Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

From the Delta variant front, the New York Times reports that “The federal government is expected to take a significant step this week toward offering booster doses to a much wider range of Americans as advisers to the Food and Drug Administration meet on Thursday and Friday [this week] to discuss recipients of the Johnson & Johnson and Moderna coronavirus vaccines.”

The Times also informs us that

Merck said on Monday that it had submitted an application to the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid.

Clearance for the drug, molnupiravir, would be a milestone in the fight against the coronavirus, experts said, because a convenient, relatively inexpensive treatment could reach many more high-risk people sick with Covid than the cumbersome antibody treatments currently being used.

The Biden administration is preparing for an authorization that could come within weeks; the pill would likely to be allocated to states, as was the case with the vaccines. States could then distribute the pills how they wish, such as through pharmacies or doctors’ practices, senior administration officials said.

If the pill wins authorization, tens of millions of Americans will most likely be eligible to take it if they get sick with Covid — many more than the supply could cover, at least initially. The federal government has placed an advance order for enough pills for 1.7 million Americans, at a price of about $700 per patient. That is about one-third the price that the government is paying for the monoclonal antibody treatments, which are generally given via intravenous infusion.

Fingers crossed on the pill.

From the hospital transparency front, Fierce Healthcare assesses a New York Times analysis of hospital pricing. Fierce Healthcare finds that cash prices can be lower than prices paid by insurers.

America’s Health Insurance Plans published a statement saying the attempt to look at the data “spotlights a lot of numbers with little context” and “often compares apples and oranges.” 

Because of these complexities, the CMS rule does not help patients “shop for services” as intended, said Delphine O’Rourke, a healthcare attorney and partner at Goodwin Procter. “I, as a consumer, don’t know at the end of the day what I’m going to be responsible for,” she said. 

To O’Rourke, it’s not surprising that at times, a hospital’s cash price is lower for a service. Since people paying cash price are generally a small segment of patients, she explained, and tend to be uninsured or undocumented, hospitals structure cash pay anticipating that it will be “challenging to collect,” O’Rourke said. (Earlier this year, the Wall Street Journal found that many times, patients who pay with cash are actually charged the highest price across hospitals.) 

Be sure to listen to this week’s Econtalk episode during which Russ Roberts interviews Sam Quinones who wrote the FEHBlog’s favorite book of 2017, Dreamland. (While the book was published in 2015, the FEHBlog discovered it from a 2017 Econtalk episode.) This week Mr. Quinones discusses the tremendous impact of fentanyl on growing our opioid epidemic. He explains that dealers learned to lace fentanyl into non-addictive drugs like cocaine and meth thereby creating daily customers for them. Because Econtalk episodes last over an hour, you can find a transcript on the website. The FEHBlog has pre-ordered Mr. Quinones new book, the “Least of Us True Tales of America and Hope in the Time of Fentanyl and Meth,” which is available on Amazon for the Kindle at around nine dollars.

Friday Stats and More

Based on the CDC’s COVID Data Tracker here is the FEHBlog’s chart of new weekly COVID cases for 2021 using Thursday as the first day of the week.

New cases are trending down. Here is a link to weekly COVID hospitalizations and here is the FEHBlog’s chart of new weekly COVID deaths for 2021:

Here is the FEHBlog’s chart of weekly COVID vaccinations distributed and administered over the 51st week of 2020 through the 38th week of 2021 again using Thursday as the first day of the week.

As of today, 64.5% of the U.S population eligible to be vaccinated and 83.1% of the U.S. population over age 65 are fully vaccinated. Here is a link to the CDC’s interpretation of its COVID statistics which happily is released on Fridays.

Following up on the CDC advisory committee’s decision, the CDC Director Rochelle Walensky issued her final decision last night. Here’s a link to MedPage Today’s report on the Director’s decision. The FEHBlog thinks that this Wall Street Journal best sums up the Director’s action:

An FDA outside panel last week hedged by backing boosters only for those over age 65 or at “high risk.” FDA Acting Commissioner Janet Woodcock on Wednesday endorsed this recommendation, but she defined “high risk” broadly to include workers who might have higher Covid exposure. 

But experts on a CDC advisory panel on Thursday disagreed with her decision. Some said young, healthy people were at low risk for severe illness, so boosters weren’t necessary. Others worried that recommending boosters broadly would send the message that vaccines didn’t work. But the CDC’s job is to make decisions based on public health costs and benefits, and our guess is that tens of millions who are vaccinated will want booster shots as breakthrough cases increase. 

Dr. Walensky overruled the CDC advisers and affirmed Dr. Woodcock’s recommendation, which is broad enough that most people who want a booster should be able to get one. The government will leave individuals to assess their own benefits and risks.

Finally the Safer Federal Workforce Task Force released more guidance today on the President’s executive order directing federal government contractors and subcontractors to implement a vaccine mandate for their employees.

Midweek update

Photo by Manasvita S on Unsplash

From the seat of government, the Wall Street Journal reports that

President Biden pressed lawmakers to reach a consensus on his sweeping social-welfare and climate proposal during a series of meetings at the White House on Wednesday, aiming to settle sharp intraparty differences that threaten to derail his multitrillion-dollar agenda.

During his sit-down with moderate Democrats, lawmakers discussed reducing the size of the $3.5 trillion social-welfare package to below $3 trillion, according to two people familiar with the meeting, while progressives continued to threaten to block passage of a separate, roughly $1 trillion infrastructure bill next week if it comes to the House floor before the social-welfare legislation.

