheriff's office said.
In Santa Cruz County, two top health officials have received death threats, including one allegedly signed by a far-right extremist group.
In May, a member of the public read aloud the home address of former Orange County health officer Nichole Quick at a supervisors' meeting and called for protesters to go to her home. "You have seen firsthand how people have been forced to exercise their First Amendment. Be wise, and do not force the residents of this county into feeling they have no other choice than to exercise their Second Amendment," said another attendee. Quick later resigned.
Protesters angry over mask mandates and stay-at-home orders have gone to the homes of health officers in multiple counties, including Orange and Contra Costa.
The executive order would allow health officials to register with the Secretary of State's Safe at Home program. Those in the program are given an alternative mailing address to use for public records so that their home addresses are not revealed.
Threats of violence have added to the already immense pressure public health officials have experienced since the beginning of the year. Amid chronic underfunding and staffing shortages, they have been working to limit the spread of the coronavirus, while also deflecting political pressure from other officials and anger from the public over business closures and mask mandates.
"California's local health officers have been working tirelessly since the start of the pandemic, using science to guide policy," said Kat DeBurgh, the executive director of the Health Officers Association of California. "It is regrettable that this order was necessary — but we are grateful for it nevertheless."
Nationwide, at least 61 state or local health leaders in 27 states have resigned, retired or been fired since April, according to a review by The Associated Press and KHN, a figure that has doubled since the newsrooms first began tracking the departures in June.
Thirteen of those departures have been in California, including 11 county health officials and the state's two top public health officials.
Dr. Sonia Angell, former director of the California Department of Public Health and state public health officer, quit in early August after a series of glitches in the state's infectious disease reporting system caused weeks-long delays in reporting cases of COVID-19.
In Placer County, north of Sacramento, health officer Dr. Aimee Sisson resigned effective Sept. 25 after the county Board of Supervisors voted to end its local COVID-19 health emergency. "It is with a heavy heart that I submit this letter of resignation," she wrote in her resignation letter. "Today's action by the Placer County Board of Supervisors made it clear that I can no longer effectively serve in my role."
Organizations across the state have expressed concern over the treatment of health officials during the pandemic, including the California Medical Association.
"Basic science has become politicized in so many parts of our state, and our country," wrote California Medical Association president Dr. Peter N. Bretan Jr. in a statement after Sisson's departure. "Public health officers are public servants who seek to do what their job description states — to protect public health."
The executive order also directs the state to assess impacts of the pandemic on health care providers and health care service plans, and halts evictions for commercial renters through March 31, 2021, among other pandemic-related matters.
KHN and California Healthline correspondent Angela Hart contributed to this report.
Shielding the identities of clinicians and statisticians on the board is meant to insulate them from pressure by the company sponsoring the trial, government officials or the public.
This article was published on Thursday, September 24, 2020 in Kaiser Health News.
Most Americans have never heard of Dr. Richard Whitley, an expert in pediatric infectious diseases at the University of Alabama-Birmingham.
Yet as the coronavirus pandemic drags on and the public eagerly awaits a vaccine, he may well be among the most powerful people in the country.
Whitley leads a small, secret panel of experts tasked with reviewing crucial data on the safety and effectiveness of coronavirus vaccines that U.S. taxpayers have helped fund, including products from Moderna, AstraZeneca, Johnson & Johnson and others. The data and safety monitoring board — known as a DSMB — is supposed to make sure the medicine is safe and it works. It has the power to halt a clinical trial or fast-track it.
Shielding the identities of clinicians and statisticians on the board is meant to insulate them from pressure by the company sponsoring the trial, government officials or the public, according to multiple clinical trial experts who have served on such panels. That could be especially important in the pressure-cooker environment of COVID vaccine research, fueled by President Donald Trump's promises to deliver a vaccine before Election Day.
