Oh joy, Bleeping Computer’s The Week in Ransomware is back after two weeks and it is chock-a-block full of useful information. Check it out.
From the entrepreneurial hacking front, Bleeping Computer also reports that “Hackers are actively scanning for and exploiting a recently disclosed Atlassian Confluence remote code execution vulnerability to install cryptominers after a PoC exploit was publicly released. Atlassian Confluence is a very popular web-based corporate team workspace that allows employees to collaborate on projects.”
Cyberscoop tells us about on going discussions on Capitol Hill about reaching a consensus on wide ranging cybersecurity incident reporting laws.
Battle lines are drawn in Congress over legislation that would require companies to report some cyber incidents to the federal government, with industry groups lining up to support a House of Representatives bill poised to create fewer challenges for business leaders than a similar proposal in the Senate.
The debate involves questions about how quickly companies would have to report attacks, what kinds of specific intrusions would trigger notification and whether failure to comply with the rules would lead to financial penalties. The idea of breach notification legislation gained momentum following last year’s discovery of the SolarWinds hack that compromised nine federal agencies and some 100 companies, as well as the Colonial Pipeline ransomware attack in May.
At issue are such questions as whether companies have 24 or 72 hours to report an incident, along with who would be on the hook outside of critical infrastructure owners and operators, if anyone.
Cyberscoop adds
The bill under discussion in the House would provide companies that share breach data protections against lawsuits, and specifies no punishments for not complying. The Senate bill authorizes financial penalties tied to a company’s gross revenue. Naturally, the private sector prefers not to face penalties, according to the Senate aide.
And while the Senate legislation leaves it to CISA to define what kinds of “cybersecurity incidents” trigger notification requirements, the House legislation defines them as those “likely to result in demonstrable harm to the national security interests, foreign relations, or economy of the United States or to the public confidence, civil liberties, or public health and safety of the American people.” Further, the Senate version requires reporting of confirmed and potential intrusions, while the House bill only applies to confirmed intrusions.
Because there is no Congressional election this year, Congress will have plenty of time this fall to resolve these differences and enact a law.
A friend of the FEHBlog called his attention this very useful list of cybersecurity resources created by the College of Healthcare Information Management Executives (“CHIME”).
FEHBlog readers, hold onto your hats. The FEHBlog has changed the COVID-19 charts presentations which he had been using since April 11, 2020. He has broken out new weekly COVID-19 cases and deaths into completely separate charts which display only information for 2021. This allows you to appreciate the dramatic vaccination driven plunge in cases and deaths that occurred in the spring of this year and the Delta variant driven surge in cases and to a lesser extent deaths that have occurred since the beginning of July. And hopefully before long we will see a final plunge without another surge.
Here’s the usual chart of vaccinations administered and distributed on a weekly basis since mid-December 2020 through this past Wednesday, September 1.
The presentation change was prompted by the David Leonhardt column which the FEHBlog discussed mid-week and this blurb written by John Tozzi that appeared in one of the many Bloomberg emails that show up in the FEHBlog’s email box during the day.
Rewind to mid-March of last year. There was a feeling that a few weeks of sheltering at home, combined with aggressive testing, tracing and isolation, would contain the epidemic in the U.S., much as aggressive actions in China and South Korea had.
That turned out to be wrong, of course. Many experts overestimated Americans’ tolerance for mitigation measures and underestimated the virus’s stealth and persistence. Non-pharmaceutical interventions wouldn’t save us. The only way to end the pandemic was a vaccine.
This spring, with millions of shots administered each day in the U.S., there was hope that the inoculation campaign would put Covid mostly behind us — at least ending the surges that threatened to overwhelm hospitals. But again we were too optimistic about the willingness of Americans to get immunized and failed to account for the resilience of the virus and its variants. * * *
As a nation, the U.S. hasn’t put Covid behind us. The public health emergency formally declared almost 18 months ago remains in place. In its early weeks, it felt like one. Now the state of emergency feels perhaps less urgent but permanent. And that requires a cognitive shift.
But that shouldn’t mean complacency. Most Covid deaths are now preventable, and we should try to prevent them. * * * In places like the U.S., with abundant access to vaccines, we have more power than ever to shape the future course of the pandemic. The question is how we will use it.
Very well put, Mr. Tozzi.
Also from the Delta variant front, here are a link to the CDC’s COVID-19 hospitalizations chart and a link to the CDC’s COVID Data Tracker Weekly Review which conveniently is issued on Friday afternoons.
Yesterday, the FEHBlog called attention to reports that the Food and Drug Administration wants to scale back the Administration’s COVID vaccination booster campaign set to launch on September 20, contingent upon necessary FDA and CDC approvals. The New York Times today writes at length on this matter. The FEHBlog personally has no problem with the system working.
Federal News Network reports that ‘More details are trickling out from the Biden administration about its vaccine and testing policy for federal employees and contractors. ‘Agencies should not ask federal employees to provide proof of their vaccination status, the Safer Federal Workforce Task Force said in a series of frequently asked questions updated Friday.
Here’s that new FAQ (there were several other new FAQs):
Q: Should agencies request documentation to verify an employee’s vaccination status?