The current federal fiscal year ends on September 30, a week from tomorrow. Before then, the Senate should be taking up the House passed stop gap / debt ceiling relief measure.

From the Delta variant front —

The Food and Drug Administration formally ratified its advisory committee’s decision on the Pfizer-BioNTech booster:

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:

individuals 65 years of age and older;

individuals 18 through 64 years of age at high risk of severe COVID-19; and 

individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

Next step in the approval for health plan coverage process is the CDC Advisory Committee on Immunization Practices (“ACIP”) hearing on September 29.

It turns out however, ACIP also is meeting today, and one of its members made news. From the Wall Street Journal

A federal health official said Wednesday there isn’t enough data to support giving a Pfizer Inc. PFE 0.07% booster dose to people who have received other Covid-19 vaccines. 

Doran Fink, a deputy director in the Food and Drug Administration’s vaccines division, made the remarks at a meeting of a key vaccine advisory panel that would recommend who should get an additional dose of the vaccine from Pfizer and partner BioNTech SE. * * *

Officials expect to have more information on this in the future. The National Institutes of Health said in June it is studying giving extra Moderna Inc.MRNA 1.54% doses to people who have received Pfizer, Johnson & JohnsonJNJ -0.36% and the Moderna vaccines.

The FDA has said it needs more time to review use of extra doses of Moderna and J&J Covid-19 vaccines.

This news article from NPR put a spring the FEHBlog’s step:

Americans may be able to breathe a tentative sigh of relief soon, according to researchers studying the trajectory of the pandemic. 

The delta surge appears to be peaking nationally, and cases and deaths will likely decline steadily now through the spring without a significant winter surge, according to a new analysis shared with NPR by a consortium of researchers advising the Centers for Disease Control and Prevention.

For its latest update, which it will release Wednesday, the COVID-19 Scenario Modeling Hub combined nine different mathematical models from different research groups to get an outlook for the pandemic for the next six months.

“Any of us who have been following this closely, given what happened with delta, are going to be really cautious about too much optimism,” says Justin Lessler at the University of North Carolina, who helps run the hub. “But I do think that the trajectory is towards improvement for most of the country,” he says.

The modelers developed four potential scenarios, taking into account whether or not childhood vaccinations take off and whether a more infectious new variant should emerge. 

The most likely scenario, says Lessler, is that children do get vaccinated and no super-spreading variant emerges. In that case, the combo model forecasts that new infections would slowly, but fairly continuously, drop from about 140,000 today now to about 9,000 a day by March. 

Deaths from COVID-19 would fall from about 1,500 a day now to fewer than 100 a day by March 2022.

In other words, it would be June 2021 again. So many Americans have now had COVID or been vaccinated, it’s hard for the FEHBlog to believe that a new variant could take hold like Delta has. Hope springs eternal for endemic COVID-19, the 21st Century flu.

Speaking of the FDA, from the Aduhelm front, STAT News reports that

Earlier this month, Biogen executives admitted publicly that the launch of Aduhelm, its treatment for Alzheimer’s disease, was going slower than expected. Privately, the company is facing a situation far bleaker than what it has publicly disclosed, forcing Biogen to consider cost-cutting measures, including layoffs.

Just over 100 patients with Alzheimer’s had been infused with Aduhelm as of Sept. 11 — a number that is rising slowly but is drastically below Biogen’s internal projections and Wall Street’s expectation that thousands of patients would be using the drug by now. STAT obtained information about the Aduhelm launch from a person with knowledge of the company’s deliberations.

Hey Biogen why not lower the ridiculously high price that you set for Aduhelm??

In other Rx news —

Walgreens Boots Alliance will pay $970 million for a majority stake in specialty pharmacy business Shields Health Solutions. Per the terms of the deal, Walgreens would have a 71% stake in the company, and the option to buy the remaining equity interests in the future.

Walgreens first bought a minority stake in Shields in 2019. The Stoughton, Mass.-based company works with hospitals to stand up specialty pharmacy programs. It currently has 70 health system partners, accounting for more than 1 million specialty patients.

  • Yesterday, the FDA “authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue removed from the body). The software, called Paige Prostate, is the first artificial intelligence (AI)-based software designed to identify an area of interest on the prostate biopsy image with the highest likelihood of harboring cancer so it can be reviewed further by the pathologist if the area of concern has not been identified on initial review.” Nifty.

Following up on yesterday’s post on a Kaufman Hall report that COVID-19 is causing hospitals to lose their shirts, MedPage today informs us that

Hospitals billed private insurers an average of $317,810 for a complex COVID-19 hospitalization, according to new data from FAIR Health.

Insurers paid out an average of $98,139 on those claims, which involved intense care like ICU stays or use of a ventilator, according to a press release from the company.

Average charges and payouts for general hospitalizations for COVID-19 were lower, at $74,591 and $33,525, respectively, the company found.

You can count on the private insurers to bail out the hospitals’ losses on Medicare and Medicaid patients.

From the health equity front, Healthcare Dive tells us about a relevant discussion that occurred at an ongoing AHIP conference

Andrew Renda, a VP at Humana who works on population health strategy, echoed the importance of staying local. Humana has more than a dozen population health strategy leads in various markets who liaison with community-based organizations in those areas to determine what methods will work best, he said.

