Friday Stats and More

COVID-19 vaccine

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Mental health care, U.S. Healthcare–

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 13th week of this year (beginning April 2, 2020, and ending March 31, 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 one year period (April 2, 2020 through March 31, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through March 31, 2021, which also uses Thursday as the first day of the week:

Bloomberg reported this afternoon that

More than 101 million people in the U.S. have received a first dose of a Covid-19 vaccine, or about 31% of the population.

Less than four months into the U.S. vaccination effort, coverage is best in people 65 years or older, with 74% of the group getting at least one dose and 54% completing vaccination, according to figures published by the Centers for Disease Control and Prevention and compiled by the Bloomberg Vaccine Tracker.

On Friday, the U.S. set a one-day record for vaccine doses reported administered, adding almost 4 million. On average, the U.S. is administering close to 3 million shots a day as of Friday’s update, also a record.

In other COVID-19 vaccination news

  • Fierce Pharm reports that Johnson & Johnson which offers a one dose vaccine has joined the two dose vaccine manufacturers Pfizer and Moderna in its vaccine on adolescents aged 12-17.
  • The Society for Human Resource Management informs us that

The following measures may increase vaccine acceptance in the workforce, according to the CDC:

1. Train interested staff to become COVID-19 vaccination ambassadors who will speak confidently and honestly, relaying personal stories about the vaccine to fellow co-workers and addressing any of their concerns.

2. Employ all available communication tools when promoting the COVID-19 vaccine to staff, including social media, internal communication channels, and posters or signs around the workplace.

3. Hold a virtual town hall where leadership, respected local medical experts and staff share their COVID-19 vaccine experiences and other vaccine facts and answer audience questions. Use experts to communicate to staff when talking about the COVID-19 vaccine. Ensure the experts present facts about the vaccine, including the risks.

4. Consider giving employees paid time off to get the vaccine and offering paid sick leave for employees who have adverse reactions.

5. Have workplace leadership take the COVID-19 vaccine, capture their experience using video or photo, and share the experience with staff.

  • In this regard, Govexec.com reports that

Next week, the Health and Human Services Department plans to open a vaccination site for federal employees in the National Capital Region.

A source familiar with the plans told Government Executive on Friday that the site will be in Gaithersburg, Maryland. “The site will provide COVID vaccinations to federal, essential, critical infrastructure workers,” said the source. Federal agencies will determine eligibility based on “job duties and [the Cybersecurity and Infrastructure Security Agency’s] guidance on the essential, critical infrastructure workforce,” which includes 24 agencies.  

The source was unsure at the moment on how many vaccine doses will be available or how many employees will be able to receive them. Employees will be notified starting Friday, April 2, the source said.

In health benefits news —

  • The Labor Department’s Employee Benefits Security Administration released ACA FAQ 45 today. FAQ 45 provides compliance guidance on Section 203 of Division BB of the Consolidated Appropriates Act 2021. Section 203 requires health plans, including FEHB plans, to prepare and keep current written analyses demonstrating compliance with the non-quantitative treatment limitations requirements of the federal mental health parity law and implementing regulations.
  • Fierce Healthcare explains how Optumcare successfully expanded the use of at home colon cancer screenings during the pandemic.

OptumCare used data analytics to flag the patients at risk for colon cancer and then reached out to them about the home test kits. While the kits included an information letter to describe the process, the clinical team also followed up four times by phone to check in with them.

If the testing results were positive or abnormal, the patient’s physician or care team would reach out directly to explain what the results meant and schedule them for future appointments to ensure care was coordinated throughout the process.

Frank said OptumCare saw a 5% higher return rate under the expanded program than in previous years, and the increased engagement drove interest in expanding other home health options such as home testing for blood glucose among diabetic patients.

  • Fierce Healthcare also informs us that

The American Medical Association innovation subsidiary Health2047 has spun off a company that uses personalized medicine to fight obesity. Phenomix Sciences is a phenotype testing company that carries out the AMA’s mission to confront chronic diseases such as obesity.

