Friday Stats and More

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, Rx coverage, Telehealth, U.S. Healthcare–

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 31st week of this year (beginning April 2, 2020, and ending August 4, 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 4, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 24, 2021, which also uses Thursday as the first day of the week:

While COVID-19 cases are soaring, the number of deaths remains stable thanks to the high vaccination rates for Americans over age 65. It is also encouraging that the number of administered vaccinations also is increasing.

In other Delta variant news:

  • Surprisingly, according to STAT News, “with nearly 20% of all U.S. Covid cases last week recorded in children, the American Academy of Pediatrics and 11 other organizations put out a consensus statement this week calling on providers conducting sports physicals to ask about children’s Covid vaccination status and to use it as an opportunity to administer a vaccine, if possible.”
  • Fierce Pharma tells us that “In a trial of nearly 480,000 healthcare workers in South Africa, Johnson & Johnson‘s one-dose vaccine helped prevent severe disease from the Delta variant, Bloomberg reports. The trial is the first piece of large-scale evidence that shows the shot works against the variant, the news service stated. In fact, Glenda Gray, one of the leaders of the work, said the vaccine may provide better protection against Delta than the Beta variant.”
  • MedPage Today reports that “Unvaccinated adults who were previously infected with COVID-19 were twice as likely to be reinfected as those previously infected but also fully vaccinated, researchers found. A case-control study in Kentucky found a more than two times higher risk of COVID-19 cases among unvaccinated adults with prior infection compared with their fully vaccinated counterparts (OR 2.34, 95% CI 1.58-3.47), reported Alyson Cavanaugh, PhD, of the CDC, and colleagues, writing in an early edition of the Morbidity and Mortality Weekly Report.“
  • In related news Precision Vaccines tells us that “The World Health Organization (WHO) issued Influenza Update N° 399 on August 2, 2021, saying, ‘Globally, despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year.'”

From the No Surprises Act (“NSA”) front, the FEHBlog discovered today that last Tuesday the tri-agencies and OPM submitted their second NSA interim final rule, which concerns the independent dispute resolution process, to OMB’s Office of Information and Regulatory Affairs for final review. OIRA already has two listening sessions concerning this rule making on its calendar. This indicates that the second interim final rule will be made public in early September, rather than on its October 1, 2021, due date.

From the federal employee front

  • Govexec brings us up to date on the development of the President’s mandatory vaccination program for federal employees. “The Safer Federal Workforce Task Force—a group President Biden created by executive order that is led by the White House, General Services Administration and Office of Management and Budget—confirmed in new guidance agencies would not initially ask for proof of vaccination, but they could follow up for documentation if they receive “a good faith allegation that strongly suggests” an employee lied on their attestation form. Those “certification of vaccination” forms will soon go out via email to all federal employees, with an Office of Management and Budget official saying that process will begin next week.  While agencies will initially rely on the honor system as it begins asking employees for their vaccination status, the administration made clear there could be consequences for lying.”
  • Govexec also discusses how Medicare Advantage plans are being integrated into FEHB plans. The trend started with HMOs and the APWU Health Plan picked it up for this year. Expect more plans to follow suit for 2022.  

In more news

  • Earlier this week, the FEHBlog noted a Reuters report that the Justice Department is preparing to file suit to block Optum’s acquisition of Change Healthcare. Fierce Healthcare reports today au contraire that “Change Healthcare President and CEO Neil de Crescenzo said Thursday he’s pleased with the company’s progress on regulatory review of its pending deal with Optum and is moving forward with plans for a successful integration. ‘We look forward to continuing to work diligently in coordination with UHG (UnitedHealth Group) to provide the necessary information requested by the DOJ (Department of Justice) and completing the transaction.'” Time will tell.
  • Medcity News informs us that “GoodRx struck a partnership with medication data giant Surescripts that would let healthcare providers access cash price information on medications. Arlington, Virginia-based Surescripts dominates the e-prescribing market, offering technology that routes clinicians’ electronic prescriptions directly to pharmacies. It’s owned by CVS Health and Express Scripts, and nearly 2 billion prescriptions were delivered through its software last year.”
  • mHealth Intelligence tells us that “While the pandemic prompted an unprecedented surge in telehealth to address healthcare needs, it also highlighted the gap between those who can access care and those who can’t. Now health systems, community health organizations, non-profits and philanthropic groups are moving to address those gaps with programs that use telehealth to extend care to those who can’t access or afford it. They’re fueling a surge in connected health charities and projects targeting the social determinants of health. Among those groups is Beam Up, an organization launched by telehealth company Beam Healthcare to address gaps in access to health food, quality education and healthcare services. Executives see a need for these services not only in other countries – a partnership with Tyto Care is equipping a handful of orphanages in Mexico with telemedicine technology – but in cities and rural regions across the United States.

