Hospitals enrolled in the 340B drug discount program may no longer be eligible after the pandemic shifted their payer mix, according to a Wednesday letter the American Hospital Association sent to HHS Secretary Xavier Becerra.
Depleted patient volumes and canceled elective surgeries lowered the proportion of hospital patients who are Medicaid and Medicare SSI patients in 2020, according to AHA. When hospitals file their Medicare cost reports reflecting those changes, they may no longer meet the criteria for the program and lose access.
AHA wants HHS to waive certain eligibility requirements for hospitals in the program to allow them continued access during the public health emergency, according to the letter.
Throughout the pandemic HHS has issued a number of regulatory flexibilities to help providers, and the hospital lobby is asking it to do so again by waiving the current eligibility requirements for the 340B drug discount program before providers experiencing a temporary shift in payer mix are kicked out.
The program requires drug companies to give discounts on outpatient drugs to providers serving a large share of low-income patients, particularly those in rural areas.
The discounts can range from 25% to 50% of the cost of the drugs, according to HRSA, which operates the program.
But many of those patients did not seek care last year, hampering hospitals’ finances and altering the mix of payers.
Hospitals currently qualify for the program based on their volume of inpatient Medicaid and Medicare SSI patients, reported through their most recently filed Medicare cost reports.
“Losing access to 340B discounted drugs and program savings could jeopardize the ability of these hospitals to provide critical services for their communities, which would be particularly catastrophic at a time when they remain on the front lines of the ongoing pandemic,” AHA said in its letter.
This latest issue comes after several years of clashes over the 340B program.
Last year, a federal appeals court sided against the hospital lobby, ruling that HHS’ significant rate cut for some 340B drugs could remain in place. HHS made the reimbursement cut arguing that the hospitals already received steep discounts for the drugs and could be incentivized to overuse them.
At the time, AHA said it was weighing its options over whether to appeal to the Supreme Court.
To head off other issues, HRSA finalized a rule late last year that created a dispute resolution process for when hospitals believed they were overcharged for 340B drugs. The drug manufacturers have a similar mechanism to raise concerns about whether hospitals received duplicate discounts.
Xavier Becerra narrowly won confirmation Thursday to lead the Department of Health and Human Services, the agency pivotal to President Biden’s urgent goal of defeating the coronavirus pandemic and expanding access to health care.
Becerra, a congressman from Los Angeles for two dozen years and then California attorney general, squeaked by on a vote of 50 to 49, the closest margin for any of the Biden cabinet members the Senate has confirmed so far.
He becomes the first Latino secretary of HHS, the largest federal department in terms of spending. The department includes agencies at the core of the federal response to the pandemic that has infected more than 29.5 million people in the United States and killed more than 535,000. They include the National Institutes of Health, the Centers for Disease Control and Prevention, the vaccine-approving Food and Drug Administration, and the Centers for Medicare and Medicaid Services, which oversees the country’s vast public insurance programs.
Sen. Ron Wyden (D-Ore.), chairman of the Senate Finance Committee, which considered the nomination, said that “after four years of going in reverse,” Becerra will make it “possible to go to drive and actually make progress for the American people, progress in terms of lowering the cost of health care.”
Republican Sen. John Barrasso (Wyo.), countered that Becerra is “an aggressive culture warrior from the radical left,” who is “out of touch with the views of the American people.” Barrasso noted that, as state attorney general, Becerra sued the Trump administration more than 150 times over immigration, environmental and health policies.
“In this time of crisis, our secretary of Health and Human Services may be the single most important member of the president’s cabinet,” Barrasso said, contending that “the president has chosen a nominee, no public health experience, extremely partisan record.”
Sen. Susan Collins (R-Maine) was the only member of the GOP to vote for Becerra’s confirmation along with a solid wall of Senate Democrats.
During his confirmation hearing last month before the Senate Finance Committee, Becerra said, “The mission of HHS — to enhance the health and well-being of all Americans — is core to who I am.”
In keeping with Biden’s emphasis on portraying his administration’s top rung as diverse and having working-class roots like his own, Becerra told the senators his immigrant parents had insurance through his father’s laborers union, making his family more fortunate when he was a boy than many of their neighbors.
As a longtime member of the House Ways and Means Committee, Becerra testified, he worked on several major pieces of health-care legislation, including the Children’s Health Insurance Program created in the late 1990s and changes to the way Medicare is run and financed, as well as the Affordable Care Act.
