Tuesday’s Tidbits

COVID-19 testing

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. 

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.

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.

Thursday Miscellany

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From the Capitol Hill front, Roll Call reports that

President Joe Biden and Democratic leaders reluctantly acknowledged Thursday that the Senate would soon recess for the year without passing their sprawling $2.2 trillion social safety net and climate spending bill or voting rights legislation. 

From the Omicron front, Bloomberg tells us that

President Joe Biden warned that unvaccinated Americans face “a winter of severe illness and death” as he urged initial doses and booster shots amid a surge of coronavirus cases and the emergence of the omicron variant.

David Leonhardt writing in his New York Times Morning column adds that “about 15 percent of American adults remain unvaccinated.”

From the COVID vaccine front, AHIP informs us that

Today, the CDC’s Advisory Committee on Immunization Practices (ACIP) convened to discuss the recent developments and safety considerations for the Janssen/Johnson & Johnson COVID-19 vaccine. 

ACIP voted unanimously to amend their recommendation: mRNA COVID-19 vaccines are preferred over the Janssen COVID-19 vaccine for the prevention of COVID-19 for those 18 years of age and older. 

Deliberations within the committee stressed the importance of updating the Clinical Considerations and educational materials regarding the vaccine to ensure that anyone who chooses to receive the Janssen adenovirus-based vaccine is informed of the potential risks.  

Earlier this week, the FDA updated its Emergency Use Authorization Fact Sheet to indicate that the Janssen vaccine is contraindicated for individuals with a history of thrombosis with thrombocytopenia syndrome (TTS).  This was based on new information showing that cases of TTS have been reported in both males and females, and that approximately 15% of TTS cases have been fatal.

Following the discussion, the Committee reviewed a presentation on safety data regarding the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years old.  Very few adverse events or severe systemic reactions were reported, with most incidents including pain, fever, fatigue, headache, and/or myalgia, and most beginning one or two days following the second dose with symptoms alleviating within a few days.  To date, there have been two deaths in children who received the vaccine, each with children who have complicated medical histories, both of which are still under investigation.

Finally, CDC presented current data about the Omicron variant.  This variant appears to be more transmissible than earlier variants, but more data is needed to know if it causes more severe illness.  Vaccines are expected to protect against severe illness, hospitalizations, and death, with booster vaccines showing increased protection than the two-dose series.  It is unclear how prior infection impacts neutralization.  CDC is continuing to monitor real-world evidence across all populations to inform further action.

Also from the omicron front, Healthcare Dive reports that

— FDA has identified three COVID-19 molecular tests that are not able to detect the omicron variant and warned that the diagnostics from Applied DNA Sciences, Meridian Bioscience and Tide Laboratories will return false negative results.

— The agency on Wednesday updated its list of tests impacted by virus mutations. While FDA continues to gather additional information and work with the three manufacturers to address these issues, it recommended the diagnostics not be used by clinical laboratory staff and healthcare providers.

— Makers of both polymerase chain reaction and rapid antigen tests have said their tests can detect omicron. Siemens Healthineers is the latest company to claim its testing portfolio is unaffected by the variant. However, Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, told test developers Wednesday during a virtual town hall that the agency continues to receive “a lot of inquiries” about omicron and its potential impact on diagnostics and will continue to focus efforts on evaluating molecular and antigen tests.

The Wall Street Journal adds that

Pfizer Inc. and BioNTech SE  say they have asked U.S. regulators to fully approve their Covid-19 vaccine for adolescents ages 12 to 15. The vaccine was fully approved by the U.S. Food and Drug Administration in August for people 16 years and older. 