Panelists agreed that the start of a successful social determinants of health program comes with data collection and interpretation.

Renda said creating data ecosystems “becomes foundational for everything else that we do,” and leads to being able to determine the correct, evidence-based interventions.

And any pilot programs should be constructed with scalability in mind, according to the executive.

Humana uses a Centers for Disease Control and Prevention assessment tool that measures the mentally and physically unhealthy days of individuals over a 30-day period as a leading indicator, followed by data on medication adherence and preventive screenings.

“I think one way to look at it is you’ve got to have the right study design to get those requests to justify the bigger investments,” Renda said.

Well put.

Also CNBC reports that “Walmart is partnering with large employers and Grand Rounds and Doctor on Demand on a new initiative called the Black Community Innovation Coalition. The new virtual-care program is aimed at combating health disparities among African American workers that taps into companies’ employee affinity groups. * * * The new program will use Grand Rounds’ health assistance platform to target outreach on specific health needs of African American workers. One of the initial programs they are looking at includes encouraging earlier maternity care for Black female employees * * *.

From the substance use front, the American Medical Association laid out a strategy to end the opioid pandemic based on a report issued today “showing a 44.4 percent decrease in opioid prescribing nationwide in the past decade.” Nevertheless “the nation continues to see increases in overdose mainly due to illicit fentanyl, fentanyl analogs, methamphetamine and cocaine, according to the U.S. Centers for Disease Control and Prevention.” The AMA recommends that the State policymakers

Stop prior authorization for medications to treat opioid use disorder. * * *

Ensure access to affordable, evidence-based care for patients with pain, including opioid therapy when indicated. * * *

Take action to better support harm reduction services such as naloxone and needle and syringe exchange services. These proven harm reduction strategies save lives but are often stigmatized.

Improve the data by collecting adequate, standardized data to identify and treat at-risk populations and better understand the issues facing communities. Effective public health interventions require robust data, and there are too many gaps to implement widespread interventions that work.

Something needs to be done because, for example, the National Institutes of Health reported today that

Overdose deaths involving methamphetamine nearly tripled from 2015 to 2019 among people ages 18-64 in the United States, according to a study by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. The number of people who reported using methamphetamine during this time did not increase as steeply, but the analysis found that populations with methamphetamine use disorder have become more diverse. Published today in JAMA Psychiatry, the study suggests that increases in higher-risk patterns of methamphetamine use, such as increases in methamphetamine use disorder, frequent use, and use of other drugs at the same time, may be contributing to the rise in overdose deaths.

“We are in the midst of an overdose crisis in the United States, and this tragic trajectory goes far beyond an opioid epidemic. In addition to heroin, methamphetamine and cocaine are becoming more dangerous due to contamination with highly potent fentanyl, and increases in higher risk use patterns such as multiple substance use and regular use,” said NIDA Director Nora D. Volkow, M.D., one of the authors of the study. “Public health approaches must be tailored to address methamphetamine use across the diverse communities at risk, and particularly for American Indian and Alaska Native communities, who have the highest risk for methamphetamine misuse and are too often underserved.”

Midweek update

As we approach the September 17 of the FDA advisory committee meeting on the COVID-19 booster, the Wall Street Journal reports that

The Food and Drug Administration said vaccines cleared in the U.S. currently provide sufficient protection against severe disease and death from Covid-19 without additional doses, potentially complicating the Biden administration’s deliberations over the need for booster shots.

The FDA released the findings Wednesday in a report analyzing data submitted by Pfizer Inc. and BioNTech SE as part of their request for authorization for their vaccine to be given as a booster shot in people 16 years and older. 

An outside panel of scientific advisers will review the FDA report on Friday, along with a companion analysis from Pfizer and other information, as part of a discussion over who needs booster shots and when.

In yesterday’s blog post, National Institutes of Health (NIH) Director Dr. Francis Collins tells us that

There’s no question that vaccines are making a tremendous difference in protecting individuals and whole communities against infection and severe illness from SARS-CoV-2, the coronavirus that causes COVID-19. And now, there’s yet another reason to get the vaccine: in the event of a breakthrough infection, people who are fully vaccinated also are substantially less likely to develop Long COVID Syndrome, which causes brain fog, muscle pain, fatigue, and a constellation of other debilitating symptoms that can last for months after recovery from an initial infection. 

These important findings published in The Lancet Infectious Diseases are the latest from the COVID Symptom Study 

NIH announced today awarding

nearly $470 million to build a national study population of diverse research volunteers and support large-scale studies on the long-term effects of COVID-19. The NIH REsearching COVID to Enhance Recovery (RECOVER) Initiative(link is external) made the parent award to New York University (NYU) Langone Health, New York City, which will make multiple sub-awards to more than 100 researchers at more than 30 institutions and serves as the RECOVER Clinical Science Core. This major new award to NYU Langone supports new studies of COVID-19 survivors and leverages existing long-running large cohort studies with an expansion of their research focus. This combined population of research participants from new and existing cohorts, called a meta-cohort, will comprise the RECOVER Cohort. This funding was supported by the American Rescue Plan.

On a related note STAT News informs us that

A company is launching out of Stanford University on Wednesday to tackle one of the most enduring challenges of digitized medicine: How do you apply data from past patients to inform the care of new ones?

