Monday Roundup

COVID-19 vaccine

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Delta variant front —

  • Govexec tells us that last Friday August 13, the Department of Justice issued its internal guidance on employee, on-site contractor, and visitor COVID-19 vaccine attestation program required by the White House. ‘Federal employees, regardless if they are working in person or teleworking, must complete a Certification of Vaccination Form and update it if there is a change in their vaccination status. ‘Employees who are not fully vaccinated will be required to obtain and provide to their supervisor (or component designee) a negative COVID-19 test result, from a test taken within the past three days, each time they enter a department facility or participate in an official meeting or function in another location other than the telework location,’ said the memo. ‘The department is developing a program to facilitate testing for employees.’”
  • The American Medical Association informs us about the reasons why moderately and severely immuno-compromised Americans who compose 2.7% of the population should get an mRNA vaccine booster. “[Food and Drug Administration] Approval of a third dose comes amid growing evidence that people with weakened immune systems do not get adequate protection from the normal two-dose regimen of Pfizer and Moderna COVID-19 vaccines. This makes immunocompromised people especially susceptible to breakthrough COVID-19 infections.”
  • The Wall Street Journal reports that Pfizer and BioNTech are starting to share clinical evidence of the value of a third booster vaccination for a broader swath of the U.S. population administered six months to a year following the first two doses. “Pfizer and BioNTech are also conducting a larger late-stage study evaluating whether a third dose safely provides more protection. The companies said they expect those results shortly and will then submit the data to the FDA. The FDA is considering a broader booster strategy, which the agency could issue in the next few weeks.”

With regard to the other public health emergency, the American Hospital Association points us to it web resources for the addressing opioid epidemic.

In healthcare business news

  • Labcorp has announced the acquisition of “Ovia Health, a digital health platform used by millions of women seeking information and support with family planning, pregnancy and parenting.”
  • CareMax, a “technology-enabled provider of value-based care to seniors, announced [on August 13] it has signed a collaboration agreement with Anthem, a national health benefits company. Through this collaboration, CareMax plans to build medical centers in areas where Anthem will offer a value-based care model to improve patient outcomes. * * * Through this collaboration agreement, CareMax plans to open approximately 50 medical centers with a focus on Indiana, Texas, Kentucky, Wisconsin, Georgia, Connecticut, and Virginia, among others.”

From the studies front

  • The University of Michigan’s Institute for Healthcare Policy and Innovation has released an eye opening study on telehealth. The FEHBlog commends it to his readership.
  • Benefits Pro tells us that “Interest in health savings accounts is on the rise, but there is still a gap in understanding about how HSAs work and how they can be used as a retirement savings tool. According to the Plan Sponsor Council of America’s (PSCA) 2021 HSA Survey, education about HSAs remains a key goal for plan sponsors. * * * The study pointed to a potential missed opportunity for employers to solicit HSA rollovers for newly hired employees, with less than 20 percent indicating they do so.”
  • The National Institutes of Health informs us that “A single two-hour session of a pain management skills class could offer as much benefit as eight sessions of cognitive behavioral therapy (CBT) for patients experiencing chronic low-back pain (CLBP), suggests a study published in JAMA Network Open(link is external). Supported by the National Center for Complementary and Integrative Health (NCCIH) and the National Institute on Drug Abuse, both part of the National Institutes of Health, the study explored whether a compressed intervention could lead to the same benefits as a longer-course of CBT.”
  • STAT News reports that the National Institute for Mental Health’s “Director Joshua Gordon told STAT the agency recognizes that new treatments for depression are needed and that it is funding research to explore the underlying biology beyond the monoamine hypothesis. When it comes to understanding depression, “there are fewer and fewer questions of importance with regard to the monoamine systems,” he said. He noted that in addition to federal funding, many startups and small companies are pursuing new treatments for depression. Currently, almost all patients with depression are first treated with medications called selective serotonin reuptake inhibitors, a class of drugs that includes both Zoloft and Prozac. They increase the amount of the neurotransmitter serotonin in the brain, which controls mood, emotions, and cognition. Serotonin and two other neurotransmitters targeted by some antidepressants, norepinephrine and dopamine, are called monoamines because they contain one chemical group called an amine.” The article also discusses those new treatments, including .

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The House of Representatives and the Senate remain on District / State work breaks this week. Of course the Congressional staff never rests. The Wall Street Journal reports that “House Speaker Nancy Pelosi (D., Calif.) on Sunday asked a top committee [the House Rules Committee] to look at moving forward on a $1 trillion bipartisan infrastructure bill along with the $3.5 trillion budget framework in an effort to balance the demands of her party’s ideological factions.” Fierce Healthcare identifies three major healthcare policy areas in the budget framework which healthcare lobbyists are watching carefully.