From the COVID vaccine mandate front, we have two court decisions:

  • The Society for Human Resources Management explains that “On Dec. 15, the 5th U.S. Circuit Court of Appeals lifted a district court’s order that had blocked the Biden administration’s COVID-19 vaccination directive for health care workers nationwide. But the requirement remains blocked in 24 states.” The 24 states are composed of 14 State plaintiffs in the 5th Circuit case and 10 State plaintiffs in the first PI. The Congressional Research Service recently wrote a report on nationwide injunctions.
  • The government contractor mandate nationwide preliminary injunction (“PI”) followed the same course as the healthcare workers preliminary injunction — a PI issued for three states followed by a court in another state issuing a nationwide injunction. Perhaps the 11th U.S. Circuit Court of Appeals which is hearing the government’s appeal of the government contractor mandate PI (Case No. 21-14269), will follow the 5th Circuit’s lead.
  • The National Law Review reports that

[Also on Dec. 15] The [U.S. Court of Appeals for the] Sixth Circuit denied en banc review in the OSHA vaccine mandate cases.  The vote was a close one, with eight judges voting in favor of initial hearing en banc.  But that’s not enough under the circuit’s rules, which require a majority of the 16 active judges to vote for en banc treatment.  As a result, the current panel reviewing the case will decide whether to continue the stay issued by the Fifth Circuit, which may end up being the most consequential decision in the case until it comes before the Supreme Court.

From the miscellany department —

  • GoodRx brings us up to date on Alzheimer’s Disease research.
  • “The HEALTH CARE TRANSFORMATION TASK FORCE (HCTTF or Task Force), a group of leading health care payers, providers, purchasers and patient organizations, today announced that its provider and payer members reported having 61 percent of their business in value-based payment arrangements at the end of 2020. Value-based care and payment arrangements focus on lowering costs and improving the quality of care to drive overall population health. The new report shows significant progress towards the goal and has increased twofold from the group’s first report of 30 percent in value-based arrangements in 2015.”

Roughly 40% of U.S. healthcare payments were tied to alternative payment models (APMs) last year, with Medicare Advantage claims representing the largest amount, a new survey found.

The survey, published Wednesday by the Health Care Payment Learning & Action Network, showed that more work needs to be done as most healthcare payments were still tied to a fee-for-service model.

“The survey shows we have made limited progress in moving away from fee for service between 2019 and 2020,” said Mark McClellan, M.D., Ph.D., director of Duke University’s Margolis Center for Health Policy and co-chair of the LAN CEO forum, during the LAN Summit Wednesday. “Most payments are still in fee-for-service, especially outside of Medicare.”

  • If you are bit confused by these findings, APMs are a type of value based pricing arrangement. Health Affairs offered a useful article on the various value based payment models earlier his year.

Midweek Update

David Ermer–Congress, COVID-19, COVID-19 testing, Federal employment benefits, Mental health care, U.S. Healthcare–

From the Capitol Hill front, Roll Call reports that

The Senate easily passed the annual defense policy bill on Wednesday, authorizing $768 billion in defense spending for fiscal 2022.

The final tally for the fiscal 2022 National Defense Authorization Act was 88-11. * * *

The legislation marks the 61st straight year that Congress has passed the NDAA. President Joe Biden is expected to sign it into law shortly.

The Federal Times discusses the federal employment aspects of the new law.

The Wall Street Journal adds that “Democrats braced for weeks of delay and uncertainty on their roughly $2 trillion education, healthcare and climate package they had hoped to finish by year end, as efforts faltered to secure the pivotal support of Sen. Joe Manchin (D., W.Va.) for the bill.”

From the Omicron front Bloomberg informs us that

The results from initial studies of the omicron variant of the coronavirus are starting to roll in almost daily, and early suspicions are gaining more support. The mutation is much better at infecting—70 times faster than delta and the original strain. But the severity of illness is likely to be much lower, according to a study from the University of Hong Kong, echoing earlier observations from doctors in South Africa where the variant was first observed. The supercharged speed of omicron’s spread in the human bronchus was found 24 hours following infection, according to the university. However, the study found it replicated in lung tissue much less efficiently than earlier mutations, which may signal “lower severity of disease.”

The FEHBlog ran across not one but two articles prognosticating about the extension of no cost sharing coverage of at home rapid antigen COVID tests scheduled for next month:

  • The Society for Human Resource Management points out a Mercer consulting report on the coverage issue.

HR consultancy Mercer explained: “Under existing guidance (see FAQ Part 43, Q/A-4), at-home COVID tests must be covered without participant cost-sharing, but only when ordered by an attending health care provider who has determined the test is medically appropriate based on current accepted standards of medical practice.”

