Tuesday Tidbits

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From the Delta variant front —

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.

Healthcare Dive tells us that

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.

Fierce Pharma reports that

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.”

Monday Roundup

Photo by Sven Read on Unsplash

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.

The Wall Street Journal adds

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.

Friday Stats and More

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

Thursday Miscellany

Happy National Women’s Equality Day! Health and Human Services Department leaders offered their views on this occasion.

From the Delta variant front

  • 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.”

Health Payer Intelligence informs that

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).

Midweek update

From the Delta variant front, the Safer Federal Workforce group issued updated guidance for federal employees receiving a COVID-19 vaccine. In short, federal agencies should

  • Allow employees to take up to 4 hours of administrative leave to get any COVID-19 dose.
  • Allow employees to take up to 2 days of administrative leave for adverse reactions to any COVID-19 vaccination dose.

Federal News Network informs us that

Nearly one month after the Biden administration first announced plans to adopt a vaccine and testing policy for federal employees and contractors, managers — presumably the ones charged with implementing and enforcing the new program on the ground level — say they’re still looking for answers about how it’ll work. * * *

Guidance has been “minimal” and the planning to date has been “stressful” for managers and supervisors, said Craig Carter, national president of the Federal Managers Association.

Professional associations don’t have exact data and they’re relying on anecdotal conversations with their members about the vaccine. But considering a little more than half of all Americans are fully inoculated against COVID-19 — and the federal workforce is in many ways a representative subset of the American public — they assume roughly 50% of the nation’s 2.1 million federal employees are unvaccinated.

That means agencies may potentially need to test about 1 million federal workers once or twice a week, the associations said.

Few things drive the FEHBlog crazier than the use of the full U.S. population as a COVID-19 vaccination benchmark because people under age 12 cannot be vaccinated at this point. 62.7% of Americans over 18 and 81.3% of Americans over 65 are fully vaccinated according to the CDC website. The FEHBlog therefore expects that at least two thirds of federal employees are fully vaccinated. The percentage should skew higher because as the FEHBlog has noted about 20% of the federl workforce is under a COVID vaccination mandate as opposed to attestation. Nevertheless, testing about 600,000 federal employees once or twice a week is no picnic for federal managers.

The Wall Street Journal reports that

  • U.S. Covid-19 hospitalizations have surpassed 100,000 for the first time since January, nearly doubling since the start of August. While the figure remains below the country’s winter peak, hospitals in some parts of the U.S. are straining under the load, and officials in states including Georgia, Kentucky, Tennessee and Idaho have requested extra personnel and resources.
  • “Federal regulators are likely to approve a Covid-19 booster shot for vaccinated adults starting at least six months after the previous dose rather than the eight-month gap they previously announced, a person familiar with the plans said, as the Biden administration steps up preparations for delivering boosters to the public.”

The Journal also offers its perspective on the lay of the land for COVID-19 tests.

Employee Benefits News tells us that

According to the most recent Mental Health Index by Total Brain and the National Alliance of Healthcare Purchaser Coalitions, feelings of anxiety increased 94% from June to July, and incidences of PTSD have spiked 83% over the past six months.

While employees of all ages are struggling to maintain good mental health, workers aged 40-59 saw the highest increases in stress, anxiety and feelings of negativity, compared to July’s data. These workers cited return to work and back to school plans as the main drivers of their fears.

The average age of a federal employee is close to 50 years old.

From the federal employee benefits front, Reg Jones discusses the pluses and minuses of deferred annuities.

It’s a fact of life that many people work for a number of years in a job and, for one reason or another, leave before they are eligible to retire. What’s different for those who work for the federal government is that during their working time there, deductions have been taken from their pay toward a civil service annuity.

While many who resign from the government ask for a refund of those contributions, some do not (often because they were not even aware that they could). Those who leave their contributions in the fund – especially those who weren’t even aware that they could get a refund – are the people I want to talk to today, as well as any of you who are thinking about resigning from the government before retirement eligibility.

Here’s why: If you leave your contributions in the retirement fund, you will be entitled to a deferred annuity if you meet some fairly minimal requirements [as explained in the article].

