Weekend update

CDC

Weekend update

David Ermer–CDC, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

The House and Senate are on district/state work breaks until April 13.

From the COVID-19 herd immunity front —

The FEHBlog always looks forward to the lead article in the Wall Street Journal’s weekend review section. Yesterday’s thought provoking article was headlined “Herd Immunity Won’t Save Us—but We Can Still Beat Covid-19 — Innovative contact tracing and just-in-time vaccination can get the pandemic under control—and prepare us for the next one.” The article, which was written by a group of epidemiologists, focuses on the worldwide eradication of smallpox which was quite an achievement in 1980 roughly 175 years after the smallpox vaccine was first administered. The article discusses the importance of the vaccine being able to prevent the disease in an infected, asymptomatic person which was the case with smallpox which had a 12 day incubation period.

Wikipedia notes

The 1947 New York City smallpox outbreak occurred in March 1947 and was declared ended on April 24, 1947. The outbreak marked two milestones for America. First, it was the largest mass vaccination effort ever conducted for smallpox in America, and second, it marked the last outbreak of smallpox in America. Within three weeks of the discovery of the outbreak, the U.S. Public Health Service, in conjunction with New York City health officials, had procured the smallpox vaccine and inoculated over 6,350,000 adults and children.[1]Of that number, 5,000,000 had been vaccinated within the first two weeks. The rapid response was credited with limiting the outbreak to 12 people, 10 of whom recovered, while 2 died.

The Wall Street Journal article explains that the COVID-19 vaccines also allow for just-in-time vaccinations:

Despite the rapid onset of viral infection (an average of 6 days after exposure, with a range of 2-14 days), Johnson & Johnson has reported success in preventing moderate to severe disease as early as 7 days after the administration of its single-dose vaccine. In a real-world study in Israel, the Pfizer vaccine also prevented severe disease soon after a single dose.

It is not too late to find, isolate and vaccinate those who do not yet have Covid-19 but are most likely to get it. It is not too late to use just-in-time vaccination to stop outbreaks in midcourse and prevent the spread of infection.

The Wall Street Journal in another herd immunity article reminds us that

“We definitely need to get kids vaccinated if we want to be as close to normal as we can,” said Octavio Ramilo, chief of infectious diseases at Nationwide Children’s Hospital, in Ohio. As governments push to move past the pandemic, vaccinating children is emerging as a key obstacle, along with initially limited supplies of vaccines.

Vaccines probably won’t be ready for use in younger children until early 2022, health experts said, in part because researchers need to test lower doses.

“The dose is not such a big leap to go from adults to teens,” said Katherine Luzuriaga, a pediatric infectious disease physician and the lead investigator of Moderna’s adolescent trial at the University of Massachusetts Medical School site. “Once we start going into the younger age groups, there’s a bit more work to determine the appropriate doses.”

As mentioned in Friday’s post, Pfizer and Moderna are testing on children. Vaccinating older high schoolers and college age kids which already is possible as the Pfizer vaccine is approved for persons over age 16 and the other two vaccines are available to persons over 18.

The FEHBlog believes that we should stay the current vaccination course until supply exceeds immediate demand likely in the next quarter of the year.

Vaccinating those at most risk of severe illness and death has been the first priority of vaccination drives. In most countries, that has meant giving priority to elderly citizens and those with conditions that heighten their risk of severe Covid-19.

The rate of hospitalization is 35 times as high, and the death rate is 1,100 times as high, among people 65 to 74 years old infected with Covid-19, compared with children ages 5 to 17, according to the U.S. Centers for Disease Control and Prevention. 

Health authorities say children don’t need to be vaccinated to start resuming certain activities like in-person learning at schools that are taking precautionary measures. Some experts caution against focusing too heavily on a specific herd immunity target, as building up population-level protection is an incremental process.

From the medical innovation front (non-COVID) —

  • Yesterday the Food and Drug Administration announced that marketing approval for

Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma.

“The FDA remains committed to advancing novel treatment options for areas of unmet patient need,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “While there is no cure for multiple myeloma, the long-term outlook can vary based on the individual’s age and the stage of the condition at the time of diagnosis. Today’s approval provides a new treatment option for patients who have this uncommon type of cancer.”

  • On Friday the FDA announced other hopeful news

The U.S. Food and Drug Administration approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs. The device is designed for patients who have severe pulmonary valve regurgitation (blood leaking backward into the right lower chamber of the heart), a condition that often results from congenital heart disease (CHD). The device, called the Harmony Transcatheter Pulmonary Valve (TPV) System, is intended to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation without open-heart surgery, which is the current standard of care. The use of the Harmony valve may delay the time before a patient needs additional open-heart surgery. It can also potentially reduce the total number of open-heart surgeries required over an individual’s lifetime.

