Tuesday’s Tidbits

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Delta variant front, David Leonhardt in the New York Times Mornings column tries to place the pre-Thanksgiving increase in COVID cases in perspective. He encourages readers to recognize that it’s the cadre over 65 and particularly those in their 80’s and 90’s who are threatened by COVID.

Covid is the threat on many of our minds. But for most people under 65, the virus may present less risk than a car trip to visit relatives this week.

The situation is more frightening for older people, especially those in their 80s and 90s. For the oldest age groups, Covid presents a real risk even after vaccination. It appears to be more dangerous than a typical flu and much more dangerous than time spent riding in a vehicle, based on C.D.C. data.

As a result, older Americans need protection during a surge. (The same is also true of a small percentage of younger people with specific vulnerabilities to Covid, like organ-transplant recipients.) The most effective way to protect vulnerable people is through vaccination — not only of them but also of others who might infect them [e.g., initial vaccinations for children beginning at age 5 and young teenagers and boosters for fully vaccinated adults, after two months for the Johnson & Johnson vaccine and six months for the mRNA vaccines.]

STAT News reminds us that the FDA will consider granting emergency use authorization to the Merck anti-viral pill for treating early COVID next Tuesday. However,

[C]linical trials for both the Pfizer and Merck antivirals focused on unvaccinated people with at least one risk factor for developing severe Covid-19. Trial data, as disclosed by the drug companies, shows them to be remarkably effective: No patient in either study died after being treated with a course of antivirals.

But it might be difficult to get the drugs outside a clinical trial setting. Depending on the particular patient, it could involve four individual steps: recognizing symptoms, receiving a positive Covid-19 test result, being prescribed an antiviral by a doctor, and picking up the pills at a nearby pharmacy.

Each step could prove difficult, Gaffney said, beginning with the challenge of recognizing symptoms during winter, when early signs of Covid-19 might be easily written off as a cold, flu, or allergies. Even if patients do quickly suspect they have Covid, diagnostic tests are still sometimes hard to come by. Many of the patients who test positive won’t have primary care physicians. And perhaps worst: The antivirals are ideally taken just three days after symptom onset, meaning the four-step process can’t face any setbacks.

Of all the challenges patients will face when seeking the antiviral treatments, the lack of access to efficient testing is by far the largest. * * *

[Céline] Gounder, a physician and NYU professor who served on President Biden’s Covid advisory board in the months before his inauguration] suggested that some immunocompromised people, for instance, should be prescribed the antivirals preemptively, if they’re exposed to Covid but haven’t tested positive — eliminating a potentially burdensome step. * * *

Ideally, though, people who live outside congregate settings would be able to access the same level of service at retail pharmacies. Other fixes, Gounder suggested, could include issuing a “standing order” for the drugs — essentially, allowing an entire city or state’s population to receive the drugs without a prescription.

In other words, we are close to having a Flonase for COVID.

From the Delta variant vaccine mandate front, the Wall Street Journal reports that

The Biden administration on Tuesday filed an emergency court motion that seeks the immediate reinstatement of its rules requiring many employers to ensure their workers are vaccinated or tested weekly for Covid-19.

The Justice Department filed the request with the Sixth U.S. Circuit Court of Appeals in Cincinnati, which last week was designated as the court that would decide legal challenges filed around the country to the vaccine-or-testing rules.

The Occupational Safety and Health Administration earlier this month formally issued the requirements, which apply to businesses with 100 or more employees. The rules cover roughly 84 million workers and are scheduled to take effect Jan. 4.

Also because the government contractor mandate requires contractors to verify its employees’ COVID vaccination status with supporting documents, the Society for Human Resource Management offers guidance on how employers can recognize fake vaccination cards.

From the tidbits department —

  • The Federal Times informs us that “Legislation introduced in the House Tuesday would not only establish credentials necessary for all future Office of Personnel Management directors, but also formally dictate the agency’s role in leading human resources through data-driven and modern policy. Under the bill, introduced by Rep. Gerry Connolly, D-Va., a nominee for OPM director would have to have prior human capital experience and be chosen without regard for political affiliation.”

The [independent dispute] system chosen by the Biden administration was expected to push insurance premiums down by 0.5% to 1%, the Congressional Budget Office estimated.

“Everyone has to give a little to get to a good place,” [HHS Secretary] Becerra said. “That sweet spot, I hope, is one where patients … are extracted from that food fight [between out of network providers and health plans]. And if there continues to be a food fight, the arbitration process will help settle it in a way that is efficient, but it also will lead to lower costs.”

