Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

From the political front, Politico reports that

[Senator] Joe Manchin (D WV) remains at the negotiating table [with his party’s leadership], despite deep concerns about President Joe Biden’s climate and social spending bill [a/k/a the Build Back Better Act]. 

After speaking with Biden on Monday afternoon, Manchin said he was still “engaged” in discussions. And as he left the Capitol, the key Democratic senator made clear he wasn’t ready to commit to voting for or against a bill that is still coming together behind closed doors.

From the White House, the President issued an executive order on improving customer service performed by government agencies. Federal News Network explains that

Jason Miller, the Office of Management and Budget’s deputy director for management, said the EO also directs agencies to coordinate work on services that reflect common life experiences, including turning 65 and planning retirement, having a child or applying for a small business loan. * * *

The executive order gives senior administration officials 90 days to select a limited number of these customer life experiences to prioritize across government. It requires Miller and other members of the President’s Management Council to update [Presidential senior advisor Neera] Tanden and White House Chief of Staff Ron Klain on progress made improving these customer life experiences every six months.

The EO also gives the General Services Administration six months to develop a roadmap of shared services that agencies can use to improve customer experience.

The administration specifically names Login.gov and the U.S. Web Design System, a set of templates meant to create a common look and feel for agency websites, as tools that all agencies should use to improve federal customer experience.

Here is a link to the White House’s press release on the Executive Order as found on performance.gov.

From the Affordable Care Act front, the Internal Revenue Services has released the final Affordable Care Act coverage reporting forms, 1095-B and 1095-C, along with the final instructions for those forms.

From the Office of Information and Regulatory Affairs’ website, we find that the federal government’s Fall 2021 regulatory agenda has been published. Here is a link to OPM’s Fall 2021 agency rule list. A chill went up the FEHBlog’s spine when he noticed that the ACA provider non-discrimination proposed rule mandated by the No Surprises Act will be published this month due to a statutory requirement. Cost curve up?

From the employer sponsored care front, Healthcare Dive reports that

— The average per-employee cost of employer-sponsored health insurance jumped 6.3% in 2021, as employees and their families resumed care delayed last year due to the pandemic, according to a new survey of employers from Mercer.

— That’s the highest annual increase since 2010. Health benefit costs outpaced growth in inflation and worker compensation through September, the employee healthcare and investment consultancy said.

— The findings raise questions of whether employers are experiencing a temporary correction to the cost trend following a minimal year-over-year increase of just 3.4% in 2020, or if they’re staring down the barrel of a new period of higher cost growth.

No doubt those questions can keep actuaries awake at night.

From the good COVID news department (yes it exists), STAT News informs us that

Paxlovid, Pfizer’s oral treatment for Covid-19, led to an 89% reduction in hospitalization and death in final data from a pivotal trial, the company said today, confirming the results of an earlier analysis.

The news should allay concerns that the efficacy of Pfizer’s pill would wane over time. Molnupiravir, a Covid-19 antiviral from Merck, appeared 50% effective in an interim trial analysis but fell to about 30% in the final tally. Both studies enrolled unvaccinated patients who were recently diagnosed with Covid-19 and had at least one risk factor for severe disease.

The next step for Pfizer is submitting the results to the FDA, which the company expects to do this month, and applying for an emergency-use authorization. The agency is yet to disclose whether it will convene a panel of expert advisers before deciding on Paxlovid.

Based on the President’s winter is coming plan, the FEHBlog’s bet is on the FDA approving the Pfizer drug without delay.

Weekend Update

Congress will remain in session for Committee business and floor voting.

The focus of attention will be the President’s Build Back Better Act. The Senate Finance Committee released the text of its portion of the Senate version of the BBB Act yesterday. The Wall Street Journal explains that

President Biden this week will lobby Sen. Joe Manchin, the centrist West Virginia Democrat, in an attempt to lock in a deal on a roughly $2 trillion social-policy and climate bill that Democrats hope to finish by Christmas.

Passage hinges largely on the support of Mr. Manchin, who hasn’t endorsed the legislation. He has repeatedly raised concerns about the cost of the bill and the potential effect of new government spending on inflation. Messrs. Biden and Manchin plan to talk early this week, a Senate aide said.

Senator Manchin’s vote is critical because the Democrat’s can’t lose one vote in the evenly divided Senate as the Republicans in the Senate all intend to vote against the bill. The Journal adds

With Democrats holding the narrowest congressional majority in decades, passing the sweeping bill is akin to threading yarn through a tiny needle. Democrats already navigated past opposition from Arizona Democratic Sen. Kyrsten Sinema on several of the tax increases they originally had proposed, making revenue-generation intended to pay for the legislation difficult.

Ms. Sinema hasn’t endorsed the House-passed bill. Democrats have also needed to write a bill that lawmakers from the party’s most progressive wing would support, along with centrists.

Because the Senate bill will not mirror the already passed House bill, the two Houses of Congress might convene a conference committee. Time will tell.

Tomorrow is the last day of the current Federal Benefits Open Season. OPM explains that

The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 13, 2021 for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) ends at 11:59 pm, in the location of your electronic enrollment system, on Monday December 13, 2021.

From the No Surprises Act front, the Kaiser Family Foundation offers a consumer friendly overview of the law’s provisions that take effect on January 1, 2021. Basically, FEHB plans will pay certain out-of-network (“OON”) providers (emergency care, air ambulance, and OON providers when the patient is treated at an in-network facility) a qualifying payment amount (“QPA”), net of the in-network cost sharing amount which is the member’s financial responsibility. If the provider is dissatisfied with the QPA, he or she must work out the matter with the health plan. The member therefore is held harmless against the outcome of that controversy.

These QPA provisions, however, are inapplicable to claims submitted for FEHB plan members who have primary Medicare coverage or in the case of fee for service plans have primary Medicare Part A only. Also if another payer is primary to the FEHB plan, e.g., a spouse’s plan, then the primary plan is responsible for compliance with the No Surprises Act. The FEHB plan is responsible only for making the secondary payment, which usually equals the primary plan’s deductibles and co-insurance.

From the health care business front, Medcity News informs us that

After a challenging quarter, insurance company Bright Health is raising $750 million in financing. In an unusual move, another insurance company is joining as an investor. Cigna Ventures and Bright’s largest shareholder, New Enterprise Associates, both participated in the financing.

Head of Cigna Ventures Tom Richards talked about potential opportunities to collaborate with NeueHealth, Bright’s provider enablement platform to help practices move to value-based contracts.

“We seek to be partners of choice and we look forward to exploring new ways that NeueHealth and Evernorth can potentially provide services to each other’s customers and clients,” he said in a news release.

