Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

From the COVID vaccination front, the CDC’s COVID Data Tracker indicates that over two-thirds of the U.S. population over five years old in fully vaccinated.

The American Medical Association’s column about “What Doctors Wish Patient Knew” explains

A Kaiser Family Foundation poll found that one-third of parents say they planned to get their children vaccinated right away. Yet other parents are taking a wait-and-see approach to COVID-19 vaccination for kids. But with the Delta-Omicron variant tag team, widespread vaccination is an essential tool for preventing COVID-19 deaths, hospitalizations and illnesses.

To help parents move from that “wait-and-see” mentality and calm their fears, two physicians shared what to know about COVID-19 vaccine safety for children.

Check it out.

From the Omicron treatment front, the Food and Drug Administration announced today that the agency has

revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) [which are made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc.] – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.

Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions. 

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as omicron. This is the case with these two treatments for which we’re making changes today. * * *

Importantly, there are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Healthcare providers should consult the NIH panel’s COVID-19 treatment guidelines and assess whether these treatments are right for their patients.

From the COVID vaccination mandate front, Federal News Network reports that

Last week’s court injunction that blocked the Biden Administration’s vaccine requirement for federal employees will put a temporary halt to disciplinary actions in federal agencies. But it won’t be of much help to feds who’d already been disciplined or fired for refusing the vaccine prior to last Friday.

That’s according to new guidance the administration’s Safer Federal Workforce Task Force issued Monday. The four-page document answers some basic questions on exactly how agencies should deal with the federal employee mandate now that a Texas judge has temporarily barred its implementation and enforcement.

Among the nuances: workers who’ve been suspended for failing to comply need to have their suspensions lifted, and new proposals to fire or suspend employees need to be “held in abeyance” for as long as the injunction is in place, the task force said. But agencies don’t need to reverse other disciplinary procedures that have already taken full effect.

From the free OTC tests front, Govexec.com asks

What group is especially vulnerable to the ravages of COVID-19 even if fully vaccinated and boosted? Seniors. And who will have an especially tough time getting free at-home COVID tests under the Biden administration’s plan? Yes, seniors.

As of Jan. 15, private insurers will cover the cost of eight at-home rapid COVID tests each month for their members — for as long as the public health emergency lasts.

Finding the tests will be hard enough, but Medicare beneficiaries face an even bigger hurdle: The administration’s new rule doesn’t apply to them.

It turns out that the laws governing traditional Medicare don’t provide for coverage of self-administered diagnostic tests, which is precisely what the rapid antigen tests are and why they are an important tool for containing the pandemic. * * *

The Medicare program does cover rapid antigen or PCR testing done by a lab without charging beneficiaries, but there’s a hitch: It’s limited to one test per year unless someone has a doctor’s order.

Because the article describes orignal Medicare as exempt, one must assume that Medicare Advantage plans also are offering reimbursement for OTC COVID tests. The original Medicare exemption is a weak cup of tea because no commercial health plans covered OTC testing before the mandate.

From the No Suprises Act front, The American Hospital Association informs us that

The Centers for Medicare & Medicaid Services will host a conference call for health care providers Jan. 26 at 1 p.m. ET on the balance billing provisions of the No Surprises Act. To participate in the Special Open Door Forum, dial 888-455-1397 and reference passcode 5109694. Slides for the call are available here. P

Participants may email questions in advance to Provider_Enforcement@cms.hhs.gov, noting “Questions for 1/26 Open Door Forum” in the subject line. A replay will be available after the call through Jan. 28 by dialing 800-308-7855 and entering the passcode.

The CMS slides are helpful.

From the telehealth front, Fierce Healthcare tells us that

Integrating virtual care can save the healthcare system significant amounts of money, as well as avoid unnecessary visits to the emergency department or urgent care center, according to a new study from Cigna.

The study, conducted alongside its telehealth arm MDLive, found that patients who saw virtual providers also saw 19% fewer visits to the ER or urgent care. In addition, virtual urgent care visits reduced duplication of care by 16% compared to other virtual primary care providers or specialists.

Cigna notes that these reductions in unneeded visits are especially crucial as hospitals face down the current COVID-19 surge, caused by the highly infectious omicron variant. 

Friday Stats and More

Based on the CDC’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 from the 27th week of 2021 through the third week of 2022:

My word, could that be a cresting of the Omicron surge as discussed in this week’s posts?

The FEHBlog’s weekly chart of new Covid deaths has bounced up and down after climbing to just over 10,000 weekly deaths during the Delta surge. .

