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KHN’s ‘What the Health?’: On Capitol Hill, Actions Have Consequences


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The reverberations from the Jan. 6 storming of the U.S. Capitol by supporters of President Donald Trump continue. A broad array of business groups, including many from the health industry, are halting contributions to Republicans in the House and Senate who voted against certifying the victory of President-elect Joe Biden. Meanwhile, Republicans in the House who have refused to wear masks or insisted on carrying weapons are being subjected to greater enforcement, including significant fines.

Away from the Capitol, the Trump administration has granted a first-in-the-nation waiver to Tennessee to turn its Medicaid program into a block grant, which would give the state potentially less federal money but more flexibility to structure the federal-state health program for those with low incomes. And in its waning days, the administration is moving to make its last-minute policies harder for Biden to undo.

This week’s panelists are Julie Rovner of KHN, Joanne Kenen of Politico, Margot Sanger-Katz of The New York Times and Kimberly Leonard of Business Insider.

Among the takeaways from this week’s podcast:

  • The decision by industry groups to cut their political contributions to some Republican lawmakers could reshape businesses’ relationships on Capitol Hill. But it’s still not clear if this announcement will affect the vast sums of political contributions that come through PACs and other unnamed sources, as well as individual contributions from corporate officials.
  • The slow start of the covid vaccination campaign points to the tension between the need to steer the vaccine to people at high risk of contracting the disease and the concerns about wasting the precious medicine. Because the vaccines that have been approved for emergency use have a relatively short shelf life, some doses may go to waste if they are reserved for specific populations.
  • The response to the vaccine among health care workers varies widely. In some areas, staffers are eager to get the shots, while in other places, some workers have been hesitant and the shots are going unused. And the federal government has not provided a strong public messaging campaign about the vaccines.
  • The Trump administration’s announcement last week that it would move to convert Tennessee’s Medicaid program to a block grant program is raising concerns among advocates for the poor, who fear that the flexibility the state is gaining could lead to enrollees getting less care, especially since the state will get a hefty portion of any savings it finds in running the program.
  • It may not be easy for the Biden administration to change this decision. Federal officials in recent weeks have been sending states, including Tennessee, letters to sign that could protect the Medicaid waivers they have received from the Trump administration and could serve as a legal guarantee that would require a long, difficult process to unwind.
  • Mental health care may be a casualty of the coronavirus pandemic. As states look to balance their budgets after a year in which revenues were slashed, they may turn to cutting mental health care services provided through Medicaid and other programs.

Also this week, Rovner interviews KHN’s Victoria Knight, who wrote the latest KHN-NPR “Bill of the Month” feature — about an unusually large bill for in-network care. If you have an outrageous medical bill you’d like to share with us, you can do that here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week that they think you should read too:

Julie Rovner: The Washington Post’s “Young ER doctors Risk Their Lives on the Pandemic’s Front Line. But They Struggle to Find Jobs,” by Ben Guarino

Margot Sanger-Katz: The New York Times’ “Why You’re Probably Not So Great at Risk Assessment,” by AC Shilton

Joanne Kenen: The Atlantic’s “Why Aren’t We Wearing Better Masks?” by Zeynep Tufekci and Jeremy Howard

Kimberly Leonard: Business Insider’s “I Was Offered a Covid Vaccine Even Though I’m Young and Healthy. Here’s How I Did It,” by Kimberly Leonard


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Delicate Covid Vaccines Slow Rollout — Leading to Shots Given Out of Turn or, Worse, Wasted

For Heather Suri, a registered nurse in Virginia, the race to vaccinate Americans against covid has thrown up some unprecedented obstacles.

The vaccines themselves are delicate and require a fair bit of focus over time. Consider Moderna’s instructions for preparing its doses: Select the number of shots that will be given. Thaw the vials for 2.5 hours in a refrigerator set between 36 and 46 degrees. Then rest them at room temperature for 15 minutes. Do not refreeze. Swirl gently between each withdrawal. Do not shake. Inspect each vial for particulate matter or discoloration. Store any unused vaccine in refrigeration.

And then there’s this: Once open, a vial is good for only six hours. As vaccines go, that’s not very long. Some flu vaccine keeps almost a month.

“This is very different, administering this vaccine. The process, it takes a whole lot longer than any mass vaccination event that I’ve been involved with,” said Suri, a member of the Loudoun Medical Reserve Corps who joined her first clinic Dec. 28, to vaccinate first responders.

Of the first two covid vaccines on the market, Moderna’s is considered more user-friendly. Pfizer-BioNTech’s shot must be stored in specialized freezers at 94 degrees below zero. Once out of deep freeze, it lasts just five days, compared with 30 days for Moderna’s.