In healthcare business news

  • Fierce Healthcare reports that “Hospitals and health systems’ economic recovery hit the brakes in July with mounting COVID-19 admissions, escalating expenses and early evidence that consumers are again postponing elective and outpatient care. Per the latest monthly report from Kaufman Hall, countrywide margins and volumes remained below pre-pandemic numbers but dipped most severely in the South and Midwest, where COVID-19 has had the greatest impact. The firm said it expects these trends to continue in the coming months.”
  • Healthcare Dive tells us that “GuideWell, the parent company of Blue Cross and Blue Shield of Florida, is set to acquire Triple S Management, the Blue Cross Blue Shield Plan and largest insurance carrier in Puerto Rico. The $900 million cash deal will add another company to GuideWell’s portfolio of health-focused subsidiaries. After the deal is complete, Triple S will become a wholly owned subsidiary of GuideWell and will continue to operate under the same brand name and management team, the two companies said Tuesday. The deal is expected to close in the first half of next year and is subject to regulatory approvals.”
  • Fierce Healthcare also reports that “Carbon Health, a primary care provider combining brick-and-mortar clinics with virtual services, bought two separate clinic chains to expand its national primary care footprint. The company bought Southern Arizona Urgent Care’s nine clinics in Tucson, Arizona, and Med7 Urgent Care’s four clinics in Sacramento, California, bringing its total to 83 clinics across 12 states. This acquisition underscores the company’s goal of becoming the largest national healthcare provider, fueled by its recent $350 million funding news.

Tuesday’s Tidbits

Photo by Michele Orallo on Unsplash

From Capitol Hill, Roll Call reports that the House Speaker Nancy Pelosi negotiated a Democrat legislative victory when the House narrowly approved a rule adopting the $3.5 trillion budget blueprint and agreeing to hold a floor vote on the Senate’s bipartisan, $1 trillion infrastructure bill no later than September 27, 2021.

Leadership is hoping to have the reconciliation package, which committees have a Sept. 15 deadline to assemble, ready for floor action around the same time as the infrastructure bill with the goal of passing both by the end of September, House Majority Leader Steny H. Hoyer told reporters on a press call Tuesday afternoon.

How soon the reconciliation package is ready “will dictate to some degree the flow of legislation,” the Maryland Democrat said. “We have not got a hard view on sequencing.”

Federal News Network informs us about three items for federal employees to watch in the bipartisan infrastructure bill.

From the Delta variant front, the American Hospital Association tells us

The Centers for Disease Control and Prevention today released research highlighting two important trends emerging from the COVID-19 pandemic regarding vaccines’ current effectiveness. The first, which looked at breakthrough infections among fully vaccinated front-line health care workers, found that, following the emergence of the SARS-CoV-2 delta variant, there has been a moderate reduction in the effectiveness of COVID-19 vaccines in preventing infection in this group. However, the authors note that “this trend should be interpreted with caution because [vaccine efficacy] might also be declining as time since vaccination increases and because of poor precision in estimates due to limited number of weeks of observation and few infections among participants.” Additionally, the CDC notes that even a sustained two-thirds reduction in infection risk underscores COVID-19 vaccinations’ continued importance and benefits in preventing deaths, hospitalizations and the virus’ spread. 

The second study reviewed SARS-CoV-2 infections in Los Angeles County over the course of nearly three months, starting in May 2021. Researchers found that approximately three out of four cases were among unvaccinated individuals. Additionally, infection and hospitalization rates among unvaccinated persons were 4.9 and 29.2 times more likely, respectively, than those in fully vaccinated persons, with little change when the delta variant took root as the nation’s dominant virus strain.

The Society for Human Resource Management discusses what the FDA’s full approval for the Pfizer vaccine means for employer COVID-19 policies.