Last but not least here is the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the 51st week of 2020 through the third week of 2022.

Here are links to the CDC’s Covid data tracker weekly review and its weekly Fluview.

In other COVID vaccination news —

  • The Wall Street Journal reports that

Vaccines and booster shots offer superior protection from the Delta and Omicron variants, according to three new studies released by the Centers for Disease Control and Prevention.

The data back up earlier findings supporting booster shots and offer the first comprehensive insight into how vaccines fare against the Omicron variant. In one of the studies published Friday, a CDC analysis found that a third dose of either the vaccine from Pfizer Inc.and BioNTech SE or Moderna Inc. was at least 90% effective against preventing hospitalization from Covid-19 during both the Delta and Omicron periods.

The American Hospital Association adds

According to data from 25 state and local health departments, adults who were unvaccinated against COVID-19 as the omicron variant emerged in December had nearly three times higher risk of infection than adults fully vaccinated against COVID-19 and five times higher risk than adults who had received a booster, the Centers for Disease Control and Prevention reported today. The highest impact of COVID-19 booster doses compared with full vaccination was recorded among persons aged 50 and older. Because of reporting lags, the influence of the omicron variant on COVID-19-associated deaths could not be evaluated by vaccination status in December, the authors note.

The FDA could authorize Pfizer’s COVID-19 vaccine for children under age 5 in the next month, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Wednesday.

“My hope is that it’s going to be within the next month or so and not much later than that, but I can’t guarantee that because I can’t out-guess the FDA,” he said during an interview with Blue Star Families, a nonprofit group that supports military families.

The younger age group will likely need three vaccine doses, he said, since two shots didn’t provide enough of an immune response during Pfizer’s clinical trials for kids ages 2-4.

In Covid vaccine mandate news, Govexec tells us

A federal court in Texas has issued an injunction against President Biden’s COVID-19 vaccine mandate for the federal workforce, pausing implementation of a requirement for more than 2 million civilian servants. 

The Biden administration has already had sweeping success with the mandate, as most agencies have seen virtually their entire workforces come into compliance. Still, federal offices across the country were just beginning to move forward with suspensions—which could eventually result in firings—for those who did not meet the requirements. Biden issued the mandate by executive order in September.    

Judge Jeffrey Brown, appointed by President Trump to the U.S. Court for the Southern District of Texas, said the case was not about whether individuals should be vaccinated or even about federal power generally. 

“It is instead about whether the president can, with the stroke of a pen and without the input of Congress, require millions of federal employees to undergo a medical procedure as a condition of their employment,” Brown wrote. “That, under the current state of the law as just recently expressed by the Supreme Court, is a bridge too far.” 

The Justice Department has appealed the decision to the U.S. Court of Appeals for the Fifth Circuit. The FEHBlog expects that the Fifth Circuit will lift the stay as soon as this weekend. The Society for Human Resource Management offers a helpful article for employers trying to keep track of the vaccine mandate decisions from the courts.

In other COVID vaccine mandate news, the Labor Department’s Wage and Hour Division announced today that

Employees [who are not exempt from the Fair Labor Standards Act] must be paid for time spent going to, waiting for, and receiving medical attention required by the employer or on the employer’s premises during normal working hours. Therefore, if an employer requires an employee to obtain a COVID-19 vaccine dose, undergo a COVID-19 test, or engage in a COVID-19 related health screening or temperature check during the employee’s normal working hours, the time that the employee spends engaged in the activity is compensable. Employees must be paid for such time during normal working hours, regardless of where the activity occurs. This is true regardless of whether the employer is subject to the OSHA Vaccination and Testing ETS.

In Covid treatment news, the Food and Drug Administration announced today that the agency “took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.”

From the Covid OTC testing coverage mandate department, the Kaiser Family Foundation has surveyed the coverage approaches of 13 large health insurers. Don’t blame the insurers on this one because health insurers don’t typically cover OTC products and the government only allow four days to implement the mandate.

From the and more department

  • In telehealth news, mHealth Intelligence tells us that

Telehealth utilization peaked in the first half of 2020 and decreased as the year came to a close, with providers predicting that virtual care use would continue to decline in upcoming years, according to the 2021 Medical Group Telehealth Survey.

AMGA Consulting conducted the survey and gathered responses from 56 medical groups representing more than 38,000 healthcare providers.