He did not mention that he was a longtime advocate of a single-payer health-care system, akin to the Medicare-for-all proposals backed by several Democratic candidates in last year’s presidential election, but rejected by Biden. Becerra has renounced his previous support since his nomination, echoing the president’s view that affordable insurance coverage should be widened by building upon the ACA.
Becerra, 63, became a lightning rod for conservatives immediately after Biden announced his selection in early December.
Senate Republicans targeted his defense of abortion rights. They contended he is unqualified because he is not a physician, though few HHS secretaries have had medical training. And they have denounced his previous advocacy of a larger government role in health insurance.
An undercurrent running through opposition to his nomination was Becerra’s leadership in recent years of a coalition of Democratic attorneys general fighting to preserve the ACA. Republicans, including President Donald Trump, are seeking to overturn the 2010 law in a case now before the Supreme Court.
Sen. James Inhofe (R-Okla.) lambasted Becerra, saying he has “an appalling track record disrespecting the sanctity of life. . . . He has no shame when it comes to his pro-abortion beliefs.”
Inhofe also criticized Becerra’s support last year for California’s ban on indoor worship services as part of the state’s efforts to slow the cornavirus’s spread. And the senator criticized Becerra’s position that undocumented immigrants should be allowed public benefits, such as Medicaid.
Senate Majority Leader Charles E. Schumer (D-N.Y.) said Republicans’ arguments against Becerra “almost verge on the ridiculous.”
Schumer said Republicans challenging Becerra’s qualifications for the job had embraced the nomination of Alex Azar as Trump’s second HHS secretary, though he was a pharmaceutical executive who also was an attorney and had no medical training.
In addition to working to tame the pandemic, which Biden has identified as the government’s job number one for now, Becerra will face many major decisions at the helm of the sprawling department over whether to continue or reverse policies established by the Trump administration.
CMS has already announced it was rescinding a significant Medicaid policy of the Trump era that had allowed states to require some residents to hold a job or be preparing for work to qualify for the safety-net insurance program. HHS officials are reviewing other Trump-era Medicaid policies.
Another HHS agency, the Administration for Children and Families, oversees the nation’s policies regarding welfare and unaccompanied children coming across the country’s borders — a flashpoint during the Trump administration.
The CDC, the government’s public-health agency, has been working to regain its footing and scientific moorings after repeated intrusions into its advice to the public by the Trump White House. The agency has been involved in the largest mass vaccination campaign in U.S. history to immunize the public against the coronavirus. And it is developing guidance on aspects of American life — and ongoing public safety measures — as research findings evolve for the virus and vaccine’s effects.
The FDA is in the thick of decisions about coronavirus vaccines, developed in record time, as additional manufacturers, such as AstraZeneca, have devised them and tested their safety and effectiveness. The three vaccines being given to about 2 million Americans a day — by Pfizer-BioNTech, Moderna and Johnson & Johnson — are being allowed so far for emergency use and have not yet secured full FDA approval.
Becerra almost certainly will continue to face hostility from social conservatives after his swearing in, expected Friday.
Roger Severino, who led HHS’s Office for Civil Rights during the Trump administration and created a division to promote “conscience and religious freedom,” is building an “HHS Accountability Project” within the conservative Ethics and Public Policy Center.
While at HHS, Severino tangled directly with Becerra during his tenure as attorney general of the nation’s most populous state, twice citing him in violation of federal laws for upholding California statutes involving abortion rights.
Severino said this week he believes those on the right might find common ground with Biden health officials on disability rights. But on matters of abortion and deference to religion, Severino said, “We will be watching.”
The Supreme Court announced Thursday it will no longer hear oral arguments later this month on an appeal over the controversial Medicaid work requirements program in New Hampshire and Arkansas.
Legal experts say the move likely means the case won’t be heard this term and possibly may not be heard at all, especially with the Biden administration signaling a different approach to work requirements.
“By taking the cases off the docket, the court is signaling that it won’t hear them this term and probably that it’ll never hear them at all,” University of Michigan Law Professor Nicholas Bagley told Fierce Healthcare.
A major question mark,though, is whether the court will vacate the decisions by several appellate courts that upheld lower court rulings that the programs should be struck down.