The company, named Atropos Health, is seeking to commercialize a consultation service designed to use mountains of existing data to quickly answer a wide range of pressing questions, such as which drug is most effective for certain kinds of cancer patients, or when antibiotics can be safely discontinued in the treatment of a particular infection.

That may seem ho-hum in a world where search engines enable instantaneous information retrieval in so many domains. But the health care industry has failed to harness that power, hamstrung by a lack of quality digital data and wary of the consequences of applying an answer incorrectly to the care of complicated human beings.

Good luck to Atropos.

In other healthcare news

  • Health Payer Intelligence usefully discusses how payers can cultivate consumer-centered digital innovation. Fierce Health reports on Blue Cross licensee Carefirst’s release of such an innovation. The innovation in this case is “a new virtual primary care practice called CloseKnit. CloseKnit will offer a slew of healthcare services in a virtual-first delivery model, including preventive care, urgent care, behavioral health care, care coordination and insurance navigation. Services are available through an app and are built to be affordable and transparently priced, according to the announcement. In-person care is provided through referrals to local providers.”
  • The Health Affairs Blog offers its insights into the proposed No Surprises Act rule on air ambulance and broker compensation reporting and HHS’s role in enforcing the new law.
  • The Department of Health and Human Services announced today that “more than 2.8 million people newly gained access to affordable health care under the Biden-Harris Administration through the 2021 Special Enrollment Period (SEP) on HealthCare.gov and State-based Marketplaces.. With the gains made during the SEP, there are now a record-breaking 12.2 million people enrolled in the federal and state marketplaces.”
  • Govexec tells us that “The Government Employees Health Association announced last week that federal employees enrolled in their Federal Employees Health Benefits Program insurance plans can receive a $75 credit on their wellness accounts, which are used to pay for health expenses like copays and prescriptions, until Dec. 31. Previously, the deadline to get the first dose of the vaccine was Sept. 6 for the incentive program, although proof of full vaccination was still required by the end of 2021. Now, in order to be eligible for the cash incentive, GEHA enrollees have until Dec. 31 to get their first dose and request the reward.”

Busy Thursday

Earlier today the President announced a comprehensive list of executive measures intended to stem the Delta variant of COVID-19 in our country. Here’s a Medscape article on this action.

One of the new measures replaces the President’s July 28 vaccination screening program for federal employees and federal government contractors with a vaccination mandate program described in this Federal News Network article. Here are links to the Executive Order for the federal employees program and the separate Executive Order for the federal government contractors program.

The Health and Human Secretary Xavier Becerra announced the Administration’s plan to lower prescription drug costs. In the FEHBlog’s view, the proposals build price controls on top of existing price controls. The president of PhRMA, the prescription drug manufacturer’s trade association, commented that

“What was released today is a laundry list of old partisan ideas and not a serious plan to address what patients pay out of pocket for prescription drugs. What it leaves out is any attempt to fix a broken insurance system that discriminates against sick patients and does nothing to hold insurers and middlemen accountable for pocketing savings from our companies that should go to patients to lower their costs.
 
“It’s hard to ignore the irony that this is being released the same day the White House is unveiling a separate plan meant to regain control of the Covid-19 pandemic. The biopharmaceutical industry is continuing to work around the clock against this pandemic while this same White House is trying to make it more difficult for our industry to continue the fight against this pandemic and plan for future health crises.” 

Alternatively and perhaps even worse for PhRMA, according to STAT News, “[S]everal advocates and lobbyists told STAT this week that lawmakers in the U.S. Senate] were zeroing in on the idea of setting prices based on the maximum price drug makers can charge several military health programs, including the VA’s, known as the Federal Ceiling Price. That price is calculated by reducing the average price paid by non-governmental wholesalers by roughly one-quarter.” This drug cost reduction initiative in its final form would be included in the $3.5 trillion budget reconciliation bill.

Yesterday, the actuarial consulting firm WillisTowersWatson released its 2021 Benefits Trend Survey.

More than two-thirds of respondents (69%) say integrating employee wellbeing into the benefit package will be the top strategic benefit objective over the next two years. Most employers (86%) cite employee emotional wellbeing as their top priority over the next two years, followed by physical wellbeing (68%) and financial wellbeing (67%).

According to the survey, employers are taking steps to support their employees’ health and wellbeing in four main areas:

Physical: Over three in four employers (77%) have added or enhanced online and virtual medical services, and over half (53%) plan to add more or enhance them in the next two years.

Emotional: 73% of employers plan to boost their support for mental health (stress, burnout and depression).

Financial: Nearly half of employers (47%) plan to add or enhance their support for financial wellbeing (savings, budgeting, loans and counseling).

Social: More than a quarter of employers (29%) plan to add or enhance support for social wellbeing (charitable donations, volunteer opportunities and social recognition).

The survey also revealed less than three in 10 employers (28%) believe their benefit programs enhance employee appreciation of the employment deal, and many are taking steps to boost support and communication. Over one-third (34%) are planning or considering the use of digital tools and technology to help employees feel connected and be productive; over half (52%) are planning or considering the use of personalized communication to specific segments of the workforce.

he Wall Street Journal”The coming flu season is on track to be much worse than the last cycle, according to health experts, who fear an influx of cases could further strain hospitals already overwhelmed by the Delta surge. The season could also strike earlier and more severely than usual, doctors and researchers said, because many people haven’t been able to build up their natural immune defenses while working from home and avoiding strangers.”

