Sen. Rick Scott (R-Fla.) issued a press release Nov. 16 suggesting that rising general inflation was behind the large increase in next year’s standard premiums for Medicare Part B.

This article was published on Wednesday, November 24, 2021 in Kaiser Health News.

By Phil Galewitz

An increase in Medicare Part B premiums means “America’s Seniors Are Paying the Price for Biden’s Inflation Crisis.” — The headline of a press release from Sen. Rick Scott (R-Fla.)

Republicans blame President Joe Biden for this year’s historic surge in inflation, reflected in higher prices for almost everything — from cars and gas to food and housing. They see last month’s 6.2% annual inflation rate — the highest in decades and mostly driven by an increase in consumer spending and supply issues related to the covid-19 pandemic — as a ticket to taking back control of Congress in next year’s midterm elections.

A key voting bloc will be older Americans, and the GOP aims to illustrate how much worse life has grown for them under the Biden administration.

Sen. Rick Scott (R-Fla.) issued a press release Nov. 16 suggesting that rising general inflation was behind the large increase in next year’s standard premiums for Medicare Part B, which covers physician and some drug costs and other outpatient services.

“Sen. Rick Scott: America’s Seniors Are Paying the Price for Biden’s Inflation Crisis” was the headline. The senator’s statement within that press release said, “We need to be LOWERING health care and drug prices and strengthening this vital program for seniors and future generations, not crippling the system and leaving families to pay the cost.” The press release from Scott says he is “slamming Biden’s inaction to address the inflation crisis he and Washington Democrats have created with reckless spending and socialist policies, which is expected to cause significant price increases on [senior] citizens and Medicare recipients.” Scott’s statement in that same press release also says the administration’s “reckless spending” will leave U.S. seniors “paying HUNDREDS more for the care they need.”

We wondered whether these points were true. Was the climbing annual inflation rate over the past several months to blame for the increase in Medicare Part B premiums?

We reached out to Scott’s office for more detail but received no reply. Upon further investigation, we found there is little, if any, connection between general inflation in the past few months and the increase in Medicare Part B premiums.

What’s the Status of Medicare Premiums?

Medicare Part B premiums have been growing steadily for decades to keep up with rising health spending.

The U.S. inflation rate, for years held at bay, has been above 4% since April, hitting 6.2% in October, the highest rate in decades.

On Nov. 12, the Centers for Medicare & Medicaid Services announced that the standard monthly premium for Medicare Part B would rise to $170.10 in 2022, from $148.50 this year. The 14.5% increase is the largest one-year increase in the program’s history.

Scott’s press release refers to the CMS report.

CMS cited three main factors for the increase: rising health care costs, a move by Congress last year that held the premium increase to just $3 a month because of the pandemic, and the need to raise money for a possible unprecedented surge in drug costs. Inflation was not on that list.

In fact, half of the premium increase was due to making sure the program was ready in case Medicare next year decides to start covering Aduhelm, a new Alzheimer’s drug priced at $56,000 per year, per patient. It’s been estimated that total Medicare spending for the drug for one year alone would be nearly $29 billion, far more than any other drug.

How Big a Hit Will Seniors Feel?

The Part B premium is typically subtracted automatically from enrollees’ Social Security checks. Because Social Security recipients will receive a 5.9% cost-of-living increase next year — about $91 monthly for the average beneficiary — they’ll still see a net gain, though a chunk will be eaten away by the hike in Medicare premiums.

About 70% of Medicare beneficiaries won’t face a 14.5% increase, anyway, because a “hold-harmless” provision in federal law protects them from premium increases that exceed Social Security’s cost-of-living increase, said Gretchen Jacobson, a vice president of the nonpartisan Commonwealth Fund. So their increase will be limited to 5.9%.

Those not covered by the hold-harmless provision are mainly high-income beneficiaries (people with incomes over $91,000 for individuals), those newly enrolled in Medicare Part B, people who receive both Medicaid and Medicare, and enrollees not receiving Social Security because they are still working.

What Role Does Inflation Play?

Several Medicare experts said the spike in the general inflation rate has little or nothing to do with the Medicare premium increase. In fact, Medicare is largely immune from inflation, because the program sets prices for hospitals and doctors.

“This is so false that it is annoying,” Paul Ginsburg, a professor of health policy at the Sol Price School of Public Policy at the University of Southern California, said of Scott’s claim that general inflation is behind the premium increase. “The effect of the inflation spike so far on prices is zero because Medicare controls prices.”

