Friday Stats and More

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 8th week of this year (beginning April 2, 2020, and ending February 24, 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:

In this regard, Bloomberg reports that

Covid-19 hospital admissions plummeted 72% in a month in the U.S. as the virus ebbed and the vaccination push accelerated.

Americans 85 years old and over saw the most pronounced drop, down 81% from January to February, according to the U.S. Centers for Disease Control and Prevention, which monitors the data through its Covid-19-Associated Hospitalization Surveillance Network.

The rate was 23.4 hospitalizations per 100,000 residents 85 and over for the week of Feb. 7-13, the latest data available. That was down from 120.3 per 100,000 four weeks earlier. The overall rate across age groups was 4.6, down from 16.7.

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths because new cases greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through February 24, 2021):

Finally here is a COVID-19 vaccinations chart for past ten weeks which also uses Thursday as the first day of the week:

In other COVID-19 vaccination news

  • The Wall Street Journal reports that

Johnson & Johnson’s JNJ -2.64% single-dose Covid-19 vaccine worked safely and should be authorized for use in the U.S., a panel of experts advised federal health regulators Friday.  The advisory committee’s unanimous vote in support of the vaccine’s authorization is the last step before the U.S. Food and Drug Administration issues a decision, which is expected Saturday. 

Yippee!

  • Reuters reports that “The U.S. Food and Drug Administration on Thursday approved storage and transportation of COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech SE at standard freezer temperatures for up to two weeks instead of ultra-cold conditions. * * * “Alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said.

In other COVID-19 news

  • The AP informs us that “February is usually the peak of flu season, with doctors’ offices and hospitals packed with suffering patients. But not this year. Flu has virtually disappeared from the U.S., with reports coming in at far lower levels than anything seen in decades.” It’s a silver lining in the COVID-19 cloud.  
  • The Centers for Medicare and Medicaid Service released updated guidance today for health plans, including FEHB plans, on coverage of COVID-19 testing and vaccinations.
  • Bloomberg reports that

States should maintain Covid-19 restrictions such as mask wearing and capacity limitations as case numbers halt their decline, the head of the U.S. Centers for Disease Control and Prevention said Friday, citing the circulation of new variants and infection rates that remain alarmingly high.

CDC Director Rochelle Walensky issued a sobering warning during a press briefing Friday, where she said the more contagious B.1.1.7 variant, first found in the U.K., now accounts for an estimated 10% of current U.S. cases, and that variants in California and New York also appear to spread more easily.

“Things are tenuous — now is not the time to relax restrictions,” Walensky said. “The latest data suggest that these declines may be stalling, potentially leveling off at still a very high number. We at the CDC consider this a very concerning shift in the trajectory.”

  • STAT News punctured a CDC recent statistic as follows:

The Centers for Disease Control and Prevention made headlines last week when it announced that Covid-19 had reduced the average life expectancy of Americans in 2020 by a full year. The news seemed to starkly illustrate the devastation wrought by our nation’s worst public health crisis in 100 years.

But there was a problem. The pandemic’s appalling toll could not have reduced life span by nearly that much. My own estimate is that when Covid-19’s ravages in 2020 are averaged across the country’s entire population, we each lost about five days of life.

The CDC’s mistake? It calculated life expectancy using an assumption that is assuredly wrong, which yielded a statistic that was certain to be misunderstood. * * * The CDC’s report boils down to a finding that bears no relation to any realistic scenario. Running the 2020 gauntlet for an entire life results in living one year less on average than running that same gauntlet in 2019.

In other healthcare news, Fierce Healthcare informs us that

Cigna will acquire telehealth platform MDLive, the insurer announced Friday morning.

Cigna has been a longtime partner of and investor in MDLive and will fold it into its Evernorth subsidiary, which houses its health services business. The deal is expected to close in the second quarter of 2021, pending regulatory approvals.

Cigna said that it expects to deliver $20 in earnings per share this year, including impacts of the acquisition, and will present additional details about the deal at its investor day on March 8.

Finally, the FEHBlog has been continuing to review the draft Postal Service bill creating a Postal Service Health Benefits Program. He has updated Wednesday’s post on the topic and he wishes to point out an important clarification on how the bill would treat Postal Service annuitants. Per the Committee staff memorandum:

The bill would require future retirees to enroll in Medicare in order to participate in the Postal Employee Benefits Program (similar to the Federal Employee Health Benefit Program but established as a separate risk pool). However, the bill includes several exceptions:

  • Residents of foreign countries and others without access to Medicare providers would not automatically be enrolled in Medicare; and
  • Retirees who do not have the requisite 40 quarters of creditable service would not be automatically enrolled in Medicare. This would include many Civil Service Retirement System (CSRS) retirees.
  • In addition, current retirees would be granted a three-month grace period from the Medicare penalty for late enrollment but would not be required to enroll.