  • The International Foundation of Employee Benefit Plans provides its insights into the new proposed rule on ACA reporting referenced in yesterday’s FEHBlog post. The proposed rule would provide:

— An Automatic 30-Day Extension of Deadline for Furnishing Statements Under Sections 6055 and 6056

— An Alternative Manner of Furnishing Statements Under Section 6055 During Taxable Years When the Individual Shared Responsibility Payment is Zero

Under the proposed alternative manner of furnishing, the reporting entity must post a clear and conspicuous notice on the entity’s website stating that responsible individuals may receive a copy of their statement upon request. The notice must include an email address, a physical address to which a request may be sent, and a telephone number that responsible individuals may use to contact a reporting entity with any questions.

The public comment period on this IRS proposed rule ends in roughly sixty days.

  • Govexec offers a helpful to-do list for the ongoing Federal Benefits Open Season from Nov. 8-Dec. 13
  1. Use the plan comparison tools available at OPM’s website and Checkbook’s Guide to Federal Health Plans to compare the top three or four health plan options for you and your family’s needs.
  2. Register to attend a virtual health fair hosted by the Federal Long Term Care Insurance Program. There will be live chat days on Nov. 12, Nov. 19, Dec. 1, and Dec. 8. 
  3. The National Active and Retired Federal Employees Association’s Federal Benefits Institute will have a variety of resources available during open season, including a live webinar series. 

Monday Roundup

Photo by Sven Read on UnsplashFr

From the Delta variant front, STAT News informs us that

Pfizer and BioNTech announced Monday that their Covid-19 vaccine was 100% efficacious in preventing infections in 12- to 15-year-olds, measured from seven days to four months after administration of the second dose of the vaccine.

The companies said the new data — a longer-term analysis of a Phase 3 trial conducted in 2,228 participants — will form the basis of an application to the Food and Drug Administration for an extension of their Covid-19 vaccine license to cover youths in the age group. 

“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a Covid- 19 vaccine in individuals 12 to 15 years of age,” Ugur Sahin, CEO and co-founder of BioNTech, said in a statement. “The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favorable safety profile of our Covid-19 vaccine across adolescent and adult populations.”

Astra-Zeneca announced late last week that

New data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination.

In an analysis of the ongoing PROVENT trial evaluating a median six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%.

About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.This includes people with blood cancers or other cancers being treated with chemotherapy, patients on dialysis, those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.2-6

The AZD7442 PROVENT trial is the first Phase III trial prospectively designed to evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic COVID-19, with targeted inclusion of high-risk and immunocompromised participants. More than 75% of PROVENT participants at baseline had co-morbidities that put them at high risk for severe COVID-19 if they were to become infected, including people who are immunocompromised and may have a reduced immune response to vaccination.

There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with  AZD7442 at either the primary or six-month analyses. In the placebo arm, there were two additional cases of severe COVID-19 at the six-month assessment, for a total of five cases of severe COVID-19 and two COVID-related deaths.

Developing new early treatment options is encouraging news. Kaiser Health News reminds us that the success of these new early anti-viral treatments hinges on widespread availability of inexpensive at home COVID tests.

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

More than 90% of federal employees have received at least one dose of the COVID-19 vaccine by the president’s deadline, a senior administration official said Monday.

Most of those employees are fully vaccinated, the Biden administration said. All told, some 95% of employees have taken steps to comply with the Biden administration’s federal vaccine mandate by the Nov. 22 deadline — a figure that includes partially and fully vaccinated employees, as well as those who have a medical or religious exception pending or approved.

“Critically, the Nov. 22 deadline is not an end point; we continue to see more and more federal employees providing their information and getting their shots,” the administration official said in an email.

Agencies will continue to collect information, as well as requests for exceptions “due to documented medical necessities” in the coming days, the White House said.

The Office of Management and Budget will release a more detailed breakdown of vaccination rates within individual agencies on Wednesday.

The Society for Human Resource Management offers an article about the role of boosters in employer sponsored vaccination programs:

All U.S. adults are now eligible to receive a COVID-19 vaccine booster, so long as a certain number of months have passed since their last dose. As employers revise their vaccination policies, they may be wondering if they should require workers to get an extra jab to be considered “fully vaccinated.” Here’s what employment law attorneys had to say. 

At least for now, employment law attorneys recommend that businesses hold off on mandating booster shots.

“At this point, I think it is probably too soon to make those updates,” said Jim Hermon, an attorney with Dykema in Detroit. 

John Thomas Jr., an attorney with McGuireWoods in Tysons, Va., noted that employers are focused on helping their employees get over the hurdle of initial vaccination. “Some geographic areas—and some industries—are still struggling to reach a critical mass of people willing to get the shot in the first place.”  * * *

Although it may be too soon for many employers to add booster shots to their vaccination policies, attorneys said workplace leaders can start planning now. 

“I think it is company-specific,” said Katherine Dudley Helms, an attorney with Ogletree Deakins in Columbia, S.C. Some workplaces have seen a high percentage of employees get vaccinated, she said, so it might make sense to add the boosters to their recommendations as the shots are authorized. 

