Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

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

The Times also informs us that

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

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

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

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

Fingers crossed on the pill.

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

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

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

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

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

ACIP Ratifies FDA Approach to COVID-19 Boosters

In an audible triggered by yesterday’s decision, the CDC’s Advisory Committee on Immunization Practices considered at today’s meeting the FDA’s approach to COVID-19 boosters. AHIP informs us that

ACIP voted today to recommend a Pfizer-BioNTech COVID-19 vaccine booster dose for:

persons aged 65 and older and long-term care facility residents;

persons aged 50 to 64 with underlying medical conditions; and

persons based on individual benefit and risk who are aged 18 to 49 years with underlying medical conditions.

Following robust discussion about the risks and benefits of each option, ACIP ultimately voted to recommend a Pfizer vaccine booster dose, at least 6 months after the primary series, for persons aged 65 and older and long-term care facility residents (by a vote of 15-0), persons aged 50 to 64 with underlying medical conditions (13-2), and persons based on individual benefit and risk who are aged 18 to 49 years with underlying medical conditions (9-6).  

The Committee voted 9-7 against recommending a single Pfizer-BioNTech COVID-19 vaccine booster dose based on individual benefit and risk for persons aged 18-64 years who are in an occupational or institutional setting where the burden of COVID-19 infection and risk of transmission are high based on safety concerns and patient selection. 

ACIP only voted on boosters for individuals in each group who had previously received the initial series of the Pfizer vaccine; FDA indicated in its Emergency Use Authorization (EUA) that there was insufficient evidence to consider using a Pfizer booster in patients who received another vaccine in the initial series and thus it was not considered in the ACIP recommendations.

The next step in the health plan coverage process is for the CDC to ratify the ACIP decision. 15 days thereafter federal law requires health plans to cover the Pfizer-BioNTech booster in these scenarios with no member cost sharing in or out of network.

In additional news from that meeting, AHIP tells us that

ACIP also evaluated data on the COVID-19 vaccine in pregnant people and adverse outcomes associated with COVID-19 infection in this population. Data showed there is no indication that vaccines are associated with spontaneous abortion, birth defects, or stillbirths, but that pregnant people who were infected with COVID-19 exhibited increased risk of preeclampsia, preterm birth, NICU admission, and death. 

In related news, Bloomberg reports that

Pregnant women who get mRNA vaccines pass high levels of antibodies to their babies, according to a study published in American Journal of Obstetrics & Gynecology – Maternal Fetal Medicine on Wednesday.

The study — one of the first to measure antibody levels in umbilical cord blood to distinguish whether immunity is from infection or vaccines — found that 36 newborns tested at birth all had antibodies to protect against Covid-19 after their mothers were vaccinated with shots from Pfizer Inc.BioNTech SE or Moderna Inc. 

“We didn’t anticipate that. We expected to see more variability,” said Ashley Roman, an obstetrician at NYU Langone Health System and co-author of the study.

That is certainly good news.

From the health equity front —

  • The Government Accountability Office issued a health care capsule on this topic. GAO’s “2-page “capsule” draws from several GAO reports to provide examples of these health disparities, such as COVID-19, maternal mortality, chronic health conditions, as well as disparities among veterans. We also offer policy considerations to help the federal government better understand health disparities and promote health equity.”

Healthcare Dive reports that

Only 75 of the 3,000 hospitals ranked by the Lown Institute Hospitals Index scored top marks across all the metrics meant to evaluate social responsibility: equity, value and outcomes, according to a report out Tuesday.

None of the top 20 hospitals from the U.S. News & World Report rankings made the cut to the honor roll, largely because of low grades in equity, Lown Institute said.

The report also ranked states by which had the most socially responsible hospitals. Topping the list were Hawaii, Delaware, Washington D.C., Oregon and Colorado while at the bottom were Kentucky, Kansas, Alabama, Mississippi and Arkansas.

From the human resources front

  • InsuranceNewsNet informs us that “Almost one in seven Americans has absolutely no plan for their future financial and health care needs, new research suggests. A recent study of 2,000 employed Americans found that only 26% have a one- to four-year plan in place. * * * Conducted by OnePoll on behalf of Bend Financial, the study also discovered * * * more than half felt overwhelmed by the mountain of paperwork surrounding their benefit options.”
  • To that end, OPM is seeking to improve the FEHB enrollment process, and FedSmith offers the first article of 2021 on the upcoming federal benefits open season. The 2022 government contribution should be released soon according to an OPM benefits administration letter.

On the business front, Beckers Payer Issues reports on senior management changes at Cigna and its Evernorth subsidiary. Among other changes, “Subsidiary Evernorth President and COO Eric Palmer was promoted to company CEO and president. Mr. Palmer will be taking over Jan. 1, 2022 for outgoing CEO Tim Wentworth, who is retiring.”