This helps explain why NARFE is willing to support the bill.

Weekend update

Photo by JOSHUA COLEMAN on Unsplash

Both the House of Representatives and the Senate are attending to committee and floor business this coming week. The House is expected to vote on the $1.9 trillion COVID-19 relief budget reconciliation bill this week. The Hill provides access to the text of the “mammoth” legislation here.

From the COVID-19 front —

  • On Friday February 26, “[t]he [Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory] committee will meet in open session to discuss [emergency use authorization] EUA of the [single dose] Janssen Biotech Inc. [a/k/a Johnson & Johnson] COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older.” This committee’s meetings on the Pfizer and Moderna vaccines were held on Thursdays, and the FDA EUA approval was issued within 48 hours after those meetings. The only turmoil was in the Pfizer hearing because Pfizer sought and received EUA for people beginning at age 16. That was a helpful move in terms of getting colleges back open in the fall.
  • Medicity News reports that the FDA late last week approved consumer purchase of the Everywell COVID-19 test without a prescription. “Users swab their nose and send in the sample, which is then processed at one of Everlywell’s partner labs. It takes one to two days to get results from the rt-PCR test. If users have a positive or an undetermined result, they’re contacted by a clinician. On Everlywell’s website, tests are priced at $109 — generally more costly than most antigen test alternatives. The company also plans to partner with retailers to sell it over the counter.”
  • NPR Shots now offers a website for COVID-19 vaccine hunters.
  • The Kaiser Family Foundation offers a COVID-19 vaccine site that covers a number of significant topics, including vaccine hesitancy, distribution, and messaging.

In other healthcare news, Kaiser Health News reports that

The federal government has penalized 774 hospitals for having the highest rates of patient infections or other potentially avoidable medical complications. Those hospitals, which include some of the nation’s marquee medical centers, will lose 1% of their Medicare payments over 12 months.

The penalties, based on patients who stayed in the hospitals anytime between mid-2017 and 2019, before the pandemic, are not related to covid-19. They were levied under a program created by the Affordable Care Act that uses the threat of losing Medicare money to motivate hospitals to protect patients from harm. * * *

“The all-or-none penalty is unlike any other in Medicare’s programs,” said Dr. Karl Bilimoria, vice president for quality at Northwestern Medicine, whose flagship Northwestern Memorial Hospital in Chicago was penalized this year. He said Northwestern takes the penalty seriously because of the amount of money at stake, “but, at the same time, we know that we will have some trouble with some of the measures because we do a really good job identifying” complications.

Other renowned hospitals penalized this year include Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in Los Angeles; UCSF Medical Center in San Francisco; Beth Israel Deaconess Medical Center and Tufts Medical Center in Boston; NewYork-Presbyterian Hospital in New York; UPMC Presbyterian Shadyside in Pittsburgh; and Vanderbilt University Medical Center in Nashville, Tennessee.

There were 2,430 hospitals not penalized because their patient complication rates were not among the top quarter. An additional 2,057 hospitals were automatically excluded from the program, either because they solely served children, veterans or psychiatric patients, or because they have special status as a “critical access hospital” for lack of nearby alternatives for people needing inpatient care.

OPM Call Letter Released

OPM Headquarters a/k/a the Theodore Roosevelt Building

Happy OPM Call Letter Day. The call letter is OPM’s call for 2022 benefit and rate proposals from FEHB carriers. Here’s the letter’s summary:

OPM maintains its focus on improving quality and affordability in the FEHB Program, as well as supporting the Biden Administration’s priority focus on health care access and equity. We expect FEHB Carriers to continueto offer forward-thinking proposals that focus onthe strategicprioritiesdescribed in this Call Letter. Our quality initiatives for the 2022 plan year relate to the COVID-19 pandemic, mental health and substance use disorder services, opioids, and prior authorizations for prescription drugs. We also remain focused on enhancements to price and quality transparency, as well as addressing surprise billing and low-value care. We are encouraging FEHB Carriers to expand coverage of certain medical foods for those affected by Inborn Errors of Metabolism (IEM), and to cover fertility preservation related to infertility caused by medical treatment (iatrogenic infertility).