CHDs affect nearly 1% of―or about 40,000―births per year in the United States.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, HSA, Telehealth, U.S. Healthcare, Uncategorized–

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 12th week of this year (beginning April 2, 2020, and ending March 24, 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 greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through March 24, 2021):

Finally here is a COVID-19 vaccinations chart for the past three months which also uses Thursday as the first day of the week:

The charts continue to look pretty good. As of today 34.6% of the U.S. population over 18 years old has received at least one dose of the COVID-19 vaccine and 46% of the U.S. population over 65 years old is fully vaccinated.

STAT News reports that

Pfizer and BioNTech said Thursday they are beginning a study aimed at showing their Covid-19 vaccine can be used in children as young as 6 months.

The study follows the launch of a separate and ongoing trial in children ages 12 to 15, which was fully enrolled in January. That study could lead to results by the end of the first half of the year, depending on the data, and then to an emergency use authorization. That will depend on the Food and Drug Administration and the Centers for Disease Control and Prevention. The vaccine already has an EUA for people 16 and older.

“The FDA, if it sees fit to do this, could, grant an EUA and get them into children in that age group by the fall, provided the CDC also agrees and that that should be the vaccine they receive,” said William Gruber, Pfizer’s senior vice president of vaccine clinical research and development.

Moderna began a similar study of their vaccine on children from age 6 months to 12 years old on March 16.

STAT News also offers “A user’s guide: How to talk to those hesitant about the Covid-19 vaccine.” Here’s one good idea:

Have a conversation

Don’t lecture your family and friends, and don’t assume you know what their concerns are. Make sure to listen.

“Try to address their concerns, not what you assume are their concerns,” said Jorge Moreno, an internist and assistant professor at the Yale University School of Medicine. While you may be thinking people are ensnared in the darkest of conspiracy theories, many may have concerns that are much simpler to address. For Moreno, who even had to convince his mother the vaccine was safe, many questions he’s received have centered around side effects, and whether they might make people too sick to work. A Carnegie Mellon University survey released this week showed 70% of vaccine-hesitant people were concerned about side effects.

“Let people know it’s OK to have questions and that having concerns is legitimate,” added Reed Tuckson, the former public health commissioner for Washington, D.C., and a founding member of the Black Coalition Against Covid, which co-developed a campaign called “The Conversation” to provide Black families credible vaccine information. “Letting people have a safe space to have this conversation is essential,” he said. “Wagging your finger against someone is not very useful.”

From the tax front:

  • The Internal Revenue Service recently announced that “amounts paid for personal protection equipment, such as masks, hand sanitizer and sanitizing wipes, for the primary purpose of preventing the spread of the Coronavirus Disease 2019 (COVID-19 PPE) are treated as amounts paid for medical care under § 213(d) of the Internal Revenue Code (Code). * * * Group health plans, including health FSAs and HRAs, under the terms of which expenses for COVID-19 PPE may not be reimbursed, may be amended pursuant to this announcement to provide for reimbursements of expenses for COVID-19 PPE incurred for any period beginning on or after January 1, 2020, and such an amendment will not be treated as causing a failure of any reimbursement to be excludable from income under § 105(b) or as causing a § 125 cafeteria plan to fail to meet the requirements of § 125.”
  • What’s more, Spotlight on Benefits explains how the IRS has clarified Pandemic-Related Relief for Dependent Care FSAs.

In healthcare business news, Healthcare Dive explains why being a hospital chief financial officer is a particularly tough job during the pandemic. Also Fierce Healthcare discusses a CIGNA telehealth study finding that

while virtual visits for other types of services declined after the initial COVID-19 spike, virtual visits for behavioral health remained in high demand. In April 2020, virtual visits made up about 50% of claims for non-behavioral health services and declined over the course of the year to account for nearly 25% today.

“Virtual behavioral health care is not only a way to access mental health services in the wake of social distancing, but it also allows us the option to pursue treatment in the privacy and comfort of our own homes,” Lustig said.

By contrast, in April, 66% of office visits for behavioral health were conducted virtually, and it’s remained largely flat since.

Behavioral telehealth users also reported higher productivity at work, according to the survey. These patients reported a 45% decrease in sick days, compared to a 28% decrease in miss workdays among patients who did not use telehealth.