On the other hand, she noted, if the workforce vaccination rate is low or vaccination has been a battle for the employer, it may be wiser to try to focus on raising the rate of initial vaccination rather than adding the booster on top of that. Even with this approach, she said, an employer can certainly support and encourage employees who are eligible and wish to get the booster shot.

“My experience is that those who do not mandate vaccinations are preparing policies and practical plans for the likelihood that they may become mandatory either because of federal requirements or because the timing is right,” Helms observed.

Just as with the initial vaccinations, she said, employers should let workers know if the company will pay for the costs associated with getting the booster, including the time spent getting the shot. Employers should also address how time off will be treated if employees have a reaction.

From the Rx coverage from, Med City News reports on Walgreen’s new strategy. “The company launched a new health division, and has doubled down on its plans to open primary care clinics with VillageMD. It faces big competitors in CVS and Walmart, and it’ll take time to see if its new strategy pays off.” Walgreen’s, of course, is not alone in this endeavor.

Neal Batra and David Betts, who have studied consumers’ thoughts on healthcare for Deloitte, said people are primarily looking for three things: meaningful interactions with their provider, visits that make economic sense, and convenience. Booking a visit a month out to spend 10 minutes with a doctor ticks none of these boxes.

“We’ve believed for a long time that this [retail approach taken by Walgreen’s, CVS Health and Walmart, among others] is the direction that consumer healthcare will go. What we see now is that playing out,” said Betts, who leads the public health transformation effort for Deloitte Consulting.

The pandemic, in some ways, accelerated that. People didn’t want to sit in busy waiting rooms, and were more open to other care modalities, like telehealth. Pharmacy chains were also given big contracts for Covid-19 testing and vaccines, driving more people to their stores.

Batra, a principal in Deloitte’s Life Sciences and Health Care practice, said “it’s super logical” for retailers to look at primary care, because it involves routine visits and engagement points.

“It’s a very natural place to enter,” he said. “Are you going to see some of these models continue what we would call an upmarket march to go after more and more complex aspects of primary care, or even dip their toe into specific therapy areas that are more specialized? It remains to be seen, but our expectation is yes.”

For example, pharmacies could offer blood-pressure measurements, and blood-glucose testing for people with prediabetes or diabetes. For retailers, the cost of doing this would be relatively low, while the value for patients would be high.

From the ACA front, the Internal Revenue Service today released a proposed rule on ACA reporting by insurers and self-funded employers, Forms 1095 and 1096. The FEHBlog still needs to review it. The reporting which was developed to support enforcement of the ACA’s tax penalties for failure to carry minimum essential coverage are a mysterious component of the zeroed out penalty world that has existed for three years. The handful of states and DC which have adopted individual mandates can use the IRS forms.

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.

Midweek Update

Photo by Josh Mills on Unsplash

From the Delta variant vaccine front, the New York Times reports

The Food and Drug Administration is aiming to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday, a move that would expand the number of Americans eligible for additional shots by tens of millions, according to people familiar with the agency’s plans.

The Centers for Disease Control and Prevention’s independent committee of vaccine experts has scheduled a meeting for Friday to discuss data on the booster dose’s efficacy and safety. If both the F.D.A. and the C.D.C. sign off this week, they will have acted strikingly quickly — a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older.

Under that scenario, any adult who received a second dose of the vaccine at least six months earlier would be officially eligible to get a booster as soon as this weekend. The F.D.A. is expected to rule without consulting its own expert panel, which has met frequently during the pandemic to review vaccine data and make a recommendation ahead of a regulatory decision.

Moderna is expected to soon submit its own request for the F.D.A. to broaden eligibility for its booster. But for now, every adult could get the Pfizer booster, according to people familiar with the planning.

From the Delta variant research front, the National Institutes of Health has announced that

Lung autopsy and plasma samples from people who died of COVID-19 have provided a clearer picture of how the SARS-CoV-2 virus spreads and damages lung tissue. Scientists at the National Institutes of Health and their collaborators say the information, published in Science Translational Medicine, could help predict severe and prolonged COVID-19 cases, particularly among high-risk people, and inform effective treatments.

From the Delta variant vaccine mandate front, Govexec tells us that

The White House will not back down from next week’s deadline for virtually all federal employees to prove they are vaccinated against COVID-19, despite calls for a delay.  The federal workforce has until Nov. 22 to provide documentation demonstrating they are inoculated or to request an exemption under an executive order issued by President Biden. 

From the opioid epidemic front, the Washington Post informs us that

The U.S. drug epidemic reached another terrible milestone Wednesday when the government announced that more than 100,000 people had died of overdoses between April 2020 and April 2021. It is the first time that drug-related deaths have reached six figures in any 12-month period. * * *

The new data shows there are now more overdose deaths from the illegal synthetic opioid fentanyl than there were overdose deaths from all drugs in 2016.

