Monday Roundup

COVID-19

Monday Roundup

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

The Senate’s bipartisan infrastructure bill cleared a cloture vote last night. The Senate is expected to pass it by tomorrow. Roll Call reports on the $3.5 trillion “human infrastructure” related budget reconciliation bill that the Congressional Democrat leadership unveiled today.

In Delta variant news

  • Federal News Network informs us that “The Defense Department is taking actions to make COVID-19 vaccines mandatory for service members by mid-September, or once the vaccines gets licensure from the Food and Drug Administration, whichever comes first.”
  • The New York Times reports that long COVID is now afflicting children. “Studies estimate long Covid may affect between 10 percent and 30 percent of adults infected with the coronavirus. Estimates from the handful of studies of children so far range widely. At an April congressional hearing, Dr. Francis Collins, director of the National Institutes of Health, cited one study suggesting that between 11 percent and 15 percent of infected youths might ‘end up with this long-term consequence, which can be pretty devastating in terms of things like school performance.’” Quite troubling. All the more reason to accelerate vaccinations for children.
  • In this regard, the Wall Street Journal reports that “As the highly contagious Delta strain tears through the country, the trends thus far suggest vaccines can turn Covid-19 into a less dangerous, more manageable disease. “Vaccines definitely make a difference,” said David Dowdy, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.A Wall Street Journal analysis shows sharp geographic divides in vaccination and hospitalization levels, with every state that has an above-average vaccine rate showing below-average hospitalizations, including in well-vaccinated New England. In the South, meanwhile, fewer people are vaccinated on average and hospitalization rates are climbing faster.” Lesson hopefully learned.

From the second quarter financials report front, Fierce Healthcare tells us that “Kaiser Permanente reported $3 billion in net income for the second quarter of the year as membership in its health plan remains steady. The health system and insurer posted total operating revenues of $23.7 billion against total operating expenses of $23.3 billion. The revenue was slightly above the $22.1 billion it earned in the second quarter of 2020. Kaiser noted in its earnings statement Friday that favorable financial market conditions resulted in $3 billion in net income, compared with $4.5 billion for the second quarter of 2020.”

From the No Surprises Act front, a friend of the FEHBlog pointed out to him that a second NSA rule has been pending at the Office of Information and Regulatory Affairs (“OIRA”) for the past month:

AGENCY: HHS-CMS          RIN: 0938-AU61   Status: Pending Review
TITLE: Reporting Requirements Related To Air Ambulance and Agent and Broker Services and HHS Enforcement Provisions (CMS-9907)
STAGE: Proposed Rule   ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 07/07/2021        LEGAL DEADLINE: Statutory

In other news —

  • Health Day tells about a severe blood shortage that is adversely affecting U.S. hospitals. “‘A blood shortage is when we have demand outpacing our supply,’ noted Paul Sullivan, senior vice president of donor services for the American Red Cross. ‘Usually it’s around some challenging period of the year. The beginning of summer, end-of-year holidays. And obviously we work hard to try to plan for those times.’ But this time is different, Sullivan said, with the COVID-19 pandemic and its fallout triggering a huge spike in hospital demands for blood. The result is a critical blood shortage that’s now seven weeks long and counting.” The article concludes “There’s more on the blood shortage and blood donations at the American Red Cross.”
  • In good news, Health Leaders Media reports that “The years-long effort to reduce unnecessary Cesarean section births in the United States is coming to fruition, an obstetrics expert says. Complications from C-sections such as hemorrhaging are widely considered to be a contributing factor to the country’s high maternal mortality rate. The federal Centers for Disease Control and Prevention have been monitoring maternal mortality since 1986. The number of pregnancy-related deaths has risen steadily since the monitoring effort began, from 7.2 deaths per 100,000 live births in 1987 to 18.0 deaths per 100,000 live births in 2014. “We are finally at the point where most hospitals are sharing their data and having conversations on an individual basis about C-section rates. We are having conversations about quality at labor and delivery units as well as about the quality of individual providers. It has taken more than a decade to get to this point,” says Amy VanBlaricom, MD, vice president of clinical operations for western states at Greenville, South Carolina-based Ob Hospitalist Group.”

Weekend update

David Ermer–Congress, COVID-19, Electronic health records, OPM, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The Senate remains in session for Committee and floor business while the House of Representatives remains on its District work break. Politico reports from the Senate floor that

The bipartisan infrastructure deal embraced by President Joe Biden and shaped by a gang of 10 senators is inching closer to clearing the chamber, with one more filibuster to clear on Sunday before the bill can pass later this week and land in the the House. * * *

[House Speaker] Pelosi and Senate Majority Leader] Schumer have devised a two-track process to enact as much of Biden’s domestic agenda as possible, pledging that the bipartisan infrastructure bill will only advance if it is married to the party-line legislation that will spend as much as $3.5 trillion on climate change action, paid leave policies and health care expansion. 

The Senate will immediately proceed to a budget setting up that massive bill on filibuster-proof ground after it completes its work on the bipartisan infrastructure bill. Schumer is also considering forcing votes on more elections legislation after Democrats’ sweeping overhaul plan failed in June.

From the Delta variant front

  • The CDC’s COVID Data Tracker informs us today that just over two thirds of Americans over age 12 and 90% of Americans over 65 have received at least one dose of a COVID-19 vaccine. The data tracker consistently has shown a 10% difference between one dose and fully vaccinated Americans which indicates to the FEHBlog that people follow through a get the second dose.
  • However, the Wall Street Journal reports about how neighbor deaths from unvaccinated neighbors has caused an Arkansas town to reconsider their reluctance to receive the COVID-19 vaccine. Another Journal article adds that “Top U.S. public-health officials on Sunday [August 8] voiced support for Covid-19 vaccination mandates imposed at the local level, while the head of a national teachers union also backed such a move in schools.”
  • Speaking of mandates, the FEHBlog found a link to the Safer Federal Workers Task Force FAQs on the Biden Administration’s vaccine screening program for federal employees, federal office visitors and on-site contractors that were released last Friday August 6. Interestingly, an FAQ indicates that

Q: Do agencies need to ask employees on maximum telework or remote workers about their vaccination status?

A: Yes, agencies should provide the Certification of Vaccination form to all employees, including employees on maximum telework and remote workers.

Healthcare Dive informs us about

  • Five intriguing panels at this week’s in-person HIMSS conference in Las Vegas.
  • A new survey conducted by Social Sciences Research Solutions for the Bipartisan Policy Center [that] concludes that telehealth is likely an ongoing viable option for consumers even after the COVID-19 pandemic winds down.
  • An overview of second quarter financial reports from health insurers.

The Biden Administration to its credit has proposed a rule rescinding the Trump Administration’s rule to establish a most favored nation pricing approach for Medicare Part B covered drugs.

Govexec reports on a recent Postal Service Board of Governors meeting attended by the three recently confirmed members whom President Biden had nominated. “The tenure of the U.S. Postal Service’s newest board members got off to a tense start on Friday as President Biden’s appointees voiced their displeasure with the agency’s direction and USPS’ leader stated he will still move forward with reforms.”

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.

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.“

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.