One thing the shots have in common: They last a paltry six hours once the first dose is removed from a vial. That short shelf life raises the stakes for the largest vaccination effort in U.S. history by forcing clinicians to anticipate the exact number of doses they’ll need each day. If they don’t get it right, precious stores of vaccine may go to waste.

During one recent clinic over several hours, Suri estimated she gave “maybe 25” shots, many fewer than the number of flu shots she’s given during similar clinics over the years.

With covid, she said, “the vaccine itself slows things down.”

The slow rollout has frustrated people who at Thanksgiving imagined millions of vaccines in arms by Christmas. Promises that 20 million would be vaccinated by New Year’s fell well short: Just 2.8 million had the first of two required shots by the end of December, according to data from the Centers for Disease Control and Prevention.

Public health officials say many factors are at play, including a shortage of workers trained to administer shots, covid protocols that require physical distancing at clinics and vaccine allocation numbers from the federal government that fluctuate by the week.

And then there are the logistics of the first covid vaccines, which are complex and make hyper-vigilant practitioners wary of opening too many vials over the course of each day, for fear that anything unused will have to be tossed. Vaccine providers also report wasted or spoiled doses to public health authorities.

“If you get to the end of your clinic and every nurse has half a vial left, what are you going to do with that vaccine?” Suri said. “The clock is ticking. You don’t want to waste those doses.”

That impulse has led some health personnel to make dramatic decisions at the end of a day: calling non-front-line health workers or offering shots to whoever is at hand in, say, a grocery store, instead of scrambling to find the health workers and residents of nursing homes in the government’s first tier for injections.

“We jumped and ran and got the vaccine,” said Dr. Mark Hathaway, an OB-GYN in the District of Columbia who received the first dose of a Moderna vaccine on Dec. 26 along with his wife, a registered nurse specializing in nutrition. Both clinicians received vaccines faster than anticipated at a Unity Health Care clinic when there were extra doses because fewer front-line health care workers than expected showed up.

“Health care workers have been priority 1a, so our first attempt has always been our staff,” said Dr. Jessica Boyd, Unity Health Care’s chief medical officer. Since then, the community health center network has broadened its criteria for extra doses to include staff members or high-risk patients visiting a clinic, she said.

Health officials encourage using the doses to get as many Americans vaccinated as quickly as possible. Public health experts say the need to vaccinate people is especially urgent as a new and more contagious variant of the virus first detected in the United Kingdom is showing up in multiple states. Some states, including New York and California, have loosened their guidelines on who can get vaccinated after an outcry over health care providers throwing away doses that didn’t meet officials’ strict criteria.

The tiers “are simply recommendations, and they should never stand in the way of getting shots in arms instead of keeping vaccine in the freezer or wasting vaccine in the vial,” Health and Human Services Secretary Alex Azar said Jan. 6, referring to CDC guidelines saying health care workers and residents and staff of long-term care facilities should be first in line, then people at least 75 years old. The Trump administration this week also said it would make more shots available by releasing second doses and urged states to broaden rules to allow anyone 65 or older and any resident with a serious medical condition to get a shot.

Pfizer-BioNTech’s ultra-cold storage requirements have made it less ideal for local public health departments and rural areas.

Both of the available vaccines arrive in multidose vials — Pfizer-BioNTech’s contains about five doses, Moderna’s 10. Neither contains preservatives and they are viable for only six months frozen. By contrast, during the H1N1 pandemic roughly a decade ago, the swine flu vaccines lasted 18 weeks to 18 months, Sen. Chuck Grassley (R-Iowa) wrote in a May 2010 letter to then-HHS Secretary Kathleen Sebelius.

“We can’t get the vaccine out fast enough; we have people dying. But, at the same time, we have to get it right,” said Claire Hannan, executive director of the Association of Immunization Managers.

The added risk of losing doses due to quick expiration is another thing “causing angst,” Hannan said. “You can’t just draw it up and let it sit. It can’t just sit out like that.”

The Trump administration fell significantly short of its promise that 20 million Americans would be vaccinated by the end of December, partly the result of a disjointed and underfunded public health system that has received limited guidance from federal officials. As of Jan. 11, 25.5 million vaccine doses had been distributed nationwide but only 9 million administered, according to the CDC.

Federal officials have released sparse data about who is getting vaccinated, but state information has shown significant variation in vaccination rates depending on the facility. New York Gov. Andrew Cuomo on Jan. 4 said New York City’s public hospital system had used only 31% of its allocated vaccines, while private health systems NewYork-Presbyterian and Northwell Health had used 99% and 62%, respectively.