From Capitol Hill – –

  • Roll Call reports on Democrat efforts to cobble together the enormous $3.5 trillion budget reconciliation bill so that a House vote on the bill can be held next week. “That ambitious timeframe, if it holds, would line up the multitrillion-dollar reconciliation bill with a vote on a smaller [one trillion] bipartisan infrastructure measure that may otherwise be defeated.”
  • In better news, from the FEHBlog’s standpoint, the Wall Street Journal tells us that “House Speaker Nancy Pelosi said Congress wouldn’t let government funding expire next week, the first hint that Democratic leaders might decouple the government’s funding from a contentious increase in the debt limit, on the same day that the Biden administration began preparing for a possible partial shutdown.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

On the Delta variant front and acccording to the CDC’s COVID Data Tracker, the United States reached two data points today — the number of COVID cases now exceeds 40 million and the percentage of Americans aged 18 and over who have received at least one dose of a COVID-19 vaccine reached 75%.

At the end of 2020, the number of cases according to the CDC stood at 20 million. In his blog, National Institutes of Health Director Francis Collins discusses a recent Nature study estimating that “the true number of [COVID] infections by the end of 2020 at more than 100 million [1]. That’s equal to just under a third of the U.S. population of 328 million. This revised number shows just how rapidly this novel coronavirus spread through the country last year. It also brings home just how timely the vaccines have been—and continue to be in 2021—to protect our nation’s health in this time of pandemic.” It also suggests to the FEHBlog that we may to closer to effective herd immunity in some areas of the U.S. than generally thought.

Also David Leonhardt in today’s New York Times tells us about another way to look at the situation.

The C.D.C. reported a terrifying fact in July: Vaccinated people with the Delta variant of the Covid virus carried roughly the same viral load in their noses and throats as unvaccinated people.

The news seemed to suggest that even the vaccinated were highly vulnerable to getting infected and passing the virus to others. Sure enough, stories about vaccinated people getting Covid — so-called breakthrough infections — were all around this summer: at a party in Provincetown, Mass.; among the Chicago Cubs; on Capitol Hill. Delta seemed as if it might be changing everything.

In recent weeks, however, more data has become available, and it suggests that the true picture is less alarming. Yes, Delta has increased the chances of getting Covid for almost everyone. But if you’re vaccinated, a Covid infection is still uncommon, and those high viral loads are not as worrisome as they initially sounded.

How small are the chances of the average vaccinated American contracting Covid? Probably about one in 5,000 per day, and even lower for people who take precautions or live in a highly vaccinated community. * * *

I will confess to one bit of hesitation about walking you through the data on breakthrough infections: It’s not clear how much we should be worrying about them. For the vaccinated, Covid resembles the flu and usually a mild one. Society does not grind to a halt over the flu.

In Britain, many people have become comfortable with the current Covid risks. The vaccines make serious illness rare in adults, and the risks to young children are so low that Britain may never recommend that most receive the vaccine. Letting the virus continue to dominate life, on the other hand, has large costs.

“There’s a feeling that finally we can breathe; we can start trying to get back what we’ve lost,” Devi Sridhar, the head of the global public health program at the University of Edinburgh, told The Times.

Well put, Mr. Leonhardt, as usual.

From the federal employee benefits front, OPM posted on the Federal Register website today a notice of changes to Federal Group Life Insurance premium rates for “Employee Basic Insurance, Option A (most age bands), Option B (most age bands), Option C (most age bands), and Post-Retirement Basic Insurance. These rates will be effective the first pay period beginning on or after October 1, 2021.”

From the tidbits department

  • Federal News Network reports that “The White House is proposing billions of dollars in supplemental funding for disaster relief and other programs, which it’s asking Congress to attach to a short-term continuing resolution that will be critical toward avoiding a government shutdown at the end of the month. ‘With the end of the fiscal year rapidly approaching, it’s clear that Congress will need to pass a short term continuing resolution to provide more time for the fiscal 2022 process to unfold,’ Shalanda Young, the Office of Management and Budget’s acting director, said Tuesday in a blog post.” 
  • Fierce Healthcare informs us that “The American Medical Association [“AMA”] released updates to its medical codes for 2022 with many tied to new technology services and the administration of COVID-19 vaccines. The AMA made 405 changes in the 2022 Current Procedural Terminology code set, including 249 new codes, 63 deletions and 93 revisions. The changes will take effect Jan. 1. ” The CPT is recognized as a HIPAA electronic transaction code set.
  • AP News reports that “Four companies in the drug industry said Saturday that enough states had agreed to a settlement of lawsuits over the opioid crisis for them to move ahead with the $26 billion deal. An announcement from the three largest U.S. drug distribution companies and a confirmation from drugmaker Johnson & Johnson, which had previously announced that it would move ahead, came Saturday. That was the deadline for the companies to decide whether there was enough buy-in to continue the settlement plan. * * * Together, the settlements are likely to represent the biggest piece of a string of settlements between companies in the drug industry and state and local governments over the addiction and overdose epidemic in the U.S.”
  • Healthcare Dive tells us that “The use of telehealth for patient visits seems to have leveled off at 20% or fewer of all appointments, more than a year and a half after COVID-19 first spurred an unprecedented jump in utilization, according to a new survey from KLAS Research and the Center for Connected Medicine.”
  • The AMA discusses “what doctors wish patients knew about a prediabetes diagnosis,” which of course is a fairly common diagnosis in our country.
  • The Wall Street Journal continues its series on the Future of Everything in healthcare with an article about sensor studded smart clothes. “From a prescription bra that signals cardiac arrest to a mosquito-proof textile, startups and scientists are developing garments for healthier living.”