A: Agencies should not request documentation to verify an employee’s vaccination status. If the agency receives a good faith allegation that strongly suggests that an employee made a false statement on the Certification of Vaccination form, the agency may request documentation as part of its investigation into the alleged false statement. If an employee who has attested to being vaccinated exhibits symptoms of COVID-19 illness, the agency should apply its safety protocols, but this is not an appropriate reason to request documentation to verify an employee’s vaccination status.
Federal News Network adds that
The administration’s latest guidance comes as the Government Managers Coalition, a group of five associations that represents federal supervisors, has asked the administration for more guidance and support to implement the new vaccine and testing policy.
“Agencies often interpret OPM guidance in different ways, as each organization views the guidance through different organizational structures and programmatic lenses and lexicons,” the coalition wrote Thursday in a letter to the Safer Federal Workforce Task Force. “This is confusing and problematic for our members who lack central, authoritative guidance.”
The coalition, which includes the Senior Executives Association, Federal Managers Association, Professional Managers Association, Federal Aviation Administration Managers Association and the National Council of Social Security Management Associations, reiterated many of the concerns they expressed to Federal News Network last week.
The Biden administration on Friday unveiled a sweeping new biosecurity plan, outlining a $65 billion proposal to remake the nation’s pandemic preparedness infrastructure in the wake of Covid-19.
The new spending would represent one of the largest investments in public health in American history: During a press briefing, Eric Lander, the White House science adviser, likened the proposal to the Apollo program of the late 1960s.
The immense funding boost would target programs aimed at developing and manufacturing vaccines, treatments, and tests more quickly. It would also provide new money for laboratory capacity, viral detection mechanisms, and early warning systems.
Please Dr. Lander build flexibility and an appreciation of unknown factors in your plans.
OPM Headquarters a/k/a the Theodore Roosevelt Building
Today OPM issued its first notice about the Federal Benefits Open Season which will run this year from Monday November 8 through Monday December 13.
[Benefits Administration Letter] BAL 21-401 provides guidance on the upcoming Federal Benefits Open Season for the Federal Flexible Spending Account Program (FSAFEDS), Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Employees Health Benefits (FEHB) Program. Attached to this BAL is a sample email and “Circle Round Your Benefits” flyer. This BAL and the attachments will be posted on our website at www.opm.gov/retirement-services/publications-forms/benefits-administration-letters/.
The BAL makes a couple of points worth noting and includes a timeline which also is partially excerpted below:
Employees find Open Season fairs a valuable resource for getting Open Season information. Due to COVID-19, we strongly encourage you to assess how in-person benefit fairs will be impacted. Consider other ways to provide information to employees such as virtual events, webcasts, or webinars. Many health plans host virtual events to provide information about Open Season to their enrollees and others. You may contact health plans for ideas and suggestions on providing information.
The Food and Drug Administration has scheduled a key meeting on coronavirus boosters with its outside advisers for Sept. 17 — just a few days before the Biden administration’s planned starting date for an extra-shot campaign.
The session, which will be public, could add much-needed clarity and transparency to a decision-making process that some people have criticized as confusing. But it also could fuel more controversy over an administration position some experts regard as premature.
Of course, the Biden administration could reduce the time pressure by postponing its “plan starting date.”
On a related note, The Wall Street Journal reports that
The Food and Drug Administration is considering whether to authorize a lower dose of Moderna Inc.’s Covid-19 vaccine for boosters than the dose given in the first two shots, people familiar with the deliberations said.
Moderna said Wednesday it is asking the FDA to authorize a 50 microgram dose, half the dosage of the first two shots. Some in the government are leaning toward authorizing the 100 microgram dose, the people said, because of concerns a lower-dose booster might not offer a durable enough boost to counter fast-changing variants of Covid-19.
No final decision has been made, the people said, as the FDA is still reviewing data from studies that tested boosters using the different doses. People who have seen the data said both doses produce a strong immune response.
Presumably a smaller dose would reduce side effects.
CNBC brings us up to date on the other COVID-19 variants of concerns besides Delta.
The CDC is monitoring four variants “of concern,” including delta, which was first detected in India and is the most prevalent variant currently circulating in the U.S.; alpha, first detected in the U.K.; beta, first detected in South Africa, and gamma, first detected in Brazil. A variant of concern is generally defined as a mutated strain that’s either more contagious, more deadly or more resistant to current vaccines and treatments.
It’s also keeping a close watch on four other variants of interest — including lambda, first identified in Peru [and presumably mu, first identified in Columbia] — that have caused outbreaks in multiple countries and have genetic changes that could make them more dangerous than other strains.
Also from the FEHB front —
Fedweek offers short but accurate guidance about OPM’s FEHB disputed claims review process.
Health Payer Intelligence informs us that “The Alliance of Community Health Plans (ACHP) is urging the federal government to take action and lower prescription drug prices with a set of recommended actions.” In addition to recommendations for Medicare Part D and the biosimilar market, ACHP makes broader recommendations such as
Targeting drug companies’ unjustifiable raising of drug prices. At the beginning of 2021, 735 drugs prices increased up to 10 percent without reason. Prescription drug prices often increase faster than the inflation rate, therefore ACHP recommended that drug manufacturers should have to provide rebates for drug price increase above the inflation rate. Drug companies should also have to follow a price transparency rule that would require manufacturers to report and justify price increases, ACHP stated.
