Thursday Miscellany

COVID-19 vaccine

Thursday Miscellany

David Ermer–ACA, CDC, Congress, COVID-19 vaccine, Federal employment benefits, OPM–
Photo by Juliane Liebermann on Unsplash

The President signed the American Rescue Plan (H.R. 1319) into law today.

Mercer provides a useful overview of the provisions of the law affecting employers. The COBRA subsidy discussed in the article does not apply to the temporary continuation coverage applicable to federal and postal employees. The COBRA subsidy in any event is only available to employees who lost health coverage due to involuntary termination of employment or reduction in hours.

On the bright side, the new law “increases the income exclusion for employer-provided dependent care assistance programs — for example, employee pretax contributions to dependent care FSAs — from $5,000 to $10,500 (and from $2,500 to $5,250 for a married individual filing a separate return) for 2021.” The FEHBlog expects that OPM will adopt this FSA change because the dependent care FSA is fully funded by the employee with no insurance risk to the employer.

Katie Keith in Health Affairs digs into the law’s financial support for the Affordable Care Act marketplace and its beneficiaries.

From the COVID front —

  • The White House has announced that the Biden administration will seek to “make every adult in the U.S. eligible for vaccination no later than May 1.” This fact sheet explains that steps that will be taken to make good on that plan.  The FEHBlog believes that this is an achievable goal.
  • David Leonhardt in the New York Times offers an interesting take on herd immunity from COVID-19. He explains that

Herd immunity is more like a light dimmer. The more people develop immunity — either from having been infected or from being vaccinated — the less easily the virus will spread.

Nearly 30 percent of Americans have now had the virus, according to Youyang Gu, a data scientist. (That includes many people who have never taken a Covid test.) About 18 percent have received at least one vaccine shot. There is some overlap between these two groups, which means that about 40 percent of Americans now have some protection from Covid.

Had these people been exposed to the virus a year ago, they could have become infected — and then spread Covid to others. Today, many are protected.

What’s more Mr. Leonhardt’s first dose of vaccination figure (18%) reflects the total U.S. population. However the vaccines generally are available only to people over 18 years of age. The Centers for Disease Control reports today that 25.1% of that population has received at least one dose of a COVID-19 vaccine. The FEHBlog nearly fell off his share today when he noticed a new statistic on the CDC site showing that 62.4% of the U.S. population over age 65 has received at least one dose of a COVID-19 vaccine. That’s great news.

In legislative / regulatory news —

  • Healthcare Dive reports that Xavier Becerra will soon receive a Senate floor vote on his nomination to serve as Secretary of Health and Human Services.
  • Govexec reports that “Postmaster General Louis DeJoy will soon request a $40 billion investment into the cash-strapped U.S. Postal Service for organizational and workforce improvements, saying the money will help address longstanding challenges the mailing agency faces.  The funds would go toward infrastructure updates such as larger facilities and new package sortation equipment, DeJoy told a panel of the House Appropriations Committee on Thursday [March 11], and reducing turnover in the USPS workforce.”
  • Healthcare Dive also discusses hospital pricing information that has been gleaned from the online reports required by the federal government’s hospital pricing transparency rule. It’s not pretty.

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.”

Weekend update

David Ermer–ACA, Congress, COVID-19 vaccine, U.S. Healthcare, Uncategorized–
Photo by JOSHUA COLEMAN on Unsplash

The House of Representatives and the Senate will be engaged in committee and floor work this coming week. Fierce Healthcare reports on healthcare provisions found in the Senate passed American Rescue Plan bill.

Insurers will likely be happy with a temporary boost to income-based subsidies for customers on the Affordable Care Act’s exchanges for 2021 and 2022.

Under current law, anyone making 400% above the federal poverty level are not eligible for subsidies to pay down the cost of insurance.

However, under the legislation, anyone making 400% above the poverty level won’t have to pay more than 8.5% of their income on health insurance.

The bill would also ensure that low-income customers won’t have to pay anything for their coverage.

Currently, those making 150% above the poverty level pay no more than 4.3% of their income on healthcare. But the legislation would make their coverage fully subsidized.

