Midweek Update

COVID-19 testing

Midweek Update

David Ermer–COVID-19 testing, HSA, OPM, Telehealth–
Photo by Manasvita S on Unsplash

Happy St. Patricks Day to all.

Congress in a recent appropriations law sought a report from the National Academy for Public Administration on the Trump Administration’s proposal to break up the Office of Personnel Management. The Federal Times reports that “A better federal workforce policy will require the Office of Personnel Management to become a more independent and authoritative agency, rather than being broken apart into other departments, a long-awaited National Academy for Public Administration study determined March 17. ”

“We strongly recommend that a central personnel agency continue to exist, and that organization is an independent, enterprise-wide human capital agency and a steward of the merit system principles,” said Terry Gerton, president and CEO of NAPA, said at a press briefing on the report. “But that organization, OPM as we know it today, really needs to build its staff capacity, encourage innovation and adopt a more data-driven, accountable and forward-looking capital management approach.”

In other federal agency news, the Federal News Network informs us that

The IRS is moving this year’s April 15 tax filing season deadline back to May 17, citing ongoing challenges from the COVID-19 pandemic. IRS Commissioner Chuck Rettig said in a statement Wednesday that the new deadline would give the public more time to take stock of their finances, while also giving agency employees more time to implement new responsibilities under the American Rescue Plan.

The Department of Health and Human Services announced today that the agency

will invest $10 billion from the American Rescue Plan to ramp up screening testing to help schools reopen, $2.25 billion to scale up testing in underserved populations, and provide new guidance on asymptomatic screening testing in schools, workplaces, and congregate settings. These measures are part of President Biden’s strategy to increase COVID-19 testing nationwide as vaccinations increase.

“COVID-19 testing is critical to saving lives and restoring economic activity,” said HHS Acting Secretary Norris Cochran. “As part of the Biden Administration’s National Strategy, HHS will continue to expand our capacity to get testing to the individuals and the places that need it most, so we can prevent transmission of the virus and defeat the pandemic.”

The U.S. Preventive Services Task Force announced yesterday a proposed B grade recommendation “on screening for prediabetes and type 2 diabetes. The Task Force recommends screening adults between ages 35 to 70 years old who are overweight or obese for prediabetes and diabetes.” The current minimum age for this screening recommendation is 40 years old. NBC News reports that

We know the rates of prediabetes and diabetes are increasing in people who are younger,” said Dr. Chien-Wen Tseng, a task force member and a professor of family medicine at the University of Hawaii’s John A. Burns School of Medicine. “Our main reason for dropping the age is to match the screening with where the problem is: If diabetes and prediabetes are occurring at a younger age, then we should be screening at a younger age.”

The Affordable Care Act requires health plans to cover USPSTF A and B recommended preventive services without member cost sharing when an eligible member receives the service in-network. If the USPSTF finalizes this recommendation later in 2021, then the ACA health plan coverage mandate for this screening would expand to people in the age 35 to 40 age group in 2023. Here is a link to background on the USPSTF’s sixteen members.

In other health industry news —

Healthcare Dive reports that

Amazon is expanding its virtual care pilot program, Amazon Care, to employees and outside companies nationwide beginning this summer in a major evolution of its telehealth initiative, as the COVID-19 pandemic continues to drive unprecedented demand for virtual care.

Amazon will also offer its on-demand primary care service to other Washington state-based companies and plans to expand its in-person service to Washington, D.C., Baltimore and other cities in the following months, the e-commerce behemoth announced Wednesday.

Employee Benefit News offers a Chief Financial Offer’s advice on health savings account funding.

Monday Roundup

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

The Wall Street Journal reports that

The House [of Representatives] looked on track to pass the latest version of the $1.9 trillion coronavirus relief package later this week, as liberal Democrats swallowed their frustration with the Senate’s changes and prepared to approve the bill for a second time.

The House is expected to narrowly pass the bill Tuesday or Wednesday, sending it to the White House for President Biden’s signature. House Majority Leader Steny Hoyer (D., Md.) had initially said the House would take its first procedural vote on the bill Monday, but processing the bill’s Senate paperwork pushed the vote slightly later in the week, aides said. 

In COVID-19 news

  • The Centers for Disease Control today released guidance for those who are fully vaccinated against the disease (meaning two weeks after the final dose).
  • The Biden Administration announced “an effort to invest $250 million to encourage COVID-19 safety and vaccination among underserved populations. The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) will offer the funding as health literacy grants to localities, who will partner with community-based organizations, to reach racial and ethnic minority, rural and other vulnerable populations. The new initiative – Advancing Health Literacy to Enhance Equitable Community Responses to COVID-19 – is expected to fund approximately 30 projects in urban communities and 43 projects in rural communities for two years. “
  • The Food and Drug Administration has given emergency use authorization for “the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.” Here’s a link to the Cue Health website.

