Monday Roundup

COVID-19 vaccine

Monday Roundup

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Medicare–
Photo by Sven Read on Unsplash

From the Omicron front, the Labor Department’s Employee Benefit Security Administration has released guidance for health plans and the Centers for Medicare and Medicaid Services has released guidance for consumers on the President’s mandate that health plans cover over the counter COVID tests for their members.

Basically, under this mandate guidance, if a health plan offers its members an online program to obtain the OTC Covid tests at no cost (for the test or shipping), then the plan can limit out of network reimbursement of OTC Covid tests to the lesser of the actual price or $12 per test. (Binax and Quickvue include two tests in a package. Consequently the maximum reimbursement for one package would be $24.)  

If a health plan plan does not offer such an online program, then it must reimburse member claims in full. (There is an section in the EBSA guidance on FWA issues.)

The guidance also allows the health plan to limit coverage of OTC Covid tests to eight tests per member / belly button per month.

The mandate takes effect this coming Saturday January 15. That’s not a lot of time for implementation. Also, in this regard, ECRI has issued a report on the usability of COVID at home antigen test kits.

On the COVID vaccine front, Medscape informs us that

The FDA on Friday shortened the time that people who received Moderna’s COVID-19 vaccine need to wait for a booster — from 6 months to 5 months.

That means Americans 18 years old and older who received their second shot of the two-dose Moderna vaccine at least 5 months ago can now get a third dose.

“The country is in the middle of a wave of the highly contagious Omicron variant, which spreads more rapidly than the original SARS-CoV-2 virus and other variants that have emerged,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. * * *

On Friday afternoon, Rochelle Walensky, MD, the director of the CDC, said she also approved of shortening the timeline for the Moderna booster dose, according to CNN. The CDC’s vaccine advisory committee recommended the FDA’s decision, and she signed off on it.

Last Wednesday, the government authorities approved the same six to five month reduction for the Pfizer vaccine.

Medscape adds that

Some Americans with a weakened immune system who face high risks for severe COVID-19 become eligible this week to receive a fourth dose of a coronavirus vaccine.

The CDC endorsed a third dose of the Pfizer or Moderna vaccines for moderately and severely immunocompromised people on Aug. 13, which is considered part of their first immunization series rather than a booster shot.

In October, the CDC said moderately and severely immunocompromised people could receive a booster shot, or a fourth dose of the vaccine, 6 months after their third dose.

But the CDC last week shortened the timeline to 5 months for a booster shot of the Pfizer or Moderna vaccines. That means immunocompromised people could begin signing up for a fourth shot later this week,  The New York Times reported.   

Bloomberg reports that

Pfizer Inc. is developing a hybrid vaccine that combines its original shot with a formulation that shields against the highly transmissible omicron variant, the drug giant’s top executive said. 

While research continues, Pfizer will evaluate the new hybrid formulation against an omicron-specific shot, and determine which is best suited to move forward by March, Chief Executive Officer Albert Bourla said at the JPMorgan Healthcare Conference on Monday. Pfizer will be ready in March to approach U.S. regulators for clearance of the modified vaccine and bring it to market, and it has already begun production, Bourla said.

Speaking of the JPMorgan Healthcare conference, being held this week, Fierce Healthcare offers a full report on other news from that event from earlier today.

Also, the FEHBlog suggests that his readers check out this week’s episode of Econtalk in which host Russ Roberts chats with Wall Street Journal reporter Greg Zuckerman about his recent book on the development of the COVID vaccines.

From the COVID treatment front, Bloomberg reports that

U.S. regulators may decide within a week or two whether to approve a shorter course of Gilead Sciences Inc.’s Covid-19 drug remdesivir that could be used for patients outside the hospital, Chief Executive Officer Daniel O’Day said in an interview.

A five-day course of the infused drug is already a mainstay for hospitalized Covid patients. Gilead has applied for U.S. clearance of a three-day course that could be used in the outpatient setting, after a big trial last year showed it could sharply reduce hospitalizations in at-risk patients. * * * Officials at the U.S. Food and Drug Administration “are working really collaboratively with us, quickly with us,” O’Day said in the interview. “Everything is moving really fast.” * * *

An an infused drug, remdesivir is more complicated to administer than the Pfizer Inc. Covid pill Paxlovid. But Gilead has an abundance of supply on hand, O’Day said in the interview. By contrast, supplies of Pfizer’s drug are limited in the short term as the company ramps up supply. * * *

Meanwhile, O’Day said that Gilead is working hard to develop a chemical cousin of remdesivir that could be given as a pill. That oral drug is about to begin human trials. If it works, it could be combined with other drugs to treat Covid, he said.

In interesting Medicare news, Healthcare Dive explains that

HHS Secretary Xavier Becerra has instructed CMS to reassess its recommendation for Medicare premiums this year after Biogen cut the price for its controversial Alzheimer’s drug Aduhelm in half.

CMS in November published a historic 14.5% hike in monthly premiums for outpatient care in 2022 — the program’s largest premium increase ever. One of the factors regulators cited for the increase was uncertainty over the cost of Aduhelm, a new and pricey drug that has raised eyebrows for unclear effectiveness.

It’s an unusual step for HHS, given the plan year has already begun, and comes just days before a CMS deadline to issue a draft decision that will shape Aduhelm coverage nationwide.

Given Medicare’s shaky financial position, one wonders why the HHS Secretary is interested in turning away additional revenue.

STAT News adds

Biogen cut the price of Aduhelm nearly in half from $56,000 a year to $28,200 in December following disappointing sales, a price some still maintain is higher than necessary. Despite the pharma giant’s high hopes for the drug, other healthcare operators have proved less certain of its efficacy.

A number of health systems have said they wouldn’t prescribe the drug to patients. Meanwhile, most major payers are waiting on CMS to issue a national coverage determination before deciding whether to cover the expensive drug.

CMS is currently hammering out a single, nationwide policy for all amyloid-targeting treatments for Alzheimer’s, which purport to slow dementia by reducing clumps of plaque in the brain. * * *

Another major variable is which patients will be eligible to receive Aduhelm, which is still unknown. Medicare is scheduled to release a draft coverage decision that could make or break the drug’s future by Wednesday. Officials are not supposed to consider a drug’s cost in deciding whether to cover it for Medicare beneficiaries.

The final coverage decision, which is scheduled to be released by April 12, could cause significant changes in how much Aduhelm could cost the Medicare program, depending on how much patient access is restricted by diagnostic test results, which physicians could prescribe the drug or other limitations.