The legislation would also offer premium assistance to cover up to 100% of COBRA costs for eligible individuals and families through the end of September.

Another change in the Senate version from the House concerns the removal of a cap on the Medicaid drug rebate, changing the removal of the cap to 2024 instead of 2023. The removal of the rebate cap, which kicks in at 100% of a drug’s average manufacturing price, will lead to higher rebates for Medicaid drugs.

The Wall Street Journal informs us that

The $1.9 trillion Covid-19 relief bill returns to the House of Representatives this week, where lawmakers will gear up for a vote as soon as Tuesday on the package following narrow approval Saturday by the Senate that came only after concessions to moderate Democrats.

The Senate changes to the bill, which first passed the House Feb. 27 with more generous unemployment provisions, mean House Speaker Nancy Pelosi must hold together her slim majority caucus for a second House vote to send President Biden’s top legislative priority to his desk.

The House is expected to hold a procedural vote on the bill Monday night, with final passage slated for Tuesday. 

Speaking of the Affordable Care Act marketplace, Katie Keith updates on the successful first two weeks of the ongoing marketplace special enrollment period.

In other healthcare news

  • Bloomberg reports on developing approaches to overcome COVID-19 hesitancy. “To do that, officials must make the process of getting shots easier, and fight misinformation about the vaccines, concerns about the speed of development and distrust of government and health-care institutions.” As of today, 23% of the eligible U.S population has received at least one dose of the COVID-19 vaccine. The FEHBlog noticed today that the Johnson & Johnson single dose vaccine is now being administered at the Maryland mass vaccination sites in Baltimore and Waldorf. It strikes the FEHBlog that the single dose vaccine will be more attractive to the hesitant.
  • NPR Shots offers a physician’s take on five types of medical visits that you should stop putting off. “Emerging evidence tells us that the health threats from postponing some tests and exams — including those for cancer and heart disease, but other crucial appointments too — outweigh the risk of running into the coronavirus at a doctor’s visit, even if the virus is prevalent in your community.”

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

Roll Call reports that the Senate continues to move forward its modified version of the American Rescue Plan which the House of Representatives passed last week. Here’s a link to the Congressional Budget Office’s report on the Senate bill.

The Senate Homeland Security and Governmental Affairs Committee held a confirmation hearing today on the President’s nominations of Shalanda D. Young to be Deputy Director, Office of Management and Budget, and Jason S. Miller to be Deputy Director for Management, Office of Management and Budget. Federal News Network sums up the hearing as follows: “President Joe Biden’s picks to serve in top positions at the Office of Management and Budget vowed on Thursday to remove hurdles from federal hiring, improve employee morale and help agencies keep their workforces safe during the pandemic.”

David Leonhardt of the New York Times does a great job putting the three current COVID-19 vaccines in perspective:

It’s the latest case of vaccine alarmism.

Many Americans are worried that Johnson & Johnson’s Covid-19 vaccine is an inferior product that may not be worth getting. Gov. Doug Burgum of North Dakota recently told The Washington Postthat he was now seeing not only “vaccine hesitancy” but also “the potential for brand hesitancy.”

The perception stems from the headline rates of effectiveness of the three vaccines: 72 percent for Johnson & Johnson, compared with 94 percent for Moderna and 95 percent for Pfizer. But those headline rates can be misleading in a few ways.

The most important measure — whether the vaccine prevents serious illness — shows the Johnson & Johnson vaccine to be equally effective as the other two. All work for nearly 100 percent of people. The picture is murkier for mild cases, but they are not particularly worrisome.

In promising news, STAT News reports that

Eli Lilly said Thursday that a study showed its experimental diabetes drug, tirzepatide, reduced patients’ blood sugar and body weight more than a rival medicine, Novo Nordisk’s Ozempic. The study compared three doses of tirzepatide — 5 mg, 10 mg, and 15 mg — to a 1 mg dose of Ozempic. Both drugs were given as injections. Tirzepatide reduced A1C, a measure of blood sugar levels, by 2.09% at the 5-mg dose, 2.37% at the 10-mg dose, and 2.46% at the 15-mg dose. For Ozempic, there was a 1.86% reduction. Patients were followed for 40 weeks.