The federal government [should] encourage the use of transparent fee-based pharmacy benefit managers (PBMs). Traditional PBMs are typically not transparent about rebates, which can encourage high-cost drug use, whereas transparent fee-based PBMs pass rebates and discounts onto payers and earn revenue through a clear administrative fee.
ACHP may be interested to know that OPM imposed a strict regime of transparent pricing on experience rated FEHB plans ten years ago. Transparent pricing, which OPM continues to fine tune, facilitates OPM audits of PBMs but does not generate substantial new savings for carriers. Instead, transparent pricing shifts PBM fees from a share of rebates and such to “a clear administrative fee” at levels which simply were not charged before 2011. It is important to add that in 2010 OPM also mandated that experience rated carriers rebid their PBM contracts triennially and those market competitions have generated substantial new savings for carriers. Also as the FEHBlog has mentioned, if OPM were to allow FEHB carriers to offer Medicare Part D EGWPs, as Congress authorized in 2003, the resulting savings, in the FEHBlog’s estimation, would generate blockbuster new savings that would actually lower FEHB premiums.
From the miscellany department —
MedPage Today tells us that “The FDA approved the injectable, long-acting atypical antipsychotic paliperidone palmitate (Invega Hafyera), a twice-yearly treatment for schizophrenia in adults who have been adequately treated with the 1- or 3-month versions of paliperidone palmitate, Janssen announced.
OPM released weather leave guidance today according to Govexec.
Healthcare Dive reports that “Four out of six infections routinely tracked at U.S. hospitals rose significantly during the COVID-19 pandemic, according to a Centers for Disease Control and Prevention data analysis published in the journal of the Society for Healthcare Epidemiology of America on Thursday. From 2019 to 2020, major increases were observed in central-line associated bloodstream infections, catheter-associated urinary tract infections, ventilator-associated events and antibiotic resistant staph infections, according to the report.”
In addition to being Wednesday, today is September 1 which marks the beginning of at least three healthcare related observances”
Each September, the American Medical Association’s (AMA) Women Physicians Section (WPS) honors physicians who have offered their time, wisdom and support to advance women with careers in medicine.
September is Sepsis Awareness Month. Here is a link to the Center for Disease Control’s Sepsis awareness page.
September is also National Recovery Month. The AMA identifies four ways that the Biden Administration can reduce the number of drug overdose deaths.
From the Delta variant front
The FEHBlog’s favorite newspaper columnist is David Leonhardt who writes a morning column for the New York Times. Mr. Leonhardt raises questions often on the FEHBlog’s mind after exploring the question with experts.This morning he pondered whether
the Delta-fueled Covid-19 surge in the U.S. finally peaked?
The number of new daily U.S. cases has risen less over the past week than at any point since June. * * *
Since the pandemic began, Covid has often followed a regular — if mysterious — cycle. In one country after another, the number of new cases has often surged for roughly two months before starting to fall. The Delta variant, despite its intense contagiousness, has followed this pattern. * * *
In the U.S., the start of the school year could similarly spark outbreaks this month. The country will need to wait a few more weeks to know. In the meantime, one strategy continues to be more effective than any other in beating back the pandemic: “Vaccine, vaccine, vaccine,” as [University of Minnesota epidemiologist Michael] Osterholm says. Or as [Johns Hopkins epidemiologist Jennifer] Nuzzo puts it, “Our top goal has to be first shots in arms.”
Hope springs eternal.
Regading increasing the number of vaccinations, Bloomberg reports today that
Vaccine mandates are set to get more common in the workplace.
A majority of U.S. employers — 52% — are planning or considering requirements for a Covid-19 shot by the end of the year, according to a survey released Wednesday by consultant Willis Towers Watson. That’s more than double the 21% of companies polled that currently have some form of mandate.
The options vary, ranging from a strict order for all employees to limiting access to certain areas to inoculated workers. About 14% of respondents also said they are weighing a health-care surcharge for people who choose not to get the vaccine, while 1% are planning to impose one, according to the survey of 961 employers, conducted Aug. 18-25.
Also Fierce Biotech explores what’s next in the mRNA pipeline. Principally for the two COVID mRNA vaccine companies with large war chests
Moderna executives tout the company’s pipeline often—so we’ll be brief here. A cytomegalovirus candidate is the furthest along in the company’s prophylactic vaccine program, while other mid-stage assets include a personalized cancer vaccine and a localized regenerative therapeutic for the heart condition myocardial ischemia.
BioNTech, meanwhile, has dozens of assets in development for a host of common conditions: malaria, tuberculosis and even certain allergies. But where the German biotech is really making a mark is in oncology, where dozens of vaccines and therapeutics are in development. Just one is in phase 2: the Roche-partnered melanoma therapy BNT122. That drug is combined with Merck & Co.’s blockbuster Keytruda to treat metastatic melanoma in a study conducted with Roche’s Genentech.
The article also discusses where other large drug manufacturers stand in the developing market.