“If the Supreme Court is not going to vacate the D.C. Circuit ruling, that means the decision on the books is one that clearly explains why work requirements are not permitted under the Medicaid statute,” said Rachel Sachs, associate professor of law at Washington University, in an interview with Fierce Healthcare.
She added that it is unlikely for the case to come back and “extremely unlikely that this issue will return in the near future.”
The Biden administration asked the court back in February to cancel the oral arguments originally scheduled for March 29. The administration said in a filing that allowing the requirements to take effect won’t promote the objectives of Medicaid to extend health insurance to low-income people.
President Joe Biden’s Department of Justice called for the court to vacate judgments of appeals courts and remand the case back to the Department of Health and Human Services so it can finish a review of all the waivers.
Arkansas Attorney General Leslie Rutledge said in a statement back in February that the legal filing seeking the delay was a “politically motivated stunt designed to avoid a Supreme Court decision upholding a program that encourages personal responsibility while still providing healthcare coverage for those seeking gainful employment.”
Arkansas’ work requirements program was installed in 2018 and led to approximately 18,000 people losing Medicaid coverage before the program was struck down by a federal judge.
Appellate courts upheld judgments from lower courts that New Hampshire and Arkansas’ programs did not meet the objectives of the Medicaid program. The states appealed to the Supreme Court, which agreed to hear the cases late last year.
Court rulings have also struck down programs in other states including Kentucky and Michigan. Kentucky pulled its program in 2019 after a Democrat was elected governor.
Arkansas and New Hampshire’s attorneys general did not return requests for comment on the Supreme Court’s decision Thursday.
The payment gap was $63,000 for primary care doctors, $178,000 for medical specialists and $150,000 for surgeons.
Doctors who work for hospital outpatient facilities get much higher payments for their services from Medicare than doctors who practice independently, according to a new study.
The research, based on Medicare claims data from 2010-2016,found that the program’s payments for doctors’ work were, on average, $114,000 higher per doctor per year when billed by a hospital than when billed by a doctor’s independent practice.
Published in Health Services Research, results found that the amount Medicare would pay for outpatient care at doctors’ offices would have been 80% higher if the services had been billed by a hospital outpatient facility. In 2010, the average set of Medicare services independent doctors performed annually for patients was worth $141,000, but charging for the same group of services would have grossed $240,000 if a hospital outpatient facility billed for them.
The payment difference varied by specialty. The payment gap was $63,000 for primary care doctors, $178,000 for medical specialists and $150,000 for surgeons.
Moreover, the study found the differential grew over time. From 2010-2016, the average difference between hospital outpatient and private practice payments grew from 80% higher to 99% higher.
WHAT’S THE IMPACT?
The main reason for these large payment differences: facility fees. For each service a doctor performs, Medicare pays hospital outpatient facilities both a fee for the doctor’s work and a fee for the facility, whereas private practices receive only doctor fees.
Although the doctor fees are a bit lower in hospital outpatient locations, the facility fees more than make up for the difference, and the total payments to hospitals are reflected in higher doctor salaries and bonuses.
The Centers for Medicare and Medicaid Services has been trying to correct this imbalance for years with policies that would pay both sites the same amount. In 2015, the Bipartisan Budget Act authorized CMS to impose site-neutral payments but grandfathered existing hospital outpatient facilities. Later, CMS expanded the equal payments to other hospital outpatient facilities, but the American Hospital Association sued to overturn this regulation.
The groups filed for a petition for a rehearing, which was denied.
In February, the Supreme Court acknowledged the AHA’s request for judicial review. The government response was due by March 15, but on March 3, Norris Cochran, acting Secretary of Health and Human Service asked for an extension until April 14 to file the government’s response, according to court documents.
The significant difference between Medicare payments to hospital outpatient facilities and independent offices has encouraged hospitals and health systems to buy doctor practices, but the study noted that good research about this has been lacking up to now.
It found little evidence of a direct relationship linking the size of the pay gap between hospital outpatient facilities and independent offices, with hospitals buying doctor practices, in particular medical specialties. But it did find that doctors whose services had larger pay gaps were more likely to have a hospital buy their practice than doctors whose services had a smaller pay gap.
In an accompanying commentary, Dr. Michael Chernew of Harvard Medical School in Boston said the study had found that the ability of hospitals and employed doctors to earn more from Medicare had resulted in a greater amount of integration.