The majority of the participants (86 percent) were part of multispecialty groups with primary care, while the remaining were either multispecialty without primary care, primary care, or single-specialty groups. * * *

The survey results suggest that although telehealth use skyrocketed during the COVID-19 pandemic, virtual care may see the most success with patients who prefer the modality over in-person care or whose health concerns can be easily addressed virtually.

The FEHBlog remains a strong proponent of hub and spoke telehealth for mental health care because every televisit is in network.

  • The American Hospital Association informs us that “The Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology seeks comments through March 25 to inform potential future rulemaking on how the ONC Health IT Certification Program could incorporate standards, implementation specifications and certification criteria to reduce the burden of prior authorization.”
  • The Congressional Budget Office released a report titled “The Prices That Commercial Health Insurers and Medicare Pay for Hospitals’ and Physicians’ Services.”

CBO examined potential explanations for why the prices paid by commercial insurers are higher and more variable than those paid by Medicare FFS. CBO’s analysis and literature review suggest the following conclusions:

— Greater market power among providers consistently leads to prices for commercial insurers that are higher than Medicare FFS’s prices and that vary more widely, both among and within areas. Hospitals and physicians’ groups may have market power because they have a dominant share of the market in an area or because an insurer sees them as essential to its network of providers.

— Some of the variation in the prices that commercial insurers pay for hospitals’ and physicians’ services is explained by differences in the prices of inputs needed to deliver those services.

— Higher hospital quality is associated with higher prices paid by commercial insurers, although whether there is a causal link between quality and prices, and the direction of any such link, is not clear.

— The share of providers’ patients who are covered by Medicare and Medicaid is not related to higher prices paid by commercial insurers. That finding suggests that providers do not raise the prices they negotiate with commercial insurers to offset lower prices paid by government programs (a concept known as cost-shifting).

IBM is selling the data and analytics assets of its Watson Health business to a private equity firm as it looks to refocus on its core cloud business.

The sale, which is expected to close in the second quarter this year has been anticipated for quite some time, and comes following the limited success of Watson Health, despite a spate of high-profile acquisitions of health information companies to bolster the enterprise.

Financial terms of the deal were not disclosed.

[F]ederal civilian employees in the U.S. will now be paid at least $15 per hour.

OPM issued a memorandum for heads of Executive departments and agencies that provides implementing guidance for how agencies should adjust pay rates for General Schedule (GS) and Federal Wage System (FWS) employees stationed in the U.S., and how to use administrative authority for other pay systems to lift the pay of federal employees who currently make less than $15 per hour. In total, these changes will impact 67,000 out of 2.2 million federal employees. The largest share of these workers, over 56,000 of them, currently work at the Department of Defense. OPM’s guidance directs agencies to implement these changes by January 30, 2022

  • To tide you over the weekend, here is a link to Healthcare Dive’s Deep Dive on four 2022 key trends for providers and payers.

Thursday Miscellany

In yesterday’s post, the FEHBlog accurately predicted that the Supreme Court would decide today whether to stay the OSHA ETS vaccination screening program and end the partial stay on the CMS healthcare worker vaccination mandate.

This afternoon, the Supreme Court issued its decision reinstating the nationwide stay of the OSHA ETS and its companion decision ending all stays on the CMS mandate. The decisions came down as many, many pundits predicted.

The Secretary of Labor who oversees OSHA commented that

“We urge all employers to require workers to get vaccinated or tested weekly to most effectively fight this deadly virus in the workplace. Employers are responsible for the safety of their workers on the job, and OSHA has comprehensive COVID-19 guidance to help them uphold their obligation. 

“Regardless of the ultimate outcome of these proceedings, OSHA will do everything in its existing authority to hold businesses accountable for protecting workers, including under the Covid-19 National Emphasis Program and General Duty Clause.”

In the OSHA ETS decision, the Supreme Court expressed the key point of administrative law on which the two cases turned:

Administrative agencies are creatures of statute. They accordingly possess only the authority that Congress has provided.

The Court reasoned that Congress had granted CMS the necessary authority to issue its broad mandate but had not granted OSHA the same level of authority.

The cases now return to the courts of appeal for a decision on the merits — 6th Circuit for the OSHA ETS case and 5th Circuit for the CMS mandate case. In the meantime the Court’s decisions on the stays will remain in place.

Given how the Court handled these stay decisions, we have a pretty good idea where the Supreme Court will land should either of those merits decisions return to the Court.Such a return likely only will happen if either appellate court disagrees with the Court’s administrative law conclusion on the merits.

In that regard, Bloomberg Law reports that

The Justice Department will appeal a Louisiana federal court’s ruling that blocked President Joe Biden‘s order for government-contractor workers to get the Covid-19 vaccine. 

