Weekend update

Weekend update

Lincoln Memorial in the Fall

The Senate is on a State work break this week which includes the Veterans’ Day holiday on Thursday. The House of Representatives is not holding votes this week but a handful or so of Committee hearings are scheduled for Tuesday and Wednesday.

Roll Call tells us that

Buoyed, finally, by forward movement on a larger package of President Joe Biden’s domestic priorities, the House late Friday cleared a Senate-passed bipartisan infrastructure bill that pours billions of dollars into roads, bridges, water systems, transit and broadband.

The long-awaited House vote sends the bill, which passed the Senate in August, to Biden for his signature. 

The House vote was 228-206, with 13 Republicans backing it despite GOP leadership whipping against the bill. All but six Democrats voted for the measure, despite the House not voting in tandem on the larger budget reconciliation package as progressives had demanded for months. 

Instead, Democrats were forced to accept a vote to adopt the rule that sets debate parameters on the reconciliation bill as a sign of progress on that measure. 

Under that rule, the House is expected to vote on the social spending / climate budget reconciliation bill during the week of November 15. The additional week is expected to allow the Congressional Budget Office to release its report on this massive spending bill

With respect to the infrastructure bill the Wall Street Journal explains that ‘

The $1 trillion package would invest in refurbishing aging roads, bridges and ports; easing transportation bottlenecks; replacing harmful lead pipes; expanding internet access; upgrading the nation’s power grid; and boosting infrastructure resilience amid growing concerns over climate change. The spending is to be paid for with a variety of revenue streams, including more than $200 billion in repurposed funds originally intended for coronavirus relief but left unused; about $50 billion from delaying a Trump-era rule on Medicare rebates; and $50 billion from certain states returning unused unemployment insurance supplemental funds.

From the COVID vaccine mandate front, the Wall Street Journal reports that the U.S. Court of Appeals temporarily stated the OSHA vaccination screening program rule applicable to private sector employers with 100 or more employees plus the Postal Service.

A three-judge panel on the New Orleans-based Fifth U.S. Circuit Court of Appeals granted an emergency stay prohibiting enforcement of the rules for now, saying they raise “grave statutory and constitutional issues.” The Fifth Circuit said it would quickly consider whether to issue an injunction against the vaccine and testing requirements, ordering the Biden administration to file initial legal papers by late Monday afternoon.

OSHA issued this emergency rule under a law providing that challenges to such rules should be brought in the U.S. Court of Appeals rather than the lower District Courts. That’s a quicker path to Supreme Court review.

Roll Call discusses federal government contractor concerns about legal risks arising from the unclear federal vaccine mandate. The Federal Acquisition Regulation implementing the President’s executive order is still weeks away. In the meantime, contractors have to rely on the Safer Federal Workforce Task Force’s subregulatory FAQs. The Task Force typically issues new FAQs on a weekly basis.

From the Delta variant front, the American Medical Association discusses the available evidence on the utility of COVID booster mixing and matching which the Food and Drug Administration recently authorized.

In other vaccine news, Precision Vaccines reports on a Lancet study on the high value of HPV vaccine:

The Lancet published a review of the UK’s national human papillomavirus (HPV) vaccination program and its positive impact on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence.

Published on November 3, 2021, this observational study shows the use of HPV vaccines dramatically reduces cervical cancer rates by almost 90% in women in their 20s who were offered the vaccine beginning at age 12.

These researchers estimated that the HPV vaccination program prevented around 450 cervical cancers and about 17,200 cases of precancerous conditions over 11 years.

HPV vaccination was most effective when given between the ages of 11 and 13 when someone is less likely to have been exposed to HPV.

“It’s a historic moment to see the first study showing that the HPV vaccine has and will continue to protect thousands of women from developing cervical cancer,” stated Michelle Mitchell, Cancer Research UK’s chief executive, in a related press statement.

The HPV vaccine when administered to boys protects against male cancers according to the CDC’s website. “The U.S. FDA has approved different types of HPV vaccines listed on this Precision Vaccinations webpage.”

Last but not least tomorrow is the opening day for the Federal Employees Benefits Open Season for 2022. Here’s a link to today’s FedWeek report on the big day. “There will be 275 [FEHB] plan choices—down by one after a few dropouts and additions—including 18 nationwide plan choices open to all, four available only to certain groups, and the rest available regionally.” December 13 is the closing day of this Open Season.