Friday Stats and More

David Ermer–ACA, CMS, COVID vaccine mandate, COVID-19, COVID-19 vaccine, SCOTUS, U.S. Healthcare–

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog chart of weekly new COVID cases for the end of June 2021 through the first week of 2022:

Omicron has produced a staggering number of new COVID cases while the number of weekly new COVID deaths has remained with a stable range for several months.

The Wall Street Journal offers an lab test based explanation for Omicron’s mild nature:

The threat posed by the Omicron variant has now come into sharper focus, with recent clinical data and laboratory studies lending support to early reports suggesting that it is milder but more transmissible than other variants of the new coronavirus.

“It spreads very, very fast, but it doesn’t appear to have the virulence or machismo to really pack as much of a wallop as the Alpha or Delta variants,” James Musser, chairman of Houston Methodist Hospital’s pathology and genomic medicine department and the leader of a new study of Omicron infections, said of the variant.

Recent laboratory studies suggest that Omicron’s lower virulence may reflect its apparent tendency to thrive in cells in the upper respiratory tract rather than in the lungs, where Covid-19 infections can cause potentially fatal breathing problems.

That’s a reassuring tidbit.

Here’s the FEHBlog’s weekly chart of COVID vaccinations from the 51st week of 2020 through the 1st week of 2022:

Throughout the holiday period the number of administered vaccinations averaged six million which is impressive. Nearly two thirds of Americans aged five years and older are fully vaccinated and half of Americans aged 50 and older also have received a booster.

Here are a link to the CDC’s interpretation of its COVID statistics and a link to the CDC’s Fluview.

From the Supreme Court front, the Wall Street Journal reports that

A majority of Supreme Court justices expressed skepticism Friday of the Biden administration’s Covid-19 vaccine-or-testing plan for large employers but somewhat less concern about a vaccination mandate for healthcare workers, in a special [four hour long] session that examined the scope of the federal government’s powers during a fast-moving pandemic.

The Court focused its attention whether the issuing agency has necessary authority to issue its broad mandate. The Court should issue a decision within a month. The Wall Street Journal adds

The Supreme Court took up the vaccine lawsuits with alacrity, acting shortly before Christmas to add a rare Friday argument to its docket, ahead of the year’s first scheduled cases. Some parts of the OSHA rules begin to take effect next week, though the agency is waiting until next month to enforce Covid-19 testing requirements. Several justices signaled the court would seek to rule quickly—and potentially could put the requirements for private employers on hold temporarily for at least a few days to give themselves time to digest the case.

From the Medicare front, the Centers for Medicare and Medicaid Services released a proposed rule with 2023 updates to the Medicare Advantage and Medicare Part D programs. Here are links to the CMS fact sheet and a Fierce Healthcare article on this development. Of note, Fierce Healthcare tells us that

The proposal takes a major aim at price concessions that Part D plans extract from drug makers, but does not affect rebates negotiated between drug makers and insurers. Under the concessions, the plan pays less money to a pharmacy if it doesn’t meet several metrics. CMS is concerned, however, that the end-user doesn’t know about the arrangement and the lower prices are not passed on at the point-of-sale.

The proposed rule also said that the negotiated prices “typically do not reflect any performance-based pharmacy price concessions that lower the price a sponsor ultimately pays for the drug.”

The proposed rule wants to require all Part D plans to apply the concessions at the pharmacy counter.

Fierce Healthcare also calls attention to the November 2020 Kaufmann Hall report on hospital service utilization.

Hospital volumes softened in November overall as operating margins remain depressed, signaling that once again consumers could be delaying or avoiding care due to the pandemic, a new report from consulting firm Kaufman Hall found.

The firm released Tuesday its latest hospital flash report detailing revenues and volumes for November before the omicron-fueled surge of COVID-19 took hold. The report found hospitals are still facing major pressures from rising expenses and labor shortages. * * *

Kaufman found that hospital volumes softened in November, with discharges dropping nearly 5% and adjusted discharges by 3.9% compared to the month before. Discharges were also down 6.1% compared with pre-pandemic levels.

Meanwhile, the average length of stay at hospitals increased by 0.8% compared to October and 8.6% compared with November 2019.

The report estimates consumers could be postponing non-COVID-19 care.  

“The potential impact of the omicron variant in future months may influence this trend further,” Kaufman’s analysis said.

Midweek update

David Ermer–COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM, Rx coverage–
Photo by Josh Mills on Unsplash

From the Omicron front —

  • David Leonhardt, writing in the New York Times, informs us that while the surge of Omicron cases is stressing hospitals, Omicron has created less hospitalizations, milder hospitalizations, and fewer deaths compared to the Delta variant which Omicron replaced.
  • Becker’s Hospital Review reports that “The national surge in COVID-19 cases fueled by the highly transmissible omicron variant may last weeks, rather than months, according to the most recent projections from the COVID-19 Scenario Modeling Hub, a consortium of researchers helping the CDC track the pandemic’s trajectory.”
  • Medscape offers expert opinions on whether the current Omicron surge will hasten the transition from pandemic to endemic. For example —

Whether the current surge will mean the predicted switch to endemic COVID-19 will come sooner, however, “is very hard to predict,” Michael Lin, MD MPH, told Medscape Medical News.

“It’s an open question,” he said, “if another highly transmissible variant will emerge.”

On a positive note, “at this point many more people have received their vaccinations or been infected. And over time, repeated infections have led to milder symptoms,” added Lin, hospital epidemiologist at Rush Medical College in Chicago, Illinois.

“It could end up being a seasonal variant,” he said.

On the COVID vaccine front, AHIP tells us that

Today the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP) recommended a single Pfizer-BioNTech COVID-19 vaccine booster dose for persons aged 12-17 years at least 5 months after their primary series, by a vote of 13-1.

The Committee reviewed real-world data from Israel and the CDC showing there are no new safety concerns following a booster in this population, and that adverse events were less common from a 3rd dose as compared to the primary series.

Members of the Committee also stressed the primary focus continues to be vaccination of unvaccinated individuals, and that there is a need to increase education and understanding of the effects of COVID-19 on children and adolescents in order to help parents make informed decisions.

The FDA noted that it continues to review data on children aged 5-11 and will update recommendations when more data is available.

On the COVID testing front, Bloomberg offers a comprehensive look at the state of the Biden Administration’s efforts to improve availability of rapid at home COVID tests. Of note to health plans —

Private insurers will reimburse for at-home tests beginning at some point next week, when a Biden administration rule is set to take effect. That will allow Americans to submit claims, and could spark an initial spike in demand. But it remains to be seen whether people will take advantage of the reimbursement as filing insurance claims can be a time-consuming and tedious task.

