Democrats Eye Medicare Negotiations to Lower Drug Prices

KFF Health News, March 23, 2021

President Joe Biden, progressives and moderates support proposals that would generally allow the government to set restrictions on brand-name drugs.

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

By Emmarie Huetteman

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.

Emmarie Huetteman: ehuetteman@kff.org, @emmarieDC  

Under New Cost-Cutting Medicare Rule, Same Surgery, Same Place, Different Bill

KFF Health News, March 23, 2021

CMS says the change was designed to give patients and doctors more options and help lower costs.

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

By Susan Jaffe

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."

Susan Jaffe: Jaffe.KHN@gmail.com, @SusanJaffe

Opinion: So You're Vaccinated Against COVID. Now What?

KFF Health News, March 22, 2021

Bottom line: Optimism is warranted, but all of us — even the vaccinated — still need to be careful.

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

By Bernard J. Wolfson

As you surely know, this country's COVID vaccination effort has been plagued by major birth pangs: registration snafus, poor communication, faulty data and a scant supply of vaccine — all exacerbated by inequitable allocation, alleged political favoritism and unseemly jockeying for shots.

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.

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

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

Some Dream — Others Scheme — To Find a Vaccine Before Spring Break

KFF Health News, March 22, 2021

Rumors on campus abound about students who are exploiting loopholes and getting vaccinated against COVID in order to party and go on spring break.

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

By Fred Mogul

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 America, COVID Vaccine Eligibility Is a 'Crazy Quilt' of State Rules

KFF Health News, March 22, 2021

The federal government bought hundreds of millions of doses of COVID vaccines but it left distribution largely up to the states.

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

By Phil Galewitz

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.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

The Hype Has Faded, but Don't Count Out Convalescent Plasma in COVID Battle

KFF Health News, March 22, 2021

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.

By JoNel Aleccia

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."

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

Blue Shield Spent Years Cultivating a Relationship with Newsom. It Got the State Vaccine Contract.

KFF Health News, March 20, 2021

Facing mounting criticism early this year over the chaotic covid-19 vaccination rollout and a growing recall effort to remove him from office, Newsom gave the insurer a $15 million, no-bid contract to take over California's life-or-death effort to quickly vaccinate its 40 million residents.

This article was published on Friday, March 19, 2021 in Kaiser Health News.

By Samantha Young and Angela Hart

SACRAMENTO — Gavin Newsom was just making a name for himself as mayor of San Francisco in 2005 when Blue Shield of California wrote him its first major check.

The young, business-friendly Democrat had exploded onto the national scene the year before by issuing same-sex marriage licenses in San Francisco, and he was pushing his next big idea, called Project Homeless Connect. The initiative would host bazaar-style events in neighborhoods across the city, linking homeless people to services like food assistance and health care.

Newsom needed financial support from businesses, and Blue Shield answered with a $25,000 contribution.

Over the next 16 years, as Newsom’s political career flourished, the health insurance behemoth became one of his most generous and trusted supporters. It contributed nearly $23 million to Newsom’s campaigns andspecial causes, according to a California Healthline analysis of political and charitable contributions. Of that, nearly 90% has funded the homelessness initiatives that critics and allies say are dearest to Newsom’s heart.

Newsom, elected governor in 2018, in turn has rewarded Blue Shield and its executives with positions of power during the coronavirus pandemic, which has claimed nearly 56,000 Californians’ lives.

Facing mounting criticism early this year over the chaotic covid-19 vaccination rollout and a growing recall effort to remove him from office, Newsom gave the insurer a $15 million, no-bid contract to take over California’s life-or-death effort to quickly vaccinate its 40 million residents. Last spring, Newsom also enlisted Blue Shield’s CEO, Paul Markovich, to help steer the state’s covid testing strategy, another component of the state’s pandemic response that had faltered.

“Blue Shield responded early and responded often,” and it was among the first to invest in Newsom’s controversial homelessness ideas, said Philip Mangano, who led homelessness policy under former President George W. Bush and now informally advises Newsom. “Gavin understood they could be depended on over the years.”

But Newsom’s decision to rely on Blue Shield is backfiring. Agrowing number of public health officials and lawmakers say Blue Shield isn’t the right choice to coordinate the state’s vaccine distribution. And California’s counties, which are implementing the state’s coronavirus response, simply refuse to sign on with the insurer.