Medicare Part B premiums, he said, reflect changes in the amount of health services delivered and a more expensive mix of drugs. “Premiums are tracking spending, only a portion of which reflects prices,” Ginsburg said. “I can’t see that the administration really had any discretion” in setting the premium increase due to the need to build a reserve to pay for the Alzheimer’s drug and make up for the reduced increase last year, he said.

Stephen Zuckerman, co-director of the Urban Institute’s health policy center, said a rise in wages caused by inflation could spur a small boost in Medicare spending because wages help determine how much the program pays providers. But, he said, such an increase would have to occur for more than a few months to affect premiums. Continued soaring inflation could influence 2023 Medicare premiums, not those for 2022. “The claim that premium increases are due to inflation in the last couple of months doesn’t make sense,” Zuckerman said.

CMS faced the challenge of trying to estimate costs for an expensive drug not yet covered by Medicare. “It is a very difficult projection to make, and they want to have enough contingency reserved,” said Jacobson, of the Commonwealth Fund.

Still, the 5.9% jump that will hit most enrollees is a relatively large premium increase, she added. Those beneficiaries will see an $8.76 monthly increase in premiums, or about $105 more for all of 2022.

Our Ruling

Scott said in a press release about the 2022 increase in Medicare Part B premiums that “America’s seniors are paying the price for Biden’s inflation crisis.”

Though his statement contains a sliver of truth, Scott’s assertion ignores critical facts that create a different impression.

For instance, Medicare policy experts said, current general inflation has little, if anything, to do with the increase in premiums. CMS said the increase was needed to put away money in case Medicare starts paying for an Alzheimer’s drug that could add tens of billions in costs in one year and to make up for congressional action last year that held down premiums.

And most seniors will not pay hundreds of dollars more for premiums because of the hold-harmless provision. About 30% of Medicare enrollees — those with high incomes and those who do not receive Social Security — will have to pay the full $21.60 a month, or about $259 for 2022, a 14.5% increase. People in this category either have higher incomes or are not yet receiving Social Security because they are still working.

The other 70% of enrollees will face a 5.9%, or $8.76 a month, increase. This means most Medicare enrollees will see a $105 increase in premiums for all of 2022, not hundreds of dollars.

We rate the claim Mostly False.

SOURCES:

Telephone interview with Stephen Zuckerman, co-director of the Health Policy Center at the Urban Institute, Nov. 19, 2021.

Telephone interview with Paul Ginsburg, professor of health policy at the Sol Price School of Public Policy at the University of Southern California, Nov. 18, 2021.

Telephone interview with Gretchen Jacobson, vice president of the Medicare program at the Commonwealth Fund, Nov. 18, 2021.

Telephone interview with Joe Antos, senior fellow with American Enterprise Institute, Nov. 18, 2021.

Sen. Rick Scott’s press release, Nov. 16, 2021.

Statista, monthly inflation rates, accessed Nov. 19, 2021.

Centers for Medicare & Medicaid Services press release about Medicare Part B premiums, accessed Nov. 19, 2021.

Medicareresources.org’s fact sheet about the Medicare hold-harmless provision, accessed Nov. 19, 2021.

Medicareresources.org fact sheet about high earners not subject to the hold-harmless provision, accessed Nov. 19, 2021.

Social Security blog about the hold-harmless provision, accessed Nov. 19, 2021.

AARP blog about the biggest-ever increase in Medicare Part B premiums, accessed Nov. 18, 2021.

Medicare Trustees Report, 2021 (see page 90 for Medicare Part B premiums by year since program inception).

KFF brief on the impact Aduhelm could have on Medicare costs, accessed Nov. 18, 2021.

CMS’ “2022 Medicare Parts A & B Premiums and Deductibles/2022 Medicare Part D Income-Related Monthly Adjustment Amounts” report, accessed Nov. 12, 2021.

Doctor groups and medical associations have lashed out at the interim final rules that HHS unveiled last month, saying they favor insurance companies in the arbitration phase.

This article was published on Tuesday, November 23, 2021 in Kaiser Health News.

By Michael McAuliff

Overpriced doctors and other medical providers who can’t charge a reasonable rate for their services could be put out of business when new rules against surprise medical bills take effect in January, and that’s a good thing, Health and Human Services Secretary Xavier Becerra told KHN, in defending the regulations.