Thursday Miscellany

David Ermer–Uncategorized–
Photo by Michele Orallo on Unsplash

The Wall Street Journal reports tonight that the Senate remains poised to pass the bipartisan infrastructure funding bill before the end of this week, notwithstanding an cautious Congressional Budget Report issued this afternoon.

From the Delta variant front

  • The Journal also informs us that “Covid-19 vaccination rates are ticking upward across the U.S., federal officials said, particularly in areas where the Delta variant is hitting hardest. Worries about the virus, growing confidence in the safety of vaccines and the influence of family and friends are all likely contributing to the increase in vaccine uptake, health authorities and residents say. More employers are also starting to institute vaccine mandates. The U.S. has administered more than 864,000 doses of Covid-19 vaccines in the past 24 hours, including 585,000 first shots, White House Covid-19 Response Coordinator Jeff Zients said Thursday during a media briefing. “Clearly, Americans are seeing the impact of being unvaccinated and unprotected,” said Mr. Zients.”
  • The New York Times tells us that “The powerful protection offered by Moderna’s Covid vaccine does not wane in the first six months after the second dose, according to a statement released by the company on Thursday morning in advance of its earnings call. But during the call, Moderna executives said they anticipated that boosters would be necessary this fall to contend with the Delta variant, which became common in the United States after the results were collected.
  • In that regard, according to the Journal, “The Food and Drug Administration expects to have a strategy on Covid-19 vaccine boosters by early September that would lay out when and which vaccinated individuals should get the follow-up shots, according to people familiar with discussions within the agency.”

On the No Surprises Act front, advocates are writing to the trig-agencies who are shaping the independent dispute resolution regulation for that law which is due on October 1. Fierce Healthcare reports that “A major hospital group is imploring the Biden administration to not tilt a dispute resolution process for handling surprise medical bills in favor of insurers. The Federation of American Hospitals (FAH) wrote to three cabinet members Thursday outlining its requests for an independent dispute resolution (IDR) to fairly resolve payment disputes for out-of-network charges. Congress called for the independent arbitration process in a law passed late last year that bans surprise medical bills.” Among other things FAH wants the tri-agencies to extend the dispute resolution deadlines set in the law. Also

FAH also wants more flexibility for batching medical claims together related to the treatment of a similar condition.“The statutory reference to ‘treatment of a similar condition’ should be broadly construed to allow batching of a wide range of clinical scenarios and payment methodologies,” FAH said. “The statutory language does not indicate that Congress intends to restrict bundling based on the diagnosis code or similar distinctions.”

The FEHBlog does not see an issue with batching emergency care but batching non-emergency care can only lead to confusion because the plan needs to know that the care was related to a confinement at an inpatient facility.

From the second quarter financial results front, Healthcare Dive reports

  • Cigna executives said Thursday that COVID-19-related costs were higher than expected in the second quarter, as was the amount of care not directly related to the virus as patients returned for services.
  • Still, the payer reported a 10% year-over-year increase in revenue to $43.1 billion, beating Wall Street expectations. The growth was driven primarily by its health services segment, Evernorth, which CEO David Cordani said was “clearly a standout” on a Thursday morning call with investors.
  • Use of behavioral health services among customers was up 40% in the quarter. Executives said on the call that they viewed this as a growth opportunity going forward as well, particularly for virtual visits considering Cigna’s acquisition of MDLive in February.

In miscellaneous news

  • Health Payer Intelligence interviews Angie Meoli, senior vice president of network strategy and provider experience at Aetna, about how the pandemic has impacted the value based care movement.
  • The federal government’s Get Smart about Drugs” site offers guidance on using over the counter medications safely.
  • Allysia Finley, a Wall Street Journal columnists, calls attention to growing evidence that that “inoculation confers significant protective benefits” beyond the targeted illness. “Growing evidence indicates that seniors who get vaccinated against illnesses such as tetanus and even the flu are much less likely to develop Alzheimer’s, the leading cause of dementia, characterized by a buildup of amyloid plaque and tau tangles in the brain. Scientists don’t completely understand why, but many hypothesize that vaccines generate a systemic immune response that can reduce inflammation in the brain, which results in neuron loss and cognitive decline.”