From the bankruptcy front, the Wall Street Journal reports that
OxyContin maker Purdue Pharma LP won court approval of a $4.5 billion bankruptcy settlement that shields its owners, members of the Sackler family, from lawsuits accusing them of contributing to the nation’s opioid epidemic in exchange for providing funding to combat the crisis.
Judge Robert Drain of the U.S. Bankruptcy Court in White Plains, N.Y., said Wednesday he will confirm a restructuring plan that will transform Purdue into a public benefit company and settle civil lawsuits filed by governments and opioid victims against the drugmaker and its owners.
The ruling can be appealed by the handful of federal and state authorities that opposed Purdue’s bankruptcy-exit plan and argued at trial that the settlement structure is unconstitutional and the Sacklers aren’t contributing enough of their wealth. Purdue’s family owners collected more than $10 billion from the company between 2008 and 2017, about half of which went to taxes or was reinvested in the business.
From the miscellany front
Homeland Security Today informs us that “The Biden Administration, in a collaboration between the General Services Administration, the White House Office of Management and Budget, the Office of Personnel Management, the Cybersecurity and Infrastructure Security Agency, and the White House Office of Science and Technology Policy, announced the U.S. Digital Corps, a new two-year fellowship that will recruit early-career technologists to contribute to high-impact efforts across the federal government. This program will work to advance the Administration priorities of coronavirus response, economic recovery, cybersecurity, and streamlining government services.” Best of luck with this initiative.
The Washington Post reports that “Childhood obesity rose significantly during the pandemic,according to a new study. The greatest change was among children ages 5 to 11, who gained an average of more than five pounds, adjusted for height, according to the study published in Journal of the American Medical Association (JAMA) Network. For the average 5-year-old (about 40 pounds), that’s a 12.5 percent weight gain. For the average 11-year-old (about 82 pounds), it’s a 6 percent weight gain, according to the study. Before the pandemic, about 36 percent of 5- to 11-year-olds were considered overweight or obese, and that increased to 45.7 percent. ‘Significant weight gain occurred during the covid-19 pandemic among youths in Kaiser Permanente Southern California, especially among the youngest children,’ the study concluded. ‘These findings, if generalizable to the U.S., suggest an increase in pediatric obesity due to the pandemic.’” No bueno.
Employee Benefits News offers an engaging article titled “Affordable ways to help your employees tend to their mental health.
Medscape reports on yesterday’s CDC Advisory Committee on Immunization Practices meeting:
“Vaccines remain effective in preventing hospitalization and severe disease but might be less effective in preventing infection or milder symptomatic illness,” Sara Oliver, MD, the CDC scientist who presented the information [about the mRNA vaccines], told the committee.
In a new data analysis released by the CDC on Sunday, unvaccinated adults were 17 times more likely to be hospitalized than vaccinated adults. Hospitalization rates were higher for unvaccinated people in all age groups.
Among the fully vaccinated, people who were hospitalized were much older, more likely to be nursing home residents and more likely to have three or more underlying medical conditions. Nearly a third had immunosuppressive conditions.
The U.S. government will resume distribution of Eli Lilly’s COVID-19 antibody drug combination in a number of states, HHS said Friday, as cases and hospitalizations in the U.S. are driven higher by the spread of the delta variant.The decision comes roughly two months after administration of Lilly’s therapy was halted by U.S. officials due to concerns of reduced efficacy against coronavirus infections stemming from the beta and gamma variants. Those are now much less prevalent compared with delta, which laboratory testing has shown remains susceptible to treatment with the dual-antibody therapy, HHS said.
Last week’s FDA approval of Pfizer’s Comirnaty vaccine boosted consumer confidence among both vaccinated and unvaccinated people.
A Harris Poll survey over the weekend found that 80% of Americans who were aware of the approval now have more confidence in it. Even more encouraging? Almost half (49%) of unvaccinated people who heard about the approval said they will “probably” or “definitely” get vaccinated.
Overall awareness of the Pfizer approval was high—79% of those surveyed by The Harris Poll were aware of the FDA thumbs-up.
From the telehealth front, Kaiser Health News discusses re-emerging state law barriers to telehealth. “’The whole challenge is to ensure maximum access to health while assuring quality,’said Barak Richman, a Duke University law professor, who said laws and policies haven’t been updated to reflect new technological realities partly because state boards want to hang onto their authority.” The article provides an overview of options available to doctors and state boards.
From the miscellany front
Beckers Hospital Review unveils six big ideas in health innovation. For example, Jason Joseph. Senior Vice President and Chief Digital and Information Officer at Spectrum Health (Grand Rapids, Mich.).As we innovate, we are forcing hidden barriers into the light via experimentation. We saw so many of these barriers uncovered within health care, such as lack of connectivity, digital competency, and the need for comprehensive managed workflow. We have shined a spotlight on how much of healthcare relies on people and inconsistent manual processes to get through the system. That needs to change, and that also requires changing a leader’s traditional mindset.
The Agency for Healthcare Quality and Research is offering a toolkit to help healthcare providers and possible health plans get patients and members engaged with the diagnosis process.