The Wall Street Journal informs us that

Johnson & Johnson said [over Tuesday night] that a second dose of its [one dose] Covid-19 vaccine was found in a study to generate a strong immune response, justifying a booster shot after eight months. * * * J&J said researchers found antibody levels increased ninefold among people who received a second dose of its vaccine, compared with one month after they received a first dose. * * *

“We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson Covid-19 vaccine, boosting eight months or longer after the primary single-dose vaccination,” [said] Dr. Mathai Mammen, global head of R&D at Janssen Pharmaceutical Cos. of Johnson & Johnson.

The Biden administration said last week that people ages 18 and older who got the Covid-19 vaccines from Pfizer Inc. or Moderna Inc. should get an extra dose eight months later, reflecting heightened concern over the highly contagious Delta variant and data showing initial immunity to Covid-19 diminishes over time. J&J’s suggested timeline would be in sync with that broader strategy.

Currently boosters are only authorized for immunocompromised people who received two-dose messenger-RNA vaccines. The Food and Drug Administration must authorize extra doses before they can be offered more broadly as recommended by the Biden administration to those 18 and older who received two-dose messenger-RNA vaccines, and it is expected to do so before Sept. 20, when health authorities said messenger-RNA boosters would become available

The CDC’s expert advisory panel on vaccines will meet next week to discuss the Biden administration’s plans for booster shots.

According to the CDC’s website, this virtual ACIP meeting will be held on August 30 and 31.

Finally STAT News reports that

The age at which adults who are overweight or obese should be screened for type 2 diabetes is going down while the prevalence of both forms of the disease is going up among children and adolescents — two developments reported Tuesday that signal a growing burden of these chronic health conditions among Americans.

The U.S. Preventive Services Task Force lowered its recommended age to 35 — down from 40 in its 2015 guidance — to test people with above-normal BMIs for elevated glucose levels that could mean prediabetes or diabetes itself. The new evidence review and recommendations, published in the Journal of the American Medical Association, would make more than 40% of adults eligible for screening, and an estimated one-third will likely meet USPSTF criteria to undertake preventive steps.

Monday Roundup

Photo by Sven Read on Unsplash

From Capitol Hill, Roll Call reports that

Speaker Nancy Pelosi floated a compromise to moderate holdouts Monday that would advance the budget resolution needed to unlock a $3.5 trillion package of aid to families, students and clean energy subsidies in exchange for a guaranteed vote on a separate, $550 billion infrastructure package.

The plan would “deem” the fiscal 2022 budget resolution adopted when the chamber adopts the combined rule for floor debate on the Senate-passed infrastructure bill and voting rights legislation. Pelosi, D-Calif., also committed to a floor vote on the infrastructure bill before Oct. 1, when current surface transportation program authorizations lapse.

The House of Representatives convened at 5 pm ET this evening and went into a recess at 5:30 pm ET for a Democrat member caucus. The House resumed its session with routine business at 6 pm ET and the House recessed again at 8 pm likely for another Democrat member caucus. [Follow-up — Early Tuesday morning the Wall Street Journal reports that “Plans to hold that vote Monday night were [later] abandoned, though, and Mrs. Pelosi said the chamber would vote on the measure on Tuesday as she left the Capitol after midnight.”

From the Delta variant front, Mondays have tended to be a good day for COVID-19 vaccine news. This morning the Food and Drug Administration “approved [for marketing] the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.” This action occurred two weeks before the Labor Day.

The Wall Street Journal reports that

The Food and Drug Administration’s approval was seen by public health officials as a key step to convince hesitant individuals to get the shot and to encourage employers to mandate it. 

“Today I’m calling on more companies in the private sector to step up with vaccine requirements that will reach millions more people,” President Biden said. “I call on you to do that—require it.” * * *

The vaccine is now eligible for off-label prescriptions—or use beyond the approved populations. That could include booster doses, according to the FDA. Prescribing the vaccine off label for children wouldn’t be appropriate as there is no data on proper dosing or safety in youth, said acting FDA Commissioner Janet Woodcock. * * *

Pfizer * * * is now permitted to market the vaccine to doctors, healthcare providers and the general public as it does with other approved products. Pfizer declined to share its marketing and advertising plans but said it seeks to take a thoughtful approach with such communications in hopes of increasing vaccine confidence. 