Midweek update

Photo by Piron Guillaume on Unsplash

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

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

From the Delta variant front

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

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

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

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

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

Hope springs eternal.

Regading increasing the number of vaccinations, Bloomberg reports today that

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

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

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

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

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

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

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

From the bankruptcy front, the Wall Street Journal reports that

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

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

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

From the miscellany front

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

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From the Delta variant front —

Medscape reports on yesterday’s CDC Advisory Committee on Immunization Practices meeting:

“Vaccines remain effective in preventing hospitalization and severe disease but might be less effective in preventing infection or milder symptomatic illness,” Sara Oliver, MD, the CDC scientist who presented the information [about the mRNA vaccines], told the committee.

In a new data analysis released by the CDC on Sunday, unvaccinated adults were 17 times more likely to be hospitalized than vaccinated adults. Hospitalization rates were higher for unvaccinated people in all age groups.

Among the fully vaccinated, people who were hospitalized were much older, more likely to be nursing home residents and more likely to have three or more underlying medical conditions. Nearly a third had immunosuppressive conditions.

Healthcare Dive tells us that

The U.S. government will resume distribution of Eli Lilly’s COVID-19 antibody drug combination in a number of states, HHS said Friday, as cases and hospitalizations in the U.S. are driven higher by the spread of the delta variant.The decision comes roughly two months after administration of Lilly’s therapy was halted by U.S. officials due to concerns of reduced efficacy against coronavirus infections stemming from the beta and gamma variants. Those are now much less prevalent compared with delta, which laboratory testing has shown remains susceptible to treatment with the dual-antibody therapy, HHS said.

Fierce Pharma reports that

Last week’s FDA approval of Pfizer’s Comirnaty vaccine boosted consumer confidence among both vaccinated and unvaccinated people.

A Harris Poll survey over the weekend found that 80% of Americans who were aware of the approval now have more confidence in it. Even more encouraging? Almost half (49%) of unvaccinated people who heard about the approval said they will “probably” or “definitely” get vaccinated.

Overall awareness of the Pfizer approval was high—79% of those surveyed by The Harris Poll were aware of the FDA thumbs-up.

From the telehealth front, Kaiser Health News discusses re-emerging state law barriers to telehealth. “’The whole challenge is to ensure maximum access to health while assuring quality,’said Barak Richman, a Duke University law professor, who said laws and policies haven’t been updated to reflect new technological realities partly because state boards want to hang onto their authority.” The article provides an overview of options available to doctors and state boards.

From the miscellany front

  • Beckers Hospital Review unveils six big ideas in health innovation. For example, Jason Joseph. Senior Vice President and Chief Digital and Information Officer at Spectrum Health (Grand Rapids, Mich.). As we innovate, we are forcing hidden barriers into the light via experimentation. We saw so many of these barriers uncovered within health care, such as lack of connectivity, digital competency, and the need for comprehensive managed workflow. We have shined a spotlight on how much of healthcare relies on people and inconsistent manual processes to get through the system. That needs to change, and that also requires changing a leader’s traditional mindset.
  • The Agency for Healthcare Quality and Research is offering a toolkit to help healthcare providers and possible health plans get patients and members engaged with the diagnosis process.

The toolkit contains two strategies, Be The Expert On You and 60 Seconds To Improve Diagnostic Safety. When paired together, these strategies enhance communication and information sharing within the patient-provider encounter to improve diagnostic safety. Each strategy contains practical materials to support adoption of the strategy within office-based practices.

Be The Expert On You is a patient-facing strategy that prepares patients and their families to tell their personal health stories in a clear, concise way. Research suggests that 79 percent of diagnostic errors are related to the patient-clinician encounter and up to 56 percent of these errors are related to miscommunication during the encounter. Environmental scan findings show that inviting patients to share their entire health story, uninterrupted, and in a way that gives clinicians the information they need can reduce diagnostic errors.

60 Seconds To Improve Diagnostic Safety prepares providers to practice deep and reflective listening for one minute at the start of a patient-encounter. Research suggests that patients are interrupted by their providers in the first 11 to 18 seconds of telling their diagnostic story. Diagnostic safety can be improved when a provider allows a patient to tell his or her health story without interruption for one minute, and then asks questions to deepen understanding.

  • Not every innovative idea makes sense to implement though. The President and Democrat leadership in Congress want the Centers for Medicare Services to “negotiate” drug prices for Medicare Part D plans. Regulatory Focus informs us that “A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.”