That’s good news for the spoke and hub telehealth companies and for health plans and consumers because the spoke and hub telehealth network therapists are in-network.

Midweek update

David Ermer–CDC, Congress, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Capitol Hill, STAT News reports that Senate leaders have reached an agreement to extend a Medicare pay bump for health care providers through 2021, a major lobbying win for hospitals.”

The Wall Street Journal reports two Senate confirmations in healthcare positions:

The Senate [today] confirmed Dr. Rachel Levine as assistant health secretary, making her the first openly transgender federal official approved by the Senate.

The vote was 52 to 48, largely along party lines, with GOP Sens. Lisa Murkowski of Alaska and Susan Collins of Maine joining all 50 Democrats.

The pediatrician and former Pennsylvania secretary of health helped steer the state’s response to Covid-19. She has also worked to increase awareness of equity issues that the LGBT community faces and is a professor of pediatrics and psychiatry at Penn State College of Medicine. 

and

Yesterday, the Senate approved Vivek Murthy, President Biden’s pick for surgeon general, by a 57-to-43 vote, marking his second stint in the post, which he held from 2014 through 2017. Dr. Murthy, who was co-chairman of Mr. Biden’s Covid-19 advisory board, has said he would use his position to provide science-based guidelines for ending the coronavirus pandemic.

From the COVID vaccine front, Medscape informs us that

White House officials said at a briefing Wednesday they are still anticipating updated vaccine data from AstraZeneca, after federal officials called Tuesday’s release of interim phase 3 data from the company “outdated information.”

“Right now, AstraZeneca is getting back with the Data and Safety Monitoring Board and will likely come out with an updated statement,” said Anthony Fauci, MD, a top COVID-19 official and chief of the National Institute of Allergy and Infectious Diseases, the agency that complained to the pharmaceutical company that their current information was “incomplete.”

Andy Slavitt, senior White House adviser for COVID-19 response, added: “Our takeaway is the importance of transparency and trust…. I would urge us not to focus on the process of the last couple days, but instead to focus on what really matters, which is what happens when these applications for these candidates are submitted to the FDA.”

FLASH — The Washington Post reported at 10:30 pm Wednesday night that

An updated company analysis of the coronavirus vaccine developed by AstraZeneca and the University of Oxford showed that the two-shot regimen was robustly effective — 76 percent at preventing symptomatic illness — according to a news release from the drugmaker late Wednesday.

The finding, only slightly lower than results announced days earlier, underscores that the vaccine being widely used by many countries appears to be a powerful tool to help end the pandemic. No severe cases of illness were reported in study volunteers who received the vaccine. Among people 65 and older, the vaccine was 85 percent effective, the company reported.

Yesterday, the FEHBlog watched a Wall Street Journal interview with Mr. Slavitt as part of the WSJ’s Health Forum. The FEHBlog really enjoyed this WSJ video featuring reporter Joanna Stern with a COVID vaccine hunter from New Jersey. It’s certainly worth five and half minutes of your day.

HR Dive reports that

Employers should offer paid sick leave to employees with “signs and symptoms” following COVID-19 vaccination, according to guidance updated March 16 by the Centers for Disease Control and Prevention.

Employers should consider on-site vaccination programs if they have a large workforce with predictable schedules and enough space to run a clinic that meets social distancing requirements, CDC said. Employers that choose to offer vaccinations should record each offer and employees’ decisions. Employers should consider off-site vaccination if they are a small- or medium-sized organization lacking the resources to host a vaccination clinic, it said.

The agency also said that whether an employer may require COVID-19 vaccinations is a matter of state or other applicable law but noted that exemptions may apply: Medical exemptions for people who are at risk for an adverse reaction because of an allergy to one of the components used in the vaccine or a medical condition; and religious exemptions for people who reject being vaccinated because of their religious beliefs.

In healthcare business news, Fierce Healthcare lets us know that

Uber is ramping up its prescription delivery business by teaming up with software company ScriptDrop. The ride-share giant will be the default delivery service for ScriptDrop pharmacies in 37 states and will eventually expand to others.

ScriptDrop works with some of the top grocery chains, pharmacy chains and health systems in the U.S., including Albertsons, Jewel-Osco, Safeway and Vons. Through the tie-up with Uber, those pharmacies will be able to leverage the company’s technology to deliver more prescriptions to more customers.

