There's something for everyone with private health insurance in the American Rescue Plan Act, but determining the best way to benefit may be confusing.
The $1.9 trillion COVID relief law that President Joe Biden signed this month will make coverage significantly more affordable for millions of people who either who have marketplace coverage, are uninsured or have lost their employer coverage. In addition, it will eliminate repayment requirements for premium tax credits. Consumers can begin to see those improvements next month, but they may need to go to healthcare.gov and update their application for the changes to take effect then.
Tuesday afternoon, the Biden administration extended the length of time that people have to enroll in or change federal marketplace plans under a COVID special enrollment period. The three-month extension means people have until Aug. 15 to sign up and review their options.
The new provisions are temporary; none will extend past 2022 unless Congress acts to make them permanent. Many healthcare advocates hope that will happen.
"If Congress can circle back and make these improvements permanent, it will go a long way toward making insurance affordable in this country," said Stan Dorn, director of the National Center for Coverage Innovation at Families USA, a nonpartisan consumer healthcare advocacy organization.
In the meantime, these provisions will help Americans get or keep their health insurance and provide economic stability as the country emerges from the COVID pandemic.
What's new:
Enhanced Premium Subsidies for Marketplace Plans
When: 2021 and 2022
Who benefits: Just about everyone who has coverage through the Affordable Care Act's marketplaces. Premium costs for people eligible for subsidies will shrink by $50 per month on average, according to the federal government, but some people will see much larger savings.
Under the ACA, people with incomes between 100% and 400% of the federal poverty level (from $12,760 to $51,040 for one person or $26,200 to $104,800 for a family of four) were eligible for premium tax credits to reduce their premiums for marketplace coverage.
But under the changes passed in the new law, how much people owe is reduced at every income level and capped at 8.5% overall.
For example, a single person who makes $30,000 annually will pay $85 per month in premiums on average under the new law for a silver-level plan instead of $195, according to an analysis by the Center on Budget and Policy Priorities. A family of four making $75,000 will pay $340 rather than $588 per month for similar coverage, the analysis found.
Everyone benefits from the changes, said Tara Straw, a senior policy analyst at the center, including people with incomes above 400% of the poverty level ($51,040 for one person) who were previously not eligible for premium tax credits.
An older customer not yet in Medicare "with an income just over 400% of the federal poverty level in some states would be paying 20% to 30% of their income toward their healthcare premium," she said. "Now that will be capped at 8.5%."
At the other end of the income spectrum, people with incomes up to 150% of the poverty level ($19,140) will owe nothing in premiums. Under the ACA, they had been required to pay up to 4.14% of their income as their share of the premium cost.
Steps to take now:
People who have marketplace coverage in one of the 36 states that use the federal healthcare.gov platform should go back in and update their applications and reselect their current plan to get new details about their subsidies starting April 1.
People with marketplace coverage in states that run their own marketplaces should check the procedures there. States including California and Rhode Island, as well as the District of Columbia, have announced they will automatically adjust enrollees' premiums.
The enhanced tax credit is in effect for all of 2021 and 2022. For premiums paid for January through April, consumers can claim those premium tax credits when they file their taxes next year.
People who don't update their applications now will still be able to claim the additional tax credit amount when their file their taxes in 2022.
The more generous premium tax credits may mean people can switch to better coverage with lower cost sharing for the same contribution. A potential snag: Switching plans may mean that amounts already paid toward a deductible under the current plan are lost. Check with the insurer.
People who bought a 2021 plan off the marketplace , perhaps because their income is too high to qualify for premium tax credits, will have to enroll in coverage on the marketplace now in order to get the new premium tax credits, said Straw.
People who are uninsured can sign up now during the COVID special enrollment period that runs through Aug. 15 on the federal exchange. (Individual states have similar special enrollment periods.) People who sign up before April 1 should go back in after April 1 to update their applications.
Free Marketplace Health Insurance for People Who Receive Unemployment Insurance
When: 2021
Who benefits: Anyone who has received or has been determined eligible to receive unemployment insurance benefits in 2021.
Under the American Rescue Plan, anyone who has received unemployment benefits this year will be considered to have income at 133% of the federal poverty level (about $17,000) for the purposes of calculating how much they owe in premium contributions for a marketplace plan. Since people with incomes up to 150% of the poverty level don't owe anything in premiums under the new law, these unemployed workers can get a zero-premium plan. If they buy a silver-level plan, they can also be eligible for cost-sharing reductions that shrink their deductible and other out-of-pocket costs.
Officials are urging people receiving unemployment insurance to enroll in a marketplace plan now to take advantage of the law's enhanced premium tax credits. The federal government said the additional savings for people who collect unemployment insurance will be available starting in early July.
Step to take now:
People who are uninsured or have marketplace coverage can still receive the enhanced premium subsidies described above in the meantime. And because the new law excludes the first $10,200 in unemployment insurance from income for the 2020 tax year, people may be able to qualify for higher premium tax credits based on lower income, Straw said.
No Payback of Excess Marketplace Subsidies
When: 2020
Who benefits: People who earned more money last year than they estimated when they signed up for marketplace coverage.
Under the ACA, people estimate their income for the upcoming year, and the marketplace estimates how much in premium tax credits can be advanced to them every month. At tax time, people reconcile their actual income with their projected income, and if they received too much in tax credits, they generally must pay it back to the government.
The new COVID relief bill eliminates that requirement for 2020. The provision could help people who received unforeseen income last year such as hazard pay or perhaps were laid off and hired back as a contractor at higher pay but without benefits, experts said.
Unfortunately, because of the timing of the new law, income tax forms and tax filing software don't reflect these changes, said Sabrina Corlette, a research professor at Georgetown University's Center on Health Insurance Reforms.
"A lot of people are going to think they owe money but they're not going to," she said.
Steps to take now:
If you've already filed your income taxes for 2020, sit tight. The IRS is reviewing the law and will provide details soon. People should not file an amended tax return at this time.
If you haven't yet filed, "some people may want to wait and see if tax software is updated to allow them to file with this adjustment on their tax return," said Straw. Last week, the IRS announced that the deadline for filing individual federal tax returns for 2020 has been extended this year from April 15 to May 17.
Subsidies to Cover 100% of COBRA Premiums
When: April through September 2021
Who benefits: People who lost their employer-sponsored coverage and want to stay on that plan.
Generally, when people get laid off and lose their employer coverage they can opt to keep it for 18 months, but they have to pay the entire premium plus a 2% administrative fee. This is done under provisions of a law known as COBRA. Under the new law, the federal government will pay the entire COBRA premium through September of this year.
For people undergoing treatment for a medical condition, it can be important to keep their coverage and existing providers. And switching plans midyear can leave people on the hook for a brand-new deductible.
But the newly enacted enhanced premium tax credits and free marketplace coverage for people who collect unemployment insurance make marketplace coverage much more affordable than in the past, experts note.
That could be important because, after September, the new COBRA subsidies will end and people will be responsible for the entire premium, unless the government puts in place a special enrollment period for that circumstance. Without another special enrollment period, they might not be able to get into a marketplace plan until January.
Steps to take now:
People who missed the original 60-day enrollment window for keeping their job-based coverage can go back and enroll in COBRA now. They have 60 days to enroll after they're notified of the new provisions under the COVID relief plan. They will not owe premiums back to their original eligibility date, but any medical claims they incurred before their enrollment won't be covered.