The proposed rules represent the Biden administration’s plan to carry out the No Surprises Act, which Congress passed to spare patients from the shockingly high bills they get when one or more of their providers unexpectedly turn out to be outside their insurance plan’s network.

The law shields patients from those bills, requiring providers and insurers to work out how much the physicians or hospitals should be paid, first through negotiation and then, if they can’t agree, arbitration. Doctor groups and medical associations, however, have lashed out at the interim final rules that HHS unveiled last month, saying they favor insurance companies in the arbitration phase. That’s because, although the rules tell arbiters to take many factors into account, they are instructed to start with a benchmark largely determined by insurers: the median rate negotiated for similar services among in-network providers.

The doctor groups say giving the insurers the upper hand will let them drive payment rates down and potentially force doctors out of networks or even out of business, reducing access to health care.

The department has heard those concerns, Becerra said, but the bottom line is protecting patients. Medical providers who have taken advantage of a complicated system to charge exorbitant rates will have to bear their share of the cost, or close if they can’t, he said.

“I don’t think when someone is overcharging, that it’s going to hurt the overcharger to now have to [accept] a fair price,” Becerra said. “Those who are overcharging either have to tighten their belt and do it better, or they don’t last in the business.”

“It’s not fair to say that we have to let someone gouge us in order for them to be in business,” he added.

Nonetheless, Becerra said he did not foresee a wave of closures, or diminished access for consumers. Instead, he suggested that a competitive, market-driven process will find a balance, especially when consumers know better what they are paying for.

“We’re willing to pay a fair price,” he said. But he emphasized that “I’ll pay for the best, but I don’t want to have to pay for the best and then three times more on top of that and get blindsided by the bill.”

Becerra also pointed to a report on surprise medical bills that HHS released Monday and that was provided to KHN in advance, highlighting the impacts of negotiation and arbitration laws already in effect in 18 states.

The report, which aggregates previous research, found people getting hit with surprise bills averaging $1,219 for anesthesiologists, $2,633 for surgical assistants, $744 for childbirth and north of $24,000 for air ambulances.

In the states that use benchmarks similar to what doctors are suggesting HHS use, such as New York and New Jersey, the report found costs rising. New York has a “baseball-style” system in which the arbiter chooses between the offers presented by the provider and the insurer, although the arbiter is told to consider the offer closest to the 80th percentile of charges. “Since the amount providers charge is typically much higher than the actual negotiated rate, this approach risks leading to significantly higher overall costs,” the report found. In New Jersey, billed charges or “usual and customary” rates are considered.

“When the arbitration process is wide open, no boundaries, at the end of the day health care costs go up, not down,” Becerra said of the methods doctors prefer. “We want costs to go down. And so we want to set up a system that helps provide the guideposts to keep us efficient, transparent and cost-effective.”

The system chosen by the Biden administration was expected to push insurance premiums down by 0.5% to 1%, the Congressional Budget Office estimated.

“Everyone has to give a little to get to a good place,” Becerra said. “That sweet spot, I hope, is one where patients … are extracted from that food fight. And if there continues to be a food fight, the arbitration process will help settle it in a way that is efficient, but it also will lead to lower costs.”

While the administration chose a benchmark that physician and hospital groups don’t like, the law does specify that other factors should be considered, such as a provider’s experience, the market and the complexity of a case. Becerra said those factors help ensure arbitration is fair.

“What we simply did was set up a rule that says, ‘Show the evidence,’” Becerra said. “It has to be relevant, material evidence. And let the best person win in that fight in arbitration.”

The interim final rules were published Oct. 7, giving stakeholders 60 days to comment and seek changes. More than 150 members of Congress, many of them doctors, have asked HHS and other relevant federal agencies to reconsider before the law takes effect Jan. 1. The lawmakers charge that the administration is not adhering to the spirit of the compromises Congress made in passing the law.

Rules that are this far along tend to go into effect with little or no changes, but Becerra said his department was still listening. “If we think there’s a need to make any changes, we are prepared to do so,” the secretary said.

The HHS report also noted that the law requires extensive monthly and annual reporting to regulators and Congress to determine if the regulations are out of whack or have undesirable consequences like those the physicians are warning of.

Becerra said he thinks the rules strike the right balance, favoring not insurers or doctors, but the people who need medical care.

“We want it to be transparent, so we can lead to more competition, and keep costs low — not just for the payer, the insurer, not just for the provider, the hospital or doctor, but for the patients especially,” he said.