From the report front, the FEHBlog noticed

Finally March 22 to 28, 2021, is National Drug and Alcohol Facts Week. “Held since 2010, NDAFW brings teens and scientific experts together to discuss the scientific facts about drugs, as well as their potential health effects on teen bodies and brains. ”

Tuesday Tidbits

David Ermer–AHRQ, CDC, COVID-19 vaccine, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

Fortune offers an insightful story about CVS Health’s CEO Karen Lynch.

Smart Brief discusses news from last week’s AHIP National Policy Conference.

The Society for Human Resource Management offers a helpful list of American Rescue Plan Act provisions impacting employers.

Medscape encouragingly reports that

Vaccination of about 88% of Americans who received the first dose of Pfizer/BioNTech or Moderna’s COVID-19 vaccines was complete, a study of over 12 million people by the U.S. Centers for Disease Control and Prevention (CDC) showed. * * * According to the analysis, about 3% of people in the United States who received the first dose of either vaccine did not get the second dose needed to complete vaccination. The agency said 8.6% had not received the second dose, but were still within the allowable interval to receive it.

As of today, 64.6% of the U.S. population over age 65 has received at least one dose of the COVID-19 vaccine and 36.6% of that group (including the FEHBlog) are fully vaccinated.

Healthcare Dive informs us that “Independent primary care docs more financially stable, but fed up with vaccine exclusion.” The FEHBlog heard today that vaccine distribution will open to more sites of care, including physician offices, once the Food and Drug Administration gives full marketing approval to the COVID-19 vaccines. The FEHBlog, however, could not find a projected date for that action, but he will keep looking.

Healthcare Dive also reports that “Virtual care company Doctor on Demand and clinical navigator Grand Rounds have announced plans to merge, creating a multibillion-dollar digital health firm.” The companies’ joint press release explains

The new company will combine Grand Rounds’ data-driven clinical navigation platform and patient advocacy tools with Doctor On Demand’s preeminent virtual care offering to provide an unparalleled member experience. It will accelerate the adoption of virtual care in key areas including primary care, specialty care, chronic condition management, and behavioral health. Owen Tripp, CEO of Grand Rounds, will serve as the CEO of the expanded business. Both companies will continue to operate under their existing brands for the time being.

“No one has done this before, combining navigation and virtual care delivery. We think it’s the future,” said Owen Tripp, co-founder and CEO of Grand Rounds. “People make unguided healthcare decisions every day, often with higher costs and worse outcomes. Now, with Doctor On Demand, we’ll offer them coordinated support on all fronts—physical, behavioral, financial, administrative—and we’ll do it for everything from acute issues to life-long health. This is truly complete care, and it’s what we all need.”

“We’re building a next-generation virtual care company with a nationwide practice of diverse, dedicated providers and a multidisciplinary care team,” said Hill Ferguson, CEO of Doctor On Demand. “By fully integrating medical and behavioral healthcare with clinical navigation, we’re impacting healthcare where it actually happens—between a patient and their provider—and ensuring that experience is seamless, personalized, and can follow the patient wherever they go.”

In continuing recognition of Patient Safety Awareness Week, here are links to the Agency for Healthcare Research and Quality’s blog post on accelerating progress in patient safety and an AHRQ article on the importance of good communication skills to achieving patient safety.

Thursday Miscellany

David Ermer–ACA, CDC, Congress, COVID-19 vaccine, Federal employment benefits, OPM–
Photo by Juliane Liebermann on Unsplash

The President signed the American Rescue Plan (H.R. 1319) into law today.

Mercer provides a useful overview of the provisions of the law affecting employers. The COBRA subsidy discussed in the article does not apply to the temporary continuation coverage applicable to federal and postal employees. The COBRA subsidy in any event is only available to employees who lost health coverage due to involuntary termination of employment or reduction in hours.

On the bright side, the new law “increases the income exclusion for employer-provided dependent care assistance programs — for example, employee pretax contributions to dependent care FSAs — from $5,000 to $10,500 (and from $2,500 to $5,250 for a married individual filing a separate return) for 2021.” The FEHBlog expects that OPM will adopt this FSA change because the dependent care FSA is fully funded by the employee with no insurance risk to the employer.

Katie Keith in Health Affairs digs into the law’s financial support for the Affordable Care Act marketplace and its beneficiaries.

From the COVID front —

  • The White House has announced that the Biden administration will seek to “make every adult in the U.S. eligible for vaccination no later than May 1.” This fact sheet explains that steps that will be taken to make good on that plan.  The FEHBlog believes that this is an achievable goal.
  • David Leonhardt in the New York Times offers an interesting take on herd immunity from COVID-19. He explains that

Herd immunity is more like a light dimmer. The more people develop immunity — either from having been infected or from being vaccinated — the less easily the virus will spread.

