The CDC's New Guidelines on COVID Risk and Masking Send Confounding Signals

KFF Health News, March 9, 2022

A recent KFF poll pointed to an underlying tension.

This article was published on Wednesday, March 9, 2022 in Kaiser Health News.

By Colleen DeGuzman

When the Centers for Disease Control and Prevention last month unveiled updated COVID-19 guidelines that relaxed masking recommendations, some people no doubt sighed in relief and thought it was about time.

People have become increasingly comfortable being out shopping, attending live events, or meeting up with friends at restaurants. And many are ready to cast aside their masks.

Still, a recent KFF poll pointed to an underlying tension. Just as a large swath of the American public, 62%, said that the worst of the pandemic was behind us, nearly half were worried about easing COVID-related restrictions — like indoor masking — too soon. The poll, conducted in February, found that 49% of adults were either "very worried" or "somewhat worried" that lifting pandemic restrictions would cause more virus-related deaths in their communities. About 50% were "not too worried" or "not at all worried" that death tolls would rise in their communities.

The CDC's move triggered some of the same mixed feelings from the public that the poll uncovered and laid bare a split within the healthcare community.

On the one hand, there's applause.

The CDC's protocol change is an indicator that the nation is approaching a "transition from the pandemic phase to an endemic phase," said Dr. Georges Benjamin, executive director of the American Public Health Association. Rather than pushing messages of prevention, Benjamin said, the agency is changing its focus to monitoring for spikes of infection.

On the other hand, there is criticism — and worry, too.

"When I hear about relaxing regulations," said Dr. Benjamin Neuman, a Texas A&M University professor and chief virologist at its Global Health Research Complex, "it sounds a lot like people giving up. And we're not there yet, and it's a little bit heartbreaking and a little bit hair-pulling."

What Are the New Guidelines, and How Are They Different?

Before the update, the CDC considered a community at substantial or high risk if it had had an infection rate of 50 or more new cases for every 100,000 residents in the previous week.

According to the agency's new community-based guidance, risk levels can be low, medium, or high and are determined by looking — over a seven-day period — at three factors: the number of new COVID cases in an area, the share of hospital beds being used, and hospital admissions.

This change had a profound impact on how COVID risk was measured across the country. For example, the day before the CDC announced the new guidelines, 95% of the nation's counties were considered areas of substantial or high risk. Now, just 14% of counties fall into the high-risk category, according to the agency.

The CDC doesn't make specific mask recommendations for areas at low risk. For areas classified as medium risk, people who have other health problems or are immunocompromised are urged to speak to their healthcare provider about whether they should mask up and take other precautions. In areas deemed to be high risk, residents are urged to wear masks in indoor public spaces.

"This more stratified approach with this combination of those factors gives us a better level of understanding of COVID-19's impact on our communities," said Keri Althoff, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health. "Specifically, the impact of severe disease and death."

But people shouldn't get rid of their masks yet, she said. Even as the nation's infection rates fall, the virus continues to spread on a global scale. "We have to fully recognize that there are so many people on this Earth who are unvaccinated internationally, and this is where the variants come from," Althoff said.

Roses and Thorns From Experts

The same week the CDC rolled out its new guidelines, it reported a national seven-day average of about 71,000 new COVID cases, along with 5,400 hospital admissions. Around 2,000 people were dying because of the disease every day.

It's numbers like these that led some public health experts to question the CDC's timing.

"I think we have prematurely opened and prematurely unmasked so many times at this point, followed by remasking and reclosing and just seeing our hospitals absolutely swamped, that I don't really trust this," said Texas A&M's Neuman.

There have been "too many times," he said, when the CDC has put down its guard and the virus came back stronger. "We're basically taking our foot off the accelerator in terms of what we're doing to slow down the virus, and that just means that there will be more virus going around and it's going to keep swirling around," he said.

The CDC's goal for easing mask mandates, Neuman speculated, was to create regulations that are more appealing and easier for people to abide by, because "it's hard to sell prudence as something really attractive." Plus, public health officials need to have a program that the entire country can follow, he said. The battle against the virus can't be won with policies "that people follow in blue states but not in red states," he added, "because the virus is very much a collective risk."

There also are questions about how effective the new approach is at signaling when risk is increasing.

Joshua Salomon, a professor of health policy at Stanford University's medical school, said that although the CDC designed its new guidance to incorporate a stronger indicator of surges, it has "a very late trigger."

Salomon looked into the delta and omicron surges and found that a rough rule of thumb during that period was that 21 days after most states rose to the high-risk level, the death rate hit three people for every million. That equals about 1,000 deaths a day at a national level.

The updated CDC guidance "is intended to provide a sort of warning that states are entering a period in which severe outcomes are expected," he said. But the new approach would not sound that alarm until death rates were already reaching that "quite high" mark.

Others, though, point to another set of numbers. They say that with 65% of Americans fully vaccinated and 44% boosted as of March 8, relaxing COVID protocols is the right decision.

The new strategy is forward-looking and continues to measure and track the virus's spread, said the APHA's Benjamin. "It allows a way to scale up and scale back the response."

Since the guidelines are based on seven-day averages, he added, they are a good way to monitor communities' risk levels and gauge which set of mandates is appropriate. "So if a community goes from green to yellow to red," he said, referring to the CDC's color-coded map that tracks counties' COVID levels, "that community will then need to modify its practices based on the prevalence of disease there."

The guidelines, Benjamin said, are "scientifically sound, they're practical." Over time, he added, more communities will move into the low and moderate categories. "The truth of the matter is that you just cannot keep people in the emergency state forever," he continued. "And this is never going to get to zero risk. … [COVID's] going to be around, and so we're going to have to learn to live with it."

What About Those Who Are Not Eligible for a Vaccine or Are Immunocompromised?

The CDC's relaxed recommendations do not prevent anyone from wearing a mask. But for millions of Americans who are immunocompromised or too young to receive a vaccine, less masking means a loss of a line of defense for their health in public spaces.

Children younger than 5 are not eligible to receive a vaccine yet, and people who are immunocompromised and are susceptible to more severe cases of the disease include cancer patients undergoing active treatment and organ transplant recipients. People living with chronic illnesses or disabilities are also vulnerable.

"You only have control of so much," Neuman said. "And if you're exposed to enough of the virus and you're doing all the right things, you can still sometimes end up with a bad result."

Masks are most effective when everyone in a room is wearing one, Neuman added, but the new mandate is similar "to victim-blaming — basically saying, 'You have a problem and so here's the extra burden to go with your problem.'"

Colleen DeGuzman: @acolleendg

CA Governor's Big Promises on Drug Prices Are Slow to Materialize

KFF Health News, March 4, 2022

As Newsom nears the end of his first term, his ambitious ideas — such as requiring California to make its own insulin and forging drug partnerships across state lines — have failed to get off the ground.

This story was published on Friday, March 4, 2022 in Kaiser Health News.

By Angela Hart and Rachel Bluth and Samantha Young

SACRAMENTO, Calif. — When Gov. Gavin Newsom took office in 2019, he promised to lower prescription drug costs for all Californians.

But now, as Newsom nears the end of his first term, his ambitious ideas — such as requiring California to make its own insulin and forging drug partnerships across state lines — have failed to get off the ground or haven't produced the hefty savings he promised.

"There are powerful forces arrayed against us — not just politicians in Washington, but drug companies that gouge Californians with sky-high prices," Newsom said on his inauguration day in January 2019. "Here in California, we have the power to stand up to them, and we will."

A few months later, he vowed California would save "hundreds of millions of dollars right away — potentially billions" — by using the state's massive purchasing power to negotiate lower drug prices for California's counties, its businesses, and other states. But so far only a few counties are participating in the program, and savings have fallen far short. Another program, which debuted Jan. 1, is intended to save the state hundreds of millions of dollars a year by consolidating drug purchasing for the 14 million low-income Californians enrolled in Medicaid, but how those savings will materialize isn't clear.

Newsom's third initiative requires the state to manufacture generic drugs, but it hasn't gotten off the ground.

Drug spending by public and private health insurers grew 5% in California during Newsom's first year in office, according to the most recent state data available — and costs are expected to continue rising in California and across the country because of increases in both pharmaceutical prices and prescription drug use.