The Wall Street Journal reports that

The coming flu season is on track to be much worse than the last cycle, according to health experts, who fear an influx of cases could further strain hospitals already overwhelmed by the Delta surge.

The season could also strike earlier and more severely than usual, doctors and researchers said, because many people haven’t been able to build up their natural immune defenses while working from home and avoiding strangers [and children are back in school].

The FEHBlog got his flu shot today.

Today’s WSJ Future of Everything article informs us that

A sports injury or trauma to cartilage around the knee, hip or shoulder joint can lead to osteoarthritis later in life—or, worse yet, the need for a new joint. So can the wear and tear that comes with age. One day, new drugs and stem-cell therapies may stop the degeneration before it starts.

Researchers are developing new techniques to protect, repair and regrow articular cartilage, the layer of connective tissue that covers the ends of bones and enables joints to move smoothly, to stop the progression of osteoarthritis and curb the need for joint replacement surgery.

Now that could reduce healthcare spending.

Labor Day Sunday

Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

OPM published in the September 3, 2021, Federal Register an Interim Final Rule extending FEHB coverage to 125 Indian tribal “297 grant” schools as required by the Consolidated Appropriations Act, 2021 (“CAA”). This CAA provision “is expected to make FEHB accessible to approximately 4,328 tribal employees of [the newly] entitled schools.”

This CAA provision expanded an Affordable Care Act (“ACA”) provision that offered Indian tribal employers the opportunity to enroll their employees in FEHB.

Tribal employers began purchasing FEHB for their employees on March 22, 2012 with coverage effective on May 1, 2012. As of April 2021, 125 tribes participate in the FEHB Program, and there are 32,178 tribal employees for a total of 64,208 covered lives.

The FEHBlog was interested to read that OPM already has contracted with some of the newly entitled schools.

Four eligible tribally controlled schools elected to begin purchasing FEHB coverage for their tribal employees on May 1, 2021 with an insurance coverage effective date of May 1, 2021. As of July 2021, 7 tribally controlled schools have enrolled in the FEHB Program

Smooth sailing. The public comment deadline on the interim final rule is November 2, 2021.

From the holiday weekend miscellany department

  • Healthcare Finance News reports that “Aetna has agreed to team up with Autism Comprehensive Educational Services to establish an Institute for Quality targeted toward individuals and families impacted by autism spectrum disorder, among other special needs. Through the new national agreement, effective August 1, Aetna members now have access to value-based autism care from ACES clinical providers.” Smart move.
  • The American Hospital Association offers some reassuring words about the No Surprises Act. The FEHBlog expects that the law will protect consumers without disrupting healthcare networks but will increase administrative costs at least for 2022 as the out-of-network providers test the independent dispute resolution (“IDR”) system. Other CAA Division BB provisions scheduled for implementation after 2022, e.g., transitional care, provider non-discrimination rule making, do pose risks to provider networks.
  • On the technology front, Fierce Healthcare discusses Apple’s plans for its health app and the Wall Street Journal tells us that “The next frontier of at-home health tracking is flush with data: the toilet.” In nothing sacred?

Have a restful Labor Day.

Friday Stats and More

FEHBlog readers, hold onto your hats. The FEHBlog has changed the COVID-19 charts presentations which he had been using since April 11, 2020. He has broken out new weekly COVID-19 cases and deaths into completely separate charts which display only information for 2021. This allows you to appreciate the dramatic vaccination driven plunge in cases and deaths that occurred in the spring of this year and the Delta variant driven surge in cases and to a lesser extent deaths that have occurred since the beginning of July. And hopefully before long we will see a final plunge without another surge.

Here’s the usual chart of vaccinations administered and distributed on a weekly basis since mid-December 2020 through this past Wednesday, September 1.

The presentation change was prompted by the David Leonhardt column which the FEHBlog discussed mid-week and this blurb written by John Tozzi that appeared in one of the many Bloomberg emails that show up in the FEHBlog’s email box during the day.

Rewind to mid-March of last year. There was a feeling that a few weeks of sheltering at home, combined with aggressive testing, tracing and isolation, would contain the epidemic in the U.S., much as aggressive actions in China and South Korea had.

That turned out to be wrong, of course. Many experts overestimated Americans’ tolerance for mitigation measures and underestimated the virus’s stealth and persistence. Non-pharmaceutical interventions wouldn’t save us. The only way to end the pandemic was a vaccine.

This spring, with millions of shots administered each day in the U.S., there was hope that the inoculation campaign would put Covid mostly behind us — at least ending the surges that threatened to overwhelm hospitals. But again we were too optimistic about the willingness of Americans to get immunized and failed to account for the resilience of the virus and its variants. * * *

As a nation, the U.S. hasn’t put Covid behind us. The public health emergency formally declared almost 18 months ago remains in place. In its early weeks, it felt like one. Now the state of emergency feels perhaps less urgent but permanent. And that requires a cognitive shift.

But that shouldn’t mean complacency. Most Covid deaths are now preventable, and we should try to prevent them. * * * In places like the U.S., with abundant access to vaccines, we have more power than ever to shape the future course of the pandemic. The question is how we will use it. 

Very well put, Mr. Tozzi.

Also from the Delta variant front, here are a link to the CDC’s COVID-19 hospitalizations chart and a link to the CDC’s COVID Data Tracker Weekly Review which conveniently is issued on Friday afternoons.