Phenomix uses a blood test called MyPhenome that it has licensed from the Mayo Clinic to allow doctors to prescribe individualized therapies. MyPhenome measures DNA as well as a person’s metabolites and hormones. These biomarkers make up a person’s phenotype, according to Phenomix.

The company’s blood-based test uses phenotype-driven multi-omics technology to predict responses to obesity interventions that the Food and Drug Administration (FDA) has approved. A multi-omics test is important because testing for obesity involves multiple factors, including genetics, metabolomics and environmental aspects, according to Phenomix CEO Mark Bagnall.

Because patients respond differently to obesity treatment, the Phenomix founders turned to AI to personalize this treatment. AI can personalize a multi-omics obesity test and analyze single-nucleotide polymorphisms, metabolites and hormones that correspond with a certain obesity phenotype, according to Bagnall.

AI can help identify a specific obesity phenotype so patients can receive the right treatment.

“[We] demonstrated in several clinical studies that knowing a patient’s phenotype doubles the likelihood of weight loss and doubles the amount of weight lost,” Bagnall said.  

Thursday Miscellany

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, OPM–
Photo by Juliane Liebermann on Unsplash

In FEHB News

  • OPM is finalizing without change its proposed rule to remedy some federal employee benefit problems that cropped up during the last, particularly lengthy government shutdown.
  • CVS Health announced yesterday that

CVS Caremark, the Pharmacy Benefit Manager (PBM) of CVS Health, is continuing its long-standing agreement to serve the Government-wide Service Benefit Plan.  Since 1993, CVS Caremark has provided high-quality pharmacy care to the Service Benefit Plan to help federal employees, retirees and their families achieve prescription drug savings and better health outcomes, while being a responsible steward of taxpayer dollars.

The expanded contract will go into effect January 1, 2022 and now includes specialty pharmacy in addition to existing retail, mail and clinical pharmacy services in the current contract.

From the COVID-19 front

  • The Wall Street Journal reports that

The FDA late Wednesday gave the green light to three tests that are meant to be used frequently or multiple times over a few days—called serial tests. Consumers will be able to buy two of them over the counter without a prescription; the other, for use in such places as schools and doctors’ offices, requires a prescription. The FDA had previously authorized them for use among people with symptoms. * * *

Wednesday’s authorizations, awarded to companies [Quidel Corp., Abbott Laboratories and Becton, Dickinson & Co.] with bulk manufacturing power, add to the tests that can be purchased over the counter among people without symptoms if they are used repeatedly, potentially enabling rapid, at-home testing to become more widely accessible and affordable.

  • Today, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses. The second revision authorizes the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted. Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly. Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.”

Midweek Update

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

The FEHBlog noticed today that OPM has posted the agenda for its annual FEHB Carrier Conference which AHIP co-hosts. While the agenda includes many hot topics, the FEHBlog is surprised that new FEHB Act Section 8902(p) / the No Surprises Act is not highlighted on the agenda.

From the COVID-19 front —

  • The Centers for Disease Control’s daily report on COVID-19 vaccinations in the U.S. reports that that over 150 million doses have been delivered.
  • Pfizer and BioNTech announced that “in [study] participants aged 12-15 years old, [their two dose COVID-19 vaccine] BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated. The companies plan to submit these data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as soon as possible to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2.” This is good news for the next school year. Testing on younger children continues.
  • The Wall Street Journal reports that “Pregnant women who get the coronavirus vaccine pass their antibodies on to their newborns, recent studies suggest, a promising sign that babies can acquire from their mothers some protection against Covid-19. At least three studies have found that women who received either the Pfizer Inc. –BioNTech SE vaccine or the Moderna Inc. shots during pregnancy had coronavirus antibodies in their umbilical-cord blood. That indicates the women’s babies got the antibodies, too. * * * Pregnant women are at higher risk of a severe case of Covid-19 and of preterm delivery if they are infected. The studies’ findings, though preliminary, suggest women could safely protect themselves and their newborns by getting vaccinated.
  • Health Payer Intelligence explains “How Payers Are Involved in Boosting COVID-19 Vaccine Confidence — Payers are targeting coronavirus vaccine confidence through collaborations, marketing tools, and incentive programs.”
  • The National Institutes of Health announced that “The Centers for Disease Control and Prevention (CDC), in collaboration with NIH, has launched an innovative community health initiative called “Say Yes! COVID Test” starting in Pitt County, North Carolina, and coming soon to Chattanooga/Hamilton County, Tennessee. As many as 160,000 residents across the two communities will have access to free, rapid antigen tests that they can administer themselves to use three times a week for one month. NIH will provide the tests (also called a home-test or at-home test) and evaluate the effectiveness of the initiative, which aims to determine if frequent self-administered COVID-19 testing helps residents reduce community transmission of SARS-CoV-2, the virus that causes COVID-19 disease.”