On the Delta variant front

  • The Wall Street Journal informs us that “Hospitalizations of Covid-19 patients in their 30s have hit a new record, U.S. government data show, a sign of the toll that the highly contagious Delta variant is taking among the unvaccinated.”
  • The message about the inportance of being vaccinated appears to be breaking through to the reluctant. Bloomberg tells us that “The U.S. reported almost 1 million Covid-19 vaccine doses on Saturday, the most for a single day since early July, reflecting a faster pace of inoculation as the delta variant spreads.” Nearly 60% of the vaccine eligible U.S. population (at least 12 years old) is fully vaccinated.

On the healthcare business front, Fierce Healthcare tells us that

UnitedHealth Group and Change Healthcare have entered into a timing agreement with the Department of Justice for their planned $8 billion merger.

In late March, DOJ made a second request for additional details and documentary information related to the merger. Under the timing agreement, which was reached on Aug. 7, UnitedHealth and Change agree to not “consummate” their merger before 120 days have passed since the two certified their compliance with the agency’s request.

The exception is if they receive written confirmation from DOJ that it has completed its investigation in that window, according to a Securities and Exchange Commission filing from Change Healthcare.

As we all know, timing is everything.

On the federal retirement front, Federal News Network reports

Federal retirements in July saw a big jump compared to last year, but the average processing time has swelled to nearly three months.

OPM received 8,922 retirement claims last month, compared to 6,819 claims in July 2020 — a 30.8% increase. Processed claims, meanwhile, only saw a 4.5% increase from 6,620 in July 2020 to 6,920 last month.

The latest numbers show that 2021 is generally seeing far more federal retirements than in 2020, when the pandemic reached its height. With the exception of January and February, every month this year has had year-over-year increases ranging from 10.8% to 47.2%.

Most notably, the 22% increase in federal retirements from June to July has led to a growing claims backlog. The inventory of claims ballooned from 24,999 in June to 27,001 in July, reversing the backlog’s downward trend after its peak in March.

Congress created two extremely complicated federal retirement programs. In the FEHBlog’s view, it’s up to those busy Congressional staffers to streamline the programs in order to facilitate automated claims processing.

Friday Stats and More

David Ermer–Congress, COVID-19, COVID-19 vaccine, Government Contracting, 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 32nd week of this year (beginning April 2, 2020, and ending August 11, 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 same period (April 2, 2020, through August 11, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 11, 2021, which also uses Thursday as the first day of the week:

Here is a link to the Centers for Disease Control’s (“CDC”) latest weekly review for the COVID data tracker upon which the FEHBlog relies. The review is aptly titled: “Put on Your Masks and Thinking Caps.”

The American Hospital Association has released on You Tube a two minute long presentation on the value of COVID-19 vaccines. It’s called Eight Things to Know About the COVID-19 Vaccine. Its message should be widely distributed.

The Federal Times reports that Kaiser Permanente which is the third largest carrier in the FEHB Program announced a COVID-19 vaccine incentive for its FEHB plan membership today.

The CDC also issued 2021-22 Flu Season FAQs today. Among thing the FEHBlog learned that “All flu vaccines will be quadrivalent (four component), meaning designed to protect against four different flu viruses. For more information: Quadrivalent Influenza Vaccine | CDC.”

In an ironic twist, check out this quote from Fierce Healthcare

“The recent emergence of the delta variant has introduced some uncertainty to our second half visits outlook,” said Ido Schoenberg, M.D., chairman and CEO of Amwell, during the call.

“With mask mandates quickly returning and also acknowledging other trends we are observing within visit mix and volumes, we need to account for these other dynamics and a likely weaker cold and flu season due to these variant-related protective measures,” he said, also noting the company does not expect extra COVID-related demand.

“Consequently, we are adjusting down our visit forecast for the remainder of the year to account for these factors,” he said.

As the French say, “quelle domage”.

But seriously folks, Revcycle Intelligence informs us that

The percentage of telehealth claim lines has stabilized at about 5 percent of medical claim lines, indicating a new balance of virtual and in-person care.

The analysis conducted by FAIR Health as part of its Monthly Telehealth Regional Tracker included data representing the privately insured population, including Medicare Advantage, and excluded Medicare fee-for-service and Medicaid claims data.

The data revealed that the percentage telehealth claim lines increased slightly to 5 percent in May 2021, from 4.9 percent the previous month. The slight increase suggests a stabilization of telehealth utilization since telehealth claim lines had declined each month from February to April of this year.