Review coverage to determine whether COBRA or marketplace coverage is the best, most affordable option.
The school's experience provides a window into the hardships millions of families across the country have endured since last March, and exemplifies why education isn't the only reason many Americans want schools to fully reopen.
This article was published on Tuesday, March 23, 2021 in Kaiser Health News.
After covid-19 forced Olivia Goulding’s Indiana middle school to switch back to remote learning late last year, the math teacher lost contact with many of her students. So she and some colleagues came up with a plan: visiting them under the guise of dropping off Christmas gifts.
One day in December, they set out with cards and candy canes and dropped by the homes of every eighth grader at Sarah Scott Middle School in Terre Haute, a city of more than 60,000 near the Illinois border where both Indiana State University and the federal death row are located. They saw firsthand how these kids, many living in poverty and dysfunctional families, were coping with the pandemic’s disruptions to their academic and social routines.
“You just have a better concept of where they’re coming from and the challenges they really do have,” Goulding said. “When you’re looking at that electronic grade book and Sally Lou hasn’t turned in something, you remember back in your mind: ‘Oh, yeah, Sally Lou was home by herself, taking care of three younger siblings when I stopped by, and I spotted her helping Johnny with his math and she was helping this one with something else.’”
The school’s experience provides a window into the hardships millions of families across the country have endured since last March, and exemplifies why education isn’t the only reason many Americans want schools to fully reopen. Schools like Sarah Scott help hold their communities together by providing households with wide-ranging support, which has become much tougher during the pandemic.
“A lot of our students are struggling emotionally,” said Sarah Scott’s principal, Scotia Brown. “They’re stressed because they’re falling behind in their work. Or they’re stressed because of the conditions they’re living with at home.”
Even before the coronavirus struck, kids at Sarah Scott faced significant obstacles that compounded the normal social challenges and surging hormones of middle school. They live in Vigo County, which has the state’s highest rate of child poverty and high rates of child neglect. Nearly 90% of students qualified for free or reduced-fee lunches. Some showed up needing to shower and change at the school, which has a food pantry that also offers clothes and hygiene products.
Things got more difficult for students when covid threw Sarah Scott’s normal schedule into disarray. Initially, the school went totally remote, then moved to partially in-person for the start of the 2020-21 school year. When covid spiked in October, Sarah Scott went remote again because not enough substitute teachers could fill in for quarantining staff. Since January, students have been spending part of each week in the school building, with no plans as of early March to open fully.
Kids were given laptops to use at home. But internet access can be problematic.
“Internet has been the worst,” said Samantha Riley, mother of seventh grader Mariah Pointer. “So many people are on it, it shuts down all the time.”
When that happens, she uses the Wi-Fi emitting from the school bus that sits in front of her apartment complex, one of several parked around the community to fill the gaps.
Even when the internet works, though, keeping kids on task at home isn’t easy. Heather Raley said she often cries from the stress of trying to make her eighth grade daughter engage online. “It just seems like we’re always butting heads over this,” Raley said. “It’s just a bigger battle getting the work done.”
As in many other communities, students are falling behind academically. Some don’t do any of their e-learning activities. Sarah Scott’s reports to child protective services for educational neglect — when caregivers aren’t getting their children to either in-person or remote classes — have more than tripled this school year.
Brown said she also worries about physical neglect and abuse, which is harder to detect when interacting with students remotely. “If you’re in an abusive home and you have to be there five days out of the week because you’re doing remote learning, you’re in that environment even more,” she said.
More time at home can also mean doing without necessities, including food.
The school helps by offering free breakfasts and lunches for in-person students and to-go lunches on remote days. Sometimes, the principal delivers boxes of groceries to students’ homes. The school recently secured a microwave for one family and an inflatable mattress for a student who’d been sharing a bed with his grandmother.
For some kids, the stress of the pandemic has worsened emotional problems and mental illness. Recently, a former Sarah Scott student who had moved out of state logged into her former teacher’s virtual class to say she planned to kill herself. The school contacted police, who checked on her. Referrals for suicidal students are up fourfold, Brown said.
School social worker Nichelle Campbell-Miller said it’s been tough counseling kids online or through text messages.
“I am all about building relationships and being in person and being able to dap you up or give you a hug and be like, ‘Hey, what’s up?’” she said, using a term for various greetings like fist bumps or elaborate handshakes. “So being online is extremely difficult for me, because you can’t really tell the tone of your student. When I’m talking to you in person, I can read your body language and I can gauge where you’re at.”
Right now, she said, the psychological well-being of her middle schoolers is even more important than education.
Many students, such as eighth grader Trea Johnson, come up against challenges on both fronts. Trea transferred to Sarah Scott two days before covid ended in-person learning.
“We struggle with school anyway,” said his mom, Kathy Poff. “Then when this pandemic came along, it just knocked our feet out from under us.”
His grades plunged. He began to hate school, Poff said. He didn’t attend his daily video meetings with his teachers. His mother fought with him to complete his online assignments.
“I usually get pretty bored,” said Trea, whose long, straight hair sometimes falls over his eyes.
Poff found him a therapist he meets with once a week. She said his mood and academic productivity have improved. He wants to be a computer programmer and has been coding in his spare time lately. She also moved his computer into her bedroom so she could better monitor him and has started paying him to do his schoolwork.
“I can’t even imagine what it would be like to be a 13-year-old going through this pandemic,” said Poff, 51, a single mother. “They’re going through changes anyway, adjusting to adolescence and figuring out who they are, and they don’t even have a social group to figure that out.”
Goulding, the math teacher, said she’s glad she and her co-workers can help provide stability and continuity during this trying period. One recent night, for example, she got a call from a truant boy’s grandmother, who said she was in poor health and raising him alone. The next day, the principal and social worker picked him up and drove him to school.
Still, Goulding lamented not seeing her most vulnerable students on the days when they are remote.
“How do I check on my kids? How do I make sure they’re eating? How do I make sure,” she paused to compose herself, her voice quavering, “they’re safe?
“You’re no longer thinking about, ‘How are they doing on their polynomials?’ You’re thinking about, you know, the reality of life.”
When selecting who would run the mass-vaccination program, the city seems to have largely ignored the Black Doctors COVID-19 Consortium, an effective group of licensed, experienced, Black health care professionals led by Dr. Ala Stanford.
This article was published on Tuesday, March 23, 2021 in Kaiser Health News.
In Philadelphia, the good, the bad and the ugly have all been on vivid display in the covid vaccine rollout.
The Bad comes with a giant serving of gall: For a while, the city put its mass-vaccination program in the hands of Andrei Doroshin, a 22-year-old with no experience in health care but what, from all reports, seemed a healthy interest in making money. It did not go well. In this episode, we get a deep dive from public-radio reporter Nina Feldman, who uncovered the debacle.
The Ugly is systemic racism: When selecting who would run the mass-vaccination program, the city seems to have largely ignored the Black Doctors COVID-19 Consortium, an effective group of licensed, experienced, Black health care professionals led by Dr. Ala Stanford.
“I think we have to look, not just in Philadelphia, but at the deep rooted problem that allows you to look at an organization that has been doing the work and overlooks them primarily for another group that’s unestablished, younger, not led by a physician and white,” said Stanford.