Friday Stats and More

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 34th week of this year (beginning April 2, 2020, and ending August 25, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

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

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through August 25, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 25, 2021, which also uses Thursday as the first day of the week:

The cases, hospitalizations, and death charts move continue to move in the wrong direction. New vaccinations remain steady as people recognize that the Delta variant is more aggressive than the 2020 wave. If there is any bright side it is that the elderly (age 65 and older) who are at the greatest risk of death from COVID-19 are the most vaccinated group in the U.S. with 81.5% fully vaccinated and another 10% at the first dose stage.

For more stats, here’s a link to the CDC’s weekly interpretative review. “As of August 26, 2021, 203 million people in the United States have received at least one dose of a COVID-19 vaccine. 172 million people are fully vaccinated. That’s 60.8% of the eligible population (12 years and older). * * * COVID-19 vaccines remain the most powerful tool we have against COVID-19, making it critical that all people get vaccinated as soon as they are eligible. To find a vaccine provider near you, visit or your state or local public health department.”

The CDC also issued its 2021-22 flu season vaccination recommendations today.

Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. * * * Balancing considerations regarding the unpredictability of timing of onset of the influenza season and concerns that vaccine-induced immunity might wane over the course of a season, particularly for older adults, vaccination is recommended to be offered by the end of October. * * * Children aged 6 months through 8 years who require 2 doses (i.e., children in this age group who have never received influenza vaccine or who have not previously received a lifetime total of ≥2 doses; see Children Aged 6 Months Through 8 Years) should receive their first dose as soon as possible after the vaccine becomes available to allow the second dose (which must be administered ≥4 weeks later) to be received, ideally, by the end of October. Children of any age who require only 1 dose for the season should also ideally be vaccinated by the end of October; vaccination of these children may occur as soon as vaccine is available because there is less evidence to suggest that early vaccination is associated with waning immunity among children compared with adults.

Also from the Delta variant front

  • The Numbers columnist in the Wall Street Journal reports that “Medical studies often use thousands of volunteers. But sometimes good things come in small packages—like a handful of people willing to contract a deadly virus. Researchers in the U.K. have deliberately infected 30 volunteers with the virus that causes Covid-19, in the first human challenge study of the disease. Infecting the volunteers—who are healthy, unvaccinated and range in age from 18 to 30—will allow the scientists to observe in real time how the virus attacks the body and, from the moment of exposure, how the immune system responds. * * * [In contrast to a large clinical study involving the use of placebo] a human challenge study of a relatively small number of participants offers precise answers to specific questions, often related to immune response. Today, human challenges conducted under the supervision of institutional review boards are routinely used to research diseases such as influenza, malaria, cholera, salmonella, shigellosis and norovirus.”
  • The Journal also reports that British scientists are making progress in carefully growing the Delta variant for use in these human challenges. The U.S. is not conducting human challenges involving COVID-19 at this time.
  • The Journal also informs us that “U.S. intelligence agencies are unable to determine conclusively how the Covid-19 pandemic emerged, a summary of a classified report released Friday said.” The article concludes “In a July 27 letter to Mr. Biden, the Democratic and Republican leaders of the Senator Foreign Relations and Intelligence committees urged the president to carry on with the investigation until the intelligence community had reached conclusions on the origin of the pandemic with a high degree of confidence. The letter urged that the inquiry examine what U.S. government funding was provided to the Wuhan Institute of Virology for advanced virus research.”

In other news —

  • The Federal Times reports that “Federal employees will get a total 2.7 percent pay raise in 2022, as President Joe Biden informed Congress Aug. 27 that he intends to exercise his authority to determine federal pay rates during a state of emergency.” The increase will breaks down into a 2.2% general increase and a 0.5% locality pay increase.
  • Fierce Healthcare tells us that “OptumRx has released its quarterly look at the drug pipeline, and two of the therapies highlighted in the report target fairly common conditions. Finerenone, or the brand name Kerendia, was approved by the Food and Drug Administration on July 9. The drug treats chronic kidney disease and type 2 diabetes. Some 26.8 million Americans have been diagnosed with diabetes, and one in three eventually develop some kind of kidney disease. Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx, told Fierce Healthcare that the drug will be entering a market where many patients are already treated by low-cost therapies. “With the entrance of this drug, some patients are going to shift from a low-cost treatment to a higher-cost treatment,” he said. The other drugs highlighted in the report are: (1) Atogepant, which is pending a brand name, a drug that treats episodic and chronic migraines; (2) Odevixibat, or the brand name Bylvay, which treats progressive familial intrahepatic cholestasis, a liver disease, and (3) Maralixibat, which also has yet to set a brand name, treats Alagille Syndrome, a rare genetic disease of the liver.
  • Healthcare Dive informs us that “COVID-19 hospitalizations continue to rise as coronavirus cases surge across the U.S. This once again puts pressure on hospital operations and will likely put downward pressure on nonprofit hospital margins, according to a new report from Fitch Ratings. In some areas, hospitalizations are higher than they were during previous surges.”