Nearly 30 percent of Americans have now had the virus, according to Youyang Gu, a data scientist. (That includes many people who have never taken a Covid test.) About 18 percent have received at least one vaccine shot. There is some overlap between these two groups, which means that about 40 percent of Americans now have some protection from Covid.

Had these people been exposed to the virus a year ago, they could have become infected — and then spread Covid to others. Today, many are protected.

What’s more Mr. Leonhardt’s first dose of vaccination figure (18%) reflects the total U.S. population. However the vaccines generally are available only to people over 18 years of age. The Centers for Disease Control reports today that 25.1% of that population has received at least one dose of a COVID-19 vaccine. The FEHBlog nearly fell off his share today when he noticed a new statistic on the CDC site showing that 62.4% of the U.S. population over age 65 has received at least one dose of a COVID-19 vaccine. That’s great news.

In legislative / regulatory news —

  • Healthcare Dive reports that Xavier Becerra will soon receive a Senate floor vote on his nomination to serve as Secretary of Health and Human Services.
  • Govexec reports that “Postmaster General Louis DeJoy will soon request a $40 billion investment into the cash-strapped U.S. Postal Service for organizational and workforce improvements, saying the money will help address longstanding challenges the mailing agency faces.  The funds would go toward infrastructure updates such as larger facilities and new package sortation equipment, DeJoy told a panel of the House Appropriations Committee on Thursday [March 11], and reducing turnover in the USPS workforce.”
  • Healthcare Dive also discusses hospital pricing information that has been gleaned from the online reports required by the federal government’s hospital pricing transparency rule. It’s not pretty.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

Roll Call reports that the Senate continues to move forward its modified version of the American Rescue Plan which the House of Representatives passed last week. Here’s a link to the Congressional Budget Office’s report on the Senate bill.

The Senate Homeland Security and Governmental Affairs Committee held a confirmation hearing today on the President’s nominations of Shalanda D. Young to be Deputy Director, Office of Management and Budget, and Jason S. Miller to be Deputy Director for Management, Office of Management and Budget. Federal News Network sums up the hearing as follows: “President Joe Biden’s picks to serve in top positions at the Office of Management and Budget vowed on Thursday to remove hurdles from federal hiring, improve employee morale and help agencies keep their workforces safe during the pandemic.”

David Leonhardt of the New York Times does a great job putting the three current COVID-19 vaccines in perspective:

It’s the latest case of vaccine alarmism.

Many Americans are worried that Johnson & Johnson’s Covid-19 vaccine is an inferior product that may not be worth getting. Gov. Doug Burgum of North Dakota recently told The Washington Postthat he was now seeing not only “vaccine hesitancy” but also “the potential for brand hesitancy.”

The perception stems from the headline rates of effectiveness of the three vaccines: 72 percent for Johnson & Johnson, compared with 94 percent for Moderna and 95 percent for Pfizer. But those headline rates can be misleading in a few ways.

The most important measure — whether the vaccine prevents serious illness — shows the Johnson & Johnson vaccine to be equally effective as the other two. All work for nearly 100 percent of people. The picture is murkier for mild cases, but they are not particularly worrisome.

In promising news, STAT News reports that

Eli Lilly said Thursday that a study showed its experimental diabetes drug, tirzepatide, reduced patients’ blood sugar and body weight more than a rival medicine, Novo Nordisk’s Ozempic. The study compared three doses of tirzepatide — 5 mg, 10 mg, and 15 mg — to a 1 mg dose of Ozempic. Both drugs were given as injections. Tirzepatide reduced A1C, a measure of blood sugar levels, by 2.09% at the 5-mg dose, 2.37% at the 10-mg dose, and 2.46% at the 15-mg dose. For Ozempic, there was a 1.86% reduction. Patients were followed for 40 weeks.

Patients who received tirzepatide also saw their body weight decline by more than those who received Ozempic. They lost an average of 7.8 kilograms, or 8.5% of their body weight at the lowest dose, 10.3 kg, an 11% decrease, on the middle dose, and 12.4 kg, a 13.1% decrease, on the highest dose. For patients on semaglutide, the decrease in body weight was 6.2 kilograms, or 6.7%.

The differences were all statistically significant.

Lilly plans to virtually present the full trial results at the American Diabetes Association’s annual scientific conference in late June 2021.