The Good is the work that Stanford and the consortium have been doing, which throws the Bad and the Ugly into stark relief. Since last spring, they’ve been working tirelessly and creatively to address disparities in the care that Black Philadelphians receive for covid-19.
Those disparities include a lack of good vaccine information from trusted sources.
Immigrant populations are eager to be vaccinated but the barriers are steep, including lower rates of technology literacy and how well they speak English.
This article was published on Tuesday, March 23, 2021 in Kaiser Health News.
In late February, a week after Virginia launched a centralized website and call center for COVID-19 vaccine preregistration, Zowee Aquino alerted the state to a glitch that could prove fatal for non-English speakers trying to secure a shot.
Callers who requested an interpreter on its new 1-877-VAX-IN-VA hotline would be put on hold briefly and then patched through. Then the line would automatically hang up on them.
It was a startling discovery for Aquino, a community health manager, and her colleagues at NAKASEC Virginia, a nonprofit that works with Asian Americans across the state. The glitch was a "direct barrier to access," she wrote to senior state officials, "and must be addressed immediately."
But that wasn't the only problem. Only two languages were offered when callers dialed in — "press 1 for English" or "press 2 for Spanish." But Virginia is home to speakers of many other languages — Chinese, Korean, Vietnamese, Arabic, Mongolian, Amharic and dozens more — who would need the help of translators to get their place in line for a vaccine.
"There's so much attention to, let's translate flyers, right? We're like, what's the point of translating a flyer that says you can call 'VAX in VA' and we have all these languages, when the phone line doesn't work consistently, or it's not even set up well for non-English, non-Spanish-speaking populations?" said Sookyung Oh, the group's Virginia director.
Concerns about equity have loomed large in the nation's mass COVID vaccination effort. Distribution of doses has been spotty among underserved populations, many of whom have been hit disproportionately by COVID hospitalizations and deaths. As Aquino found, barriers to vaccinating those groups begin with providing basic information about the shots and getting people registered.
Several individuals in interviews said the immigrant populations they work with, including Asians and Latinos, are eager to be vaccinated. But the barriers are steep, including lower rates of technology literacy and how well they speak English, if at all.
"Especially in stressful situations, they are not trying to struggle through English," said Oh, who described trying to secure a vaccine appointment for her mother — a Korean woman who lives in Philadelphia — as a "complete clusterf***" because the city's registration portal isn't available in that language.
President Joe Biden announced this month that by May 1 the federal government would launch a website and new call center to help people find vaccine appointments, but officials have declined to elaborate on whether the website will be translated into non-English languages and which languages will be available through the call center. A spokesperson for the Department of Health and Human Services did not respond to questions about language access.
Approximately 5.3 million U.S. households have limited English proficiency, according to the U.S. Census 2019 American Community Survey. And, it found, nearly 68 million people speak a language other than English at home.
The CDC's website for COVID-19 vaccine information is comprehensively translated into four languages: Chinese, Korean, Spanish and Vietnamese. The federal agency has drafted other flyers about vaccines, but which languages the materials are available in varies considerably. A "Facts about COVID-19 Vaccines" flyer is translated into nearly two dozen languages, including Arabic, French, Tagalog, Russian, Somali and Urdu. Other documents are not translated at all; if they are, Spanish is the most common translation.
"It's really concerning that the information is not available in different languages," said Bert Bayou, director of the Washington, D.C., chapter of African Communities Together, which works with immigrants across the metropolitan area.
Virginia in mid-February released a centralized online preregistration system and a new hotline for vaccinations, a full month after residents 65 and older and those with certain medical conditions could register for appointments. As of mid-March, the state health department's portal could be translated only into Spanish, spoken by nearly 8% of the state's population. Similarly, the District of Columbia's vaccine preregistration website that launched this month was initially available only in English, although officials were working to have it translated into additional languages before the month is out.
Any agency that fails to inform limited-English speakers of how to access their services — in this case, vaccinations — could be found to have violated federal laws that prohibit discrimination in healthcare on the basis of race, color, national origin and other factors, said Mara Youdelman, a managing attorney at the National Health Law Program, a civil rights advocacy organization.
"If they launch a website and they choose not to have it translated into multiple languages, I would say at a minimum that they should have some taglines on the webpage about where to get more information," Youdelman said. Even beyond the law, making the vaccination process as accessible as possible to non-English speakers is "the necessary thing to do and the right thing to do."
Otherwise, she said, "we're not going to reach the herd immunity we all want and need to get life back to normal."
Fairfax County, the most populous county in Virginia, maintained its own registration portal, but officials only on March 15 launched a Spanish registration website, two months after the state significantly broadened vaccine eligibility. In the interim, Spanish speakers had been directed to download a PDF questionnaire, and then call a phone line to relay their information for an eventual appointment. Roughly 14% of the county's population identifies as Spanish-speaking, according to the 2019 American Community Survey.
In Virginia, many immigrants are left with the heavily promoted VAX-IN-VA hotline, where access to interpretation services was uneven. The state eventually added a "press 3" menu option for help in a different language — although the "press 2" and "press 3" prompts are spoken in English — that allowed non-English and non-Spanish speakers to more easily connect with interpreters in more than 100 languages.
Yet their needs often fall to the back of the line because the languages are so discrete and, after Spanish, there's no "obvious" third language that's prioritized, Oh said. Census data shows that more than 1.3 million Virginians speak a language other than English at home, including about 310,000 who speak Asian and Pacific Island languages and 295,000 who speak Indo-European languages.
A state spokesperson said that, upon reviewing call logs, in some situations the callers were the ones who may have hung up while on hold, and other times call center agents may have accidentally hung up. Records showed that this occurred fewer than 10 times, mostly all during the first week.
"We had a small handful of issues but looking forward we have not uncovered any ongoing issues," Vaccinate Virginia spokesperson Dena Potter wrote in an email. She did not respond to questions about whether state officials planned to translate Virginia's preregistration portal into other languages and whether the system might violate federal civil rights laws.
Nationally, Asian Americans have had lower COVID mortality rates than other minorities, including Black and Latino Americans. However, there are troubling signs that underscore the urgency to boost vaccination rates. According to data compiled by the American Public Media Research Lab, the four-week period between early February and early March was the deadliest stretch of the pandemic for Asian, Latino, white and Indigenous Americans. Roughly 3,730 new deaths were reported among Asian Americans. Among Hispanics, 16,780 new deaths were reported.
To figure out whether they're eligible and to get vaccine appointments, non-English speakers rely on the clinics that treat them, English-speaking friends and family, and other nonprofits that serve immigrant communities. Without reliable information across languages, health centers and other nonprofits worry about what fills the void: Rumors and false information proliferate not only on U.S. social media platforms but apps like WhatsApp and WeChat used around the world.
"They're not your Facebook and your Instagram chats," said Andrea Caracostis, CEO of the HOPE Clinic in Houston, a federally qualified health center that treats patients from at least 60 countries. "I think language issues and misinformation from abroad is going to erode a lot of the work that we do."
The Houston area is home to one of the largest Vietnamese populations in the country. In late January, the clinic prioritized Vietnamese seniors for shots after receiving about 500 doses from the city. To make it happen, Caracostis said, they partnered with local Vietnamese doctors, nurses and even medical students to help. Clinic staff members translated immunization release forms before patients showed up.