“When you target a priority group, it’s inefficient. When you open it up to a larger group, it’s efficient … but you’re not going to have enough supply,” Hannan said. “You still have the challenge of getting those health care workers vaccinated and no matter any way you slice it, you still have limited supply. You can’t please everyone.”

While Pfizer’s vaccine has largely been earmarked for large institutions like hospitals and nursing homes, Moderna’s has been more widely distributed to smaller sites like public health departments and clinics run by volunteers. State and local officials have begun or will soon vaccinate other priority populations, including police officers, teachers and other K-12 school employees, and seniors overall.

Unlike the covid vaccines, many flu vaccines come in prefilled syringes — each syringe’s cap is removed only when a shot is given, which speeds the process and eases some concerns about storage. However, relying on prefilled syringes during a pandemic has its own complications, according to Michael Watson, former president of Valera, a Moderna subsidiary: They take up more fridge space. They’re more expensive. And they can’t be used for frozen products, he said.

“For all these reasons, a vial was the best and only option,” he said.

In Ohio, Eric Zgodzinski, health commissioner for Toledo-Lucas County, said two-thirds of first responders the county surveyed said they would get the vaccine. Still, he said, his department has encountered situations in which a covid vaccine dose is left over in an open vial and officials have turned to a waiting list to find someone who can arrive within minutes to get a jab.

His department also has an internal running list of potential vaccine takers, including health department staffers, people in congregate care settings or those who had scheduled vaccination appointments for later on.

“We’re not going to open up a vial for one individual and figure out nine other people right away,” said Zgodzinski, whose department planned to distribute 2,200 doses of the Moderna vaccine the week of Jan. 4.

“If I have one dose left, who can I give it to?” he added. “A shot in the arm for anybody is better than it being wasted.”

San Francisco editor Arthur Allen and senior correspondent JoNel Aleccia contributed to this report.

Is Your Covid Vaccine Venue Prepared to Handle Rare, Life-Threatening Reactions?

As the rollout of covid-19 vaccines picks up across the U.S., moving from hospital distribution to pharmacies, pop-up sites and drive-thru clinics, health experts say it’s vital that these expanded venues be prepared to handle rare but potentially life-threatening allergic reactions.

“You want to be able to treat anaphylaxis,” said Dr. Mitchell Grayson, an allergist-immunologist with Nationwide Children’s Hospital in Columbus, Ohio. “I hope they’re in a place where an ambulance can arrive within five to 10 minutes.”

Of the more than 6 million people in the U.S. who have received shots of the two new covid vaccines, at least 29 have suffered anaphylaxis, a severe and dangerous reaction that can constrict airways and send the body into shock, according to the Centers for Disease Control and Prevention.

Such incidents have been rare — about 5.5 cases for every million doses of vaccine administered in the U.S. between mid-December and early January — and the patients recovered. For most people, the risk of getting the coronavirus is far higher than the risk of a vaccine reaction and is not a reason to avoid the shots, Grayson said.

Still, the rate of anaphylaxis so far is about five times higher for the covid vaccines than for flu shots, and some of those stricken had no history of allergic reactions. In this early phase of the vaccine rollout, all the patients were treated in hospitals and health centers that could offer immediate access to full-service emergency care.

As states look to scale up distribution, the shots will be administered by a varied assortment of professionals at venues including drugstores, dental offices and temporary sites attended by National Guard troops, among others. Health officials say every site involved in the wider community rollout must be able to recognize problems and have the training and equipment to respond swiftly if something goes wrong.

“We are really pushing to make sure that anybody administering vaccines needs not just to have the EpiPen available but, frankly, to know how to use it,” said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, in a call with reporters. She was referring to a common epinephrine injector that many people with severe allergies carry with them. Those health care workers must also know the warning signs of the need for advanced care, she added.

Anaphylaxis typically occurs within minutes and can cause hives, nausea, vomiting, dizziness or fainting, and life-threatening problems such as low blood pressure and constricted airways. Initial treatment is an injection of epinephrine, or adrenalin, to reduce the body’s allergic response. However, severely affected patients can require intensive treatments including oxygen, IV antihistamines and steroids such as cortisone to save their lives. Community sites are unlikely to have these treatments on hand and would need quick access to emergency responders.

Anybody administering vaccines needs not just to have the EpiPen available, but, frankly, to know how to use it.