THE LARGER TREND
However, the authors pointed out that the Medicare payment difference is only one of many factors that have contributed to the huge increase in the share of doctors employed at hospitals over the past decade. For example, they found a higher probability of a doctor going to work for a hospital in highly concentrated hospital markets and rural areas.
Other studies, they said, have established that some health systems use integration with doctors’ offices as a bargaining chip with commercial health insurance plans. Also, some doctors may find that independent practice is less viable than it used to be for a variety of reasons.
It has also been suggested that many younger doctors prefer hospital employment to private practice because they crave economic security and work-life balance.
It’s been estimated that even the payments to hospitals vs. doctors could save CMS $11 billion over 10 years. But the paper illustrates that the payment disparities can also create broader market distortions because consolidation of hospitals and doctors’ offices has been shown to lead to higher prices overall.
The Medicare Act “prohibits Medicare payment for services that are not furnished within the United States,” according to the filing.
RemoteICU, a telemedicine provider group, is suing the Department of Health and Human Services and the Centers for Medicare and Medicaid Services for not reimbursing telehealth services provided by physicians who are located outside the United States, according to a federal lawsuit filed last week in Washington.
RICU wants reimbursement for telehealth services provided within the U.S., but not necessarily by a physician who lives within its borders.
The company employs physicians who live outside the country, but are U.S. board-certified critical-care specialists and licensed in one or more U.S. jurisdictions. With RICU’s telecommunications system, these physicians can provide critical-care services in U.S. hospital ICUs, the lawsuit said.
“Although RICU’s physicians live abroad, they serve as full-time, permanent staff members of the U.S. hospitals at which they serve patients,” the company said in the court filing.
“By employing U.S.-licensed intensivists who live overseas, RICU has enabled the American healthcare system to recapture talent that would otherwise be lost to it – and this has helped to alleviate the ongoing shortage of intensivists in American hospitals.“
However, after the company reached out to several officials from HHS and CMS, it was notified that Medicare could not reimburse the client hospitals for RICU’s services, because the Medicare Act “prohibits Medicare payment for services that are not furnished within the United States,” according to the filing.
The company is seeking a preliminary injunction to stop HHS and CMS from denying Medicare reimbursement for telehealth services on the basis of a provider’s physical location outside of the United States at the time of service.
WHAT’S THE IMPACT?
RICU claims that, by failing to reimburse for the critical care telehealth services provided by its physicians, HHS and CMS are causing “immediate harm both to RICU and to the public.”
It argues that it’s filling a gap in critical care that has been exacerbated by the pandemic.
“There remains [a] significant unmet need for critical care services, as desperately sick patients have overwhelmed ICU resources across the country,” RICU said in the court filing.
“In some cases, lack of adequate care can mean the difference between life or death. And one of the groups most at risk from death and serious illness due to COVID-19 is the elderly – the very same population that relies upon Medicare.”
Without reimbursement, RICU says that some of its current clients, as well as potential customers, will not be able to offer its services.
The company argues that this causes “significant, unrecoverable monetary damages” because tele-ICU providers that use physicians located within the U.S. are eligible for reimbursement and therefore have a competitive edge over RICU.
Further, it says that it has already begun losing business because of hospitals’ inability to receive Medicare reimbursement.
“The Critical Care Ban is causing irreparable harm to RICU, which is suffering ongoing financial and reputational harms that cannot be remedied in the future,” the court filing said.
“The balance of the equities favors an injunction, because Defendants have already admitted that there is a desperate medical need for the critical care that RICU would provide but for the Critical Care Ban.
“And, finally, preliminary injunction would be in the public interest because, across the United States, Americans stricken by the COVID-19 pandemic are in desperate need of critical care – a need that RICU can help meet. It is not hyperbole to say that the requested injunctive relief is in the public interest because it could save lives.”
Under the Biden Administration, the DOJ says the ACA can stand even though there is no longer a tax penalty for not having health insurance.
The Department of Justice, under the Biden Administration, has told the Supreme Court that it has changed its stance on the Affordable Care Act.
The DOJ previously filed a brief contending that the ACA was unconstitutional because the individual mandate was inseverable from the rest of the law.
Following the change in Administration, the DOJ has reconsidered the government’s position and now takes the position that the ACA can stand, even though there is no longer a mandate for consumers to have health insurance or face a tax penalty, according to a February 10 filing.