Mercer noted that “group health plans and insurers currently may (but are not required to) provide coverage of at-home tests without participant cost-sharing even absent a health care provider’s determination of medical necessity. While we await important details, it seems quite possible that forthcoming guidance will significantly expand the scope of required coverage of at-home COVID testing without participant cost-sharing, in short, by eliminating the need to involve a health care provider.”

  • Health Payer Intelligence notes that “In a letter to CMS, the Alliance of Community Health Plans (ACHP) has requested that the federal government establish certain requirements for at-home COVID-19 testing coverage.” ACHP letter builds on Mercer’s concerns.

From the substance use disorder front —

Overdose deaths involving the synthetic opioid, illicitly-manufactured fentanyl (IMF), skyrocketed across the country from 2019 to 2020, researchers found.

Between July 2019 and December 2020, IMF-involved overdose deaths nearly doubled in the West (93.9%), increased 65% in the South and 33% in the Midwest, reported Julie O’Donnell, PhD, of the CDC’s National Center for Injury Prevention and Control in New Orleans, and colleagues.

Moreover these deaths were quick, as 56% of people who died from an IMF-involved overdose did not have a pulse when first responders arrived on the scene, and approximately 40% of IMF-involved deaths also involved a stimulant, O’Donnell’s group wrote in the Morbidity and Mortality Weekly Report.

  • The NIH HEAL Initiative reported that texting and related apps can be used to lengthen use of drugs taken to treat opioid use disorder. Here’s the background:

Medications such as methadone, buprenorphine, and naltrexone are highly effective for treating opioid use disorder. Yet only a fraction of people who could benefit actually receive these medications. Worse, about half of those who start taking them discontinue use within the first 6 months of treatment. Research has shown that the longer people continue treatment, the better their outcome is and the lower their risk of overdose.

  • On the bright side, NIH also reports that

The percentage of adolescents reporting substance use decreased significantly in 2021, according to the latest results from the Monitoring the Future survey of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States. In line with continued long-term declines in the use of many illicit substances among adolescents previously reported by the Monitoring the Future survey, these findings represent the largest one-year decrease in overall illicit drug use reported since the survey began in 1975. The Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

From the this and that department —

  • Health Affairs unveiled the National Health Care Spending Report for 2020:

US health care spending increased 9.7 percent to reach $4.1 trillion in 2020, a much faster rate than the 4.3 percent increase seen in 2019. The acceleration in 2020 was due to a 36.0 percent increase in federal expenditures for health care that occurred largely in response to the COVID-19 pandemic. At the same time, gross domestic product declined 2.2 percent, and the share of the economy devoted to health care spending spiked, reaching 19.7 percent. In 2020 the number of uninsured people fell, while at the same time there were significant shifts in types of coverage.

  • The Wall Street Journal graphically points out that emergency room charges can vary significantly for common emergencies in downtown Boston.
  • Fierce Healthcare tells us that

UnitedHealth Group has pushed back the deadline for its nearly $8 billion acquisition of Change Healthcare, according to a new filing with the Securities and Exchange Commission.

Change said in the filing that UnitedHealth informed the company that it was pushing back the deal’s outside date to April 2022. Previous filings suggested that the acquisition could close as early as late February.

Within the merger agreement, both companies have the right to push back the outside date.

UnitedHealth and Change are awaiting the completion of an investigation into the merger by the Department of Justice, which has been probing the deal on antitrust grounds.

Monday Roundup

David Ermer–Congress, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Roll Call discusses the Senate Parliamentarian’s role in refereeing budget reconciliation bills like the Build Back Better Act.

Senate committees have been updating the House-passed $2.2 trillion climate and social spending package text to ensure it complies with budget reconciliation rules, but most have yet to begin the formal review process with the Senate parliamentarian known as “the Byrd bath.”

Majority Leader Charles E. Schumer sent a “Dear Colleague” letter on Monday reiterating his goal to pass the legislation in the Senate before Christmas. But the update he provided on the procedural steps needed to get there suggests senators will be lucky if they can meet that deadline. 