Fentanyl is many times more powerful than morphine, leading to more frequent fatal overdoses. It is increasingly laced into other drugs, such as cocaine, and counterfeit pills, killing some who consume it unknowingly.

During the worst of the pandemic, more users were alone, reducing the chances that other users or bystanders could call first responders in the event of an overdose, experts have said. * * *

The number of opioid prescriptions issued by health-care providers has declined sharply as the crisis continues.

Addiction preys on young and middle-aged adults, who make up the bulk of those with drug-related substance use disorder.

Compounding the problem is the fact as related by Sam Quinones in his recent book the Least of Us that while a lethal dose of heroin takes about 15 minutes to kill a person, a lethal dose of fentanyl will take a minute or two to do so. That’s hardly enough time to administer naloxone which can pull people back from the brink of death. The FEHBlog wishes that Pfizer and Merck could develop a pill to cure substance abuse.

From the Open Season front, Reg Jones in Fedweek offers thoughts on how to use the ongoing federal benefits open season to the readers’ advantage.

From the No Surprises Act front, Healthcare Dive reports that

A key sticking point [stemming from the tri-agencies’ independent dispute resolution interim final rule] is the arbitration process, and how the qualifying payment amount (QPA) — determined by a plan’s median in-network contracted rate for a geographic area — is used to arrive at rates for out-of-network providers.

The Association of Air Medical Services filed a lawsuit in federal [district] court [for the District of Columbia, No. 1:21-cv-03031] challenging the rules Tuesday, claiming reliance on a QPA strays from Congress’ intent when passing the law that “no single statutory factor receives special weight” in the arbitration process.

As the FEHBlog previously noted, the Texas Medical Association has filed a similar lawsuit in the Lone Star State.

Encouragingly, Healthcare Dive adds that

The rules guiding the arbitration process are a form of consumer protection, 63 organizations representing patients, consumers, unions and employers said in a Tuesday letter.

An over reliance on out-of-network charges, particularly among Wall Street-backed providers, extracts maximum costs from patients, employers and health systems, thus driving up premiums and contributing to ever-rising healthcare spending in America, they said.

“As outlined in the interim final rule, it is only by reinforcing the QPA as the overriding and primary factor for determining final payment that the No Surprises Act can achieve the $17 billion in cost savings outlined by the Congressional Budget Office,” the groups wrote.

Amen

Also from the NSA front, the tri-agencies and OPM released an interim final rule implementing NSA Section 204’s burdensome yet aggregated prescription drug and healthcare cost reporting requirements imposed on health plans. The accompanying fact sheet explains

Summary of the November 17, 2021 IFC

This IFC requires plans and issuers in the group and individual markets to submit certain information on prescription drug and other health care spending to the Departments annually, including:

General information regarding the plan or coverage;

Enrollment and premium information, including average monthly premiums paid by employees versus employers; 

Total health care spending, broken down by type of cost (hospital care; primary care; specialty care; prescription drugs; and other medical costs, including wellness services), including prescription drug spending by enrollees versus employers and issuers;

The 50 most frequently dispensed brand prescription drugs;

The 50 costliest prescription drugs by total annual spending;

The 50 prescription drugs with the greatest increase in plan or coverage expenditures from the previous year; 

Prescription drug rebates, fees, and other remuneration paid by drug manufacturers to the plan or issuer in each therapeutic class of drugs, as well as for each of the 25 drugs that yielded the highest amount of rebates; and 

The impact of prescription drug rebates, fees, and other remuneration on premiums and out-of-pocket costs.

The IFC provides that plan sponsors, issuers, and FEHB carriers generally will be required to submit this information aggregated at the state/market level, rather than separately for each plan. To ensure that the Departments and OPM are able to conduct meaningful data analysis and identify prescription drug trends, the IFC further provides uniform standards and definitions, including for identifying prescription drugs regardless of the dosage strength, package size, or mode of delivery.

Applicability Date and Comment Period

The CAA requires plans and issuers to begin submitting the required information to the Departments by December 27, 2021, and to submit this information by June 1 of each year thereafter. However, the Departments have announced that they will exercise discretion to provide temporary deferral of enforcement with regard to the December 27, 2021 and June 1, 2022 deadlines, and that they will not initiate enforcement action against a plan or issuer that submits the required information for 2020 and 2021 by December 27, 2022. OPM also will allow its FEHB carriers to report information for 2020 and 2021 by December 27, 2022.

Comments on this IFC are due at 5 p.m. on January 24, 2022.

Before long, health plans, and especially FEHB carriers, will be spending most of their time reporting data to the government.

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.

Friday Stats and More

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the wee, here is the FEHBlog’s weekly chart of new COVID cases this year:

New cases plateaued this week. Weekly new COVID hospitalizations continue their down trend. For the latest week, the number of new admissions was 5,025 compared to a peak of 16,478 in the first week of 2021.