Dr. Nancy Messonnier, CDC

Scientists are still investigating what’s triggering the severe reactions to the Pfizer-BioNTech and Moderna mRNA vaccines. They suspect the culprit may be polyethylene glycol, or PEG, a component present in both vaccines that has been associated with allergic reactions.

Even as they call for education and support for providers, experts are urging the more than 50 million Americans with allergies — whether to foods, insect venom, medications or other vaccines — to be proactive about finding a venue that’s properly prepared. Before scheduling a vaccine, contact the site and ask pointed questions about its emergency precautions, said Dr. Kimberly Blumenthal, quality and safety officer for allergy at Massachusetts General Hospital.

“Ask the question: Do they have an anaphylaxis kit? Can they take vital signs?” she said. People who routinely carry EpiPens should remember to bring them when they are vaccinated, she added.

A CDC website details a list of equipment and medications that sites should have on hand and urges that all patients be observed for 15 minutes after vaccination or 30 minutes if they’re at higher risk for reactions. The list recommends — but does not require — that sites stock the more intensive treatments, such as IV fluids. People who experience severe reactions shouldn’t get the recommended second dose of the vaccine, the agency said.

“Appropriate medical treatment for severe allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of an mRNA COVID-19 vaccine,” the site says.

Still, that’s a tall order, given the scope of the vaccination effort. The federal government is sending vaccines to more than 40,000 pharmacy locations involving 19 chains, including CVS, Walgreens, Costco and Rite Aid. At the same time, dozens of pop-up inoculation sites are ramping up in New York City, and drive-thru clinics have been set up in Ohio, Florida and other states.

Drive-thru sites, in particular, worry allergists like Blumenthal, who said it’s crucial to recognize symptoms of anaphylaxis quickly. “If you’re in a car, are you going to have your windows open? Where are the medicines? Are you in a parking lot?” she said. “It just sounds logistically more challenging.”

Ask the question: Do they have an anaphylaxis kit? Can they take vital signs?

Dr. Kimberly Blumenthal, Massachusetts General Hospital

In Columbus, more than 2,400 people had been vaccinated by Jan. 6 at a drive-thru clinic set up at the Ohio Expo Center. No allergic reactions have been reported, according to Kelli Newman, a spokesperson for Columbus Public Health. But if they occur, she said, health officials are prepared.

“We have a partnership with our EMS and they are observing those being vaccinated for 15 minutes to make sure there are no adverse reactions,” Newman said in an email. “They have two EMS trucks available with emergency equipment and epinephrine, if needed.”

Similarly, representatives for CVS Health and Walgreens said they have the staff and supplies to handle “rare but severe” reactions.

“We have emergency management protocols in place that are required for all vaccine providers, which, following a clinical assessment, may include administering epinephrine, calling 911 and administering CPR, if needed,” Rebekah Pajak, a spokesperson for Walgreens, said in an email.

If the vaccine sites have appropriately trained staffers, plus adequate supplies and equipment, the vast majority of people should opt for the shot, especially as the pandemic continues to surge, said Dr. David Lang, immediate past president of the American Academy of Allergy, Asthma & Immunology and chairman of the department of immunology at the Cleveland Clinic.

“The overwhelming likelihood is that you won’t have anaphylaxis and the overwhelming benefit far exceeds the risk for harm,” Lang said.

Biden’s First Order of Business May Be to Undo Trump’s Policies, but It Won’t Be Easy

The party split in Congress is so slim that, even with Democrats technically in the majority, passing major health care legislation will be extremely difficult. So speculation about President-elect Joe Biden’s health agenda has focused on the things he can accomplish using executive authority. Although there is a long list of things he could do, even longer is the list of things he is being urged to undo — actions taken by President Donald Trump.

While Trump was not able to make good on his highest-profile health-related promises from his 2016 campaign — including repealing the Affordable Care Act and broadly lowering prescription drug prices — his administration did make substantial changes to the nation’s health care system using executive branch authority. And many of those changes are anathema to Democrats, particularly those aimed at hobbling the ACA.

For example, the Trump administration made it easier for those who buy their own insurance to purchase cheaper plans that don’t cover all the ACA benefits and may not cover preexisting conditions. It also eliminated protections from discrimination in health care to people who are transgender.

Trump’s use of tools like regulations, guidance and executive orders to modify health programs “was like an attack by a thousand paper cuts,” said Maura Calsyn, managing director of health policy at the Center for American Progress, a Democratic think tank. Approaching the November election, she said, “the administration was in the process of doing irreparable harm to the nation’s health care system.”

Reversing many of those changes will be a big part of Biden’s health agenda, in many cases coming even before trying to act on his own campaign pledges, such as creating a government-sponsored health plan for the ACA.