The FEHBlog has provided links to topics that he does not routinely cover. The proposals are due on May 31, 2021. Good luck carriers.

On the COVID-19 front, MedScape encouragingly reports that

Researchers know by now the available COVID-19 vaccines prevent people from getting COVID around 95% of the time. But the million-dollar question remains: Are people less likely to spread the illness after they get the vaccine? According to preliminary data, the odds are good.

“The looming question is, if the person who’s been vaccinated gets infected, does that person have the capability to transmit it to another person,” Anthony Fauci, MD, the White House COVID-19 Response Team’s chief medical adviser, said during a White House briefing Wednesday. “Some studies are pointing in a very favorable direction.”

Fauci cited studies from Spain and Israel published this month, showing the amount of viral load — or the amount of the COVID-19 virus in someone’s body — is significantly lower if someone gets infected after they’ve been vaccinated, compared with people who get infected and didn’t have the vaccine. Lower viral load means much lower chances of passing the virus to someone else, Fauci says.

“There’s a direct correlation with viral load and transmission,” he says. “In other words, higher viral load, higher transmissibility; lower viral load, very low transmissibility.”

Also, the Department of Health and Human Services announced today “new actions to expand COVID-19 testing capacity across the country. These actions will improve the availability of tests, including for schools and underserved populations; increase domestic manufacturing of tests and testing supplies; and better prepare the nation for the threat of variants by rapidly increasing virus genome sequencing.”

From Capitol Hill, this Congressional Budget Office report to the House Ways and Means Committee on the COVID-19 budget reconciliation bill provides a useful overview of the healthcare and employee benefit proposals in the bill. The Speaker intends to pass the $1.9 trillion relief measure by the end of this month.

Health Payer Intelligence discusses a recent Health Affairs article positing that “whether care is affordable for members depends on more than just pricing; affordability is also tied to how clustered healthcare events—and, by extension, healthcare spending—are in a single year.”

The conclusion of this study has clear implications for payers. When members skip care due to affordability, they miss key preventive care services which can result in higher healthcare spending downstream in the members’ healthcare journeys. During the pandemic, payers have waived primary care costs in order to incentivize members to continue receiving care for this very reason. The researchers called on payers, employers, and lawmakers to explore methods for spreading members’ healthcare costs out over time [e.g. monthly deductibles rather than annual deductibles, low copays for essential medicines like insulin].

As we reach the end of the 4th Quarter 2020 financial reporting season, Healthcare Dive summarizes the reports from major health insurers.

Monday Roundup

Photo by Sven Read on Unsplash

Good news on the COVID-19 front —

Bloomberg’s headline story this evening is that

More Americans have received at least one dose of a Covid-19 vaccine than have tested positive for the virus, an early but hopeful milestone in the race to end the pandemic.

As of Monday afternoon, 26.5 million Americans had received one or both doses of the current vaccines, according to data gathered by the Bloomberg Vaccine Tracker. Since the first U.S. patient tested positive outside of Seattle a year ago, 26.2 million people in the country have tested positive for the disease, and 441,000 have died, according to data from Johns Hopkins University.

The U.S. has been administering shots at a faster daily rate than any country in the world, giving about 1.35 million doses a day, according to data gathered by Bloomberg. While the rollout stumbled in its early days, in the six weeks since the first shots went into arms almost 7.8% of Americans have gotten one or more doses, and 1.8% are fully vaccinated.

“It’s worth noting that today, for the first time, the data said that more people were vaccinated than were reported as newly diagnosed cases,” said Paula Cannon, a professor of microbiology at the University of Southern California’s Keck School of Medicine. “That’s worth celebrating. I’m all for that win.

A New York Times columnist earlier today explained

Right now, public discussion of the vaccines is full of warnings about their limitations: They’re not 100 percent effective. Even vaccinated people may be able to spread the virus. And people shouldn’t change their behavior once they get their shots.

These warnings have a basis in truth, just as it’s true that masks are imperfect. But the sum total of the warnings is misleading, as I heard from multiple doctors and epidemiologists last week.

“It’s driving me a little bit crazy,” Dr. Ashish Jha, dean of the Brown School of Public Health, told me.

“We’re underselling the vaccine,” Dr. Aaron Richterman, an infectious-disease specialist at the University of Pennsylvania, said.