"It's going to take a village," she said.
Groups are assembling teams of volunteers to make preregistration calls and appointments, and setting up pop-up registration sites in church parking lots in poorer neighborhoods.
"You can answer questions right on the spot," said Wanda Pierce, co-chair of Arlington County's Complete Vaccination Committee, a 40-plus-person group formed to ensure equitable distribution of vaccines in that Virginia suburb of Washington. County officials have organized preregistration pop-ups, typically done alongside other services for low-income residents, such as clothing and food distribution. A recent pop-up held at Macedonia Baptist Church, a Black church in a lower-income area of the county, saw a handful of limited-English speakers preregister for vaccines, according to organizers.
Recent polling has found that vaccine hesitancy is dipping among minority groups; however, they are still more likely to take a "wait and see" approach than white Americans. And many are struggling to secure appointments.
A March poll from KFF found that among adults who have gotten at least one dose of vaccine, 39% said someone else had helped them find or schedule an appointment. Hispanic adults were more likely than white adults to say they did not have enough information about where or when they could get vaccinated.
Spanish-language needs and outreach to Latinos haven't been adequately prioritized, said Luis Angel Aguilar, the Virginia state director of CASA. In addition to language access, "there's not enough communication and information now on where and who to call," he said.
"It's so easy for people to give up and say, 'You know, I tried,'" added Nancy White, president of the Arlington Free Clinic, which treats low-income minorities and counts Spanish, Mongolian and Amharic speakers among its patients.
The clinic, instead of signing up patients through Virginia's preregistration portal, is using its own system to get its patients vaccinated since the clinic receives an allocation of doses directly from the county. After an early pilot program to vaccinate seniors 75 and older, Arlington Free Clinic this month began vaccinating people 65 and up and those with chronic medical conditions. It relies on over 100 volunteer interpreters to help patients navigate the healthcare system.
"You can do it," White said of getting around language issues, "but it takes a lot of time and a lot of manpower."
Democrats, newly in control of Congress and the White House, are united behind an idea that Republican lawmakers and major drugmakers fiercely oppose: empowering the Department of Health and Human Services to negotiate the prices of brand-name drugs covered by Medicare.
But they do not have enough votes without Republican support in the Senate for the legislation they hope will lower the price consumers pay for prescription drugs. That raises the possibility that Democrats will use a legislative tactic called reconciliation, as they did to pass President Joe Biden's COVID relief package, or even eliminate the Senate filibuster to keep their promise to voters.
Regardless, Democrats hope to authorize Medicare negotiations on payments for at least some of the most expensive brand-name drugs and to base those prices on the drugs' clinical benefits. Such a measure could put Republicans in the uncomfortable position of opposing an idea that most voters from both parties generally support.
As chairman of a health and retirement subcommittee, Sen. Bernie Sanders (I-Vt.) on Tuesday was set to hold one of this Congress' first hearings on drug prices, seen as a way for Sanders and his allies to highlight that drug prices in the United States are among the highest in the world.
Dr. Aaron Kesselheim, a Harvard Medical School professor who researches the drug industry and will testify at the hearing, said there is no practical reason the federal government cannot negotiate a price based on independent assessments of a drug's clinical benefits — as every other industrialized nation, and even some state Medicaid programs, do.
"The real reason is the drug industry's lobbying power," he said.
Negotiating Medicare drug prices has ebbed and flowed as a political issue for years, repeatedly defeated in Congress under pressure from the pharmaceutical industry. The government has been banned from negotiating Medicare drug prices since the creation of the Part D prescription drug benefit in 2006. Instead, the optional private plans through which Americans get Medicare drug benefits negotiate with drugmakers.
It has been two years since Congress summoned executives from Big Pharma companies and pharmacy benefit plans to Capitol Hill for a scolding over skyrocketing prices and the loopholes and secretive contracts they use to block competitors and secure profits.
Despite then-President Donald Trump's keen interest in lowering drug prices, most proposals by both Democrats and Republicans on Capitol Hill went nowhere under Republican leaders, who argue government intrusion in the free market would hamper future innovation. They point to an estimate from the Congressional Budget Office suggesting the cuts to drugmakers' revenue under Medicare negotiations could lead to nearly 40 fewer new drugs being developed in the next 20 years.
The government currently approves about 30 drugs per year.
The drug industry, bolstered by its quick efforts to develop a vaccine, has seen public opinion turn in its favor after several years of sharp declines. In early 2020, before the pandemic shut down much of the United States, only about one-third of Americans rated the industry positively, according to a Harris public opinion poll. In February, as vaccination efforts ramped up, about 62% rated it positively — a larger turnaround than any other industry in the past year.
PhRMA, the lobbying organization that represents brand-name drugmakers, came out strong this month against the administration's first drug-pricing action, a measure in Biden's sprawling COVID relief package that is expected to result in drugmakers paying higher rebates to state Medicaid programs for their drugs.
Brian Newell, a PhRMA spokesperson, suggested the fight is just beginning for Democrats. "The American people reject government price setting when they realize it will lead to fewer new cures and treatments and less access to medicines," Newell said in a statement. "Our industry has partnered closely with policymakers in fighting the pandemic, and we hope they will partner with us to develop solutions that will lower drug costs for patients, protect access to life-saving medicines and preserve future innovation."
The Power of Negotiation
Though they disagree on some of the details, such as how far penalties should go, Democrats are united on the need to address drug pricing. Biden, progressives like Sanders and moderates such as Sen. Joe Manchin (D-W.Va.) support proposals that would generally allow the government to set restrictions on brand-name drugs. Researchers say these drugs, initially priced without any competition or regulation, are a leading factor driving up costs for Americans, their employers and the government.
In 2019, the Democratic-controlled House passed legislation that would allow the secretary of Health and Human Services to negotiate the prices for at least 25 of the most expensive drugs marketed in the United States that lack at least one competitor — prices that could be available to people insured by private plans as well. Senate Republicans refused to consider the bill, arguing the policy would discourage drug development.
Top Democrats, including Sen. Ron Wyden of Oregon, chairman of the Senate Finance Committee, say that is likely to be incorporated into drug-pricing reform this year.
Under the 2019 House bill, the negotiated price could not exceed 120% of the highest price in one of six other industrialized nations. Drugmakers would face escalating penalties for not complying.
Sanders and some Democrats took a slightly different path in the previous Congress, sponsoring a package that would enable Medicare negotiations, as well as allow the importation of drugs and broadly tie drug prices to median drug prices in Canada, the United Kingdom, France, Germany and Japan.
But party leaders prefer the House proposal for negotiating prices as a model for this year's efforts.
In addition to allowing negotiated payments for drugs, Democrats also want to cap prices so they could not rise faster than inflation and limit how much Medicare beneficiaries pay out-of-pocket each year.
Democrats say there are more savings to be gained through giving negotiating power to the government, which would have more heft than any individual plan. In 2017, Medicare accounted for about 30% of the nation's total retail spending on prescription drugs, according to KFF.
Advocates of Medicare negotiation often cite the Veterans Health Administration as a possible model, noting the government already negotiates with drugmakers on behalf of retired service members and often secures drug prices that are about 35% lower than those paid by Medicare beneficiaries.