Chris Jennings, a health adviser to Presidents Barack Obama and Bill Clinton, said he refers to those Trump health policies as “bird droppings. As in you have to clean up the bird droppings before you have a clean slate.”

Republicans, when they take over from a Democratic administration, think of their predecessor’s policies the same way.

Though changing policies made by the executive branch seems easy, that’s not always the case.

“These are issue-by-issue determinations that must be made, and they require process evaluation, legal evaluation, resource consideration and timeliness,” said Jennings. In other words, some policies will take more time and personnel resources than others. And health policies will have to compete for White House attention with policies the new administration will want to change on anything from the environment to immigration to education.

Even within health care, issues as diverse as the operations of the ACA marketplaces, women’s reproductive health and stem cell research will vie to be high on the list.

A Guide to Executive Actions

Some types of actions are easier to reverse than others.

Executive orders issued by the president, for example, can be summarily overturned by a new executive order. Agency “guidance” can similarly be written over, although the Trump administration has worked to make that more onerous.

Since the 1980s, for example, every time the presidency has changed parties, one of the incoming president’s first actions has been to issue an executive order to either reimpose or eliminate the “Mexico City Policy” that governs funding for international family planning organizations that “perform or promote” abortion. Why do new administrations address abortion so quickly? Because the anniversary of the landmark Supreme Court abortion decision Roe v. Wade is two days after Inauguration Day, so the action is always politically timely.

Harder to change are formal regulations, such as one effectively banning Planned Parenthood from the federal family planning program, Title X. They are governed by a law, the Administrative Procedure Act, that lays out a very specific — and often time-consuming — process. “You have to cross your t’s and dot your legal i’s,” said Nicholas Bagley, who teaches administrative law at the University of Michigan Law School.

And if you don’t? Then regulations can be challenged in court — as those of the Trump administration were dozens of times. That’s something Biden officials will take pains to avoid, said Calsyn. “I would expect to see very deliberate notice and comment rule-making, considering the reshaped judiciary” with so many Trump-appointed judges, she said.

What Comes First?

Undoing a previous administration’s actions is an exercise in trying to push many things through a very narrow tube in a short time. Department regulations have to go not just through the leadership in each department, but also through the Office of Management and Budget “for a technical review, cost-benefit analysis and legal authority,” said Bagley. “That can take time.”

Complicating matters, many health regulations emanate not just from the Department of Health and Human Services, but jointly from HHS and other departments, including Labor and Treasury, which likely means more time to negotiate decisions among multiple departments.

Finally, said Bagley, “for really high-profile things, you’ve got to get the president’s attention, and he’s got limited time, too.” Anything pandemic-related is likely to come first, he said.

Some items get pushed to the front of the line because of calendar considerations, as with the abortion executive orders. Others need more immediate attention because they are part of active court cases.

“You have all these court schedules and briefing schedules that will dictate the timeline where they make all these decisions,” said Katie Keith, a health policy researcher and law professor at Georgetown University.

The Trump administration’s efforts to allow states to set work requirements for many low-income adults who gained Medicaid coverage under the Affordable Care Act’s expansion of the program is the highest-profile Trump action that falls into that latter category. The Supreme Court has agreed to hear a case challenging HHS approval of work requirements for Arkansas and New Hampshire in the next few months. Some Democrats are concerned about how the high court, with its new conservative majority, might rule, and the Biden administration will have to move fast if officials decide they want to head off that case.

But court actions also might help the Biden administration short-circuit the onerous regulatory process. If a regulation the new administration wants to rewrite or repeal has already been blocked by a court, Biden officials can simply choose not to appeal that ruling. That’s what Trump did in ending insurance company subsidies for enrollees with low incomes in 2017.

Allowing a lower-court ruling to stand, however, is not a foolproof strategy. “That raises the possibility of having someone [else] intervene,” said Keith. For example, Democratic attorneys general stepped in to defend the ACA in a case now pending at the Supreme Court when the Trump administration chose not to. “So, you have to be pretty strategic about not appealing,” she said.

Adding On?

One other big decision for the incoming administration is whether it wants to use the opportunity to tweak or add to Trump policies rather than eliminate them. “Is it undoing and full stop?” asked Keith. “Or undoing and adding on?”

She said there is “a full slate of ideologically neutral” policies Trump put out, including ones on price transparency and prescription drugs. If Biden officials don’t want to keep those as they are, they can rewrite them and advance other policies at the same time, saving a round of regulatory effort.

But none of it is easy — or fast.