And what’s more —

  • Healthcare Dive has a helpful wrap up article on the HIMSS conference. Take a look.
  • Federal News Network reports that the General Services Administration released federal employee travel per diems for the fiscal year beginning October 1, 2021. The combined per diems provide a cap of the federal contractor travel expenses that can be charged against an experience rated FEHB contract.
  • From Capitol Hill, Roll Call reports that nine centrist House Democrats have told Speaker Pelosi in writing that “We will not consider voting for a budget resolution until the bipartisan Infrastructure Investment and Jobs Act passes the House and is signed into law.” Roll Call adds that “Together, they’ve got more than enough support to stall the budget in the narrowly divided House where Democrats can lose no more than three members on party-line votes. No Republicans are expected to vote for the budget resolution, which is needed to begin the process on a $3.5 trillion reconciliation package chock full of Democratic priorities.”

Midweek Update

David Ermer–AHRQ, CDC, Congress, COVID-19, COVID-19 vaccine, Medicare, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The American Hospital Association informs us that

The Senate early this morning approved on a party line vote a $3.5 trillion budget resolution, which included reconciliation instructions which will provide the majority party with the means to pass a comprehensive reconciliation package with just 51 votes in the Senate, rather than the usual 60-vote hurdle. The House will reconvene on Aug. 23 to consider the budget resolution. Once the resolution has passed both chambers, the House and Senate majorities can proceed with the reconciliation process, a resolution to which is expected in the fall. 

Bloomberg adds

Translating the budget framework into law will require Biden and Democratic congressional leaders keeping their party’s moderate and progressive wings marching together.

Just hours after passage of the budget blueprint, Senator Joe Manchin, a Democrat from West Virginia, said he couldn’t support a social spending bill with a $3.5 trillion price tag. Senator Kyrsten Sinema, an Arizona Democrat, has said the same. One Democratic objection is all it would take to scuttle the package in the Senate.

Time will tell but we are talking about $3.5 trillion on top of the $1 trillion infrastructure bill and multi-trillion COVID-19 relief bills that Congress has passed in the last 18 months. It appears that Congress is trying to disprove the adage that money can’t solve all problems.

One of the initiatives in the budget reconciliation package is to add dental, vision, and hearing coverage to Medicare. Kaiser Health News discusses the issue here.

From the Delta variant front

  • The Centers for Disease Control’s Advisory Committee on Immunization Practice released a helpful report on COVID-19 adverse side effects which it summarized as follows

What is already known about this topic?

Rare serious adverse events have been reported after COVID-19 vaccination, including Guillain-Barré syndrome (GBS) and thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccination.

What is added by this report?

On July 22, 2021, the Advisory Committee on Immunization Practices reviewed updated benefit-risk analyses after Janssen and mRNA COVID-19 vaccination and concluded that the benefits outweigh the risks for rare serious adverse events after COVID-19 vaccination.

What are the implications for public health practice?

Continued COVID-19 vaccination will prevent COVID-19 morbidity and mortality far exceeding GBS, TTS, and myocarditis cases expected. Information about rare adverse events should be disseminated to providers, vaccine recipients, and the public.

  • Forbes tells us that today “The Centers for Disease Control and Prevention encouraged anyone pregnant and breastfeeding to get vaccinated against coronavirus Wednesday, pointing to a growing amount of evidence that vaccines are safe and effective as new cases and hospitalizations linked to the virus surge across the country.” The Washington Post adds “Just 23 percent of pregnant women have received at least one shot of vaccine.”
  • Also from Forbes as schools begin to reopen “Vaccine rates among teenagers have remained lower than the U.S. population overall, with only 43% of 12- to 15-year-olds and 52.8% of 16- and 17-year-olds receiving at least a first dose as compared with 58.9% of the total population and 71.2% of adults.”
  • The Boston Globe discusses this teenage hesitancy issue — “The top reservation among parents of unvaccinated teens was the lack of information about the long-term effects of the shot, followed by concerns about side effects and fertility — despite conclusive evidence that the vaccine has no negative impacts on reproduction. Dr. Jill Kasper, a pediatrician at Cambridge Health Alliance, said she typically encounters ‘very little hesitancy’ from parents about routine adolescent vaccinations. That hasn’t been the case with COVID-19.”

The HHS Agency for Healthcare Quality and Research issued two noteworthy studies today. Here are the topline findings

  • #1 Overuse or low-value procedures may result in patient physical, psychological, or emotional harm. This study explored the association between eight low-value care procedures and length of stay (LOS) and cost. All eight procedures were associated with increased LOS and cost, particularly spinal fusion. Patients receiving low-value care may be exposed to increased risk of adverse events and hospital-acquired conditions.
  • #2 Medication administration errors made by parent or caregivers can result in medication errors at home. This systematic review found that 30% to 80% of pediatric patients experience a medication error at home, and that the risk increases based on characteristics of the caregiver and if a prescription contains more than two drugs.