And from the survey front —

  • The International Foundation of Employee Benefit Plans released its “2020 Employee Benefits Survey [which] provides benchmarking data on their health care offerings, covered dependents, plan funding, dental and orthodontia benefits, prescription drug offerings and other benefits.”
  • Becker’s Hospital Review identifies two dozen health care facilities that offer care to long haul COVID-19 patients.

Tuesday Tidbits

David Ermer–COVID-19, COVID-19 vaccine, Medicare, U.S. Healthcare–

Happy National Doctors’ Day “It is a day to celebrate the contribution of physicians who serve our country by caring for its’ citizens.”

The American Hospital Association reports that

Anticipating possible congressional action to extend the moratorium on the 2% sequester cut to all Medicare payments, the Centers for Medicare & Medicaid Services today said it has instructed Medicare administrative contractors to hold all claims with dates of service on or after April 1, 2021, for a short period. The MACs will automatically reprocess any claims paid with the reduction applied if necessary, the agency said. 
  
The Senate last week passed a bill that, among other health care provisions, would eliminate the 2% cut to all Medicare payments, known as sequestration, until the end of 2021. The House is expected to take up the Senate-passed bill the week of April 13 when it returns to Washington D.C.

Bloomberg News informs us that

The World Health Organization’s chief said a mission to study the origins of the coronavirus in China was too quick to dismiss the theory of a lab leak, with the U.S. and other governments joining in criticism of the investigation.

WHO Director-General Tedros Adhanom Ghebreyesus said the probe didn’t adequately analyze the possibility of a lab accident before deciding it’s most likely the pathogen spread from bats to humans via another animal. In a briefing to member countries Tuesday, he said he is ready to deploy additional missions involving specialist experts.

“Although the team has concluded that a laboratory leak is the least likely hypothesis, this requires further investigation,” Tedros said in a statement. The WHO chief has consistently said all lines of inquiry are open, but Tuesday’s comments mark the first time he’s speculated about the possibility of an accidental escape.

The American Medical Association offers a podcast in which Christopher J.L. Murray, MD, director of the Institute for Health Metrics and Evaluation at the University of Washington offers his perspective on the future course of COVID-19 in the U.S. this year.

A physician and health economist whose career has focused on improving health globally by improving health evidence, Dr. Murray outlined these three challenges to making herd immunity a reality and preventing another wave of illness this fall or winter:

Vaccines will not be as effective at preventing infection from the SARS-Co-V-2 B.1.351 variant that emerged in South Africa or the P.1 variant that emerged in Brazil, or future variants.

Not enough individuals will receive the vaccine to achieve herd immunity.

Those who had previous COVID-19 infections from one variant may not have protection from being reinfected with a new variant.

When vaccines were approved, everyone thought the U.S. would get to herd immunity by late summer or the fall because the number of people who have been vaccinated combined with the 20% of Americans who had already been infected and had immunity would push America to the level needed for herd immunity, preventing another wave next winter, Dr. Murray said.

“But if it turns out there isn’t cross-variant immunity, then the only way to get to the point where you don’t have a third wave next winter is through vaccination,” he said.

In related news, Kaiser Health News reports that “A new poll of attitudes toward covid vaccinations shows Americans are growing more enthusiastic about being vaccinated, with the most positive change in the past month occurring among Black Americans.”