From the Omicron front, Bloomberg reports (recall last week’s post about U.S. experts tracking the U.K.’s experience with Omicron because the United Kingdom started to experience Omicron cases before the U.S.):

Prime Minister Boris Johnson warned the U.K. is facing a “tidal wave” of omicron infections and set an end-of-year deadline for the country’s booster vaccination program. Infections in the U.K. from the new variant doubled in the last day and now make up a third of new cases in London. 

Anthony Fauci, U.S. President Joe Biden’s chief medical adviser, said omicron appears able to evade vaccines and some Covid-19 treatments but that a booster shot can increase protection. At least 30 U.S. states are reporting cases of the variant.  

CNBC adds that “Covid booster shots are “optimal care” as the deadly virus continues to mutate and spread, but the U.S. government is staying firm for the time being on the definition of fully vaccinated, top U.S. infectious disease expert Dr. Anthony Fauci said Sunday.”

Friday Stats and More

Based on the Centers for Disease Control’s COVID data tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new COVID cases for 2021:

STAT News reports today that Omicron may give Delta a run for its money.

As the Omicron variant snowballs in South Africa and widens its inroads in Europe, evidence is mounting that it can outcompete the highly transmissible Delta variant — a potential warning signal for the United States.

The Wall Street Journal adds that

The U.K. is emerging as a testing ground in the battle for dominance between the new Omicron variant of the coronavirus and Delta, the earlier strain that is currently driving most infections in the U.S. and Europe.

How Britain fares against Omicron will offer clues to the U.S. and the rest of the industrialized world about how the variant behaves in a highly vaccinated population, how sick those who are infected get and if its dozens of mutations have given Omicron enough of an advantage on the evolutionary ladder to starve Delta of the hosts it needs to stay on top.

The CDC’s weekly new COVID hospitalizations chart up week to week from 6.500 to 7,500 which is 54% below the number of new hospitalizations in January 2020. The Wall Street Journal adds that

As the pandemic heads into its third year, doctors are screening more effectively for these clots and improving treatment regimens, marking a significant medical advance alongside the vaccines and antiviral pills under review for Covid-19 that get the most attention.

Even before test results come in, doctors may sometimes treat patients with a high dose of anticoagulants if they suspect blood clots, often termed thrombosis, said Michael Streiff, a clot specialist at Johns Hopkins University.

“The incidence of thrombosis was very high in the beginning but has declined over time. I think this is due to better supportive care,” Dr. Streiff said.

Still, some doctors say there’s much to be done to improve outcomes further. Recent studies are helping to define more precise treatment protocols for clots.

Here’s the FEHBlog weekly chart of new COVID deaths for 2021:

The Wall Street Journal notes that

The Omicron variant of Covid-19 has so far caused mostly mild cases of Covid-19 in a small group of largely vaccinated people in the U.S., federal data show.

Among at least 43 people infected with the variant in 25 states in recent days, there has been one hospitalization and no deaths so far, the Centers for Disease Control and Prevention said Friday.

Out of 43 cases identified between Dec. 1 and Dec. 8, nearly 80% of the people infected with Omicron were fully vaccinated, according to CDC data, and one-third had received a booster shot. Fourteen percent of the people had a previous Covid-19 infection. Patients most commonly reported mild symptoms like cough, fatigue, congestion or runny nose, the CDC said. Nearly 60% of cases were in people 18 to 39 years old.

The report is an early piece of the picture scientists are working to assemble on Omicron’s infectiousness and virulencerelative to other variants.

Here’s the FEHBlog’s weekly chart of new COVID vaccinations administered and distributed from the 51st week of 2020 through the 49th week of 2021:

This past week was the first week since June 2021 that administered vaccinations topped 10 million. Slightly over 50% of the U.S. population over 65 is boostered according to the CDC.

Here is a link to the CDC’s weekly interpretation of its COVID statistics which urges all Americans aged 16 and older to get boostered.

From the flu front, the CDC reports that seasonal flu activity remains low but continues to increase. The CDC encourages Americans to fight the flu by getting vaccinated, engage in preventative measures, and take flu antiviral drugs if your doctor prescribes them. We are about a month away from the CDC giving the same advice about COVID.

From the Capitol Hill front, FedWeek informs us that

Congress is moving toward passing a compromise version of the annual DoD authorization bill (S-1605) containing a number of provisions affecting personnel policies government-wide, including two new weeks of paid leave for federal employees on the death of a son or daughter.

The new “parental bereavement leave” replaces a House provision that would have expanded the authority for federal employees to take paid time rather than unpaid time for parental purposes covered by the Family and Medical Leave Act. The Senate version had not included any provision on parental leave.

The compromise provision uses the same definitions for children as under the FMLA; rules likely will be needed to define the policy, including the effective date.

The bill also: extends long-running authorities for all agencies to pay certain special allowances to employees working in areas of active military operations; requires OPM to perform a study of allowances for employees working in remote areas; and orders OPM to establish or update occupational series in the fields of software development, software engineering, data science, and data management.

However, the final version drops House language to require OPM to redefine locality pay areas for wage grade employees so that they align with the areas used for the GS system. Currently, in some cases wage grade employees receive smaller raises than GS employees at the same location. The bill however encourages OPM to address that issue. 

From the judicial front

  • The Society for Human Resource Management brings us up to date on oral arguments before the U.S. Supreme Court this week on human resources and employee benefit issues.
  • The Coalition against Surprise Billing blasted the American Medical Association and the American Hospital Association for bringing a lawsuit against the independent dispute resolution regulations under the No Surprises Act.

From the healthcare business front —

New York-based Hydrogen Health, a joint venture between Anthem, investment firm Blackstone and digital primary care company K Health, is launching its virtual primary care offerings nationwide, the provider announced Dec. 9. 

Anthem and its partners formed Hydrogen Health in April 2021 to leverage artificial intelligence to drive down healthcare costs in both employer and consumer markets. The joint venture offers employers and insurers text and video-based digital primary care, and taps K Health’s artificial intelligence to personalize that care. 

Hydrogen Health shared that since its initial launch with Anthem, its customers now include multiple Fortune 500 companies and other large employers. 

Moving into 2022, the plan anticipates it will expand the conditions it can diagnose and manage and grow its membership by 10 million — all digitally, according to the announcement. 

  • Healthcare Dive reports that on CVS Health’s investors day held yesterday.

— CVS Health plans to ramp up its acquisitions of physician practices and clinics as it continues to pursue its primary care strategy and races with other retail pharmacies to build out medical networks.

— The Woonsocket, Rhode Island-based healthcare behemoth already operates a network of MinuteClinics, urgent care locations staffed by nurse practitioners. But CVS wants to broaden its care delivery strategy into a primary care model, including “physician-led primary care centers with integrated virtual and home assets,” CVS EVP and president of pharmacy services Alan Lotvin said Thursday at CVS’ investor day.