Midweek update

From the Delta variant front, the Safer Federal Workforce group issued updated guidance for federal employees receiving a COVID-19 vaccine. In short, federal agencies should

  • Allow employees to take up to 4 hours of administrative leave to get any COVID-19 dose.
  • Allow employees to take up to 2 days of administrative leave for adverse reactions to any COVID-19 vaccination dose.

Federal News Network informs us that

Nearly one month after the Biden administration first announced plans to adopt a vaccine and testing policy for federal employees and contractors, managers — presumably the ones charged with implementing and enforcing the new program on the ground level — say they’re still looking for answers about how it’ll work. * * *

Guidance has been “minimal” and the planning to date has been “stressful” for managers and supervisors, said Craig Carter, national president of the Federal Managers Association.

Professional associations don’t have exact data and they’re relying on anecdotal conversations with their members about the vaccine. But considering a little more than half of all Americans are fully inoculated against COVID-19 — and the federal workforce is in many ways a representative subset of the American public — they assume roughly 50% of the nation’s 2.1 million federal employees are unvaccinated.

That means agencies may potentially need to test about 1 million federal workers once or twice a week, the associations said.

Few things drive the FEHBlog crazier than the use of the full U.S. population as a COVID-19 vaccination benchmark because people under age 12 cannot be vaccinated at this point. 62.7% of Americans over 18 and 81.3% of Americans over 65 are fully vaccinated according to the CDC website. The FEHBlog therefore expects that at least two thirds of federal employees are fully vaccinated. The percentage should skew higher because as the FEHBlog has noted about 20% of the federl workforce is under a COVID vaccination mandate as opposed to attestation. Nevertheless, testing about 600,000 federal employees once or twice a week is no picnic for federal managers.

The Wall Street Journal reports that

  • U.S. Covid-19 hospitalizations have surpassed 100,000 for the first time since January, nearly doubling since the start of August. While the figure remains below the country’s winter peak, hospitals in some parts of the U.S. are straining under the load, and officials in states including Georgia, Kentucky, Tennessee and Idaho have requested extra personnel and resources.
  • “Federal regulators are likely to approve a Covid-19 booster shot for vaccinated adults starting at least six months after the previous dose rather than the eight-month gap they previously announced, a person familiar with the plans said, as the Biden administration steps up preparations for delivering boosters to the public.”

The Journal also offers its perspective on the lay of the land for COVID-19 tests.

Employee Benefits News tells us that

According to the most recent Mental Health Index by Total Brain and the National Alliance of Healthcare Purchaser Coalitions, feelings of anxiety increased 94% from June to July, and incidences of PTSD have spiked 83% over the past six months.

While employees of all ages are struggling to maintain good mental health, workers aged 40-59 saw the highest increases in stress, anxiety and feelings of negativity, compared to July’s data. These workers cited return to work and back to school plans as the main drivers of their fears.

The average age of a federal employee is close to 50 years old.

From the federal employee benefits front, Reg Jones discusses the pluses and minuses of deferred annuities.

It’s a fact of life that many people work for a number of years in a job and, for one reason or another, leave before they are eligible to retire. What’s different for those who work for the federal government is that during their working time there, deductions have been taken from their pay toward a civil service annuity.

While many who resign from the government ask for a refund of those contributions, some do not (often because they were not even aware that they could). Those who leave their contributions in the fund – especially those who weren’t even aware that they could get a refund – are the people I want to talk to today, as well as any of you who are thinking about resigning from the government before retirement eligibility.

Here’s why: If you leave your contributions in the retirement fund, you will be entitled to a deferred annuity if you meet some fairly minimal requirements [as explained in the article].

In healthcare business news

  • Fierce Healthcare reports that “Hospitals and health systems’ economic recovery hit the brakes in July with mounting COVID-19 admissions, escalating expenses and early evidence that consumers are again postponing elective and outpatient care. Per the latest monthly report from Kaufman Hall, countrywide margins and volumes remained below pre-pandemic numbers but dipped most severely in the South and Midwest, where COVID-19 has had the greatest impact. The firm said it expects these trends to continue in the coming months.”
  • Healthcare Dive tells us that “GuideWell, the parent company of Blue Cross and Blue Shield of Florida, is set to acquire Triple S Management, the Blue Cross Blue Shield Plan and largest insurance carrier in Puerto Rico. The $900 million cash deal will add another company to GuideWell’s portfolio of health-focused subsidiaries. After the deal is complete, Triple S will become a wholly owned subsidiary of GuideWell and will continue to operate under the same brand name and management team, the two companies said Tuesday. The deal is expected to close in the first half of next year and is subject to regulatory approvals.”
  • Fierce Healthcare also reports that “Carbon Health, a primary care provider combining brick-and-mortar clinics with virtual services, bought two separate clinic chains to expand its national primary care footprint. The company bought Southern Arizona Urgent Care’s nine clinics in Tucson, Arizona, and Med7 Urgent Care’s four clinics in Sacramento, California, bringing its total to 83 clinics across 12 states. This acquisition underscores the company’s goal of becoming the largest national healthcare provider, fueled by its recent $350 million funding news.