WHY THIS MATTERS
Hospitals and health systems support the change in position.
“Without the ACA, millions of Americans will lose protections for pre-existing conditions and the health insurance coverage they have gained through the exchange marketplaces and Medicaid. We should be working to achieve universal coverage and preserve the progress we have made, not take coverage and consumer protections away,” said American Hospital Association CEO and president Rick Pollack.
The Supreme Court is expected to return a decision before the end of the term in June.
THE LARGER TREND
The Supreme Court heard oral arguments on November 10, 2020 regarding whether the elimination of the tax penalty made the remainder of the ACA invalid under the law.
The DOJ sided with the Trump Administration and Republican states that brought the legal challenge, while 20 Democratic attorneys general supported the ACA and asked the court for quick resolution.
The American Hospital Association, other trade groups and individual hospitals filed petitions Feb. 10 asking the U.S. Supreme Court to reverse appeals court decisions in two cases involving outpatient payment cuts to hospitals.
One lawsuit hospitals are asking the Supreme Court to hear challenges HHS’ payment reductions in 2019 for certain outpatient off-campus provider-based departments.
Under the 2019 Medicare Outpatient Prospective Payment System final rule, CMS made payments for clinic visits site-neutral by reducing the payment rate for evaluation and management services provided at off-campus provider-based departments by 60 percent.
In an attempt to overturn the rule, the AHA, the Association of American Medical Colleges and dozens of hospitals across the nation sued HHS. They argued CMS exceeded its authority when it finalized the payment cut in the OPPS rule. They further claimed the site-neutral payment policy violates the Medicare statute’s mandate of budget neutrality.
HHS argued that under the Bipartisan Budget Act of 2015 it has authority to develop a method for controlling unnecessary increases in outpatient department services. Since “method” is not defined in the statute, the government argued its approach satisfies generic definitions of the term. U.S. District Judge Rosemary M. Collyer rejected that argument and set aside the regulation implementing the rate reduction in September 2019.
HHS filed an appeal in the case, and the appellate court reversed the lower court’s decision July 17.
The second lawsuit hospitals are asking the Supreme Court to hear challenges HHS’ nearly 30 percent cut to 2018 and 2019 outpatient drug payments for certain hospitals participating in the 340B Drug Pricing Program.
A district court sided with hospitals and found the payment reductions were unlawful. Two members of a three-judge panel of the U.S. Court of Appeals overturned that ruling in July.
The hospitals argue in both petitions that the Supreme Court should review the cases because of the “excessive deference” the appeals court gave to HHS’ interpretation of the respective governing statutes.
The owner of two pharmacies and a management company in Florida pleaded guilty Jan. 25 to his role in a $931 million healthcare fraud scheme. He is the seventh defendant to plead guilty in the scheme, according to the U.S. Justice Department.
Larry Smith pleaded guilty to conspiracy to commit healthcare fraud, and his sentencing is set for Oct. 25. In his written plea agreement, Mr. Smith admitted to conspiring with others to defraud pharmacy benefit managers into paying for fraudulent prescriptions. As part of the plea agreement, Mr. Smith agreed to pay restitution of $24.9 million and forfeit approximately $3.1 million.
An indictment charged Mr. Smith and others with a nationwide conspiracy to defraud pharmacy benefit managers by submitting $931.4 million in bills for fraudulent prescriptions purchased from a telemarketing company. After improperly soliciting patient information, the marketing companies received approvals through telemedicine prescribers then sold the prescriptions to pharmacies in exchange for kickbacks, said Derrick Jackson, special agent in charge at HHS’ Office of Inspector General in Atlanta.
In September 2018, HealthRight, a telemedicine company, and its CEO Scott Roix pleaded guilty to conspiracy to commit healthcare fraud for their roles in the scheme. They agreed to pay $5 million in restitution. Mr. Roix’s sentencing is scheduled for Oct. 25.
Mihir Taneja, Arun Kapoor, Maikel Bolos and Sterling-Knight Pharmaceuticals also pleaded guilty in December 2020, according to the Justice Department.
By the time President-elect Joe Biden takes the oath of office on Wednesday, more than 400,000 Americans will have died of covid-19 — a dismal milestone in the deadly pandemic.