The number of COVID-related deaths continues it decline according the FEHBlog’s chart:

Distribution and administration of COVID vaccines was up sharply the past two weeks. At least one million doses were administered daily last week.

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

As of November 4, 2021, 426.7 million vaccine doses have been administered. Overall, about 222.6 million people, or 67% of the total U.S. population, have received at least one dose of vaccine. About 193.2 million people, or 58.2% of the total U.S. population, have been fully vaccinated.* About 21.5 million additional/booster doses in fully vaccinated people have been reported. As of November 4, 2021, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 1,510,524, a 55.8% increase from the previous week.

The best news is Pfizer’s announcement of a successful trial of antiviral pill to tame early COVID.

  • PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19
  • In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
  • Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible

The Merck pill that Great Britain approved this week and the FDA will consider this month had the following reporting efficacy in its trial —

  • At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died

The FEHBlog points this out to illustrate the strength of the Pfizer pill not to downplay the Merck pill.

The public health strategy for defeating COVID always has been a combination of testing, drugs, and vaccines. Nobody expected the vaccines to lead the pack, but the FEHBlog is grateful that testing and drugs finally are catching up to the wonderous vaccines. You combine these new drugs with rapid at home tests like the recently FDA approved FlowFlex on top of the vaccines, and you are left with endemic COVID in the FEHBlog’s view. As the FEHBlog is not a medical expert, let’s close this section with a squib from STAT News:

The development of oral medicines that can be used to treat Covid early on could blunt the impact of the pandemic.

Nahid Bhadelia, the founding director of the Center for Emerging Infectious Diseases Policy & Research at Boston University, called oral antiviral pills “incredibly important” because existing treatments such as monoclonal antibodies must be given intravenously or as shots.

“With an oral antiviral, patients have more time and greater access to a treatment that will keep them out of the hospital,” Bhadelia said. “But the promise of oral antivirals will only be recognized if they’re available at your local pharmacy, and you can afford it, and you can get the test that tells you that you’re positive for Covid, so you can actually take advantage of this drug. So, the promise is there, but the rest of the pieces need to come together.”

From the tidbits department —

Morning Consult reports that

  • 72% of U.S. adults who have used telehealth said they’ve accessed virtual care through their regular provider or health plan, while another 17% have gotten care through a direct-to-consumer platform and 11% have used both types of services.
  • 53% of U.S. adults said they’d rather use in-person health care than telehealth moving forward, but that share fell to 45% among those who have used telehealth in the past.
  • Among the challenges for on-demand telehealth is getting coverage for the services, as traditional payers and providers roll out their own virtual care options.

The HHS Agency for Healthcare Quality and Research reports that

The Lehigh Valley Health Network (LVHN) used an AHRQ initiative to expand treatment for opioid use disorders in Pennsylvania. As a result, primary care physicians are now using medication-assisted treatment to care for their patients with opioid use disorders.  This new practice has been a success; as of fall 2021, 75 percent of patients who initiated treatment have returned in the following calendar month to continue treatment. With addiction treatment, this number of returning patients represents a major improvement, as most patients traditionally end treatment quickly.

With eight hospitals and numerous health centers, physician practices, rehabilitation locations, and other outpatient locations, LVHN serves patients in seven eastern Pennsylvania counties. LVHN used AHRQ resources to integrate treatment for opioid use disorder into primary care practice.

“In one visit, a patient can get his diabetes and blood pressure medications, plus his medication for opioid use disorder, without feeling the judgement of going to an addiction specialist,” noted Gillian A. Beauchamp, M.D., LVHN emergency physician. “When you’re sitting in a primary care waiting room, nobody knows why you’re there, so you don’t feel the stigma you might in another setting of care.”

Bloomberg tells us that

Even though the [COVID pandemic] upheaval increased risk factors for suicide like financial stress, the number of Americans who took their own lives decreased by 3% in 2020, the Centers for Disease Control’s statistical group reported this week

Suicides had increased steadily this century before peaking in 2018 with 48,000 annual deaths. That number declined slightly in 2019 and continued to drop in 2020, to less than 46,000, according to the CDC’s provisional data. In April, when shutdowns were most severe, the U.S. saw the lowest number of suicides in any month of 2020, 14% below the previous year’s total that month.

Federal News Network reports

In an ongoing effort to inject more young talent into the federal workforce, the Office of Personnel Management is out with yet another new hiring policy.

The latest policy, which OPM will publish as an interim rule Friday, is designed to help agencies more easily recruit and hire recent college graduates into administrative and professional positions in the federal government.

The new hiring policy means agencies can noncompetitively appoint qualified and eligible college graduates to permanent career positions at or below the General Schedule 11 level, OPM said. In a blog post on the new policy, OPM Director Kiran Ahuja said recent gradates have a chance to earn up to $72,000 a year under this new authority.