Yet Newsom, a Democrat who is running for reelection in November, argues that California's initiatives are leading the nation and that realizing cost savings can take years.

Newsom's office declined to answer questions about the cost savings shortfalls, but his administration provided written responses to some KHN queries.

Leveraging the Power of Government

When Newsom announced that California would contract with its counties, its businesses, and other states to buy drugs in bulk — and expand existing bulk purchasing agreements across state agencies — he said the initiative would save "hundreds of millions," if not billions.

Three years later, the state has seen some modest savings — but nothing near what Newsom predicted.

Although it seemed as though Newsom was announcing a new program to partner with California's counties, its businesses, and other states, he was building on state drug discount agreements that predated his administration.

"The state was already doing it," said Jane Horvath, a consultant who advises state policymakers on 'healthcare costs. "They've sort of opened it up to counties to participate."

California for years has negotiated with drug manufacturers to get discounts on prescription drugs for state-run hospitals, jails, and other entities that buy and dispense drugs. Newsom's 2019 executive order expanded those agreements to allow other entities to benefit, akin to giving them a coupon code that is applied at checkout. Though Newsom initially said two other states were interested in joining the program, none have.

So far, three populous counties — Los Angeles, Orange, and Sacramento — have joined. County officials and the Newsom administration say the state's pricing agreements have saved money, but how much is unclear — they have given different figures and time frames.

The state Department of General Services, which oversees the Statewide Pharmaceutical Program, said the three counties saved about $500,000 from January 2021 to September 2021. But Sacramento County in February reported saving nearly $700,000 on drugs for its jails "in a little over a year."

How many state agencies have banded together to buy cheaper drugs is also unclear. The Newsom administration said the California State University system joined the program and saved $476,000 over five months. The governor's office also said the state saved $3 million over five months on mental health medications under an August 2021 bulk purchasing arrangement.

Other states have been banding together for years to get discounts.

Oregon Health Authority pharmacy director Trevor Douglass runs a drug purchasing consortium with Washington that has saved both states at least $142 million since 2016. Nevada plans to join the consortium, and Douglass said he is in talks with Delaware and Wisconsin — but hasn't heard from California.

"I would be happy to hear from California tomorrow," Douglass said. "I would have been happy to hear from them yesterday."

Overhauling Medicaid Drug Purchasing

Starting in January, a single company started administering prescription drugs for all of California's Medicaid patients, most of whom previously got their medications through about two dozen managed-care plans.

But the state contractor, Magellan Health, was woefully understaffed and unprepared when the transfer occurred Jan. 1, and thousands of patients were left without critical medications. The state and Magellan have worked to address some of the shortfalls, but some physicians say problems persist. 

Newsom's administration projects the state will save $414 million in the 2022-23 budget year, mostly by securing rebates from drug companies now forced to deal with the nation's most populous state at the negotiating table. The state expects to double those savings the following budget year.

However, it's too soon to tell whether Newsom's experiment will succeed. Health insurance plans are skeptical, citing industry-backed studies that show high prescription drug costs in the few states that run their own programs.

"We think the assumptions, the savings, are exaggerated," said John Baackes, CEO of L.A. Care Health Plan, the largest publicly operated health plan in the country. "That would be a polite way to say it."

Newsom isn't alone in pushing his state away from managed care as a cost-saving measure.

In July, Ohio will begin using a single health contractor for its Medicaid program, which the state estimates will save the Buckeye State $186 million in fiscal year 2022-23. New York is planning to make the switch in April 2023.

In Missouri, Josh Moore, the state's Medicaid pharmacy director, said there's no question that the state's move in 2009 to buy drugs for Medicaid enrollees has saved taxpayers millions of dollars through rebates alone. Today, he said, the state collects 99% of drug rebates offered by drug companies to state and federal governments, compared with the 90% to 95% that states typically claim through managed-care plans, which don't always catch or follow up on billing errors.

"Small percentages make large numbers whenever we talk about the kind of money that we're talking about in Medicaid pharmacy systems," Moore said.

Diving Into the Generic Drug Market

In 2020, Newsom's proposal to create a California generic drug brand, CalRx, became law and required the state to manufacture the drugs or partner with drug manufacturers.

The law calls on the state to "enter into partnerships" to produce or distribute generic prescription drugs and at least one form of insulin. The Newsom administration is in discussions with drug manufacturers and has made some progress, but no contracts have been inked, according to prepared responses from Rodger Butler, a spokesperson for the state Health and Human Services Agency.

Vishaal Pegany, assistant secretary for the Health and Human Services Agency, told lawmakers at a hearing in January that the state is focusing on developing insulin and other generic drugs that would serve a large population, as well as drugs that are high-cost or in short supply. But the state isn't sharing details about which other drugs California might produce, the names of the drug companies it's negotiating with, or how long producing the first CalRx drugs might take.

The state had previously been in talks with Utah-based nonprofit drug company Civica Rx, but Senior Vice President Allan Coukell declined to say whether the company is still working with the state.

State Sen. Richard Pan (D-Sacramento), who authored the 2020 generic drug bill, said California must also eventually develop the ability to manufacture its own generic drugs. "You can't just stand up a factory overnight and we have a learning curve, so right now we have to find a generic manufacturer that wants to play ball with California," Pan said. "But I hope in the long run we will stand up our own manufacturing capacity so we're not constrained by a company willing to work with us."

Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this article.

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

Angela Hart: ahart@kff.org, @ahartreports

Rachel Bluth: rbluth@kff.org, @RachelHBluth

Fact Check: Biden Sets High Bar in 1st State of the Union Speech

KFF Health News, March 2, 2022

Biden's one-hour speech was given to a largely unmasked crowd in the House chamber, a sign of the diminished threat of the omicron variant.

This article was published on Wednesday, March 2, 2022 in Kaiser Health News.

By Victoria Knight and Colleen DeGuzman

President Joe Biden argued forcefully for the power of democracy while calling out Russia's invasion of Ukraine in a March 1 State of the Union address that soon turned to the domestic concerns of the economy, inflation, and COVID-19. 

Biden's one-hour speech was given to a largely unmasked crowd of lawmakers, Supreme Court justices, and Cabinet members in the House chamber, a sign of the diminished threat of the omicron variant.

Speaking about the coronavirus, Biden attempted to thread the needle between being optimistic and on guard, saying the nation was entering a phase in which "COVID-19 need no longer control our lives," although the U.S. should stay focused on expanding vaccines, treatments, and testing and monitoring new variants. And when Biden introduced Ukrainian ambassador Oksana Markarova, who was in the gallery as a guest of first lady Jill Biden, the room — much more crowded than for a speech there in April last year — responded with a standing ovation.

As expected, Biden used the address to condemn Russian President Vladimir Putin's use of force against Ukraine while touting the strength of the Ukrainian people and the NATO alliance.

He also went through a fairly lengthy domestic to-do list that touched on a number of health policy issues.

He spoke about the need to cut the cost of prescription drugs, citing the high price tag of insulin. Joshua Davis, a 13-year-old Virginia boy who has Type 1 diabetes, attended the speech as another one of the first lady's guests. He watched and applauded from the gallery as Biden urged capping the cost of insulin at $35 a month "so everyone can afford it." Biden also renewed his call to let "Medicare negotiate lower prices for prescription drugs." 

The president promised nursing home reforms through the Medicare program that would lead to higher quality-of-care standards. He unveiled what he called his "Unity Agenda for the Nation." It includes initiatives aimed at ending the opioid epidemic, taking on the nation's mental health needs — especially those of children — improving services for veterans, and ending cancer. He was also firm in the need to protect access to healthcare, preserve women's reproductive rights, and advance maternal healthcare.

KHN and PolitiFact's team of reporters and editors watched it all. You can read the detailed fact check here. Here are the healthcare highlights:

"Under the new guidelines, most Americans and most of the country can now go mask-free. And based on projections, more of the country will [cross] this point in the next couple of weeks."

This is accurate. Under updated guidelines that the Centers for Disease Control and Prevention released Feb. 25, about 70% of Americans live in communities with low to medium risk from COVID and will be allowed to go out in public and indoor spaces maskless. 

The agency considers counties to be at high risk if they are recording 200 or more new infections for every 100,000 people, or if 10% or more of hospital beds have been occupied by COVID patients within the previous seven days. An area is also deemed at high risk if 10 or more people for every 100,000 residents are being admitted to hospitals for the disease. 