Newsom’s political future now hinges, in part, on how quickly Blue Shield — which is still charged with leading how vaccines are allocated — can get shots into Californians’ arms. The Republican-driven recall campaign slams him for his response to the pandemic and for violating his own public health recommendations when he dined last fall at the exclusive French Laundry restaurant in Napa Valley with people from outside his household.

Recall organizers say they have submitted 2.1 million signatures, and county election officials have until April 29 to certify that at least 1.5 million are valid in order for the state to set a recall election this fall.

Newsom did not respond to interview requests.

Blue Shield, which has already contributed $269,000 to a political account that Newsom could tap to fight a recall election, also declined multiple interview requests. But in an email, spokesperson Don Campbell said the Oakland-based company regularly supports candidates who share its mission of improving health care access and affordability.

“There is no financial or other benefit being bestowed upon, or accrued by, Blue Shield,” Campbell said. “Blue Shield was asked by the state to help with vaccines. Our reward is to help save lives.”

✦✦✦

Blue Shield isn’t alone in donating to the governor and his projects. Other interest groups have given more, such as Silicon Valley’s Facebook and the health care giant Kaiser Permanente, which covers about one-quarter of the state’s population. (KHN is not affiliated with Kaiser Permanente.)

Kaiser Permanente is advising Blue Shield on vaccine distribution and has a special agreement with the state to vaccinate Californians — including patients outside its system. Kaiser Permanente also invested in homelessness projects in San Francisco after Newsom got them off the ground, and twice last year responded to Newsom’s pleas for corporate dollars to combat the state’s toughest crises: It gave $25 million to a state homelessness fund set up by Newsom and $9.75 million to an immigrant covid relief fund.

But unlike Blue Shield, which gave $20 million to the homelessness fund, Kaiser Permanente has never donated to Newsom as a political candidate, according to local and state campaign records. Blue Shield has given to Newsom in every elected office he has held over the past 20 years.

“That’s how the game works. It’s just about standard influence peddling,” said David McCuan, a Sonoma State University political scientist. “What’s different here is the degree, or the depth of what [Blue Shield] has done under this governor.”

Over time, the company has funded Newsom and his policy initiatives in a way it hasn’t contributed to other politicians at the local or state level, records show, helping elevate him to higher office.

Blue Shield wrote its first check to Newsom for $500 in 2002, when the company was based in San Francisco and he was a city supervisor pushing an ambitious social welfare agenda to help both poor people and businesses that were growing impatient with the explosion of homeless people sleeping in front of their establishments and crowding hospital emergency rooms. It was Blue Shield’s only donation to a local political race in California that year, according to records with the secretary of state’s office.

After he had ascended to the mayor’s office, 14 of Blue Shield’s top executives, including Markovich, contributed a combined $5,150 — on a single day, Aug. 22, 2007 — according to campaign statements filed with the San Francisco Ethics Commission. The company’s contributions continued when he served as lieutenant governor from 2011 to 2019.

But the company’s investment in Newsom soared during the 2018 gubernatorial race. Blue Shield and its executives contributed $71,550 to Newsom’s campaign, and the company partnered with powerful labor unions to form a special committee that allowed them to spend unlimited amounts of money on Newsom’s behalf. Blue Shield chipped in nearly $1 million to that effort, and also gave $1 million to a committee formed by health industry groups to defeat one of Newsom’s primary opponents, then-state treasurer John Chiang.

After Newsom won the election, Blue Shield contributed $100,000 to his inauguration celebration and cut a $50,000 check in his name to a charity supporting firefighters.

With Newsom in office, Blue Shield focused on again giving to the governor’s deepest passion: homelessness. In January 2020, the same month Newsom promised to dedicate unprecedented resources to combating homelessness, Blue Shield announced its $20 million donation to his homelessness fund, which later transformed into “Project Homekey.” That initiative is intended to finance the conversion of more than 6,000 hotel rooms across the state into housing units.

“No one sector can solve the homelessness crisis alone,” Blue Shield quoted Newsom as saying in its Jan. 17, 2020, press release announcing its donation. “It’s our collective responsibility to meet this moment with bold action and intentional leadership — and that’s exactly what Blue Shield’s leadership is doing.”