Thursday Miscellany

From the Delta variant vaccine front, The American Hospital Association informs us that

  • The Centers for Medicare & Medicaid Services today issued an interim final rule requiring COVID-19 vaccinations for workers in most health care settings, including hospitals and health systems, that participate in the Medicare and Medicaid programs. The rule is effective Nov. 5. Under the regulation, all eligible workers must be fully vaccinated by Jan. 4, 2022.
  • Also this morning, the Occupational Safety and Health Administration (“OSHA”) issued an emergency temporary standard requiring all employees at private businesses with 100 or more workers to be vaccinated by Jan. 4 or get tested for COVID-19 weekly.

The Society for Human Resource Management (SHRM) provides us with SHRM’s Top Takeaways from the OSHA ETS:

  • Employees must be fully vaccinated by January 4, 2022, and employers must require unvaccinated employees to mask and produce a negative test on at least a weekly basis.
  • Employers are required to have a written vaccination policy.
  • The OSHA ETS does not apply to employees who do not report to a workplace where there are other individuals such as coworkers or customers are present; employees working from home; or employees who work exclusively outdoors.
  • The OSHA ETS does not require employers to provide or pay for tests.
  • Employers must pay employees for the time it takes to get vaccinated.
  • Employers must ensure all unvaccinated employees are masked.
  • Employers must report COVID-19 fatalities and hospitalizations to OSHA.
  • The OSHA ETS reaffirms that employers must provide reasonable accommodations.
  • According to the Department of Laborvaccine, testing and face-covering requirements preempt inconsistent state and local requirements.

Closer to home, the OSHA ETC does not apply to workplaces subject to EO 14042 on Requiring Coronavirus Disease 2019 Vaccination for Federal Contractors. However, Govexec points out that

“Under the [Occupational Safety and Health Act], the U.S. Postal Service is treated as a private employer,” said OSHA’s emergency temporary standard, set to officially publish in the Federal Register on Friday. “It is therefore required to comply with this [emergency temporary standard] in the same manner as any other employer covered by the act.” 

The [Labor Department] spokesperson added that there are about 500,000 postal workers and confirmed that the rule applies to all of them.

Federal New Networks adds that

The Biden administration on Thursday pushed back the deadline for federal contractors to comply with its vaccine mandate.

Contractors now have until Jan. 4, 2022, the same deadline the White House set for private sector companies with 100 employees or more to comply with vaccine and testing requirements from the Labor Department’s Occupational Safety and Health Administration. * * *

The White House said it will not apply the OHSA emergency temporary standard or the CMS rule to workplaces subject to the federal vaccine mandate for contractors, so employers won’t have to track multiple requirements.

While federal contractors now have the same Jan. 4 deadline as other private sector companies, there’s a key difference between the two policies.

Under the new OSHA standard, companies with 100 employees or more have to ensure their workers have received either one or both shots by Jan. 4 — or tests for COVID-19 at least weekly.

Under the federal vaccine mandate for contractors, employees don’t have the option to be tested weekly, at least not at this point.

Govexec reports that “The Office of Personnel Management on Wednesday reminded agencies that they must grant federal employees administrative leave to accompany their children to get the COVID-19 vaccine, following the news that more children are now able to get vaccinated.” It would be helpful if OPM gave direct guidance to FEHB carriers on the contractor vaccine mandate.

From the Delta variant front, STAT News reports that

Britain granted conditional authorization on Thursday to the first pill shown to successfully treat Covid-19 so far. It also is the first country to OK the treatment from drug maker Merck, although it wasn’t immediately clear how quickly the pill would be available.

The pill was licensed for adults 18 and older who have tested positive for Covid-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate Covid-19 would take four pills of the drug, known molnupiravir, twice a day for five days.

An antiviral pill that reduces symptoms and speeds recovery could prove groundbreaking, easing caseloads on hospitals and helping to curb outbreaks in poorer countries with fragile health systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.

Molnupiravir is also pending review with regulators in the U.S., the European Union, and elsewhere. The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness in late November.

From the preventive care front —

The Associated Press informs us that

A government advisory committee on Wednesday recommended that all U.S. adults younger than 60 be vaccinated against hepatitis B, because progress against the liver-damaging disease has stalled. 

The decision means that tens of millions of U.S. adults — mostly between the ages of 30 and 59 — would be advised to get shots. Hepatitis B vaccinations became standard for children in 1991, meaning most adults younger that 30 already are protected.

“We’re losing ground. We cannot eliminate hepatitis B in the U.S. without a new approach,” said Dr. Mark Weng of the Centers for Disease Control and Prevention.

The Advisory Committee on Immunization Practices voted unanimously to approve the recommendation Wednesday. The CDC’s director, Dr. Rochelle Walensky, must sign off on it before it becomes public policy, but it’s not clear when she will decide.

The American Cancer Society tells us about the proper use of lung screenings to detect cancer in this Lung Cancer Awareness Month.