The U.S. Court of Appeals for the Fifth Circuit will be the third federal appeals court to consider a challenge to the measure. A coalition of three states—Louisiana, Mississippi, and Indiana—sought to block the mandate for companies that do business with the federal government. U.S. District Court Judge Dee Drell of the Western District of Louisiana granted a preliminary injunction in December. 

The federal contractor mandate—which won’t be enforced while litigation proceeds—would apply to roughly a quarter of the U.S. workforce, and affect businesses including Lockheed Martin Corp., Microsoft Corp., Alphabet Inc.‘s Google, and General Motors Co.

Appeals are ongoing in the Eleventh and Sixth circuits, respectively, over a nationwide injunction against the measure from a Georgia federal court and a narrower one from a Kentucky federal judge for a coalition that includes Ohio and Tennessee. A Missouri federal court also blocked the executive order, but that ruling has yet to be appealed.

From the Omicron front, David Leonhardt writing in today’s New York Times cautiously senses that the Omicron surge is cresting in our country following Europe’s and South Africa’s leads. “To be clear, the current emergency is not on the verge of ending. Cases appear to be peaking only in places where Omicron arrived early, mostly in the Northeast. In much of the country, cases are still soaring.”

From the Covid vaccine front, the AP reports that

Distrust, misinformation and delays because of the holidays and bad weather have combined to produce what authorities say are alarmingly low COVID-19 vaccination rates in U.S. children ages 5 to 11.

As of Tuesday, just over 17% were fully vaccinated, more than two months after shots became available to the age group. While Vermont is at 48%, California is just shy of 19% and Mississippi is at only 5%.

Vaccinations among the elementary school set surged after the shots were introduced in the fall, but the numbers have crept up slowly since then, and omicron’s explosive spread appears to have had little effect.

The low rates are “very disturbing,” said Dr. Robert Murphy, executive director for the Institute for Global Health at Northwestern University’s Feinberg School of Medicine. “It’s just amazing.”

Parents who hesitate “are taking an enormous risk and continuing to fuel the pandemic,” Murphy said.

From the telehealth front, STAT News informs us that

A handful of virtual care companies are inking new types of contracts that reward them for keeping patients’ cost low and penalize them for overspending — a model known as risk-sharing. It’s a departure from the traditional “fee-for-service” billing process, and a move  companies hope could help them get paid for the services they offer in addition to virtual doctors’ appointments, like in-app messaging, medication reminders, and digital health coaching. They’re also betting that embracing risk could endear them to the health plans and employers they depend on for contracts.

Execs from companies like Heartbeat Health and Teladoc say they’re in the very early stages of cementing these contracts. While there’s no clear roadmap for how to structure them, whether they take hold could clarify how virtual care will fit into the brick-and-mortar healthcare system and incentivize those companies to work with traditional providers on prevention, said Jennifer Goldsack, CEO of the Digital Medicine Society. “There is an opportunity to reimagine what health care looks like when it is around the patient,” she told Mohana. Read the full story

From the healthcare cost front, STAT News tells us that

— Medical cost growth trailed that of other industries in 2021, though rising pressure from the omicron variant could fuel future increases in healthcare costs.

— Prices for goods and services skyrocketed at the fastest pace in four decades, rising 7% between December 2020 and December 2021, according to new data released Wednesday from the Bureau of Labor Statistics.

— By comparison, prices for healthcare services rose roughly 2.5% last year, while the cost of medical care goods rose just 0.4%. However, that slow rate of growth could accelerate as COVID-19 cases persist in 2022 and beyond.

From the miscellany department —

  • The Agency for Healthcare Quality and Research’s Acting Director Dr. David Meyers looks back at 2021.
  • Biopharma Dive considers five questions facing gene therapy in 2022.
  • Fierce Healthcare notes that

As the healthcare system faces significant labor challenges, a new report suggests pharmacists are well positioned to fill some of the critical gaps.

The analysis, conducted by Express Scripts and the Columbia University Mailman School of Public Health, found that a majority of pharmacists see their roles transitioning to more direct patient care responsibilities over the next decade.

  • AARP’s Public Policy Institute examines the importance of medication literacy in the medication decision-making of older adults.

While health literacy is widely understood as a quality measure of health care decision making, another related measure calls for increased attention, particularly regarding older adults: medication literacy. Medication literacy is the degree to which individuals can obtain, comprehend, communicate, calculate, and process patient-specific information about their medications to make informed medication and health decisions in order to safely and effectively use their medications, regardless of the mode by which the content by which the content is delivered (i.e., written, oral, or visual).