Patients who received tirzepatide also saw their body weight decline by more than those who received Ozempic. They lost an average of 7.8 kilograms, or 8.5% of their body weight at the lowest dose, 10.3 kg, an 11% decrease, on the middle dose, and 12.4 kg, a 13.1% decrease, on the highest dose. For patients on semaglutide, the decrease in body weight was 6.2 kilograms, or 6.7%.

The differences were all statistically significant.

Lilly plans to virtually present the full trial results at the American Diabetes Association’s annual scientific conference in late June 2021.

In concerning news, the Centers for Disease Control informs us that “a new paper from CDC, in partnership with the University of Utah, estimates that the national healthcare costs associated with infections from six multidrug-resistant pathogens can be substantial at more than $4.6 billion annually.   This is one of the largest studies to estimate the cost associated with high-priority antibiotic-resistant pathogens. Issues highlighted in the study align with data and threats in CDC’s 2019 Antibiotic Resistance (AR) Threats Report. This includes the impact of resistant infections in the community, which can put more people at risk, make spread more difficult to identify and contain, and threaten the progress made to protect patients in healthcare.”  

Finally, Fierce Healthcare lets us know that

Greater liquidity, a stable payer mix and higher-acuity patients helped major hospital chains end 2020 with massive profits despite a financial roller coaster caused by the pandemic.

The latest earnings reports from several for-profit and not-for-profit hospital chains come as patient volumes continue to drift below pre-pandemic levels and as major hospital groups have raised the alarm about financial hardship faced by many hospitals around the country. 

And while plenty of health systems around the country are struggling, experts say many of the largest health systems around the nation have remained profitable.

[However] Rural and more independent and smaller facilities already operate on narrower profit margins which have been exacerbated by the pandemic. These financial headwinds could cause more consolidation among such facilities.

Midweek Update

David Ermer–Congress, COVID-19 vaccine–
Photo by Manasvita S on Unsplash

Roll Call has laid its hands on the Senate’s version of the House’s American Rescue Plan bill and it reports on the differences between the two bills. In the healthcare realm

Another key health care change would fully subsidize health insurance premiums under the federal law known as COBRA for workers who leave their jobs. The House-passed bill and earlier Senate drafts would have required workers to chip in 15 percent of their premiums, while subsidizing the remainder.

Healthcare Dive reports that

The Senate Finance Committee voted along party lines Wednesday morning to send California Attorney General Xavier Becerra’s nomination as HHS secretary to the Senate for a full vote. After a 14-14 tie vote, the nomination will move forward but now requires debate and two floor votes. All Republicans on the committee voted against the nominee, citing his lack of healthcare-specific experience and support for abortion rights. The date for a full vote is not yet set, but Becerra is still likely to be confirmed.

Fierce Healthcare informs us that at yesterday’s House Energy and Commerce Committee hearing on the future of telehealth:

House [Energy and Commerce] health subcommittee chair Rep. Anna Eshoo said  it’s time to make telehealth flexibilities enacted during the COVID-19 pandemic permanent to help close gaps in care.

The Centers for Medicare & Medicaid Services (CMS) waived many telehealth payment policies during the public health emergency, which helped open up access to virtual care. It drove 10.6 million Medicare beneficiaries to use telehealth visits by the end of July, Eshoo said during a Committee on Energy and Commerce health subcommittee hearing.

“The wide adoption of telehealth has been a bright spot during a very dark time in our country,” she said. “For the first time, we’ve had substantiative data on the quality and the use of telehealth at scale.”

America’s Health Insurance Plans and the Blue Cross Blue Shield Association announced today the creation of the Vaccine Community Connectors pilot initiative. Participation in the initiation is open to all health insurers.

[The initiative] aims to enable the vaccination of 2 million seniors age 65+ in America’s most at-risk, vulnerable and underserved communities – such as African American and Hispanic communities. Insurance providers will focus on their members and the communities they serve. They are working to reach this important goal quickly, depending upon the increasing availability of vaccine supply. 

Bravo.