Under the new rules, residents of high-risk areas will have to mask up. In medium-risk communities, however, masks are recommended only for those who are immunocompromised. In communities with low levels of COVID, there is no recommendation to wear a mask.

In addition, recent CDC projections for the next four weeks suggest continued drops in hospitalizations and deaths. If those forecasts play out, more Americans will likely be able to go maskless.

"75% of adult Americans are fully vaccinated, and hospitalizations are down by 77%. Most Americans can remove their masks and stay in the classroom and move forward safely."

This is a largely accurate description of official numbers and guidance. According to the CDC, as of March 1, 75% of Americans 18 or older are fully vaccinated, or 193,643,363 people. 

It was unclear what the starting point was for Biden's claim that COVID-related hospitalizations are down by 77%, but about 60,000 people with the coronavirus are hospitalized nationally, down from about 160,000 in January, according to New York Times data. This translates to a 62.5% drop.

Additionally, it is accurate that most Americans are not required to wear a mask under the CDC's updated guidelines.

"The American Rescue Plan is helping millions of families on Affordable Care Act plans save $2,400 a year on their healthcare premiums." 

This is accurate. The American Rescue Plan Act expanded subsidies for marketplace health insurance plans to many Americans — more than 3 million — who didn't previously qualify for them. 

The subsidies meant Affordable Care Act insurance premiums for many families were much lower. The Department of Health and Human Services estimated that for 4 in 5 enrollees it would cost $10 or less a month, after tax credits, to sign up for health insurance. 

The $2,400-per-year savings appears to be derived from a 2021 HHS press release that described examples of how the expanded subsidies will save money, such as: "A family of four making $90,000 will see their premiums decrease by $200 per month." That would translate to $2,400 per year. 

Estimates from other organizations support savings in this number range. According to KFF, a nonprofit health policy organization, individual consumers could save, on average, $70 per month on health insurance because of the American Rescue Plan subsidies. For a family of three, that would translate to a savings of $210 per month, or about $2,500 per year. But not all kids would necessarily automatically qualify for ACA coverage — many instead qualify for the Children's Health Insurance Program, known as CHIP. 

Still, KFF's 2021 subsidy calculator shows that a 40-year-old couple with two kids who make 200% of the poverty level (a midrange income) would receive $16,247 per year in subsidies. Compared with a KFF subsidy calculator dating back before the American Rescue Plan, that same family would have received $13,878 in subsidies. That's exactly a $2,369 difference in savings. 

"So, the $2,400 does seem very reasonable," said Cynthia Cox, vice president and director for the program on the ACA at KFF.

PolitiFact reporters Jon Greenberg, Louis Jacobson, and Amy Sherman contributed to this report.

Victoria Knight: vknight@kff.org, @victoriaregisk

Colleen DeGuzman: @acolleendg

J&J-Vaxxed, mRNA-Boosted, and Pondering a Third Shot

KFF Health News, March 1, 2022

With J&J seemingly destined to be a benchwarmer among COVID vaccines in the U.S., it often has been left out of public discourse and guidance on COVID.

This article was published on Tuesday, March 1, 2022 in Kaiser Health News.

By Bernard J. Wolfson

Yes, we are all exhausted by the COVID pandemic. Flummoxed by the constantly shifting science and guidelines. Worried about a succession of scary new variants, each with its own name, like hurricanes.

But a sizable minority — nearly 17 million U.S. residents, including me — has its own special quandary. Our initial vaccine was Johnson & Johnson, which was just one shot, and that has many of us confused. Are we fully vaccinated, even with a booster, or should we get a third shot to catch up with the 92 million vaccinees who got two doses of Pfizer or Moderna early on and have since been boosted? Since J&J has largely disappeared from the public eye, actionable information is in scarce supply — not to mention that the guidance is constantly shifting, for everybody.

On April 4, 2021, I dutifully traveled across Los Angeles to line up for my J&J shot at a mass vaccination site. Like many of my J&J brethren, I was following the advice of public health officials to take the first available vaccine.

At the time, J&J was kind of a cool newcomer among COVID-19 vaccines. The protection it provided against illness, though apparently less than that afforded by the so-called messenger RNA (mRNA) vaccines from Pfizer and Moderna, seemed sufficient to ward off serious illness.

And while those vaccines required two shots, J&J was billed as "one and done" — a big advantage for people with needle phobia and for transient populations, including farmworkers, people living in homelessness, and inmates in county jails. Its easy storage requirements, compared with the deep freeze needed to handle the Pfizer and Moderna vaccines, also made it a good choice for remote rural populations.

But just days after I got my shot, the reputation of J&J entered what would prove to be a disastrous tailspin, with news of the vaccine's link to a rare but potentially deadly blood clotting disorder. That prompted federal health officials to hit the pause button on it, only to clear it 10 days later and then reverse course in December by recommending the Moderna and Pfizer vaccines over J&J's, mainly because of studies that intensified the blood clot concern.

In the interim, J&J was plagued by production snafus and concerns about its vaccine's efficacy. Research showed a disproportionate share of breakthrough infections among J&J vaccinees during a COVID surge on Cape Cod last summer. State data from California covering most of 2021 paints a similar picture, not only for infections but also for hospitalizations and deaths.

With J&J seemingly destined to be a benchwarmer among COVID vaccines in the U.S., it often has been left out of public discourse and guidance on COVID.

"Very little J&J vaccine is currently being used, which is part of the reason that people don't talk about it very much anymore," says Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center in Nashville, Tennessee.

When the Biden administration first recommended boosters in August, it initially excluded J&J vaccinees, citing a lag in the data.

No wonder the citizens of J&J Nation have been feeling a bit like neglected stepchildren.

"I wish I had chosen something that more people had received so I could get more information," says Leah Justman, a 39-year-old resident of Los Angeles, who preferred the J&J shot last April because she was breastfeeding her newborn baby at the time, was nervous about the new mRNA technology, and thought J&J was "more similar to getting a regular vaccine."

Now, she says, she feels as if there's a bit of a stigma attached to being a J&Jer: "When I go to restaurants or show that I'm vaccinated, people are like, 'Oh my God, you got J&J.' It's almost like a joke, where people think, 'Thank God I didn't get it.'"

In December, Justman got the half-dose Moderna booster recommended by the Centers for Disease Control and Prevention. That leaves her behind the curve compared with Moderna and Pfizer recipients who received two full doses initially and a booster later on. She worries about how long she will be protected and what her next move should be.

There appears to be a growing consensus in scientific circles that one shot of J&J was never enough and that it could account for the lower efficacy compared with the mRNA vaccines.

"A lot of us believe it should have been a two-dose vaccine all along," says Bradley Pollock, associate dean for public health sciences at the UC Davis School of Medicine. In coming months, he says, "it is entirely possible that they're going to say a three-dose schedule is full vaccination."

That got me thinking about whether I am fully vaccinated. Factoring in the half-dose Moderna booster I received in late October, I'm still behind those who've had three Pfizer or Moderna shots.

I've spoken to several J&J vaccinees who, thinking similar thoughts, sought a second booster even though the current federal guideline for J&J vaccinees calls for just one mRNA booster, two months or more after the initial vaccination.

I recently went online to book an appointment for a second Moderna booster. On my first try, I got a message from the pharmacy saying I wasn't eligible. A second pharmacy allowed me to book a slot, but I canceled at the last minute after receiving dissuasive emails (albeit mild ones) from two of my expert sources.

"It's not as quantitative as you're making it out to be," wrote Dr. George Rutherford, a professor of epidemiology at UCSF. The J&J and mRNA vaccines work differently, he said, "so it's not like one J&J plus one Moderna equals 1.5 Pfizer doses. I don't think it will make you sick, but I'd just sit tight. Omicron is going away."

New research suggests that as few as two COVID shots could be enough to protect most people from serious illness and death for many months, or even years.

If you are among the nearly 17 million J&J people and have had a booster, consider standing pat like I finally did. But if you haven't had a booster yet, do so ASAP. It seems clear, or at least as clear as anything can be where COVID is concerned, that if you are vaccinated and boosted, your risk of developing severe illness is very low.