Pfizer made its FDA marketing approval application last May and Moderna, which produces the other mRNA vaccine, applied for FDA marketing approval in June so Moderna now moves from the on deck circle to at bat.

Federal News Network informs us that “The Pentagon said Monday that it will require service members to receive the COVID-19 vaccine now that the Pfizer vaccine has received full approval. Pentagon spokesman John Kirby said Defense Secretary Lloyd Austin is making good on his vow earlier this month to require the shots once the Food and Drug Administration approved the vaccine. He said guidance is being developed and a timeline will be provided in the coming days.”

Govexec tells us that

During the White House’s daily press briefing, Press Secretary Jen Psaki said that some agencies may roll out requirements that subsets of the federal workforce must be vaccinated, similar to those announced for health care workers at the Veterans Affairs and Health and Human Services departments. Across the federal government, agencies are working to implement President Biden’s requirement that all federal workers and contractors either attest that they have been vaccinated against COVID-19 or submit to a stringent regimen of wearing masks and being tested regularly for the virus.

“I expect there will be more . . . we certainly expect there will be more mandates for factions of federal employees,” Psaki said. “I think you’re looking more at agency-to-agency, or different factions of the government at this point, but expect there will be more on that front.”

In the meantime, federal employee unions have already begun engaging with management at various agencies to negotiate how the Biden administration’s vaccine mandate will be implemented. Matt Biggs, president of the International Federation of Professional and Technical Employees, said that although his union publicly announced its support for the vaccine mandate, it is working to ensure workers’ rights are protected, regardless of whether they elect to be vaccinated.

In other vaccine news, the UPI reports

Most teens and young adults want to get vaccinated against COVID-19, a survey published Friday by JAMA Health Forum found.

About 75% of people ages 14 to 24 years in the United States who responded to the survey, conducted by the University of Michigan’s Institute for Healthcare Policy and Innovation, said they would get the shot, the data showed.

Most agreed with the statement that vaccination was important to “help stop the spread [of the virus], as well as get back to normal as soon as possible,” the researchers said.

Still, about 42% of respondents said they were concerned about COVID-19 vaccine side effects and 12% indicated they worried about the shot’s effectiveness, according to the researchers.

From the health savings account front, Benefits Pro informs us that

Devenir has given another peek into the current state of HSAs with its demographic survey. Among its key findings:

  • As of December 31, 2020, the study estimates there were over 30 million HSAs covering 63 million people in the United States.
  • Nearly 1 in 5 Americans in their 30s had a health savings account by the end of the year.
  • HSAs are just as popular with older Americans: Account holders over 50 years of age held more than $44 billion in their accounts, with an average balance of just over $4300.

The study also found that HSAs are being used in every state in the country, with some states reporting nearly 77% of the privately insured populations being covered by an HSA. See our slideshow above for the states with the highest and lowest numbers of people covered by HSAs, and click here for the full study.” Here’s a link to another interesting Benefits Pro article on HSAs.

From the telehealth front, mHealth Intelligence reports that

The pandemic has proven the value of telehealth to parents, according to a recent survey by Nemours Children’s Health. But it has also highlighted the need to continue emphasizing the value of virtual visits to overcome barriers to care and improve health and wellness.

A survey of more than 2,000 adults conducted earlier this year in conjunction with Amwell found that while 35 percent of parents used telehealth prior to the COVID-19 crisis (based on a 2017 survey), that percentage jumped to 77 percent during the pandemic. In addition, almost 80 percent have accessed pediatric telehealth services, compared to 35 percent before the pandemic.

Overall, the survey reports, more than 60 percent of parents want to continue using connected health services after the pandemic – including almost 30 percent of parents who hadn’t used any telehealth in the past.

“While one might expect that factors such as income or access to technology are barriers to telehealth, this survey underscores how telehealth proved to be a viable solution to expanding access and reducing disparities in providing timely care during COVID-19,” R. Lawrence Moss, MD, president and CEO of Nemours Children’s Health System, said in a press release. “Regulations that were eased during the pandemic need to become permanent to support telehealth access for the long-term. Telehealth can be part of building health equity among people experiencing social, economic and family challenges.”