Midweek Update

David Ermer–CMS, COVID-19, Federal employment benefits, Rx coverage, U.S. Healthcare–

It turns out that OPM Director Kiran Ahuja held her first virtual press conference this morning.

  • The Federal Times discusses her conversation with reporters about implementing the President’s vaccination mandate and piloting an online retirement application for federal employees.
  • Federal News Network and FCW paint with broader brushes about Ms. Ahuja’s goals and challenges.

The FEHBlog noticed today that the OPM senior staff bios on its website provide a good picture of Director Ahuja’s team.

On the Delta variant front

  • Kaiser Health News makes a convincing economic agreement for receiving a COVID-19 vaccination.
  • The New York Times reports that “With a new surge of coronavirus infections ripping through much of the United States, the Food and Drug Administration has accelerated its timetable to fully approve Pfizer-BioNTech’s coronavirus vaccine, aiming to complete the process by the start of next month, people familiar with the effort said. President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.”

On the 2nd quarter financial reports front, Healthcare Dive reports that

Returning utilization of health services and higher-than-expected COVID-19 care costs drove CVS Health’s net income in the second quarter down 7% year over year to $2.8 billion, the healthcare behemoth reported Wednesday.

The payer business, which includes Aetna, reported a medical loss ratio of 84.1%, up significantly from 70.3% the same time last year. The hike in MLR, which was higher than both internal and analyst forecasts, is especially acute compared to the second quarter of 2020, which saw a severe dip in utilization as COVID-19 lockdowns and elective procedure restrictions kicked into gear.

However, CVS beat Wall Street expectations for both earnings and revenue, with topline of $72.6 billion, up 11% year over year, driven mostly by growth in government products. The Woonsocket, Rhode Island-based company raised its full-year guidance following the results.

In legal news, Business Insurance informs us that “The U.S. Department of Justice is weighing a possible lawsuit to block UnitedHealth Group’s (UNH.N) nearly $8 billion deal to acquire health care analytics and technology vendor Change Healthcare (CHNG.O), the Information reported on Tuesday.”

From the federal employee benefits front, Reg Jones tells us in FedWeek that “One valuable feature of the Federal Long Term Care Insurance Program is its more generous rules regarding coverage in retirement, as compared with the FEHB health insurance and FEGLI life insurance programs.” Of course, the greater flexibility may be explained by the facts that FEHB and FEGLI coverage are government funded while FLTCIP is fully member funded. Still it’s useful information.

In other mid-week news

  • The Center for Medicare and Medicaid Innovation released its 2020 report to Congress today.
  • STAT News tells us that “For all the explosive controversy over the approval of the first treatment for Alzheimer’s disease in nearly 20 years, hardly any patients have actually gotten it yet. The drug’s eye-popping, $56,000 annual price and questionable benefit to patients have been a shock to the bureaucracy that makes the health care system run — and that’s having a clear effect on uptake. Some analysts estimated last month that fewer than 100 patients were dosed in the first weeks after the therapy was approved, though availability will likely ramp up over the coming months.”
  • Health Payer Intelligence discusses “five ways payers have tackled mental, hehavioral Healthcare in 2021. As the coronavirus pandemic becomes more manageable and vaccination rates increase nationwide, payers are channeling funds into mental and behavioral healthcare programs.” That’s a sound focus of attention.

Tuesday’s Tidbits

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

From the Delta variant front

  • Govexec and FedWeek provide their respective updates on implementation of the Administration’s vaccine mandate. It’s not moving quickly.
  • Federal News Network informs us that “The Postal Service, as an independent agency, is setting its own rules on masks and vaccines apart from the rest of the federal workforce, but is seeing an uptick in employees who need to quarantine as the delta variant of COVID-19 presents new challenges for the agency.”
  • The Society for Human Resource Management offers advice on topics that should be covered in an employer’s COVID-19 vaccination policy.
  • Medscape gives us a report on a Delta variant “media briefing today sponsored by the Infectious Diseases Society of America.” “Because the Delta variant of SARS-CoV-2 spreads more easily than the original virus, the proportion of the population that needs to be vaccinated to reach herd immunity could be upwards of 80% or more, experts say. Also, it could be time to consider wearing an N95 mask in public indoor spaces regardless of vaccination status * * *. Furthermore, giving booster shots to the fully vaccinated is not the top public health priority now. Instead, third vaccinations should be reserved for more vulnerable populations — and efforts should focus on getting first vaccinations to unvaccinated people in the United States and around the world.”