In the FEHBlog’s view the Affordable Care Act converted health plans into public utilities. Aside from the wisdom of imposing this public health responsibility on health plans, this approach does not make sense due to the high administrative cost of processing paper claims. It will become a side show.

On the COVID treatment front, STAT News reports that

The Biden administration doubled its order of Covid-19 pills from Pfizer, a move that will modestly increase the limited U.S. supply of the treatment in the short term amid a record-setting surge in coronavirus cases, The New York Times writes. The new order will eventually provide enough pills for an additional 10 million Americans, bringing the government’s total order of the drug to 20 million treatment courses. But they will not all be available right away. Only 35,000 of the additional courses will be delivered this month, and 50,000 more in February, supplementing 350,000 treatment courses that were already expected over the next two months.

From the COVID vaccine mandate front, Govexec reports that the Postal Service has asked the Occupational Health and Safety Administration for “a 120-day extension to implement the [vaccinate or test] rule, saying that would allow enough time to update its systems for record collection and bargain with its unions over the details.”

From the Rx coverage front

  • Reuters reports that “Pfizer Inc  and Germany’s BioNTech SE  will develop an mRNA-based vaccine for viral infection shingles, collaborating for the third time after th success of their COVID-19 vaccine based on the same technology.
  • Healthcare Dive offers its observations on where drug prices are headed this year.
  • Biopharma Dive identifies five Food and Drug Administration approval decisions to watch in the first quarter of 2022.
  • In related news, mHealth Intelligence tells us that

“Researchers from the University of Massachusetts Amherst, Syracuse University and SUNY Upstate Medical University have collaborated to create a wireless sensor designed to prevent opioid relapses and overdoses. * * *

The opioid epidemic has steadily worsened across the country since the late 1990s. In 2019, nearly 50,000 people in the U.S. died from opioid-related overdoses, according to data from the National Institute on Drug Abuse. Further, around 21 to 29 percent of patients prescribed opioids for chronic pain misuse them, the federal data shows.  

To combat this issue, the research team — headed by Tauhidur Rahman, PhD, an assistant professor in the College of Information and Computer Sciences at UMass Amherst and co-director of the MOSAIC Lab — is developing a sensor, which will use machine learning to pinpoint psychophysiological signs in real time and determine whether they are consistent with opioid cravings. Cravings are one of the main drivers behind relapses and overdoses.

If a craving is identified, the sensor providers the user with mindfulness-based interventions. These ultimately could be customized based on the user’s behaviors and clinician input.

“Nothing like this exists today,” Rahman said in the news release. “And we believe that mobile technologies can provide an effective mechanism for people with addiction to monitor their condition and manage their cravings better.”

Cool.

From the OPM front, Govexec reports that

The Office of Personnel Management is set to publish regulations implementing a 2021 law aimed at improving agency accountability for acts of discrimination and whistleblower retaliation against federal workers.

The Elijah E. Cummings Federal Employee Antidiscrimination Act, named for the late lawmaker who led the House Oversight and Reform Committee and signed on Jan. 1, 2021, encourages agencies to take action against federal employees who are found to be responsible for “intentional” acts of discrimination or retaliation, and be more transparent with the public when such incidents are adjudicated.

In a proposed rule set to be published to the Federal Register Thursday, OPM said that [among other new requirements] agencies will be expected to post a notification on their public-facing websites within 90 days of the finalization of any case in which the agency was found to have discriminated or retaliated against a federal employee.

Tuesday’s Tidbits

David Ermer–ACA, CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Lots of updates from the Centers for Disease Control (“CDC”) today

  • “Today, CDC is updating our recommendation for when many people can receive a booster shot, shortening the interval from 6 months to 5 months for people who received the Pfizer-BioNTech COVID-19 Vaccine.  This means that people can now receive an mRNA booster shot 5 months after completing their Pfizer-BioNTech primary series.  The booster interval recommendation for people who received the J&J vaccine (2 months) or the Moderna vaccine (6 months), has not changed.”
  • The CDC released a study of over 40,000 COVID- vaccinated pregnant women.

In a retrospective cohort of >40,000 pregnant women, COVID-19 vaccination during pregnancy was not associated with preterm birth or small-for-gestational-age at birth overall, stratified by trimester of vaccination, or number of vaccine doses received during pregnancy, compared with unvaccinated pregnant women.

These data support the safety of COVID-19 vaccination during pregnancy. CDC recommends COVID-19 vaccination for women who are pregnant, recently pregnant, who are trying to become pregnant now, or who might become pregnant in the future.

  • As expected, the CDC revised and lengthened its revised COVID quarantine and isolation policy by, e.g., adding “at home testing when available,” right at the time that at home COVID test are hard to purchase. What’s more, the Wall Street Journal reports the prices for those tests are jumping at Walmart and Kroger because the White House curiously let a price support program lapse. Govexex informs about how government agencies had been struggling to implement this CDC guidance even before today’s changes.

Also from the Omicron front, Medscape tells us about a British study finding that

Protection against hospitalization from COVID-19 vaccines is “good” against the Omicron variant of SARS-CoV-2, an analysis has found.

The risk for adults of being admitted to hospital with Omicron was approximately one third (Hazard Ratio 0.33, 95% CI 0.30 to 0.37) of that for the Delta variant, the UK Health Security Agency (UKHSA) said in a technical briefing.

The analysis also found that the risk of presentation to emergency care, or being admitted to hospital, with Omicron – whether testing for symptomatic or asymptomatic infection – was approximately half of that for Delta (Hazard Ratio 0.53, 95% CI 0.50 to 0.57).

From the Affordable Care Act front – –

  • The International Foundation of Employee Benefit Plans announced that “The Centers for Medicare and Medicaid Services (CMS) issued the proposed 2023 actuarial value (AV) calculator and methodology.” This should be useful when preparing FEHB 2023 benefit and rate proposals.
  • The Labor Department’s Employee Benefit Security Administration announced that it is seeking speakers to talk at an ACA listening session about the ACA’s provider non-discrimination provision, known as Section 2706. In Division BB of the Consolidated Appropriations Act of 2021, Congress tasked the ACA regulators with adopting a rule interpreting Section 2706. The listening session bears on that effort.

