FEHBlog

Midweek Update

Photo by Manasvita S on Unsplash

Bloomberg reports today that

The B.1.1.7 variant of the coronavirus, first found in the U.K., has overtaken the initial form of the virus in the U.S. and is now the country’s most common strain, the head of the Centers for Disease Control and Prevention said Wednesday. CDC Director Rochelle Walensky said at a briefing that the version had overtaken other mutations that have emerged, as well as the initial version of the virus in the U.S.

The Centers for Disease control has identified the B.1.1.7 variant as a “variant of concern” which means

A variant for which there is evidence of an increase in transmissibility, more severe disease (increased hospitalizations or deaths), significant reduction in neutralization by antibodies generated during previous infection or vaccination, reduced effectiveness of treatments or vaccines, or diagnostic detection failures.

Here is the CDC’s breakdown on the B.1.1.7. variant:

Name
(Pango lineage)
Spike Protein SubstitutionsName
(Nextstraina)
First DetectedBEI Reference IsolatebKnown Attributes
B.1.1.7Δ69/70
Δ144Y
(E484K*)
(S494P*)
N501Y
A570D
D614G
P681H
20I/501Y.V1United KingdomNR-54000external icon~50% increased transmission 5

Likely increased severity based on hospitalizations and case fatality rates 6
Minimal impact on neutralization by EUA monoclonal antibody therapeutics 7, 14
Minimal impact on neutralization by convalescent and post-vaccination sera 8,9,10,11,12,13,19

WebMD adds that “Of the three “variants of concern” recognized by the World Health Organization and the CDC, studies have shown that the mRNA vaccines created by Pfizer/BioNTech and Moderna, as well as the Novavax vaccine, remain highly effective against the B.1.1.7 variant, which was first recognized in the United Kingdom. * * * Johnson & Johnson, Moderna, and Pfizer are all exploring options to make their vaccines more effective against the variants [of concern].”

The Wall Street Journal offers a helpful tip — “Pharmacies and health officials are making a plea to Americans who received their Covid-19 vaccines: Cancel the other shots you booked.” That is sensible advice.

The Department of Health and Human Service reports today that “more than half a million consumers have already signed up for health insurance through HealthCare.gov as a result of the Biden Administration’s Special Enrollment Period (SEP) for the COVID-19 Public Health Emergency. * * * Today’s report from the Centers for Medicare & Medicaid Services (CMS), which covers plan selections from February 15 to March 31, also shows gains in enrollment among historically uninsured communities, including Black consumers and Americans near the poverty level. Of applicants who identified a race, 17% identified as Black – compared to about 11% in both 2020 and 2019 during the same time period. Among consumers requesting financial assistance, 41% report being at or slightly above the federal poverty level, compared to 38% in 2020 and 33% in 2019.” The SEP continues until August 15, 2021. Will / can HHS make the open enrollment permanent?

In other heathcare / healthcare business news:

  • Healthcare Dive reports “UnitedHealth Group has named longtime executive Brian Thompson as the new chief executive officer of its health benefits business, UnitedHealthcare, the biggest private payer in the U.S.”
  • The CDC discusses the “Surprising Link Between Chronic Kidney Disease, Diabetes, and Heart Disease.”

Risk factors for each condition are similar and include high blood sugar, high blood pressure, family history, obesity, unhealthy diet, and physical inactivity.

High blood sugar can slowly damage the kidneys, and, over time, they can stop filtering blood as well as they should, leading to CKD. Approximately 1 in 3 adults with diabetes has CKD.

When the kidneys don’t work well, more stress is put on the heart. When someone has CKD, their heart needs to pump harder to get blood to the kidneys. This can lead to heart disease, the leading cause of death in the United States. Change in blood pressure is also a CKD complication that can lead to heart disease. Luckily, preventing or managing one condition can help you prevent and manage the others and lower the risk for more complications [as explained in the article].

  • The Labor Department today issued FAQs and model forms to help ERISA governed plans implement the free COBRA continuation coverage available from April 1 through September 30, 2021, for COBRA-eligible folks who lost their ERISA coverage due to an involuntary termination or reduction in hours. This offer does not extend to FEHB enrollees who are covered under a different continuation of coverage program colloquially known as TCC>
  • Fedweek offers Reg Jone’s column on benefits available on the death of a current federal employee. These are very valuable rights that protect the employee’s family.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

Bloomberg reports that “President Joe Biden said [today] he wants all American adults eligible for a coronavirus vaccine by April 19, two weeks earlier than his previous goal. All but two states are already set to meet that goal, with Oregon and Hawaii having planned to open up vaccines to all non-minors on May 1.”