Schumer said Senate committees are continuing informal conversations with Senate Parliamentarian Elizabeth MacDonough about their pieces of the package and “making necessary technical and ‘Byrd proofing’ edits to the House bill.” The Byrd rule requires any policy changes made through reconciliation to have more than a “merely incidental” impact on the budget, among other restrictions.

From the COVID vaccine front, Medscape informs us that

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI(cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

“This study supports what we’ve been seeing. People identified and treated early and appropriately for the rare complication of COVID-19 vaccine-related myocarditis typically experienced only mild cases and short recovery times,” American Heart Association (AHA) President Donald M. Lloyd-Jones, MD, said in a podcast.

“Overwhelmingly, the data continue to indicate the benefits of COVID-19 vaccine far outweigh any very rare risks of adverse events from the vaccine, including myocarditis,” Lloyd-Jones added.

and that

The U.S. Food and Drug Administration on Friday authorized the use of Eli Lilly’s COVID-19 dual-antibody therapy in treating mild to moderate symptoms in all children, including newborns, who are at risk of severe illness.

The therapy, bamlanivimab plus etesevimab, was previously authorized for children aged 12 years and older and weighed at least 88 pounds.

“Children under one year of age, who are exposed to the virus that causes COVID-19, may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

The FDA authorization also allows the administration of the therapy as a preventive measure in children who are exposed to the virus.

Per STAT News

People who received the Pfizer (PFE)-BioNTech (BNTX) vaccines may get as much benefit from a Johnson & Johnson (JNJ) booster shot as a Pfizer one, The New York Times explains, citing the findings of a small study released on Sunday. Researchers at Beth Israel Deaconess Medical Center in Boston studied 65 people who had received two shots of the Pfizer vaccine. Six months after the second dose, the researchers gave 24 of the volunteers a third dose of the Pfizer vaccine and gave 41 the Johnson & Johnson shot. The study was funded in part by Johnson & Johnson and has not yet been published in a scientific journal.

As of today according to the Centers for Disease Control, 60% of the U.S. population is fully vaccinated and 25% of the U.S. population over age 18 has had a booster.

From the Delta variant testing front

  • The American Medical Association reviews the different COVID tests that are available in our country. The article warns that the at home tests must be performed correctly. This will be useful information to share with health plan members.
  • A friend of the FEHBlog pointed out this HHS website that lists low or or no COVID cost testing facilities in each of the states and DC. Another friend of the FEHBlog informed him that local public libraries in the Washington DC area offer at home rapid COVID tests like Binax to their visitors at no cost. The FEHBlog learned long ago that when a health plan is asked to provide a service or supply that it typically does not cover, like over the counter drugs or tests, you typically can find a government resource to fill the gap. To soften the financial blow of the the President’s unexpected mandate that health plans cover the cost of at home rapid COVID tests, health plans also should consider educating members about community resources.

Speaking of which, Health Payer Intelligence reports on payer efforts to fund various community resources to address the social determinants of health, a thoughtful idea particularly at the holiday season.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, Rx coverage–

From the Capitol Hill front, Roll Call reports that

The Senate looks set to clear a House-passed a temporary spending bill Thursday night that would keep the lights on at federal agencies through Feb. 18, buying 11 more weeks to try to resolve partisan disputes over funding levels and policy riders that have stalled progress on fiscal 2022 appropriations.

The stopgap measure passed the House on a 221-212 vote earlier in the evening. The Senate timeline cleared up once it became apparent a group of GOP conservatives would get an up-or-down vote on an amendment to bar funding to implement a new private sector vaccine mandate.

“I think we’re gonna get our amendment at a 50-vote threshold,” Sen. Roger Marshall, R-Kan., told reporters after the House vote. 

A Senate GOP leadership aide said the vote would occur in that chamber Thursday evening. With three absences on the Republican side, senators expected Marshall’s amendment to be defeated, which would set up a vote on clearing the stopgap bill for President Joe Biden’s signature ahead of a midnight Friday deadline to avert a partial government shutdown.