The toolkit contains two strategies, Be The Expert On You and 60 Seconds To Improve Diagnostic Safety. When paired together, these strategies enhance communication and information sharing within the patient-provider encounter to improve diagnostic safety. Each strategy contains practical materials to support adoption of the strategy within office-based practices.
Be The Expert On You is a patient-facing strategy that prepares patients and their families to tell their personal health stories in a clear, concise way. Research suggests that 79 percent of diagnostic errors are related to the patient-clinician encounter and up to 56 percent of these errors are related to miscommunication during the encounter. Environmental scan findings show that inviting patients to share their entire health story, uninterrupted, and in a way that gives clinicians the information they need can reduce diagnostic errors.
60 Seconds To Improve Diagnostic Safety prepares providers to practice deep and reflective listening for one minute at the start of a patient-encounter. Research suggests that patients are interrupted by their providers in the first 11 to 18 seconds of telling their diagnostic story. Diagnostic safety can be improved when a provider allows a patient to tell his or her health story without interruption for one minute, and then asks questions to deepen understanding.
Not every innovative idea makes sense to implement though. The President and Democrat leadership in Congress want the Centers for Medicare Services to “negotiate” drug prices for Medicare Part D plans. Regulatory Focus informs us that “A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.”
From the Delta variant front, the CDC’s Advisory Committee on Immunization Practices met today. It turns out that the principal topic at the meeting was reviewing the Food and Drug Administration’s final marketing approval for the Pfizer-BioNTech COVID-19 vaccine. ACIP ratified that decision, which was a foregone conclusion.
Health experts advising the U.S. government on vaccines expressed initial support for giving booster shots to people vaccinated against Covid-19, starting with healthcare workers, nursing-home residents and others immunized earliest.
Members of the Advisory Committee on Immunization Practices, or ACIP, on Monday indicated their agreement with the Biden administration’s plans to offer the extra doses. Yet they said the priority should remain increasing vaccinations of unvaccinated people, and that boosters shouldn’t distract or impede from doing that.
When giving boosters, some panel members added, the priority should be preventing severe disease in people at highest risk of becoming sick with Covid-19, as opposed to preventing infections.
For more information, here’s a link to the presentation slides for today’s ACIP meeting.
OPM helpfully sent FEHB plan carriers the following standard guidance to FEHB carriers today about Hurricane Ida:
Due to Hurricane Ida impacting the Gulf Coast and connecting states, we remind you that under Section 2.2 BENEFITS PROVIDED, you are authorized, “To pay for or provide a health service or supply in an individual case which does not come within the specific benefits provisions of the contract, if the Carrier determines the benefit is within the intent of the contract, and the Carrier determines that the provision of such benefit is in the best interest of the Federal Employees Health Benefits Program.”
If you decide to apply Section 2.2, we ask that you demonstrate maximum flexibility, including the following:
· Relax certain provisions such as pre-certification requirements that the plan must be notified within 2 business days of an emergency admission.
· Relax requirements about notification and levels of benefit payment if victims are taken to non-plan and/or non-PPO hospitals or other treatment centers.
· Allow certain FEHB members to get additional supplies of medications as backup, if necessary.
· Though charges for work-related injuries sustained by Federal workers are payable by the Office of Workers’ Compensation Programs (OWCP), we are encouraging FEHB plans to provide immediate payment and seek subsequent reimbursement from OWCP.
Today, the Department of Health and Human Services announced the establishment an Office of Climate Change and Health Equity. The Wall Street Journal notes that “The new office is likely to spur initiatives touching on many aspects of healthcare, HHS officials announced Monday. It is expected to offer protections for populations most at risk—including the elderly, minorities, rural communities and children, and the office could eventually compel hospitals and other care facilities to reduce carbon emissions.”
STAT News identifies three trends divined from research on telehealth utilization by Medicare beneficiaries during the COVID-19 pandemic. The FEHBlog’s attention was drawn to this trend:
Telemedicine use has not varied substantially by race and ethnicity. Many commenters * * * have expressed concern that telemedicine will widen disparities of care. Surprisingly, this has not by borne out by the data. Through the end of 2020, we observed no substantive differences in the proportion of beneficiaries using telemedicine by race and ethnicity: 51% of non-Latino white beneficiaries, 55% of Black beneficiaries, and 56% for both Latino and Asian beneficiaries.
This pattern may in part reflect the fact that people of color are more likely to live in urban areas, where the use of telemedicine is higher. Beneficiaries living in large metropolitan counties were substantially more likely to use telemedicine than those living in rural areas.
STAT News also offers a fascinating peak inside Pfizer’s Pearl River (NY) Research Center where a “team of “variant hunters,” as they call themselves, race to track changes in the fast-mutating SARS-CoV-2. A “virus farmer” grows the latest variants so researchers can test how they fare against the vaccine. And a colleague known as the “graphing unicorn” converts the data into intelligible results overnight.” Extraordinary.
The Senate remains on a State work break this week while the House of Representatives has scheduled a few Committee meetings but no floor voting.