  • Money offers a comprehensive update on the President’s mandate that health plans cover over the counter COVID tests effective on Saturday January 15.

Monday Roundup

Photo by Sven Read on Unsplash

From the Omicron front, STAT News reports that

The Omicron variant now accounts for 73% of Covid-19 infections being diagnosed in the United States, and in some parts of the country 90% of infections are caused by viruses from the Omicron strain, the Centers for Disease Control and Prevention said late Monday.

Though it’s been clear from Omicron’s astonishing spread elsewhere that it would rapidly take over from Delta as the dominant variant in this country, the speed is nevertheless startling to witness.

“What we are watching unfold is microbial evolution. This is remarkable,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. “But this is what these viruses can do.”

The Centers for Disease Control updated its Omicron website today.

This Wall Street Journal article indicates the obtaining an mRNA booster (Moderna or Pfizer) will provide protection against Omicron as well as Delta.

The Centers for Medicare and Medicare Services today updated their “vaccine toolkit designed for issuers of group and individual health insurance and Medicare Advantage health plans.”

From the COVID vaccine mandate litigation front, the American Hospital Association reports that

Over the weekend, and as of this writing, eight groups of challengers to the OSHA vaccine mandate filed emergency applications with the U.S. Supreme Court asking the high court to once again stay the mandate following the Sixth Circuit’s Dec. 17 decision to lift the Fifth Circuit’s previously entered stay.
 
Today, the Supreme Court asked the federal government for a response to the challengers’ applications by Dec. 30 by 4 p.m. If that sounds familiar, it is because Dec. 30 at 4 p.m. is also the date and time the challengers to the CMS vaccine mandate will be filing their responses to the federal government’s Supreme Court application asking the court to stay the Missouri and Louisiana preliminary injunctions enjoining the CMS mandate. Both sets of applications will be briefed at the same time and the Supreme Court will have the opportunity to rule on the fate of both the CMS and OSHA vaccine mandates at the same time, if it so chooses.

The FEHBlog can find no word about whether the government has appealed to the Supreme Court the 11th Circuit’s decision last Friday to maintain in force the stay on the federal government contractor COVID vaccine mandate. The FEHBlog will keep looking.

From the healthcare business front —

  • Fierce Healthcare informs us that “Amazon has consolidated its healthcare efforts under one central organization and tapped a former Prime executive to run the businesses. The tech giant elevated Neil Lindsay to the new role of senior vice president of health and brand within Amazon’s worldwide consumer business, an Amazon spokesperson confirmed to Fierce Healthcare.”
  • mHealth Intelligence reports that “Supermarket retailer Hy-Vee, Inc. has launched a telehealth platform that allows individuals to receive treatments and prescriptions through the mail. The new service, RedBox Rx, offers virtual health consultations through a partnership with Reliant Immune Diagnostics’ telehealth platform MDbox.”
  • Healthcare Dive tells us that

Software giant Oracle is acquiring EHR vendor Cerner for $28.3 billion, the two companies announced Monday. The deal is expected to close sometime next year.

It will be Oracle’s largest acquisition to date, with the next highest being the 2005 purchase of PeopleSoft Inc. for $10 billion. The deal further pushes Oracle into the healthcare market, where its presence is mostly in data use efficiency for payers and providers. Oracle’s areas of focus include database software and cloud systems.

Cerner will be a dedicated business unit within Oracle, according to the Monday press release. Voice-enabled user interfaces will be a key focus with a goal to “deliver zero unplanned downtime in the medical environment.”

From the too little too late front, STAT News tells us that

Biogen said Monday that it has reduced the price of its Alzheimer’s drug Aduhelm by half and is planning a series of cost-cutting measures across the company next year that aim to save $500 million.

The moves follow a disappointing commercial launch of Aduhelm, as well as anger over the drug’s high price. 

The new, lower price for Aduhelm is $28,200, or roughly half what the drug cost when it launched in June. Insurance companies balked at its original list price, averaging $56,000 a year per patient, while physicians have fervently questioned whether Biogen’s supporting evidence merited the drug’s approval by the Food and Drug Administration, let alone widespread use. * * *

Biogen is announcing the Aduhelm price cut less than one month before Medicare is expected to make an all-important decision on whether and how widely to pay for the drug. A draft ruling is expected in January, followed by a final decision in the spring.