From the healthcare business front

  • Fierce Healthcare tells us that “Centene Corporation has completed its acquisition of Magellan Health, the insurer announced Tuesday. The $2.2 billion deal closes exactly one year after its announcement on Jan. 4, 2021. The combination will create one of the country’s largest behavioral health platforms, including 41 million unique members. * * * In addition to its behavioral health platform, Magellan will add 5.5 million members to Centene’s government program, 16 million pharmacy members and 2 million pharmacy benefit management members.”
  • Healthcare Dive reports that “HCA Healthcare has purchased the largest urgent care chain in Florida, MD Now Urgent Care, the health system said Tuesday. The deal closed at the end of 2021 for an undisclosed sum. The deal gives HCA 59 urgent care centers in a state where it already has a significant presence, with 47 hospitals.” 

From the tidbits department

  • STAT News interviews Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “[2022] will have to be a year where we transition to working alongside the pandemic, as opposed to being dominated by the pandemic,” Dr. Marks told STAT in a wide-ranging interview. Let’s hope so.
  • Medpage Today brings us up to date on Biogen’s Aduhelm saga and considers 2022 biggest hurdles for heathcare in the U.S.
  • The new acting National Institutes of Health director Dr. Larry Tabak is continuing the tradition of writing a weekly director’s blog. This week’s issue concerns science’s 2021 breakthroughs, e.g., the COVID pills.

Monday Roundup

David Ermer–ACA, COVID-19, COVID-19 testing, COVID-19 vaccine, No Surprises Act, Rx coverage–
Photo by Sven Read on Unsplash

From the Omicron front, the Wall Street Journal reports that

The seven-day average of daily reported Covid-19 cases in the U.S. reached a pandemic record 403,385 on Sunday, according to a Wall Street Journal analysis of Johns Hopkins University data. The fresh peak arrived even as most states paused reporting during the New Year’s holiday weekend. Reporting delays will likely lead to spikes in reports of cases this week as states catch up. While Covid-19 tests remain in short supply in much of the U.S., Covid-19 testing was less robust last year, complicating comparisons between pandemic surges.

Hospitalizations for confirmed or suspected Covid-19 reached a seven-day average of 97,855 on Monday, according to data posted by the U.S. Department of Health & Human Services. That is up 41% in the past two weeks but below both the pandemic peak of 137,510 on Jan. 10, 2021, and the smaller peak of 102,967 on Sept. 4, 2021, during the Delta surge.

Bloomberg adds that

While omicron may be good at evading the attacks of antibodies, recent studies have also shown that it has far less success avoiding the second-line defenses of vaccines and prior infections: T-cells and B-cells.

T-cells are responsible for attacking a virus once it makes its way into the body’s cells if antibodies fail to prevent infection in the first place. In a recent study by Burgers and colleagues, scientists used white blood cells from Covid patients to show that about 70-80% of the T-cell response is preserved compared with previous strains of the virus. That means that for those who are either vaccinated or had a Covid infection in the past 6 months, it is likely their T-cells can recognize omicron and fight it off relatively quickly. 

This latest research will need to be followed up with further study. If it holds up to additional scrutiny, it just might explain why current infections appear to be more mild than in previous waves of the virus.

Yet, AP reports that

As the COVID-19 omicron variant surges across the United States, top federal health officials are looking to add a negative test along with its five-day isolation restrictions for asymptomatic Americans who catch the coronavirus, the White House’s top medical adviser said Sunday.

Dr. Anthony Fauci said the Centers for Disease Control and Prevention is now considering including the negative test as part of its guidance after getting significant “pushback” on its updated recommendations last week.

Adding to current mandatory testing is not going to push the COVID ball further toward endemic status particularly when people who actually may be infected soon will need a test to gain access to a COVID pill. It is time for the government to rethink its testing strategy. As a physician explained in a thought provoking Atlantic article

I will admit to being as self-interested as any other human. Despite recognizing the need for vaccine and test equity, I received three Pfizer shots as soon as I was eligible, and I’ve kept a stash of rapid-detection kits in my closet. But my own cognitive dissonance, and that of other privileged people, has become untenable in the face of Omicron’s case surge. Given the reality of our testing shortages, it’s time we started cutting back, where and when we can.

From the COVID vaccine front, AHIP tells us that

“Today the Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to expand the use of a single booster dose of the vaccine to include its use in individuals as young as 12 years of age.

“The FDA reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series. The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals.

“The amended EUA additionally:

  • Decreases the time between the completion of primary vaccination of the Pfizer COVID-19 Vaccine and a booster dose to at least five months.
  • Allows for a third primary series dose for certain immunocompromised children 5 through 11 years of age.

“Peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer COVID-19 Vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant. Authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant.

“Children 5 through 11 years of age who are fully vaccinated and are not immunocompromised do not need a third dose at this time, but the FDA will continue to review information and communicate with the public if data emerges suggesting booster doses are needed for this pediatric population.”

From the Health and Human Services Department front —

  • Prof. Katie Keith has published in the Health Affairs Forefront the third installment of her review of the proposed 2023 Notice of Benefit and Payment Parameters. This one focuses on the Affordable Care Act’s risk adjustment provisions.
  • The Department issued today its own upbeat discussion of the recently implemented consumer billing protections provided by the No Surprises Act.
  • While the ACA risk adjustment provisions don’t apply the FEHB, the consumer billing protections do. Indeed the consumer billing protections wisely apply to both insured and uninsured folks. All consumers should become familiar with these protections.

From the prescription drug front, STAT News informs us that

As 2022 gets under way, pharmaceutical companies have so far raised wholesale prices by a median of 4.9% on more than 450 prescription medicines, an overall annual increase that is comparable to the price hikes seen over the past three years, according to a new analysis.

The numbers are preliminary, though, because still more price increases are expected to be disclosed by drug makers later this month, since not every company has reported their latest prices to industry databases. Nonetheless, the early indication is that many drug makers are keeping price hikes in check due to ongoing bad publicity that has sparked sustained political pressure.

Analyzing pharmaceutical price hikes has become a ritual each January as drug makers boost prices to meet financial goals. But as poll after poll finds more Americans are complaining about the cost of prescription medicines, these companies have gradually shied away from mid-year increases and also generally limited price hikes below double digits in hopes of avoiding still more negative headlines.

Drug Channels adds

Reality has again failed to cooperate with the politically motivated cries of “skyrocketing drug prices” or anecdotes about companies “jacking up prices” 

Brand-name drug prices continue to decline, while the prices of other healthcare products and services continue to rise. For 2021, brand-name drugs’ net prices dropped for the fourth consecutive year. Meanwhile, brand-name drug list prices grew more slowly than overall inflation. What’s more, we project that the gross-to-net bubble for patent-protected brand-name drugs will exceed $200 billion in 2021. See our updated analysis [that may be found in the linked article]. 

The factors that drive declining brand-name drug prices remain for 2022, suggesting that these trends will continue. 