The CDC’s Advisory Committee on Immunization Practices meets tomorrow and Tuesday to discuss expanding Pfizer/Biontech boosters to the age 16 and older population. Currently the boosters are only available for the moderately and severely immunocompromised population. (N.B. In Monday’s New York Times David Leonhardt writes an insightful column on the expansion question. He suggests that COVID-19 vaccine immunity may not be waning enough to justify the expansion.
Immunity does probably wane modestly within the first year of receiving a shot. For this reason, booster shots make sense for vulnerable people, many experts believe. As Dr. Céline Gounder of Bellevue Hospital Center told my colleague Apoorva Mandavilli, the C.D.C.’s data “support giving additional doses of vaccine to highly immunocompromised persons and nursing home residents, not to the general public.”
The current booster shots may do little good for most people. The vaccines continue to provide excellent protection against illness (as opposed to merely a positive Covid test). People will eventually need boosters, but it may make more sense to wait for one specifically designed to combat a variant. “We don’t know whether a non-Delta booster would improve protection against Delta,” Dr. Aaron Richterman of the University of Pennsylvania told me.
A national policy of frequent booster shots has significant costs, financially and otherwise. Among other things, the exaggerated discussion of waning immunity contributes to vaccine skepticism.
While Americans are focusing on booster shots, other policies may do much more to beat back Covid, including more vaccine mandates in the U.S.; a more rapid push to vaccinate the world(and prevent other variants from taking root); and an accelerated F.D.A. study of vaccines for children.
As always, we should be open to changing our minds as we get new evidence. As Richterman puts it, “We have time to gather the appropriate evidence before rushing into boosters.”
FCW interviewed “OPM’s Senior Advisor to the Director on Diversity, Equity, Inclusion and Accessibility Mini Timmaraju.” The President’s recent executive order on this topic set Oct. 3 as the deadline for agencies to finish a preliminary assessment of human resources practices and agency workforces.” Ms. Timmaraju’s team is helping other agencies prepare these documents. The article further explains that
At the same time, OPM is working on its own reorganization, which will reestablish an Office of Diversity, Equity, Inclusion and Accessibility as a standalone program office that reports directly to the OPM director.
It was absorbed into the Employee Services Center during the Trump administration, and its workforce has been “reduced” over the last four years, Timmaraju said.
Internal DEIA work at OPM is also moving from the agency’s Equal Opportunity Employment to Human Resources.
The new office will focus on governmentwide initiatives, according to OPM. It’ll have three sub-organizations, focused on policy and development, analytics and accountability and outreach and technical assistance.
The goal is to rightsize the team back to similar levels seen during the Obama administration, Timmaraju said. The office had 12 full-time equivalent employees in fiscal year 2016, according to budget documents.
OPM is also recruiting a Senior Executive Service-level director for the office. The job listing on USAJobs says that the agency is currently reviewing applications.
In healthcare news
The Wall Street Journal reports that “CVS Health is among several retailers including Walmart Inc. and Walgreens Boots Alliance Inc.,that are experimenting with offering counseling services in or near stores. They see potential as the Covid-19 pandemic has prompted more people to seek help for addiction, depression and other issues, according to federal data. “It’s creative and we certainly need the help,” said Ken Duckworth, medical director of the National Alliance on Mental Illness. “It’s an interesting idea to post a mental-health resource at a place where people already are at.” The FEHBlog heartily agrees.
The Food and Drug Administration approved on Friday August 27 “the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke—a stroke caused by a blockage of blood flow to the brain with long-lasting symptoms—using vagus nerve stimulation (VNS). ‘People who have lost mobility in their hands and arms due to ischemic stroke are often limited in their treatment options for regaining motor function” said Christopher M. Loftus, M.D., acting director of the FDA’s Center for Devices and Radiological Health’s Office of Neurological and Physical Medicine Devices. “Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using vagus nerve stimulation. Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke.’” Cool.
The Drug Enforcement Administration offers ten strategies for keep youngsters and teenagers off drugs. A friend of the FEHBlog, who is a psychiatrist explained that brain development continues until the mid-twenties. If you start a bad habit before your late twenties it will be harder to break than a bad habit that begins after the mid-twenties. Business Insider sums it up as follows: “Neuroscientists are confirming what car rental places already figured out — the brain doesn’t fully mature until age 25. Up until this age, the prefrontal cortex — the part of the brain that helps curb impulsive behavior — is not yet fully developed.”
On Wednesday August 25, the President led a summit conference between his administration and business leaders about cybersecurity. The Wall Street Journal reports that the President
called the issue “the core national security challenge we are facing.”
Top tech executives, including Apple Inc.’s Tim Cook, Amazon.com Inc.’s Andy Jassy, Microsoft Corp.’s Satya Nadella and Alphabet Inc.’s Sundar Pichai attended the White House meeting, according to a list of participants shared by an administration official. The guest list also included JPMorgan Chase & Co. CEO Jamie Dimon and Brian Moynihan, president and CEO of Bank of America Corp. , among other representatives of the financial industry.
Here’s a link to the White House’s fact sheet on the conference which highlights its significant accomplishments. Cyberscoop adds that “While impressive, observers noted, those commitments will require considerable follow-up, from expansion to other sectors to policy changes that could emerge from closer-knit relationships between industry and government.”
