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.”

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