In the tidbits department

  • Healthcare Dive reports that “In what appears to be a break from the gloom physicians have felt over the past year due to the COVID-19 pandemic, independent medical practices “feel stronger, resilient, and positive about the future of their practice and the industry,” according to a new survey by Kareo.”
  • The Patient Centered Outcomes Research Institute tells us that “As the nation’s primary funder of patient-centered comparative clinical effectiveness research, PCORI examines the important questions that patients face and helps create an informed healthcare system. Congressional reauthorization in 2019 broadened this scope, giving PCORI the opportunity to chart a bold new direction as it looks at today’s health and healthcare challenges, including many exacerbated by the COVID 19 pandemic. To realize this opportunity fully, PCORI is crafting an ambitious strategic roadmap to guide future research funding and related initiatives.”
  • Fierce Healthcare informs us that “Consumer out-of-pocket spending on healthcare is set to hit an estimated $491.6 billion, or about $1,650 per person, in the U.S., according to a recent report. The number is a roughly 10% increase over last year’s total and is expected to maintain a continual annual growth rate of 9.9% for the next five years, according to healthcare market research group Kalorama Information. * * * Kalorama highlighted a handful of government, business and demographic trends that are expected to drive consumers’ out-of-pocket spending outward in a release summarizing the full report.”

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 testing, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

The American Hospital Association (“AHA”) reports that “Lawmakers in the U.S. Senate this weekend unveiled the text of a bipartisan infrastructure package that has been under negotiation for several months. The package does not rescind any Provider Relief Funds as an offset for the package, though it does extend the Medicare sequester for one additional year, through fiscal year 2031.” Fierce Healthcare points out two other healthcare provisions in the bill. Fierce Healthcare adds that

The Senate is expected to vote this week on the package. It will then consider a $3.5 trillion package that could clear the chamber via a procedural move called reconciliation that ensures budget bills can pass via a simple majority and bypass the 60 votes needed to break a filibuster.

Democrats have sought to add more healthcare related provisions in the $3.5 trillion package, including adding dental, vision and hearing benefits to Medicare.

Sen. Ron Wyden, D-Oregon, told Fierce Healthcare last week that he is working to add drug pricing provisions into the package, including giving Medicare the authority to negotiate for lower prices.

From the Delta variant front

  • Federal News Network discusses federal employee reaction to the President’s COVID-19 vaccination mandate.
  • The Society for Human Resource Management offers solid advice to employers on how businesses should respond to the Delta variant.
  • The American Medical Association discusses how providers can address high blood pressure problems worsened by the pandemic.

From the employee perspective front, Health Payer Intelligence tells us that “Employees are looking for employers to bolster preventive care services, mental healthcare, and access to employees’ providers in their employer-sponsored health benefits, a Marathon Health survey revealed. The researchers surveyed over 1,100 employees—all of whom were working full-time—and 430 human resource leaders in June 2021. “While Americans prize healthcare above every other benefit, our survey also indicates employees and employers see major shortcomings in their healthcare plans. This is especially true when it comes to cost, preventive care, and mental health,” Jeff Wells, co-founder and chief executive officer of Marathon Health, summarized in the press release.”

From the regulatory front today the Centers for Medicare and Medicaid Services finalized the fiscal year 2022 Medicare Part A payment policies for inpatient hospital care.

Before taking into account Medicare disproportionate share hospital (DSH) payments and Medicare uncompensated care payments, the increase in operating payment rates, increases in capital payments, increases in payments for new medical technologies, increases in payments due to implementation of the imputed floor, and other changes will increase hospital payments in FY 2022 by $3.7 billion, or 3.1 percent. CMS projects Medicare DSH payments and Medicare uncompensated care payments to decrease in FY 2022 compared to FY 2021 by approximately $1.4 billion. Overall, CMS estimates hospitals payments will increase by $2.3 billion.

Here is a link to the AHA’s generally favorable reaction to the final rule.

Weekend update

David Ermer–ACA, Congress, COVID-19, U.S. Healthcare–

The House of Representatives is on a long District work break this month while the Senate has one more week of Committee business and floor voting before that body begins its State work break.