In other healthcare news —

  • Healthcare Dive reports that “for the first time since Fair Health started tracking monthly telehealth claims, COVID-19 became one of the top five diagnoses in the U.S. in December as cases surged, the nonprofit said in a report released Thursday. Overall, telehealth claim lines increased 2,817% year over year, rising from just 0.22% of all medical claim lines in December 2019 to 6.51% in December 2020. Mental health conditions continue to be the No. 1 telehealth diagnosis nationwide.” It’s the last sentence that caught the FEHBlog’s attention.
  • Benefits Pro writes about the important role that employers and their health plans can help in reducing employee obesity issues. “’Overweight and obesity, which require a comprehensive approach, are top health concerns for employers around the world,’ said Ellen Kelsay, president and CEO of Business Group on Health. ‘Employers play a major part in offering quality health care, understanding obesity’s inextricable link to mental health, lessening the stigma surrounding it and addressing some of the social determinants of health.’ By 2025, one in five adults worldwide will be affected by obesity, according to the organization’s new report, ‘The Global Landscape for Overweight and Obesity: A Guide for Employers.’ As overweight and obesity rates surge worldwide, large employers are positioned to address the chronic medical conditions on multiple fronts, the report said.”
  • The New York Times reports that “When the pandemic struck last year, many Americans rushed to stock up on alcohol, causing retail sales of wine, beer and liquor to surge across the country. But the uptick in sales was a worrying sign for health experts focused on cancer prevention. In recent years, a growing number of medical and public health groups have introduced public awareness campaigns warning people to drink with caution, noting that alcohol is the third leading preventable cause of cancer, behind tobacco and obesity. * * * [Consumer S]urveys continue to show that most people remain unaware of the risks. When the American Institute for Cancer Research surveyed Americans two years ago to gauge their awareness of different cancer risk factors, the results were striking: fewer than half were aware of the alcohol-cancer link.”

Friday Stats and More

David Ermer–COVID-19, COVID-19 testing, 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 9th week of this year (beginning April 2, 2020, and ending March 3, 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 greatly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through March 3, 2021):

Finally here is a COVID-19 vaccinations chart since mid-December 2020 which also uses Thursday as the first day of the week:

These are all encouraging charts. The CDC reports that as of today 21.7% of eligible Americans (over age 18) have received at least one dose of the COVID-19 vaccine and 11.2% of received two doses.

The CDC’s FluView continues to report that “Seasonal influenza activity in the United States remains lower than usual for this time of year.”

The Wall Street Journal informs us that

A new study on the topic in JAMA Cardiology is based on the screening of 789 professional athletes who tested positive for Covid-19 between May and October in Major League Baseball, Major League Soccer, the National Hockey League, National Football League, and the men’s and women’s National Basketball Association. 

The paper shows that 0.6% of those athletes ultimately had findings suggestive of inflammatory heart disease. Five athletes were held out of competition because of their cardiac results. Three had myocarditis, which is heart inflammation, and two had pericarditis, which is swelling of the tissue that surrounds the heart. All had had moderate cases of Covid.

The findings suggest that long-term heart complications in non-severe Covid cases are unlikely—and that sports leagues are still likely to continue with cardiac screenings during the pandemic.

Govexec offers an interesting interview with National Institutes of Health Director Dr. Francis Collins.

Tuesday Tidbits

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The Wall Street Journal reports this evening that “President Biden said the U.S. would have enough Covid-19 vaccines for all American adults by the end of May, two months earlier than he had previously said, after regulators authorized the one-shot Johnson & Johnson vaccine and Merck & Co. agreed to help produce it.” That is very encouraging news.

Politico reports that the President has agreed to comply with Neera Tanden’s request that he withdraw her nomination as Office of Management and Budget Director. “Biden’s statement indicated that he expects Tanden to serve in another role in his administration.”

And here are some tidbits for you —

  • The House Energy and Commerce Committee held a future of telehealth hearing today. “It is critical to the health, safety and equitable access of our patients to ensure we can continue to provide telehealth services after the end of the public health emergency,” said Megan Mahoney, M.D., chief of staff at Stanford Health Care, who testified at the hearing.
  • Medpage Today reports that ” Insufficient evidence exists to support any strategy where patients either delay their second dose or only receive one dose of COVID-19 mRNA vaccines [Pfizer and Moderna], even if they have been previously infected with the virus, CDC staff told the agency’s Advisory Committee on Immunization Practices (ACIP) at its Monday meeting. And ACIP committee members seemed to agree * * *.”
  • Fierce Pharma reports on two recent Food and Drug Administration emergency use authorizations of at home COVID-19 tests.
  • A friend of the FEHBlog pointed him to this STAT News article written by HHS Office of Inspector General Officials discussing the “importance of adding patients’ diagnoses to their prescriptions.” For example, [d]iagnosis information on prescriptions could help pharmacists identify safety issues,” and electronic prescription systems can accommodate diagnosis information.
  • CMS, which enforces the HIPAA electronic transaction rules, issued a factsheet on savings available to healthcare providers who use those electronic transactions. “According to data from the 2020 CAQH Index, 16% of medical plans and 36% of dental plans do not fully use electronic HIPAA standard transactions to conduct eligibility and benefits inquiries and responses. The CAQH Index estimates that medical and dental providers could save approximately $7 billion per year by completing eligibility and benefits checks using the HIPAA standard.” Health plans should share this information with their recalcitrant network providers.
  • Healthcare Dive informs us about four healthcare anti-trust issues to watch in 2021.
  • Health Payer Intelligence reports that “Blue Cross and Blue Shield of Illinois (BCBSIL) is tackling maternal care disparities in its state by financially supporting community-based interventions that focus on increasing education among new mothers and providing in-person and digital support. ‘By taking a holistic approach to supporting prenatal care that considers the social and economic factors impacting the health of mothers and newborns, we are working to help create an environment that fosters access to affordable benefits, equitable care delivery and wherever possible, better health outcomes,’ said Anita Stewart, MD, medical director at BCBSIL.” Well done.

Friday Stats and More

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Telehealth, U.S. Healthcare, Uncategorized–

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

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Medicare–

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

David Ermer–COVID-19, COVID-19 testing, COVID-19 vaccine, OPM, U.S. Healthcare–
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

David Ermer–ACA, Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
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

David Ermer–Congress, COVID-19, COVID-19 testing, HIPAA Privacy and Security Rules–

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

David Ermer–Congress, COVID-19 testing, COVID-19 vaccine, OPM, U.S. Healthcare–
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.