On the federal employment front —

  • Govexec reports on the latest Postal Service reorganization. “The Postal Service now has about 500,000 career employees, down nearly 300,000 from its peak near the turn of the century. USPS has grown its non-career workforce dramatically in that time, which now numbers more than 100,000.”
  • Federal News Network reports that “Far fewer federal employees retired in 2020 compared to previous years, and for some, the pandemic and new telework arrangements have played a prominent role in their decisions to delay and their views about their jobs. A total of 92,008 federal employees retired in 2020, the fewest in nearly 10 years, according to a Federal News Network analysis of monthly data from the Office of Personnel Management. By contrast, OPM processed 101,580 retirements in 2019 and 107,612 in 2018.”

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.

Weekend Update

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

Congress is session this week for committee and floor business. On Tuesday morning the House Energy and Commerce Committee will hold a hearing on “The Future of Telehealth: How COVID-19 is Changing the Delivery of Virtual Care”

The Wall Street Journal reports that

The task of passing a coronavirus relief package now rests with the Senate, where Democrats must grapple with emerging divisions over some components of the plan, including a minimum-wage increase. The House early Saturday morning passed [largely along party lines] President Biden’s $1.9 trillion package, which would fund vaccine distribution, enhance and extend federal unemployment benefits, and send direct checks of $1,400 to many Americans and $350 billion to state and local governments.

As mentioned in last Thursday’s post, the Democrat leadership in Congress is trying to figure out a way for the Senate to pass the entire bill under budget reconciliation which requires all fifty Democrat senators plus the Vice President. The $15 minimum wage provision found in the House bill remains a wild card in the Senate.

The President officially sent Kiran Ahuja’s nomination to be OPM Director to the Senate last Wednesday. Federal News Network forecasts six “challenges” that Ms. Ahuja will need to address once confirmed.

In most excellent news, the Food and Drug Administration gave emergency use authorization to the single dose Johnson and Johnson vaccine yesterday and the Centers for Disease Control seconded this action today. This means that health plans, including FEHB plans, become liable for reimbursing administration costs for the Johnson and Johnson vaccine without member cost sharing in 15 days / March 15, 2021. Per CNN with the blessing of these two agencies

[T]he federal government may then begin distributing the 3.9 million available doses of the vaccine, perhaps as soon as Monday.”I just want to state explicitly how very grateful I am that we now have three highly effective vaccines,” said ACIP member Dr. Matthew Daley of the Institute for Health Research with Kaiser Permanente Colorado.

The company has pledged to have 20 million doses available by the end of March and 100 million doses by summer.The vaccine, made by Johnson & Johnson’s Janssen vaccine arm, can be kept at regular refrigerator temperatures, which experts said would make it much easier to distribute than vaccines made by Moderna and Pfizer/BioNTech.

The Wall Street Journal sums it up for us as follows:

The pandemic has opened a new era for vaccines developed with gene-based technologies, techniques that have long stumped scientists and pharmaceutical companies, suggesting the possibility of future protection against a range of infectious disease.

Johnson & Johnson’s Covid-19 vaccine, which was authorized Saturday for use in the U.S., is at the vanguard of a class of shots designed to mobilize a person’s immune defenses against the disease. It will be the first Covid-19 vaccine administered in the U.S. that uses viral-vector technology, which employs an engineered cold virus to ferry coronavirus-fighting genetic code to the body’s cells.

J&J’s vaccine is the third to be authorized in the U.S. after ones from Pfizer Inc. and its partner, BioNTech SE, and Moderna Inc. In a late-stage trial, J&J’s single-shot vaccine was 66% effective in preventing moderate to severe cases of the disease that has killed more than 500,000 people in the U.S. and about 2.5 million world-wide.

“This is one of those giant leap moments for us. These are fundamental shifts in how we will build vaccines for the future,” said C. Buddy Creech, director of Vanderbilt University’s vaccine research program. “I think this really ushers in a golden age of vaccinology.”

By the way the Centers for Disease Control has created its own COVID-19 vaccine finder website. According to the CDC’s COVID-19 data tracker website, currently nearly 20% of the eligible U.S. population has received at least one dose of the vaccine and 10% have received both doses.