Behind the scenes in our meeting with @BlueShieldCA CEO Paul Markovich. We cannot solve our homelessness crisis alone in California, and we are so thrilled for Blue Shield's $20mm investment in our statewide homelessness fund. #CaliforniaForAll @CAgovernor @GavinNewsom pic.twitter.com/Ug6AdneFBw

— Kathleen Kelly Janus (@kkellyjanus) January 28, 2020

The donation to Project Homekey came shortly before covid derailed Newsom’s sweeping health and homelessness agenda. But Newsom’s confidants say the relationship he forged with Blue Shield assured him that the company could quickly turn around the state’s troubled vaccination program.

“Because of their early investment, there was a level of trust — I would even say camaraderie — established going forward,” Mangano said. “Blue Shield took a risk way back when Gavin was becoming mayor. There are other organizations like Kaiser Permanente who have since staked out positions in support, but they weren’t there early and they weren’t the ones taking the greatest risk.”

✦✦✦

When Newsom announced that Blue Shield would take over California’s vaccine distribution, he emphasized the job would be in the hands of a nonprofit with an expansive provider network equipped to quickly get vaccines into arms. While it remains a nonprofit, the state stripped Blue Shield of its tax-exempt status in 2014, alleging it operated much like a for-profit insurance company.

The insurer, which covers about 4 million Californians, took in $21 billion in revenue in 2019, the most recent year for which data is available, with net income of slightly more than $573 million. The same year, it paid Markovich $7.5 million, plus benefits.

The National Committee for Quality Assurance has given Blue Shield a poor rating for efficient patient care. And on the chief job Newsom is asking it to do — getting vaccines to patients — Blue Shield is average, ranking 3 out of 5 in the national ranking on flu shots.

No other state appears to have delegated the vaccination job to an insurer, said Dr. Georges Benjamin, executive director of the American Public Health Association. And because counties refuse to contract with Blue Shield, the Newsom administration is scrambling to give counties the option to work with the state government instead.

A growing number of state and local lawmakers are calling the deal a waste of taxpayer money.

“I don’t think having Blue Shield step in is going to get teachers vaccinated any quicker. I don’t think it’s going to get the 70-year-old Black folks vaccinated any quicker,” said state Sen. Sydney Kamlager (D-Los Angeles), adding that she has “more faith” in her local public health experts than in Blue Shield. “And they’re not doing it for free.”

Newsom has insisted that the insurer won’t be allowed to profit.

But critics of the deal argue that even though Blue Shield isn’t technically allowed to make money off vaccinating Californians, the company stands to gain enormous prestige.

Since taking over the program on March 1, Markovich has appeared in press conferences and the company has produced slick advertising urging Californians to get vaccinated. In one ad, viewers are left with the image of the company’s blue logo on a black screen.

“This is not about making money. This is about the marketing opportunity it represents. It’s huge,” said Michael Johnson, a Blue Shield whistleblower who left his post as director of public policy in 2015. “The reason Blue Shield has been selected for this is not because of its capabilities, but because of its relationship with Newsom.”

Methodology

How California Healthline compiled data about political and charitable spending by Blue Shield of California and Kaiser Permanente

Political contributions: Blue Shield of California made direct contributions to Gavin Newsom’s personal campaign accounts for every political office he has held since 2002, when he served as a San Francisco supervisor. These contributions can be found on the California secretary of state’s website or the San Francisco Ethics Commission website.

Additionally, Blue Shield has given large contributions to a ballot measure account run by the governor called “Newsom’s Ballot Measure Committee,” which can accept unlimited amounts of money. Those contributions can be found on the California secretary of state’s website. And Blue Shield made sizable contributions, known as “independent expenditures,” to two ballot measure committees that benefited Newsom’s 2018 gubernatorial bid. One, “Newsom for Governor 2018, Sponsored by Labor Organizations and Blue Shield of California,” was also supported by the Service Employees International Union and teachers, police and firefighters unions. The other, “Chiang for Governor 2018; Health Care Providers for Fiscal Accountability Opposed to John,” also received contributions from the California Medical Association and California Dental Association.

Charitable contributions: Blue Shield and Kaiser Permanente have made “behested payments,” which are donations to charities and other nonprofit organizations in elected officials’ names. Blue Shield gave in Newsom’s name to “Project Homeless Connect” while he was mayor and “Project Homekey” as governor.