“It’s going to save your life — that’s where the emphasis has to be right now,” Dr. Peter Hotez of the Baylor College of Medicine said.

The Moderna and Pfizer vaccines are “essentially 100 percent effective against serious disease,” Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said. “It’s ridiculously encouraging.”

Let’s go.

On the COVID-19 testing front, the Wall Street Journal reports that

The Biden administration said it has reached a $230 million deal with Australian diagnostics company Ellume USA LLC to produce at-home, over-the-counter Covid-19 tests. 

The Food and Drug Administration previously authorized the test. So far, the FDA has cleared three Covid-19 tests that can be processed entirely at home, but Ellume’s is the only one that doesn’t require a prescription. None are widely available at this point. 

The company is expected to produce 19 million tests a month by the end of the year, Andy Slavitt, senior adviser to the White House Covid-19 response team, said Monday. Based on the agreement, 8.5 million tests will be guaranteed to the U.S. government. 

Smart move.

In other news —

  • Roll Call brings us up to date on the COVID-19 relief bill developments on Capitol Hill.
  • Katie Keith helpfully updates us on Affordable Care Act litigation in the Health Affairs blog.
  • Dispatch Health and Humana announced ” an [interesting] agreement to provide Humana members with access to an advanced level of care in the home – to help enhance patients’ experience and health outcomes. These services will be available in Denver, Colo., and Tacoma, Wash., with expansion to additional markets in Texas, Arizona and Nevada planned for later this year. The agreement will provide members living with multiple chronic conditions – such as cellulitis, kidney and urinary tract infections, chronic obstructive pulmonary disease, heart failure and many others – an opportunity to be treated safely at home and thereby avoid hospital visits. Last November, the U.S. Centers for Medicare & Medicaid Services announced a waiver program to allow qualified health care providers to offer acute, hospital-level care in the home. The Dispatch-Humana agreement is believed to be the country’s first program to provide hospital-level care involving a national payer.

In pharmacy C-suite news —

  • Healthcare Dive reports that “Karen Lynch has officially stepped into the CEO role at CVS Health [on February 1, 2021]. Lynch previously served as president of the Aetna business, and was a key figure in directing CVS Health’s COVID-19 response.”
  • AP reported last week that “Walgreens has tapped Starbucks executive Roz Brewer as its new CEO, which will make her the only Black woman leading a Fortune 500 company. Starbucks announced Tuesday January 26 that Brewer was departing after a little more than three years as its chief operating officer. Walgreens later confirmed that Brewer will take over as its CEO on March 15.

Good luck.

COVID-19 Vaccine update and more

Last night, the FDA granted Moderna emergency use authorization for administering its mRNA based COVID-19 vaccine to Americans aged 18 and older. About an hour ago, the CDC’s Advisory Committee seconded this decision which means that health plans, including FEHB plans, must begin to provide in-network and out-of-network coverage for administration of the Moderna vaccine on January 3, 2021. That is certainly good news.

Last night, as CBS News reports, the Senate joined the House of Representatives in approving a two day extension of the continuing resolution funding the federal government, and the President signed the resolution into law. The Hill adds this afternoon that

Speaker Nancy Pelosi (D-Calif.) told Democratic House members during a conference call Saturday that a deal is within reach as soon as negotiators hammer out an agreement on language being pushed by Sen. Pat Toomey(R-Pa.) to wind down the Federal Reserve credit lending facilities. Pelosi told colleagues that the “good news” is “we’re right within reach” of resolving that disagreement.

In other news —

  • The American Medical Association offers advice on which masks work best in warding off COVID-19.
  • The federal government’s Cybersecurity and Infrastructure Security Agency (“CISA”) offered updated guidance today on the SolarWinds backdoor hack.
  • Bloomberg provided this interesting observation on the scope of this hack:

At least 200 organizations, including government agencies and companies around the world, have been hacked as part of a suspected Russian cyber-attack that implanted malicious code in a widely used software program, said a cybersecurity firm and three people familiar with ongoing investigations.

The number of actual hacking victims has been one of many unanswered questions surrounding the cyber-attack, which used a backdoor in SolarWinds Corp.’s Orion network management software as a staging ground for further attacks.