Thursday Stats and More

David Ermer–ACA, AHRQ, CDC, COVID-19, COVID-19 vaccine, No Surprises Act–

Based on the CDC’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s final weekly calendar for 2021 and it’s a stunner:

STAT News features a timely article captioned “Beyond Case Counts: What Omicron is teaching us.”

Brace yourself: Case counts are going to reach astounding heights. Already, reported infections have doubled in just a few weeks. The average daily number of infections is greater than 300,000. (It’s likely that our case counts will become increasingly less reliable as well, given both the shortcomings of our testing infrastructure and the growing use of at-home tests.)  

But, in large part because the immunological landscape today is far different than what it was two years ago, cases are less likely to result in severe disease than was the case at the start of the pandemic. 

Back then, a rise in cases inevitably led to an increase in hospitalizations and deaths. When vaccines went into wide use, those metrics started to become decoupled; cases could rise sharply but hospitalizations and deaths occurred at a lower level than before. In the current phase of the pandemic, the distance between those metrics is growing even greater. * * *

[A] key question relates to how long we’ll be in Omicron’s grasp. South Africa’s bellwether wave soared to extraordinary heights — then quickly began to ebb. Data from several European countries also suggest that Omicron waves may be short, sharp shocks compared to the waves that have preceded it. But too little is yet known to predict with any confidence whether the experience of a country with a relatively young population, such as South Africa, will hold true in a country with an older population, such as the United States. 

Here’s a link to the FEHBlog’s final weekly chart of new COVID deaths:

As cases have skyrocketed, deaths have ranged between 5,000 and 10,000 per week for over four months.

Here’s the FEHBlog’s weekly chart of new COVID vaccinations administered and distributed from the 51st week of 2020, when the vaccinations became available to the public, and the 52nd week of 2021:

The number of administered COVID vaccines has dropped during the holidays. Currently, 72.8% of Americans aged 18 and older are fully vaccinated and 36.3% of that cadre are boostered. Nearly 50% of Americans aged 50 and older are boostered.

Also from the COVID vaccine front, the Hill reports that

The Food and Drug Administration (FDA) is expected to approve booster shots of Pfizer and BioNTech’s COVID-19 vaccine for 12- to 15-year-olds on Monday, people familiar with the agency’s plan told The New York Times.

In addition to that broadened policy, the FDA also intends to announce that both children and adults could seek their booster shot five months after their second dose, instead of the previously advised six months. Immunocompromised children ages 5 to 11 are also expected to be allowed boosters, according to the Times.

The Times reported that the vaccine advisory committee for the Centers for Disease Control and Prevention (CDC) is set to meet next week to vote on approving the FDA’s policy changes, which CDC Director Rochelle Walensky is expected to endorse. 

From the No Surprises Act front, CMS has released a handy, comprehensive overview of the federal independent review process. Check it out.

From the Affordable Care Act front, Prof. Katie Keith writing in Health Affairs Forefront has released two of three articles on the ACA 2023 Notice of Benefit and Payment Parameters released earlier this week — link to Part 1 and link to Part 2. Part 1 includes a discussion of proposed changes to the medical loss ratio calculation and Part 2 discusses the standardized benefit requirements that the FEHB mentioned earlier this week.

From the health disparity front, the Agency for Healthcare Research and Quality issued its 2021 report on national healthcare qualities and disparities, the nineteen report in this series. Here’s a link to the report’s executive summary.

From the New Year’s Eve front, the New York Times made available this guidance:

“Many public health experts agree that you can celebrate with your favorite people as long as you’re taking precautions.
“To help you make a decision and gauge the level of risk, The Times has this quiz.”

Midweek update

David Ermer–ACA, CDC, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Patient safety, U.S. Healthcare–

From the Omicron front, the Washington Post reports that breakthrough Omicron cases are becoming the new normal in the U.S.

Long-anticipated holiday plans fell apart as people — young and old, vaccinated and unvaccinated — tested positive right and left. Those with negative tests worried it was only a matter of time.

They are likely right, according to Robert Frenck, professor of pediatrics and director of the Vaccine Research Center at the Cincinnati Children’s Hospital. “You know what? You’re probably going to get covid,” he said, but if you have been vaccinated you are unlikely to become seriously ill.

Oddly, in the FEHBlog’s view, the article does not mention the additional natural immunity gained from a mild case of Omicron.

STAT News raises three “big” questions about the Biden administration’s Covid response in 2022 —

1. Will the government broaden its focus beyond vaccines? STAT News explains that

Even before there were Covid-19 vaccines, there were commonsense tools used to prevent the disease from spreading: Wearing masks, and avoiding indoor gatherings with large numbers of other people.

But two years into the pandemic, the U.S. is still laser-focused on vaccines, and has largely ignored other factors. In particular, federal regulators haven’t done much to incentivize Americans to wear higher-quality face coverings, or to maintain better filtration and cleaner air in indoor spaces.

On the bright side, the FDA approved two new rapid over the counter COVID tests today on an emergency use basis. The more the merrier.

2. Will people who feel sick have better options for tests and treatments? STAT News explains rapid COVID tests are short in supply and pricey and the Biden Administration’s government solutions won’t be implemented for weeks. Similarly we have two exciting COVID pills which won’t be widely available for months.

3. Forget a third vaccine dose — will Americans need a fourth, too? To the FEHBlog that seems like a foregone conclusion.

From our other epidemic front, MedPage Today reports that

The volume of opioids dispensed from retail pharmacies fell by about 21% from 2008-2009 to 2017-2018, but cuts were not uniform, national prescription records showed.

Changes in opioid prescribing varied substantially by county, patient, and prescriber, reported Bradley Stein, MD, PhD, of the RAND Corporation in Pittsburgh, and co-authors in Annals of Internal Medicine. * * *

Per-capita morphine milligram equivalents (MMEs) fell by 22.6% in metropolitan counties and by 34.6% in counties with the highest rates of fatal opioid overdoses, the researchers found. In multiple counties, opioid prescribing increased over time. Some states had counties with both increases and substantial decreases, and these counties often were next to each other.

People 18 to 25 years old experienced the sharpest decrease in prescription opioids (66.6%) per capita, followed by those 26 to 35 (57%). Patients 56 to 65 had essentially no change (0.1% decline), while those 66 and older had a 12% drop.

People covered by commercial insurance had a 41.5% decline per capita. Those with Medicaid had a 27.7% reduction, and those with Medicare had a 17.5% drop.