From the research front, the National Institutes of Health announced the results of a study of pregnant women:

Drinking alcohol and smoking tobacco cigarettes throughout the first trimester of pregnancy is associated with nearly three times the risk of late stillbirth (at 28 or more weeks), compared to women who neither drink or smoke during pregnancy or quit both before the end of the first trimester, according to a study funded by the National Institutes of Health. Although prenatal smoking is known to increase stillbirth risk, the researchers conducted the study to examine how smoking combined with alcohol use might influence the risk. The researchers also confirmed the higher stillbirth risk from alcohol alone, which has been suggested by earlier, less comprehensive studies.

In healthcare business news, Healthcare Dive tells us that

  • “Google is dissolving its health division, Google Health, after three years as the head of the unit, David Feinberg, departs to become CEO of health IT vendor Cerner.
  • “Google is splitting its health projects and teams across several other divisions of the company, according to an Aug. 19 internal memo to employees from Jeff Dean, the head of Google’s research division, obtained by Insider.
  • Alphabet’s Google created the Google Health division in 2018 to bring its health initiatives under a single umbrella. The Mountain View, California-based company remains committed to healthcare and will continue to invest in the space, but the goal of the reshuffling is to put its teams in the areas that make the most sense for its projects, a​ Google spokesperson told Healthcare Dive.”

Finally, the American Medical Association President Gerald E. Harmon, MD, opines on the actions that the medical community needs to take into order for American life expectancy to resume its upward track:

The AMA is committed to vigorous advocacy and broad-based collaboration to help people everywhere live longer, healthier lives. Our longstanding efforts targeting heart disease and type 2 diabetes—two of our country’s most common and most devastating chronic diseases—bring physicians in multiple practice settings and specialties together with patients, community groups, and both public- and private-sector organizations to better treat those struggling with these conditions, and also to prevent at-risk individuals from developing them.

The AMA Opioid Task Force and our Pain Care Task Force work with lawmakers and policymakers to guide their decision-making, to shift the perspective from responding to overdoses to preventing them, and to develop clinical best practices to reverse and eventually end the epidemic of fatal overdoses that worsened once the pandemic began.

Additional AMA efforts target: (1) behavioral health integration and suicide prevention;(2)firearm safety; (3) reducing maternal mortality; (4) eliminating racial and ethnic disparities in health care; (5) ensuring that digital health technology improves patient care and health outcomes, and (6) transforming medical education to ensure physicians are prepared to meet patient needs today and tomorrow.

Weekend update

Photo by Dane Deaner on Unsplash

The Senate remains on its State work break this week while the House of Representatives returns to vote on the Democrat $3.5 trillion budget blueprint and possibly the bipartisan $1 trillion infrastructure bill, both of which have cleared the Senate, among other measures. The Wall Street Journal reports

Dozens of liberal House Democrats have said they would not vote for the infrastructure bill until the broader budget package passes the Senate, in a bid to use their muscle to maintain pressure on centrist Democrats, some of whom have expressed concerns over the size and cost of a $3.5 trillion bill.

“Frankly, if we were to pass the bipartisan [infrastructure] bill first then we lose leverage,” said Rep. Ritchie Torres (D., N.Y.). If the nine centrist Democrats don’t budge, “it’s a recipe for gridlock because I can assure you that members like me have no intention of budging on our position,” Mr. Torres said. The centrist Democrats reiterated their position in a series of coordinated statements on Friday.

Mrs. Pelosi can lose no more than three Democrats on votes expected to be opposed by all Republicans. In an effort to appease the centrists, Mrs. Pelosi has scheduled a vote Monday night that would procedurally advance both the infrastructure bill and the budget framework. Centrists indicated that step was insufficient, since it wouldn’t pass the infrastructure bill. They worry that yoking the two bills together could result in months of delay before the broader $3.5 trillion budget package is ready for a vote.

This will be an interesting vote.

From the Delta variant front, Bloomberg reports that

The roll out of a third dose of Covid vaccine has sparked debate on ethical and political grounds, since a large swath of the human population is yet to receive any inoculation. But the case for boosters on scientific grounds is building.