Healthcare Dive informs us that

  • CVS Health said its Aetna unit will offer virtual primary care to self-funded employers nationwide in a move that underscores the growing popularity of telehealth services fueled by the COVID-19 public health emergency.
  • Using Teladoc Health’s physician-led care team model, the Aetna Virtual Primary Care service is intended to help strengthen the patient-doctor relationship and improve access to care, the vertically integrated company announced Tuesday. Members can receive health services remotely and in person.

Such support for primary care should be applauded.

In other healthcare news

  • STAT News reports that The Department of Veterans Affairs has decided not to cover a new Alzheimer’s drug from Biogen [Adulhelm], citing insufficient evidence of “a robust and meaningful clinical benefit” and concerns about safety. In a notice issued by the agency, the VA said it will make exceptions for “highly selected patients” and listed several hurdles that must be cleared before the medicine will be covered, such as requiring it to be prescribed by providers who specialize in treating dementia and ensuring patients had recently received MRI brain scans. * * * ‘Its bad news for Biogen,’ said Ira Loss of Washington Analysis, which tracks legislative and regulatory issues affecting the pharmaceutical industry for investors, who noted several private insurers have either declined or delayed coverage for the drug. ‘The VA is a big buyer of medicines. And you don’t like this kind of publicity, that’s for sure.’”
  • Fierce Healthcare continues to report from the HIMSS conference in Las Vegas. “Health IT giant Epic launched a new customer story-sharing website that lets Epic users share insights, tips and creative ideas around using health IT to improve their organizations and patient care. The site, EpicShare.org, combines insights from industry leaders, quick tips on improving outcomes and performance, in-depth case studies as well as a “Hey Judy” column from Epic founder and CEO Judy Faulkner.”

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The Wall Street Journal reports

The Senate passed a roughly $1 trillion infrastructure package with broad bipartisan support Tuesday, advancing a central piece of President Biden’s economic agenda that would amount to one of the most substantial federal investments in roads, bridges and rail in decades.

With 19 Republicans including Senate Minority Leader Mitch McConnell (R., Ky.) joining all 50 Democrats to pass the bill 69 to 30, the legislation sailed through the Senate. The bill will face a more complicated path in the House, where Democrats have yoked the fate of the infrastructure effort to the passage of a broad $3.5 trillion antipoverty and climate effort. 

Professor Katie Keith in the Health Affairs blog discusses the Administration’s health policy objectives in the budget reconciliation bill that the Senate is now taking up. “Vice President Harris emphasized the need for Congress to build on these [Affordable Care Act special enrollment period] coverage gains by 1) extending the American Rescue Plan Act subsidy enhancements; 2) closing the Medicaid coverage gap; 3) expanding Medicare to include dental, vision, and hearing coverage; and 4) lowering prescription drug costs.”

Becker’s Hospital review tells us how COVID-19 vaccination rates have changed in the states for the week ended August 9. The rates in 40 states lead by Mississippi (and the District of Columbia) are up and only 10 states are down.

STAT News informs us that

As the world amasses experience with Covid-19 vaccines, something we should have known from the start is coming into sharp focus.

Vaccines that are injected into arm muscles aren’t likely to be able to protect our nasal passages from marauding SARS-CoV-2 viruses for very long, even if they are doing a terrific job protecting lungs from the virus. If we want vaccines that protect our upper respiratory tracts, we may need products that are administered in the nose — intranasal vaccines.

Can they be made? Probably. Will they do what we want them to do, if they are made? Possibly. Is there still room for this type of next-generation product, given the record number of Covid vaccines that have already been put into use? Potentially. Will it be difficult to get them through development? Likely.

In this regard the National Institutes of Health reports on a successful animal study of a COVID-19 intranasal vaccine based on the Oxford / Astra Zeneca model. What’s more, “[a] clinical trial at the University of Oxford is now testing intranasal vaccination in human volunteers.”

Fierce Healthcare is running a daily HIMSS21 roundup from the conference being held in Las Vegas this week.

Reg Jones writes in FedWeek about FEHB coverage for adult children of federal employees and annuitants who are incapable of self support. This is a rather unique feature of the Program.

Finally the Wall Street Journal reports that

The U.S. Postal Service plans to charge more for packages shipped during the holidays, including those sent by individuals, to offset the rising cost of deliveries at the busiest time of the year.