The Wall Street Journal reports from the Delta variant front

While the number of cases in the U.S. had climbed, the number of Americans getting vaccinated also surged, particularly in states like Louisiana, Arkansas and Mississippi, where the rates of vaccination were lower, the officials said. Roughly 60% of eligible Americans are fully vaccinated.

The Journal adds that

One recent vaccine recipient was Manny Cid, the 37-year-old mayor of Miami Lakes[, Florida]. He held off on getting a vaccine earlier in the pandemic because the virus seemed to affect mostly older people and he worked out daily and felt healthy, he said. Over time, his thinking changed as he saw young athletes and acquaintances suffer severe bouts of Covid-19. Then the Delta variant emerged, along with research showing people infected with it carry 1,000 times the viral material of people with the original strain. He decided to get a shot Monday.

“Seeing the impact of the Delta variant, attending funerals of people I highly respect, seeing more and more young people in bad shape…that’s really scary,” Mr. Cid said. “We’ve got to protect ourselves.”

In an interesting development, Health Payer Intelligence informs us that “Based on 75 individual [Affordable Care Act] marketplace rate filings, the coronavirus pandemic is not expected to meaningfully affect healthcare spending in 2022, a Peterson-Kaiser Family Foundation (KFF) Health System Tracker brief explained.”

The Centers for Disease Control reminds us that August is National Immunization Awareness Month. Hey health plans, “National Immunization Awareness Month (NIAM) is an annual observance held in August to highlight the importance of vaccination for people of all ages. Use these resources to assist you in communicating to healthcare professionals, parents, and patients about immunization during August and throughout the year.“

Cybersecurity Saturday

David Ermer–Cybersecurity–

The Federal Bureau of Investigation announced that on July 28, 2021, “The Cybersecurity and Infrastructure Security Agency (CISA), Australian Cyber Security Centre (ACSC), United Kingdom’s National Cyber Security Centre (NCSC) and Federal Bureau of Investigation (FBI) released a joint cybersecurity advisory today, highlighting the top Common Vulnerabilities and Exposures (CVEs) routinely exploited by cyber actors in 2020 and those vulnerabilities being widely exploited thus far in 2021. Cyber actors continue to exploit publicly known—and often dated—software vulnerabilities against broad target sets, including public and private sector organizations worldwide. It’s recommended that organizations apply the available patches for the 30 vulnerabilities listed in the joint cybersecurity advisory and implement a centralized patch management system.” Check it out because as the FBI explains “One of the most effective best practices to mitigate many vulnerabilities is to update software once patches are available and as soon as is practicable. Focusing cyber defense resources on patching those vulnerabilities that malicious cyber actors most often use should be ingrained in the culture of every organization. This approach offers the potential of not only bolstering network security, but also impeding the disruptive, destructive operations of our adversaries.”

To help reduce such vulnerabilities, the federal government’s Cybersecurity and Infrastructure Security Agency (“CISA”) announced yesterday July 30

the launch of its VDP Platform for the federal civilian enterprise, the latest shared service offered by CISA’s Cyber Quality Services Management Office (QSMO) and provided by BugCrowd and EnDyna. The VDP Platform provides a single, centrally managed online website for agencies to list systems in scope for their vulnerability disclosure policies, enabling security researchers and members of the general public to find vulnerabilities in agency websites and submit reports for analysis. The Department of Homeland Security (DHS), the Department of Labor (DoL), and the Department of Interior (DoI) are among the agencies planning to leverage this platform at the onset. * * *

Through this crowdsourcing platform, Federal Civilian Executive Branch (FCEB) agencies will now be able to coordinate with the security research community in a streamlined fashion and those reporting incidents enjoy a single, usable website to facilitate submission of findings. The platform encourages collaboration and information sharing between the public and private sectors by allowing uniquely skilled researchers to submit vulnerability reports, which agencies will use to understand and address vulnerabilities that were previously unidentified. BugCrowd and EnDyna, the service providers, will conduct an initial assessment of the vulnerability reports submitted. This initial assessment will free up agencies’ time and resources and allow agencies to focus on those reports that have real impact. * * *

For more information about QSMO and CISA’s new VDP platform, visit Cyber QSMO Marketplace, VDP Fact Sheet, or contact us at QSMO@cisa.dhs.gov.