So as the FEHBlog expect, no government shutdown which is good news.

From the Delta variant front —

STAT News informs us that

Health officials on Thursday reported the country’s second Covid-19 infection from the Omicron variant in a Minnesota resident who notably did not travel internationally recently, unlike the first case.

The case in Minnesota is an adult male who had been vaccinated and, in early November, received a booster shot. He lives in Hennepin County, which includes Minneapolis, state health officials said. He developed mild symptoms on Nov. 22, was tested on Nov. 24, and no longer has symptoms. 

The man had been in New York City in the days leading up to feeling sick and attended the Anime NYC 2021 convention at the Javits Center from Nov. 19 to Nov. 21. Minnesota health officials are collaborating with New York City authorities and the Centers for Disease Control and Prevention on their case investigation.

Bloomberg adds

In some of the first data to come back on the omicron variant of the coronavirus, researchers in South Africa, where it was first identified, say the mutation is spreading faster than the delta strain. There also seems to be a greater risk of reinfection—where previously infected people get the virus again. Three times higher, in fact. But scientists also said hospitalizations in South Africa remain muted, a sign that may be attributable in part to vaccinations. Shabir Madhi, a vaccinologist at the University of the Witwatersrand, said he’s “optimistic that in this resurgence, while the total number of cases will probably be greater, hospitalizations and deaths will be lower.” —David E. Rovella

The Wall Street Journal reports that

Early laboratory studies suggest that a Covid-19 antibody treatment developed byGlaxoSmithKline GSK 0.24% PLC and Vir Biotechnology Inc. VIR -2.19% is effective against the Omicron variant, the companies said, setting it apart from similar therapies that appear to work less well against the highly mutated strain.

The companies said Thursday that they had tested the drug, called sotrovimab, against certain individual mutations found in Omicron, which has now been detected in at least 24 countries, including the U.S. Glaxo and Vir said the findings were preliminary and they would need to test the treatment against the whole of the mutated spike protein found in the variant to confirm the result. The companies published the preliminary research, which hasn’t yet been peer reviewed.

From the White House, the President announced a bevy of new COVID control measures today. Of particular interest to health plans is the following one:

Providing health plan coverage of no-cost rapid, over-the-counter (OTC) COVID-19 tests:  To expand access and affordability of at-home COVID-19 tests, the Departments of Health and Human Services, Labor and the Treasury will issue guidance by January 15th to clarify that individuals who purchase OTC COVID-19 diagnostic tests will be able to seek reimbursement from their group health plan or health insurance issuer and have insurance cover the cost during the public health emergency. Workplace screening would remain consistent with current guidance. 

That workplace guidance currently requires the employer to fund the cost of testing, e.g., in programs that require vaccinations or weekly testing / masking. However, I think that once this Pandora’s box is open, employers will be telling their employees to pick up a test at the local pharmacy if they need to be tested. What’s stopping them? Healthcare Dive explains that the mandate will remove the market incentive currently on manufacturers to lower costs.

The plan is a potential boon for medtech companies that produce at-home tests. With insurers on the hook for payment, it may drive up demand, particularly among those who were sensitive to prices before. Abbott, BD and Quidel are big players in the at-home testing space.

Furthermore the FEHBlog doesn’t see the sense in taking this step before the Food and Drug Administration give emergency use authorization to Merck and Pfizer COVID pills to treat COVID at its onset.

From the COVID vaccine mandate front, Beckers Hospital Review reports that

HHS is appealing a federal court’s decision to temporarily block the start of its vaccination mandate for healthcare workers, according to Bloomberg Law. 

U.S. District Judge Terry Doughty in Louisiana granted a preliminary injunction Nov. 30 halting the vaccination rule for healthcare workers until legal challenges are resolved.  * * *

HHS Secretary Xavier Becerra and other defendants filed an appeal Dec. 1. The U.S. Court of Appeals for the 5th Circuit will hear the appeal. 

From the pharmacy front —

Healthcare Dive informs us that

CVS Health and Microsoft are forming a strategic alliance to co-develop products around the areas of personalized care and digital health, the two companies announced Thursday.