MMEs plummeted by 70.5% among emergency physicians, even though these doctors are likely to prescribe opioids predominantly to people with acute pain, the researchers noted. The top two opioid prescribers, primary care physicians and pain specialists, also saw reductions in MMEs of 40% and 15.4%, respectively. MMEs fell by 49.3% among surgeons and by 59.5% among oncologists.

From the COVID vaccine mandate front, the Eleventh Circuit U.S. Court of Appeals which is hearing a challenge to a nationwide stay of the government contractor mandate (Case No.  21-14269), decided yesterday not to hear the case before the entire court rather than a three judge panel and today to decline the government’s request to accelerate the briefing and argument calendar. Consequently the stay will remain in effect at least through January 2022.

From the Federal Register front, the Department of Health and Human Services finalized its rescission of the Trump Administration’s most favored nation drug pricing rule. Smart move.

Thursday Stats and More

David Ermer–ACA, CDC, COVID treatment, COVID-19, COVID-19 vaccine, No Surprises Act–

Happy Festivus, dear readers. Because the FEHBlog won’t be posting on Christmas Eve or Christmas Day, he has moved up the COVID Stats report to today’s post. Therefore, the FEHBlog also wishes you a Merry Christmas

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new COVID cases for 2021:

Bloomberg notes that

The omicron variant’s case rate has now exceeded the worst days of the first delta-fueled wave, and more cities and countries are imposing precautions. But there’s more research showing it to be less severe than previous mutations. That said, two doses and a booster of the vaccine most widely used around the world isn’t enough to fight off omicron. China’s Sinovac shot didn’t produce sufficient levels of neutralizing antibodies, research found. Another study however showed a third dose of AstraZeneca’s vaccine, like that of Moderna and Pfizer-BioNTech, significantly boosts protection against the variant. 

Here’s the FEHBlog’s weekly chart of new COVID deaths which has operated within the same range for the past three months:

Finally, here’s the FEHBlog’s weekly chart of new COVID vaccinations distributed and administered from the 51st week of 2020 through the 51st week of 2021:

The number of COVID vaccines, including boosters, topped 500,000,000 today according to the CDC. 71% of Americans aged 12 and older are fully vaccinated and over one third of Americans aged 18 and older are boostered.

David Leonhardt in his New York Times’ Morning column offers an array of convincing statistics showing the importance of being fully vaccinated and boostered against COVID.

STAT News reports that

The Food and Drug Administration on Thursday granted emergency authorization to Merck’s molnupiravir, an antiviral pill shown to reduce hospitalization and death in cases of Covid-19, but only in cases where other FDA-authorized Covid treatments are not accessible or clinically appropriate.

The approval comes a day after the FDA authorized an antiviral pill from Pfizer for much broader use in patients as young as 12. 

“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

A Merck spokesperson said Merck is ready to ship hundreds of thousands of courses of treatment within days of authorization and 1 million courses over the next few weeks in the U.S. Ten million courses are ready to be packaged and distributed worldwide.

Bloomberg adds its perspective on the FDA’s EUAs of COVID pills yesterday and today.

The U.S. has cleared its first two Covid-19 treatment pills. Now comes the hard part: deciding who should get one. Merck’s molnupiravir was authorized Thursday by the Food and Drug Administration for use in some infected adults at high risk of severe illness. The U.S. will soon have 3 million courses of it available. Meanwhile, Pfizer’s Paxlovid, authorized earlier this week, showed stronger clinical trial data. But it will only be available in limited quantities at first, as Pfizer takes months to ramp up manufacturing. Regulators are signaling they prefer Pfizer’s pill, but concede Merck’s drug is better than nothing. Regardless, availability may depend on which state you live in. —David E. Rovella

In the linked article Bloomberg explains that

Just like Covid-19 testing sites and vaccines, Covid-19 treatment pills will be in short supply for months until production can increase.

The federal distribution to states will be based on population, and it will likely be up to doctors to prescribe Pfizer Inc.’s Paxlovid. The National Institutes of Health said it will release recommendations on how to allocate treatments.* * *

“Product will be limited at first and ramp up significantly in the coming months,” the department [of Health and Human Services] said. “An initial 65,000 courses of Paxlovid will be made available for shipment to states and territories and will begin arriving at dispensing sites by the end of December.”

The U.S. will have 265,000 Pfizer courses by the end of January and 10 million courses by July. It will also have 3 million of Merck & Co.’s Covid pill, developed with partner Ridgeback Biotherapeutics LP, by the end of January.

Doctors will be looking for the Merck and Pfizer pills to fill a gap for high-risk patients, who until now have been treated with monoclonal antibody therapies to keep them from needing hospital care.

Some of the most widely used antibody treatments from Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. appear far less effective against omicron than earlier variants because they target regions on the virus’s spike protein that have changed during its evolution.

In No Surprises Act (“NSA”) news —

  • The Centers for Medicare and Medicaid Services released FAQS for out-of-network providers who may be impacted by the NSA which takes effect on January 1, 2022.
  • The FEHBlog has been looking more deeply into the federal independent dispute resolution (“IDR”) process under this law. The IDR process allows an out-of-network provider with claims subject to the NSA to negotiate its payment with the health plan and if unsatisfied bring the payment issue to baseball arbitration using a CMS approved arbitrator. CMS has posted a list of the five currently approved organizations certified to conduct IDR arbitrations. The FEHBlog checked out a couple of these organizations and found out that at least two of them also are CMS approved independent review organizations (“IRO”) which decide health plan claim disputes under the Affordable Care Act. (In the FEHBP OPM acts as the IRO.)
  • The FEHBlog also learned that out-of-network providers who obtain patient consent to waive their NSA rights cannot access the IDR process on that consenting patient’s claims. Health plans will need to be on the lookout for the provider’s notice that the NSA rights waiver has been accepted by the patient / plan member. Here is a link to the consent form. In these cases which the FEHBlog expects to be relative few in number, the plan would pay the out-of-network provider using the ACA emergency care rules or the plan allowance for non-emergency services.
  • Generally only providers, e.g., primary surgeon, lead oncologist, who manage the patient’s care can seek patient consent to waive NSA rights. Ancillary providers, e.g., anesthesiologists, radiologist, pathologists, hospitalists, are locked into using the IDR process. This was a sound decision by the ACA regulators. Kaiser Family Foundation offers a useful compendium of these rules.
  • What’s more, Thompson Reuters reports that

HHS has released instructions for reporting data under a transparency provision included in the Consolidated Appropriations Act, 2021 (CAA , Division BB, Section 204), which requires group health plans and insurers to annually report prescription drug and health care spending, premiums, and enrollment information to the government

OPM has required FEHB carriers to comply with this reporting requirement via OPM’s reporting authority under the FEHB Act, 5 U.S.C. Sec. 8910. This strikes the FEHBlog as a bit of a stretch as Congress did not apply NSA Section 204 to the FEHBP in the NSA law and Section 8910 contemplates carriers providing reports to OPM. When FEHB carriers find themselves obligated to submit reports to HHS, a separate law outside the FEHB Act vests that authority in the other agency, e.g., Section 111 Medicare eligibility reporting to CMS. In any event, the enforcement deadline for the 2020 and 2021 reference year reporting under Section 204 is December 27, 2022.