Yesterday, the FEHBlog called attention to reports that the Food and Drug Administration wants to scale back the Administration’s COVID vaccination booster campaign set to launch on September 20, contingent upon necessary FDA and CDC approvals. The New York Times today writes at length on this matter. The FEHBlog personally has no problem with the system working.

Federal News Network reports that ‘More details are trickling out from the Biden administration about its vaccine and testing policy for federal employees and contractors. ‘Agencies should not ask federal employees to provide proof of their vaccination status, the Safer Federal Workforce Task Force said in a series of frequently asked questions updated Friday.

Here’s that new FAQ (there were several other new FAQs):

Q: Should agencies request documentation to verify an employee’s vaccination status?

A: Agencies should not request documentation to verify an employee’s vaccination status. If the agency receives a good faith allegation that strongly suggests that an employee made a false statement on the Certification of Vaccination form, the agency may request documentation as part of its investigation into the alleged false statement. If an employee who has attested to being vaccinated exhibits symptoms of COVID-19 illness, the agency should apply its safety protocols, but this is not an appropriate reason to request documentation to verify an employee’s vaccination status.

Federal News Network adds that

The administration’s latest guidance comes as the Government Managers Coalition, a group of five associations that represents federal supervisors, has asked the administration for more guidance and support to implement the new vaccine and testing policy.

“Agencies often interpret OPM guidance in different ways, as each organization views the guidance through different organizational structures and programmatic lenses and lexicons,” the coalition wrote Thursday in a letter to the Safer Federal Workforce Task Force. “This is confusing and problematic for our members who lack central, authoritative guidance.”

The coalition, which includes the Senior Executives Association, Federal Managers Association, Professional Managers Association, Federal Aviation Administration Managers Association and the National Council of Social Security Management Associations, reiterated many of the concerns they expressed to Federal News Network last week.

STAT News informs us that

The Biden administration on Friday unveiled a sweeping new biosecurity plan, outlining a $65 billion proposal to remake the nation’s pandemic preparedness infrastructure in the wake of Covid-19.

The new spending would represent one of the largest investments in public health in American history: During a press briefing, Eric Lander, the White House science adviser, likened the proposal to the Apollo program of the late 1960s.

The immense funding boost would target programs aimed at developing and manufacturing vaccines, treatments, and tests more quickly. It would also provide new money for laboratory capacity, viral detection mechanisms, and early warning systems.

Please Dr. Lander build flexibility and an appreciation of unknown factors in your plans.

Midweek update

Photo by Piron Guillaume on Unsplash

In addition to being Wednesday, today is September 1 which marks the beginning of at least three healthcare related observances”

  • Each September, the American Medical Association’s (AMA) Women Physicians Section (WPS) honors physicians who have offered their time, wisdom and support to advance women with careers in medicine.
  • September is Sepsis Awareness Month. Here is a link to the Center for Disease Control’s Sepsis awareness page.
  • September is also National Recovery Month. The AMA identifies four ways that the Biden Administration can reduce the number of drug overdose deaths.

From the Delta variant front

The FEHBlog’s favorite newspaper columnist is David Leonhardt who writes a morning column for the New York Times. Mr. Leonhardt raises questions often on the FEHBlog’s mind after exploring the question with experts.This morning he pondered whether

the Delta-fueled Covid-19 surge in the U.S. finally peaked?

The number of new daily U.S. cases has risen less over the past week than at any point since June. * * *

Since the pandemic began, Covid has often followed a regular — if mysterious — cycle. In one country after another, the number of new cases has often surged for roughly two months before starting to fall. The Delta variant, despite its intense contagiousness, has followed this pattern. * * *

In the U.S., the start of the school year could similarly spark outbreaks this month. The country will need to wait a few more weeks to know. In the meantime, one strategy continues to be more effective than any other in beating back the pandemic: “Vaccine, vaccine, vaccine,” as [University of Minnesota epidemiologist Michael] Osterholm says. Or as [Johns Hopkins epidemiologist Jennifer] Nuzzo puts it, “Our top goal has to be first shots in arms.”

Hope springs eternal.

Regading increasing the number of vaccinations, Bloomberg reports today that

Vaccine mandates are set to get more common in the workplace. 

A majority of U.S. employers — 52% — are planning or considering requirements for a Covid-19 shot by the end of the year, according to a survey released Wednesday by consultant Willis Towers Watson. That’s more than double the 21% of companies polled that currently have some form of mandate. 

The options vary, ranging from a strict order for all employees to limiting access to certain areas to inoculated workers. About 14% of respondents also said they are weighing a health-care surcharge for people who choose not to get the vaccine, while 1% are planning to impose one, according to the survey of 961 employers, conducted Aug. 18-25.

Also Fierce Biotech explores what’s next in the mRNA pipeline. Principally for the two COVID mRNA vaccine companies with large war chests

Moderna executives tout the company’s pipeline often—so we’ll be brief here. A cytomegalovirus candidate is the furthest along in the company’s prophylactic vaccine program, while other mid-stage assets include a personalized cancer vaccine and a localized regenerative therapeutic for the heart condition myocardial ischemia.

BioNTech, meanwhile, has dozens of assets in development for a host of common conditions: malaria, tuberculosis and even certain allergies. But where the German biotech is really making a mark is in oncology, where dozens of vaccines and therapeutics are in development. Just one is in phase 2: the Roche-partnered melanoma therapy BNT122. That drug is combined with Merck & Co.’s blockbuster Keytruda to treat metastatic melanoma in a study conducted with Roche’s Genentech.