Yet the crucial task he faces— rapidly distributing coronavirus vaccines to the American public — is one that most experts one year ago didn’t think would even be an option by this point. Few expected multiple vaccines to be approved within a year — a record for vaccine development, by any measure. And although the rollout has been criticized, Israel and Great Britain are the only major nations the United States lags in vaccinations per capita and its daily rate of immunizations has more than doubled in the past two weeks.
“You have my word: We will manage the hell out of this operation,” Biden said in a speech on Friday, announcing his own vaccination plan.
Regardless of whether one views the vaccine effort up to this point as a failure or success, this much is true: Biden and his new administration will face an enormous task, not only in getting the vaccines distributed but also in ramping up testing, convincing Americans to follow public health recommendations and responding to the economic fallout from the pandemic.
Here are six key promises Biden is making about his pandemic response:
1. Administer 100 million doses of coronavirus vaccine during the first 100 days of his administration.
Biden previously cited this as a goal. He reiterated it Friday while rolling out a broader plan for coronavirus vaccinations
The plan would require a rate of 1 million immunizations per day — and the United States isn’t too far away from that goal right now. Nearly 800,000 Americans are getting shots every day on average. That’s a considerable improvement from two weeks ago, when the daily rate was closer to 350,000.
The 100-shot goal is “absolutely a doable thing,” Anthony S. Fauci, direct of the National Institute for Allergy and Infectious Disease, told NBC’s Chuck Todd yesterday.
“The feasibility of his goal is absolutely clear; there’s no doubt about it,” Fauci said. “That can be done.”
But top Biden advisers are also cautioning ramping up immunizations will be gradual and will require lots of coordination.
“The first days of that 100 days may be substantially slower than it will be towards the end,” Michael Osterholm, a member of Biden’s covid-19 task force, told Stat News.“It’s not going to occur quickly … you’re going to see the ramp-up occurring only when the resources really begin to flow.”
2. Set up mass vaccination clinics.
By the end of his first month in office, Biden has promised to open 100 federally managed clinics to administer shots. According to his vaccination plan, these sites would be set up by the Federal Emergency Management Agency. The federal government would reimburse states for sending National Guard members to help run them.
Biden says he also wants to deploy mobile units to rural and underserved areas, along with boosting the role already being played by pharmacies in distributing shots.
This approach would diverge significantly from how things are being done now, with the Trump administration leaving it up to hospitals, doctors, pharmacies and state public health departments to administer the shots. Some cities and states have set up large vaccination sites, but many haven’t.
“Overall, the president-elect’s plan lays out a more muscular federal role than the Trump administration’s approach, which has relied heavily on each state to administer vaccines once the federal government ships them out,” Anne Gearan, Amy Goldstein and Laurie McGinley report.
“Many of the elements — such as seeking to expand the number of vaccination sites and setting up mobile vaccination clinics — were foreshadowed in a radio interview Biden gave last week and in an economic and health ‘relief plan’ he issued Thursday, which contains a $20 billion request of Congress to pay for a stepped-up campaign of mass vaccination,” our colleagues add.
3. Allow federally qualified health centers to directly access vaccines.
These community health centers — which receive higher government reimbursements but are required to accept all patients regardless of their ability to pay — are a core part of the nation’s safety net for low-income Americans.
Biden’s plan proposes a new program “to ensure [federally qualified health centers] can directly access vaccine supply where needed,” although here, too, it’s unclear exactly how that might work.
Under the Trump administration’s plan, these centers have been asked to enroll with state health departments as vaccine providers. States were then supposed to communicate to the federal government how many doses were needed and where they should go.
How well this is actually working is “all over the map,” said Amy Simmons Farber of the National Association of Community Health Centers. She said supplies vary from county to county and many health centers have received their supplies with little notice, making it challenging to prioritize and plan.
Farber declined to comment on the Biden plan, saying she doesn’t have a lot of details about it. But she’s “very encouraged by the recognition of the important role health centers have played in fighting the pandemic and the need to adequately resource them.”
4. Use the Defense Production Act to ensure plenty of vaccine supplies.
Several times over the course of the pandemic, President Trump has invoked the Defense Production Act, which allows the president to require companies to prioritize contracts deemed essential for national security.
Biden says he will invoke DPA to ensure a steady stream of these supplies, which include glass vials, stoppers, syringes, needles and the capacity for companies to rapidly fill vaccine vials and finish packaging them.