But with Aduhelm delivering paltry revenue, Biogen is also being forced to downsize the company. On Monday, Biogen said it would implement a series of cost-cutting measures in 2022 that are expected to total approximately $500 million. Details will be announced in the first quarter. 

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.

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 ScientificQiagen 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.

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:

Here is a link to the CDC’s weekly chart of new COVID hospital admissions which trended up by 5.4% from last week. However, the FEHBlog’s weekly chart of new COVID deaths has begun to trend down again.

Here’s FEHBlog’s weekly chart of new COVID vaccinations distributed and administered.

The vaccinations administered line continues to trend up. The CDC’s COVID vaccinations site now displays vaccinations administered to the age 5 to 11 group. Nearly 70% of the over age 12 population is fully vaccinated, and 97.5% of the age 65+ population has received at least one dose of the COVID vaccine. That’s impressive.

In Delta variant booster news, the CDC informs us that over one quarter of the age 50+ has received the booster. AHIP informs us that

Today the Food and Drug Administration (FDA) amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines, authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. This amendment expands the use of booster doses of both vaccines to include all adults at least six months after completion of the primary vaccination series of the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) also met today to discuss further clinical recommendations on the use of COVID-19 vaccine booster doses for adults. After reviewing the most recent safety and efficacy data of the Pfizer and Moderna booster doses, which showed the vaccines to be safe, the Committee unanimously (11-0) voted in favor of authorizing:

— A single COVID-19 vaccine booster dose is recommended for persons aged 18 and olderwho received an mRNA COVID vaccine primary series based on individual benefits and risks, at least 6 months after the primary series, under the FDA’s Emergency Use Authorization (EUA).

— A single COVID vaccine booster dose is recommended for persons aged 50 and older who received an mRNA COVID vaccine, at least 6 months after the primary series, under the FDA’s EUA.

Any FDA-approved or authorized COVID-19 vaccine can be used for a booster dose, regardless of vaccine received for a primary series.

The committee emphasized that the top priority continues to be vaccination of the unvaccinated, and that potential side effects of vaccination, such as incidence of myocarditis and pericarditis, need continual monitoring as more data becomes available.

Medscape adds that

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, signed off on a recommendation Friday evening to let all US adults get a COVID-19 booster shot.

The endorsement, following a unanimous vote by a panel of CDC advisors earlier in the day backing a third dose of a Moderna or Pfizer mRNA COVID vaccine, now means everyone over the age of 18 is eligible for a booster.

According the ACA FAQ 50, health plans now must covered vaccines administered to the expanded group.

Here is a link to the CDC’s weekly interpretation of its COVID statistics.

In other news / the “more”:

  • The Department of Health and Human Services announced today that “Today, the Biden-Harris Administration unveiled details about the establishment of a new federal advisory committee, the Ground Ambulance and Patient Billing (GAPB) Advisory Committee. As mandated through the No Surprises Act, the GAPB Advisory Committee will be charged with providing recommendations to the Secretaries of Health and Human Services (HHS), Labor, and Treasury on ways to protect consumers from exorbitant charges and balance billing when using ground ambulance services. * * * Learn more about the GAPB Advisory Committee and the Federal Register Notice – PDF.”
  • Beckers Hospital News reports that “Insurers need more evidence of the clinical benefit of Biogen’s controversial Alzheimer’s drug Aduhelm before they start paying for it, Bloomberg reported Nov. 18. Bloomberg surveyed 25 of the nation’s largest insurers, and none of them deemed the drug “medically necessary.” Most indicated they view the drug as experimental and said they needed to see more evidence on the drug’s ability to slow cognitive decline.”
  • Govexec tells us that “About 90% of NASA employees have received at least one dose of a COVID-19 vaccination, according to agency data, but about 1,150 workers are seeking an exemption to President Biden’s governmentwide mandate.”
  • mHealth Intelligence informs us that “The number of outpatient visits after hospital discharges remained stable during the COVID-19 pandemic but telehealth use for these visits increased, suggesting that telehealth was a substitute for in-person care rather than an addition, a study published in JAMA Health Forum revealed.”
  • The Wall Street Journal provides an overview of currently available and near future COVID treatments.

Thursday Miscellany

OPM Headquarters a/k/a the Theodore Roosevelt Building

The FEHBlog discovered OPM’s Agency Financial Report for the 2021 fiscal year, dated November 2020, on its website tonight. The most interesting discussion of the FEHB begins at page 125, the start of OPM’s response to the Inspector General’s top management challenges paper.