New federal guidance allows for a second booster if your immune system is compromised by, for example, cancer treatment, HIV, or an organ transplant. If you're not immunocompromised but are worried about weak protection, you can try to persuade a pharmacist or the staffers at a vaccination site to give you another shot. It won't be easy, but it's possible. Or talk to your doctor, who may be willing to prescribe one.

Now that I've spent most of this column pointing out the problems with the J&J vaccine, it's only fair that I say a few positive things about it.

First, even though it appears to be less effective than the Pfizer and Moderna shots, the J&J vaccine still provides a high degree of protection against serious illness and is vastly preferable to no vaccine. J&J, which is cheaper than the mRNA vaccines and easier to transport, also has a critical role to play in low-income countries with large rural populations and poor transportation infrastructure.

Even in the United States, where use of the J&J shot has declined sharply, it's helpful to have the vaccine in stock. It's a good alternative for those who are anxious about the mRNA shots and would otherwise not get vaccinated.

And it's always possible that demand for it could return. The mRNA vaccines carry a risk of heart inflammation for young men, a side effect that appears to be short term in most cases. But if future studies show it can lead to permanent damage or even death, "that would make the J&J vaccine potentially at least as attractive, if not more attractive," says Dr. Walter Orenstein, a professor of epidemiology at Emory University in Atlanta.

The vaccines are still new, many clinical trials have yet to yield unambiguous results, and every new variant throws doubt on data collected when a different strain was dominant.

"It may turn out to be true that three doses or two doses and a variant-focused booster are going to turn out to be best. We don't know yet," says Dr. Gregory Poland, director and founder of the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota. "And the way things have been going, we will barely be getting the answers to those questions, and more time will have passed, and a new variant will arrive."

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

Biden's Blanket Statement — 'No More Surprise Billing' — Doesn't Quite Cover It

KFF Health News, March 1, 2022

"Millions of hardworking Americans will no longer have to worry about unexpected medical bills," President Joe Biden said in a Feb. 10 speech about lowering healthcare costs.

This article was published on Tuesday, March 1, 2022 in Kaiser Health News.

By Victoria Knight

During a Feb. 10 speech about lowering healthcare costs, President Joe Biden made a sweeping declaration that Americans would no longer need to worry about surprise medical bills.

"No more surprise billing. No more," said Biden. "Millions of hardworking Americans will no longer have to worry about unexpected medical bills."

Biden was referring to a bipartisan law, the No Surprises Act, that was passed by Congress during the Trump administration in late 2020 and took effect on Jan. 1, 2022. The law is supposed to protect consumers from often-expensive out-of-network medical bills.

The president offered this example of the kinds of bills the law would prevent: "If your healthcare plan did not cover a particular doctor but you didn't even know he was being consulted and you get an extra bill for $2,000-$5,000 — they can't do that anymore."

Still, Biden exaggerated when he said there would be no more surprise billing. He had a point that the new law would provide newfound protection against certain charges for millions of people, but his statement went further than what the law accomplishes.

We decided to dig in and find out how far the law goes to prevent unexpected medical costs.

Surprise Bills and the No Surprises Act, Explained

The No Surprises Act primarily protects consumers against certain types of medical bills: those received by patients for care at an out-of-network facility — specifically, a hospital, a hospital outpatient department, or an ambulatory surgery center; or from an out-of-network medical provider whom patients did not get to choose. The act also protects patients from "surprise" bills from an out-of-network air ambulance transport. Out of network means the doctor doesn't take your medical insurance or isn't included on the list of approved providers in your insurance network.

The federal government estimates that the law will apply to about 10 million surprise bills a year. They are often associated with emergency care provided when patients must go to the closest medical facility and can't check the network status of the facility or emergency room physicians. They also may stem from nonemergency hospitalizations or surgeries at an in-network facility that involve a provider, such as an anesthesiologist or radiologist, who is out of network and bills separately.

Before the law, patients could be left on the hook for charges much higher than their insurer's in-network negotiated rate because their health plan might pay only part of the bill or deny the claim completely.

Trying to get any portion of an out-of-network bill covered often required lots of paperwork and phone time with insurance providers, and consumers were sometimes still left with a big bill.

However, with the No Surprises Act, consumers are shielded from these out-of-network bills. Insurance companies are required to cover the out-of-network claims, paying providers the rate they pay for the service when it is delivered by an in-network provider or facility and leaving consumers responsible for only the in-network cost sharing. Finally, the new law created an arbitration process that kicks in if the insurer and provider dispute the payment rates and takes the consumer out of the negotiation.

"So if the new law works well, patients should not only save money, they could be relieved of some complicated claims-filing paperwork," said Karen Pollitz, a senior fellow for health reform and private insurance at KFF.

A Few Caveats

Although the No Surprises Act is relatively comprehensive for out-of-network bills, some notable exceptions could result in large bills for consumers, said Loren Adler, associate director of the University of Southern California-Brookings Schaeffer Initiative for Health Policy.

One glaring omission is that charges associated with using a ground ambulance to get to a hospital in an emergency are not covered. A 2021 Peterson-KFF Health System Tracker analysis found that half of emergency ground-ambulance rides resulted in an out-of-network charge for those with private health insurance.

It's also important to note that politicians often use the term "surprise bills" as shorthand for out-of-network bills. Certain large medical bills that consumers receive for in-network care may be "surprising" to them, but, technically, they won't fit under the No Surprises Act if they're not an out-of-network bill.

"There are certainly plenty of things that are surprises in the medical system," said Adler. "Such as people don't realize they have a deductible, and that's a surprise. Or your insurance company denies a claim, and that's a surprise."

This can be confusing to consumers who receive a bill that has nothing to do with what the No Surprises Act was designed to address. For instance, consumers can still be subject to huge fees because of hospital overcharges or insurer mistakes, as shown in many stories in the KHN "Bill of the Month" series.

Still, the four health policy experts we consulted told us that Biden's statement was mostly accurate.

"My general reaction is that it's broadly correct," said Benedic Ippolito, a senior fellow and healthcare expert at the American Enterprise Institute. "But it's not quite true to say that there are bills that you don't need to worry about anymore."

Consumers Should Still Beware

There are a couple of other sticking points in the No Surprises Act that could mean patients still end up with a large or surprising medical bill.

Currently, the interim final rule implementing the No Surprises Act leaves some medical facilities — including urgent care centers, birthing centers, hospice, addiction treatment facilities, and nursing homes — off the list of places covered by the law.

One other issue: Facilities can ask patients to sign a prior written consent that waives their rights under the No Surprises Act in certain situations; this allows patients to be charged out-of-network prices for procedures. Medical providers are not allowed to ask patients to sign the form for emergency care or for services in which the patient doesn't choose the doctor.

"That's not to say that there is absolutely zero risk," said Matthew Fiedler, a fellow with the USC-Brookings Schaeffer Initiative for Health Policy. "Probably the scenario I am most worried about is post-stabilization care following emergency care."

Fiedler said that could mean an out-of-network facility would be able to charge a patient at out-of-network rates if it received the prior written consent and showed that the patient could have traveled to an in-network facility; or, perhaps, for certain services in which the patient doesn't choose the doctor.

Even in those cases, the provider would have to get patients to sign a form they may not understand in which they waive their rights and put themselves at risk of getting an out-of-network bill they weren't expecting. "That's not impossible, but I think it's probably also not trivial," Fiedler said. "So, all things considered, I think we are talking about really unusual scenarios."

Even so, it's important for consumers to be aware that while the No Surprises Act will protect them from most out-of-network bills, they could still receive other types of surprising bills because the U.S. has such a complex healthcare system. While effective, the law is not infallible.

Our Ruling

Biden declared that because of the No Surprises Act, which took effect in January, millions of Americans will no longer have to worry about unexpected medical bills. It's estimated the law will protect against 10 million surprise bills a year.

Although it's true that consumers are now shielded from many out-of-network bills, which are often termed "surprise bills" by lawmakers, patients still could end up with other types of large and unexpected medical bills. Biden's statement is a bit too general and sweeping and needs clarification and additional context.

We rate this claim Mostly True.