The reason is delta. The most-infectious coronavirus variant to emerge so far is in a race with the human immune system, and there’s mounting evidence that delta is winning — at least initially. Fully vaccinated individuals infected with the variant have peak virus levels in the upper airways as high as those lacking immunity, a large study from the U.K. showed last week.

That suggests people with delta-induced breakthrough infections also may be capable of transmitting the virus, frustrating efforts to curb the Covid pandemic. Waning antibody levels in some highly vaccinated populations such as Israel have prompted calls to offer boosters to blunt fresh waves of hospitalizations

“The science is the boosters work, and they will definitely help,” said Shane Crotty, a virologist and professor at the La Jolla Institute for Immunology’s Center for Infectious Disease and Vaccine Research in California.

In fully vaccinated, healthy adults, booster shots from Moderna Inc. as well as Pfizer Inc. and its partner BioNTech SE cause antibodies to rebound to peak levels, if not well beyond, Crotty said in a Zoom interview Friday. Those antibodies are also likely to be more durable and adept at fighting a wider range of SARS-CoV-2 strains, he said. That’s especially helpful in fighting delta.

That’s important information.

From the physician compensation front, Fierce Healthcare informs us that

Physician pay barely increased in 2020, while productivity plummeted due to the pandemic, a new survey found. 

According to the latest AMGA medical group compensation and productivity survey, which reached nearly 400 medical groups representing more than 190,000 providers, increases in compensation were modest, while productivity impact was significant. 

“The trends we saw in this year’s survey were the obvious result of flat compensation combined with a decline in volume of services,” AMGA consulting president Fred Horton said in a press release. “Medical groups paid a steep price to retain their physician talent,” the statement went on, noting that the pandemic has emphasized the need for health providers to “reconsider their compensation plans so that they rely less on obligatory annual pay increases and more on incentivizing productivity that rewards valuable outcomes.” 

Transitioning to value-based compensation structures will create more resiliency against “future economic downturns,” he said.

The decline in productivity was driven by canceled elective procedures, diminishing access to health services for certain patients during the year and fear around seeking in-person care due to COVID-19, the group noted in its press release. 

Speaking of value-based compensation, a friend of the FEHBlog called his attention to this Atlantic magazine article about low value surgical care.

In 2017, the journal Plos One published a survey of 2,100 American doctors. Sixty-five percent of the respondents reported that 15 to 30 percent of all medical care was unnecessary, including an estimated 11 percent of all procedures. What’s more, 70 percent of the responding doctors said that they believed profit was a driving factor. “The best way to lower health-care costs in America is to stop doing things we don’t need,” Marty Makary, a professor at Johns Hopkins School of Public Health and a co-author of the Plos One study, told me. Some medical institutions—Kaiser Permanente and the Mayo Clinic among them—no longer link physician pay to the quantity of procedures performed for this reason. * * *

In 2017, the journal Plos One published a survey of 2,100 American doctors. Sixty-five percent of the respondents reported that 15 to 30 percent of all medical care was unnecessary, including an estimated 11 percent of all procedures. What’s more, 70 percent of the responding doctors said that they believed profit was a driving factor. “The best way to lower health-care costs in America is to stop doing things we don’t need,” Marty Makary, a professor at Johns Hopkins School of Public Health and a co-author of the Plos One study, told me. Some medical institutions—Kaiser Permanente and the Mayo Clinic among them—no longer link physician pay to the quantity of procedures performed for this reason.

The legal system acts as a final backstop. Most of the False Claims Act cases filed each year are health-care related, including cases concerning unnecessary surgeries. In 2020, the government recovered $2.2 billion in fraud and abuse via the False Claims Act, $1.8 billion of which was health-care related. Payouts for medical-malpractice claims in the U.S. hover around $4 billion each year. Although the law provides a route for the federal government to recoup costs, it cannot undo the procedures.