From the Delta variant vaccine front, Politico reports tonight that

The Food and Drug Administration on Friday is expected to authorize Moderna’s Covid-19 booster shot for all adults — a move that would come in tandem with the clearance of Pfizer-BioNtech’s booster for widespread use, two people with knowledge of the matter told POLITICO.

The decision comes just days after Moderna officially asked the FDA to green-light its booster for Americans 18 and older, and reflects the administration’s growing unease over the recent rise in Covid-19 cases across the nation.

The FDA had previously planned to authorize Pfizer’s booster shot this week, enabling the government to roll out shots to millions more people ahead of the Thanksgiving holiday.

But after Moderna filed a similar request on Wednesday, officials began debating whether to speed that authorization along as well, the people with knowledge of the matter said.

The FDA declined to comment.

From the Open Season front, Govexec discusses how to get the biggest bang for your buck in dental benefits if you are a federal or postal employee / annuitant.

From the telehealth front, Fierce Healthcare informs us that

In a report from Quest Diagnostics released Monday, 67% of the over 500 primary care physicians surveyed said they fear they missed signs of drug abuse in their patients during the pandemic.

And nearly all of them were prescribing those often-misused drugs—a whopping 97% reported prescribing opioids within 6 months of taking the survey.

Their concerns extend beyond the pandemic into telemedicine use today. Only 50% of physicians said they were confident they could recognize signs of drug misuse during telehealth visits, a far cry from the 91% that said the same of in-person patient interactions.

From the Rx coverage front, the Wall Street Journal reports that

CVS Health Corp. said Thursday it will close 900 stores over the next three years, nearly 10% of its U.S. locations, while adding more health services at remaining locations.

The largest U.S. pharmacy chain said it would close 300 stores a year while adding primary-care offices at certain sites as well as converting more stores into so-called health hubs with offerings such as diagnostic testing, mental-health services and hearing exams.

“The company has been evaluating changes in population, consumer buying patterns and future health needs to ensure it has the right kinds of stores in the right locations for consumers and for the business,” CVS said in a statement.

A CVS spokesman said the company doesn’t yet have a list of which stores are closing, a process that will begin early next year. 

From the strategy front, Federal News Network tells us that

The Biden administration on Thursday laid out the vision for its President’s Management Agenda, detailing three broad goals and four values that will drive a multi-year, multi-faceted effort throughout the government.

The initial vision is a roadmap that explains how the administration will build capacity within government agencies to make good on the president’s broader agenda, Jason Miller, deputy director for management at the Office of Management and Budget, said.

“The how matters. This president has been clear from day one that how we do things shapes what we can do,” Miller told reporters Wednesday evening.

To that end, the Biden administration said values of equity, dignity, accountability and results would drive its PMA priorities. Each priority has multiple underlying strategies.

Those priorities are:

Strengthening and empowering the federal workforce

Delivering excellent, equitable and secure federal services and customer experiences

Managing the business of government to “build back better”

“This simple, yet powerful three-part approach builds on lessons learned across administrations, while also repairing damage done over time to the federal government, by strengthening its capacity to deliver results,” Miller said.

The administration wanted to keep the PMA simple, and it explicitly wanted to avoid setting “dozens and dozens of new initiatives,” Miller added.

Meritalk adds

The Office of Personnel Management (OPM) and the Office of Management and Budget (OMB) are set to release their four-year strategic plan later this month, according to OPM Director Kiran Ahuja, who previewed what the Federal government can expect to see in that plan.

During an FCW event today, Ahuja said the four-year strategic plan is currently “in OMB’s hands and will be released fairly soon.” Ahuja also said the plan will focus on rebuilding the Federal workforce.

“We have an opportunity to remake it, both in the early career talent that we need to bring in, as well as the importance of professional development opportunities,” Ahuja said.

She went on to say the plan will also focus on the Federal workforce becoming “the model employer,” through both telework and remote work flexibilities, as well as “a whole range of efforts,” including providing support to the Federal workforce and leaning in to “a hybrid work environment and being an example there.”

It seems like yesterday that OPM released its last four year plan in 2018.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill, we learn that “U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) today introduced their highly anticipated, bipartisan Cures 2.0 legislation that some leading health care organizations are calling a potential “game changer” in how the U.S. conducts biomedical research going forward.” Here’s a link\ to a Fierce Healthcare article on the bill.