As pharmaceutical companies work to produce one as quickly as possible, the board's anonymity has stirred concerns that the cloak of secrecy could, paradoxically, allow undue influence. Whitley, for example, represents the specialized world these experts inhabit — a professor revered in academia who also is paid by the drug industry.
Any political pressure to rush pharmaceutical companies or lean on federal regulators to prematurely greenlight a vaccine would undermine a system put in place to ensure public safety. Calls are growing for companies and the government to be more open about who's involved in reviewing the vaccine trials and whether board members have any conflicts of interest.
"We want to know they're truly independent," said Dr. Eric Topol, director of the Scripps Research Translational Institute and a specialist in clinical trials. "The lack of transparency is exasperating."
Data and safety monitoring boards have existed for decades to vet new drugs and vaccines, acting as a backstop to help ensure unsafe products don't make their way to the public. Typically, there's one board for each product. This time, a joint DSMB with 10 to 15 experts will review unblinded data across trials for multiple coronavirus vaccines whose development the U.S. government has helped fund, according to five people involved in the Trump administration's Operation Warp Speed or other coronavirus vaccine work. It is run through the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and consists of outside scientists and statistical experts, not federal employees, NIH Director Francis Collins said on a call with reporters.
"Until they are convinced that there's something there that looks promising, nothing is unblinded and sent to the FDA," Collins said. "I doubt if there have been very many vaccine trials ever that have been subjected to this size and the rigor with which it's being evaluated."
The NIH safety board oversees trials in the U.S. from Moderna, Johnson & Johnson and AstraZeneca, U.S. officials and others involved in Operation Warp Speed said, but not Pfizer, which is fully funding its clinical trial work and established its own five-member safety panel. Pfizer has attested that it can conclusively determine by late October the effectiveness of its vaccine, being jointly developed with German company BioNTech. It secured a $1.95 billion purchase agreement with the Department of Health and Human Services for the first 100 million doses produced. The agreement gives HHS the option to buy an additional 500 million doses.
Moderna, Johnson & Johnson and AstraZeneca, which have either started or are aiming to soon begin large-scale trials in the U.S. involving thousands of patients, collectively have received more than $2 billion in government funds for vaccine development; billions more have been meted out under agreements similar to the HHS contract with Pfizer to buy millions of vaccine doses. Having one safety board oversee multiple trials could allow researchers to better understand the field of products and apply consistency across evaluations, clinical trial experts said in interviews.
One big advantage "could be more standardization," said Dr. Walter Orenstein, associate director of the Emory Vaccine Center at Emory University and a former senior official at the Centers for Disease Control and Prevention. "They can look at that data and look at all the trials instead of just doing one trial."
But it also means that one board has an outsize influence to dictate which coronavirus vaccines eventually succeed or come to a halt, all while most of their identities remain secret. The NIH declined to name them, saying they were "confidential" and could be identified only once a study was complete.
One exception to the mystery is Whitley, who was appointed as chair by Dr. Anthony Fauci, the nation's top infectious disease official. Fauci said that following a "combination of input from us and from him and other colleagues, the people who had the greatest expertise in a variety of areas, including statistics, clinical trials, vaccinology, immunology, clinical work," were selected for the panel.
Whitley's role became public when his university announced it, an unusual move. He is a professor as well as a board member of Gilead Sciences, which recently signed a contractwith Pfizer to manufacture remdesivir to treat COVID-19 patients. Whitley, who's been on Gilead's board since 2008, conducted research that led to remdesivir's development.
In 2019, he was paid roughly $430,000 as a Gilead board member, according to documents filed with the Securities and Exchange Commission. That same year, he received more than $7,700 in payments from GlaxoSmithKline for consulting, food and travel, according to a federal database that tracks drug and device company payments to physicians.