CVS said it plans to use Microsoft’s computing capabilities to deliver more customized health recommendations when and where consumers need them as the retail pharmacy giant continues to focus on digitally enabled and consumer-centric health services. The two will also look for new ways to leverage technology and machine learning to automate CVS operations and reduce waste.

Fierce Healthcare tells us that

CVS Pharmacy is expanding an in-app feature for visually impaired patients, which reads prescription information out loud, to all of its nearly 10,000 U.S. locations.

The solution, called Spoken Rx, was designed in collaboration with the American Council of the Blind. Patients enrolled in the program can scan the labels on their prescription containers and have their information, including the medication’s name and directions for use, read out loud to them in either English or Spanish.

* * * The feature is free to all patients who enroll. CVS can provide a standalone speaker device to read prescription labels if the patient doesn’t have a smartphone.

CVS also offers ScripTalk on its website, which allows patients who get their medications delivered to their homes to have their prescriptions read aloud through the separate ScripTalk app. The pharmacy giant first made the service available in 2014.

The company has options for braille and large-print prescription labels through their online pharmacy too.

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Telehealth, U.S. Healthcare–

From the Delta variant vaccination and treatment front, AHIP informs us that

The Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) held a meeting to discuss the safety and efficacy of the COVID-19 antiviral treatment molnupiravir, developed by Merck and Ridgeback Biotherapeutics. The oral treatment is the first COVID-19 therapy that could be taken outside a clinical setting. The Committee reviewed data by Merck and the FDA on molnupiravir’s toxicity, efficacy, and safety, and discussed concerns over treatment of pregnant persons and the potential effects of viral mutation and evolution. Initial data from Merck showed that molnupiravir reduced the hospitalization risk among high-risk patients by 48%, however data released November 26 suggests the reduction in hospitalizations may be closer to 30%.

The Committee voted 13-10 that the potential benefits of molnupiravir outweigh the known and potential risks when used for the treatment of mild-moderate COVID-19 in adult patients who are within 5 days of symptom onset and are at high risk of severe COVID-19, including hospitalization or death. Given concerns about the potential harmful effects on fetal development, Committee members further stressed the need for pregnancy testing prior to taking molnupiravir.

The FDA will review AMDAC’s conclusions and formally decide whether or not to grant emergency use authorization (EUA) to molnupiravir in the coming weeks. 

Acting Food and Drug Commissioner Dr. Janet Woodcock announced

The [Food and Drug Administration] is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more. 

Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks.

Healthcare Dive informs us that

The emergence of a new COVID-19 variant, named Omicron (B.1.1.529), is putting pressure on diagnostics manufacturers who test for the presence of SARS-CoV-2 to ensure its results are not impacted. Thermo Fisher Scientific, Qiagen and Lucira Health were quick to claim their tests can detect the emerging variant.    

The Wall Street Journal reports that

The Omicron variant of the Covid-19 virus could lead to more infections among vaccinated people, according to several scientists, but some said there were reasons to believe the shots would protect against severe disease.

While the new variant might evade the antibodies generated in reaction to the vaccines, the virus will likely remain vulnerable to immune cells that destroy it once it enters the body, said Ugur Sahin, co-founder of BioNTech SE, which sells a Covid-19 shot with partner Pfizer Inc.

“Our message is: Don’t freak out, the plan remains the same: Speed up the administration of a third booster shot,” Dr. Sahin said in an interview Tuesday.

In that regard, Govexec.com notes that “Pfizer/BioNTech are expected to apply for approval for their booster shots for 16 and 17 year olds and the FDA “could authorize extra shots within roughly a week,” The New York Times reported on Monday.”

In COVID vaccine mandate legal news, the FEHBlog was quite surprised to read in Govexec that

On Tuesday, a federal judge temporarily blocked the COVID-19 vaccine mandate for federal contractors in three states.

U.S. District Judge Gregory Van Tatenhove, who serves in the U.S. District Court for the Eastern District of Kentucky, issued a preliminary injunction for the vaccine mandate for federal contractors and subcontractors in all covered contracts in Kentucky, Ohio and Tennessee. Following President Biden’s issuance of the executive order on the mandate on September 9, there have been numerous legal challenges. 