Yesterday, the Centers for Disease Control (“CDC”) released a report finding that “The principal mode by which people are infected with SARS-CoV-2 (the virus that causes COVID-19) is through exposure to respiratory droplets carrying infectious virus. It is possible for people to be infected through contact with contaminated surfaces or objects (fomites), but the risk is generally considered to be low.” As this BBC News article illustrates, last Spring we were quite worried about contracting COVID-19 from contaminated surfaces. In any event, thank heavens that we have the vaccines.

Federal News Network reports that front line federal employee access to the COVID-19 vaccine depends upon their employing agency.

If you are a federal employee working in the field, like Food and Drug Administration inspectors, Forest Service rangers or Custom and Border Protection officers, getting a COVID-19 vaccine from your agency isn’t a sure thing.

The Department of Homeland Security is making an all-out effort to vaccinate all 300,000 employees.

Other agencies like the Agriculture Department or the IRS are asking employees to take a path through their state and local governments.

This inconsistent application of agency support for “frontline” workers to receive one of the three inoculations has the potential to create a have and have nots among agencies.

Hopefully as the COVID-19 vaccine supply continues to expand and access restrictions are removed, these unfortunate quirks in the process will be ironed out quickly.

In other healthcare related tidbits

  • On April 12, the CDC will be sponsoring its decennial meeting on healthcare associated infections.
  • The Food and Drug Administration released a COVID-19 update today. The FEHBlog wonders when the FDA will take up granting full marketing approval for the Pfizer and Moderna vaccines and when AstraZeneca will file an emergency use authorization with the FDA for its COVID-19 vaccine. Those steps take us closer to ironing out the process quirks.
  • MedPage Today reports that

A personalized, hands-on care strategy for patients struggling with addiction was effective at reducing hospital readmission, a randomized trial found. In a comparison of hospitalized adults with substance use disorder involving opioids, cocaine, or alcohol, those who received Navigation Services to Avoid Rehospitalization (NavSTAR) care saw far better outcomes than those who simply received treatment as usual, according to Jan Gryczynski, PhD, of the Friends Research Institute in Baltimore, and colleagues.

  • Health Payer Intelligence informs us that

A digital therapeutic weight loss program led to major medical cost savings, according to a Rally Health Inc. study that points to wellness programs as cost-effective strategies to tackle the obesity epidemic. The study published in Obesity examined program data over a three-year period to analyze medical cost trends for those participating in Rally Health’s Real Appeal weight loss intervention program.

Researchers compared medical costs for a group of participants in the digital therapeutic wellness program with costs for a control group of non-participants. The control group was selected to match the intervention group in terms of health risk, baseline medical costs, age, gender, geographic region, and chronic conditions.

The study found that the wellness programming resulted in significant weight loss. There was an average weight loss of 3 percent for 4,790 program participants who attended at least one session over a 52-week period. In addition to providing positive member outcomes, the wellness program lowered medical expenditures significantly. Costs for the intervention cohort were 12 percent less than costs for the control group. What’s more, the savings of the wellness program cohort were 2.3 times more than program costs, marking significant return on investment.

  • Adam Fein reports in his Drug Channels blog that

The drug channel is consolidating, both vertically and horizontally. For evidence, look no further than Drug Channels Institute’s estimates of pharmacy benefit manager (PBM) market share, which are shown in the chart below. For 2020, DCI estimates that the three biggest PBMs [CVS Health (including Caremark and Aetna), the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group] accounted for more than three-quarters of total equivalent prescription claims. * * * This concentration helps plan sponsors and payers, which can maximize their negotiating leverage by combining their prescription volumes within a small number of PBMs. 

Monday Roundup

Photo by Sven Read on Unsplash

The Wall Street Journal offers an interesting story about how many patients with long or long haul COVID-19 (about 10% of total case) wind up receiving cognitive rehabilitation.

Cognitive problems are some of the most persistent and common long-term symptoms that people struggle with months after getting Covid. Patients report short-term memory problems, slow processing speeds, poor word recall and difficulty multitasking. To help them, doctors at medical centers including Mayo Clinic, Yale and Johns Hopkins are starting to refer some patients to cognitive rehabilitation more typically used for patients with concussions and other traumatic brain injuries. 

AHIP presents an interview with Kim Lauersdorf, Vice President of Marketing at EmblemHealth, about crafting communications about vaccinations, including the COVID-19 vaccines.

“What should health care organizations take away from the study, what are some next steps to help drive vaccine adoption and acceptance?“

Lauersdorf: As health care professionals, we need to accept responsibility when communicating to our base and know that if we are not intentional of the language we use, the voices we amplify, and the methodologies we use to get our messages out, we will perpetuate greater health disparity.