On the whole, Washington has been especially cautious when it comes to covid, which has helped the city avoid the worst of the pandemic.

This article was published on Monday, November 22, 2021 in Kaiser Health News.

By Amanda Michelle Gomez

A mile northeast of Capitol Hill in Washington, D.C., along what’s known as the H Street corridor, about half the people crowding the sidewalks are wearing masks. Perhaps it’s because they know that when they step into any business or establishment here, they will have to put one on anyway. The capital, after all, is one of the few remaining cities or states nationwide that mandate masks for public indoor spaces — at least it has, until today.

“We have a bunch of rule followers,” said Claire Bengur, the owner of Atlas Salon, which has been in the neighborhood since 2018. “I am so thankful that my salon is in D.C.” She’s been glad to have a mask requirement, she said, because it’s impossible to do clients’ hair without standing close to them.

Bengur is unsure how to feel about Mayor Muriel Bowser’s decision to roll back the mandate. As the covid-19 pandemic has worn on, many Washingtonians have come to view masking as something between a habit and a security blanket. Even when the rule was lifted for about two months starting in May, many people continued to use masks in places like grocery stores. While face coverings will still be required in select spaces, such as public transit and schools, the District of Columbia will no longer require them in private businesses like Atlas Salon. And that has triggered mixed feelings.

Bengur had been debating whether to continue to ask clients to wear masks because the district gives businesses that option. But at the same time, “there is a certain level of excitement … like I don’t want to wear masks forever.” She ultimately decided to let clients choose for themselves. Bengur and her staff feel more at ease than they did earlier in the pandemic because her salon requires proof of vaccination.

A block away at the H Street Northeast location of Solidcore, a boutique fitness chain that started in the district, CEO Bryan Myers had an it’s-about-time take. “This will be game-changing for our clients’ comfort while working out and the health of our industry,” he said.

On the whole, Washington has been especially cautious when it comes to covid, which has helped the city avoid the worst of the pandemic. Now, the mayor is moving away from ordering protective measures and instead offering recommendations based on vaccination status.

This change can partly be explained by adjustments in the district health department’s goal, which no longer is to reach zero cases. Viewing covid as more of an “endemic” disease — one regularly found in particular populations — Bowser explained her decision this way: “This does not mean that everyone needs to stop wearing their masks. But it does mean that we are shifting the government’s response to providing you risk-based information.” While she’s reserved the right to reinstate the mandate, Bowser has doubled down on her decision. “Quite frankly, I don’t expect many D.C. residents will change their current behavior,” she said Friday during an interview on a local radio show.

The shift has some residents feeling perplexed, if not nervous, especially given the timing.

Children ages 5 to 11 just became eligible for vaccination, so they are not fully immunized yet, and infections are likely to climb with the holidays coming. Cases have already increased in half the states. That neighboring Montgomery County reinstated its mask mandate over the weekend leaves some people all the more baffled. A majority of district council members are already pushing the mayor to reconsider. Meanwhile, the White House, just steps from the mayor’s office, is not lifting its mask requirement, noting that the Centers for Disease Control and Prevention recommends one given the substantial level of community transmission.

“I’m a little bit iffy about the whole thing,” said Sandra Basanti, co-owner of Pie Shop, which offers fresh pies and live music on H Street.

Basanti has two young children who are not yet fully vaccinated. She’s unsure whether she’ll require customers to wear masks but expects to — at least at first. She’s hesitant because staffers received pushback when Pie Shop became one of the first venues in town to impose a vaccine requirement. She would like to see Washington follow New York City’s example and require proof of vaccination to enter public spaces such as shopping centers, sports arenas and theaters.

“We were just kind of waiting for the city to make that call for us so that we wouldn’t have to fight people on it, and they never did,” said Basanti. “I just don’t want to make the staff feel like they now also have to be the mask police again.”

“Being the mask police sucks,” she added.

The owner of the dive bar across the street agrees. “I’m very exhausted with arguing with people about masks and all the different things,” said Tony Tomelden of the Pug, which will not require patrons to wear masks but will insist that they be vaccinated. “Once a week, at least, there’s some kind of argument with some customer.”

Tomelden worries that talk of endemic covid means leaders are moving on without addressing all the pandemic-induced needs of small businesses beyond masking. “I’m so tired of begging for a break on bills and for grants and that kind of thing, but we’re still not fully recovered,” he said.