Midweek Update

From the Delta variant front –

  • In a joint statement, a group of high ranking HHS public health experts explained today that

“We have developed a plan to begin offering [COVID-19 vaccination] booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster. We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them.

“We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”

The FEHBlog will be in line for his third dose of the Pfizer vaccine when the time comes.

  • The Wall Street Journal reports that “Early data from Israel suggests a booster shot of Pfizer Inc.’s Covid-19 vaccine can significantly improve immunity in those aged 60 and above, as the U.S. and other countries plan additional doses to increase protection against the highly infectious Delta variant.”
  • Health Affairs reports on a study suggest”[ing] that the early COVID-19 vaccination campaign was associated with reductions in COVID-19 deaths. As of May 9, 2021, reductions in COVID-19 deaths associated with vaccines had translated to value of statistical life benefit ranging between $625 billion and $1.4 trillion.” The smartest move that the government made was to prioritize the elderly who suffered the most deaths during the pre-vaccination era of COVID-19.

From the federal employee vaccination screening program front, the Safer Federal Workforce task force issued a set of FAQs on COVID-19 testing employees, contractors and visitors who cannot attest to receiving a COVID-19 vaccination. The FEHBlog was pleased to read that the FAQs impose the testing cost on the agencies, not on the FEHB Program, which is the proper legal outcome under the federal CARES Act (unnumbered FAQ 3). Federal News Network makes its own observations on the Testing FAQs here.

In healthcare utilization news, Healthcare Dive reports that

  • More than one in 10 adults ages 16 to 64 said they delayed or went without needed healthcare services due to virus fears in the past 30 days, an April survey from the Urban Institute funded by the Robert Wood Johnson Foundation found. 
  • One in 10 parents delayed seeking care for their children for that reason, according to the report published Wednesday.
  • Hispanic and Black adults, along with adults with lower incomes, reported delaying care at higher rates than other groups. Adults with chronic health problems were also more likely than those without such conditions to say they went without needed care.

It’s worth noting that this survey was conducted during the month that vaccinations became widely available and before the Delta variant broke out.

In other healthcare news

  • Govexec reports that “Officials at the Centers for Disease Control and Prevention announced on Wednesday that the agency is launching a new organization to focus on disease forecasting.  The Center for Forecasting and Outbreak Analytics will be a hub for research and innovation aimed at mitigating the effects of future disease threats. Its launch comes as the federal government continues to fight the coronavirus pandemic and now the rapidly spreading Delta variant. It will build on current modeling efforts at the agency. * * * The center’s initial funding will come from the $1.9 trillion American Rescue Plan enacted in March for coronavirus relief.”
  • The NCQA Blog discusses the hospital at home movement in the U.S. “Humana Home Solutions​ Vice President Dr. Amal Agarwal estimated that up to 35% of Medicare Advantage spending might be addressable at home. As Mayo Clinic Platform President John Halamka explained, hospital at home also “brings the family back into wellness.” This matters because family involvement affects patient satisfaction.” Interestingly the experts explained that hospital at home care is best suited for mid-level acuity patients, not folks who need the ICU or folks who don’t require hospitalization.

Dr. Halamka used an accessible and memorable analogy to outline the long-term possibilities for hospital at home.

He explained that the tractor manufacturing company John Deere transformed itself into a data company by covering its tractors with sensors. The sensors report back information about the weight and volume of crops that customers harvest—soybeans, for example. The predictive value of the information reported to John Deere is so high that the data are now used to forecast soybean prices.

Likewise, Americans are filling their homes and strapping to their bodies millions of behavioral and biometric sensors.

“We are instrumenting homes with sensors to gather patient data that we can use to understand not only that patient’s progression, but aggregating and analyzing that data [to] understand the progression of similar patients,” said Halamka.

Well put, Doctor.

  • In support of extending initiatives like this to rural areas of the country, the Department of Health and Human Services announced today “key investments that will strengthen telehealth services in rural and underserved communities and expand telehealth innovation and quality nationwide. These investments—totaling over $19 million—are being distributed to 36 award recipients,” such as “Telehealth Centers of Excellence (COE) program: $6.5 million is being awarded to 2 organizations to assess telehealth strategies and services to improve health care in rural medically underserved areas that have high chronic disease prevalence and high poverty rates. The Telehealth COEs will be located in academic medical centers and will serve as telehealth incubators to pilot new telehealth services, track outcomes, and publish telehealth research. The COEs will establish an evidence-base for telehealth programs and a framework for future telehealth programs.’

Midweek Update

Photo by Josh Mills on Unsplash

The American Hospital Association informs us that

The Senate early this morning approved on a party line vote a $3.5 trillion budget resolution, which included reconciliation instructions which will provide the majority party with the means to pass a comprehensive reconciliation package with just 51 votes in the Senate, rather than the usual 60-vote hurdle. The House will reconvene on Aug. 23 to consider the budget resolution. Once the resolution has passed both chambers, the House and Senate majorities can proceed with the reconciliation process, a resolution to which is expected in the fall. 