Thursday Miscellany

From the Delta variant vaccine front, The American Hospital Association informs us that

  • The Centers for Medicare & Medicaid Services today issued an interim final rule requiring COVID-19 vaccinations for workers in most health care settings, including hospitals and health systems, that participate in the Medicare and Medicaid programs. The rule is effective Nov. 5. Under the regulation, all eligible workers must be fully vaccinated by Jan. 4, 2022.
  • Also this morning, the Occupational Safety and Health Administration (“OSHA”) issued an emergency temporary standard requiring all employees at private businesses with 100 or more workers to be vaccinated by Jan. 4 or get tested for COVID-19 weekly.

The Society for Human Resource Management (SHRM) provides us with SHRM’s Top Takeaways from the OSHA ETS:

  • Employees must be fully vaccinated by January 4, 2022, and employers must require unvaccinated employees to mask and produce a negative test on at least a weekly basis.
  • Employers are required to have a written vaccination policy.
  • The OSHA ETS does not apply to employees who do not report to a workplace where there are other individuals such as coworkers or customers are present; employees working from home; or employees who work exclusively outdoors.
  • The OSHA ETS does not require employers to provide or pay for tests.
  • Employers must pay employees for the time it takes to get vaccinated.
  • Employers must ensure all unvaccinated employees are masked.
  • Employers must report COVID-19 fatalities and hospitalizations to OSHA.
  • The OSHA ETS reaffirms that employers must provide reasonable accommodations.
  • According to the Department of Laborvaccine, testing and face-covering requirements preempt inconsistent state and local requirements.

Closer to home, the OSHA ETC does not apply to workplaces subject to EO 14042 on Requiring Coronavirus Disease 2019 Vaccination for Federal Contractors. However, Govexec points out that

“Under the [Occupational Safety and Health Act], the U.S. Postal Service is treated as a private employer,” said OSHA’s emergency temporary standard, set to officially publish in the Federal Register on Friday. “It is therefore required to comply with this [emergency temporary standard] in the same manner as any other employer covered by the act.” 

The [Labor Department] spokesperson added that there are about 500,000 postal workers and confirmed that the rule applies to all of them.

Federal New Networks adds that

The Biden administration on Thursday pushed back the deadline for federal contractors to comply with its vaccine mandate.

Contractors now have until Jan. 4, 2022, the same deadline the White House set for private sector companies with 100 employees or more to comply with vaccine and testing requirements from the Labor Department’s Occupational Safety and Health Administration. * * *

The White House said it will not apply the OHSA emergency temporary standard or the CMS rule to workplaces subject to the federal vaccine mandate for contractors, so employers won’t have to track multiple requirements.

While federal contractors now have the same Jan. 4 deadline as other private sector companies, there’s a key difference between the two policies.

Under the new OSHA standard, companies with 100 employees or more have to ensure their workers have received either one or both shots by Jan. 4 — or tests for COVID-19 at least weekly.

Under the federal vaccine mandate for contractors, employees don’t have the option to be tested weekly, at least not at this point.

Govexec reports that “The Office of Personnel Management on Wednesday reminded agencies that they must grant federal employees administrative leave to accompany their children to get the COVID-19 vaccine, following the news that more children are now able to get vaccinated.” It would be helpful if OPM gave direct guidance to FEHB carriers on the contractor vaccine mandate.

From the Delta variant front, STAT News reports that

Britain granted conditional authorization on Thursday to the first pill shown to successfully treat Covid-19 so far. It also is the first country to OK the treatment from drug maker Merck, although it wasn’t immediately clear how quickly the pill would be available.

The pill was licensed for adults 18 and older who have tested positive for Covid-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate Covid-19 would take four pills of the drug, known molnupiravir, twice a day for five days.

An antiviral pill that reduces symptoms and speeds recovery could prove groundbreaking, easing caseloads on hospitals and helping to curb outbreaks in poorer countries with fragile health systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.

Molnupiravir is also pending review with regulators in the U.S., the European Union, and elsewhere. The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize the pill’s safety and effectiveness in late November.

From the preventive care front —

The Associated Press informs us that

A government advisory committee on Wednesday recommended that all U.S. adults younger than 60 be vaccinated against hepatitis B, because progress against the liver-damaging disease has stalled. 

The decision means that tens of millions of U.S. adults — mostly between the ages of 30 and 59 — would be advised to get shots. Hepatitis B vaccinations became standard for children in 1991, meaning most adults younger that 30 already are protected.

“We’re losing ground. We cannot eliminate hepatitis B in the U.S. without a new approach,” said Dr. Mark Weng of the Centers for Disease Control and Prevention.

The Advisory Committee on Immunization Practices voted unanimously to approve the recommendation Wednesday. The CDC’s director, Dr. Rochelle Walensky, must sign off on it before it becomes public policy, but it’s not clear when she will decide.