The agency on Tuesday proposed adding surcharges on most packages shipped domestically between Oct. 3 and Dec. 26, saying the fees would apply to both commercial and retail customers. That means it won’t just be Amazon.com Inc.,Target Corp. TGT 0.63% and other big holiday shippers paying higher-than-normal rates; it will also cost more to ship a box of cookies to grandma.

The agency said the added fees, ranging from 25 cents for smaller packages to $5 for heavier items traveling longer distances, are in line with broader industry practices to charge more during the holiday season.

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.”

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.

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.

Tuesday’s Tidbits

David Ermer–AHRQ, COVID-19, COVID-19 vaccine, Federal employment benefits, Medicare, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Delta Variant front —

Federal News Network reports that

The White House is strongly considering requiring federal employees to show proof they’ve been vaccinated against the coronavirus or otherwise submit to regular testing and wear a mask — a potentially major shift in policy that reflects growing concerns about the spread of the more infectious delta variant.https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html

The possible vaccine mandate for federal employees — regardless of the rate of transmission in their area — is one option under consideration by the Biden administration, according to a person familiar with the plans who spoke on condition of anonymity to discuss deliberations that have yet to be made public. The White House is expected to announce its final decision after completing a policy review this week.

Govexec adds that “Federal law does not prohibit public and private entities from mandating coronavirus vaccines, even though those vaccines do not yet have full authorization from the Food and Drug Administration, according to a legal opinion from the Justice Department posted on Monday.”

Other press reports indicate that the President may announce his decision this Thursday, and in the FEHBlog’s view if he approves this action, many private sector employers in and outside of healthcare will follow suit.

The Centers for Disease Control recommended today that “To maximize protection from the Delta variant and prevent possibly spreading it to others, [vaccinated Americans should] wear a mask indoors in public if you are in an area of substantial or high transmission.” It turns out the Washington DC is an area of substantial transmission. Bloomberg adds that “It’s not just Arkansas and Louisiana, where the delta variant has been raging, that are affected by the Centers for Disease Control and Prevention’s new recommendation for vaccinated people to mask indoors in some parts of the country. Most major U.S. urban areas also fall under the scope of the advisory.”

In today’s Tidbits —

  • Beckers Hospital Review informs us that U.S. News and World Report has issued its annual U.S. hospital rankings with the Mayo Clinic claiming the top spot “for the sixth consecutive year.” Becker’s also comments on the new health equity section found in those rankings.
  • The Congressional Research Service has released a report on the No Surprises Act which it describes as an “Overview of Federal Consumer Protections and Payment for Out-of-Network Services.”
  • The HHS Agency for Healthcare Research and Quality has issued a report providing and “Overview of Clinical Conditions With Frequent and Costly Hospital Readmissions by Payer, 2018.”
  • Becker’s Payer Issues discusses a Forbes interview with Liz Fowler, who is director of the Center for Medicare and Medicaid Innovation at HHS. “Here are four conclusions CMMI has drawn over a decade of experimentation, according to Forbes: (1) Voluntary initiatives narrowed participation as only providers who saw financial gain opted in; (2) Separate alternative payment models and multiple bundles for specialty groups leads to fragmentation, taking away from value-based care. (3) Initiatives like per-member per-month payments only temporarily work, but don’t sustain new practices once phased out, and (4) In benchmarking, models need to leverage retrospective benchmarks or prospective ones with guardrails to ensure accuracy and feasibility of approaches.”
  • Medcity News offers an interesting account of how certain hospital got the pricing transparency job done correctly.
  • Fierce Health tells us that Blue Cross licensee “Anthem is investing nearly $90 million in affordable housing across Indiana. The $87.9 million investment will fund 1,139 affordable apartment units, townhomes and single-family homes across 11 communities in the state, Anthem announced on Saturday. The initiative was unveiled at a ribbon-cutting for a recently completed complex in Culver, a six-building, 48-unit complex.” Well done.
  • Healthcare Dive reports that health insurer Centene reported a $353 million dollar loss for the second quarter of 2021 as members returned to the doctors’ offices. “There was a “broad return to the doctor’s office” in March and April, CFO Drew Asher said, but Centene had expected the slight downtick in May utilization to persist. That did not happen. Instead, utilization increased again in June.”
  • 401k Specialist informs us that the President has nominated New York City attorney Lisa M. Gomez to be Assistant Secretary of Labor for Employee Benefits. “The Senate-confirmed position oversees the Labor Department’s Employee Benefits Security Administration (EBSA), tasked with regulation and enforcement of private-sector retirement and health plans.” Ms. Gomez is also an FEHB lawyer and an esteemed colleague of the FEHBlog. She deserves a swift Senate confirmation for this important post.