First, it’s clear that terminology matters. The widely used term “shot”, for example, evokes significant negative connotations across all populations, but specifically in low-income, younger, and Black communities. Clinically, it evokes needles, injection, and pain. Non-clinically, it evokes violence. Continued usage of the term will drive continued disparity in vaccine adoption.

Second, we must amplify trusted voices. People, across the board, trust their primary care providers above all other messengers. To take this even further, people have more trust in primary care providers who look like them or come from their same communities.

In addition, word of mouth—especially from trusted sources—is as important today as it ever was. Even more so, as we are each dealing with a worldwide crisis, coupled with a large scale, new, possible way out of it. We have to understand that this is all new territory that this generation has never experienced before. That too fosters hesitation.

Third, we must use multiple channels to get our messages out. While there has been an increase in digital health adoption, as seen through rising telehealth usage, we have to know that many of our communities still don’t have reliable Internet access or access to certain technology. We have to get our message to all of those we serve to ensure vaccine adoption doesn’t perpetuate existing health disparities.

The American Hospital Association reports on five takeaways from a maternal / mental healthcare conference. Here’s one of them:

Technology alone will not be enough.

The COVID-19 pandemic has proven how crucial technology is for health care delivery. Telehealth improves access to OB/GYNs, doulas, lactation consultants and specialists. Remote patient monitoring, chat and text-based navigation services, and apps have provided additional ways to support and coordinate care. 

Yet, speakers acknowledged technology alone will not be enough. Melissa Hanna, founder and CEO of Mahmee, which delivers data-driven care coordination and personalized support to new moms, shared “technology will not be the end all be all solution” to our challenges in maternal health. She also shared, “this is always going to be about care, and it’s plenty of people working together to center the experiences of mothers, and be there in a proactive way to guide, support and advocate.” 

We have seen firsthand that a combined approach of offering health care services through technology and human connection can drive better outcomes for mothers. Mayo Clinic developed the OB Nest program to optimize prenatal care for low-risk expectant mothers. The program uses a combination of in-person and telehealth prenatal visits, home monitoring, and a social media community that allows patients to share their experiences with other mothers. It also has dedicated nurses that help with patient education and serve as a resource for mothers throughout the program. This combination has provided pregnant moms with more autonomy in their prenatal care. 
 

In other benefit news

  • Fierce Healthcare reports that Verizon has jumped into the telehealth market with an offering directed at providers of care.

Many hospitals and health clinics have adopted video conferencing services during the pandemic for providing patient care. BlueJeans Telehealth, which launched Monday, was designed from the ground up for healthcare organizations to simplify the virtual experience and offer greater access to care, Verizon executives said in a press release.

  • Employee Benefit News informs us that

Benefitfocus, a cloud-based software solutions provider for healthcare and benefits administration, published a report on the current state of employee benefits. The research provides insight into employee enrollment behavior for the last four years, and takes a closer look at how 2020 impacted employee benefits.

The EBN article offers an interview with Benefitfocus’s director of consumer advocacy.

Finally former NTEU President Robert Tobias presents in Govexec.com his thoughts on the National Academy of Public Administration’s recent report on the future of OPM.

Weekend update

Photo by Michele Orallo on Unsplash

Happy Easter!

Congress remains on State/district work breaks for the coming week.

As of the beginning of this week, according the CDC’s website, 75.4% of the U.S population over age 65 and 40.2% of the U.S. population over age 18 has received at least one dose of the COVID-19 vaccine. 54.5% of the over age 65 population and 23.2% of the over 18 age population have been fully vaccinated.

That’s progress. Here are a couple of interesting angles on the vaccine distribution process:

  • The Wall Street Journal reports that “Johnson & Johnson’s Covid-19 vaccine has found a niche among organizations that work with the homeless, who say the one-dose shot is better-suited for a population that can be difficult to reach twice.”

[H]ealthcare workers say they have been surprised to find many homeless people specifically requesting the J&J vaccine, which is branded as Janssen, a unit of J&J. Some of them point out that the shot was still effective even though it was tested after Covid-19 variants entered the mix. Others say they are worried about getting a vaccine once, let alone twice, given the potential side effects.

“If you’re in a shelter, or don’t have a home, those side effects are different than if you can stay at home,” said Bobby Watts, chief executive of the National Health Care for the Homeless Council, which supports hundreds of providers that cater to the homeless.