GlaxoSmithKline and Sanofi are jointly developing a vaccine that's received $2 billion from the U.S. government under Operation Warp Speed; however, Whitley, through a university spokesperson, said his DSMB has not seen any GlaxoSmithKline COVID protocols. The companies have yet to begin phase 3 trials. Although he chairs a separate GSK data and safety monitoring board for a pediatric vaccine, he was vetted and cleared by the NIH conflict-of-interest committee with its knowledge of his involvement, the spokesperson said.
"When handled responsibly, it is appropriate for physicians to collaborate with external entities," said UAB spokesperson Beena Thannickal, saying the university works with physicians to ensure that industry engagement is appropriate. "It facilitates a critical exchange of knowledge and accelerates and advances clinical treatments and cures, and it fuels discovery."
Multiple experts praised his skill — Dr. Walter Straus, an associate vice president at the drug company Merck & Co., said Whitley is an "éminence grise" in pediatrics whom people trust.
"I actually trust that process, and the fact that they asked Rich to do it makes me feel reassured because he's so good," said Dr. Jeanne Marrazzo, director of the University of Alabama-Birmingham's division of infectious diseases.
Multiple scientists who have participated in data and safety monitoring boards maintain it's important to keep the board anonymous to shield them against pressure or even for their safety. For example, when trials were conducted in San Francisco for HIV/AIDS research, the board was confidential to protect members from patients desperate for treatment, said Susan Ellenberg, a professor of biostatistics, medical ethics and health policy at the University of Pennsylvania who's written extensively on the history of DSMBs.
If approached by a patient, it "would be very hard to tell you, 'Oh I can't help you.' It's an unreasonable burden," said Ellenberg, who said she was involved in coronavirus-related safety boards but would not name them.
As part of a large-scale clinical trial, the DSMB and a statistician or team that prepares data for those individuals are generally the only ones who see unblinded data about the trial, making it clear who is getting what treatment. A firewall is set up between them and executives from the sponsoring company with financial interests in the trial. The companies sponsoring COVID vaccine trials are not part of any closed sessions during which unblinded data is reviewed. Those are limited to members of the DSMB, the NIAID executive secretary and the independent unblinded statistician who is presenting the data, a NIAID spokesperson said.
DSMB members or their family members should have no professional, proprietary or financial relationship with the sponsoring companies, and the NIAID DSMB executive secretary vetted all members for potential conflicts of interest, NIAID said in response to questions from KHN. Members are paid $200 per meeting.
"It's generally done out of a sense of public service," said Dr. Larry Corey of the Fred Hutchinson Cancer Research Center, who is working with NIH officials to oversee the U.S. coronavirus vaccine clinical trials. "You're doing it because of your sense of altruism and obligation to knowing the important role it plays in clinical research and the important role it plays in preserving the scientific integrity of important trials."
Moderna, AstraZeneca, Johnson & Johnson and Pfizer have each released protocols that include details on when their DSMBs would review unblinded information about trial participants, and at what points they could recommend pausing or stopping trials. The vaccine data and safety board organized by NIAID advises a broader oversight group consisting of the drug companies sponsoring the trial and representatives from NIAID and HHS' Biomedical Advanced Research and Development Authority that reviews the DSMB recommendations. Ultimately, the drug company has final authority over whether to submit its data to the Food and Drug Administration.
Moderna and Johnson & Johnson are each aiming for their vaccines to have 60% efficacy, which means there would need to be 60% fewer COVID cases among vaccinated individuals in their trials. AstraZeneca's target is 50%. The FDA has said any coronavirus vaccine must be at least 50% effective to secure approval from regulators. While the parameters of their clinical trials have similarities, there are some differences, including when and how many times the DSMB can conduct interim reviews to assess whether each vaccine works.
Pfizer is similarly aiming for its vaccine to be 60% effective. The company allows for four interim reviews of the data starting at 32 cases — a schedule that has been criticized by some researchers who contend it makes it easier for the company to stop the trial prematurely.