Midweek Update / At Last a COVID Pill!

David Ermer–ACA, CDC, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, U.S. Healthcare–

From the Omicron front, STAT News reports that

The Food and Drug Administration on Wednesday authorized Paxlovid, a pill developed and made by Pfizer, as a treatment for Covid-19, a significant step in the battle against the SARS-CoV-2 virus.

The drug was authorized for use in people as young as 12 so long as they weigh at least 88 pounds.

The authorization of an oral antiviral to beat back Covid has been eagerly anticipated because such a medicine could reach large numbers of people infected with the virus and prevent them from becoming seriously ill or hospitalized. Existing medicines, such as monoclonal antibodies, must be given intravenously or as injections.

Still, initial supplies of Paxlovid will be limited. Pfizer has said it expects to produce more than 180,000 courses of the treatment this year. The company said Wednesday it now expects to provide 120 million courses by the end of 2022, up from 80 million previously, thanks in part to new contract manufacturers. Pfizer has contracted with the U.S. government to provide 10 million courses by the end of 2022 at a cost of $5.29 billion.

Once readily available, Paxlovid will be the answer to a positive COVID test, rather than 10 days of quarantine or hospitalization. Jingle bells, indeed.

Speaking of the FDA, MedPage Today informs us that

The FDA approved the first monotherapy for bipolar-related depressive episodes, Intra-Cellular Therapies announced Monday.

The atypical antipsychotic lumateperone (Caplyta) gained an indication for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. It was first approved for adults with schizophrenia in December 2019. * * *

“The efficacy, and favorable safety and tolerability profile, make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients,” said Roger McIntyre, MD, of the University of Toronto, in a statement released by the manufacturer. “Caplyta is approved for a broad range of adult patients including those patients with bipolar II depression who have been underserved with limited treatment options.”

Switching back to the Omicron front, the Wall Street Journal reports that

New data from Scotland and South Africa suggest people infected with the Omicron variant of coronavirus are at markedly lower risk of hospitalization than those who contracted earlier versions of the virus, promising signs that immunity as a result of vaccination or prior infection remains effective at warding off severe illness with the fast-spreading strain.

The findings begin to fill in unknowns around the severity of the disease caused by Omicron, a major variable critical to health authorities around the world as they gauge how to react to the new variant.

Scientists are still unsure how the positive findings around hospitalizations will stack up against another major variable: Omicron’s much increased transmissibility. Both variables are likely to change depending on local conditions, such as the proportion of the population that has been vaccinated against Covid-19.

“This is a qualified good news story,” said Jim McMenamin, incident director for Covid-19 at Public Health Scotland, and one of the authors of the Scottish study, at a briefing. “It’s important we don’t get ahead of ourselves. A smaller proportion of a much greater number of cases can still mean a substantial number of people that might experience severe Covid infections that could lead to hospitalization.”

From the COVID vaccine mandate challenge front, the Journal also tells us that

The Supreme Court on Wednesday said it would hold fast-track oral arguments early next month to consider whether the Biden administration can enforce Covid-19 vaccine-or-testing rules for large private employers, as well as vaccine requirements for many healthcare workers.

The cases, set for argument on Jan. 7, could go a long way to determining how much latitude the administration has to combat the coronavirus pandemic in the workplace.

The high court issued a pair of short, written orders to schedule the arguments, in response to a growing pile of emergency appeals asking the justices to intervene.

The cases haven’t yet been fully litigated in the lower courts; the Supreme Court will be deciding whether the Biden administration rules can be implemented for now. But practically speaking, the court’s decision is likely to determine whether the requirements survive. 

Curiously, it does not appear that the stay of the government contractor mandate will be presented to the Supreme Court. Instead the parties have agreed to expedite briefing and the oral arguments on the merits of the case.

From the OSHA ETS front, the Society for Human Resource Management reports that


Now that a federal appeals court has revived the Occupational Safety and Health Administration’s (OSHA’s) emergency temporary standard (ETS), covered employers will need to prepare a written COVID-19 vaccination-or-testing policy by Jan. 10.

Under the ETS, employers may choose to require vaccination or allow covered employees who are unvaccinated to wear a mask and provide proof of a negative COVID-19 test on a weekly basis. The start date for the testing requirement has been extended to Feb. 9, but many other components of the ETS take effect on Jan. 10, such as the requirement for employers to determine the vaccination status of each employee and develop a written policy.

“Keep it simple,” recommended Eric Hobbs, an attorney with Ogletree Deakins in Milwaukee. “Do not include anything in the plan that you can’t follow through on.”

The Supreme Court is unlikely to rule on the OSHA ETS mandate stay before January 10, 2022.

From the Federal employee compensation front, Federal News Network reports that

President Joe Biden on Wednesday signed an executive order making federal pay raises official for many civilian employees in 2022.

As expected, General Schedule employees will receive an across-the-board federal pay raise of 2.2% in 2022, plus an additional 0.5% locality pay adjustment, to total a 2.7% average increase.

An Office of Personnel Management official confirmed the 2.7% federal pay raise to Federal News Network Wednesday evening. The agency hasn’t yet posted detailed pay tables describing pay rates for each locality pay area.

The raises take effect Jan. 1, or more specifically during the first pay period in January.

Under OPM’s regulations, Open Season changes take place on January 1 for annuitants and on the first day of the first pay period in the new year for employees. GSA’s federal employee calendar for 2022 shows that January 2 is the first day of the first pay period for next year.

From the Affordable Care Act front, the FEHBlog apologizes that he left a sentence off yesterday’s post about the current federal fiscal year’s PCORI fee. To close the unintended loop, IRS Notice 2022-04 states that “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2021, and before October 1, 2022, is $2.79” per bellybutton.

Winter is here!