The Office of Management and Budget’s Office of Federal Procurement Policy sets policy for government contracts including the OPM contracts that create FEHB plans. Recently the President nominated Biniam Gebre to be OFPP Director, which is subject to Senate confirmation. Federal News Network interviewed former OFPP Directors about the President’s nomination. Check it out.

Friday Stats and More

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 33rd week of this year (beginning April 2, 2020, and ending August 18, 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 18, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 18, 2021, which also uses Thursday as the first day of the week:

Here’s a link to the CDC’s weekly interpretation of its COVID-19 statistics.

Politico reports that “More than one million Americans received a dose of Covid-19 vaccine on Thursday[August 19] , a benchmark the nation has not met in nearly seven weeks amid a resurgence of the coronavirus pandemic.”

HealthDay informs us that

Antibodies generated by COVID-19 vaccines are effective against the Delta variant and other coronavirus variants of concern, new research shows.

The findings may help explain why most vaccinated people have avoided the surge of Delta variant cases sweeping across the United States.

“In face of vaccination, Delta is relatively a wimpy virus,” said study co-author Ali Ellebedy, an associate professor of pathology and immunology at Washington University School of Medicine in St. Louis.

Good to hear.

The Wall Street Journal tells us that

The Food and Drug Administration is expected next week to grant full approval of the Covid-19 vaccine from Pfizer Inc. and partner BioNTech SE, according to people familiar with the planning, an action that could spur more vaccination requirements by employers and encourage more people who are hesitant to get vaccinated. * * *

Once fully approved, the vaccine would be eligible for off-label prescriptions, such as booster doses, according to the FDA. However, analysts said, the critical element for broad boosting is a recommendation from the Advisory Committee on Immunization Practices to the FDA, as physicians often follow ACIP recommendations.

With full approval, Pfizer would likely be permitted to market the vaccine to doctors, providers and the general public as it does with other approved products. The FDA is permitted to restrict such communications with emergency authorization.

The Journal adds that

Of the three authorized vaccines in the U.S., only Pfizer has submitted all the required information to the FDA, according to the companies, and analysts expect it to be the first receive clearance. 

Moderna Inc., whose authorized two-dose shot uses similar mRNA technology as the Pfizer-BioNTech, has said it is still completing rolling data submissions.Johnson & Johnson, whose shot was authorized in February, has said it plans to file for full approval later this year.

Fierce Healthcare reports that Janet Woodcock will not be nominated for a promotion from acting to permanent Food and Drug Commissioner due in large part to Aduhelm fallout.

From the regulatory front

  • After issuing a minimalist Affordable Care Act (“ACA”) FAQ 48 earlier this week, the ACA regulatory departments issued a blockbuster ACA FAQ 49 about payer transparency rule implementation and enforcement delays and answering many No Surprises Act (“NSA”) implementation issues left hanging by the first NSA interim final rule (“IFC”) released July 1.
  • OMB’s Office of Information and Regulatory Affairs (“OIRA”) has scheduled more meetings on the second No Surprises Act IFC which concerns the independent dispute resolution process. Those listening sessions now run late into next week. That means that the IFC won’t be released before the week of August 30 but that still would be about a month before the statutory deadline.
  • The American College of Emergency Physicians and Blue Cross each met with OIRA this past week. Here are links to their supporting letters. BCBSA OIRA IDR 8.17.21.pdf and ACEP EDPMA Pre-IDR Rulemaking Letter (8.10.21).pdf Common sense as expressed in the Blue Cross letter must prevail if the parties want to avoid having the second IFC also create major system changes.
  • The Society for Human Resource Management informs us that “covered employers [such as FEHB plan carriers] now have until Oct. 25 to file their 2019 and 2020 EEO-1 reports, according to a recent announcement from the U.S. Equal Employment Opportunity Commission (EEOC). Although the reporting deadline has been delayed several times during the COVID-19 pandemic, the agency said it will not authorize any more extensions.”

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

Yesterday’s HHS COVID-19 booster plan for all of the U.S. has generated expert opposition as reported in STAT News and Forbes. From STAT, for example

“I would have preferred that this had been vetted a little bit more,” said Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia, who is on an expert committee that advises the FDA on vaccines. “This just seems to be a declaration without the kind of vetting you would like to have seen.”