Bloomberg adds

Translating the budget framework into law will require Biden and Democratic congressional leaders keeping their party’s moderate and progressive wings marching together.

Just hours after passage of the budget blueprint, Senator Joe Manchin, a Democrat from West Virginia, said he couldn’t support a social spending bill with a $3.5 trillion price tag. Senator Kyrsten Sinema, an Arizona Democrat, has said the same. One Democratic objection is all it would take to scuttle the package in the Senate.

Time will tell but we are talking about $3.5 trillion on top of the $1 trillion infrastructure bill and multi-trillion COVID-19 relief bills that Congress has passed in the last 18 months. It appears that Congress is trying to disprove the adage that money can’t solve all problems.

One of the initiatives in the budget reconciliation package is to add dental, vision, and hearing coverage to Medicare. Kaiser Health News discusses the issue here.

From the Delta variant front

  • The Centers for Disease Control’s Advisory Committee on Immunization Practice released a helpful report on COVID-19 adverse side effects which it summarized as follows

What is already known about this topic?

Rare serious adverse events have been reported after COVID-19 vaccination, including Guillain-Barré syndrome (GBS) and thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccination.

What is added by this report?

On July 22, 2021, the Advisory Committee on Immunization Practices reviewed updated benefit-risk analyses after Janssen and mRNA COVID-19 vaccination and concluded that the benefits outweigh the risks for rare serious adverse events after COVID-19 vaccination.

What are the implications for public health practice?

Continued COVID-19 vaccination will prevent COVID-19 morbidity and mortality far exceeding GBS, TTS, and myocarditis cases expected. Information about rare adverse events should be disseminated to providers, vaccine recipients, and the public.

  • Forbes tells us that today “The Centers for Disease Control and Prevention encouraged anyone pregnant and breastfeeding to get vaccinated against coronavirus Wednesday, pointing to a growing amount of evidence that vaccines are safe and effective as new cases and hospitalizations linked to the virus surge across the country.” The Washington Post adds “Just 23 percent of pregnant women have received at least one shot of vaccine.”
  • Also from Forbes as schools begin to reopen “Vaccine rates among teenagers have remained lower than the U.S. population overall, with only 43% of 12- to 15-year-olds and 52.8% of 16- and 17-year-olds receiving at least a first dose as compared with 58.9% of the total population and 71.2% of adults.”
  • The Boston Globe discusses this teenage hesitancy issue — “The top reservation among parents of unvaccinated teens was the lack of information about the long-term effects of the shot, followed by concerns about side effects and fertility — despite conclusive evidence that the vaccine has no negative impacts on reproduction. Dr. Jill Kasper, a pediatrician at Cambridge Health Alliance, said she typically encounters ‘very little hesitancy’ from parents about routine adolescent vaccinations. That hasn’t been the case with COVID-19.”

The HHS Agency for Healthcare Quality and Research issued two noteworthy studies today. Here are the topline findings

  • #1 Overuse or low-value procedures may result in patient physical, psychological, or emotional harm. This study explored the association between eight low-value care procedures and length of stay (LOS) and cost. All eight procedures were associated with increased LOS and cost, particularly spinal fusion. Patients receiving low-value care may be exposed to increased risk of adverse events and hospital-acquired conditions.
  • #2 Medication administration errors made by parent or caregivers can result in medication errors at home. This systematic review found that 30% to 80% of pediatric patients experience a medication error at home, and that the risk increases based on characteristics of the caregiver and if a prescription contains more than two drugs.

Healthcare Dive informs us that

  • CVS Health said its Aetna unit will offer virtual primary care to self-funded employers nationwide in a move that underscores the growing popularity of telehealth services fueled by the COVID-19 public health emergency.
  • Using Teladoc Health’s physician-led care team model, the Aetna Virtual Primary Care service is intended to help strengthen the patient-doctor relationship and improve access to care, the vertically integrated company announced Tuesday. Members can receive health services remotely and in person.

Such support for primary care should be applauded.

In other healthcare news

  • STAT News reports that The Department of Veterans Affairs has decided not to cover a new Alzheimer’s drug from Biogen [Adulhelm], citing insufficient evidence of “a robust and meaningful clinical benefit” and concerns about safety. In a notice issued by the agency, the VA said it will make exceptions for “highly selected patients” and listed several hurdles that must be cleared before the medicine will be covered, such as requiring it to be prescribed by providers who specialize in treating dementia and ensuring patients had recently received MRI brain scans. * * * ‘Its bad news for Biogen,’ said Ira Loss of Washington Analysis, which tracks legislative and regulatory issues affecting the pharmaceutical industry for investors, who noted several private insurers have either declined or delayed coverage for the drug. ‘The VA is a big buyer of medicines. And you don’t like this kind of publicity, that’s for sure.’”
  • Fierce Healthcare continues to report from the HIMSS conference in Las Vegas. “Health IT giant Epic launched a new customer story-sharing website that lets Epic users share insights, tips and creative ideas around using health IT to improve their organizations and patient care. The site,, combines insights from industry leaders, quick tips on improving outcomes and performance, in-depth case studies as well as a “Hey Judy” column from Epic founder and CEO Judy Faulkner.”