In concerning news, the Centers for Disease Control informs us that “a new paper from CDC, in partnership with the University of Utah, estimates that the national healthcare costs associated with infections from six multidrug-resistant pathogens can be substantial at more than $4.6 billion annually.   This is one of the largest studies to estimate the cost associated with high-priority antibiotic-resistant pathogens. Issues highlighted in the study align with data and threats in CDC’s 2019 Antibiotic Resistance (AR) Threats Report. This includes the impact of resistant infections in the community, which can put more people at risk, make spread more difficult to identify and contain, and threaten the progress made to protect patients in healthcare.”  

Finally, Fierce Healthcare lets us know that

Greater liquidity, a stable payer mix and higher-acuity patients helped major hospital chains end 2020 with massive profits despite a financial roller coaster caused by the pandemic.

The latest earnings reports from several for-profit and not-for-profit hospital chains come as patient volumes continue to drift below pre-pandemic levels and as major hospital groups have raised the alarm about financial hardship faced by many hospitals around the country. 

And while plenty of health systems around the country are struggling, experts say many of the largest health systems around the nation have remained profitable.

[However] Rural and more independent and smaller facilities already operate on narrower profit margins which have been exacerbated by the pandemic. These financial headwinds could cause more consolidation among such facilities.

Thursday Miscellany

David Ermer–CDC, COVID-19, Employee Wellness Programs, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

In a welcome spurt of cautious optimism, Bloomberg reports this evening

The U.S. vaccine supply is poised to double in the coming weeks and months, according to an analysis by Bloomberg, allowing a broad expansion of doses administered across the country. * * * A review of drugmakers’ public statements and their supply deals suggests that the number of vaccines delivered should rise to almost 20 million a week in March, more than 25 million a week in April and May, and over 30 million a week June. By summer, it would be enough to give 4.5 million shots a day.  * * * The analysis assumes drugmakers will meet their new delivery targets — not a guarantee in a year-old pandemic where much has gone wrong.

The FEHBlog’s bet, for what it’s worth, is that Bloomberg’s analysis proves correct.

The urgency of rapid COVID-19 vaccine distribution is reinforced by the Centers for Disease Control’s report today that U.S. life expectancy dropped by one year during the first six months of last year.

For perspective, take a look at the American Medical Association’s interview of John Barry, the author of the Great Influenza. To wit –

In 1918, people didn’t buy the government’s take on the pandemic. They saw what was happening. The disease was much more virulent, killing between 50 million and 100 million people. That would be between 225–450 million people today after adjusting for population. In Philadelphia, Barry said, priests would drive horse-drawn carts down the street calling for people to bring out their dead.

Mr. Barry urges truth telling by all parties holding public trust. By the way, the Great Influenza is fascinating reading.

In regulatory news —

  • Fierce Healthcare informs us that “President Joe Biden has chosen Chiquita Brooks-LaSure to lead the Centers for Medicare & Medicaid Services (CMS), according to a report in The Washington Post.” This post requires Senate confirmation.
  • The National Law Journal reports that “The U.S. Equal Employment Opportunity Commission (EEOC) announced last Friday that it was withdrawing two proposed rules regarding the incentives employers can provide their employees as part of a wellness program without violating the Americans with Disabilities Act (ADA) or Genetic Information Nondiscrimination Act (GINA). Originally, the proposed rules had stated that, for the most part, employers could offer only “de minimis” incentives for employees participating in a wellness program—incentives that potentially could apply to employees receiving a coronavirus (COVID-19) vaccine. With the withdrawal of those rules, employers have little guidance in terms of what incentives, if any, they may offer employees”
  • The Health and Human Services Inspector General announced a court ordered delay in effective date of the Trump Administrations’ rule banning prescription drug rebates in Medicare Part D (but not the FEHBP) to January 1, 2023.
  • The Internal Revenue Service issued guidance implementing the following cafeteria plan changes created by the Consolidated Appropriations Act, 2021. The new law

Provides flexibility with respect to carryovers of unused amounts from the 2020 and 2021 plan years;

Extends the permissible period for incurring claims for plan years ending in 2020 and 2021;

Provides a special rule regarding post-termination reimbursements from health FSAs during plan years 2020 and 2021;

Provides a special claims period and carryover rule for dependent care assistance programs when a dependent “ages out” during the COVID-19 public health emergency; and

Allows certain mid-year election changes for health FSAs and dependent care assistance programs for plan years ending in 2021.

This notice also provides additional relief with respect to mid-year elections for plan years ending in 2021. 

Weekend update

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Uncategorized–
Photo by JOSHUA COLEMAN on Unsplash

Happy Valentines Day.