Offit thinks boosters may eventually be needed. But he’s not convinced they are needed now. Almost all the evidence to date suggests protection against severe disease is still holding and may well last several years, he said.

“So the notion that we are trying to get ahead of it by boosting after eight months I think is premature,” he said, also arguing that using more doses in the U.S. will inevitably slow vaccination in low-income countries.

Forbes adds

The impending rollout of booster doses in the U.S. could thwart vaccine export and donations to nations which are in desperate need of inoculating their most vulnerable residents, experts worry. “To me it just essentially shows that here is another rich nation that is really prioritizing its own population before thinking about the global response,” says Rupali Limaye, from Johns Hopkins Bloomberg School of Public Health, who studies vaccine inequity and hesitancy.

The FEHBlog hopes that the HHS experts have not gotten too far out in front of their skis on this issue.

In other vaccine news, CVS Health announced today

Flu shots are now available at all CVS Pharmacy and MinuteClinic locations across the country. Both CVS Pharmacy and MinuteClinic, the retail health clinic of CVS Health inside select CVS Pharmacy and Target stores, offer convenient options for people of all ages to get their flu shot, seven days a week with expanded evening and weekend hours.

“Getting your flu shot is a great way to be proactive about your health and the health of your community,” said Angela Patterson, DNP, FNP-BC, NEA-BC, FAANP, Chief Nurse Practitioner Officer, MinuteClinic and Vice President, CVS Health. “It’s an easy way to protect yourself and those around you who may be more vulnerable to serious complications from the flu, such as infants and young children, older adults, and people with certain chronic health conditions.”

In health plan coverage news, Fierce Healthcare informs us that

Most insurers are no longer waiving cost sharing for COVID-19 treatments as healthcare use rebounded from lows exacerbated by the pandemic, a new analysis found.

The analysis, released Thursday from the Kaiser Family Foundation, found 72% of large health plans are no longer providing cost-sharing waivers as of this month. Another 10% of plans expect to phase out the waivers by the end of October. * * *

An earlier analysis from Kaiser found that large group enrollees hospitalized for pneumonia, which requires similar treatment costs to COVID-19, paid out an average $1,300 out-of-pocket.

“Although this is a large amount to most patients, and could be an incentive to get vaccinated, it still only represents a fraction of the cost born to society for these largely preventable hospitalizations,” the analysis said.

In encouraging news, STAT News reports that Michael Segel and Blake Lash, two scientists who work in the lab of CRISPR pioneer Feng Zhang at Boston’s Broad Street Institute, have discovered a new CRISPR related technology. “This new method of delivering different RNA payloads, called SEND, for Selective Endogenous eNcapsidation for cellular Delivery, was reported today in Science. It has the potential to address significant and longstanding limitations to translating powerful gene editing and gene replacement technologies, as well as mRNA — the guts of the most successful Covid-19 vaccines — into broadly useful therapies.” The article concludes “It’s too soon to say whether SEND will ultimately challenge lipid nanoparticles and viral vectors as the dominant methods for delivering gene editing treatments and gene therapies. But it does offer some distinct advantages.” Bravo.

From the miscellany department

  • AHIP’s Blog discusses the rise of social media influencers in healthcare.
  • Fierce Healthcare reports that by closing on its deal to acquire Kindred at Home, Humana has become the largest provider of home healthcare in our country. “Kindred will be folded into the insurer’s Home Solutions business arm and will adopt Humana’s payer-agnostic health services branding, CareWell, under which it will operate as CenterWell Home Health beginning next year.”
  • Healthcare Dive reports that the American Hospital Association has “sent a letter Wednesday to top officials in the White House, HHS, Department of Justice and Federal Trade Commission defending health system M&A and attempting to shift Washington’s rising antitrust focus from providers to commercial health plans.” After all the best defense is a strong offense. But Healthcare Dive adds that “The letter included an updated AHA-funded study on the benefits of hospital mergers, which was previously criticized by outside experts for cherry-picked data, among other methodological weaknesses.”