The Robert Woods Johnson Foundation has updated its report on the state of childhood obesity in our country.

From the healthcare business front —

Fierce Healthcare reports that

Cigna wrapped up third-quarter earnings for major national payers Thursday morning, where it reported $1.6 billion in profit for the quarter.

The results surpassed Wall Street expectations, according to Zacks Investment Research. Cigna also brought in $44.3 billion in revenue in the third quarter, according to the earnings report, which also beat analysts’ projections.

Both figures were up significantly year over year, Cigna said. In the third quarter of 2020, the insurer earned $1.4 billion in profit and brought in $41 billion in revenue. * * *

Due to the results, Cigna raised its guidance and now expects $20.35 in earnings per share for 2021. The insurer expects full-year revenues of $172 billion.

Fierce Healthcare also catalogs “new [healthcare M&A] deals that were revealed, closed or called off during the month of October.

In that regard Beckers Payer Issues reports that

UnitedHealth Group and Change Healthcare entered into an amended agreement with the Justice Department not to finalize the healthcare companies’ proposed $13 billion deal until late February.

Four things to know:

1. Under the new timing arrangement, the companies agreed not to consummate their deal before Feb. 22, 2022, according to Change Healthcare’s Nov. 3 earnings report

2. The new date amends a previous timing agreement announced in August, under which, UnitedHealth and Change agreed to wait at least 120 days after certifying compliance with the Justice Department’s request for more information. Both organizations had agreed to not certify compliance with the request before Sept. 15, meaning the 120 days would have expired in January 2022.

3. The organizations announced the proposed acquisition in January. Change shareholders approved the deal despite backlash from hospital groups arguing that the proposed combination is anticompetitive. 

4. On March 24, the Justice Department issued a second information request to the organizations. In the Nov. 3 earnings report, Change Healthcare shared that it and UnitedHealth “certified substantial compliance” with the second request.

Also STAT News provides a “progress report on Big Retail’s ambitions in health care.” This point impressed the FEHBlog

[T]he physical assets of retail players stand to give them a substantial leg up in parts of the country not already saturated by startups and other rivals, including the Midwest and broad swaths of the South.

“Most people in America live close to some of these retail giants and not to a health care provider,” said Gadelrab, who visited a Walmart for the first time to get tested for Covid-19.

Even for retailers’ significantly buzzier rivals, such as hybrid care startups Carbon Healthand women’s care-focused Tia, physical locations have remained a core part of their business models amid the pandemic, pitting their offerings somewhat against the services offered by Walmart, in particular.

“For us, the physical experience has been around making preventive health something women want to engage in before something is wrong,” said Carolyn Witte, Tia’s co-founder and chief executive officer.

That physical proximity could prove especially useful, Gadelrab said, as parts of the U.S. health care system begin to shift away from a fee-for-service treatment model to one based on value-based or preventive care, since it could theoretically allow retail giants to keep more consistent tabs on patients, much in the same way popular telehealth tools check in regularly with their users. At the same time, retailers also maintain reams of data on consumer health and wellness spending, and more recently, vaccination status — information that could be used to better inform their health care offerings or reach more potential clients.

Monday Roundup

Photo by Sven Read on Unsplash

From the Delta variant front —

  • The Wall Street Journal reports “Federal officials said they would do more to get over-the-counter Covid-19 tests to consumers, after some manufacturers have struggled to meet demand after the Delta surge drove increased demand from individuals, schools and businesses.” Better late, etc. Here’s a link to the HHS press release.
  • The Journal also reports that “Moderna Inc.’s MRNA 7.05% Covid-19 vaccine was generally safe and induced the desired immune responses in children ages 6 to 11 in a clinical trial, according to the company. The Cambridge, Mass., company said Monday that it would submit the results to health regulators in the U.S., Europe and elsewhere in seeking authorization to widen the use of its shots to include this younger age group. The company announced the interim data in a press release, and results haven’t yet been published in a peer-reviewed medical journal. * * * An FDA decision on the Pfizer vaccine in children [ages 5 to 11] could come soon, following an advisory panel meeting scheduled for Tuesday. 
  • The Centers for Disease Control informs us in a newly issued study on Delta variant cases

What is already known about this topic?

The SARS-CoV-2 B.1.617.2 (Delta) variant is highly transmissible; however, whether it causes more severe disease in adults has been uncertain.

What is added by this report?

Analysis of COVID-NET data from 14 states found no significant increases in the proportion of hospitalized COVID-19 patients with severe outcomes during the Delta period. The proportion of hospitalized unvaccinated COVID-19 patients aged 18–49 years significantly increased during the Delta period.

What are the implications for public health practice?