— CVS plans to add a few hundred primary care centers to its network of MinuteClinics, drugstores and health-focused HealthHUB locations launched a few years ago, as it moves from an episodic to more longitudinal approach to care, Lotvin said. CVS also wants to eventually add more specialty services to compete as the retail healthcare market becomes increasingly saturated.

From the benefit design front, Health Payer Intelligence informs us that “Employing personalized, in-home chronic disease management services can have a significant impact on spending for seniors with chronic conditions, a study from Avalere found.”

Patients with quadriplegia saw the highest healthcare spending difference in total cost of care after receiving home healthcare. The group that received the home healthcare solution spent $12,807. In contrast, the group that did not receive in-home chronic disease management support spent nearly $30,000 more, with average spending of $42,709.

The condition that ranked lowest in the top ten chronic conditions was intestinal obstruction or perforation. But even for this condition, patients with the intervention spent on average $17,738 less than their counterparts.

Despite the major differences in total cost of care between the two groups, the group that received the targeted home healthcare intervention did not display drastic differences between healthcare spending levels before and after implementing the intervention.

Thursday Miscellany

Photo by Clarisse Meyer on Unsplash

From the Capitol Hill front, Roll Call reports that

The Senate broke a logjam over the statutory debt limit Thursday, clearing a measure that would allow Democrats to increase the nation’s borrowing capacity on their own without any Republican assistance necessary.

On a 59-35 vote, the Senate sent President Joe Biden a bill granting a one-time exemption to Senate rules so that a debt ceiling increase can go straight to final passage on a simple majority vote, rather than first having to clear a 60-vote procedural hurdle. 

Passage of the fast-track process legislation effectively ends weeks of partisan brinkmanship over whether and how to raise the statutory debt limit. Without congressional relief, the government may be unable to meet all its financial obligations after Dec. 15, Treasury Secretary Janet L. Yellen has warned.

Democrats have yet to release the bill that will actually raise the debt limit, though Senate Majority Leader Charles E. Schumer and Speaker Nancy Pelosi hope to clear that measure before Wednesday to meet Yellen’s deadline.

The legislation heading to the White House also would delay Medicare cuts that would otherwise be triggered Jan. 1, including across-the-board reductions to provider reimbursements as well as separate cuts to physician and laboratory services payments. It would temporarily waive statutory pay-as-you-go rules that would require steeper Medicare cuts next year as well as major reductions in farm price supports and a host of other federal benefits.

So Congress will remain in session next week.

Govexec adds that “The House on Thursday approved a package of reforms to add new protections to federal civil servants, further empower agency watchdogs and limit who can lead federal offices on a temporary basis.” The bill now heads over to the Senate.

From the COVID vaccine front, AHIP informs us that

The U.S. Food and Drug Administration (FDA) today authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for 16- and 17-year-olds. Eligible teens will be able to get the shot once they are at least six months past their second dose.

New data from Israel published this week showed that a Pfizer booster increased immunity among citizens 16 and older, and though the study focused on the Delta variant, Pfizer announced this week that a third dose can help fight the Omicron variant.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) are not expected to meet to develop new clinical recommendations for teen boosters, according to a report from Politico.

From the COVID vaccine mandate front, Federal News Network tells us that

The Biden administration offered more details Thursday for federal contractors tracking the multiple legal challenges to the president’s vaccine mandate, while reporting a slight increase in the number of executive branch employees who have complied with their agency’s own requirements.

Agencies will not enforce the provisions of the president’s federal contractor vaccine mandate while a nationwide preliminary injunction is in place, the Biden administration said.

Specifically, the government won’t enforce those clauses embedded in existing contracts where the work is performed inside the United States or an outlying area and is subject to a recent court order, according to a brief update to the Safer Federal Workforce Task Force issued Thursday.

the Wall Street Journal adds that

General Electric Co., Union Pacific Corp. and other large employers have suspended Covid-19 vaccine requirements for workers after a U.S. court ruling blocked the Biden administration’s plan to mandate vaccines for federal contractors.

A federal judge on Tuesday issued a nationwide preliminary injunction after concluding that federal procurement law didn’t give the administration the clear authority to impose the vaccine rules for contractors. Lawyers for the federal government filed a notice of appeal Thursday.

The court’s injunction applies to the federal government, including OPM, not to the government contractors. The government contractors therefore are free to choose whether or not to continue with their vaccine mandate programs while government enforcement of the program is enjoined. This news nevertheless suggests that the squeeze may not be worth the fallout.

From the No Surprises Act front, the American Hospital Association announced that

The American Hospital Association (AHA) and American Medical Association (AMA), representing hospitals, health systems, and physicians, sued the federal government today over the misguided implementation of the federal surprise billing law. The associations are joined in the suit by plaintiffs including Renown Health, UMass Memorial Health and two physicians based in North Carolina. 

The complaint was filed in the U.S. District Court for the District of Columbia. The plaintiffs also have moved for a preliminary injunction or a summary judgment.

The provider groups are freaking out over the regulator’s decision to use the plan’s payment in No Surprises Act situations, known as the qualifying payment amount, as the lodestar for baseball arbitration purposes in the No Surprises Act independent dispute resolution process. The QPA is based on the health plan network’s median payment as of January 2019 adjusted for inflation and regional differences. The QPA should be similar to what plans pay in-network providers which always has been materially more than the out-of-network rate which usually is based on Medicare’s fee schedule. Paying the out of network providers more than the in-network doctors under the No Surprises Act would disrupt health plan networks. The rule’s lodestar use of the QPA is perfectly reasonable.

From the miscellany department –

  • Beckers Payer Issues reports that “CMS is continuing to use discretion on enforcing payer data exchange guidelines introduced in a May 2020 interoperability rule, HHS stated in a Dec. 7 notice.  * * * “We are now announcing that we expect to extend this exercise of enforcement discretion of the payer-to-payer data exchange requirement until we are able to address the identified implementation challenges through future rulemaking,” the notice stated. “We anticipate providing an update on any evaluation of this enforcement discretion notification and related actions during calendar year 2022.” This is one of the 21st Century Cures Act’s three interoperability initiatives for HHS regulated health plans.
  • “Health and Human Services Secretary Xavier Becerra today announced that Lawrence A. Tabak, D.D.S., Ph.D., the principal deputy director of the National Institutes of Health (NIH), will serve as the acting director of NIH effective December 20, 2021.”

President Joe Biden selected 230 federal leaders to receive a Presidential Rank Award in 2021, nearly double the usual number of employees recognized.