The article also discusses where other large drug manufacturers stand in the developing market.

From the bankruptcy front, the Wall Street Journal reports that

OxyContin maker Purdue Pharma LP won court approval of a $4.5 billion bankruptcy settlement that shields its owners, members of the Sackler family, from lawsuits accusing them of contributing to the nation’s opioid epidemic in exchange for providing funding to combat the crisis.

Judge Robert Drain of the U.S. Bankruptcy Court in White Plains, N.Y., said Wednesday he will confirm a restructuring plan that will transform Purdue into a public benefit company and settle civil lawsuits filed by governments and opioid victims against the drugmaker and its owners. 

The ruling can be appealed by the handful of federal and state authorities that opposed Purdue’s bankruptcy-exit plan and argued at trial that the settlement structure is unconstitutional and the Sacklers aren’t contributing enough of their wealth. Purdue’s family owners collected more than $10 billion from the company between 2008 and 2017, about half of which went to taxes or was reinvested in the business.

From the miscellany front

  • Homeland Security Today informs us that “The Biden Administration, in a collaboration between the General Services Administration, the White House Office of Management and Budget, the Office of Personnel Management, the Cybersecurity and Infrastructure Security Agency, and the White House Office of Science and Technology Policy, announced the U.S. Digital Corps, a new two-year fellowship that will recruit early-career technologists to contribute to high-impact efforts across the federal government. This program will work to advance the Administration priorities of coronavirus response, economic recovery, cybersecurity, and streamlining government services.” Best of luck with this initiative.
  • The Washington Post reports that “Childhood obesity rose significantly during the pandemic,according to a new study. The greatest change was among children ages 5 to 11, who gained an average of more than five pounds, adjusted for height, according to the study published in Journal of the American Medical Association (JAMA) Network. For the average 5-year-old (about 40 pounds), that’s a 12.5 percent weight gain. For the average 11-year-old (about 82 pounds), it’s a 6 percent weight gain, according to the study. Before the pandemic, about 36 percent of 5- to 11-year-olds were considered overweight or obese, and that increased to 45.7 percent. ‘Significant weight gain occurred during the covid-19 pandemic among youths in Kaiser Permanente Southern California, especially among the youngest children,’ the study concluded. ‘These findings, if generalizable to the U.S., suggest an increase in pediatric obesity due to the pandemic.’” No bueno.
  • Employee Benefits News offers an engaging article titled “Affordable ways to help your employees tend to their mental health.

Weekend update

Photo by Dane Deaner on Unsplash

The Senate remains on a State work break this week while the House of Representatives has scheduled a few Committee meetings but no floor voting.

The CDC’s Advisory Committee on Immunization Practices meets tomorrow and Tuesday to discuss expanding Pfizer/Biontech boosters to the age 16 and older population. Currently the boosters are only available for the moderately and severely immunocompromised population. (N.B. In Monday’s New York Times David Leonhardt writes an insightful column on the expansion question. He suggests that COVID-19 vaccine immunity may not be waning enough to justify the expansion.

Immunity does probably wane modestly within the first year of receiving a shot. For this reason, booster shots make sense for vulnerable people, many experts believe. As Dr. Céline Gounder of Bellevue Hospital Center told my colleague Apoorva Mandavilli, the C.D.C.’s data “support giving additional doses of vaccine to highly immunocompromised persons and nursing home residents, not to the general public.”

The current booster shots may do little good for most people. The vaccines continue to provide excellent protection against illness (as opposed to merely a positive Covid test). People will eventually need boosters, but it may make more sense to wait for one specifically designed to combat a variant. “We don’t know whether a non-Delta booster would improve protection against Delta,” Dr. Aaron Richterman of the University of Pennsylvania told me.

A national policy of frequent booster shots has significant costs, financially and otherwise. Among other things, the exaggerated discussion of waning immunity contributes to vaccine skepticism.

While Americans are focusing on booster shots, other policies may do much more to beat back Covid, including more vaccine mandates in the U.S.; a more rapid push to vaccinate the world(and prevent other variants from taking root); and an accelerated F.D.A. study of vaccines for children.

As always, we should be open to changing our minds as we get new evidence. As Richterman puts it, “We have time to gather the appropriate evidence before rushing into boosters.”

FCW interviewed “OPM’s Senior Advisor to the Director on Diversity, Equity, Inclusion and Accessibility Mini Timmaraju.” The President’s recent executive order on this topic set Oct. 3 as the deadline for agencies to finish a preliminary assessment of human resources practices and agency workforces.” Ms. Timmaraju’s team is helping other agencies prepare these documents. The article further explains that

At the same time, OPM is working on its own reorganization, which will reestablish an Office of Diversity, Equity, Inclusion and Accessibility as a standalone program office that reports directly to the OPM director.

It was absorbed into the Employee Services Center during the Trump administration, and its workforce has been “reduced” over the last four years, Timmaraju said.

Internal DEIA work at OPM is also moving from the agency’s Equal Opportunity Employment to Human Resources.

The new office will focus on governmentwide initiatives, according to OPM. It’ll have three sub-organizations, focused on policy and development, analytics and accountability and outreach and technical assistance.

The goal is to rightsize the team back to similar levels seen during the Obama administration, Timmaraju said. The office had 12 full-time equivalent employees in fiscal year 2016, according to budget documents.