“This is not a case about whether vaccines are effective. They are. Nor is this a case about whether the government, at some level, and in some circumstances, can require citizens to obtain vaccines. It can,” wrote Van Tatenhove. “The question presented here is narrow. Can the president use congressionally delegated authority to manage the federal procurement of goods and services to impose vaccines on the employees of federal contractors and subcontractors? In all likelihood, the answer to that question is ‘no.’”

The New York Times adds

A federal judge issued a preliminary injunction on Tuesday to halt the start of President Biden’s national vaccine mandate for health care workers, which had been set to begin next week. 

The injunction, written by Judge Terry A. Doughty, effectively expanded a separate order issued on Monday by a federal court in Missouri. The earlier one had applied only to 10 states that joined in a lawsuit against the president’s decision to require all health workers in hospitals and nursing homes to receive at least their first shot by Dec. 6 and to be fully vaccinated by Jan. 4.

“There is no question that mandating a vaccine to 10.3 million health care workers is something that should be done by Congress, not a government agency,” Judge Doughty of U.S. District Court for the Western District of Louisiana wrote. He added: “It is not clear that even an act of Congress mandating a vaccine would be constitutional.”

The plaintiffs, he added, also have an “interest in protecting its citizens from being required to submit to vaccinations” and to prevent the loss of jobs and tax revenue that may result from the mandate.

It looks like the vaccine mandates are creating more work Judicial Panel on Multidistrict Litgation.

From the HIV front —

  • The National Institutes of Health tells us that “Among people with HIV worldwide who are receiving antiretroviral therapy (ART), adults are getting closer to the global target of 95% achieving viral suppression, but progress among children and adolescents is lagging and long-term viral suppression among all groups remains a challenge. These findings of a study funded by the National Institutes of Health suggest that substantial efforts are needed to help people with HIV durably suppress the virus. The findings were published today in the journal The Lancet HIV.”
  • The Centers for Disease Control informs us that “Improving access to and use of HIV services for [men having sex with men] MSM, particularly Black MSM, Hispanic/Latino MSM, and younger MSM, is essential to ending the HIV epidemic in the United States.”
  • Here is a link to the CDC’s website on HIV treatment.

From the tidbits department —

  • Fierce Healthcare calls to our attention the fact that

The Business Group on Health has identified several trends in health and wellness to keep an eye on next year, which they say highlight the sense of “collective urgency” employers and their workforces feel.

For example, the organization echoed an ongoing industry trend: virtual care isn’t going away following a massive increase in use during the pandemic. However, the Business Group argues that taking full advantage of its strengths will require integration with in-person offerings.

  • The Society for Human Resource Management, having lost respect for the Delta variant, discusses how the Omicron variant may impact the workplace.
  • AHRQ tells us that “Patients with retail medications to treat opioid use disorders spent on average 3.4 times more for out-of-pocket prescriptions than the rest of the U.S. population, according to an AHRQ-study published in the Journal of Substance Abuse and Treatment.” No bueno.
  • Also “AHRQ has released an updated Chartbook on Rural Healthcare that shows that people in rural areas face difficulty getting timely, high-quality, affordable healthcare. 
  • HHS’s Office for Civil Rights which enforces the HIPAA Privacy and Security Rules now has settled in OCR’s favor 25 complaints against healthcare providers for allegedly violating HIPAA’s individual right to access medical records.

Thanksgiving Wrap Up

David Ermer–COVID-19, COVID-19 testing, U.S. Healthcare–

From the Delta variant mandate front, Federal News Network reports that

The federal government is at 96.5% compliance with the Biden administration’s COVID-19 vaccination mandate for employees and contractors, including civilian and military personnel.

Monday was the deadline to get vaccinated, and as of yesterday, the U.S. Agency for International Development, the departments of Commerce, Transportation, the Office of Personnel Management and the Small Business Administration all have at least 99% compliance with the mandate among employees. That includes the percentage of agency employees covered by a vaccination requirement with at least one dose of a COVID-19 vaccination, or a pending or approved exception or extension. Again, that’s for compliance — when it comes to actual vaccination or employees with at least one dose of a COVID vaccine, the compliance rates hovered between 86.1% and 97.8%.