Sources

The Brookings Institution, Understanding the No Surprises Act, Feb. 4, 2021

The Centers for Medicare & Medicaid Services, No Surprises: Understand Your Rights Against Surprise Medical Bills, Jan. 3, 2022

CNN, "Patients Won't Have to Fear as Many Surprise Medical Bills Come January," Dec. 28, 2021

Congress.gov, H.R.133 – Consolidated Appropriations Act, 2021, 116th Congress (2019-20)

Email interview with Karen Pollitz, a senior fellow for health reform and private insurance at KFF, Feb. 11, 2022

KFF, No Surprises Act Implementation: What to Expect in 2022, Dec. 10, 2021

KFF, Ground Ambulance Rides and Potential for Surprise Billing, June 24, 2021

NPR, "Here's What the New Ban on Surprise Medical Billing Means for You," Dec. 30, 2021

Phone interview with Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy, Feb. 14, 2022

Phone interview with Benedic Ippolito, a senior fellow and expert in healthcare at the American Enterprise Institute, Feb. 11, 2022

Phone interview with Matthew Fiedler, a fellow with the USC-Brookings Schaeffer Initiative for Health Policy on Feb. 11, 2022

The White House, Remarks by President Biden on the Biden-⁠Harris Administration's Work to Lower Healthcare Costs, Feb. 10, 2022

Victoria Knight: vknight@kff.org, @victoriaregisk

From Alabama to Utah, Efforts to Vaccinate Medicaid Enrollees Against COVID Run Into Obstacles

KFF Health News, February 28, 2022

There is no nationwide compilation of how many Medicaid enrollees have been vaccinated.

This article was published on Monday, February 28, 2022 in Kaiser Health News.

By Phil Galewitz

Medicaid enrollees continue to get vaccinated against COVID at far lower rates than the general population despite vigorous outreach efforts by government officials and private organizations to get low-income people inoculated, according to data from several states.

That leaves many Medicaid enrollees — who tend to be sicker than those with private insurance — at higher risk for severe illness, hospitalization, or death from the virus.

Nationally, more than 215 million Americans — including 75% of adults and 57% of children ages 12 to 17 — are fully vaccinated, according to the Centers for Disease Control and Prevention. Among children 5 to 11 years old, who have only been eligible for a shot since early November, about 25% have been fully vaccinated. A vaccine has not yet been authorized for children younger than 5.

There is no nationwide compilation of how many Medicaid enrollees have been vaccinated.

But in Utah — one of a handful of states that publish that data — fewer than half of adult Medicaid enrollees are fully vaccinated.

Disparities exist in every age and racial/ethnic group that the state publishes data on. For example, about 40% of Black Medicaid enrollees are vaccinated, compared with 56% of Black people overall. Among Hispanics, 38% of Medicaid enrollees are vaccinated, compared with 51% of the overall Hispanic population. (Hispanic people can be of any race or combination of races.) Among children 12 to 18, about 35% of Medicaid enrollees are vaccinated, compared with 57% overall.

Officials at Molina Healthcare, which is one of Utah's four Medicaid managed-care plans and has about 90,000 members, said overcoming resistance to the COVID vaccine has been difficult. One of the biggest hurdles is getting in touch with members. Molina officials told a Utah Medicaid advisory board in January that they can't reach 40% of their members because they don't have correct addresses or phone numbers.

"It's worrying," said Brian Roach, division services manager at the Utah Department of Health, which oversees the federal-state health insurance program for low-income residents. "We still see little increases every month, but it is not enough to close the gap," he added. "There has been no silver bullet to solve this issue."

Roach said he is not surprised Medicaid health plans have difficulty reaching members. "The Medicaid population is pretty transient, and people change jobs and move," he said.

Under federal rules implemented for the COVID public health emergency, states can't remove people from the Medicaid rolls if their income changes, so enrollees have generally not had to check in with the state to renew their eligibility. As a result, states might not have updated contact information.

Personal contact with someone trusted by the enrollee is crucial to persuading members to get vaccinated. Harley Jones, a senior manager at Project Hope, a global humanitarian relief group, said unvaccinated people often need to hear from someone they know, such as a clinic nurse, to persuade them to get the shots. Since last summer, the nonprofit has been using a federal grant to help free health clinics in Texas boost vaccination rates.

"It's been a year since the mass vaccination clinics, and this is a slow slog," he said. "What works is finding the trusted voice for people who is from their community, knows the culture, and that one-on-one can take hours or a month to pay off."

The federal government has authorized nearly $400 million for vaccination outreach efforts to underserved communities.

Utah's difficulty getting Medicaid enrollees vaccinated is mirrored in other states.

In Ohio, 54% of adult Medicaid enrollees are at least partly vaccinated, compared with 73% of adults in the general state population.

Washington state has vaccinated 43% of its Medicaid enrollees 5 and older, compared with 76% of all state residents in that age group.

In Virginia, 41% of Medicaid enrollees 5 and older are vaccinated, compared with 76% of state residents in that age group.

In California, about 54% of Medicaid members 5 and older are at least partly vaccinated, compared with 81% of state residents in that age group.

Dr. Christopher Chen, medical director for the Washington Medicaid program, said that since Medicaid enrollees are more likely to be in poorer health, they are more likely to benefit from the vaccine to prevent complications from COVID. "It's definitely something to be concerned about," he said.

Washington, he noted, increased pay to doctors and pharmacists to vaccinate Medicaid enrollees and agreed to pay doctors to counsel patients about the vaccine. The state also gave its Medicaid health plans access to data showing which of their members had not been immunized so they could reach out to those people.

The University of Alabama received a $1 million federal grant last July to increase vaccination rates in an 18-county rural region in the southern part of the state where African Americans make up the majority of the population. Under the plan, community health workers canvass the region to inform residents about the benefit of the vaccine. The initiative also provides a $15 incentive payment for getting a shot.

Since last summer, many of the counties have seen vaccination rates double. But because the rates were so low to begin with, most of the area still has fewer than half of residents vaccinated.

Dr. Hee Yun Lee, who oversees the grant and is associate dean for research at the University of Alabama School of Social Work, said many people lack easy access to shots because they don't have cars and mistrust of vaccines runs strong.

Another obstacle has been skepticism from some pastors, who told congregations not to fear COVID, Lee said. They also incorrectly told congregants that the disease can't afflict them while they attend church, she said. A gathering of more than 300 people in a church recently led to an outbreak.

"There are a lot of misconceptions about the virus here," she said.

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

The Demise of Single-Payer in California Trips Up Efforts in Other States

KFF Health News, February 28, 2022

Health policy experts agree that California's failure to adopt single-payer dampens momentum across the country.

This article was published on Monday, February 28, 2022 in Kaiser Health News.

By Angela Hart  

SACRAMENTO — Single-payer healthcare didn't stand a chance in California this year.

Even in this deep-blue bastion, Democratic lawmakers shied away from legislation that would have put state government in charge of healthcare and taxed Californians heavily to do so — a massive transformation that would have forced them to take on the powerful healthcare industry.

Gov. Gavin Newsom, who had promised to spearhead single-payer when he ran for governor four years ago, dashed its chances this year when he declined to publicly support it.

Instead, the first-term Democrat, who is running for reelection this November, is pushing for "universal healthcare," which aims to provide all Californians with coverage but, unlike single-payer, would keep private health insurance intact.

Newsom's retreat devastated progressive activists and the powerful California Nurses Association union, which championed the cause. The death of single-payer in the nation's most populous state also deals a major blow to similar campaigns elsewhere in the nation — which had looked to California for inspiration and leadership — casting doubt on their ability to succeed.

"We're also fighting in New York, but just like in California, there's not 100% Democratic consensus among legislators," said Ursula Rozum, co-director of the Campaign for New York Health, which is working to pass single-payer legislation. "It feels like a constant question of 'Can we win this?'"

Health policy experts agree that California's failure to adopt single-payer dampens momentum across the country.

"California, given its size and politics, has always been a bellwether for progressive policy, so this certainly sends a signal to other states about how hard this is," said Larry Levitt, executive vice president for health policy at KFF.

But Rozum and single-payer activists in Colorado, Washington state, and elsewhere say that rather than giving up, they are taking key lessons from California's failure: It is essential to win — and keep — support from the governor. Groups pushing single-payer must unite Democrats, bringing in business-friendly moderates and broader support from organized labor. And they say they must learn how to counter intense lobbying by doctors, hospitals, and health insurance companies fighting to preserve the status quo.