Kaiser Permanente gave to Project Homekey and a state covid immigrant relief fund in Newsom’s name. Behested payments to state elected officials are disclosed on the California Fair Political Practices Commission website, and behested payments to Newsom when he was mayor are on the San Francisco Ethics Commission website.

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

The Case for Donating US COVID Vaccines Overseas

KFF Health News, March 19, 2021

Epidemiologists are urging the Biden administration to make plans for getting surplus U.S. COVID vaccine supplies overseas once Americans are vaccinated.

This article was published on Friday, March 19, 2021 in Kaiser Health News.

By Arthur Allen

A Senate committee grilled federal officials about the shortage of vaccines to protect Americans against a pandemic virus. Two months later, the U.S. public had lost interest in the virus, and millions of vaccines were sitting in warehouses — although poor countries still needed them.

This happened during the 2009-10 swine flu pandemic. One official on the hot seat was Dr. Nicole Lurie, who was in charge of preparedness and response at the Department of Health and Human Services. Today, she's a senior adviser at the Coalition for Epidemic Preparedness Innovations, which is helping to vaccinate the world against COVID. And she's worried about history repeating itself.

Lurie told Congress back then that vaccine production was unpredictable. In any case, the swine flu virus turned out to be relatively tame, but the experience holds a lesson for today, she said: Pandemics shift directions quickly, so it's best to be prepared for threats and opportunities — anywhere in the world.

In particular, Lurie and others are urging the Biden administration to make plans for getting surplus U.S. COVID vaccine supplies overseas once Americans are vaccinated. They note that the administration has secured at least 700 million doses of vaccines — more than enough to fully vaccinate every adult and child in the U.S. — by the end of July. The current focus must be the United States, which has had more COVID cases and deaths than any other country. But in the longer term, global immunization will be crucial.

"We need to take care of the problem everywhere to be able to take care of it anywhere," said Dr. Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, a remark echoed in a petition circulated by leading U.S. scholars. "Even if we get high-level vaccine coverage here, we'll still be vulnerable to imported variants that are less responsive to the first-generation vaccines. It's going to be an ongoing problem."

Vaccine experts and activists give the Biden administration high marks for reengaging with the World Health Organization and its global partners. They also understand that the United States has to take care of itself first.

"Until we have enough for Philadelphia, I don't see them wanting to give vaccine away," said Feinberg, who is 64, lives in Philadelphia and had yet to be vaccinated as of March 18. "We have a long way to go."

In the coming months, however, many believe the Biden administration should at least partially pivot to a global approach. The Trump administration wisely spread its risk on vaccine development, spending $14 billion on contracts with eight different companies. Five now have vaccines authorized for use in the United States or overseas.

"Now that there are five vaccines that work, the hedging is looking a lot more like hoarding," said Tom Hart, North American executive director of One, a global anti-poverty group. "You don't need more than one or two inoculations to become immune. As soon as you become immune, you need to share."

Biden is committed in principle to sharing vaccine doses with the world. On Day One, the administration issued a national security memorandum calling on the secretaries of state and HHS to promptly deliver Biden "a framework for donating surplus vaccines, once there is sufficient supply in the United States, to countries in need."

In a largely symbolic move, the administration on Thursday said it planned to provide 1.5 million doses of vaccine to Canada and 2.5 million to Mexico. The donation would come from a cache of vaccine produced by AstraZeneca, which has yet to apply for its use in the United States.

The administration also has promised other countries cash for vaccines. It pledged $4 billion to the COVAX facility, the coordinating group that aims to distribute 2 billion COVID vaccines to low-income and middle-income countries by the end of the year. Half of that money has been paid out.

The administration is also helping to expand vaccine manufacturing in the developing world — a key objective to protect these countries against COVID, as well as routine childhood diseases and future pandemics.

Biden and the leaders of India, Australia and Japan just signed an agreement that calls on the U.S. International Development Finance Corp., which supports projects in poorer countries, to help Biological E., an Indian pharmaceutical company, produce 1 billion COVID vaccine doses by the end of 2022. Johnson & Johnson, Novavax and AstraZeneca have partnered with several Indian manufacturers over the past year in unusually cooperative arrangements.

But donating vaccine would be the quickest way to help — and here the picture is murkier. The administration hasn't said when or how it will determine there is a "sufficient supply" of U.S. vaccine to be shared.

Federal officials are working on the framework for future donations, an HHS official said.