That’s good news.

In Delta variant testing news, David Leonhardt in the New York Times Mornings column brings us a handy guide rapid COVID tests which are will work hand in glove with the Merck early COVID treatment pill that the Food and Drug Administration will consider for emergency use authorization next week.

The Covid tests that you take in a doctor’s office or testing center are usually PCR tests, which are designed to identify whether you have any amount of the Covid virus. They can sometimes come back positive even if you had the virus weeks earlier and have not been infectious for a long time.

The rapid tests — also known as antigen tests — are designed to tell whether you are infectious. That’s why they are such a powerful public-health tool. They can prevent somebody with the virus from spreading it to others.

“For too long, people thought of testing as an extra and not the core, and it needs to be thought of as the core,” Mara Aspinall, a professor at Arizona State University and former biotechnology executive, told Kaiser Health News.

The most widely available antigen test seems to be BinaxNOW, from Abbott. You should also feel comfortable using QuickVue, Ellume and Flowflex, among others. If you search for one of these tests online and a website points you to a different brand, do some research. Others can be very expensive.

Both CVS and Walgreens have search engines that let you find tests for sale near you. I recommend calling the store to confirm it still has them in stock — and then immediately going to buy it. A store may limit you to buying one test pack at a time. * * *

The F.D.A. approved three more tests this week, and the Biden administration continues to spend more to expand their availability.

By Christmas and New Year, tests should be easier to find than they are this week.

Fingers crossed.

In other news

After months of speculation, President Biden on Wednesday announced his intent to nominate the acting director of the Office of Management and Budget—currently Deputy Director Shalanda Young—to become the permanent leader. He also announced his pick to replace Young as deputy director. 

Young, a veteran of the House Appropriations Committee, has been serving as acting OMB director since the end of March when she was confirmed as deputy director, which followed the withdrawal of Neera Tanden’s nomination for the top job. Lawmakers from both parties immediately called on the administration to tap Young for the director role. 

Nani Coloretti, who the president will formally nominate as OMB deputy director, is currently a senior vice president at the Urban Institute. She has previously served in senior roles at the Housing and Urban Development and Treasury departments and Consumer Financial Protection Bureau. * * *

OMB’s role in advancing the administration’s priorities is critical. It manages the federal budget process, regulatory matters, procurement and management of the federal workforce (as demonstrated in the outline of the president’s management agenda released last week), including the return to office process and implementation of the coronavirus vaccine mandate.

Young is currently on maternity leave, so Jason Miller, OMB deputy director for management, is handling the day-to-day responsibilities. While the clock ran out earlier this month for some acting positions under the 1998 Federal Vacancies Reform Act, there is no time limit for acting OMB directors. 

  • Healthcare Dive provides an overview of third quarter financial reports from non-profit healthcare facilities, such as the Cleveland Clinic.

Nonprofit giant Cleveland Clinic posted operating revenue of $3.1 billion in the third quarter, up 13% year over year as net patient revenue swelled on an influx of patient activity. The Ohio academic medical center’s topline was also helped by higher outpatient pharmacy revenue, as utilization of outpatient and specialty drugs increased.

However, pandemic pressures weighed heavily on nonprofits in the quarter ended Sept. 30, as spending drove down operating incomes for systems like Providence Health, CommonSpirit and Kaiser Permanente, which shelled out more on overtime and staffing agencies, pharmaceuticals and medical supplies to respond to increased volumes.

The trend was common but not universal: Minnesota-based Mayo Clinic is an outlier, reporting a robust operating margin of 8% as revenue growth kept well above costs.

Cleveland Clinic operates 19 hospitals and a number of outpatient and ambulatory surgery centers, along with physician offices. Its network is most concentrated in northeast Ohio and Florida, though the system also operates centers in Toronto, Las Vegas and Abu Dhabi.

Have a wonderful Thanksgiving holiday.