"We've seen what happened in California, so we are working hard to get our governor on the record in support of single-payer so she will sign it when it gets to her desk," Rozum said. "And just like there, our union movement is divided. We know we need them to have any chance of moving forward with our bill."

So far, single-payer proponents haven't been able to broaden their movement beyond liberal activists or convince people that they should pay higher taxes in exchange for scrapping healthcare premiums, deductibles, and copays.

The only state that has passed single-payer, Vermont, didn't implement it.

Vermont adopted a single-payer plan in 2011 with unequivocal support from its then-governor, Democrat Peter Shumlin. But he abandoned the effort in 2014 amid growing concerns about tax increases and runaway healthcare costs.

"There isn't a political party in the world that's going to raise their hands every year to increase taxes on hard-working citizens," Shumlin told KHN. "That's the big mistake I made in Vermont."

But progressive dreams for single-payer didn't die when Vermont retreated. "Medicare for All" became a liberal rallying cry for Democrats nationally when Vermont Sen. Bernie Sanders stumped for it during his presidential campaigns. After President Joe Biden was elected, the movement shifted to the states, in part because Biden has opposed Medicare for All.

Activists in Colorado are mobilizing for another single-payer campaign after the overwhelming defeat of a 2016 ballot initiative that failed partly because of intense healthcare industry opposition. Organizers in Washington state are pushing legislation and trying to get a single-payer initiative on the ballot next year.

Shumlin said Democrats must be prepared to take on deep-pocketed industry groups and rein in soaring healthcare spending — or they'll be confronted with the political difficulty of constantly raising taxes.

"California is the best state to lead this because it has the fifth-biggest economy in the world. It's all about scale," Shumlin said. "And if California gets it right, other states and the federal government will follow. But this is hard stuff, so get ready to get bloodied."

Some Democratic lawmakers and the California Nurses Association had hoped California would lead the way this year and that Newsom would be their champion.

State Assembly member Ash Kalra (D-San Jose) introduced legislation sponsored by the union that would have created government-run health insurance for all state residents while significantly raising taxes on employers, employees, and businesses to pay for it. State estimates pegged the cost at roughly $360 billion a year, with a little less than half coming from tax increases and the rest from the federal government.

On Newsom's first day in office in 2019, he said, "I committed to this and I want folks to know I was serious." But since then, he has distanced himself from single-payer.

Instead, he has created a commission to study the concept and asked the Biden administration for permission to collect federal money that flows to the state via the Affordable Care Act, Medicaid, and Medicare, which California could use to help finance a single-payer system. But Biden can't simply approve the request — California would need complicated federal waivers and approval from Congress.

Newsom has shifted to a platform of "universal healthcare," which includes Medicaid coverage for all income-eligible unauthorized immigrants and state-funded subsidies for Californians who buy health insurance from Covered California, the state's Obamacare insurance exchange.

Newsom said in January that he has long believed single-payer is "inevitable" but signaled that the federal government should take the lead.

Kalra decided not to bring his bill up for a vote in the state Assembly, saying on Jan. 31 that he couldn't muster enough support.

"It makes it harder to get the votes you need when I'm trying to convince my colleagues that there's an absolute path to success," Kalra said. "We have a governor who campaigned on single-payer, and if we're going to successfully have single-payer healthcare in California, at some point we need his engagement and it needs to be genuine."

Kalra said he's considering introducing another bill next year but conceded that he must shift his strategy to bring more Democrats and unions into the campaign.

These are lessons other states are heeding.

"There's no question that had California passed a single-payer healthcare plan, we'd be in a position in the state of Washington to say, 'Look what California is doing,'" said Andre Stackhouse, campaign director for Whole Washington, an advocacy group trying to get a single-payer initiative on the ballot next year.

Stackhouse worked on behalf of California's single-payer campaign this year, helping with a phone-banking campaign to pressure lawmakers. He's part of a new national coalition called Medicare for All Everywhere, a group of organizers and volunteers working to identify why single-payer efforts fail and how to overcome political and lobbying obstacles.

California was a key test, he said. "We've learned all the ways Democrats can kill a bill, but we can't spend all of our time grieving this loss and the huge setback that it is," Stackhouse said.

For instance, a major goal for the movement is to persuade more unions to join the fight. Although the nurses union is leading the battle in California, other unions are against single-payer.

"As trade unionists, we believe everybody should have healthcare, but there's a big fear that we're going to lose the benefits that we have," said Chris Snyder, political director for the local International Union of Operating Engineers in Northern California. "We have our own healthcare trust fund, and we don't want benefits that we've fought for for decades to be taken away or watered down."

Lack of union support is a major problem in New York, where Democratic Assembly member Richard Gottfried has introduced a single-payer bill in every legislative session for the past 30 years.

"What is keeping the bill from moving in the legislature is opposition from public employee unions," Gottfried said. "They feel they have negotiated excellent coverage, so we need to convince them that the New York Health Act is as good or better than what they have now."

Gottfried said he has been negotiating with teachers, sanitation workers, and other trade unions on legislative language that would provide "more explicit guarantees" that union members would receive better coverage without paying more out-of-pocket than they already do.

It's not clear if the measure will get a vote this year.

"Whichever state goes first will help build momentum for other states," he said.

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

Angela Hart: ahart@kff.org, @ahartreports

Healthcare Firms Were Pushed to Confront Racism. Now Some Are Investing in Black Startups.

KFF Health News, February 28, 2022

In healthcare, there are long-standing and well-documented disparities in care for Black and white patients.

This article was published on Monday, February 28, 2022 in Kaiser Health News.

By Blake Farmer, Nashville Public Radio

NASHVILLE, Tenn. — Marcus Whitney stands out in Nashville's $95 billion healthcare sector as an investor in startups. In addition to co-founding a venture capital firm, he's organized an annual health tech conference and co-founded the city's professional soccer club.

And, often, he's the only Black man in the room.

So in summer 2020, as Black Lives Matter protesters filled city streets around the country following George Floyd's murder, Whitney pondered the racial inequalities that are so obvious in his industry — especially locally.

"I sat at the intersection of two communities — one that I was born into and one that I had matriculated into," he said.

On a quiet Sunday morning after the protests died down, he pounded out a long letter to his peers that pointed out those making the most money from Nashville's for-profit healthcare industry are still almost all white men.

Whitney hit publish on Monday, leading to weeks of intense conversations.

The racial reckoning of the past couple of years has inspired many industries to take a look at their histories and practices. In healthcare, there are long-standing and well-documented disparities in care for Black and white patients.

Those disparities have carried over into who gets funding for research and health startups. Of the nation's more than 900,000 healthcare and social assistance companies, which include home health and other health services, roughly 35,000 — or fewer than 4% — are Black-owned, according to data from the U.S. Census Bureau. 

Whitney wrote that this problem isn't his to fix, but he realized he's in a unique position as one of the few Black venture capitalists in healthcare. So his firm, Jumpstart Foundry, launched a dedicated fund to get behind Black entrepreneurs in healthcare. The letter was "pretty key" to pulling in investors, he said.

The fund is called Jumpstart Nova. It's a tiny slice of the estimated $42 billion of venture funding invested last year in health tech. But it did exceed its initial goal, raising $55 million from the likes of pharmaceutical giant Eli Lilly, medical supplier Cardinal Health, and the hospital chain that started Nashville's healthcare industry, HCA. 

Each corporation measures its annual profits in the billions of dollars, so the fund represents only a sliver of their investments. But Jumpstart is also just one part of their broader diversity investment initiatives. For example, Indianapolis-based Eli Lilly has committed $92 million to Black-led venture capital firms since December 2020, according to company spokesperson Carrie Martin Munk.

Whitney said he didn't have to convince those blue-chip firms that investing in Black founders was a wise move, but he did have to make the case that they would have enough promising startups from which to choose.

"That was really emblematic of the fact that there was a disconnect between the communities. These investors simply did not know enough Black people to know whether or not there were enough deals out there," Whitney said. "This is not like an indictment of them. This is the reality of our country."

Jumpstart Nova is the lead investor in three of the four companies it's working with so far. That means Whitney's team scrutinizes the business plan, vouches for the founder, and draws up all the financial and legal documents so it's easier for others to come along.

"It's validation. You need someone to say, 'We're in,'" said Dr. Derrell Porter, founder of San Francisco-based Cellevolve Bio, one of the first startups to land a lead investment from Jumpstart Nova. 