Closing tidbits —

  • Fierce Healthcare identifies the Centers for Medicare and Medicaid Services “payment models the Biden administration has pulled for review or delayed.”
  • Health Payer Intelligence discusses large insurer platforms designed to help their self-funded customers coordinate their health benefit offerings.

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–ACA, Congress, COVID-19, COVID-19 vaccine, U.S. Healthcare, Uncategorized–

The FEHBlog was wondering today whether the clinical trial review board had given AstraZeneca a heads up about its concerns with the company’s press release before making the midnight press release on that topic. The New York Times reports that

“Only hours after AstraZeneca announced encouraging news about the effectiveness of its Covid-19 vaccine on Monday, a group of medical experts charged with monitoring the company’s clinical trial made a highly unusual accusation: AstraZeneca had essentially cherry-picked data to make its vaccine look better.

The accusation, in a two-page letter sent Monday to the company and federal officials, was a fresh blow to the credibility of a vaccine whose low price and relatively easy storage have made it critical to the global fight against the coronavirus pandemic.”

In other words, AstraZeneca, which is partnering with the University of Oxford, knew about the credibility concerns yet didn’t pull back the press release in the face of such criticism. The company’s failure to respond lead to a “sharply worded” statement  from the the National Institute of Allergy and Infectious Diseases [issued] on Tuesday shortly after midnight, disclosing the panel’s concerns.

The New York Times explains that

The fight is about the degree of effectiveness of a vaccine that is considered highly safe and effective.

While AstraZeneca said on Monday that its vaccine appeared to be 79 percent effective at preventing Covid-19, the panel of independent experts said the actual number may have been between 69 percent and 74 percent. The mass availability of a vaccine with even a 69 percent efficacy rate could help the world conquer the coronavirus.

But the public airing of a conflict between a pharmaceutical company and a board overseeing a clinical trial is almost unheard-of. It is certain to trigger extra scrutiny of the vaccine by the Food and Drug Administration and other regulators if, as expected, AstraZeneca seeks their authorization to use it on an emergency basis in the United States.

This is a sad state of affairs.

And now for some tidbits

  • The Department of Health and Human Services announced today its decision to the extend the Affordable Care Act marketplace special enrollment period for an additional three months. The last day to enroll will be August 15 instead of May 15, 2021.
  • Fierce Healthcare reports that “The Senate is likely to consider a bill this week that would extend a moratorium on 2% cuts to Medicare payments, according to the American Hospital Association. The extension is a major priority for hospital and doctor groups that say providers are still suffering financially due to the COVID-19 pandemic.”
  • In a piece of good news, Healthcare Dive informs us that

After cancer screenings for breast and colon cancers plummeted at the outset of the COVID-19 pandemic, they rebounded by the end of July, according to a new report in the Journal of General Internal Medicine that analyzed the private insurance claims of 6.8 million people ages 45 to 64.

In fact, the rate of women seeking mammograms was higher by the end of July than in the months leading up to the pandemic. Prior to mid-March, or when the public health crisis began, the median weekly rate of mammogram screenings were 87.8 women per 10,000 beneficiaries. That figure improved to 88.2 screenings per 10,000 beneficiaries by the end of July.

However, the rate of colonoscopies did not return to pre-pandemic levels, but returned to near normal, according to the researchers. In the months leading up to the crisis, median weekly colonoscopy rates were 15.1 per 10,000 beneficiaries and later rebounded to only 12.6 per 10,000 beneficiaries.

  • The Federal News Network reports on the Postal Service’s long awaited ten year business plan which was released today.
USPS aims to hit break-even year by 2023 under 10-year infrastructure plan

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, Mental health care, OPM–
Photo by Sven Read on Unsplash

The big news today is Astra Zeneca’s announcement that its two dose COVID-19 vaccine “demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation.

This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo.

Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.

The vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.

Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus. We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization [EUA”].”

Typically these trial result announcements have been made a week or two submission of the EUA application to the FDA and then the FDA takes two to three weeks to approve the application. Consequently, it appears that a fourth COVID-19 vaccine will be online in mid-to-late April.