On a related note, per CISA,

The National Security Agency (NSA) has released an information sheet with guidance on securing wireless devices while in public for National Security System, Department of Defense, and Defense Industrial Base teleworkers, as well as the general public. This information sheet provides information on malicious techniques used by cyber actors to target wireless devices and ways to protect against it. CISA encourages organization leaders, administrators, and users to review NSA’s guidance on Securing Wireless Devices in Public Settings and CISA’s Security Tip on Privacy and Mobile Device Apps for information on protecting devices and data.

These preventive measures are timely because according to Security Weekly, “A global study commissioned by IBM Security shows that the average cost of a data breach exceeded $4.2 million during the coronavirus pandemic, which the company pointed out is the highest in the 17-year history of its “Cost of a Data Breach” report.”

Last but not least, here is a link to Bleeping Computer’s The Week in Ransomware.

Ransomware continues to be active this week, with new threat actors releasing new features, No More Ransom turning five, and a veteran group rebrands.

This week marked the fifth anniversary of No More Ransomware, where they announced that they had saved €1 billion in ransom payments through the decryptors on their platform.

We also saw ransomware groups continue to innovate with LockBit 2.0 now using group policiesto automate the deployment of their ransomware over a Windows domain.

I shared what I know about the inner conflict of the Babuk ransomware gang that led to the Admin starting a new RAMP cybercrime forum and the rest of the team launching Babuk version 2.0.

Finally, DoppelPaymber has rebranded as a new ransomware operation known as Grief, which began operating in May.

Also Bleeping Computer informs us that “A new ransomware gang named BlackMatter is purchasing access to corporate networks while claiming to include the best features from the notorious and now-defunct REvil and DarkSide operations.” Oh joy.

Friday Stats and More

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In other news

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

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Rx coverage, Telehealth–

From the Delta Variant front

  • As explained in this White House fact sheet, President Biden announced, among other things, that “to help protect workers and their communities, every federal government employee and onsite contractor will be asked to attest to their vaccination status. Anyone who does not attest to being fully vaccinated will be required to wear a mask on the job no matter their geographic location, physically distance from all other employees and visitors, comply with a weekly or twice weekly screening testing requirement, and be subject to restrictions on official travel. * * * These rules should not only apply to federal workers and onsite contractors. President Biden is directing his team to take steps to apply similar standards to all federal contractors. The Administration will encourage employers across the private sector to follow this strong model.”
  • The FEHBlog was struck by the fact that President intends to apply the mandate to federal contractors which group includes all of the FEHB carriers. If President were to flow down the mandate to federal subcontractors, he would pick up a large chunk of the American economy. This mandate whatever its scope would be accomplished by an amendment to the Federal Acquisition Regulation or perhaps regulator interpretations of the FAR which already includes a lot of provisions on worker safety. Time will tell.
  • Govexec reports on federal employee union and organization responses to the vaccine mandate which has been mixed. The Wall Street Journal adds that “Two prominent business groups, the U.S. Chamber of Commerce and Business Roundtable, said they welcomed Mr. Biden’s actions.”
  • The Wall Street Journal reports on private sector employers that have implemented a vaccine mandate, including Morgan Stanley, Google and Facebook. These mandates have been tied to office reopenings.

In telehealth business news —

Healthcare Dive reports that

Teladoc Health saw its year-over-year total revenue more than double in the second quarter of this year, coming in above Wall Street expectations and hiking its full-year guidance for the second time this year after offering mild expectations in February.

Analysts noted, however, that membership numbers were stale and the hospital business was slower than expected for the quarter. Shares were down 6% in morning trading Wednesday.

In a call with investors Tuesday, executives tried to steer the conversation toward per-member revenue metrics and touted new contracts, including with major Blues payer HCSC and a primary care platform agreement in the works with an unnamed national payer.

Fierce Healthcare reports that “Amwell is acquiring two digital health companies for $320 million to expand its services beyond telehealth visits. The virtual care company is scooping up SilverCloud Health, a digital mental health platform, and Conversa Health, which offers automated virtual healthcare. The addition of the two companies’ technology will help to differentiate Amwell from other telehealth players, company executives said.”

In prescription drug news, STAT News tells us more about the interchangeable insulin biosimilar that the Food and Drug Administration approved for marketing yesterday. Of note

The agency endorsed Semglee, a copy of long-acting Lantus (insulin glargine), that it first approved last year. * * * But Lantus, which is sold by Sanofi (SNY), already faces competition from several other long-acting insulins. And the company that sells Semglee – Viatris (VTRS), which was created last year when Mylan merged with Pfizer’s Upjohn unit – faces the same challenges winning coverage from health insurers. * * *

The real impact rests with patients whose out-of-pocket costs are more closely tied to the wholesale price for Semglee, according to Sonia Oskouei, vice president of biosimilars at Cardinal Health, a large pharmaceutical wholesaler. Those who pay cash or have high deductible health insurance typically pay more than others, which is where the “market opportunity” exists, she explained.