"Our primary focus is to vaccinate Americans first. However, the U.S. will not be completely safe until the entire world is safe," said the official, who spoke on condition of anonymity.

White House press secretary Jen Psaki said last week that Biden "wants to be overprepared and oversupplied," with extra doses that could be used for "booster shots." That's a fuzzy goal, however, since it's unclear when or whether or what type of booster shots could be needed.

It's also not clear whether vaccine donations would all go through COVAX, which decides where to send them, or would be given out bilaterally to allies like Mexico.

This is a shame, said Hart, of One, because vaccine sharing could have a big payoff in building goodwill. China and Russia, which already have donated or sold their vaccines in Africa, the Mideast and Latin America, "are increasing their spheres of influence through vaccine diplomacy," he said. "People don't soon forget when you saved their lives and the lives of their families."

Now is the time to think about these issues, Lurie said. During the swine flu pandemic, tens of millions of unused U.S. influenza vaccines were held in warehouses for months, awaiting shipment overseas, because of cumbersome rules imposed by the U.S., the World Health Organization and overseas governments.

"There were 68 steps that no one knew about," Lurie recalled. "My favorite was the fumigation certificate required for the wood pallet for exporting doses to the Philippines."

Merck faced similar problems when it tried to ship its Ebola vaccine to West Africa during the 2014-16 epidemic there. Commercial and trade rules, Food and Drug Administration regulations and other red tape make shipping an unlicensed vaccine out of the country very complex, said Feinberg, who was then a senior Merck scientist. "It took a lot of jumping through hoops to even send the vaccine to Guinea or Liberia or Sierra Leone."

The donations to Canada and Mexico would apparently come from some 30 million doses that AstraZeneca has reportedly warehoused in Ohio while the company prepares to submit data to the FDA for authorization of the vaccine. The U.S. could put those doses to good use by exporting them if they are not going to be used here, Lurie said. "That would be a fine alternative to having the vaccine just sitting in a warehouse."

However, several countries have suspended use of the AstraZeneca vaccine while European drug regulators study reports that the vaccine might cause blood clots. Exporting U.S.-made supplies of this vaccine now would be a mistake, Feinberg said, because it could undermine confidence with the perception that the U.S. was offloading a vaccine the FDA hadn't deemed worthy.

"The administration has been thoughtful in addressing the key issues," he said. "In the long term and maybe even the short term, that may be better than a one-time donation of doses."

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

Arthur Allen: ArthurA@kff.org, @ArthurAllen202

COVID-Inspired Montana Health Insurance Proposal Wouldn't Kick In for 2 Years

KFF Health News, March 19, 2021

Montana is one of six states without a mini-COBRA program, despite the estimate that around 100,000 Montanans work at businesses with 19 or fewer employees.

This article was published on Friday, March 19, 2021 in Kaiser Health News.

By Sara Reardon

For employees of small businesses in Montana suddenly laid off during the COVID-19 pandemic, maintaining health insurance coverage could be a struggle.

Employers with 20 or more workers offer a bridge insurance program made possible by a federal law known as the Consolidated Omnibus Budget Reconciliation Act, or COBRA. The law allows people who have left a job voluntarily or involuntarily to keep their former employer's health insurance plan for 18 months by paying the premium that the employer used to cover.

But smaller Montana businesses employing fewer than 20 people are not required to offer such a program, potentially leaving people without continuing coverage if they are laid off. Now, a bill moving through the Montana Legislature would create a "mini-COBRA" law that would require any small business with a group health insurance plan to offer continuing coverage for up to 18 months at the employee's expense starting in 2023.

Montana is one of only six states without a mini-COBRA program, despite the estimate that around 100,000 Montanans work at businesses with 19 or fewer employees. Rep. Mark Thane (D-Missoula), the bill's sponsor, said it was brought to his attention last year by a constituent who worked at such a business.

"The concern, I think, was exacerbated during the pandemic when people were in layoff status and lost access to group health insurance plans," Thane said.

He added that the legislation would not cost Montana taxpayers anything — the premiums are paid by individuals — and that it would bring Montana in line with most other states. The measure, House Bill 378, passed the House 84-14 on March 2 and is pending in the Senate.

Business and trade groups said they opposed the measure because of the additional paperwork it might mean for small mom-and-pop businesses.

"Why do we need to add more red tape and regulations to small businesses?" David Smith, executive director of the Montana Contractors Association, asked a Senate committee on Wednesday.