The Presidential Rank Awards are one of the most prestigious civil service recognitions and come with a 35% of base salary award for Distinguished Rank recipients, who have demonstrated sustained, extraordinary career accomplishments, and a 20% award for Meritorious Rank recipients, who have demonstrated sustained accomplishments.

Congratulations to the recipients.

Midweek Update

From the Omicron front, and as a public service, the FEHBlog notes this Wall Street Journal A-hed article from yesterday explaining the proper pronunciation of Omicron:

“There isn’t one way of saying Omicron,” said Armand D’Angour, professor of classical languages and literature at the University of Oxford. “First of all, you know, we’re not there, we haven’t recorded it.”

Egbert Bakker, professor of ancient Greek at Yale University, says the letter is pronounced “AWE-mee-kron” in both modern and ancient Greek. But he is open to other forms: “Some people would say ‘oh-MIKE-ron,’ that is the Americanized way. I wouldn’t do it but I don’t think it’s completely unacceptable.”

Isn’t Egbert a perfect name for an Ivy League professor of foreign languages?

Also, the Wall Street Journal reports that

Pfizer Inc. and BioNTech SE  said that a third dose of their Covid-19 vaccine neutralized the Omicron variant in lab tests but that the two-dose regimen was significantly less effective at blocking the virus.

A third dose increased antibodies 25-fold compared with two doses against the Omicron variant, the companies said. Still, two doses may prove effective in preventing severe illness from Covid-19, they said, because immune cells are able to recognize 80% of parts of the spike protein that the vaccine targets.

The results were issued in a press release by the companies, and weren’t peer reviewed and published in a scientific journal.

As of today, just over 200 million Americans are fully vaccinated against COVID according the CDC. Next Tuesday December 14 will mark the first anniversary of COVID vaccinations outside of trials in the U.S.

From the Federal Benefits Open Season front, FedWeek reminds us that

December 13 is the last day of the current open season for electing or changing coverage in FEHB and FEDVIP for the 2022 plan (calendar) year of each program.

If current enrollees make no changes, they will retain the same coverage next year, subject to new premium rates and coverage terms. In practice, only single-digit percentages change plans, levels of coverage within plans that have more than one, or type of enrollment (between family coverage and self plus one, for example).

In contrast to the FEHB and FEDVIP programs, a new enrollment is required each year for those who want a health care flexible spending account, a dependent care account, or both in the following year. The dependent care maximum remains $5,000 while the health care maximum is rising $2,850.

OPM encourages FEHB plan enrollees to use its online FEHB and FEDVIP Plan comparison tools.

From the telehealth front —

Healthcare Dive reports that

— COVID-19 was no longer among the top five telehealth diagnoses nationwide in September, though use of virtual care rose overall, according to new data from nonprofit Fair Health.

— In August, COVID-19 was among the top five diagnoses nationally and in every U.S. census region except the Northeast. In September, the only region where the it ranked in the top five was the Midwest.

— However, national telehealth use (measured as a percentage of all medical claim lines) rose more than 2% in September for the second straight month as the delta variant gained a foothold in the U.S. following a sustained period of decline early this year.

Kaiser Health News discusses the provider push for expanded coverage of audio-telehealth services.

From the benefit design front, Health Payer Intelligence tells us that

UnitedHealthcare has launched a new employer-sponsored health plan for Arizona residents that seeks to prioritize customer support experiences and lower member premiums.

The Doctors Plan of Arizona is the result of a partnership between the payer and the accountable care organization (ACO) Banner Health Network. The plan will serve Maricopa and Pinal County residents who receive employer-sponsored health coverage.

Banner Health Network frequently partners with health plans and providers to increase access to affordable care, the press release noted. The ACO’s network includes primary and specialty care physicians.

Through the Doctors Plan of Arizona, members will gain access to Banner Health’s network of more than 5,000 physicians and 15 medical centers.

Additionally, the plan will offer members a chance to potentially save up to 15 percent on premiums compared to other traditional health plans. The plan will also offer zero-dollar copays for primary care and urgent care visits, around-the-clock access to telehealth visits, and care coordination from the member’s primary care provider.

UnitedHealthcare will work to improve the customer experience with a personalized concierge approach. The payer’s Doctors Plan of Arizona will include a customer service team that has access to patient data from the provider and the health plan, allowing for more streamlined coordination, the press release stated.

The FEHBlog’s love affair with the ACO concept has not abated.

Health Payer Intelligence also discusses nutritional benefits.

Payers face a variety of challenges in expanding nutritional benefits, particularly due to the lack of ability to measure outcomes, but there are ways to navigate this uncertainty, according to a report from McKinsey & Company (McKinsey).

Among American adults who have at least one chronic condition, 60 percent also have poor nutrition, the report noted. This social determinant of health tends to occur hand-in-hand with some of the most expensive conditions in the US such as hypertension, obesity, and diabetes.

Check out the McKinsey report and the article for nutritional benefit tips.

Finally the Internal Revenue Service today released its draft Fringe Benefits Tax Guide for 2022 which may come in handy for 2022 budgeting purposes.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports that

The House and Senate are moving swiftly toward passing legislation introduced Tuesday that would limit Senate debate on debt limit legislation to 10 hours, creating a loophole in that chamber’s 60-vote legislative filibuster rules.in his Morning’s column in the New York Times andor a vote Tuesday night, Speaker Nancy Pelosi wrote in a letter to lawmakers, along with a revised fiscal 2022 defense policy bill that would be sent to the Senate separately.

The two legislative vehicles are unrelated bills that previously passed both chambers with amendments; using them to carry the budget and defense measures allows Senate leaders to avoid a time-consuming motion to proceed in that chamber. Instead, only one cloture vote per bill would be needed. 

Senate Minority Leader Mitch McConnell, who briefed his caucus at lunch on Tuesday, blessed the arrangement in comments to reporters. He said the new debt limit measure could pass as early as Thursday, after the Senate clears the bill to create an expedited process.

“I’m confident that this particular procedure coupled with the avoidance of Medicare cuts will achieve enough Republican support to clear the 60 vote threshold,” McConnell said.

If Congress accomplishes all of these actions, it may just call it quits at the end of this week which was the original schedule. A delay in Medicare cuts is extremely important to the medical facility and provider professional associations.

On the COVID vaccine mandate front, a federal district judge in Georgia today ordered a nationwide preliminary injunction against enforcement of the federal government contractor mandate per Govexec which adds

The Biden administration’s vaccine rule for private businesses and vaccine mandate for Medicare- and Medicaid-certified providers and suppliers are also temporarily blocked by courts. So far, the vaccine mandate for federal employees has not been stopped.

This PI applies to all FEHB plan contractors and subcontractors.