Like residents, public health experts are not in agreement on whether the district is acting prematurely.

“It makes sense,” Dr. Lynn Goldman, dean of the Milken Institute School of Public Health at George Washington University, said of the mayor’s decision. She reasoned that, thanks to vaccination, the district has few covid hospitalizations and deaths. “At the same time … we don’t really know how it’s going to go.”

Meanwhile, Dr. David Dowdy, an associate professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, said he generally recommends against easing restrictions at a time like this. “My expectation is that we’re likely to see something of an increase in cases over the winter,” he said, “and then this probably is going to become after that point in time something of an endemic disease.”

“We’ve come this far. It probably is not too difficult to keep our guard up for a couple more months,” he added. “But the flip side of that is we’ve been doing this for a really long time and people are very tired.”

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, sees Washington’s experience as emblematic of what can happen when leaders do not clearly explain their response to covid or why mask mandates are imposed or withdrawn.

Part of the challenge, Osterholm said, is that the explanations are unsatisfying. “We do not understand why surges start or stop,” he said. “Why they start and stop surely can’t be tied to human mitigation strategies. What can be tied to those is how big those surges get.”

The U.S. produced covid-19 vaccines in record time, but, nearly two years into the pandemic, consumers have few options for cheap tests that quickly screen for infection.

This article was published on Monday, November 22, 2021 in Kaiser Health News.

By Rachana Pradhan and Hannah Norman

While developing a rapid test that detects the coronavirus in someone’s saliva, Blink Science, a Florida-based startup, heard something startling: The Food and Drug Administration had more than 3,000 emergency use authorization applications and didn’t have the resources to get through them.

“We want to try to avoid the EUA quagmire,” said Peb Hendrix, the startup’s vice president of operations. Its test is still in early development. On the advice of consultants, the company is weighing an alternative route through the FDA to the U.S. market.

“It’s just the way our government works,” Hendrix said, which is a challenge for businesses that are “anxious to get started and think they’ve got something that can help.”

The U.S. produced covid-19 vaccines in record time, but, nearly two years into the pandemic, consumers have few options for cheap tests that quickly screen for infection, though they are widely available in Europe. Experts say the paucity of tests and their high prices undermine efforts in the U.S. to return to normal life.

Some experts say the FDA’s approach to clearing rapid tests has been onerous and overly focused on exceptional accuracy to detect positive results, rather than on what would really benefit people en masse: speedy results. The main use of rapid tests is to screen people so they can safely attend work, school, meetings or gatherings. This screening can then be followed up with a more sensitive, lab-based polymerase chain reaction (PCR) test for diagnosis.

The FDA has authorized just 12 over-the-counter options for rapid tests. But the problems go beyond that agency: The Biden administration recently put $3 billion toward boosting the supply of rapid tests, but public health and industry experts say the government didn’t move quickly enough early in the pandemic to support development and manufacturing.

“Should we have had an equivalent of Operation Warp Speed for testing?” asked Mara Aspinall, a co-founder of life sciences fund BlueStone Venture Partners and a board member for OraSure Technologies, which received FDA authorization for an over-the-counter rapid test. “Absolutely. … For too long, people thought of testing as an extra and not the core, and it needs to be thought of as the core.”

During the pandemic, the FDA has received more than 4,500 emergency use authorization and related requests for covid tests, according to FDA spokesperson Jim McKinney. The agency says it is prioritizing reviews of at-home and point-of-care tests that can be produced in high volumes. Two recently authorized tests alone could boost availability by as much as 13 million tests a day, McKinney said, adding that it would “efficiently review the submissions that will have the biggest impact on the nation’s testing needs.”

In addition to the slow pace of approvals, manufacturing bottlenecks created by materials and labor shortages are keeping prices high. Prices of rapid tests range from $14 for a two-pack to well over $50 a test, far from affordable for regular use.

The FDA says it can’t move more quickly as it balances ensuring that safe and useful devices reach the marketplace with the urgent need to deliver options for widespread daily testing.

“The FDA carefully weighs the known and potential risks and … benefits of emergency use authorization for COVID-19 diagnostic tests based on sound science,” McKinney said in response to questions. But he noted many submissions “are incomplete or contain insufficient information.”

Startups said navigating the ins and outs of this regulatory apparatus is daunting. E25Bio of Cambridge, Massachusetts, is developing a low-cost antigen test, which detects covid by identifying proteins called antigens. Since July 2020, the company has repeatedly adjusted its FDA application as the agency updates its recommendations. The requirement that test results be reported directly to federal health authorities has added to delays.