In response, Thane said he acknowledges the concerns, but added, "I don't see it as an overwhelming paperwork burden."

Mini-COBRAs are not intended to be long-term health insurance plans. For one thing, they generally are expensive. On average, employees with job-based single coverage pay less than 20% of their full insurance premiums (for family coverage, it averages 27%). Under COBRA or mini-COBRA, a former employee pays 100%, plus a 2% administrative fee that goes to their former employer. Montana's bill is modeled on North Dakota's mini-COBRA legislation and provides 18 months of coverage at 102% of the premium and an additional 11 months at 150% of the premium.

Mini-COBRAs are unlikely to be widely used for another reason. The federal exchange created by the Affordable Care Act that sells individual insurance plans is a less expensive option that is better for most people, said Louise Norris, co-owner of a health insurance brokerage in Colorado who writes about health insurance. After all, job loss is among the conditions that qualify a person to buy an ACA exchange plan outside the open enrollment period.

Norris said COBRA might be a better option for patients who are in the middle of treatment, for instance, and don't want to switch physicians. People who have already paid off most of their maximum out-of-pocket costs might also prefer to continue with the same plan rather than starting over at zero with a new plan. "That's where COBRA and mini-COBRA are really attractive," Norris said.

Thane added that people who were laid off during the pandemic but expect to be rehired within a few months might also choose a mini-COBRA to tide them over.

But because the new Montana law, if it passes, wouldn't take effect until 2023, its usefulness in that scenario is likely to be minimal. It also won't come soon enough for Montanans who work at businesses with fewer than 20 employees to take advantage of a provision in the recently passed $1.9 trillion COVID relief bill that will pay for individuals' COBRA and mini-COBRA premiums through September.

Still, Thane hoped that the plan will give more options to employees of small businesses. "Given the competitive labor market, it's become increasingly important for small entities to offer benefit plans to hire and retain folks," he said.

Doctors Found Jet Fuel in Veteran's Lungs. He Can't Get Full Benefits.

KFF Health News, March 19, 2021

A retired Army staff sergeant had suffered catastrophic lung damage from breathing incinerated waste burned in massive open-air pits and probably other irritants during his tour of duty in Iraq.

This article was published on Friday, March 19, 2021 in Kaiser Health News.

By Michael McAuliff

The lungs Bill Thompson was born with told a gruesome, harrowing and unmistakable tale to Dr. Anthony Szema when he analyzed them and found the black spots, scarring, partially combusted jet fuel and metal inside.

The retired Army staff sergeant had suffered catastrophic lung damage from breathing incinerated waste burned in massive open-air pits and probably other irritants during his tour of duty in Iraq.

"There's black spots that are burns, particles all over; there's metal. It was all scarred," said Szema, a pulmonologist and professor who studies toxic exposures and examined Thompson's preserved lung tissue. "There was no gas exchange anywhere in that lung."

Thompson is still alive, surviving on his second transplanted set of lungs. Yet the story burned into the veteran's internal organs is not one that has been entirely convincing to the U.S. government.

The military has not linked the burn pits to illness. That means many who were exposed to burn pits and are sick do not qualify for benefits under any existing program.

Retirement and health benefits for members of the military depend on factors like length of service, active or reserve status, deployments to combat zones and whether the military considers specific injuries or illnesses to be service-related. Thompson has been able to get care through the Department of Veterans Affairs for his lung disease but has not been able to secure other benefits, like early retirement pay.

"I was denied my Army retirement because if it was not a combat action, then I don't receive that retirement," Thompson said at a Senate Veterans' Affairs Committee hearing last week on service members' exposures to toxic substances.

Thompson is one of at least 3.5 million veterans since 2001 who have served in war zones where the U.S. military decided to dispose of its trash by burning it, according to VA estimates.

It's not clear how many people within that population have gotten sick from exposure. Only a small fraction — 234,000 — have enrolled in the VA's online burn pit registry. Veterans' advocacy groups have said the majority of claims to the agency stemming from toxic exposures are denied, even as most former service members report contacts with toxins in their deployments.

Soldiers returning from tours in the global war on terror have reported debilitating illnesses almost from its beginning, but got little traction with the military. This year, though, the likelihood of congressional action is high, with Democrats expressing interest and a president who suspects burn pits are to blame for his son's death.