Flashback to 2019
Fresh off the campaign trail and invigorated by polls showing about 8 in 10 Americans believe drug prices are unreasonable, senior lawmakers from both parties called the leaders of brand-name drugmakers and pharmacy benefit managers to testify about rising drug costs in early 2019.
That year saw a wave of bills introduced, the most ambitious of which constrained the cost of brand-name drugs through direct price controls. Trump, who bucked his party and supported Medicare negotiation and other price-setting measures, offered a series of changes that mostly fell apart under court challenges.
Sen. Chuck Grassley (R-Iowa) and Wyden, then the chairman and top Democrat on the Finance Committee, respectively, unveiled a proposal that, among other measures, would cap the price Medicare pays for brand-name drugs to the pace of inflation and trigger rebates if prices rise too quickly.
Medicaid already uses a similar inflation cap — and tends to pay lower prices on drugs than Medicare. The HHS inspector general has said Medicare could collect billions of dollars from the drug industry if it followed Medicaid's lead.
But other Republicans refused to support Grassley on the bill, saying inflation caps amount to government intrusion in the free market, and Republican leaders never brought it up for a vote. Even Wyden said he was not sure he could vote for the proposal unless he was afforded an opportunity to offer a broader cost-containment measure, including price negotiation.
"We're not going to sit by while opportunities for seniors to use their bargaining power in Medicare are frittered away," Wyden said at the time.
The former legislative partners are still pushing the issue. Grassley has continued to press lawmakers to consider the earlier bill. Wyden has said he intends to "build off the bipartisan work" he did with Grassley and work with the House-passed Medicare negotiation bill as Democrats consider a reform package this year.
A cost-saving change in Medicare launched in the final days of the Trump administration will cut payments to hospitals for some surgical procedures while potentially raising costs and confusion for patients.
For years, the Centers for Medicare & Medicaid Services classified 1,740 surgeries and other services so risky for older adults that Medicare would pay for them only when they were admitted to the hospital as inpatients. Under the new rule, the agency is beginning to phase out that requirement and, on Jan. 1, 266 shoulder, spine and other musculoskeletal surgeries were crossed off what's called the "inpatient-only list." By the end of 2023, the list — which includes a variety of complicated procedures including brain and heart operations — is scheduled to be gone.
CMS officials said the change was designed to give patients and doctors more options and help lower costs by promoting more competition among hospitals and independent ambulatory surgical centers. But they forgot one thing.
While removing the surgeries from the inpatient-only list, the government did not approve them to be performed anywhere else. So patients will still have to get the care at hospitals. But because the procedures have been reclassified, patients who have them in the hospital don't have to be considered admitted patients. Instead, they can receive services on an outpatient basis.
CMS pays hospitals less for care provided to beneficiaries who are outpatients, so the new policy means the agency can pay less than it did last year for the same surgery at the same hospital and Medicare outpatients will usually pick up a bigger part of the tab.
"The impetus for this is for Medicare to save money," said Dr. James Huddleston, a professor of orthopedic surgery at the Stanford University Medical Center and the chair of the American Association of Hip and Knee Surgeons' Health Policy Council. "The oldest trick in the book is to say the patients don't need to be cared for in an expensive hospital setting."
But since seniors will still have to go to the hospital, "it's sort of a distinction without a difference," he added.
"This is not about a different care setting, or giving more choice to providers," said Judith Stein, executive director of the Center for Medicare Advocacy. "It's about Medicare billing practices that will further confuse hospital patients."
When unveiling the final rule in December, then-CMS Administrator Seema Verma said the change would give seniors and their physicians more options for care "without micromanagement from Washington." She promised the new policy would also let seniors avoid hospitals, especially during the COVID-19 pandemic, and free up needed beds.
CMS did add services that it will cover when provided by ambulatory surgery centers this year, a spokesperson said last month, but those don't include procedures that were on the inpatient-only list.
Dr. Catherine MacLean, chief value medical officer at New York City's Hospital for Special Surgery, said CMS should have tested the change as a pilot project to be sure it's safe for patients. "These are big procedures," she said, with a lot of "cutting, sewing and bleeding" that require post-surgery monitoring due to a significant risk of complications, especially for patients with multiple health problems.
The change applies to adults who have government-run Medicare insurance, but some Medicare Advantage plans sold by private companies have similar policies.
CMS officials said the change was a response to numerous requests seeking assurance that payment requirements do not override physicians' judgment and assessment of their patients' conditions. But health care groups representing millions of providers opposed it.
Even though seniors getting this care will be considered outpatients, they may still stay in the hospital overnight or longer, often on the same floor as those who are admitted, getting the same nursing care, lab tests and drugs with one big difference: their bill.
Patients admitted to the hospital typically receive an all-inclusive package of services and pay only this year's Medicare hospital deductible of $1,484 for a stay of up to 60 days. They also pay 20% of doctors' charges. Medicare picks up the rest of the bill.
Outpatient services are charged differently, with the patient typically paying 20% of the Medicare-approved amount for each service. That's one payment for the outpatient surgery plus, for example, a second payment for blood transfusions, and more payments depending on what may be included in the surgery charge and how many other separately billed items the patient needs. (And, like admitted patients, outpatients also pay 20% of doctors' charges.)
As with other outpatient services, in most cases each charge cannot exceed $1,484. "However, your total copayment for all outpatient services may be more than the inpatient hospital deductible," according to the federal government's annual guide sent to all Medicare beneficiaries.
Patients will also be hit with a "facility fee" up to several thousand dollars to cover the hospital's overhead costs, said Richard Gundling, senior vice president at the Healthcare Financial Management Association. After Medicare pays its portion, outpatients owe 20% of the facility fee. And because Medicare prescription drug plans don't cover medication ordered for hospital patients, they're treated as if they have no drug insurance and can be charged exorbitant amounts for drugs they routinely take at home.
Another item that can be tacked onto the bill for outpatients — but not admitted patients — is called "excess charges." Providers who do not accept the Medicare-approved amount as full payment can charge up to an extra 15% of that amount. Medicare pays none of these extra charges.
These surprise expenses can add up even for people who buy supplementary or Medigap health insurance to cushion the sticker shock. These private policies cover some portion of the patient's payments for Medicare-approved charges. Only the most expensive policies cover "excess charges." Otherwise, when Medicare doesn't cover something, Medigap doesn't chip in, so the patient is on the hook for the total charge.
In addition, Stein warned that the new rule will "sometimes limit their Medicare coverage when they need care after leaving the hospital." Medicare patients don't qualify for nursing home coverage even if they stay in the hospital for the required three days. That time doesn't count because they were not admitted to the hospital — something Medicare patients who are in the hospital for observation care have complained about for years, forcing some to sue the government for a change.
Outpatients may also find it more difficult to get home health care. Medicare pays home care agencies more for people after a hospital inpatient stay, but those who are not admitted may have trouble finding agencies willing to serve them at Medicare's lower reimbursement, said Stein.
A procedure that was on the inpatient-only list can still be provided to an admitted hospital patient, if health care providers can justify the need based on their clinical judgment. But there's no guarantee that CMS will agree the admission was necessary and cover it.
Since the Biden administration inherited the new policy, critics are hoping CMS will rescind it.