From the Delta variant front, David Leonhardt who is the FEHBlog’s go-to COVID columnists recommends in his Morning column in the New York Times today

For now, vaccinated people can reasonably continue to behave as they were — but many should feel urgency about getting booster shots. Older people and others who are vulnerable, like people receiving cancer treatment, should continue to be careful and ask people around them to test frequently.

Unvaccinated people remain at substantial risk of serious illness. About 1,000 Americans have been dying each day of Covid in recent weeks, the vast majority of them unvaccinated.

Look up case and deaths counts for your county here.

From the Rx coverage front, Drug Channels released its

annual deep dive into employer-sponsored coverage for prescription drugs. 

For 2021, employers backed away slightly from high-deductible health plans. However, their pharmacy benefit designs increased the use of coinsurance for specialty and fourth-tier drugs. These designs have significantly raised patients’ out-of-pocket obligations and are likely to have reduced adherence. 

Manufacturers’ patient support funds help offset patients’ higher expenses. But employer plans are rapidly adopting copay accumulators, which allow payers and PBMs to absorb these funds. 

From the health benefits trends front, the Society for Human Resource Management informs us that

Three-quarters of health insurers say that managing a health plan’s network of care providers is critical to controlling rising medical costs.

The finding is from consultancy Willis Towers Watson’s 2022 Global Medical Trends Survey, conducted from July through September 2021 among 209 leading insurers globally.

The plan features mostly likely to keep costs under control, insuers said, were:

— Contracting with high-quality, cost-competitive doctors and hospitals for in-network coverage (cited by 75 percent of respondents).

— Requiring preapproval for scheduled inpatient services (67 percent).

— Offering telehealth services (63 percent).

Telehealth or virtual care rose to the third spot from the fifth position last year, “a sign that more insurers see potential savings from remote options for diagnosing and treating patients,” according to the report.

Yesterday was the deadline for submitting public comments on the the second No Surprises Act interim final rule, which concerns the independent dispute resolution process. For a ying and yang take on the comments, here are links to American Hospital Association’s comments and to AHIP’s comments.

Let’s wrap it up with a bunch of HHS tidbits

  • HHS today announced its plan to “propose a national “Birthing-Friendly” hospital designation on the Hospital Compare section of the CMS Care Compare website, and also encourages states to provide 12 months postpartum coverage to people with Medicaid and CHIP.”
  • The National Institutes of Health reported that “Researchers identified brain cells that help suppress hunger and regulate food intake” and that “The findings may help lead to better treatments for excessive eating and obesity.”
  • NIH also announced “The winners of the National Institutes of Health’s Decoding Maternal Morbidity Data Challenge were announced today in conjunction with the White House “day of action” on maternal health. Twelve prizes were awarded to seven winners who proposed innovative solutions to identify risk factors in first-time pregnancies. Without a prior pregnancy for comparison, it is difficult to identify risks for adverse pregnancy outcomes. Early detection of these risks can help reduce pregnancy complications and prevent maternal deaths.”
  • The Agency for Healthcare Quality and Researched released

A final report on strategies to improve patient safety and reduce medical errors has been delivered to Congress by the U.S. Department of Health and Human Services in consultation with AHRQ. Required by the Patient Safety Act of 2005, the report was made available for public review and comment and review by the National Academy of Medicine. It outlined several strategies to accelerate progress in improving patient safety, including using analytic approaches in patient safety research, measurement, and practice improvement to monitor risk; implementing evidence-based practices into real-world settings through clinically useful tools and infrastructure; encouraging the development of learning health systems that integrate continuous learning and improvement in day-to-day operations; and encouraging the use of patient safety strategies outlined in the National Action Plan by the National Steering Committee for Patient Safety. 

Access the final report, “Strategies to Improve Patient Safety: Final Report to Congress Required by the Patient Safety and Quality Improvement Act of 2005” (PDF, 1.16 MB).

  • The Centers for Disease Control “announced today that it has awarded $22 million to nearly 30 organizations around the world to combat antimicrobial resistance (AR) and other healthcare threats through the establishment of two new networks—the Global Action in Healthcare Network (GAIHN) and the Global AR Laboratory and Response Network (Global AR Lab & Response Network).”

Citing mounting evidence of ongoing harm, U.S. Surgeon General Vivek H. Murthy on Tuesday issued a public health advisory on the mental health challenges confronting youth, a rare warning and call to action to address what he called an emerging crisis exacerbated by pandemic hardships.

Symptoms of depression and anxiety have doubled during the pandemic, with 25% of youth experiencing depressive symptoms and 20% experiencing anxiety symptoms, according to Murthy’s 53-page advisory. There also appear to be increases in negative emotions or behaviors such as impulsivity and irritability — associated with conditions such as attention deficit hyperactivity disorder or ADHD.

And, in early 2021, emergency department visits in the United States for suspected suicide attempts were 51% higher for adolescent girls and 4% higher for adolescent boys compared to the same time period in early 2019, according to research cited in the advisory.

Monday Roundup

Photo by Sven Read on Unsplash

From Capitol Hill, Roll Call discusses the Senate Parliamentarian’s role in refereeing budget reconciliation bills like the Build Back Better Act.

Senate committees have been updating the House-passed $2.2 trillion climate and social spending package text to ensure it complies with budget reconciliation rules, but most have yet to begin the formal review process with the Senate parliamentarian known as “the Byrd bath.”

Majority Leader Charles E. Schumer sent a “Dear Colleague” letter on Monday reiterating his goal to pass the legislation in the Senate before Christmas. But the update he provided on the procedural steps needed to get there suggests senators will be lucky if they can meet that deadline. 

Schumer said Senate committees are continuing informal conversations with Senate Parliamentarian Elizabeth MacDonough about their pieces of the package and “making necessary technical and ‘Byrd proofing’ edits to the House bill.” The Byrd rule requires any policy changes made through reconciliation to have more than a “merely incidental” impact on the budget, among other restrictions.

From the COVID vaccine front, Medscape informs us that

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI(cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

“This study supports what we’ve been seeing. People identified and treated early and appropriately for the rare complication of COVID-19 vaccine-related myocarditis typically experienced only mild cases and short recovery times,” American Heart Association (AHA) President Donald M. Lloyd-Jones, MD, said in a podcast.

“Overwhelmingly, the data continue to indicate the benefits of COVID-19 vaccine far outweigh any very rare risks of adverse events from the vaccine, including myocarditis,” Lloyd-Jones added.

and that

The U.S. Food and Drug Administration on Friday authorized the use of Eli Lilly’s COVID-19 dual-antibody therapy in treating mild to moderate symptoms in all children, including newborns, who are at risk of severe illness.