Pfizer declined to name the individuals on its monitoring committee, saying only that the group consisted of four people "with extensive experience in pediatric and adult infectious diseases and vaccine safety" and one statistician with a background in vaccine clinical trials. An unblinded team supporting its data-monitoring committee — which includes a medical monitor and statistician — will review severe cases of COVID-19 as they are received and any adverse events associated with the trial at least weekly.
"There is an irresolvable tension between speed and safety," said Dr. Gregory Poland, the head of Mayo Clinic's Vaccine Research Group. "Efficacy is pretty easy to figure out. It's safety that's the issue."
California Healthline editor Arthur Allen contributed to this report.
Reopening colleges drove a coronavirus surge of about 3,000 new cases a day in the United States, according to a draft study released Tuesday.
The study, done jointly by researchers at the University of North Carolina-Greensboro, Indiana University, the University of Washington and Davidson College, tracked cellphone data and matched it to reopening schedules at 1,400 schools, along with county infection rates.
"Our study was looking to see whether we could observe increases both in movement and in case count — so case reports in counties and all over the U.S.," said Ana Bento, an infectious disease expert and assistant professor at Indiana University's School of Public Health.
"Then we tried to understand if these were different in counties where, of course, there were universities or colleges, and particularly, to see if these increases were larger in magnitude in colleges with face-to-face instruction primarily," she said.
Nearly 900 of those schools opened primarily with in-person classes, according to the draft study.
The research examines the period from July 15 to Sept. 13. It does not name specific institutions or locations, but researchers found a correlation between schools that attempted in-person instruction and greater disease transmission rates.
Just reopening a university added 1.7 new infections per day per 100,000 people in a county, and teaching classes in person was associated with a 2.4 daily case rise, the study found.
"No such increase is observed in counties with no colleges, closed colleges or those that opened primarily online," the study says.
Factoring in whether students came from places where disease incidence was high added 1.2 daily cases per 100,000 people.
Daily new case counts nationwide during the study period ranged from a high of 70,000 to a low of 30,000, according to data compiled by The New York Times.
The authors are not calling it a mistake for colleges to have opened, considering the many variables each school faced. But earlier reporting on reopening plans around the country found a welter of chaotic efforts that did not conform to a single standard, suggesting the potential for disaster when students returned.
In fact, numerous reports surfaced around the country showing frightening COVID spikes in college towns, often blamed on partying by students. Even at the University of Illinois, a school lauded for its preparations and robust testing, more than 2,000 cases have been reported on campus since students went back last month. Cases there peaked about a week after classes began and have fallen since then.
The authors are not faulting irresponsible young people, either, since they studied class instruction methods, not behavior off campus, where some students have acted extremely poorly.
"I think that it's slightly unfair, perhaps, to say, 'Oh, students are congregating and creating these bad behaviors that lead to outbreaks,'" Bento said. "I think it's more this idea of when you see a huge influx from all over the country, or from different counties, into a college town that we know had a very low burden of COVID throughout the first months, all of a sudden we have this increased probability of infection, because we have a large community of individuals that were susceptible still."
Rather than lay blame, she said, the idea of the study was to measure the problem and then use that data to better figure out how to respond, which is the subject of a future study.
"In order for you to open online, hybrid or meet face to face, there needs to be a different combination of strategies that allows you to catch [cases] early so you're able to control community spread, which is the biggest problem here," Bento said.
The researchers hope to have that work done relatively soon, well before colleges start spring semesters.
There are some unanswered questions, such as how much of the surge in cases is simply from sick students testing positive when they arrive versus catching COVID-19 after they arrive — and how much students spread the virus to the community or the other way around.
Another is how well specific types of responses mitigated the spread, and whether different local safety measures helped or hurt.
And there is an alarming caveat: The work almost certainly did not capture the full extent of the campus-linked surge.
"While this study estimates around a 3,000 increase in daily cases, we have to take into account that this is actually likely an underestimate, because we still don't see" people who are asymptomatic, Bento said.