One big problem is just having enough bodies available to do the work. “There was so much that undermined and hollowed out the federal workforce; there’s a lot of rebuilding that needs to done,” said Calsyn of the Center for American Progress. And Trump officials ran so roughshod over the regulatory process in many cases, she said, “even putting those processes back in place is going to be hard.”

Incoming officials will also have other time-sensitive work to do. Writing regulations for the newly passed ban on “surprise” medical bills will almost certainly be a giant political fight between insurers and health care providers, who will try to re-litigate the legislation as it is implemented. Rules for insurers who sell policies under the ACA will need to be written almost immediately after Biden takes office.

Anyone waiting for a particular Trump policy to be wiped from the books will likely have to pack their patience. But law professor Bagley said he’s optimistic it will all get done.

“One of the things we’ve grown unaccustomed to is a competent administration,” he said. “When people are competent, they can do a lot of things pretty quickly.”

KHN’s ‘What the Health?’: Georgia Turns the Senate Blue


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Surprise Democratic victories in Georgia’s two runoff elections this week will give Democrats control of the Senate, which means they will be in charge of both houses of Congress and the White House for the first time since 2010. Although the narrow majorities in the House and Senate will likely not allow Democrats to pass major expansions to health programs, it will make it easier to do things such as pass fixes for the Affordable Care Act.

Meanwhile, the speedy development and approval of vaccines to protect against covid-19 is being squandered by the lack of a national strategy to get those vaccines into people’s arms. Straightening out and speeding up vaccinations will be a major priority for the incoming administration of President-elect Joe Biden.

This week’s panelists are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Alice Miranda Ollstein of Politico and Mary Ellen McIntire of CQ Roll Call.

Among the takeaways from this week’s podcast:

  • The Georgia election results will make it easier for some of Biden’s Cabinet picks to be confirmed, including Xavier Becerra, his choice to head the Department of Health and Human Services.
  • Among the ACA fixes that congressional Democrats may seek is a restoration of a small penalty for people who do not have health coverage. That could negate the case before the Supreme Court now that was brought by Republican state officials.
  • One strategic error in the covid vaccine distribution efforts was that the release of the vaccine was not coupled with a major messaging campaign to explain what the vaccine does and dispel fears about it.
  • Late last month, a federal court blocked the Trump administration from implementing a plan to tie what Medicare pays for some drugs to the prices in other countries. It’s not clear if the Biden administration will continue the legal fight to keep the program, but the president-elect has suggested he is more interested in bringing down drug prices by negotiating with manufacturers.
  • The Trump administration has sued retail giant Walmart, alleging it unlawfully dispensed opioids from its pharmacies.

Also, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: The New York Times’ “One Hospital System Sued 2,500 Patients After Pandemic Hit,” by Brian M. Rosenthal

Alice Miranda Ollstein: Politico’s “Congress Using COVID Test That FDA Warns May Be Faulty,” by David Lim and Sarah Ferris

Mary Ellen McIntire: Bloomberg News’ “The World’s Most Loathed Industry Gave Us a Vaccine in Record Time,” by Drew Armstrong

Anna Edney: STAT News’ “How It Started: A Q&A With Helen Branswell, One Year After Covid-19 Became a Full-Time Job,” by Jason Ukman


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Listen: How Operation Warp Speed Became a Slow Walk

KHN Editor-in-Chief Elisabeth Rosenthal appeared on Diane Rehm’s “On My Mind” podcast on NPR to discuss the bottlenecks that have prevented doses of precious covid-19 vaccine from making it from drugmakers’ factories into patients’ arms. It didn’t have to be this way, she explains.

San Francisco Wrestles With Drug Approach as Death and Chaos Engulf Tenderloin

SAN FRANCISCO — In early 2019, Tom Wolf posted a thank-you on Twitter to the cop who had arrested him the previous spring, when he was homeless and strung out in a doorway with 103 tiny bindles of heroin and cocaine in a plastic baggie at his feet.

“You saved my life,” wrote Wolf, who had finally gotten clean after that bust and 90 days in jail, ending six months of sleeping on scraps of cardboard on the sidewalk.

Today, he joins a growing chorus of people, including the mayor, calling for the city to crack down on an increasingly deadly drug trade. But there is little agreement on how that should be done. Those who demand more arrests and stiffer penalties for dealers face powerful opposition in a city with little appetite for locking people up for drugs, especially as the Black Lives Matter and Defund the Police movements push to drastically limit the power of law enforcement to deal with social problems.

Drug overdoses killed 621 people in the first 11 months of 2020, up from 441 in all of 2019 and 259 in 2018. San Francisco is on track to lose an average of nearly two people a day to drugs in 2020, compared with the 178 who had died by Dec. 20 of the coronavirus.