President Joe Biden's son Beau died of brain cancer in 2015 at age 46. He had deployed to Iraq in two sites with burn pits — at Baghdad and Balad — around the same time Thompson was at Camp Striker, near the Baghdad airport.

"Because of exposure to burn pits — in my view, I can't prove it yet — he came back with stage 4 glioblastoma," Biden said in a 2019 speech.

In testimony at the March 10 hearing, Shane Liermann, who works for the group Disabled American Veterans, told the committee that 78% of burn pit claims are denied. "Part of the problem is VA is not recognizing that exposure as being toxic exposures," Liermann said.

Aleks Morosky, with the Wounded Warrior Project, said that in his group's survey of 28,000 veterans last year, 71% said they had "definitely" been exposed to toxic substances or hazardous chemicals, and 18% said they had "probably" been exposed. Half of those people rated their health as poor or fair. Only about 16% of the service members who believed they had suffered exposure said they got treatment from the VA, and 11% said they were denied treatment.

Thompson, who is 49, said care for his lung disease is often slow and sometimes denied. It took the VA three years to approve an air purifier for his home to filter out allergens, and the VA refused to help pay for the removal of dust-trapping carpets, he said.

Thompson's presence at the hearing, though, was not just meant to put the spotlight on the VA. The military's entire approach to toxic exposure is a morass that leaves ill soldiers and veterans like Thompson trying to navigate a bureaucracy more labyrinthine than the Pentagon's corridors.

After Thompson was shipped back to Fort Stewart in Georgia, his medical ordeal was at first addressed within the military system, including a year at Walter Reed National Military Medical Center in Bethesda, Maryland, where doctors found his lungs filled with titanium, magnesium, iron and silica.

Yet he said he didn't qualify for the Army's traumatic-injury insurance program, which might have helped him pay to retrofit his home in West Virginia. And he can't get his military retirement pay until he's 60.

"I may not live to be age 60. I turn 50 this year," Thompson said.

Illustrating the problem, several officials at the hearing with the Department of Defense, the Army and the National Guard were unable to explain why Thompson — with 23 years of service between the Guard and Army — might have such a hard time qualifying for retirement benefits when the evidence of his lungs and the findings of the Army's own doctors are so vivid and extreme.

For advocates who have been working on the problem for decades, it reminds them all too vividly of Agent Orange, which the military is still coming to grips with.

"It's already been, since the first Persian Gulf [War] — we're talking 30 years — and since burn pits were again active, since 2001," said Liermann. "We're way behind the curve here."

Although Congress has done relatively little to deal with burn pits, many members seem to at least be thinking along the same lines. The Senate Veterans' Affairs hearing promised to be something of a kickoff to a year when lawmakers are poised to offer a slew of bills designed to confront the military's inability to care for service members poisoned during their deployments.

"Make no mistake about it," said the committee chairman, Sen. Jon Tester (D-Mont.). "We hold these hearings for two reasons: to gather information for the committee members and to help educate the VA that they might take action before Congress does."

Republicans have also shown growing interest in the problem, offering targeted bills to ensure a handful of toxin-related diseases are covered by the VA.

At the hearing, conservative freshman Sen. Tommy Tuberville (R-Ala.) seemed especially moved.

"We got to do a better job of taking care of our young people," Tuberville said. "If we're going to go to war, we got to understand we got to pay the price for it on both ends."

There is also likely to be high-profile support and attention when revised legislation starts rolling out this spring.

The broadest bill likely to be offered was first introduced by Sen. Kirsten Gillibrand (D-N.Y.) in the Senate and Rep. Raul Ruiz (D-Calif.) in the House in late 2019, with a boost from former "Daily Show" host Jon Stewart and a cadre of 9/11 responders who are turning their attention to toxic exposures.

Indeed, Ruiz and Gillibrand's legislation is modeled in part on the 9/11 health act that passed in 2015. The burn pit bill would remove the burden of proving a service-related connection.

It would vastly simplify the lives of people like Thompson.

"I am a warrior of the United States of America. I gave my lungs for my country," Thompson said.

He was cut off before he could finish, but his prepared remarks concluded, "Hopefully, after hearing my story, it will bring awareness for not only me but others who are battling the same or similar injuries related to burn pit exposures from Iraq or Afghanistan."

Michael McAuliff: @mmcauliff ‏

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