Lower vaccination coverage in adults aged 18–49 years likely contributed to the increase in hospitalized patients during the Delta period. COVID-19 vaccination is critical for all eligible adults, including adults aged <50 years who have relatively low vaccination rates compared with older adults.

From the COVID vaccine mandate front

  • The Equal Employment Opportunity Commission released new FAQ guidance on “Vaccinations – Title VII and Religious Objections to COVID-19 Vaccine Mandates.”
  • The Senate today confirmed the President’s nominee, Douglas Parker as Assistant Secretary of Labor in charge of the Occupational Health and Safety Administration by a 50 to 41 vote. Govexec adds that “Douglas Parker, most recently chief of California’s Division of Occupational Safety and Health, [will lead] the workplace safety agency that has about 1,800 employees. Parker previously served as deputy assistant secretary for policy in the Labor Department’s Mine Safety and Health Administration under the Obama administration and was part of the Biden transition team on worker health and safety issues.” OSHA is responsible for the pending vaccination screening program rule applicable to private sector employers with 100 or more employees.

On a related note, Federal News Network tell us that

The federal workforce used just slightly more than half of the funds Congress set aside earlier this year for a special emergency leave program.

The American Rescue Plan Act, which Congress passed into law in March, created a $570 million emergency paid leave fund that allowed federal employees to take time off for a variety of pandemic-related reasons.

Employees were each eligible for 600 hours, or 15 weeks, of paid leave to quarantine, recover from a personal infection or care for a family member sick with COVID-19. They could also use the emergency paid leave to recover from adverse symptoms after receiving the COVID-19 vaccine.

The Office of Personnel Management was responsible for administering the fund on behalf of the executive branch and U.S. Postal Service. OPM formally launched the program at the end of April.

Eligible federal employees had until Sept. 30 to request emergency paid leave, per the sunset date in the American Rescue Plan, or earlier if the funds were exhausted before that date.

From the cost and frequency of healthcare front —

  • The American Hospital Association issued a report about the cost of healthcare over the past decade / the first decade of the Affordable Care Act, particularly the cost of hospital care versus health insurance premiums.
  • Fierce Healthcare reports that “Common elective surgeries are starting to recover volume lost during COVID-19 lockdown measures, according to a new study by Epic Health Research Network. No common elective surgery is back at pre-pandemic volumes, though some are nearing it, the study found.”

From the Rx coverage front —

  • Healthcare Dive informs us that “National employer group the Purchaser Business Group on Health is starting a new company to develop healthcare products for large employers, frustrated by unmet need and rising costs. The venture, called Emsana Health, launched on Monday with its first business unit, a pharmacy benefit manager called EmsanaRx. Emsana will develop products designed with and for PBGH member organizations, which include Walmart, Costco, Microsoft, Intel and Tesla, among others, but products will be available to outside companies as well, a PBGH spokesperson confirmed.”
  • Fierce Healthcare adds that “The Mark Cuban Cost Plus Drug Company PBC also launched its own PBM this week, The Wall Street Journal reported. Cuban’s company aims to sell generic drugs at a transparent, fixed rate, and to achieve this united manufacturing, distribution and pharmacy services under one roof, according to the article. Cuban, a billionaire investor, told the WSJ he agreed to back the venture after receiving a pitch via email from its now-CEO, Alex Oshmyansky M.D., Ph.D. The PBM will begin to bid for clients next year and aims to be fully up and running by 2023, Oshmyansky told WSJ. “The supply chain for distributing pharmaceuticals to patients is so cumbersome and broken,” he told the outlet. “We decided the only way to get our drugs to the people who need them is to build a parallel supply chain where we have control of all the intermediary players and ensure the same level of transparency at every level.”
  • Health Payer Intelligence reports that “Prescription digital therapeutics (PDTs) coverage remains nascent, as the adoption rate is only at 40 percent among the minority of payers who have familiarity with PDTs, according to a survey that Avalere conducted for Pear Therapeutics. A post from the Institute for Patient Access defined PDTs most succinctly. ‘Prescription digital therapeutics are software programs that physicians prescribe as a form of treatment,’ the post explained. ‘The software captures patients’ information about symptoms or progress that can then be shared or remotely accessed by their providers. The technology has been found to help patients adhere to their treatment plans.’”

From the FEHB Open Season front, OPM today released a spreadsheet identifying those FEHB plans for which the 2022 employee contribution for self and one coverage will be more than the 2022 employee contribution for self and family coverage. In all cases the total premium for self and family coverage is more the total premium for self plus one coverage. The employee contributions become upside down due to the vagaries of the government contribution formula. It was a Congressional mistake to add the self plus one tier to FEHB given the relatively small family size in FEHB plans.

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.