From the Food and Drug Administration front —

  • The Wall Street Journal reports that “Pfizer said it asked U.S. health regulators to authorize its oral Covid-19 drug for use in high-risk patients, putting the pill on a path that could make it available for people to take at home by the end of the year.  Clearance from the U.S. Food and Drug Administration would give patients and doctors an easy-to-use treatment to keep people out of the hospital early in the course of the disease.” Moreover, “Pfizer Inc. is licensing its experimental Covid-19 antiviral to a global health organization in an effort to make the pill more readily available to people in low- and middle-income countries. Under the licensing agreement, the United Nations-backed Medicines Patent Pool will work with other drugmakers to manufacture the pill for use in 95 countries, including in sub-Saharan Africa, Pfizer and the nonprofit said Tuesday.”
  • The agency announced that authorizing “marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy and other behavioral methods to help with pain reduction in patients 18 years of age and older with diagnosed chronic lower back pain. “Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Pain reduction is a crucial component of living with chronic lower back pain. Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain.”

From the Delta variant vaccine mandate front, Reason informs us that

The ping-pong ball has been drawn, and the U.S. Court of Appeals for the Sixth Circuit is the winner. All of the various state, industry, and union challenges to the Occupational Safety and Health Administration’s Emergency Temporary Standard (ETS) mandating large employers to require vaccination or regular testing and masking of employees will be consolidated into a single proceeding in the Sixth Circuit.

Given that challenges had been filed in all twelve regional circuits, and there are over three-dozen parties, this will be one bear of a case. Red states and employer groups initially filed in the more conservative circuits, including the Fifth Circuit which issued a stay on Friday, arguing that OSHA’s action was unlawful. Blue states and progressive groups responded by filing challenges in more liberal circuits, alleging that OSHA’s ETS is too lax. Each side was trying to increase the chances that the case would be consolidated on favorable turf by increasing the number of favorable circuits in the lottery draw.

Today the Labor Department referred the case to the Joint Panel on Multidistrict Litigation which conducted the lottery. The Sixth Circuit’s case presenting the legality of the OSHA ETS is Kentucky v. OSHA, No 21-4031. Bloomberg adds that “Although the Fifth Circuit temporarily halted the rule before the case was transferred, the Sixth Circuit will have the authority to modify or lift that order.” The case ultimately is expected to be resolved at the Supreme Court.

From the Centers for Disease Control front

  • The CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) has created a website full of “the links to access select information from NCCDPHP on health equity and racial/ethnic disparities.”
  • The CDC also has made available a pre-diabetes risk test for consumer use along with suggestions on how to deal with this condition.

From the federal employee benefits front, Federal News Network informs us

Some same-sex spouses of deceased federal employees and retirees will have another shot at earning survivor benefits from the federal government, the Office of Personnel Management announced this week.

A new notice, scheduled for publication in the Federal Register Wednesday, describes how widows or widowers who meet a specific set of criteria can apply for federal survivor benefits that they were previously ineligible for or, in some cases, denied.

OPM also has created an online “support center” for federal retirees. Check it out.

From the prescription drug pricing front, Healthcare Dive tells us that

Price hikes taken last year by AbbVie on its anti-inflammatory drug Humira increased U.S. healthcare spending by $1.4 billion, an amount unsupported by evidence showing any new health benefits, the Institute for Clinical and Economic Review said in a new report.

Humira, which treats rheumatoid arthritis and other diseases, was one of nine high-cost drugs singled out by ICER for large price increases without corresponding data proving greater effectiveness or new clinical uses.

Humira’s net price rose 9.6% in 2020, the watchdog group said in its report. The increase in net price, which reflects what insurers pay after rebates, actually exceeded AbbVie’s hike to the drug’s list price, a reversal of what usually happens during negotiations with drugmakers.

STAT news adds that

The findings, which appear amid ongoing national turmoil over the cost of prescription drugs, mark the third time that ICER has attempted to identify price hikes on big-selling drugs for which no new clinical evidence was offered. The exercise has underscored a debate over the value of medicines and the extent to which price hikes occur beyond medical inflation, even after rebates are counted.

At the same time, however, ICER also noted that overall net prices for prescription drugs in the U.S. market declined in the past several years, and even wholesale price increases have not exceeded the broader inflation rate. This helped restrain health insurance premiums, which benefited patients, although not necessarily in relation to specific medications.

Finally an intriguing telehealth tidbit from mHealth Intelligence

The number of outpatient visits after hospital discharges remained stable during the COVID-19 pandemic but telehealth use for these visits increased, suggesting that telehealth was a substitute for in-person care rather than an addition, a study published in JAMA Health Forum revealed.