Depending on the pharmacy, Semglee injector pens cost about $150 to $180 without insurance for a typical month’s supply, compared to $340 or more for the same supply of Lantus, according to the GoodRx web site.

Also STAT News informs us that “Emergent BioSolutions (EBS) plans to resume Covid-19 vaccine production at its Baltimore plant after getting the green light from the FDA, according to The Wall Street Journal. The Baltimore plant had been shut down after FDA inspectors determined there was severe contamination at the plant, which makes the Johnson & Johnson (JNJ) vaccine. While domestic demand for the J&J shot has dwindled in recent months, the Biden administration is seeking to export the vaccine to countries needing protection against Covid-19.” The loss of the Johnson & Johnson to the U.S vaccination campaign will be noted in histories as the one dose is effective with socially vulnerable communities.

Midweek update

David Ermer–COVID-19, OPM, Rx coverage, U.S. Healthcare, Uncategorized–

From the Delta variant front:

  • The Wall Street Journal offers a helpful set of FAQs on the Delta variant of COVID-19.
  • The Journal also reports that “President Biden is expected to announce Thursday that his administration will require federal employees to get vaccinated or be regularly tested for Covid-19, according to a person familiar with the discussions. * * * The person familiar with the situation said no decision has been finalized, and the policy is still under review. The person said the administration is also strongly considering more stringent masking protocols for unvaccinated federal workers. Such policies could affect millions of workers, depending on which categories of employees were included.
  • Federal News Radio writes out a laundry list of “tricky legal questions” posed by the vaccine mandate, according members of the bar. The FEHBlog expects that the courts will resolve these questions in the government’s favor expeditiously.
  • Bloomberg reports that vaccinations rates are up sharply in the areas of the country where the Delta variant is running amuk. In the end you can count on common sense prevailing.
  • The Journal also informs us that “Protection against symptomatic Covid-19 from Pfizer Inc. and partner BioNTech SE’s vaccine diminished over time but remained strong after six months, according to data released by the companies Wednesday. The efficacy of the vaccine protecting against symptomatic disease dropped every two months, to 84% after six months from a peak of 96% within two months of vaccination, a decline that may add urgency to Pfizer’s push to administer an additional dose to maintain protection. The companies reported that cumulatively the vaccine was 91% effective at preventing symptomatic Covid-19 during the first six months, in line with the analysis that was first reported earlier this year.”

On the new drug / drug research front

  • The Food and Drug Administration today approved for marketing “the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.” Outstanding.
  • The National Institutes of Health (NIH) announced that “Researchers have identified a cellular defect common to familial and sporadic forms of ALS [/ Lou Gehrig’s Disease]. The NIH-funded study may point to possible therapeutic target for the disease.” Encouraging.

In other NIH news, the director of the National HEAL Initiative provides an update on the program’s efforts. She describes her program as follows:

HEAL’s mission is to find scientific solutions to help end addiction long-term. And although this goal is concrete, it’s not always simple. We recognize that people face real-world challenges accessing high-quality care for pain and addiction, and our research needs to take this into account. As I’ll describe in the post, HEAL is funding several studies to accelerate research to practice to improve health, as well as to prevent unnecessary loss of life from overdose.

Good luck with that worthy effort.

In FEHB news, Reg Jones has posted a Fedweek column on children’s benefits under the program.

Healthcare Dive continues to report on second quarter financial reporting from health insurers. Today, Humana reported. According to Healthcare Dive,

Non-COVID-19 medical use bounced back faster than expected during the second quarter, Humana executives told investors Wednesday. The insurer was able to post net income of $588 million as COVID-19 treatment costs for its members fell faster than anticipated, compared to $1.8 billion a year ago as patients deferred care amid the pandemic.

Humana, which insures a large portion of seniors through Medicare, did disclose that is has noticed COVID-19 admissions increasing in recent weeks, a potentially troubling sign.

The payer experienced robust membership growth in its Medicaid business while it reported declines in the fully-insured commercial segment. Overall, total medical membership was up slightly compared to the prior-year period.