  • Health Payer Intelligence informs us that “To ensure COVID-19 vaccine access for homebound individuals, the Commonwealth of Massachusetts has partnered with the Commonwealth Care Alliance (CCA), a health plan that says it has proven best practices for vaccinating this population.” “The Commonwealth defines a “homebound” individual as anyone who needs assistance from two or more people to leave home. In Massachusetts, there are about 20,000 individuals who meet this definition.”

As one of the first healthcare organizations in the country to vaccinate homebound individuals, CCA has also been part of the national discussion around strategies to ensure COVID-19 vaccine access for this population. Last month, CCA joined AHIP in briefing the White House, promoting the prioritization of homebound individuals in COVID-19 vaccine delivery efforts and underlining CCA’s best practices in this endeavor.

Speaking of AHIP, the organization on Friday announced

AHIP’s new SEP landing page also features other important resources to help guide consumers through the SEP, including fast facts, an educational blog, a link to a Get Covered Connector tool offered by Young Invincibles, and a link to a Health Insurance Marketplace Calculator provided by the Kaiser Family Foundation.

“Health insurance coverage is an important way to protect your health and financial stability, especially during the COVID-19 pandemic,” said Matt Eyles, president and CEO of AHIP.  “Health insurance available through the individual marketplaces cover products and services such as COVID-19 care and vaccines, mental health care and support, $0 copay preventive care, regular doctor visits and prescription medications to keep you healthy, and much more.”

In other COVID-19 news, Kaiser Health News provides details on over-the-counter COVID-19 testing kits.

Even with vaccines, epidemiologists say, rapid tests are desperately needed because more testing, along with mask-wearing and physical distancing, will get people back in offices and classrooms and help catch cases that go undetected. * * *

[M]any experts support the widespread distribution of cheap, rapid tests, even if they aren’t as sensitive as lab-run alternatives, and see a demand. In Germany, the supermarket chain Aldi began selling rapid tests in early March, roughly $30 for a five-pack, and sold out within hours. One recent study found that if a pack of tests was mailed to every household in the U.S. — even assuming that up to 75% would go into the garbage — they would save thousands of lives and avert millions of infections. “Don’t let perfect be the enemy of good,” said study co-author and Yale University professor A. David Paltiel. “This doesn’t have to work perfectly to make a huge difference.”

The Federal News Network shares opinions that it obtained from former OPM officials on the recent National Academy of Public Administration report on the agency.

Janice Lachance, the Clinton-era OPM director, sees the budget as a good starting point for the Biden administration and the new director. The president nominated Kiran Ahuja, a former chief of staff for the agency, for the role.

“The new director has a tremendous opportunity to go in there, do a very effective assessment of the situation and make a reasonable request that covers all of the things that need to be done — and that we want to do,” said Lachance, who currently serves as an executive vice president for the American Geophysical Union. “The NAPA report is very aspirational. What is it going to take to get OPM from where it is today to this desired state that’s articulated in the NAPA report over how many years?”

The new director, Lachance added, will need to make the case why an empowered OPM will help resolve the federal government’s talent problems.

Cybersecurity Saturday

April is National Supply Chain Integrity Month!

In partnership with the Office of the Director of National Intelligence (ODNI), the Department of Defense, and other government and industry partners, CISA is promoting a call to action for a unified effort by organizations across the country to strengthen global supply chains.

This week’s focus is on Building Collective Supply Chain Resilience.

Monday April 5 is the effective date for the Health and Human Services Department’s Office of National Coordinator for Health IT (“ONC”) information blocking rule which implements part of the 2016 Cures Act. According to Fierce Healthcare,

While health IT experts have been calling for interoperability for years, they say this particular rule could finally be a major step in achieving a meaningful level of data sharing far beyond what’s been seen before in the healthcare sector.

If effectively enforced, the mandate that prohibits information blocking has the potential to revolutionize how patients interact with the healthcare system, said Deven McGraw, a health privacy expert and co-founder and chief regulatory officer at Ciitizen, a consumer health technology company.

“[The information blocking rule] has enormous potential to open up data sources that have previously been closed to patients but hold rich data about patients and that would be potentially game changing for them to tap into and access,” she told Fierce Healthcare.

EHR Intelligence reports on the ONC’s annual meeting held last Monday.

[National Coordinator Mickey] Tripathi identified the importance of “taking health IT to the next level” by making EHR adoption ubiquitous, delivering on the potential of FHIR-based capabilities, and making interoperability a priority by building on past accomplishments.

“One of the things that we should recognize is that there’s been tremendous progress made in interoperability,” he said. “I don’t think the industry gets enough credit for the amount of progress that’s been made in interoperability.”

The ONC leader said credit is lacking because interoperability permitted purposes remain focused on treatment purposes only, rather than the rest of the healthcare sector.