As many as 18,000 SolarWinds’ customers received a malicious update that included the backdoor, but the number that was actually hacked — meaning the attackers used the backdoor to infiltrate computer networks — is likely to be far fewer.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

More good news on the COVID-19 vaccine front:

  • Becker’s Health IT reports that “Healthcare workers in Indiana who tried signing up for the first round of COVID-19 vaccinations Dec. 14 overwhelmed the state’s enrollment website, resulting in down time, according to Indianapolis NBC affiliate WTHR.” Why is this good news? Because now that the COVID-19 vaccine is a reality, people will want the jab as the call it in Britain. That’s human nature.
  • The Wall Street Journal reports that “The Food and Drug Administration [“FDA’] said Tuesday that the Covid-19 vaccine developed by Moderna Inc. was “highly effective,” setting the stage for an emergency authorization later this week that would add a second vaccine to the arsenal against the pandemic.” Here’s a link to the Moderna briefing document for Thursday’s meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee.

A friend of the FEHBlog pointed out the following encouraging FDA announcement

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” 

The announcement today of the first fully at-home OTC COVID-19 diagnostic test follows last month’s authorization of the first prescription COVID-19 test for home use and last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample. The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing. The Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription. 

On the omnibus / COVID-19 relief bill front, the Wall Street Journal reports

The top four congressional leaders discussed a coronavirus relief package and sweeping spending bill on Tuesday and planned to return for another meeting in the evening, as lawmakers raced to reach an agreement before critical support programs expire at year’s end.

House Speaker Nancy Pelosi (D., Calif.), Senate Majority Leader Mitch McConnell (R., Ky.), Senate Minority Leader Chuck Schumer (D., N.Y.) and House Minority Leader Kevin McCarthy (R., Calif.) first conferred in the afternoon, with the meeting of both parties’ leaders a signal that they could be ready to make the difficult decisions needed to cut a deal. 

The group will meet again late Tuesday. 

“We’re continuing to work. I think there’s progress. We’ll get back together,” Mr. McCarthy said following the afternoon meeting.

Treasury Secretary Steven Mnuchin, who spoke to Mrs. Pelosi earlier Tuesday for more than an hour, also joined the first meeting by phone. 

The legislative text must be released tomorrow if Congress want to stick with the current December 18 deadline for action.

A friend of the FEHBlog pointed out the Office of Management and Budget’s Office of Information and Regulatory Affairs has issued its Fall 2020 Unified Agenda of “Regulatory and Deregulatory Actions. Here’s a link to the OPM agenda. The FEHBlog noticed a FEHBP centralized enrollment proposed rule and a final FEHBAR rule involving the Truth in Negotiations Act threshold change which the FEHBlog called to OPM’s attention.

In other healthcare news

  • Health Payer Intelligence offers “Five Pivotal Payer Industry Trends To Watch in 2021.”
  • Healthcare Finance News reports that various healthcare trade associations have asked a federal district court in Maryland to preliminarily enjoin implementation of the Trump Administration’s Medicare Part B international drug price index pilot scheduled for January 1, 2021. The motion was filed on December 10 and the government filed its opposition today.
  • A friend of the FEHBlog pointed out this NIH press release on the state of bad teenager habits.

Findings released today from the most recent Monitoring the Future (MTF) survey of substance use behaviors and related attitudes among teens in the United States indicate that levels of nicotine and marijuana vaping did not increase from 2019 to early 2020, although they remain high. The annual MTF survey is conducted by the University of Michigan’s Institute for Social Research, Ann Arbor, and is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

In the four years since the survey began including questions on nicotine and marijuana vaping, use of these substances among teens have increased to markedly high levels From 2017 to 2019, the percentage of teenagers who said they vaped nicotine in the past 12 months roughly doubled for eighth graders from 7.5% to 16.5%, for 10th graders from 15.8% to 30.7%, and for 12th graders from 18.8% to 35.3%. In 2020, the rates held steady at a respective 16.6%, 30.7%, and 34.5%. However, somewhat encouragingly, daily, or near daily (20 occasions in the past 30 days), nicotine vaping declined among 10th and 12th graders from 2019 to 2020, by close to half — from 6.8% to 3.6% in 10th grade and from 11.6% to 5.3% in 12th grade.

Midweek update

Photo by Manasvita S on Unsplash

Govexec reports that

The House on Wednesday [December 9] passed a stopgap funding bill 343-67 that would give lawmakers an additional week to come up with full-year spending legislation and avoid a government shutdown later this month.  The continuing resolution would last for one week, setting a new funding deadline of Dec. 18. The Senate must still pass the CR and President Trump must sign it by Friday to avoid a government shutdown, which both are expected to do. 