5. Sign executive actions to combat the virus.
Biden has promised a raft of executive actions in his first ten days as president, laid out over the weekend in a memo from incoming White House Chief of Staff Ron Klain. They’ll include a number of pandemic-related orders.
On Inauguration Day, Biden intends to issue a mask mandate on federal property and for interstate travel, while encouraging all Americans to wear masks for what he’s calling a “100 Day Masking Challenge.”
The following day, Thursday, he’ll sign executive orders aimed at helping schools and businesses reopen safely, expanding testing, protecting workers and establishing clearer public health standards. And on Friday, Biden will direct his Cabinet secretaries to take immediate action to deliver economic relief to families.
“President-elect Biden will take action — not just to reverse the gravest damages of the Trump administration — but also to start moving our country forward,” Klain wrote.
6. Launch a vaccine education campaign.
The memo says Biden will run a “federally-run, locally-focused public education campaign.”
“The campaign will work to elevate trusted local voices and outline the historic efforts to deliver a safe and effective vaccine as part of a national strategy for beating covid-19,” it says.
But the transition team hasn’t detailed how the education campaign might differ from one launched by the Trump administration last month.
The Department of Health and Human Services said it plans to spend $250 million on efforts to promote vaccine awareness. It kicked off the effort with a $150,000 buy on YouTube for ads that feature Fauci and Food and Drug Administration Commissioner Stephen Hahn.
States were anticipating a windfall after federal officials said they would stop holding back second doses. But the approach had already changed, and no stockpile exists.
When Health and Human Services Secretary Alex Azar announced this week that the federal government would begin releasing coronavirus vaccine doses that had been held in reserve for second shots, no such reserve existed, according to state and federal officials briefed on distribution plans. The Trump administration had already begun shipping out what was available, starting at the end of December, taking second doses for the two-dose regimen directly off the manufacturing line.
Now, health officials across the country who had anticipated their extremely limited vaccine supply as much as doubling beginning next week are confronting the reality that their allocations will remain largely flat, dashing hopes of dramatically expanding access for millions of elderly people and those with high-risk medical conditions. Health officials in some cities and states were informed in recent days about the reality of the situation, while others were still in the dark Friday.
Because both of the vaccines authorized for emergency use in the United States are two-dose regimens, the Trump administration’s initial policy was to hold back second doses to protect against manufacturing disruptions. But that approach shifted in recent weeks, according to the officials, who spoke on the condition of anonymity because they were not authorized to discuss the matter.
Operation Warp Speed, which is overseeing vaccine distribution, stopped stockpiling second doses of the Pfizer-BioNTech vaccine at the end of last year, those officials were told. Shipping of the last reserve doses of Moderna’s supply, meanwhile, began over the weekend.
The shift, in both cases, had to do with increased confidence in the supply chain, so Operation Warp Speed leaders felt they could reliably anticipate the availability of doses for booster shots — required three weeks later in the case of the Pfizer-BioNTech product and four weeks later under Moderna’s protocol.
But it also meant there was no stockpile of second doses waiting to be shipped, as Trump administration officials suggested this week. Azar, at a briefing Tuesday, said, “Because we now have a consistent pace of production, we can now ship all of the doses that had been held in physical reserve.” He explained the decision as part of the “next phase” of the nation’s vaccination campaign.
Those in line for their second shots are still expected to get them on schedule because second doses are prioritized over first shots and states are still receiving regular vaccine shipments. But state and local officials say they are angry and bewildered by the shifting directions and changing explanations about supply. Their anxiety was deepened by projections that a highly contagious virus variant would spread rapidly throughout the United States and as daily covid-19 deaths averaged 3,320 this week.
The health director in Oregon, Patrick M. Allen, was so disturbed that he wrote Azar on Thursday demanding an explanation. In his letter, he recounted how Gustave F. Perna, the chief operating officer of Operation Warp Speed, had “informed us there is no reserve of doses, and we are already receiving the full allocation of vaccines.”
“If true, this is extremely disturbing, and puts our plans to expand eligibility at grave risk,” Allen wrote. “Those plans were made on the basis of reliance on your statement about ‘releasing the entire supply’ you have in reserve. If this information is accurate, we will be unable to begin vaccinating our vulnerable seniors on Jan. 23, as planned.”