As in other parts of the country, most of the overdoses have been linked to fentanyl, the powerful synthetic opioid that laid waste to the eastern United States starting in 2013 but didn’t arrive in the Bay Area until about five years later. Just as the city’s drug scene was awash with the lethal new product — which is 50 times stronger than heroin and sells on the street for around $20 for a baggie weighing less than half a gram — the coronavirus pandemic hit, absorbing the attention and resources of health officials and isolating drug users, making them more likely to overdose.

The pandemic is contributing to rising overdose deaths nationwide, according to the Centers for Disease Control and Prevention, which reported last month that a record 81,000 Americans died of an overdose in the 12 months ending in May.

“This is moving very quickly in a horrific direction, and the solutions aren’t matching it,” said Supervisor Matt Haney, who represents the Tenderloin and South of Market neighborhoods, where nearly 40% of the deaths have occurred. Haney, who has hammered City Hall for what he sees as its indifference to a life-or-death crisis, is calling for a more coordinated response.

“It should be a harm reduction response, it should be a treatment response — and yes, there needs to be a law enforcement aspect of it too,” he said.

Tensions within the city’s leadership came to a head in September, when Mayor London Breed supported an effort by City Attorney Dennis Herrera to clean up the Tenderloin by legally blocking 28 known drug dealers from entering the neighborhood.

But District Attorney Chesa Boudin, a progressive elected in 2019 on a platform of police accountability and racial justice, sided with activists opposing the move. He called it a “recycled, punishment-focused” approach that would accomplish nothing.

People have died on the Tenderloin’s needle-strewn sidewalks and alone in hotel rooms where they were housed by the city to protect them from covid-19. Older Black men living alone in residential hotels are dying at particularly high rates; Blacks make up around 5% of the city’s population but account for a quarter of the 2020 overdoses. Last February, a man was found hunched over, ice-cold, in the front pew at St. Boniface Roman Catholic Church.

The only reason drug deaths aren’t in the thousands, say health officials, is the outreach that has become the mainstay of the city’s drug policy. From January to October, 2,975 deaths were prevented by naloxone, an overdose reversal drug that’s usually sprayed up the nose, according to the DOPE Project, a city-funded program that trains outreach workers, drug users, the users’ family members and others.

Outreach groups in the Tenderloin distribute meals, substance abuse services and naloxone — a medication designed to rapidly reverse an opioid overdose. (Rachel Scheier)

“If we didn’t have Narcan,” said program manager Kristen Marshall, referring to the common naloxone brand name, “there would be no room at our morgue.”

The city is also hoping that this year state lawmakers will approve safe consumption sites, where people can do drugs in a supervised setting. Other initiatives, like a 24-hour meth sobering center and an overhaul of the city’s behavioral health system, have been put on hold because of pandemic-strained resources.

Efforts like the DOPE Project, the country’s largest distributor of naloxone, reflect a seismic shift over the past few years in the way cities confront drug abuse. As more people have come to see addiction as a disease rather than a crime, there is little appetite for locking up low-level dealers, let alone drug users — policies left over from the “war on drugs” that began in 1971 under President Richard Nixon and disproportionately punished Black Americans.

In practice, San Francisco police don’t arrest people for taking drugs, certainly not in the Tenderloin. On a sunny afternoon in early December, a red-haired young woman in a beret crouched on a Hyde Street sidewalk with her eyes closed, clutching a piece of foil and a straw. A few blocks away, a man sat on the curb injecting a needle into a thigh covered with scabs and scars, while two uniformed police officers sat in a squad car across the street.

Last spring, after the pandemic prompted a citywide shutdown, police stopped arresting dealers to avoid contacts that might spread the coronavirus. Within weeks, the sidewalks of the Tenderloin were lined with transients in tents. The streets became such a narcotics free-for-all that many of the working-class and immigrant families living there felt afraid to leave their homes, according to a federal lawsuit filed by business owners and residents. It accuses City Hall of treating less wealthy ZIP codes as “containment zones” for the city’s ills.

The suit was settled a few weeks later after officials moved most of the tents to designated “safe sleeping sites.” But for many, the deterioration of the Tenderloin, juxtaposed with the gleaming headquarters of companies like Twitter and Uber just blocks away, symbolizes San Francisco’s starkest contradictions.

Mayor Breed, who lost her younger sister to a drug overdose in 2006, has called for a crackdown on drug dealing.