The American Cancer Society tells us about the proper use of lung screenings to detect cancer in this Lung Cancer Awareness Month.

The Robert Woods Johnson Foundation has updated its report on the state of childhood obesity in our country.

From the healthcare business front —

Fierce Healthcare reports that

Cigna wrapped up third-quarter earnings for major national payers Thursday morning, where it reported $1.6 billion in profit for the quarter.

The results surpassed Wall Street expectations, according to Zacks Investment Research. Cigna also brought in $44.3 billion in revenue in the third quarter, according to the earnings report, which also beat analysts’ projections.

Both figures were up significantly year over year, Cigna said. In the third quarter of 2020, the insurer earned $1.4 billion in profit and brought in $41 billion in revenue. * * *

Due to the results, Cigna raised its guidance and now expects $20.35 in earnings per share for 2021. The insurer expects full-year revenues of $172 billion.

Fierce Healthcare also catalogs “new [healthcare M&A] deals that were revealed, closed or called off during the month of October.

In that regard Beckers Payer Issues reports that

UnitedHealth Group and Change Healthcare entered into an amended agreement with the Justice Department not to finalize the healthcare companies’ proposed $13 billion deal until late February.

Four things to know:

1. Under the new timing arrangement, the companies agreed not to consummate their deal before Feb. 22, 2022, according to Change Healthcare’s Nov. 3 earnings report

2. The new date amends a previous timing agreement announced in August, under which, UnitedHealth and Change agreed to wait at least 120 days after certifying compliance with the Justice Department’s request for more information. Both organizations had agreed to not certify compliance with the request before Sept. 15, meaning the 120 days would have expired in January 2022.

3. The organizations announced the proposed acquisition in January. Change shareholders approved the deal despite backlash from hospital groups arguing that the proposed combination is anticompetitive. 

4. On March 24, the Justice Department issued a second information request to the organizations. In the Nov. 3 earnings report, Change Healthcare shared that it and UnitedHealth “certified substantial compliance” with the second request.

Also STAT News provides a “progress report on Big Retail’s ambitions in health care.” This point impressed the FEHBlog

[T]he physical assets of retail players stand to give them a substantial leg up in parts of the country not already saturated by startups and other rivals, including the Midwest and broad swaths of the South.

“Most people in America live close to some of these retail giants and not to a health care provider,” said Gadelrab, who visited a Walmart for the first time to get tested for Covid-19.

Even for retailers’ significantly buzzier rivals, such as hybrid care startups Carbon Healthand women’s care-focused Tia, physical locations have remained a core part of their business models amid the pandemic, pitting their offerings somewhat against the services offered by Walmart, in particular.

“For us, the physical experience has been around making preventive health something women want to engage in before something is wrong,” said Carolyn Witte, Tia’s co-founder and chief executive officer.

That physical proximity could prove especially useful, Gadelrab said, as parts of the U.S. health care system begin to shift away from a fee-for-service treatment model to one based on value-based or preventive care, since it could theoretically allow retail giants to keep more consistent tabs on patients, much in the same way popular telehealth tools check in regularly with their users. At the same time, retailers also maintain reams of data on consumer health and wellness spending, and more recently, vaccination status — information that could be used to better inform their health care offerings or reach more potential clients.

Midweek Update

From the Delta variant front —

STAT News offers an in-depth report on the Delta plus (AY.4.2) variant that has shown up in the United Kingdon. The article concludes

It’s possible that whatever transmission advantage AY.4.2 has over Delta is so narrow that it will take a while for it to start to gain on its parent strain in places beyond the United Kingdom. Also, there’s a lot of randomness when a new form of a pathogen gets introduced into an area — many imported cases simply die out without setting off a transmission chain. If AY.4.2 has just a small edge over Delta, then probability dictates it would require more imported cases for some to take off than if something much more transmissible arrived.

Some variants also don’t circulate everywhere — a lot depends on what other versions of the virus are out there, and what the local environment looks like. The Alpha and Delta variants were so much more transmissible than the other iterations of the virus that were present when they emerged and encountered so many susceptible people that they became dominant. The Beta and Gamma variants, however, only caused issues in the regions where they emerged; there were cases detected elsewhere, but they never drove outbreaks globally.

At this point, it’s too early to say what impact, if any, AY.4.2 will have in the United States. It takes higher levels of population immunity to slow more transmissible pathogens, but between vaccinations and past infections, the country has a big wall of protection out there, with vulnerable pockets interspersed. For now, U.S. modeling still indicates a continued ebbing of the epidemic.

In other encouraging news, the Wall Street Journal informs us that

A widely available antidepressant holds promise as a treatment for Covid-19, according to a new study. Covid-19 patients who received fluvoxamine were significantly less likely to require hospitalization than those who didn’t, in the largest clinical trial evaluating the antidepressant’s effect on Covid-19 to date.