“As a smaller company, we didn’t have the capabilities to develop that technology at first,” said Bobby Brooke Herrera, co-founder and chief science officer. E25Bio now has a mobile app that verifies results and sends the anonymized data to public health authorities.

Another speed bump: The FDA requires U.S. clinical trials, making the company’s data from Latin America unusable.

Herrera hopes to sell the over-the-counter rapid test in the U.S. for less than $5, cheaper than anything currently on the market.

Hendrix said Blink Science is considering a different path to FDA approval. Known as de novo, it can be used to bring novel, low-risk medical devices to market. For now, he said, the company is likely to prioritize approval in developing countries where vaccination rates are much lower than in the U.S.

Steradian Technologies, which hopes to launch a 30-second breath test, says it was told by regulatory consultants and others who ran into snags in the EUA process that it “might not be worth it” because the agency is so backed up, according to Tra Tran, the company’s director of development and clinical affairs. The FDA’s regular approval process might be the best option.

“We don’t have the budget to spend on doing an EUA and then being told, ‘Well, actually you wasted six months and hundreds of thousands of dollars,’” she said. “Only certain people have the capital to be able to afford staying in this FDA regulatory process for forever.”

The Companies’ View

Several public health experts and people in the testing industry said that the Biden administration’s recent moves will help supply but that meeting demand will take time.

Australian test-maker Ellume received $232 million in federal funds in February to boost U.S. manufacturing of its rapid at-home test, but the company says its new plant in Frederick, Maryland, won’t start production until December. It could eventually manufacture 15 million tests a month.

The FDA authorized Ellume’s over-the-counter covid test in December 2020, but the road has been rocky: The company recalled 2.2 million tests in the U.S. because of “higher-than-acceptable false positive” results, the FDA said, and the FDA warned that their use “may cause serious adverse health consequences or death.” All came from Ellume’s Australian facility.

IHealth Labs, which received FDA authorization Nov. 5 for a test priced at $14 for a two-pack, says that by January it will be able to make 200 million tests a month.

OraSure aims to make 4 million covid tests a month by January and 8 million a month by June. It plans to scale up to 200 million covid tests annually — but not until 2024.

Scott Gleason, OraSure’s interim chief financial officer, said the company faces headwinds at its plant in Pennsylvania’s Lehigh Valley. “We’re having some challenges with hiring enough people to work in our factories to meet the demand,” he said. A two-pack has recently retailed between $14 and $24, and that price won’t drop anytime soon, Gleason said.

Ellume has faced shortages of swabs, steel for its facility and electronics components for the tests.

The View From the FDA

The FDA has authorized more than 400 covid tests, including at-home options and those processed by a medical provider or a lab. The FDA is still getting more than 100 EUA submissions for covid tests per month, many from overseas. But, McKinney said, the vast majority are not for the type most needed now: tests for over-the-counter use.

The FDA may be reluctant to ease its scrutiny. The pandemic’s first-iteration rapid tests, like Abbott Laboratories’ ID Now, raised safety and accuracy concerns, and the FDA has sent warning letters to at least six companies selling bogus rapid tests and has issued numerous recalls. Separately, the agency put over 260 tests that detect covid antibodies on a “do not use” list.

“If we did to antigen tests what happened with antibody tests, we would completely destroy the credibility of the test,” said Aspinall, the venture capitalist. “As frustrating as this is, I have to respect the FDA for ensuring that we continue to have quality tests.”

The agency’s review times for covid test EUA applications have improved, according to an assessment by consulting firm Booz Allen Hamilton. Approvals were generally cleared faster than denials. As of March, the median time for the FDA to grant authorization was seven days and 38 days for denials. When the country isn’t in a national emergency, getting through the FDA’s reviews might take months or years.

Nonetheless, the bottlenecks are felt by Americans trying to keep their employees and families safe.

LabCentral — a biotech co-working facility in Cambridge, Massachusetts, that was part of E25Bio’s testing study — requires participating startups to test workers twice a week. That’s a costly safety measure for a nonprofit, said Celina Chang, LabCentral’s vice president, so it recently bought rapid tests from Germany for $1.50 each.

“In order to test people twice a week on a regular basis for months on end,” she said, “we need it to be, just the same as anyone, affordable.”