The therapy, bamlanivimab plus etesevimab, was previously authorized for children aged 12 years and older and weighed at least 88 pounds.

“Children under one year of age, who are exposed to the virus that causes COVID-19, may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

The FDA authorization also allows the administration of the therapy as a preventive measure in children who are exposed to the virus.

Per STAT News

People who received the Pfizer (PFE)-BioNTech (BNTX) vaccines may get as much benefit from a Johnson & Johnson (JNJ) booster shot as a Pfizer one, The New York Times explains, citing the findings of a small study released on Sunday. Researchers at Beth Israel Deaconess Medical Center in Boston studied 65 people who had received two shots of the Pfizer vaccine. Six months after the second dose, the researchers gave 24 of the volunteers a third dose of the Pfizer vaccine and gave 41 the Johnson & Johnson shot. The study was funded in part by Johnson & Johnson and has not yet been published in a scientific journal.

As of today according to the Centers for Disease Control, 60% of the U.S. population is fully vaccinated and 25% of the U.S. population over age 18 has had a booster.

From the Delta variant testing front

  • The American Medical Association reviews the different COVID tests that are available in our country. The article warns that the at home tests must be performed correctly. This will be useful information to share with health plan members.
  • A friend of the FEHBlog pointed out this HHS website that lists low or or no COVID cost testing facilities in each of the states and DC. Another friend of the FEHBlog informed him that local public libraries in the Washington DC area offer at home rapid COVID tests like Binax to their visitors at no cost. The FEHBlog learned long ago that when a health plan is asked to provide a service or supply that it typically does not cover, like over the counter drugs or tests, you typically can find a government resource to fill the gap. To soften the financial blow of the the President’s unexpected mandate that health plans cover the cost of at home rapid COVID tests, health plans also should consider educating members about community resources.

Speaking of which, Health Payer Intelligence reports on payer efforts to fund various community resources to address the social determinants of health, a thoughtful idea particularly at the holiday season.

Midweek Update

From Capitol Hill, The Wall Street Journal reports that

Lawmakers worked Wednesday to reach an agreement on a short-term spending patch to avoid a potential partial government shutdown this weekend, with Democrats and Republicans still haggling over the details of the funding extension.

Party leaders had initially hoped to release an agreement earlier this week. Democrats have eyed a spending patch that would last until mid-or-late-January, while Republicans have pushed for a longer extension.

With just days until the government runs out of current funding at 12:01 a.m. on Saturday, Dec. 4, lawmakers will need to act quickly to pass the eventual agreement through the House and Senate. Meeting that tight timeline would require unanimous consent in the Senate to waive some of the chamber’s procedural hurdles, and any individual senator can slow down the process.

The article points out that Congressional leadership from both parties expects a continuing resolution to pass without a government shutdown. Of course we know from past experience that because the funding runs out on a Saturday, Congress has some additional time to complete work on the continuing resolution over the weekend if necessary.

From the Delta variant front the Centers for Disease Control announced today that

The California and San Francisco Departments of Public Health have confirmed that a recent case of COVID-19 among an individual in California was caused by the Omicron variant (B.1.1.529). The individual was a traveler who returned from South Africa on November 22, 2021. The individual had mild symptoms that are improving, is self-quarantining and has been since testing positive. All close contacts have been contacted and have tested negative.

The FEHBlog senses that Delta variant is becoming jealous over the attention that the Omicron varian is receiving.

From the Delta variant vaccine mandate front, the Society for Human Resource Management tells us that

Consultancy Willis Towers Watson conducted a survey of large U.S. companies from Nov. 12-18 and asked if they currently require employees to be vaccinated against COVID-19 or plan to do so; 543 companies responded to the survey. Respondents indicated that they: 

— Currently require vaccinations (18 percent).

— Will require vaccinations only if OSHA’s ETS takes effect (32 percent).

— Plan to mandate vaccinations regardless of the ETS status (7 percent). 

Few employers (3 percent) with vaccination mandates have reported a spike in resignations, although nearly 1 in 3 (31 percent) of those planning mandates were very concerned that this could contribute to employees leaving their organizations. On the other hand, nearly half of employers (48 percent) believe vaccine mandates could help recruit and retain employees.

In addition to vaccine mandates, many large employers have taken or plan to take the following actions to protect employees who are returning to the workplace, saying that they will:

— Offer COVID-19 testing (84 percent), most on a weekly basis (80 percent).

— Require unvaccinated employees to pay for testing unless prohibited by state law (25 percent).

— Require or plan to require masks to be worn indoors (90 percent).

In hospital news, Healthcare Dive reports that

Hospitals saw operating margins continue to erode in October, declining 12% from September under the weight of rising labor costs, according to a national median of more than 900 health systems calculated by Kaufman Hall. It was the second consecutive monthly drop and comes as facilities are preparing for the fast-spreading omicron variant of the coronavirus.

Although expenses remained highly elevated, patient days and average length of stay fell for the first time in months in October, likely reflecting lower hospitalization rates as the pressure of treating large numbers of COVID cases began to ease, Kaufman Hall said in its latest report.

At the same time, operating room minutes rose 6.8% from September, pointing to renewed patient interest in elective procedures.

Fierce Healthcare adds that

Despite the threat of daily fines, hospitals have so far been slow to publish their prices online in accordance with a new federal regulation.

Radiology services look to be no exception, with new study data now suggesting roughly two-thirds of U.S. hospitals have not published commercial negotiated prices for at least one of the 13 radiology services designated as a common shoppable service by the Centers for Medicare & Medicaid Services (CMS). Hospitals are required to publish these prices in compliance with CMS’ Hospital Price Transparency final rule.

Further, the hospitals that did share their radiology service commercial negotiated prices appear to be all over the map, often setting price tags that varied by hundreds or thousands of dollars for certain imaging services.

The analysis—published in Radiology by Michigan State University and Johns Hopkins researchers—found than a mean 2,053 out of 5,700 hospitals (36%) had reported a price for one of these services as of Sept. 6.

From the telehealth front, Healthcare Dive informs us that

When U.S. patients envision their future medical care, the majority see telehealth playing a role. But when presented with the choice between an in-person or video visit for nonemergent care, most prefer a traditional in-office visit, according to new research analyzing consumer telehealth preferences.

The survey conducted by the nonprofit Rand Corporation published in JAMA on Wednesday found those who leaned toward in-person care were more willing to pay for their preferred visit modality, while those who preferred video visits were more sensitive to out-of-pocket costs.

Of the respondents who had used telehealth at least once since last March, only 2.3% said they were unwilling to use telehealth in the future, suggesting the method’s continued importance in hybrid models of care even after the pandemic — though it’s unlikely to be most patients’ first choice, researchers said.