Fluvoxamine belongs to a class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. It is commonly used to treat obsessive compulsive disorder and is also prescribed for depression. In use for decades, fluvoxamine has been shown to be safe and costs about $4 for a 10-day course, said Edward Mills, one of the study’s lead researchers and a professor of health sciences at McMaster University in Hamilton, Ontario. He said fluvoxamine’s low cost and wide availability make it a compelling alternative to other Covid-19 therapies including monoclonal antibody treatments, which are costly and require an infusion. Another treatment, Merck & Co. and Ridgeback Biotherapeutics LP’s experimental molnupiravir pill, will cost the U.S. government around $700 per course in the U.S.

“For both poor countries and even wealthy countries, it’s a great option,” Dr. Mills said of fluvoxamine. * * *

“This is exciting data,” said Daniel Griffin, chief of infectious disease at healthcare-provider network ProHealth New York, who wasn’t involved in the study. “There are several other trials that are in progress and if they confirm this finding, this may end up being standard of care.”

In related good treatment news, STAT News tells us that “In a notable bid to widen access to Covid-19 remedies, Merck has agreed to license its widely anticipated antiviral pill to the Medicines Patent Pool, which in turn can now strike deals with other manufacturers to provide versions of the drug to 105 low and middle-income countries.”

From the gene therapy front, the National Institutes of Health (NIH) announced that the “U.S. Food and Drug Administration, [NIH], 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease. While there are approximately 7,000 rare diseases, only two heritable diseases currently have FDA-approved gene therapies. The newly launched Bespoke Gene Therapy Consortium (BGTC), part of the NIH Accelerating Medicines Partnership (AMP) program and project-managed by the Foundation for the National Institutes of Health (FNIH), aims to optimize and streamline the gene therapy development process to help fill the unmet medical needs of people with rare diseases.

In a more practical development,

Aetna®, a CVS Health® company, announced the launch of its designated Gene-based, Cellular, and Other Innovative Therapies™ (GCIT) network. This network is designed to enable members’ access to new therapies that treat and potentially cure rare genetic diseases, while helping to manage the high cost of these therapies. Aetna’s national GCIT network includes access to more than 75 designated GCIT service providers that have demonstrated quality and value in the delivery of GCIT services.

Beginning January 1, 2022, Aetna’s designated GCIT network will provide three gene therapy services, including Luxturna, Spinraza and Zolgensma for the treatment of inherited retinal disease and spinal muscular atrophy. The GCIT network is included as a standard medical benefit in all Aetna fully insured plans and is also available to self-insured plans.  

From the reports and studies front

NIH released

Part two of the latest Annual Report to the Nation on the Status of Cancer [which] finds that cancer patients in the United States shoulder a large amount of cancer care costs. In 2019, the national patient economic burden associated with cancer care was $21.09 billion, made up of patient out-of-pocket costs of $16.22 billion and patient time costs of $4.87 billion. Patient time costs reflect the value of time that patients spend traveling to and from health care, waiting for care, and receiving care, according to the report.

The report, appearing October 26, 2021, in JNCI: The Journal of the National Cancer Institute, is the most comprehensive examination of patient economic burden for cancer care to date and includes information on patient out-of-pocket spending by cancer site, stage of disease at diagnosis, and phase of care. While this analysis is about the costs that are directly incurred by patients, which are critical to patient finances, the total overall costs of cancer care and lost productivity in the United States are much larger.

The Patient Centered Outcomes Research Institute (PCORI) announced its adoption of “five National Priorities for Health, which serve as ambitious long-term goals to guide PCORI’s funding of patient-centered comparative clinical effectiveness research (CER) and other engagement, dissemination and implementation, and research infrastructure initiatives. The adopted National Priorities for Health are:

  • Increase Evidence for Existing Interventions and Emerging Innovations in Health 
  • Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research 
  • Advance the Science of Dissemination, Implementation, and Health Communication 
  • Achieve Health Equity, and
  • Accelerate Progress Toward an Integrated Learning Health System”

From the substance use front, “Health and Human Services Secretary Xavier Becerra today announced the release of the new HHS Overdose Prevention Strategy, designed to increase access to the full range of care and services for individuals who use substances that cause overdose, and their families.  This new strategy focuses on the multiple substances involved in overdose and the diverse treatment approaches for substance use disorder. * * * For more information on the new Overdose Prevention Strategy, visit: www.hhs.gov/overdose-prevention/.  Read the full issue brief here: https://aspe.hhs.gov/reports/overdose-prevention-strategy

From the teleheath front, Healthcare Dive takes “a look at Teladoc’s primary care strategy from its head of US group health. Kelly Bliss teased upcoming clients for a new virtual-first primary care product and parsed out Teladoc’s growth strategies for 2022 and beyond.” Enjoy.