"The decision ought to be made by the surgeons in consultation with their patients," said Dr. Joseph Bosco, a vice chair of NYU Langone Health's department of orthopedic surgery and president of the American Academy of Orthopaedic Surgeons. "We don't need the federal government or health insurance companies interfering in the doctor-patient relationship."
Still, as of Friday, over 118 million shots had gone into arms, and about 42 million people, 12.6% of the nation's population, had been fully vaccinated. Nearly one-quarter of U.S. residents have had at least one dose.
The vaccine rollout is finally ramping up — just as the deadly winter surge has ended, dramatically reducing infection rates, hospitalizations and deaths. President Joe Biden has promised enough vaccine for every adult in the country by the end of May and dangled the hope of a return to semi-normalcy by July 4.
We'll see if that happens. Unfortunately, ill-advised behavior, or a mutant strain of the COVID virus — or both — could still ignite another surge. And we're not entirely certain to what extent vaccination prevents you from infecting unvaccinated people, or for how long it protects against COVID.
Bottom line: Optimism is warranted, but all of us — even the vaccinated — still need to be careful.
In case you missed it, the Centers for Disease Control and Prevention issued new public health guidelines March 8 that offered a small glimpse of what the not-so-distant future might hold if enough people are vaccinated. The most striking point was that it's OK for vaccinated individuals to meet indoors with unvaccinated members of another household, without masks, as long as nobody in that household is at risk for severe COVID.
That's big news if you've not seen your children or grandchildren in person for a while. If you are fully vaccinated, it's now likely safe to visit with them indoors without masks, regardless of their vaccination status. You can even hug them.
As long as they don't live too far away, that is: The CDC still frowns on long-distance travel.
If everybody in your group is vaccinated, so much the better. In that case, hosting a maskless dinner party inside your home, for example, is "likely a low risk," according to the new guidance.
But Dr. George Rutherford, a professor of epidemiology at the University of California-San Francisco, warns not to interpret this new freedom too liberally: "People say, 'Oh, we can have a wedding reception for 50 people at a hotel as long as they are all vaccinated.' I say, 'What about the people serving you — are they all vaccinated? And the band?'"
Public health experts and the CDC agree that if you are vaccinated and in the company of people who aren't — or if you don't know their status — you should continue the safeguards of masking and maintaining your distance.
"What I tell people who are vaccinated is, 'You should assume you are one of the 5 or 6% for whom the vaccination will fail, and that everyone around you is a super spreader," Rutherford says.
That means you should probably tap your inner brakes before going to a movie, working out in a gym, boarding an airplane or dining indoors at a restaurant.
A series of columns by Bernard J. Wolfson addressing the challenges consumers face in California's healthcare landscape.
Dr. Walter Orenstein, associate director of the Emory Vaccine Center and professor of infectious diseases at Emory University School of Medicine, points to a possible side benefit of the new CDC approach. "It may enhance vaccine uptake if it shows people that once you get vaccinated you have more freedom to do things," he says.
Orenstein, like most public health experts, acknowledges that we still have an incomplete picture of COVID and how the vaccines will work in the real world. Officials must set guidelines based on the best data available at the time, he says. "If, in fact, there is a marked spike in cases as a result, they will have to revise them."
For now, Orenstein says, he is incorporating the new guidelines into his personal life. "We hadn't had people over to our house in ages, and last night we had a couple over," he says. They were all vaccinated, and they didn't wear masks.
Others are wary of easing up too soon, even if they've been vaccinated.
"I feel a real sense of relief, but it hasn't changed my behavior," says Sam Sandmire, a 65-year-old retired gymnastics coach in Boise, Idaho, who's had two doses of the Moderna vaccine. "I still mask up and will continue to mask up and social distance until the science shows that I can't infect others."
Andy Mosley, 74, says he is not entirely convinced by the new CDC statement. "The information that we could start hanging out with each other again was laced with a lot of qualifiers," says Mosley, a resident of Temecula, California, who's also had two shots of the Moderna vaccine. "That tells me they are not really sure about it."
But he may alter his behavior in one instance. He has not seen his daughter, a chef who lives in San Francisco, since October 2019. She is scheduled for surgery soon and may need his help. "Because she's been immunized and I've been immunized and her roommate has been immunized, I would feel safe going up there," Mosley says. "So that would be a change. But I would drive; I wouldn't fly."
Many others, including state and local politicians, are less cautious. Texas recently did away with its mask mandate. Florida has remained largely open for business through much of the pandemic.
In California, 13 counties accounting for nearly half the state's population have reopened gyms, movie theaters and indoor restaurant dining — albeit at reduced levels. That includes Los Angeles County, one of the hardest-hit regions in the U.S. during the winter surge. And Gov. Gavin Newsom has suggested that California's four-level color-coded system for phased reopening could soon add a "green" tier — meaning pretty much back to normal.
However, Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, says localities that open too soon "are going to be in big trouble shortly" because of a new surge he expects to be triggered by a fast-spreading COVID strain first detected in the United Kingdom, which is projected to become the dominant strain in the U.S. sometime this month.
For now, stick with masking and physical distancing in most social and commercial encounters. Get vaccinated as soon as it's your turn and try to persuade the people in your lives to do the same. The more people vaccinated, the greater the protection for the community.
In the near future, we may all have extra incentive to get vaccinated: Proof of vaccination could be required for air travel, sports events, concerts and other mass public gatherings. This is being considered in some parts of the U.S. and is already happening in some countries.
Israel, for example, has begun issuing six-month vaccination "passports" that would allow entry to sporting events, restaurants and other public venues. That has "created this kind of push for people who otherwise might not be that interested in getting vaccinated to get vaccinated," Rutherford says.
Hawaii, Florida, Seattle and the South of France are on the minds of New York City college students. Those are some of the destinations that undergrads mentioned when asked where they'd go for spring break, if they weren't grounded by COVID-19.
"I'd be getting a house with 10 people, with a pool, and we'd be going crazy in Miami," said Sile Ogundeyin, 22, a senior economics major at Columbia University, who was sitting on the steps of the library with his friends.
"I was supposed to be in London for study abroad this semester, so I probably would've gone someplace close to there for spring break — maybe in southern Europe," said New York University sophomore Aliyah Verdiner, 20, a business major from Brooklyn. "That would've been a lot of fun, but I guess not this year."
Some students, however, are being more adventurous. Rumors on campus abound about students who are exploiting loopholes and getting vaccinated against COVID in order to party and go on spring break.
"She's going skiing in Vermont with a bunch of friends," Aliza Abusch-Magder said of her roommate, whom she declined to name. "She's very excited to be going to parties and — how do I say this? — making up for lost time in quarantine."
Abusch-Magder said her roommate was "calling on something in her medical history that doesn't actually affect her day-to-day, to qualify for the vaccine." Other young people shared similar reports, such as of peers getting vaccinated who had asthma in their past but not their present.
"I just don't think it's ethical," said Abusch-Magder, a first-year English major from Atlanta. But she also expressed doubt that such behavior is widespread at Columbia.
"I think here it's an outlier, and I think at some schools it's standard," she said, echoing what she'd heard from high school friends on other campuses. "There's a very high standard of ethics here, and there's a lot of discourse on it."