In the coming week, the Senate is on a State work period and the House of Representatives remains engaged in committee work. Fierce Healthcare reports that last Thursday

The House Ways and Means Committee voted 24-18 along party lines Thursday to approve a section of a $1.9 trillion COVID-19 relief package that includes the [two year long Affordable Care Act] subsidy boost. * * * [Also [t]he House Energy and Commerce Committee released legislation aimed at expanding Medicaid coverage and eligibility. * * * The legislation now moves to the House Budget Committee, which will roll it into the final package and send to the House floor [later this month].

On the COVID-19 vaccination front —

Students as young as first grade [age 6] might be able to get vaccinated against COVID-19 by September, White House chief medical adviser Dr. Anthony Fauci predicted in an interview published by ProPublica on Thursday.

Fauci cited clinical trials now underway in the U.S. from vaccine developers Pfizer and Moderna to test the safety and efficacy of the doses in children. He had said previously that the Food and Drug Administration might allow for vaccinations in American children “by the time we get to the late spring and early summer.” 

  • The Wall Street Journal reports that

Walmart Inc., the U.S.’s largest retailer and private employer, is set to become one of the biggest distributors of the Covid-19 vaccine as the federal government enlists retail pharmacies to accelerate what has been a choppy rollout.

Last week, 21 retail chains and pharmacy networks started administering those doses, including CVS, Walgreens, Kroger and grocers in all 50 states. The government initially plans to give around a million doses a week directly to pharmacies. Around 200,000 of those are going to Walmart, a spokeswoman said.

That is in part because out of the roughly 5,000 U.S. stores under the company’s Walmart and Sam’s Club banners, about 4,000 are located in what the federal government defines as medically underserved areas.

  • The Washington Post informs us about volunteer COVID-19 vaccine hunter who are helping the elderly get their protection. Bravo.
  • According to the CDC’s COVID-19 vaccine tracker, over six million doses COVID-19 vaccines were administered from February 11 through February 13. 38,292,270 Americans have receive their first dose and another 14,077,440 have received both doses of either the Pfizer or the Moderna vaccine. We are likely only two weeks away from the single dose Johnson & Johnson vaccine joining this portfolio.

Friday Stats and More

David Ermer–AHRQ, CDC, COVID-19, U.S. Healthcare–
Image result for abraham lincoln birthday

Happy Lincoln’s Birthday.

Based on the Centers for Disease Control’s COVID-19 Case Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through the 6th week of this year (beginning April 2, 2021, and ending February 10, 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 greatly exceed new deaths. Accordingly here is a chart of new weekly COVID-19 deaths over the period April 2, 2020, through February 10, 2021):

Finally here is a COVID-19 vaccinations chart from December 17, 2020, through February 10, 2021, which also uses Thursday as the first day of the week:

The Wall Street Journal sums it up well for this week :

U.S. Covid-19 deaths [a lagging indicator] appear to finally be slowing, following a broad and steep decline in both newly reported cases and hospitalizations in recent weeks.

While daily deaths remain near record highs, the average number of coronavirus-related fatalities has broadly fallen in recent days, dropping from a seven-day average of 3,172 on Feb. 1 to 2,765 on Wednesday, according to a Wall Street Journal analysis of Johns Hopkins University data.

Vaccinations, meanwhile, appear to be increasing, with about two million shots administered Thursday, according to a Wall Street Journal analysis of data from the Centers for Disease Control and Prevention.

In other vaccination news —

  • Medpage Today informs us about CDC changes to its adult and children vaccination recommendations which were released yesterday.
  • HR Dive reports that

The Society for Human Resource Management and 41 other business groups including the U.S. Chamber of Commerce have asked the U.S. Equal Employment Opportunity Commission (EEOC) to clarify “the extent to which employers may offer employees incentives to vaccinate.”

In a Feb. 1 letter to EEOC Chair Charlotte Burrows HR Dive obtained from the HR Policy Association, a signee, the groups wrote that incentives may aid in coronavirus vaccine distribution. But many employers are concerned about the liability they could create in offering such incentives, the letter said.

The signees asked EEOC to clarify how they might offer vaccination incentives without infringing upon the boundaries established by the Americans with Disabilities Act and other laws enforced by the agency. Specifically, the groups requested that the agency issue guidance that defines “what qualifies as a permissible incentive as broadly as possible.” An EEOC spokesperson said the agency appreciates “input from all stakeholders and will review the letter carefully.”