The Wall Street Journal adds that “A flurry of competing proposals for another coronavirus relief package ricocheted around the Capitol Wednesday, as lawmakers hunted for ways to resolve a thorny debate over liability protections that has stymied progress for weeks.” A December 9 fact sheet on the bipartisan proposal was made available today. Check it out.

In Presidential transition news, President-elect Biden announced the following additional healthcare appointments earlier this week:

  • Vivek Murthy, M.D., for a second tour of duty as surgeon general
  • Rochelle Walensky, MD, Harvard professor, as CDC director
  • Marcella Nunez-Smith, MD, Yale Professor, as COVID-19 Equity Task Force Chair
  • Jeff Zients, Deputy OMB Director for Management in Obama Administration, as Covid-19 czar.
  • Anthony Fauci, MD, as Coordinator of COVID-19 response and Counselor to the President
  • Sidebar — Still waiting for FDA Commissioner appointment
  • Added Cathie McQuiston, AFGE Deputy GC, to the OPM review team

Tomorrow December 10 is the date set for the FDA Vaccines and Related Biological Products Advisory Committee virtual meeting on the Pfizer-BioNTech emergency use authorization application for its COVID-19 vaccine. The CDC’s Advisory Committee on Immunization Practices will meet on Friday December 11 and vote on Sunday December 13 per Reuters. “

Dr. William Schaffner, an infectious disease expert and non-voting member of the CDC’s ACIP, said the gap between the two ACIP meetings will allow the FDA time to draft and issue an emergency use authorization (EUA) before the ACIP vote. That schedule could change, however, if FDA advisers have questions or request more data [tomorrow], he said.

Today the FDA announced that it has

authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal.

This home sample collection kit can be purchased online or in a store without a prescription. It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional.

“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing.”

Most excellent.

Health Payer Intelligence reports that

Blue Cross and Blue Shield is calling on payers to bolster vaccination rates by expanding access to care, connecting with members through digital platforms, hosting free flu vaccine clinics, and utilizing data to target support for at-risk communities The effort comes in response to a drastic decrease in the number of vaccinations this year, compared with 2019 data.

Monday Roundup

Photo by Sven Read on Unsplash

Another Monday, another COVID-19 vaccine — the newest from Oxford University (UK) and Astrazeneca. The Times of London reports that

Oxford University scientists said this morning that they had created “a vaccine for the world” as trial results showed that their Covid-19 jab worked well enough to apply immediately for regulatory approval.

The vaccine involves two injections, administered at least a month apart, and the results suggest that using a lower first dose could boost efficacy to 90 per cent. However, that finding relied on limited data and may be amended.

Overall, a trial involving 24,000 people suggested that the vaccine was about 70 per cent effective.

It prevented severe disease and the need to be admitted to hospital, and there are promising early signs that it might also block transmission of the virus. No dangerous side-effects were reported, and the British medical regulator has begun to review safety and efficacy data.

Britain has ordered 100 million doses, and Astrazeneca, the drug company that is working with Oxford, said this morning that four million of those would be ready to be sent to care homes, GP clinics and other vaccination centres by the end of the year.

The Oxford vaccine can be stored in a normal fridge, making it easier to handle than Pfizer’s competing inoculation, which must be stored at about minus 70C. It is also considerably cheaper, costing a few pounds per dose. It is possible that the first doses could be administered before Christmas.

The FEHBlog heard on Fox Business this morning that a separate phase three trial for the Oxford vaccine is ongoing in our country. Oxford and Astrazeneca will present an emergency use authorization request to our Food and Drug Administration (“FDA”) based on that as yet uncompleted trial. The trial referenced in the Times of London article was conducted in the United Kingdom and Brazil. The FDA does not require that the phase three trials be conducted in the U.S. For example, the agency approved the Ebola vaccine based on a phase three trial conducted in Africa, but of course there’s no problem finding COVID-19 patients here.

Reuters reports that the FDA’s Vaccines and Related Biological Products Advisory Committee will meet on December 10 to review the Pfizer / BioNTech emergency use application for its COVID-19 vaccine. The FDA is not bound by the Committee’s recommendation. Here is a link to the full FDA press release.

A friend of the FEHBlog recommended the 20 minute long Journal podcast interview with the founder of BioNTech Dr. Ugur Sahin. The FEHBlog found that podcast fascinating listening.