It's impossible to know how often college students are getting vaccinated. Rumors about it happening illegitimately are widespread, but most of the stories appear to be secondhand. And many aren't so nefarious on closer examination, because some vaccinated students are actually eligible; they work in labs or healthcare settings, or they have underlying health issues that put them at high risk for severe COVID.
"I put in my height. I put in my weight. And it said I was obese," said Shira Michaeli, who was sitting on the Columbia library steps, "attending" an online lecture on human rights on her laptop. Obesity qualifies you for early vaccination in at least 29 states.
Michaeli is a bit ambivalent, because she feels healthy, and she's comfortable with her body weight, which she believes is not really a "comorbidity." But she said she has had breathing problems ever since suffering a bad case of COVID last year. And she also plans to be a camp counselor this summer. So she feels she qualifies for the vaccine on a few counts, even if her body mass index is what officially qualifies her.
"I think, for a while, I was really insecure about it, and then I thought, 'Listen, for most of my life [my weight] has been bad for me. Clothing hasn't been my size. People haven't been … " Michaeli's voice trailed off. "But for once in my life, it'll benefit me, instead of hurting me."
The 19-year-old Bronx native was scheduled to receive her first shot the next day, so she was several weeks away from being fully vaccinated. She said it wouldn't have mattered for spring break, anyway, because she had planned to stay close to her dorm, working on papers, perhaps sleeping in a little more than usual, and getting coffee with friends.
"I'm excited to get vaccinated, but I don't think it's going to give me any freedom other people don't have," Michaeli said. "I think I'll be a little less anxious, but I don't think it's going to change any of my behavior. I think there are plenty of people being unsafe, so I don't have any wiggle room to be unsafe."
Down in Greenwich Village, at NYU, there's very little tension among the vaccine haves and have-nots when it comes to spring break — because there isn't much of a spring break. It's a single day, added to create a long weekend in March.
But that doesn't keep Simran Hajarnavis from dreaming.
"If there wasn't COVID, and there was a real spring break, I'd probably try to plan something with my friends," she said, turning to one of them and asking: "Want to go to Hawaii?"
Sitting in Washington Square Park, Hajarnavis and her girlfriends said they're not too worried about being vaccinated right away, as long as they get their shots in time to study abroad in their upcoming junior year.
A few yards away, Aishani Ramireddy said she has already gotten her vaccine, but she's not doing anything differently from any other student.
"It's definitely weird," she said. Ramireddy's mother is a physician in Los Angeles. She said that, when she was home, she got the vaccine at the end of the day, at her mother's office, because there were unused doses that would have been thrown out. Still, she feels conflicted about it.
"It just felt like such a privilege to even have that as an option," Ramireddy said.
Another NYU student, Anna Domahidi, from Chicago, also had an option to get a vaccine, but declined. She doesn't hold it against her friend Ramireddy, but she does question another friend, who she said talked up his childhood asthma to qualify for a shot. Domahidi still thinks he crossed an ethical line, even though he lives with a parent who's immunocompromised: "That's, like, a little better in my mind, but I don't know."
This story comes from KHN's health reporting partnership with NPR.
In North Carolina, the nation's leading tobacco producer, any adult who has smoked more than 100 cigarettes in their lifetime can now be vaccinated against COVID.
In Florida, people under 50 with underlying health conditions can get vaccinated only if they have written permission from their doctor.
In Mississippi, more than 30,000 COVID vaccine appointments were open Friday — days after the state became the first in the contiguous United States to make the shots available to all adults.
In California — along with about 30 other states — people are eligible only if they are 65 or older or have certain health conditions or work in high-risk jobs.
How does any of this make sense?
"There is no logical rationale for the system we have," said Graham Allison, a professor of government at Harvard University. "We have a crazy quilt system."
Jody Gan, a professional lecturer in the health studies department at American University in Washington, D.C., said the lack of a national eligibility system reflects how each state also makes its own rules on public health. "This hasn't been a great system for keeping, you know, the virus contained," she said.
The federal government bought hundreds of millions of doses of COVID vaccines from Pfizer, Moderna and Johnson & Johnson — as well as other vaccines still being tested — but it left distribution largely up to the states. Some states let local communities decide when to move to wider phases of eligibility.
When the first vaccines were cleared for emergency use in December, nearly all states followed guidance from the federal government's Centers for Disease Control and Prevention and restricted use to front-line health workers and nursing home staffs and residents.
But since then states have gone their own way. Some states have prioritized people age 75 and older, while others have also allowed people who held certain jobs that put them at risk of being infected or had health conditions that put them at risk to be included with seniors for eligibility. Even then, categories of jobs and medical conditions have varied across the country.
As the supply of vaccines ramped up over the past month, states expanded eligibility criteria. President Joe Biden promised that by May 1 all adults will be eligible for vaccines and at least a dozen states say they will beat that date or, as in the case of Mississippi and Alaska, already have.
But the different rules among states — and sometimes varying rules even within states — created a mishmash. This has unleashed "vaccine jealousy" as people see friends and family in other states qualify ahead of them even if they are the same age or have the same occupation. And it has raised concerns that decisions on who is eligible are being made based on politics rather than public health.
The hodgepodge mirrors states' response overall to the pandemic, including wide disparities on mask mandates and restrictions for indoor gatherings.
"It's caused a lot of confusion, and the last thing we want is confusion," said Harald Schmidt, an assistant professor of medical ethics and health policy at the University of Pennsylvania.
As a result, some Americans frantically search online every day for an open vaccine appointment, while vaccines in other states go wanting.
The assorted policies have also prompted thousands of people to drive across state lines — sometimes multiple state lines — for an open vaccine appointment. Some states have set up residency requirements, although enforcement has been uneven and those seeking vaccines are often on the honor system.
Todd Jones, an assistant professor of economics at Mississippi State University near Starkville, said the confusion signals a need for a change in how the government handles the vaccine. "The Biden administration should definitely be thinking about how it might want to change state allocations based on demand," Jones said. "If it does become clear that some states are actually not using lots of their doses, then I think it would make sense to take some appointments from these states to give to other states that have higher demand."
Jagdish Khubchandani, a professor of public health at New Mexico State University, said no one should be surprised to see 50 different eligibility systems because states opposed a uniform federal eligibility system.
"Many governors don't want to be seen as someone who listens to the federal government or the CDC for guidance," he said. Florida Gov. Ron DeSantis, a Republican, has boasted of ignoring the CDC advice when he opted to make anyone 65 and older eligible beginning in December.
"There is a lot of political posturing in deciding eligibility," Khubchandani said.
To be sure, governors also wanted the flexibility to respond to particular needs in their states, such as rushing vaccines to agricultural workers or those in large food-manufacturing plants.
Jones said the decision to open vaccines to all adults in the state may sound good, but Mississippi has one of the nation's lowest vaccination rates. Part of that is attributed to hesitancy among some minority communities and conservatives. "It's good news everybody can get it, but there doesn't seem to be a whole lot of demand for it."
Jones, 34, was able to go online for a shot on Tuesday and was vaccinated at a large church a short drive from his home on Thursday morning. "I was very happy," he said.
The treatment that infuses blood plasma from recovered COVID patients into people newly infected to boost their immune response has not lived up to the hype.
This article was published on Monday, March 22, 2021 in Kaiser Health News.