OPM is also recruiting a Senior Executive Service-level director for the office. The job listing on USAJobs says that the agency is currently reviewing applications.

In healthcare news

  • The Wall Street Journal reports that “CVS Health is among several retailers including Walmart Inc. and Walgreens Boots Alliance Inc.,that are experimenting with offering counseling services in or near stores. They see potential as the Covid-19 pandemic has prompted more people to seek help for addiction, depression and other issues, according to federal data. “It’s creative and we certainly need the help,” said Ken Duckworth, medical director of the National Alliance on Mental Illness. “It’s an interesting idea to post a mental-health resource at a place where people already are at.” The FEHBlog heartily agrees.
  • The Food and Drug Administration approved on Friday August 27 “the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke—a stroke caused by a blockage of blood flow to the brain with long-lasting symptoms—using vagus nerve stimulation (VNS). ‘People who have lost mobility in their hands and arms due to ischemic stroke are often limited in their treatment options for regaining motor function” said Christopher M. Loftus, M.D., acting director of the FDA’s Center for Devices and Radiological Health’s Office of Neurological and Physical Medicine Devices. “Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation. Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke.’” Cool.
  • The Drug Enforcement Administration offers ten strategies for keep youngsters and teenagers off drugs. A friend of the FEHBlog, who is a psychiatrist explained that brain development continues until the mid-twenties. If you start a bad habit before your late twenties it will be harder to break than a bad habit that begins after the mid-twenties. Business Insider sums it up as follows: “Neuroscientists are confirming what car rental places already figured out — the brain doesn’t fully mature until age 25. Up until this age, the prefrontal cortex — the part of the brain that helps curb impulsive behavior — is not yet fully developed.”

Friday Stats and More

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 33rd week of this year (beginning April 2, 2020, and ending August 18, 2021); using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through August 18, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 18, 2021, which also uses Thursday as the first day of the week:

Here’s a link to the CDC’s weekly interpretation of its COVID-19 statistics.

Politico reports that “More than one million Americans received a dose of Covid-19 vaccine on Thursday[August 19] , a benchmark the nation has not met in nearly seven weeks amid a resurgence of the coronavirus pandemic.”

HealthDay informs us that

Antibodies generated by COVID-19 vaccines are effective against the Delta variant and other coronavirus variants of concern, new research shows.

The findings may help explain why most vaccinated people have avoided the surge of Delta variant cases sweeping across the United States.

“In face of vaccination, Delta is relatively a wimpy virus,” said study co-author Ali Ellebedy, an associate professor of pathology and immunology at Washington University School of Medicine in St. Louis.

Good to hear.

The Wall Street Journal tells us that

The Food and Drug Administration is expected next week to grant full approval of the Covid-19 vaccine from Pfizer Inc. and partner BioNTech SE, according to people familiar with the planning, an action that could spur more vaccination requirements by employers and encourage more people who are hesitant to get vaccinated. * * *

Once fully approved, the vaccine would be eligible for off-label prescriptions, such as booster doses, according to the FDA. However, analysts said, the critical element for broad boosting is a recommendation from the Advisory Committee on Immunization Practices to the FDA, as physicians often follow ACIP recommendations.

With full approval, Pfizer would likely be permitted to market the vaccine to doctors, providers and the general public as it does with other approved products. The FDA is permitted to restrict such communications with emergency authorization.

The Journal adds that

Of the three authorized vaccines in the U.S., only Pfizer has submitted all the required information to the FDA, according to the companies, and analysts expect it to be the first receive clearance. 

Moderna Inc., whose authorized two-dose shot uses similar mRNA technology as the Pfizer-BioNTech, has said it is still completing rolling data submissions.Johnson & Johnson, whose shot was authorized in February, has said it plans to file for full approval later this year.

Fierce Healthcare reports that Janet Woodcock will not be nominated for a promotion from acting to permanent Food and Drug Commissioner due in large part to Aduhelm fallout.

From the regulatory front

  • After issuing a minimalist Affordable Care Act (“ACA”) FAQ 48 earlier this week, the ACA regulatory departments issued a blockbuster ACA FAQ 49 about payer transparency rule implementation and enforcement delays and answering many No Surprises Act (“NSA”) implementation issues left hanging by the first NSA interim final rule (“IFC”) released July 1.
  • OMB’s Office of Information and Regulatory Affairs (“OIRA”) has scheduled more meetings on the second No Surprises Act IFC which concerns the independent dispute resolution process. Those listening sessions now run late into next week. That means that the IFC won’t be released before the week of August 30 but that still would be about a month before the statutory deadline.
  • The American College of Emergency Physicians and Blue Cross each met with OIRA this past week. Here are links to their supporting letters. BCBSA OIRA IDR 8.17.21.pdf and ACEP EDPMA Pre-IDR Rulemaking Letter (8.10.21).pdf Common sense as expressed in the Blue Cross letter must prevail if the parties want to avoid having the second IFC also create major system changes.
  • The Society for Human Resource Management informs us that “covered employers [such as FEHB plan carriers] now have until Oct. 25 to file their 2019 and 2020 EEO-1 reports, according to a recent announcement from the U.S. Equal Employment Opportunity Commission (EEOC). Although the reporting deadline has been delayed several times during the COVID-19 pandemic, the agency said it will not authorize any more extensions.”