His firm is trying to streamline the process of commercializing promising cell therapies. Hundreds are in development, and of those, each is customized for a patient by using the patient's own cells. The therapies target cancer, central nervous system diseases, or viruses. Cellevolve is partnering with academic medical centers and small biotech companies in an attempt to make the commercializing process more similar to how a pharmaceutical company shepherds a drug to market.

"Marcus was one of the few investors that I spoke to that immediately got what we're talking about," Porter said. "He was like, 'This is either not going to work at all, or it's going to be massive. It's nowhere in between.'"

Porter said his only discomfort has been feeling pressured at times to play the role of a Black entrepreneur with a hard-scrabble upbringing. "Folks are looking for the story to tug on their heart strings," he said. "But that wasn't my life."

He grew up in Compton, California, in a middle-class family, with a mother who is a nurse and a father in construction. "I can't tell you this traumatic, inner-city, drama-filled narrative," said Porter, who has an M.D. and an MBA from the University of Pennsylvania. 

Jumpstart is primarily looking for Black-led companies with untapped profit potential. But the venture fund's backers also say they expect some startups will work on fixing health inequities.

One of the fund's initial investments is in DrugViu, which consolidates the medical records of people with autoimmune diseases — particularly underrepresented people of color — so their personal health data can more easily be included in scientific research.

Dr. James Hildreth, president of Meharry Medical College in Nashville, said he hopes some startups will work to ensure health inequities don't get worse, especially now that so many new companies in healthcare are built around using artificial intelligence. Hildreth said he fears what big data could do without Black representation in the decision-making process or — as DrugViu is trying to resolve — in the clinical data.

"The people designing the algorithms can unconsciously sometimes put their own biases into how the algorithms are designed and how they function," he said.

The historically Black medical school launched its own for-profit arm in 2021 to seek "profitable activities that align with Meharry's mission of eliminating health disparities." Meharry has also invested in the Jumpstart Nova fund. Hildreth said he sees it as an opportunity to make money and to make a statement to students.

"We believe enough in the ingenuity, the innovation, and the intelligence of folks who look like us that we're willing to invest in them," Hildreth said. "With the expectation that the companies that come out of this fund are going to have a huge impact, not just on our communities, but people in general." 

Blake Farmer, Nashville Public Radio: bfarmer@wpln.org, @flakebarmer

Other States Keep Watchful Eye on Snags in Washington's Pioneering Public-Option Plan

KFF Health News, February 23, 2022

The Washington public option is more of a public-private partnership: The plan was designed by the state but is offered by private insurance companies.

This article was published on Wednesday, February 23, 2022 in Kaiser Health News.

By Markian Hawryluk

With prospects dim for the U.S. to adopt a single-payer "Medicare for All" program, healthcare reform advocates turned instead to an insurance plan designed by the government that could compete with private insurance plans sold on the healthcare exchanges. The idea behind this "public option" is that it could ultimately expand healthcare access by making a lower-cost plan available to consumers.

But that public-option plan, though backed by Presidents Joe Biden and Barack Obama, also has gone nowhere because of political opposition in Congress.

Some states have picked up the banner and are creating their own public-option plans. But they, too, are facing formidable opposition from the healthcare establishment, which is resisting the pressure to reduce costs on the back end so that consumers can pay less.

Washington state, in its second year of offering the nation's first public-option health insurance plan, has learned an important lesson: If you want hospitals to participate, you're probably going to have to force them.

The Washington public option is more of a public-private partnership: The plan was designed by the state but is offered by private insurance companies. Anyone buying their own policy on the state's health insurance marketplace can sign up for a public-option plan and, depending on their income, may receive significant subsidies from the federal government to lower its cost. But two years in, the plans are available in only 25 of the state's 39 counties, enrollment numbers have been underwhelming, and state leaders blame hospitals.

"The plans had a hard time getting networks put together because the hospitals wouldn't play," said state Rep. Eileen Cody, the Washington legislator who introduced the public-option bill in 2019. "They're a big part of the problem."

Officials from the Washington State Hospital Association said that more hospitals than not are voluntarily participating in public-option plans. But, they noted, the public option relies on cutting payments to hospitals to control costs and ties reimbursement to Medicare rates, which don't cover hospitals' cost of providing care.

"If patients opt to join a public-option plan rather than private insurance, over time it could create financial challenges, especially for small, rural providers operating on thin margins," said Chelene Whiteaker, senior vice president of government affairs for the hospital group.

State legislators last year voted to mandate that hospitals contract with a public-option plan if public-option plans weren't available in each county in 2022. That mandate will go into effect for 2023.

Now, other states looking at a public option are learning from Washington's challenges. Colorado and Nevada, which are implementing public-option plans for 2023 and 2026, respectively, have already incorporated ways of forcing hospitals to participate. And other states considering a public option — including Connecticut, Oregon, New Jersey, and New Mexico — are likely to follow suit.

"One thing that the states have learned is you cannot make it optional for hospitals to participate," said Erin Fuse Brown, director of the Center for Law, Health & Society at Georgia State College of Law. "Otherwise, there's just no way for the public option to have a chance. It will never build a sufficient network."

Washington's public option was designed to save consumers money primarily by lowering what hospitals and doctors get paid, capping aggregate payments at 160% of what Medicare would pay for those services. By comparison, health plans had been paying providers an average of 174% of Medicare rates.

Public-option plans are available to anyone and come in the same gold, silver, and bronze tiers as private plans on the health insurance exchange. Proponents estimated the cap would result in public-option plans having premiums 5% to 10% lower than traditional plans on the exchange. But public-option premiums were, on average, 11% higher than the lowest silver plan premium available in each county on the marketplace in 2021, and a public-option plan was the silver plan with the lowest premium in just nine counties. Silver plans cover, on average, about 70% of healthcare costs. Only 1% of people buying plans on the exchange chose public-option plans in 2021.

Public-option premiums for 2022 came in about 5% lower than public-option premiums in 2021. This year's enrollment numbers have not been finalized — the state is waiting to see how many of the people who signed up complete the process by paying their premiums.

"We know premiums are what drive decision-making in terms of enrollment," said Liz Hagan, director of policy solutions for United States of Care, a nonprofit that advocates for improving healthcare access. "People often don't look at anything other than the premium. They rarely look at the out-of-pocket costs."

But exchange officials say that savvy consumers are finding that the public-option plans are less expensive in the long run. Compared with traditional exchange plans, they have lower deductibles and provide more services not subject to the deductible.

"Premium is still king," said Michael Marchand, chief marketing officer for the Washington Health Benefit Exchange. "But we have a lot of people who have gotten a lot smarter about how they're pricing out something."

Marchand also said it may take a few years for a new product like the public-option plan to gain traction in the marketplace. Insurance companies may have priced their plans a little high in the first year, not knowing what to expect. Now, with a year under their belt, they have lowered premiums somewhat.

Washington's stumble out of the gate reflects the difficulty of lowering healthcare costs while working within the current system. Legislators originally wanted to cut payment rates to hospitals and other providers much more, but they raised the cap in the legislation so hospitals wouldn't oppose the bill. Now, it's unclear whether the payment cap is low enough to reduce premiums.

"That's kind of the big trade-off," said Aditi Sen, a health economist with the Johns Hopkins Bloomberg School of Public Health. "You are trying to lower premiums enough that people will enroll, but not so much that providers won't participate."

That will be a challenge for any state or federal public-option plan. There are only so many ways to lower premiums. Hospitals, doctors, and other healthcare professionals have pushed back hard against any cuts in their payment rates, while insurance plans balk at plans that could eat into their profits.

Plans can reduce the size of their provider network to save money, but consumers dislike plans that limit what doctor they can see. Public-options plans could rely on existing public health programs, like Medicare and Medicaid, which already pay lower rates than commercial insurance, but government-run insurance plans carry negative connotations for many consumers.

Sen and her colleagues found that in 2021, Washington counties with public-option plans were primarily in areas where hospital and physician payment rates were lower than those in other parts of the state. That may have helped insurers build out networks and still stay under the 160% provider payment cap.

Five of the 12 private insurers that sell plans on the exchange offer public-option plans.