Last Monday, the FEHBlog attended a Federal Contract Institute webinar on combatting ransomware. The speakers, who were lawyers, suggested placing as many speed bumps, e.g., dual authentication, encryption, DMARC, as you reasonably can in front of the ransomware crook. Your run of the mill ransomware crook will switch intended victims if the first intended victims servers appear difficult to crack. The speakers also recommended supplementing NIST 800-171 , which focuses on preserving the confidentiality of data, with NIST IR 8374 , a June 21 draft which focuses on preserving the integrity and available of data. The speakers noted the CISA’s www.ransomware.gov site provides a helpful double check to identify available speed bumps.
Speaking of ransomware, the author of Bleeping Computer’s The Week in Ransomware must be on vacation because the FEHBlog cannot find the August 27 issue. In any event, Bleeping Computer does report that yesterday August 27, ‘T-Mobile’s CEO Mike Sievert said that the hacker behind the carrier’s latest massive data breach brute forced his way through T-Mobile’s network after gaining access to testing environments.” Cyberscoop adds that
“Americans already trying to avoid calls from telemarketers, call support scammers and long-winded in-laws now have another reason to ignore that ringing phone: ransomware hackers. Scammers affiliated with a digital extortion outfit known as Hive are using phone calls to dial victims who are infected with a malicious software strain that locks up their files until they agree to pay a hostage fee, according to an August 25 FBI alert. Investigators first observed hackers deploying the malware in June, with attackers leveraging Microsoft’s Remote Desktop Protocol to infect business networks.”
Here are a couple of cybersecurity defense links that are worth a gander in the FEHBlog’s opinion:
Security Week discusses how threat detection is evolving.
The publication also explains how to defeat (avoid?) a false sense of cybersecurity.
Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 34th week of this year (beginning April 2, 2020, and ending August 25, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):
and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:
The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through August 25, 2021):
Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 25, 2021, which also uses Thursday as the first day of the week:
The cases, hospitalizations, and death charts move continue to move in the wrong direction. New vaccinations remain steady as people recognize that the Delta variant is more aggressive than the 2020 wave. If there is any bright side it is that the elderly (age 65 and older) who are at the greatest risk of death from COVID-19 are the most vaccinated group in the U.S. with 81.5% fully vaccinated and another 10% at the first dose stage.
For more stats, here’s a link to the CDC’s weekly interpretative review. “As of August 26, 2021, 203 million people in the United States have received at least one dose of a COVID-19 vaccine. 172 million people are fully vaccinated. That’s 60.8% of the eligible population (12 years and older). * * * COVID-19 vaccines remain the most powerful tool we have against COVID-19, making it critical that all people get vaccinated as soon as they are eligible. To find a vaccine provider near you, visit vaccines.gov or your state or local public health department.”
The CDC also issued its 2021-22 flu season vaccination recommendations today.
Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. * * * Balancing considerations regarding the unpredictability of timing of onset of the influenza season and concerns that vaccine-induced immunity might wane over the course of a season, particularly for older adults, vaccination is recommended to be offered by the end of October. * * * Children aged 6 months through 8 years who require 2 doses (i.e., children in this age group who have never received influenza vaccine or who have not previously received a lifetime total of ≥2 doses; see Children Aged 6 Months Through 8 Years) should receive their first dose as soon as possible after the vaccine becomes available to allow the second dose (which must be administered ≥4 weeks later) to be received, ideally, by the end of October. Children of any age who require only 1 dose for the season should also ideally be vaccinated by the end of October; vaccination of these children may occur as soon as vaccine is available because there is less evidence to suggest that early vaccination is associated with waning immunity among children compared with adults.
Also from the Delta variant front
The Numbers columnist in the Wall Street Journal reports that “Medical studies often use thousands of volunteers. But sometimes good things come in small packages—like a handful of people willing to contract a deadly virus. Researchers in the U.K. have deliberately infected 30 volunteers with the virus that causes Covid-19, in the first human challenge study of the disease. Infecting the volunteers—who are healthy, unvaccinated and range in age from 18 to 30—will allow the scientists to observe in real time how the virus attacks the body and, from the moment of exposure, how the immune system responds. * * * [In contrast to a large clinical study involving the use of placebo] a human challenge study of a relatively small number of participants offers precise answers to specific questions, often related to immune response. Today, human challenges conducted under the supervision of institutional review boards are routinely used to research diseases such as influenza, malaria, cholera, salmonella, shigellosis and norovirus.”
The Journal also reports that British scientists are making progress in carefully growing the Delta variant for use in these human challenges. The U.S. is not conducting human challenges involving COVID-19 at this time.
The Journal also informs us that “U.S. intelligence agencies are unable to determine conclusively how the Covid-19 pandemic emerged, a summary of a classified report released Friday said.” The article concludes “In a July 27 letter to Mr. Biden, the Democratic and Republican leaders of the Senator Foreign Relations and Intelligence committees urged the president to carry on with the investigation until the intelligence community had reached conclusions on the origin of the pandemic with a high degree of confidence. The letter urged that the inquiry examine what U.S. government funding was provided to the Wuhan Institute of Virology for advanced virus research.”