“We haven’t quite figured out how to integrate all the various layers of interoperability into a seamless experience,” he added.

But, Tripathi said ONC is still trying to decipher how local, state, and regional health information exchange (HIE) networks fit within nationwide networks, such as eHealth Exchange and CommonWell Health Alliance.

In significant news for government contractors, Cyberscoop reports that

Under a forthcoming White House order, companies that do business with the federal government would have to meet software security standards and swiftly report cyber incidents to a new entity within the Department of Homeland Security, sources familiar with a draft version of the document said.

The order’s other upgrades to federal agency security include use of multi-factor authentication and improvements to FedRAMP, the federal process for authorizing and continuously monitoring the security of cloud services.

Federal agencies would need to use data encryption and develop plans for shifting to a “zero trust” model, which assumes that organizations should not automatically assume they can trust anyone or anything inside the network. They would need to keep logs for cyber incidents.

Some of the steps might not come to fruition for some time because they will require additional federal rulemaking, an oft-slow process that includes several phases of public comment.

On the hacking front, Bleeping Computer reports

The Federal Bureau of Investigation (FBI) and the Cybersecurity and Infrastructure Security Agency (CISA) warn of advanced persistent threat (APT) actors targeting Fortinet FortiOS servers using multiple exploits.

In the Joint Cybersecurity Advisory (CSA) published today [April 2], the agencies warn admins and users that the state-sponsored hacking groups are “likely” exploiting Fortinet FortiOS vulnerabilities CVE-2018-13379, CVE-2020-12812, and CVE-2019-5591.

The attackers are enumerating servers unpatched against CVE-2020-12812 and CVE-2019-5591, and scanning for CVE-2018-13379 vulnerable devices on ports 4443, 8443, and 10443.

Following up on last week’s Cybersecurity Saturday post, Business Insurance reports that

The cyberattack that crippled CNA Financial Corp.’s computer systems nearly two weeks ago has been contained and the insurer has reestablished the functionality of its email, according to an update posted to the CNA website Thursday.

Cyberscoop informs us

The company did say, however, that it now believes it has the attack contained and has ascertained that the hackers and their ransomware lacked the ability to automatically move around in internal and external systems. Bleeping Computer reported that the Phoenix CryptoLocker ransomware was involved, possibly with links to a cybercriminal collective dubbed Evil Corp.

CNA said it was still communicating with regulators, law enforcement and outside forensics experts. CyberScoop has learned that CNA has enlisted help from CrowdStrike.

Friday Stats and More

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 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

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

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

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.

Monday Roundup

Photo by Sven Read on Unsplash

Bloomberg reports that the United States is on pace to administer three million doses of COVID-19 vaccine daily as supplies increase and states widen eligibility.

The Wall Street Journal adds that

Covid-19 vaccines from Moderna Inc. and from Pfizer Inc. and partner BioNTech SE are highly effective in preventing infections in real-world conditions, federal health officials said, further evidence that vaccinations can slow the spread of the virus.

The vaccines were 90% effective at reducing the risk of infection two weeks after a second dose, according to a study of nearly 4,000 healthcare workers, first responders and other essential workers published by the U.S. Centers for Disease Control and Prevention on Monday.

In addition, the data indicated the vaccines can reduce the risk of coronavirus infections whether or not they cause symptoms, the CDC said.

As of today, 49.2% of the U.S. population over age 65 is fully vaccinated against COVID-19, and 72.8% of that population has received at least one dose of the COVID-19 vaccine. What’s more, the Department of Health and Human Services announced issuing grants to help public agencies bring this age group and disabled people as close as possible to 100% vaccinated. “Older adults are more likely to have a severe illness, be hospitalized, or die from COVID-19; adults 65 and older account for 8 of every 10 COVID-19-related deaths. People with disabilities also often are at increased risk; in fact, a recent study found that intellectual disability is the greatest risk factor after age.” 

In relevant business news —

  • Healthcare Dive reports that “The U.S. Department of Justice is embarking on a deeper review of UnitedHealth Group’s $13 billion acquisition of data analytics company Change Healthcare following entreaties from powerful hospital lobby the American Hospital Association over anticompetitive concerns.”
  • The Society for Human Resource Management shares HR professional views on how the pandemic has changed the workplace over the past year. The FEHBlog particularly likes this one :

“We definitely learned that it’s not enough to just set people loose in a work-from-home environment. This isn’t about trusting employees to do their work unsupervised, either. We have complete trust in our employees, and this was never brought into question. The problem is that people have different proficiencies with tech and different abilities to work without guidance.”
—Carter Seuthe, CEO of Credit Summit, based in Austin, Texas