Insurance companies that had previously offered plans in Washington were able to cobble together networks based on existing contracts with hospitals and physician groups. But two carriers new to the Washington exchange had to start from scratch and negotiate prices with providers for their public-option plans. Some of the insurance companies tried to offer public-option plans in other counties but could not persuade hospitals, particularly those in larger hospital systems, to accept their rates.

Washington saw enrollment in public-option plans start to climb during a special enrollment period launched in mid-2021 because of the COVID-19 pandemic. The American Rescue Plan Act also provided more subsidies, which made all plans on the exchange more affordable. But those subsidies are due to expire at the end of the year unless Congress votes to extend them. An extension is included in the Biden administration's Build Back Better legislation, but it has stalled in Congress.

Washington legislators approved other moves to make the public option more affordable. They set aside $50 million in state subsidies, but officials must still determine how to allocate those funds. And lawmakers authorized the state to pursue a waiver with the federal government that could allow the state to keep more of the savings achieved through premium reductions. Currently, lower premiums also mean lower subsidies from the federal government. The state can request those savings be passed through to consumers.

Washington did not pursue such a waiver before implementing its public-option plan, but many believe the Biden administration might be more amenable to such a request than the Trump administration.

State progress on public-option plans comes amid disappointment among many progressives that Congress did not implement a federal public option under the Affordable Care Act to compete with private plans on the marketplaces.

Washington state officials realize that because they were the first to implement a public option, other states will be watching them closely to see how it all plays out. "We're not the only ones, but we're the furthest along," Cody said. "Other people can learn from our mistakes."

Markian Hawryluk: MarkianH@kff.org, @MarkianHawryluk

An $80K Tab for Newborns Lays Out a Loophole in the New Law to Curb Surprise Bills

KFF Health News, February 23, 2022

Cigna said it lacked documentation that the NICU care for the twins qualified as an emergency.

This article was published on Wednesday, February 23, 2022 in Kaiser Health News.

By Jay Hancock

When Greg and Sugar Bull were ready to start a family, health challenges necessitated that they work with a gestational surrogate. The woman who carried and gave birth to their twins lived two states away.

The pregnancy went well until the surrogate experienced high blood pressure and other symptoms of preeclampsia, which could have harmed her and the babies. Doctors ordered an emergency delivery at 34 weeks' gestation. Both infants had to spend more than a week in the neonatal intensive care unit.

It was April 2020, early in the pandemic. Unable to take a plane, the Bulls drove from their home in Huntington Beach, California, to the hospital in Provo, Utah. They had to quarantine in Utah before they could see the children in the hospital.

A couple of weeks later, after the babies could eat and breathe on their own, the Bulls took them home to California.

Then the bills came.

The Patients: Scarlett and Redford Bull, newborn twins covered by a Cigna policy sponsored by Greg Bull's employer. The gestational surrogate had her own insurance, which covered her care.

Medical Service: Neonatal intensive care when the babies were born prematurely after emergency induced labor. Scarlett spent 16 days in the NICU; Redford, 10.

Total Bill: $117,084. The hospital was out of network for the infants. Cigna paid for some of Scarlett's care, for reasons the Bulls couldn't figure out. The Bulls were left on the hook for about $80,000, for both babies. Their account was ultimately sent to collections.

Service Provider: Utah Valley Hospital in Provo, Utah, one of 24 hospitals run by Intermountain Healthcare, a nonprofit with about $8 billion in revenue.

What Gives: The Bulls' ordeal points up a loophole in coverage for emergency care — even under the No Surprises Act, which took effect Jan. 1 and outlaws many kinds of surprise medical bills.

Patients who need prompt, lifesaving treatment often don't have time to find an in-network hospital. In the past, health plans sometimes have said they would pay for emergency care even if it's out of network. The No Surprises Act now makes this a legal requirement in every state. The provider and insurer are supposed to negotiate a reasonable payment, leaving the patient out of the equation.

But what if the insurance company denies that the care is for an emergency? Or the hospital doesn't supply the paperwork to prove it?

That's what happened to the Bulls. Cigna said it lacked documentation that the NICU care for the twins qualified as an emergency.

So the Bulls began receiving insurance explanations showing huge balances owed to Utah Valley. The family had expected to owe its out-of-network, out-of-pocket maximum of $10,000 for the twins' care. They assumed most of the bills would be paid by Cigna soon. They weren't.

"I was, like, there is no way this can be real," said Sugar Bull, an interior designer.

"Dear Scarlett Bull," began one of Cigna's letters, addressed to a 6-month-old baby. "We found the service requested is not medically necessary."

How could NICU care not qualify? The gestational surrogate was admitted to obstetrics by her doctor without going through the emergency department, which prompted Cigna to initially conclude there was no emergency, said Dylan Kirksey of Resolve Medical Bills, a consultancy that eventually worked with the Bulls to resolve the claims.

To establish that there was, Cigna asked for daily progress notes and other medical records on the infants. The Bulls tried to get the hospital to comply. Cigna kept saying it hadn't received the necessary documentation.

The Bulls appealed. Sugar spent hours with insurance paperwork and hold music. But almost a year later, about $80,000 in bills remained. Utah Valley sent the accounts to collections, Sugar Bull said. It was the last thing she had time for.

"I own a company, and I am super busy, and we had twins," she said. "Every two weeks or so, I would feel a panic and righteous anger about it. And I would keep pushing and calling, and it would take like five hours every time."

Though they disputed what they were being charged, the Bulls agreed to pay the hospital $500 a month for five years to settle just one of the babies' bills, in an attempt to keep their good credit.

Resolution: With seemingly nowhere else to turn, the family hired Resolve, which beats a path through the claims jungle in return for a portion of the money it saves clients.

"It was a lot of prodding" to get Utah Valley to give Cigna the information it needed to pay the hospital, said Kirksey, a senior advocate with Resolve, which was founded in 2019 and has 16 employees. He said he had to give the hospital a detailed list of steps to take and then follow up with multiple calls and emails per week.

In the end, most of the errors causing the Bulls' nightmare were on the hospital's side, Kirksey said. But instead of supplying what Cigna needed, Utah Valley went after the Bulls.

"The hospital repeatedly failed to provide a detailed list of services and important clinical information, despite our continuous efforts to secure the information," said Cigna spokesperson Meaghan MacDonald.

"There were no errors on the hospital's part," said Utah Valley spokesperson Daron Cowley. "Utah Valley Hospital properly billed for services provided to the twins and provided the requested information to Cigna in a timely manner."

The hospital didn't bill the Bulls for outstanding balances until nine months after the twins were born and didn't send the accounts to collections until six months after that, "after the family did not return the legally required paperwork to set up a payment plan," he said.

Finally, in fall 2021, the bills were settled. The twins were 1½ years old. To compensate Resolve for curing the balance, the Bulls paid the company about 10% — $8,000.

The fee, though substantial and unrelated to medical care, was worth it to avoid the much larger debt, said Greg Bull, who works in finance. "At the end of the day, it was such a relief for it to be a smaller amount," he said. Still, many families could not have afforded it.

The Takeaway: About 1 in 5 emergency room visits are at facilities that are out of network for the patient's insurance, research has shown. The No Surprises Act requires insurers to cover non-network emergency treatment with the same patient cost sharing as in-network care. It also prohibits hospitals from billing patients extra.

But if the insurer denies that the care was for an emergency or doesn't obtain documentation to prove it, the claim can still be rejected and the patient left on the hook.

"That's a coding issue we see a lot," said Kirksey, especially "if the person didn't literally check in through the emergency room."

If this happens, insurance experts urge patients to immediately appeal the decision to the insurance company, a process the law requires to be available. Unfortunately, that usually requires more phone calls, paperwork, and waiting. (If the appeal with the insurer fails, patients can then turn to an independent reviewer, like their state insurance board, state attorney general's office, or the No Surprises Help Desk.)

"It would be a critical step for the consumer to leverage their appeal rights … and get the determination that it was an emergency service from the get-go," said Kevin Lucia, co-director of the Center on Health Insurance Reforms at Georgetown University.

Once it's established that the visit was for an emergency, he said, protections from the No Surprises Act clearly apply.

The No Surprises Act is a step in the right direction. But it is clear that loopholes and minefields remain.

Stephanie O'Neill contributed the audio portrait with this story.

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Jay Hancock: jhancock@kff.org, @JayHancock1

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