CAVEAT: Bloomberg reports Tuesday morning that

AstraZeneca Plc may have released outdated information about its Covid-19 vaccine trial, giving an “incomplete” view of the efficacy of the shot, said the leading U.S. agency on infectious diseases.

The Data and Safety Monitoring Board, charged with ensuring the safety and accuracy of AstraZeneca’s vaccine trial, has expressed concerns to the National Institute for Allergy and Infectious Diseases that the information released about the testing results included outdated information.

This “may have provided an incomplete view of the efficacy data,” the agency said in a statement early Tuesday, without elaborating.

“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” said the group headed by Anthony Fauci, the top U.S. infectious disease official.

Astra Zeneca needs this news like it needed a hole in the head as one of the FEHBlog’s grandmothers would say.

The Centers for Disease Control offers guidance on how to talk about COVID-19 vaccines with friends and family. The FEHBlog’s general advice is simply get it. The key consideration is that all three available vaccines as well as the Astra Zeneca vaccine have 100% efficacy on preventing severe hospitalization or death from COVID-19.

The Hill reports that the Senate confirmed by a 68-29 vote the President’s nomination of Boston Mayor Marty Walsh to be Secretary of Labor. This is an important position with respect to the Affordable Care Act and ERISA as well as labor affairs.

EHR Intelligence discusses the growing role of state run health information exchanges in achieving health information interoperability.

The CMS interoperability rule addresses admission, discharge, and transfer (ADT) notifications. Providers need to fulfill a CMS condition of participation that will require all healthcare facilities to send outbound event notifications by May 2021.

All healthcare facilities must send direct electronic notifications to a patient’s provider once the patient is admitted, discharged, or transferred from another facility.

Health information exchanges are in a prime position to help prepare their clients accordingly.

This is a nifty idea, but why not give electronic notice to the health plan too?

In its latest call letter for FEHB carrier benefit and rate proposals, OPM encouraged carriers to pay attention to controlling low value care. Health Payer Intelligence discusses a relevant JAMA Open Network study finding that “there are at least 13 areas of low-value care in which Medicare Advantage and Medicare alike are not reducing healthcare spending,” among them, “antibiotics for acute upper respiratory infection, antibiotics for influenza, anxiolytic, sedative, or hypnotic medication, benzodiazepine for depression, an opioid for headache, an opioid for back pain, nonsteroidal anti-inflammatory drug (NSAID) for hypertension, heart failure, or kidney disease, radiograph for back pain, and MRI or CT for back pain or for headaches.”

From the healthcare innovation front —

  • Health IT Analytics informs us that “Statistical suicide risk prediction models could be implemented cost-effectively in healthcare organizations and may help save many lives each year, according to a study published in JAMA Psychiatry.”
  • mHealth Intelligence reports that “Researchers at the University of Cincinnati are developing a small drone, that, equipped with telehealth tools, can enter a house to facilitate virtual visits, drop off or pick up supplies, even survey living conditions.”

From the “Big Bowl of Wrong” front, the Wall Street Journal reports that “Hospitals that have published their previously confidential prices to comply with a new federal rule have also blocked that information from web searches with special coding embedded on their websites, according to a Wall Street Journal examination.” Yet, nn the bright side “After the Journal approached hospitals about its findings, the search-blocking code was removed from sites including those of HCA, Penn Medicine and Beaumont, and of South Dakota-based Avera Health, Tennessee-based Ballad Health, Maine’s Northern Light Health and Gundersen Health System in Wisconsin.” Good job Journal.

Weekend update

David Ermer–ACA, AHRQ, Congress, COVID-19, COVID-19 vaccine–
Photo by Mark Tegethoff on Unsplash

The House of Representatives is engaged in committee work this week which will be followed by three weeks of district work. The Senate will engage in a floor voting, including a confirmation vote on the Secretary of Labor nominee Martin Walsh tomorrow, as well as committee work.