The Federal Initiative for the Tenderloin was one such effort, announced in 2019. It aims to “reclaim a neighborhood that is being smothered by lawlessness,” U.S. Attorney David Anderson said at a recent virtual news conference held to announce a major operation in which the feds arrested seven people and seized 10 pounds of fentanyl.

Law enforcement agencies have blamed the continued availability of cheap, potent drugs on lax prosecutions. Boudin, however, said his office files charges in 80% of felony drug cases, but most involve low-level dealers whom cartels can easily replace in a matter of hours.

He pointed to a 2019 federal sting that culminated in the arrest of 32 dealers — mostly Hondurans who were later deported — after a two-year undercover operation involving 15 agencies.

“You go walk through the Tenderloin today and tell me if it made a difference,” said Boudin.

Hyde Street between Golden Gate and Turk is one of the Tenderloin’s most notorious blocks. Drugs are routinely sold and consumed in broad daylight, sometimes yards away from police officers. (Rachel Scheier)

His position reflects a growing “progressive prosecutor” movement that questions whether decades-old policies that focus on putting people behind bars are effective or just. In May, the killing of George Floyd by the Minneapolis police energized a nationwide police reform campaign. Cities around the country, including San Francisco, have promised to redirect millions of dollars from law enforcement to social programs.

“If our city leadership says in one breath that they want to defund the police and are for racial and economic justice and in the next talk about arresting drug dealers, they’re hypocrites and they’re wrong,” said Marshall, the leader of the DOPE Project.

But Wolf, 50, believes a concerted crackdown on dealers would send a message to the drug networks that San Francisco is no longer an open-air illegal drug market.

Like hundreds of thousands of other Americans who’ve succumbed to opiate misuse, he began with a prescription for the painkiller oxycodone, in his case following foot surgery in 2015. When the pills ran out, he made his way from his tidy home in Daly City, just south of San Francisco, to the Tenderloin, where dealers in hoodies and backpacks loiter three or four deep on some blocks.

When he could no longer afford pills, Wolf switched to heroin, which he learned how to inject on YouTube. He soon lost his job as a caseworker for the city and his wife threw him out, so he became homeless, holding large quantities of drugs for Central American dealers, who sometimes showed him photos of the lavish houses they were having built for their families back home.

Looking back, he wishes it hadn’t taken six arrests and three months behind bars before someone finally pushed him toward treatment.

“In San Francisco, it seems like we’ve moved away from trying to urge people into treatment and instead are just trying to keep people alive,” he said. “And that’s not really working out that great.”

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

Many Health Plans Now Must Cover Full Cost of Expensive HIV Prevention Drugs

Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.

Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every three months for lab work and clinic visits.

Luckily for Howard, his doctor at Las Vegas’ Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.

“If I hadn’t been able to get into the trial, I wouldn’t have kept taking PrEP,” said Howard, 68, using the shorthand term for “preexposure prophylaxis.” Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.

Starting this month, most people with private insurance will no longer have to decide whether they can afford to protect themselves against HIV. Most health plans must begin to cover the drugs then without charging consumers anything out-of-pocket (some plans already began doing so last year).

Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an “A” or “B” rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.

The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.

In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1,000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it’s not clear if insurers are required to pick up all those costs.

“Cost sharing has been a problem,” said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. “It’s not just getting on PrEP and taking a pill. It’s the lab and clinical services. That’s a huge barrier for folks.”

Whether you’re shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.

Q: How can people find out whether their health plan covers PrEP medications without charge?

The plan’s list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.

Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn’t owe anything out-of-pocket, no matter which tier they are on.

In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.

But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar’s coverage.

Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.

“I acted like a shopper of insurance, just like any person would do,” he said. “Even when the information is correct, [it’s so] difficult to find [and there’s] no uniformity.”

It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.

Q: Are all three drugs covered without cost sharing?

Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn’t require prior authorization by the insurer. But if someone wants to take the name-brand drug, they have to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.

Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?

That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have bloodwork every three months to test for HIV, hepatitis B and sexually transmitted infections, and to check their kidney function.

The task force recommendation doesn’t specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.

“If you’ve got a high-deductible plan and you’ve got to meet it before those services are covered, that’s going to add up,” said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. “We’re trying to emphasize that it’s integral to the intervention itself.”

A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.

There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn’t be charged for it.

CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. “CMS intends to contact state regulators, as appropriate, to discuss issuer’s compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing,” the agency said in a statement.

Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?

If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.

“They’d have to appeal to the insurance company and then to the state if they don’t succeed,” said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. “Most people don’t know to do that.”

Q: Are uninsured people also protected by this new cost-sharing change for PrEP?

Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don’t benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.

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