From the seeking public comment front —

  • The National Committee for Quality Assurance is seeking “feedback on proposed new measures, changes to existing measures and proposed measures for retirement. Public comment is now open for HEDIS® Measurement Year 2022.” The public comment deadline is March 11, 2021.
  • HHS’s Agency for Healthcare Research and Quality “encourage [interested parties] to review the draft report [titled “Strategies to Improve Patient Safety: Draft Report to Congress for Public Comment and Review by the National Academy of Medicine”] and send comments to PSQIA.RC@ahrq.hhs.gov no later than Feb. 16. We’ll review feedback in developing a final report for Congress later this year.” That’s not much time as the notice was posted today.

Weekend Update

David Ermer–CDC, Congress, COVID-19, U.S. Healthcare–
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Happy Super Sunday LV!

The House of Representatives is engaged in committee work. The Senate is engaged in floor and committee work. The Wall Street Journal reports that

Senate Democrats said they expect a short impeachment trial starting this week for former President Donald Trump as they also seek to push ahead with the Biden administration’s proposed $1.9-trillion economic-relief bill.

The two events, combined with continuing hearings and votes on President Biden’s cabinet nominees, presage competing priorities as the new Democratic majority—which is reliant on Vice President Kamala Harris to break tied votes—is still figuring out key details on the trial process and on what provisions to include in the bill.

The Senate Homeland Security and Governmental Affairs is holding a confirmation hearing for Office and Management and Budget Director nominee Neera Tanden on Tuesday morning. The Senate Health Education Labor and Pension Committee is holding a confirmation hearing for the President’s Education Secretary and Labor Secretary nominees on Thursday morning.

On the COVID-19 front

  • The Wall Street Journal’s lead article this afternoon reports that

Vaccination drives hold out the promise of curbing Covid-19, but governments and businesses are increasingly accepting what epidemiologists have long warned: The pathogen will circulate for years, or even decades, leaving society to coexist with Covid-19 much as it does with other endemic diseases like flu, measles, and HIV. The ease with which the coronavirus spreads, the emergence of new strains and poor access to vaccines in large parts of the world mean Covid-19 could shift from a pandemic disease to an endemic one, implying lasting modifications to personal and societal behavior, epidemiologists say.

That’s not a shocker in the FEHBlog’s book. An endemic status would be a vast improvement over what we have faced for the past year.

  • Speaking of which, NPR Shots offers the latest advice on upgrading your COVID-19 masks.

“A cloth mask might be 50% effective at blocking viruses and aerosols,” says Linsey Marr, a researcher at Virginia Tech who studies airborne virus transmission. “We’re at the point now … that we need better than 50%.” When you’re outdoors, where fresh air can quickly disperse virus droplets and smaller particles, a cloth mask is still fine, Marr says. But infectious particles can accumulate indoors, and that’s when you want a better mask. “I am now wearing my best mask to the grocery store. I wasn’t before,” Marr says.

The article explains what Ms. Marr means.

Scientists probing the origins of the coronavirus are wrapping up a lengthy investigation in China and have found “important clues” about a Wuhan seafood market’s role in the outbreak. Peter Daszak, a New York-based zoologist assisting the World Health Organization-sponsored mission, said he anticipates the main findings will be released before his planned [Wednesday] Feb. 10 departure.  * * * “It’s the beginning of hopefully a really deep understanding of what happened so we can stop the next one,” he said over Zoom late Friday. “That’s what this is all about — trying to understand why these things emerge so we don’t continually have global economic crashes and horrific mortality while we wait for vaccines. It’s just not a tenable future.”

In miscellaneous healthcare news —

As every financial professional worth their salt knows, HSAs are a unicorn in the tax world. The accounts are funded with pretax income, grow tax-free and are not taxed when used for eligible expenses — the “triple tax” benefits for which they are so renowned. They represent one of the most efficient ways to squirrel away money for retirement. But they are also kneecapped by their pairing with high-deductible health plans, which are not always optimal for people who regularly anticipate big medical bills.

And while more people have opened HSAs, largely as more employers have opted for high-deductible plans, they are used more like checking accounts than as the long-term saving and investing vehicles they were designed to be.

The pandemic also appears to be having some consequences for HSA use, with those affected by job loss depleting their accounts and those who have remained employed being able to save more than ever, financial advisers say.

The FEHBlog believes that health plans should educate members about getting the most out of their HSA arrangements.

  • A friend of the FEHBlog pointed out that on February 5, the Food and Drug Administration “authorized marketing of a new prescription only device [know as eXciteOSA] intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep.”