In other news —
The Federal Times reports that “Federal employees will get a total 2.7 percent pay raise in 2022, as President Joe Biden informed Congress Aug. 27 that he intends to exercise his authority to determine federal pay rates during a state of emergency.” The increase will breaks down into a 2.2% general increase and a 0.5% locality pay increase.
Fierce Healthcare tells us that “OptumRx has released its quarterly look at the drug pipeline, and two of the therapies highlighted in the report target fairly common conditions. Finerenone, or the brand name Kerendia, was approved by the Food and Drug Administration on July 9. The drug treats chronic kidney disease and type 2 diabetes. Some 26.8 million Americans have been diagnosed with diabetes, and one in three eventually develop some kind of kidney disease. Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx, told Fierce Healthcare that the drug will be entering a market where many patients are already treated by low-cost therapies. “With the entrance of this drug, some patients are going to shift from a low-cost treatment to a higher-cost treatment,” he said. The other drugs highlighted in the report are: (1) Atogepant, which is pending a brand name, a drug that treats episodic and chronic migraines; (2) Odevixibat, or the brand name Bylvay, which treats progressive familial intrahepatic cholestasis, a liver disease, and (3) Maralixibat, which also has yet to set a brand name, treats Alagille Syndrome, a rare genetic disease of the liver.
Healthcare Dive informs us that “COVID-19 hospitalizations continue to rise as coronavirus cases surge across the U.S. This once again puts pressure on hospital operations and will likely put downward pressure on nonprofit hospital margins, according to a new report from Fitch Ratings. In some areas, hospitalizations are higher than they were during previous surges.”
Becker’s Hospital Review tells us that “The FDA has extended the shelf life of Pfizer’s COVID-19 vaccine from six months to nine months, the agency said Aug. 24. The shot can now be stored at temperatures up to minus-76 degrees Fahrenheit, up from minus-130 degrees Fahrenheit, for up to nine months, up from six months. The agency said the updated shelf life applies to batches that expired before the extension, as long as they were stored at proper temperatures.” The
The Wall Street Journal offers an FAQ article on COVID 19 vaccination boosters.
The Society for Human Resource Management discusses employer policies, similar to the federal government’s, which require routine COVID-19 testing for unvaccinated employees.
Bloomberg reports that COVID-19 testing has regained popularity to such an extent that “CVS Health Corp. is limiting customers’ purchases of rapid, over-the-counter Covid-19 tests, with a maximum of six packages available online and four in its pharmacies, as the spread of the delta variant spurs demand. Put in place this week, the limits apply to Abbott Laboratories’s BinaxNOW along with a test from the startup Ellume, according to an email from a CVS spokesperson. Both tests are available without a prescription.” According to the article, Abbott is ramping up its production of these tests.
In employment news, Govexec reports that “the U.S. Postal Service is planning to hire 100,000 employees in 2021, looking to fill vacancies that have contributed to logjams in the mailing agency’s network and widespread delivery delays. * * * The Postal Service is currently seeking drivers, letter carrier assistants, mail handlers, processing clerks and others.”
Employers are anticipating that the coronavirus pandemic will continue to have a long-term impact in 2022, particularly in the areas of mental health and chronic disease needs, according to Business Group on Health’s recent 2022 Large Employers’ Health Care Strategy and Plan Design survey. The researchers surveyed 136 large employers in June 2021. These employers provided healthcare coverage for a total of more than 8 million employees and dependents.
That roughly matches the FEHB’s enrollment.
Speaking of mental healthcare
Fierce Healthcare tells us about “a recent study by CertaPet, a telehealth company, which analyzed the 50 most populous U.S. cities to find the best and worst places to live for mental health treatment.” According to this survey Denver sits at the top and Dallas rests on the bottom.
Healthcare Dive reports that “Meditation and mindfulness startup Headspace and on-demand mental healthcare app Ginger have announced plans to merge into a single company, called Headspace Health, valued at $3 billion, the two companies said Wednesday. The two startups focused on mental health and wellness have each raised more than $200 million in venture funding from investors. As Headspace Health, the two companies will offer support for mental health symptoms from anxiety to depression to more complex diagnoses, selling direct to consumer and to employers and health plans.”
Finally the FEHBlog was surprised to read in the Wall Street Journal that
The U.S. Chamber of Commerce and a Texas affiliate withdrew a suitfiled to block parts of a federal rule requiring insurers and employers to disclose prices they pay for healthcare services and drugs. The withdrawal, in a filing late Wednesday, came after the Biden administration delayed enforcement of provisions of the rule that were the focus of the suit. * * *Daryl Joseffer, senior vice president at the U.S. Chamber Litigation Center, said in a statement that the Biden administration decision “was a positive and constructive response to our lawsuit.” There are still “significant issues” with the rule, he said, and “we’ll continue to monitor the developments, and that includes evaluating whether in the future the Chamber will bring a new lawsuit.” An email sent Friday by the Tyler Area Chamber of Commerce to the U.S. Chamber, viewed by The Wall Street Journal, said it wanted to withdraw from the suit “based on feedback from community leadership.”
PCMA, the prescription benefit manager trade association, continue to pursue its similar lawsuit pending in the D.C. federal court (No. 1:21-cv-02161).
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