In other news —

  • Drug Channels offers its take on CVS Health’s recent announcement to right size its number of retail pharmacies (a roughly 10% reduction) and add even more healthcare focus to the remaining locations.
  • Today “the Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) to solicit stakeholder and public feedback that will be used to inform potential changes and future rulemaking to improve the organ transplantation system and seek to enhance the quality of life of those living with organ failure.”
  • Becker’s Hospital Review discusses and provides interesting executive interview on how healthcare providers and health plans are seeking to improve and expand mental healthcare.
  • This week’s Econtalk episode on our sense of hearing is outstanding. Check it out.

Tuesday’s Tidbits

From the Delta variant vaccination and treatment front, AHIP informs us that

The Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) held a meeting to discuss the safety and efficacy of the COVID-19 antiviral treatment molnupiravir, developed by Merck and Ridgeback Biotherapeutics. The oral treatment is the first COVID-19 therapy that could be taken outside a clinical setting. The Committee reviewed data by Merck and the FDA on molnupiravir’s toxicity, efficacy, and safety, and discussed concerns over treatment of pregnant persons and the potential effects of viral mutation and evolution. Initial data from Merck showed that molnupiravir reduced the hospitalization risk among high-risk patients by 48%, however data released November 26 suggests the reduction in hospitalizations may be closer to 30%.

The Committee voted 13-10 that the potential benefits of molnupiravir outweigh the known and potential risks when used for the treatment of mild-moderate COVID-19 in adult patients who are within 5 days of symptom onset and are at high risk of severe COVID-19, including hospitalization or death. Given concerns about the potential harmful effects on fetal development, Committee members further stressed the need for pregnancy testing prior to taking molnupiravir.

The FDA will review AMDAC’s conclusions and formally decide whether or not to grant emergency use authorization (EUA) to molnupiravir in the coming weeks. 

Acting Food and Drug Commissioner Dr. Janet Woodcock announced

The [Food and Drug Administration] is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more. 

Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks.

Healthcare Dive informs us that

The emergence of a new COVID-19 variant, named Omicron (B.1.1.529), is putting pressure on diagnostics manufacturers who test for the presence of SARS-CoV-2 to ensure its results are not impacted. Thermo Fisher Scientific, Qiagen and Lucira Health were quick to claim their tests can detect the emerging variant.    

The Wall Street Journal reports that

The Omicron variant of the Covid-19 virus could lead to more infections among vaccinated people, according to several scientists, but some said there were reasons to believe the shots would protect against severe disease.

While the new variant might evade the antibodies generated in reaction to the vaccines, the virus will likely remain vulnerable to immune cells that destroy it once it enters the body, said Ugur Sahin, co-founder of BioNTech SE, which sells a Covid-19 shot with partner Pfizer Inc.

“Our message is: Don’t freak out, the plan remains the same: Speed up the administration of a third booster shot,” Dr. Sahin said in an interview Tuesday.

In that regard, Govexec.com notes that “Pfizer/BioNTech are expected to apply for approval for their booster shots for 16 and 17 year olds and the FDA “could authorize extra shots within roughly a week,” The New York Times reported on Monday.”

In COVID vaccine mandate legal news, the FEHBlog was quite surprised to read in Govexec that

On Tuesday, a federal judge temporarily blocked the COVID-19 vaccine mandate for federal contractors in three states.

U.S. District Judge Gregory Van Tatenhove, who serves in the U.S. District Court for the Eastern District of Kentucky, issued a preliminary injunction for the vaccine mandate for federal contractors and subcontractors in all covered contracts in Kentucky, Ohio and Tennessee. Following President Biden’s issuance of the executive order on the mandate on September 9, there have been numerous legal challenges. 

“This is not a case about whether vaccines are effective. They are. Nor is this a case about whether the government, at some level, and in some circumstances, can require citizens to obtain vaccines. It can,” wrote Van Tatenhove. “The question presented here is narrow. Can the president use congressionally delegated authority to manage the federal procurement of goods and services to impose vaccines on the employees of federal contractors and subcontractors? In all likelihood, the answer to that question is ‘no.’”

The New York Times adds

A federal judge issued a preliminary injunction on Tuesday to halt the start of President Biden’s national vaccine mandate for health care workers, which had been set to begin next week. 

The injunction, written by Judge Terry A. Doughty, effectively expanded a separate order issued on Monday by a federal court in Missouri. The earlier one had applied only to 10 states that joined in a lawsuit against the president’s decision to require all health workers in hospitals and nursing homes to receive at least their first shot by Dec. 6 and to be fully vaccinated by Jan. 4.

“There is no question that mandating a vaccine to 10.3 million health care workers is something that should be done by Congress, not a government agency,” Judge Doughty of U.S. District Court for the Western District of Louisiana wrote. He added: “It is not clear that even an act of Congress mandating a vaccine would be constitutional.”

The plaintiffs, he added, also have an “interest in protecting its citizens from being required to submit to vaccinations” and to prevent the loss of jobs and tax revenue that may result from the mandate.

It looks like the vaccine mandates are creating more work Judicial Panel on Multidistrict Litgation.

From the HIV front —

  • The National Institutes of Health tells us that “Among people with HIV worldwide who are receiving antiretroviral therapy (ART), adults are getting closer to the global target of 95% achieving viral suppression, but progress among children and adolescents is lagging and long-term viral suppression among all groups remains a challenge. These findings of a study funded by the National Institutes of Health suggest that substantial efforts are needed to help people with HIV durably suppress the virus. The findings were published today in the journal The Lancet HIV.”
  • The Centers for Disease Control informs us that “Improving access to and use of HIV services for [men having sex with men] MSM, particularly Black MSM, Hispanic/Latino MSM, and younger MSM, is essential to ending the HIV epidemic in the United States.”
  • Here is a link to the CDC’s website on HIV treatment.

From the tidbits department —

  • Fierce Healthcare calls to our attention the fact that

The Business Group on Health has identified several trends in health and wellness to keep an eye on next year, which they say highlight the sense of “collective urgency” employers and their workforces feel.

For example, the organization echoed an ongoing industry trend: virtual care isn’t going away following a massive increase in use during the pandemic. However, the Business Group argues that taking full advantage of its strengths will require integration with in-person offerings.

  • The Society for Human Resource Management, having lost respect for the Delta variant, discusses how the Omicron variant may impact the workplace.
  • AHRQ tells us that “Patients with retail medications to treat opioid use disorders spent on average 3.4 times more for out-of-pocket prescriptions than the rest of the U.S. population, according to an AHRQ-study published in the Journal of Substance Abuse and Treatment.” No bueno.
  • Also “AHRQ has released an updated Chartbook on Rural Healthcare that shows that people in rural areas face difficulty getting timely, high-quality, affordable healthcare. 
  • HHS’s Office for Civil Rights which enforces the HIPAA Privacy and Security Rules now has settled in OCR’s favor 25 complaints against healthcare providers for allegedly violating HIPAA’s individual right to access medical records.