David Ermer–ACA, COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Clarisse Meyer on Unsplash

The Wall Street Journal reports that “The 2021 winter solstice [took] place on Tuesday, Dec. 21, at 3:59 p.m. Coordinated Universal Time (UTC), the international standard time used by astronomers. That is 7:59 a.m. Pacific Time and 10:59 a.m. Eastern Time. * * * On the winter solstice, our planet’s [23.5 degree] tilt brings the South Pole closest to the sun—and the Antarctic Circle gets 24 hours of daylight. The North Pole is tilted away from the sun, and the Arctic Circle is shrouded in darkness for nearly a full day. * * * The winter solstice in the Northern Hemisphere marks the point at which the season’s short days start to lengthen—continuing until the summer solstice in June, when there is the longest period of daylight and the shortest period of darkness there.”

Winter solstice 2019 was pre-pandemic. Winter solstice 2020 conincided with the introduction of the mRNA vaccines in the U.S. and this winter solstice is expected to coincide with the introduction of the early onset COVID pills from Pfizer and Merck.

Bloomberg informs us that

The U.S. Food and Drug Administration is poised to authorize a pair of pills from Pfizer Inc. and Merck & Co. to treat Covid-19 as soon as this week, according to people familiar with the matter — a milestone in the fight against the pandemic that will soon expand therapies for the ill.

An announcement may come as early as Wednesday, according to three of the people. They asked not to be identified ahead of the authorization and cautioned that the plan could change. 

Pfizer’s pill, Paxlovid, and Merck’s molnupiravir are intended for higher-risk people who test positive for the coronavirus. The treatments, in which patients take a series of pills at home over several days, could ease the burden on stretched hospitals with infections poised to soar through the winter in the U.S. 

This is similar to the roll out of the mRNA vaccines which initially administered to higher-risk people as well as first responders. FiercePharma tells us that “Pfizer expects to make 80 million courses of COVID drug Paxlovid by the end of 2022.” Bloomberg adds that “’It’s the biggest thing to happen in the pandemic after vaccines,’” said Eric Topol, director of the Scripps Research Translational Institute.” For what it’s worth, the FEHBlog shares this sentiment.

In other COVID treatment news, Medscape reports that

A “definitive study” from Johns Hopkins University researchers and others shows that convalescent plasma can cut hospital admissions for COVID-19 by 54% if therapy is administered within 8 days of symptom onset.

In the study of 1181 adults randomly assigned to high-titer convalescent plasma or placebo, 2.9% of people receiving the therapy were hospitalized compared to 6.3% who received placebo control plasma.

This translates to a 54% risk reduction for hospitalization with convalescent plasma. * * *

Whereas many convalescent plasma studies were done in hospitalized patients, this is one of only a handful performed in outpatients, the researchers note.

There is a regulatory catch. The FDA restricted emergency use authorization (EUA) for convalescent plasma in February 2021 to include only high-dose titer plasma and to limit the therapy to hospitalized patients with early disease or for immunocompromised people who cannot mount an adequate antibody response.

[Dr. David] Sullivan and colleagues hope their findings will prompt the FDA to expand the EUA to include outpatients.

From the White House front, the President spoke this afternoon about an enhanced federal government response to Omicron, including federal government run testing and vaccination sites and federally funded home delivery of rapid COVID tests.

Govexec explains that

The administration will launch federal testing sites around the country, standing up the first in New York City before Christmas. It will establish subsequent sites in states and communities where capacity is constrained, a senior administration official who spoke to reporters on the condition of anonymity said on Monday, with those going up in January and February. The government will once again deploy hundreds of federal personnel to boost vaccination capacity around the country, with the goal of boosting capacity by thousands of shots per week. The Federal Emergency Management Agency will oversee pop-up vaccination sites operated by the federal government, with the first ones going to Washington and New Mexico.  * * *

The White House also announced it was purchasing 500 million tests and will soon set up a website for any Americans to order one for free. The tests will be available in January and delivered by mail for free, though the White House is still finalizing how many each individual will be entitled to order. The administration pledged to boost its use of the Defense Production Act to boost the supply of at-home, rapid tests.

It’s not yet clear whether this initiative replaces the earlier proposal to have health plans reimburse their members for these over the counter tests.

The San Franciso Chronicle seeks to put the transmissibility of Omicron in perspective

The reproductive number known as R0, pronounced “R naught,” measures a disease’s transmissibility at the beginning of a pandemic with no preexisting immunity, said Warner Greene, a virologist and senior investigator at the Gladstone Institutes in San Francisco. It represents how many people one sick person will infect.

According to a study released in October, the original COVID-19 strain that emerged from Wuhan has an R0 value of 2.79. The delta variant has a value of between 5 to 6 — about twice as contagious as the original strain.

Chicken pox has an R0 value of 9-10. The R0 value of measles is estimated at 12 to 18.

Greene said to really know the true R0 value of omicron, more information is needed. He cited an estimate from Martin Hibberd, a professor of emerging infectious diseases at the London School Of Hygiene & Tropical Medicine, that omicron could have an R0 of 10.

Chin-Hong said “a lot more fully vaccinated people will get breakthrough infections, but will not likely get very ill and are very unlikely to die.”

For unvaccinated people, the situation is much more serious.

“It will be very difficult to avoid getting infected with omicron,” Swartzberg said. “You may have been lucky with the other variants and the ancestral strain. It’s unlikely you will be with omicron. The unvaccinated will be the biggest spreaders of omicron and they will be the ones most likely hospitalized from it.”

No joke.

From the National Institutes of Health front —

  • “Yesterday the U.S. Food and Drug Administration announced its first approval of a long-acting HIV prevention medication. Developed by ViiV Healthcare, the medicine is long-acting cabotegravir injected once every two months. FDA has approved the medicine for use by adults and adolescents weighing at least 35 kilograms who are at risk of sexually acquiring HIV. This milestone marks a vital expansion of biomedical HIV prevention options available to people in the United States.”
  • “Despite important advances in the understanding and treatment of oral diseases and conditions, many people in the U.S. still have chronic oral health problems and lack of access to care, according to a report by the National Institutes of Health. Oral Health in America: Advances and Challenges, is a follow-up to the seminal 2000 Oral Health in America: A Report of the Surgeon General.” * * * “The authors make several recommendations to improve oral health in America, which include the need for health care professionals to work together to provide integrated oral, medical, and behavioral health care in schools, community health centers, nursing homes, and medical care settings, as well as dental clinics. They also identify the need to improve access to care by developing a more diverse oral health care workforce, addressing the rising cost of dental education, expanding insurance coverage, and improving the overall affordability of care.”

From the Affordable Care Act front, the Internal Revenue Service announced today that the applicable dollar amount that health plans must use to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2021, and before October 1, 2022, is $2.79″ per bellybutton. The immediately preceding years fee was $2.66 per bellybutton.