Healthcare Dive reports that

  • The House passed a bill Friday to extend the pause on Medicare sequester cuts until Dec. 31. The cuts have been on hold for a year but are set to go back into effect at the end of March.
  • The bill passed on a 246-175 bipartisan vote and also exempts the latest $1.9 trillion pandemic relief bill from budget rules that would have imposed additional cuts on Medicare payments to providers.
  • “We now look forward to working with the U.S. Senate to achieve relief from the pending Medicare sequester cuts before they go into effect,” the American Hospital Association said in a Friday statement.

Medicare sequester cuts tend to boomerang on private sector health plans, including FEHB plans.

Following up on Friday’s Stats and More, the FEHBlog compared new weekly COVID-19 cases and deaths per 100,000 by age groups as of January 2, 2021, and last Wednesday March 17, 2021.

This chart has a left axis measured in hundreds
This chart’s left axis ranged from zero to sixteen.

Because the March 17 new deaths rates are not visible in this chart, here are those numbers that the FEHBlog copied from the CDC’s website for last week’s new death statistics by age group

 Week ended 3-17-202118-2425-3435-5455-6465-7980+
New Deaths  per 100,000 00000.010.03

That, my friends, illustrates the work of the COVID-19 vaccines over the past two and half months. The Wall Street Journal reports today

Both the production and administration of shots have picked up in recent weeks. Now, some 2.5 million people in the U.S. are vaccinated daily on average, up from about 500,000 in early January, though many who want a vaccine still can’t get it.

The increased output should be enough to fully vaccinate 76 million people in the U.S. in March, another 75 million in April and then 89 million more in May, according to estimates from Evercore ISI analysts. The Pfizer-BioNTech and Moderna vaccines require two doses.

By midsummer, 75% of Americans 12 years old and above should be vaccinated, according to Morgan Stanley. The vaccines aren’t currently authorized for anyone younger than 16, but companies may have results this spring for studies of the shots in adolescents 12 and older, which, if positive, could lead to vaccinations for that age group. The companies are also starting to test the vaccines in children younger than 12, but results of those studies aren’t expected until late this year. 

Keep your sunny side up.

In other healthcare news:

  • Katie Keith in the Health Affairs Blog informs us that the impact of American Rescue Plan’s new ACA marketplace subsidies will be made known to consumers on April 1, 2021.

Enhanced subsidies are available for the entire 2021 plan year to anyone who qualifies and enrolls in marketplace coverage. This includes individuals who enrolled during the 2021 open enrollment period (and have had coverage since January 2021), individuals who enrolled before the American Rescue Plan was enacted (during special enrollment periods in 2021), and individuals who will enroll during the rest of 2021.

Consumers will be able to see the availability of the enhanced subsidies at HealthCare.gov beginning on April 1. But the process to “claim” these enhanced subsidies will look slightly different for new consumers versus existing consumers. (This process will also vary for consumers in states with their own marketplaces, which may adopt policies and timelines that differ from those for HealthCare.gov.)

Just like any other year, individuals can choose to receive all or some of the enhanced PTC in advance (i.e., have it paid to the insurer on their behalf each month) or wait to receive PTC at tax time in 2022 (i.e., while paying full premiums to the insurer each month). Because the cost of health insurance is so high for so many people, most marketplace enrollees opt for advance PTCs to reduce the amount they owe in monthly premiums.

The federal ACA marketplace and many state ACA marketplaces are in the middle of a special Open Season that run until May 15, 2021.

  • The HHS Agency for Healthcare Research and Quality’s Director concluded Patient Safety Week with reflections available at this link. Among the observations were the following:

The quest to learn more about what contributes to diagnostic inaccuracies and delays has already been a focus area for AHRQ. We began investing in diagnostic safety and quality research in 2007 and have helped build interest around the topic. Diagnostic error harms too many and costs too much .  

When I think about options for tackling the issue of diagnostic safety, I’m reminded of the progress we’ve made with our successful Healthcare-Associated Infections (HAI) Program. AHRQ’s HAI Program is dedicated to understanding the problems that can harm patients, identifying what works to prevent infections, and then developing, testing, and refining tools to put that knowledge into practice on the front lines of care. AHRQ has achieved a great deal working alongside clinicians, patients, and other stakeholders focused on HAI prevention throughout government and the private sector.