Friday Stats and More

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 30th week of this year (beginning April 2, 2020, and ending July 28, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

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

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through July 28, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through July 28, 2021, which also uses Thursday as the first day of the week:

Due to the Delta variant, new cases and hospitalizations are trending up while new deaths have remained low for two months.

Happily COVID-19 vaccinations are trending up again. As of today according to the CDC, 60% of the U.S. population over age 18 and 80% of those over age 65 are fully vaccinated. GEHA, the largest employee organization plan in the FEHB, announced that it has extended its COVID-19 vaccine incentive program to Labor Day, September 6.

The CDC defended its new masking policy for the vaccinated population by pointing to a case in which as reported by the Wall Street Journal

127 vaccinated people infected with the Delta variant during the outbreak appeared to carry as much virus as 84 unvaccinated or partially vaccinated people who became infected. The report referred to an outbreak in Barnstable County, Mass. Local officials there have said that at least 430 confirmed Covid-19 cases have been linked to one cluster following festivities over the July 4 weekend in Provincetown, on the tip of Cape Cod.

Among the 469 cases linked to the Barnstable outbreak in the CDC report, nearly 75% were fully vaccinated. For people with breakthrough infections, almost 80% had symptoms of cough, headache, sore throat or fever. Four were hospitalized and no deaths were reported, the CDC said. Infected people reported attending densely packed indoor events and outdoor events at bars, restaurants and houses.

Toward the conclusion of the article the journalist speaks with Dr. Ashish Jha, dean of the public-health school at Brown University.

Dr. Jha said he thinks this week’s guidance recommending masking in high-risk areas of the U.S. was reasonable, but also risked suggesting that vaccines aren’t effective against the Delta variant, which could discourage unvaccinated people from getting shots. We have the tools to address this variant, and they’re called vaccines,” Dr. Jha said.

The FEHBlog certainly would wear a mask at an indoor or outdoor super spreader event in a high risk area like the one where the FEHBlog is temporarily living, Travis County Texas. It’s worth noting this US Health Weather map which gauges the risk of catching a respiratory infection like COVID-19 or the flu in a particular US county. Ironically, my county of permanent residence, Montgomery County, Maryland, is low risk.

STAT News adds that the Food and Drug Administration is accelerating the process of reviewing Pfizer-Biotech’s application for full marketing approval of their COVID-19 vaccine. (Moderna also has made this filing.)

A typical review of an application like Pfizer’s takes 10 months. The agency granted Pfizer a “priority review” for its vaccine earlier this month, which signifies that staff will strive to finish the review of the application within six months. At the same time, he FDA has said it does not expect the process to take that long — a view echoed even by President Biden.

“My expectation …  is that sometime, maybe in the beginning of the school year, at the end of August, beginning of September, October, they’ll get a final approval” Biden said last week when asked when the FDA would formally approve the Covid-19 vaccines, including the one developed by Pfizer and its partner BioNTech.

Jesse Goodman, who led the FDA’s biologics center from 2003 to 2009, said that the August-September time frame is “possible … if all goes smoothly.” He said the idea of a sprint is “reasonable,” so long the biologics center follows the normal chain of command for reviewing these applications.

In other news

  • Federal News Network tells us that “The House of Representatives on Thursday cleared a $600 billion package of seven spending bills, a small step forward in boosting civilian agency funding next year.The seven-bill “minibus” cleared the House Thursday afternoon by a 219 to 208 vote. The minibus is silent on federal pay for 2022, a silent endorsement of President Joe Biden’s proposed 2.7% raise for civilian employees. * * * The spending package also includes $42 million for the Office of Personnel Management over current levels and allows the agency to stand up an IT working capital fund.” The House is close to completing approval of the twelve appropriations bills. The Senate has not begun to vote on those bills and new federal fiscal year begins in two months, October 1.
  • The Congressional Budget Office released its financial analysis of the President’s budget proposal for the upcoming new federal fiscal year.
  • The ICD10 Monitor explains that yesterday the Centers for Medicare and Medicaid Services finalized four Medicare Part A payment rules which take effect on October 1 — skilled nursing facilities (SNFs), hospices,
  • inpatient rehabilitation facilities (IRFs), and inpatient psychiatric facilities (IPFs). The Monitor’s article summarizes each final rule.
  • The American Hospital Association offers a useful article on approaches to resolving COVID-19 vaccine hesitancy.
  • Fierce Healthcare informs us about insurer comments on the third 2022 Notice of Benefit and Payment Parameters, which proposed changes to the ACA marketplace.