Six months after it was controversially hailed by Trump administration officials as a "breakthrough" therapy to fight the worst effects of COVID-19, convalescent plasma appears to be on the ropes.
The treatment that infuses blood plasma from recovered COVID patients into people newly infected in hopes of boosting their immune response has not lived up to early hype. Some high-profile clinical trials have shown disappointing results. Demand from hospitals for the antibody-rich plasma has plunged. After a year of large-scale national efforts to recruit recovered COVID patients as donors and the collection of more than 500,000 units of COVID convalescent plasma, known as CCP, some longtime advocates of the therapy say they're now pessimistic about its future.
"I fear the CCP train has left the station," said Dr. Michael Busch, director of the Vitalant Research Institute, one of the largest blood-center based transfusion medicine research programs in the U.S. "We created all this enthusiasm, and then these studies came out and they say this stuff didn't work in the first place."
But that sentiment is by no means universal. Other respected proponents say we are watching the science progress in real time, and it's simply too soon to count out convalescent plasma. They note that larger studies employing more calibrated doses of convalescent plasma and more targeted groups of patients, during a set window in their illness, have met the standards for moving forward and may show promise.
"It's just been a really interesting story to see it unfold," said Dr. Julie Katz Karp, director of transfusion medicine at Thomas Jefferson University Hospitals in Philadelphia. "People are doing a good job of reading the literature, but one week the answer is 'yes,' the next week, 'maybe not.'"
Convalescent plasma was thrust into the national conversation last August, when the Food and Drug Administration, under political pressure, made the decision to authorize the treatment for emergency use despite objections from federal government scientists cautioning that the therapy was unproven. In the months since, tens of thousands of Americans have been infused with plasma.
Enthusiasm faded in recent weeks following two serious setbacks: A large federal clinical trial, dubbed C3PO, testing the use of convalescent plasma in high-risk patients who came to an emergency room with mild to moderate COVID symptoms was halted late last month after researchers concluded that, while the infusions caused no harm, they were unlikely to benefit patients. That same week, a pooled analysis of 10 convalescent plasma studies, published in JAMA, found no clear benefit.
In January, the FDA scaled back the emergency authorization of convalescent plasma, limiting its use to hospitalized COVID patients early in the course of the disease and those with medical conditions that impair immune function. The agency also said that only plasma with high concentrations of virus-fighting antibodies could be used after May 31.
At the same time, the COVID surge that engulfed the U.S. through much of the winter eased, sending demand for convalescent plasma plummeting. Hospital infusions fell from a high of about 30,000 units a week at the start of the year to about 7,000 per week in early March.
Further complicating matters, federal contracts worth $646 million that paid U.S. blood centers to collect COVID convalescent plasma are about to expire, prompting centers nationwide to reconsider whether the complicated process of collecting the plasma is still worth the work. Given the added complexity, blood centers have been reimbursed $600 to $800 a unit for the COVID product, compared with the $100 price for a regular unit of fresh, frozen plasma.
"We're not getting orders," said Dr. Louis Katz, chief medical officer at the Mississippi Valley Regional Blood Center in Davenport, Iowa. "I don't want to collect a product that is not going to get used and will cost me more money."
Officials with the American Red Cross have paused direct collection of convalescent plasma, citing changes required by the FDA's revised emergency use authorization and an "evolving" market. People previously infected with COVID may still donate whole blood, and those units that test positive for high levels of antibodies could be used as CCP.
Even as they acknowledge the setbacks, plasma proponents say declaring its death just a few months into the research would be a foolish overreach. The idea of using plasma from recovered patients to treat the newly ill is a century-old concept that has been employed on an experimental basis during a host of plagues, including the devastating 1918 flu, the 1930s measles outbreak and, more recently, Ebola.
Rather than abandon efforts, scientists need to refine the way convalescent plasma is used and temper their expectations, said Dr. Michael Joyner, principal investigator of the Mayo Clinic-led program that supplied convalescent plasma for more than 100,000 U.S. patients last year.
"This is an unstandardized dose of an unstandardized product being given to all comer patients for a disease with variable progression," Joyner said in an email. "So it is unrealistic to expect cookie-cutter results like you get for statin/heart attack trials."
Joyner and others pointed to research that continues to show promise. In mid-February, scientists in Argentina reported that giving convalescent plasma with very high concentrations of antibodies within three days of onset of mild COVID symptoms helped slow the progression of disease in older patients. In mid-March, researchers in the U.S. and Brazil reported in a study that has not yet been peer-reviewed that plasma therapy didn't improve symptoms during hospitalization for patients with severe cases of COVID. But it was associated with a 50% reduction in death after 28 days that "may warrant further evaluation," the authors wrote.
Oversight committees this month gave the nod to two federally funded clinical trials of convalescent plasma to continue enrolling hundreds of patients. One, led by researchers at Johns Hopkins University, is testing convalescent plasma in people who were infected and developed symptoms of COVID but were not hospitalized. The other, led by scientists at Vanderbilt University, is testing high-potency plasma in hospitalized patients.
There's no question "antibodies work against the virus," said Dr. David Sullivan, a professor of molecular microbiology and immunology at Johns Hopkins University and a principal investigator for the institution's plasma trials.
"It's all dose and time," Sullivan said, adding that giving convalescent plasma with high concentrations of antibodies within the first few days of infection is crucial.
The most promising use of convalescent plasma might come from "super donors," people who were infected with COVID and then vaccinated, said Dr. Michael Knudson, co-medical director of the DeGowin Blood Center at the University of Iowa Carver College of Medicine.
Knudson said his early research shows plasma from recovered then vaccinated people can provide five to 20 times more neutralizing antibody than the plasma from those who have not been vaccinated. "This would be almost a completely different product compared to what is used to date," he wrote in a presentation to colleagues.
Joyner and others believe "boosted" plasma could be used as a potent antiviral treatment early in infection, similar to how monoclonal antibodies — laboratory-made proteins that act like human antibodies in the immune system — are used. It could be a cheaper option for low-resource countries unable to afford the monoclonal treatments at more than $1,200 per dose.
Even the National Institutes of Health scientists conducting the halted C3PO trial, Dr. Simone Glynn and Dr. Nahed El Kasser, agreed that more data about the usefulness of convalescent plasma is needed. "The answer is no, it is not the final word," they said in an emailed statement.
But overcoming skepticism about the use of any type of convalescent plasma, let alone "super" plasma, won't be easy, given the roller coaster of recent results. And broad use of convalescent plasma will depend on continued funding. If the federal contracts with blood collectors are not renewed, COVID convalescent plasma likely will be paid for by hospitals or private insurers, depending on where patients receive the treatment.
In the meantime, the federal government, along with academic centers and private donors, has continued to fund the Hopkins and Vanderbilt trials. And the federal Biomedical Advanced Research and Development Authority has allocated at least $27 million to for-profit companies that collect COVID convalescent plasma from paid donors to create hyperimmune globulin, a purified and concentrated form of plasma that may halt disease. Results from late-stage clinical trials of that therapy are expected later this spring.
"I think that it would be a mistake to stop now," said Dr. Claudia Cohn, chief medical officer of the AABB, an international nonprofit focused on transfusion medicine and cellular therapies. "We have some evidence that it works and evidence that we can produce high-titer plasma. Let's see what we can do to keep people out of the hospital."