Govexec.com reports that “The departments of Defense and State, as well as the Veterans Affairs Department’s Veterans Health Administration, the Bureau of Prisons and Indian Health Service, will all receive a direct allocation of vaccines from the Centers for Disease Control and Prevention. The plan was spelled out in a COVID-19 Vaccination Program Interim Playbook, which was first reported by CNBC.” 

Following up on the major Health and Human Services rule makings on Fridays here are article with industry reaction:

  • As the FEHBlog expected, Fierce Healthcare reports that “A hurried final rule aimed at tying drug prices to those paid by foreign countries could lead to providers paying more for drugs than what they will get reimbursed by Medicare, according to several providers and experts.” It really makes you wonder why the American Medical Association’s House of Delegates conditionally endorsed adding a public option to the ACA marketplace earlier this month.
  • Fierce Healthcare further informs us that “CMS’ Stark, anti-kickback updates draw praise from hospitals, concern from physician groups.”
  • Health Payer Intelligence discusses the Medicare rule restricting the use of prescription drug rebates in Medicare Part D effective January 1, 2022. The FEHBlog cannot understand why if drug manufacturers want to end the rebate practices, it does not assure (with an enforcement mechanism) the health insurance industry and the government that the price reductions will balance out the lost rebates.

Happy National Rural Health Day

Photo by Tomasz Filipek on Unsplash

It is National Rural Health Day which HHS’s Health Resources and Services Administration is proud to celebrate.

The Defense Department reports on yesterday’s Operation Warp Speed press conference. The Wall Street Journal adds that

Initially, people will be vaccinated at hospitals and large medical centers because supplies will be limited, said Marion Whicker, deputy chief of supply, production and distribution at Operation Warp Speed, the federal initiative to speed development of Covid-19 drugs and vaccines. “When you see vaccines start to equal or exceed demand is when you’ll see it out of the pharmacies,” said Ms. Whicker.

According to Endpoint News, “BioNTech CEO Ugur Sahin told CNN Wednesday that they and Pfizer plan to file for an emergency use authorization for their jointly developed vaccine on Friday [/ tomorrow].

The Wall Street Journal further reports on the COVID-19 front that

U.S. hospitals say they are facing the pandemic’s largest surge armed with treatment improvements that allow them to save lives, care for more patients and accelerate the recovery of coronavirus sufferers.

HCA Healthcare Inc., one of the nation’s largest hospital chains with 186 hospitals, has more intensive-care capacity as the sickest patients recover more quickly. At the Mayo Clinic’s hospital in Rochester, Minn., coronavirus patients now stay a median of five days, half as long as in March. The time Covid-19 patients spend at Advocate Aurora Health’s 26 Midwestern hospitals has fallen 25% on average since May.

The shift could be a result of several factors and more study is needed, said doctors and researchers. But the results are consistent with anecdotal reports from doctors saying that new tools and a better understanding of how Covid-19 attacks the body are helping to improve medical outcomes.

Also HHS announced today launching

a pilot program with five states to use portable, cartridge-based COVID-19 molecular test kits that provide rapid results. The pilot program will assess how to best integrate diagnostic technology developed by Cue Health, Inc., into strategies for disease surveillance and infection control in institutions such as nursing homes.

Used successfully as the primary molecular point-of-care (POC) test to control the spread of COVID-19 within in the National Basketball Association “bubble,” as well as by leading healthcare providers in the U.S., the nasal swab POC test generates results in about 20 minutes. Currently, molecular COVID-19 tests provided by HHS must be sent to a laboratory for interpretation, which can take two to three days.

The Centers for Disease Control and the American Medical Association, the American Hospital Association and the American Nursing Association are encouraging Americans to curb holiday travel and scale back holiday gatherings due to the recent surge in COVID-19 cases. That’s a useful message for health plans circulate to members and employees.

Following up on this week’s launch of Amazon’s online Pharmacy, the Drug Channels blog comments that

This announcement is much less disruptive than it appears to be. Amazon is copying the GoodRx discount card model—including GoodRx’s partnership with Express Scripts. At the same time, Amazon is launching a mail pharmacy that will accept insurance and be in PBM pharmacy networks. Amazon’s actions are another negative headwind for retail pharmacies, but not a fatal blow to the system. Perhaps Amazon will one day become a true disrupter. For now, Amazon is choosing to join the drug channel, not fundamentally change it.

Healthcare Dive lets us in other expert insights on this development.