HHS spokesman Michael Pratt confirmed in an email that the final reserve of second doses had recently been released to states but did not address Azar’s comments, saying only, “Operation Warp Speed has been monitoring manufacturing closely, and always intended to transition from holding second doses in reserve as manufacturing stabilizes and we gained confidence in the ability for a consistent flow of vaccines.”
But the explanations by the federal government were conflicting. The 13 million doses made available for states to order this week — for delivery next week — represented “millions more” than in previous weeks, Pratt said. He also said states have not requested the full amount they have been allocated.
Guidance circulated Friday among HHS officials acknowledged, however, that “the notion that there is a large bolus of second doses that will be released to jurisdictions is not accurate.” And state and municipal health officials said their allocations for next week had increased only marginally, if at all.
Chicago Public Health Commissioner Allison Arwady said her city’s share had gone from about 32,000 doses to 34,000 doses. “I have stopped paying a whole lot of attention to what is being said verbally at the federal level right now,” she said.
Nirav Shah, the director of Maine’s Center for Disease Control and Prevention, said he learned only Friday, by calling his state’s designated contact at Warp Speed, that the reserve no longer existed.
Maine still plans to broaden vaccination next week to those 70 and older. “Who is in line will not change,” Shah said. “The velocity of that line will change because this bolus of doses that we intuited was coming based on Azar’s comments is not coming.”
In an email that reached some state officials Friday morning, Christopher Sharpsten, an Operation Warp Speed director, called it a “false rumor” that “the federal government was holding back vaccine doses in warehouses to guarantee a second/booster dose.”
In fact, that information had come fromAzar, who said Tuesday that the “next phase” of the country’s vaccination campaign involved “releasing the entire supply we have for order by states, rather than holding second doses in physical reserve.”
Azar’s comments Tuesday followed a Jan. 8 announcement by President-elect Joe Biden’s transition team that his administration would move to release all available doses rather than holding half in reserve for booster shots. Biden’s advisers said the move would be a way to accelerate distribution of the vaccine, which is in short supply across the country.
Azar initially said the Biden plan was shortsighted and potentially unethical in putting people at risk of missing their booster shots. When he embraced the change four days later, however, he did not say that the original policy had already been phased out or that the stockpile had been exhausted. Trump administration officials and Biden’s team alike have sought to reassure the public that increasing the pace of immunizations would not endanger booster shots.
Azar also signaled to states that they would soon see expanded supply, urging them to begin vaccinating adults 65 and older and those under 64 with high-risk medical conditions. Officials in some states embraced that directive, while others said that suddenly putting hundreds of thousands of additional people at the front of the line would overwhelm their capacity.
In subsequent conversations with state and local authorities, federal officials sought to temper those instructions, said people who participated in the conversations. Perna, for instance, spoke directly to officials in at least two of the jurisdictions receiving vaccine supply, explaining that allocations would not increase and that they did not have to broaden eligibility as they had previously been told, according to a health official who was not authorized to discuss the matter.
The revised instructions led some state and local officials to hold off on changes. One state health official noted that the updated eligibility guidance announced Tuesday did not appear on the website of the CDC, even though it was stated as federal policy by Azar and by Robert R. Redfield, the CDC director, in their remarks. Under the original recommendations, adults 65 and older and front-line essential workers were to comprise the second priority group, known as Phase 1b, after medical workers and residents and staffers of long-term-care facilities.
There was additional confusion from another change Azar announced this week — making allocation of doses dependent on how quickly states administer them. He originally said that would not take effect for two weeks.
But Connecticut Gov. Ned Lamont (D) on Thursday tweeted that federal officials had notified him that the state would receive an additional 50,000 doses next week “as a reward for being among the fastest states” to get shots into arms. West Virginia, meanwhile, which is moving at the fastest clip, according to CDC data, did not get any additional doses, said Holli Nelson, a spokeswoman for the state’s National Guard.
In a sign that the incentive structure may not be long-lived, a senior Biden transition official, speaking on the condition of anonymity to address ongoing deliberations, said this week that the team did not look kindly on a system that “punishes states.”
Biden has said he wants to see 100 million shots administered within his first 100 days — an aim that will depend on quickly accelerating the pace of immunization. Together, Pfizer and Moderna have agreed to sell 200 million doses to the United States by the end of March, which is enough to fully vaccinate 100 million people.