Monday Roundup

Photo by Sven Read on Unsplash

From the Capitol Hill front, the Hill reports that Senate continues to squabble over the must pass National Defense Authorization Act for the current federal fiscal year. Meanwhile Roll Call informs us that

Democrats and Republicans on Monday haggled over details of a stopgap spending bill that appears likely to run into late January at a minimum, with Republicans still trying to extend the duration into February or March.

Sources said House Appropriations Chair Rosa DeLauro, D-Conn., wants to file the temporary spending bill Tuesday with a goal of passing it in the House on Wednesday. That would presumably give the Senate enough time to clear it for President Joe Biden’s signature before the current stopgap funding law expires Friday.

Extending the continuing resolution into late January would represent a compromise between DeLauro, who previously was pushing for a shorter two-week CR, and senators from both parties who say more time is needed to wrap up work on fiscal 2022 appropriations bills.

Negotiations were ongoing, however, with Republicans arguing for more time. Senate Appropriations ranking member Richard C. Shelby told reporters Monday night that he prefers a stopgap through February or March. “I think it gives us more time to seriously sit down,” the Alabama Republican said.

From the Delta variant front, David Leonhard sagely writes in this New York Time column this morning

The public reaction to new Covid-19 variants has followed a familiar cycle. People tend to assume the worst about two different questions — whether the variant leads to faster transmission of the Covid virus and whether it causes more severe illness among infected people.

The first of those worries came true with the Alpha and Delta variants: Alpha was more contagious than the original version of the virus, and Delta was even more contagious than Alpha. But the second of the worries has largely not been borne out: With both Alpha and Delta, the percentage of Covid cases that led to hospitalization or death held fairly steady.

This pattern isn’t surprising, scientists say. Viruses often evolve in ways that help them flourish. Becoming more contagious allows a virus to do so; becoming more severe has the potential to do the opposite, because more of a virus’s hosts can die before they infect others.

It is too soon to know whether the Omicron variant will fit the pattern. But the very early evidence suggests that it may. Unfortunately, Omicron seems likely to be more contagious than Delta, including among vaccinated people. Fortunately, the evidence so far does not indicate that Omicron is causing more severe illness * * * .

The Boston Globe reports that

The Centers for Disease Control and Prevention [(CDC) today] broadened its recommendation for COVID-19 booster shots to include all adults because of the new Omicron variant. The agency had previously approved boosters for all adults, but only recommended them for those 50 years and older or living in long-term care settings.

“Everyone ages 18 and older should get a booster shot either when they are six months after their initial Pfizer or Moderna series or two months after their initial J&J vaccine,” CDC Director Dr. Rochelle Walensky said in a statement.

Healthcare Dive adds

Facing a coronavirus variant that experts fear could more easily evade vaccine protection, drugmakers raced last week to set in place plans to respond to omicron, the latest threat in the nearly two-year-old COVID-19 pandemic. 

BioNTech, which partnered with Pfizer to develop one of the world’s most effective coronavirus vaccines, is already working on a version of its shot tailored to omicron and expects adapting it could take as little as six weeks. Moderna and Johnson & Johnson, makers of two other vaccines for COVID-19, both said they would advance omicron-specific candidates, as did Maryland-based Novavax, which aims to soon ask for U.S. approval of its shot. 

On a related note, last Wednesday, the CDC released a health alert about increasing seasonal flu activity especially among young adults and in college and university settings.

On the Delta variant vaccine mandate front, the Biden Administration came to its senses today by announcing per Govexec that “it would delay until 2022 [a/k/a post holiday season] issuing suspensions and other serious penalties related to noncompliance with its mandate that the federal workforce be vaccinated against COVID-19.”

The White House Safer Federal Workforce Task Force updated guidance on its website to reflect the change, encouraging agencies to issue a letter of reprimand prior to more serious sanctions against noncompliant employees, as well as allowing for multiple rounds of suspensions before agencies move to fire them.

“Agencies may consider the length of the education and counseling period or following an initial brief suspension (14 days or less) with a longer second suspension (15 days or more), rather than moving from a first suspension to proposal of removal,” the task force wrote. “That said, consistency across government in enforcement of this government-wide vaccine policy is desired, and the executive order does not permit exceptions from the vaccination requirement except as required by law.”

Also Reuters reports that

A federal judge on Monday blocked in 10 states a Biden administration vaccine requirement, finding the agency that issued the rule mandating healthcare workers get vaccinated against the coronavirus likely exceeded its authority.

The ruling by U.S. District Judge Matthew Schelp in St. Louis prevents the U.S. Centers for Medicare and Medicaid Services (CMS) from enforcing its vaccine mandate for healthcare workers until the court can hear legal challenges brought by the 10 states. * * *

“Congress did not clearly authorize CMS to enact this politically and economically vast, federalism-altering, and boundary-pushing mandate, which Supreme Court precedent requires,” [Judge Schelp] wrote.

[Judge] Schelp’s ruling applied in the 10 states that brought the case: Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota and New Hampshire.

A Washington Post article reminded the FEHBlog of this New York Times squib posted on November 21

The article concludes

In Suffolk County, [on Long Island] Odette R. Hall, the chief medical examiner, is using the new mass spectrometer to dig through deaths, to figure out whether fentanyl or its analogues were to blame — or, she fears, whatever novel drug is coming next.

“Whatever is happening on the street,” Dr. Hall said, “is always going to be a step ahead.”

The Washington Post reports that

Forensic analysts have identified a new and highly potent family of synthetic opioids in the District’s illicit drug supply, a worrisome discovery in a city already struggling with a wave of fatal overdoses that shows no signs of abating. The opioids, found on used syringes examined by scientists at the D.C. Department of Forensic Sciences in September and October, are called protonitazene and isotonitazene, respectively. Experts estimate that each is at least several times more powerful than fentanyl, the synthetic opioid that has displaced heroin in many parts of the United States and is now responsible for the majority of the country’s drug overdoses, including those in the nation’s capital. * * *

It is unknown whether fentanyl testing strips — which alert users to the possibly higher potency of their drugs — pick up the presence of the nitazene family of substances. And more of the overdose antidote naloxone, commonly known as Narcan, may be needed to revive someone who has used the new drugs.

“For us, it is concerning,” [D.C. Public Health Lab chemist Alexandra] Evans said. “Naloxone should work, but because of the potency additional doses might be required.”