Finally, the Choosing Wisely campaign is offering a information and a webinar that address one of the points in OPM’s recent call letter for 2022 benefit and rate proposals from carriers:

In Building A Better Health Care System Post-Covid-19: Steps for Reducing Low-Value and Wasteful Care, Corinna Sorenson, PhD, Duke-Margolis Center for Health Policy, and colleagues outline the impact of the pandemic on low-value care, and the potential opportunities it presents to create a better health care system post COVID-19. She elaborates further on this topic in her January 2021 Choosing Wisely webinar recording.

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.

President nominates an OPM Director

David Ermer–Congress, COVID-19 vaccine, OPM, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

The Federal Times, Govexec, and Federal News Network all report on today’s announcement that the President is nominating Kiran Ahuja to be OPM Director. Ms. Ahuja led the President’s transition review team lead for the agency. “Ahuja has over 20 years of public service and philanthropy experience. She’s currently the CEO of Philanthropy Northwest, and she spent several years as a career civil rights attorney at the Justice Department.” Her nomination is subject to Senate confirmation. In due course, the President also is expected to nominate an OPM Deputy Director and an OPM Inspector General.

Healthcare Dive reports on the first confirmation hearing for the President’s nominee for Secretary of Health and Human Services, Xavier Becerra. Mr. Becerra “told senators on the health committee Tuesday morning he would continue work he did as California attorney general to combat anticompetitive practices in healthcare and go after providers that ‘unfairly jack up prices on patients.'” According to the report, Mr. “Becerra will be back in the hot seat Wednesday for his second confirmation hearing, this one in front of the Senate Finance Committee. That will be the committee voting on whether to send his nomination to the full Senate for a vote.”

Tomorrow, the Senate Homeland Security and Governmental Affairs Committee at 10 am and the Senate Budget Committee at noon each will hold a business meeting on whether to advance to the Senate floor the President’s nomination of Neera Tanden to be Director of the Office of Management and Budget.

Tomorrow at 10 AM, the House Oversight and Reform Committee will hold a hearing on “Legislative Proposals to Put the Postal Service on Sustainable Financial Footing.” The Committee Staff explains in a memorandum,

the Committee will hold a hybrid hearing to review legislative proposals to place the Postal Service on a more sustainable financial footing. The Committee will consider a discussion draft that includes several provisions to relieve the financial burdens under which the Postal Service is currently operating and to enhance transparency regarding performance. That draft is being circulated with this memo. The discussion draft includes provisions on Medicare integration [for Postal annuitants participating along with Postal employees in a separate program within the FEHB] , repealing a requirement for the Postal Service to pre-fund retiree health care, and service performance standards.”

Earlier today, the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee held a hearing on the availability of COVID-19 vaccinations. The hearing featured testimony from executives at the companies manufacturing those vaccines. Fierce Healthcare reports that “Pfizer, Moderna and Johnson & Johnson execs say [at the hearing] they’re working all the angles on increasing COVID-19 vaccine production and expect to amp up weekly deliveries by tens of millions by the end of March.”  

In that regard, a friend of the FEHBlog pointed him to this NIH Director’s blog entry released today

For the millions of Americans now eligible to receive the Pfizer or Moderna COVID-19 vaccines, it’s recommended that everyone get two shots. The first dose of these mRNA vaccines trains the immune system to recognize and attack the spike protein on the surface of SARS-CoV-2, the virus that causes COVID-19. The second dose, administered a few weeks later, boosts antibody levels to afford even better protection. People who’ve recovered from COVID-19 also should definitely get vaccinated to maximize protection against possible re-infection. But, because they already have some natural immunity, would just one shot do the trick? Or do they still need two?

A small, NIH-supported study, published as a pre-print on medRxiv, offers some early data on this important question [1]. The findings show that immune response to the first vaccine dose in a person who’s already had COVID-19 is equal to, or in some cases better, than the response to the second dose in a person who hasn’t had COVID-19. While much more research is needed—and I am definitely not suggesting a change in the current recommendations right now—the results raise the possibility that one dose might be enough for someone who’s been infected with SARS-CoV-2 and already generated antibodies against the virus.

Encouraging news.

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.