In other prescription drug coverage news, the Wall Street Journal reports this evening that

The Trump administration is planning on Friday [/ tomorrow] to roll out two final rules aimed at lowering drug prices—one curbing rebates paid to middlemen in Medicare and another pegging the prices of certain prescription drugs in the U.S. to their prices in other developed countries, according to a person familiar with the planning. The plans, slated to be announced in the White House Rose Garden, have been a signature pledge of President Trump’s since his 2016 election campaign. Both rules are expected to be final, meaning they have completed the required public comment period and can take effect immediately.

“Immediately” in this setting would not prevent the incoming Biden Administration from putting the brakes on the iniative without trouble, in the FEHBlog’s opinion.

In other news —

  • According to a press release, “The Sequoia Project, a non-profit and trusted advocate for nationwide health information exchange, patient identity management experts collaborated with the Blue Cross Blue Shield Association (BCBSA) to apply A Framework for Cross-Organizational Patient Identity Management for the payer community and develop person matching strategies. Today, The Sequoia Project published Person Matching for Greater Interoperability: A Case Study for Payers which demonstrates high matching accuracy rates, and provides actionable insights for improving person identity matching across the payer community, a critical component of successful health information exchange and interoperability.” Helpful.
  • According to Fierce Healthcare, “While insurers are set to weather COVID-19’s financial storm, an inability to keep up with how the pandemic is changing healthcare will be credit-negative in the long term, according to a new report from Moody’s Investors Service. The coronavirus pandemic has put a spotlight on chronic conditions, the need for continued investment in telehealth and virtual care and the drive toward value-based care, according to the report. Health plans that are able to adapt to these changing trends are far better positioned for long-term success, Moody’s said.”

Midweek update

Photo by Manasvita S on Unsplash

More good COVID-19 vaccine news today. The Wall Street Journal reports that following up on Monday’s favorable initial report on the phase three study of their COVID-19 vaccine, Pfizer and BioNTech announced the final report on that study.

Pfizer Inc. said it will ask health regulators to authorize its experimental Covid-19 vaccine within days, after reporting the shot was 95% effective in its pivotal study and showed signs of being safe. The company’s plans, announced Wednesday, mean the shot is on track to go into distribution by the end of the year, if the regulators permit.

Pfizer and BioNTech said that of the nearly 44,000 adults in the U.S. and in other countries who took part in the study, 170 developed Covid-19 with at least one symptom. Out of those, just eight had taken the vaccine, while 162 had received a placebo. The resulting 95% effectiveness rate puts the shot’s performance on par with shingles and measles vaccines. It is also consistent with last week’s peek at how it did in an analysis of the first 94 subjects to fall sick.

The infected subjects included 10 severe cases of Covid-19, with nine in the placebo group and one in the vaccine group. The vaccine was effective across different ages, races and ethnic groups, and it was more than 94% effective in adults over 65 years old, the companies said. About 42% of the trial participants are from racial or ethnic minority groups, while 41% are ages 56 to 85, the companies said.

Moreover, medical device manufacturer Lucira Health announced today that

Late yesterday the U.S. Food and Drug Administration (FDA) authorized the first prescription molecular diagnostic test for COVID-19 that can be performed entirely at home. The FDA issued an Emergency Use Authorization (EUA) to Lucira Health, Inc. for its single-use, user-friendly COVID-19 All-In-One Test Kit that can produce a positive or negative result at home within 30 minutes. Lucira’s test kit is differentiated by its simple ‘swab, stir and detect’ design. Clinical trials showed 100% of patients were successfully able to perform the Lucira test in about two minutes. That is significantly faster than labs which currently take two to seven days to generate similarly accurate test results. The Lucira™ COVID-19 All-In-One Test Kit is expected to be available to patients served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale, in the near future. By early spring 2021, it is expected to be available nationally through health care providers.

Healthcare Dive indicates that the initial price for the test will be about $50.

Benefits Pro points us to a CIGNA report titled “Health and Wellness in Workplaces: What Works? ROI Analysis of Health and Wellness Interventions” which “is the largest global review of the impact of workplace wellness interventions, according to researchers.” Top line findings are that focused wellness programs deliver the greatest impact for employers and that mental health interventions yield the most significant return on the employer’s investment.

Fierce Healthcare reports that the American Medical Association’s House of Delegates is on the warpath against employer sponsored high deductible plans. “In 2010, about 25.3% of people were enrolled in a high-deductible plan, with that number rising to 40% in 2016.” The article overlooks the important fact that participating in such a plan is the key to opening a triple tax free health savings account.