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.

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 —

• MedCity News reports that

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.”

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.”

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.

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.