Friday Stats and More

Rx coverage

Friday Stats and More

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, No Surprises Act, Rx coverage, SCOTUS, U.S. Healthcare–

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

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

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

The Wall Street Journal adds that

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

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

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

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

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

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

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

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

The Wall Street Journal notes that

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

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

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

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

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

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

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

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

From the Capitol Hill front, FedWeek informs us that

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

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

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

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

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

From the judicial front

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

From the healthcare business front —

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

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

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

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

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

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

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

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

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

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

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

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

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, COVID vaccine mandate, COVID-19, Government Contracting, Mental health care, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports that

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

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

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

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

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

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

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

This PI applies to all FEHB plan contractors and subcontractors.

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

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

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

Look up case and deaths counts for your county here.

From the Rx coverage front, Drug Channels released its

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

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

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

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

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

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

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

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

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

— Offering telehealth services (63 percent).

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

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

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

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

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

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

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

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

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

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

Friday Stats and More

David Ermer–Congress, COVID-19, COVID-19 vaccine, OPM, Rx coverage–

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

The Wall Street Journal reports that

The new Omicron variant was identified in more than a dozen people in at least nine states, early evidence of its presence across the U.S.

While some of the people in the U.S. who have contracted the Omicron variant of the coronavirus that causes Covid-19 had recently traveled to southern Africa, where it was first identified last week, at least two states reported community spread of the new variant. States to report Omicron cases span the country from Hawaii to California and New York.

“It’s certainly spreading in the U.S.,” said Samuel Scarpino, managing director of pathogen surveillance at the Rockefeller Foundation. 

The Delta variant begs to note add “all of the other cases are mine.”

Here is a link to the CDC’s chart of new COVID hospitalizations which continues to trend up.

Here is the FEHBlog weekly chart of new COVID deaths for 2021

Oddly the number of deaths popped up last week.

Here’s the FEHBlog’s weekly new COVID vaccinations delivered and administered during the last two weeks of 2020 and this year.

In this regard, the Wall Street Journal reports that

The U.S. has plenty of Covid-19 vaccines but retail pharmacies are struggling to quickly administer them in some places.

Vaccine seekers in some states face waits of days or weeks for doses as local health officials hustle to improve access to meet surging demand. CVS Health Corp.  Walgreens Boots Alliance Inc. and Walmart Inc., which are facing staffing shortages, now say they may not be able to accommodate people without appointments.

Millions of Americans are newly eligible for booster shots, and federal health officials in November recommended the vaccine for use in children as young as 5 years old. Concerns about the risks posed by the new Omicron variant also are driving more people to get vaccinated, health officials say.

An average of 1.4 million doses were administered daily in the U.S. in the week ended Thursday, a 22% increase from the previous week, which included Thanksgiving, according to the Centers for Disease Control and Prevention.

(The FEHBlog’s chart does not show a sharp increase because the government was not reporting vaccination statistics over the four day Thanksgiving weekend.)

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

The Society for Human Resource Management discusses the impact of Omicron and the President’s COVID awareness program on employers.

From the influenza front, the CDC reports that “Seasonal influenza activity in the United States remains low, but in recent weeks, the number of influenza virus detections reported by clinical and public health laboratories has increased, and the percent of outpatient visits for respiratory illness has trended upward.” Next week is National Flu Vaccination Week.

From the Capitol Hill front, Federal News Network informs us that as expected,

President Joe Biden signed a continuing resolution Friday to keep funding federal government operations for another three months [precisely February 18, 2022], avoiding a government shutdown.

The  passed the Senate late last night by a margin of 69-28, while the House had approved the same measure earlier in the day on a party line vote, with only one Republican voting in favor.

Federal News Network reports at length about the House Oversight and Reform Committee vote approving an Committee leadership sponsored bill to strengthen OPM (H.R. 6066). The article notes that today OPM Director Kiran Ahuja “spoke at a virtual discussion hosted by NAPA. She reiterated that rebuilding the agency is one of her top priorities. In the last year, OPM has hired about 340 new employees, Ahuja said.”

From the pharmacy / PBM front —

  • Forbes interviews Walgreens CEO Roz Brewer about her primary care oriented strategy for the large pharmacy chain.
  • Fierce Healthcare tells us that

Express Scripts has launched a new solution that aims to integrate prescription discount card pricing into members’ existing benefits.

Through the new Right Price offering, a member who is eligible for savings through a discount card will automatically see those savings applied at the pharmacy counter. Matt Perlberg, senior vice president of supply chain at Express Scripts, told Fierce Healthcare that the pharmacy benefit manager most often sees these discounts come into play for members who have yet to meet their deductible.

For about 2% of claims, members who are purchasing generic drugs but have not yet met the deductible may find these coupon cards lead to a lower price than their drug benefits, Perlberg said.

In other strategy news, Beckers Payer Issues reports that

UnitedHealth Group CEO Andrew Witty said during a Forbes Annual Healthcare Summit discussion he is exploring how the company’s payer and provider branches can work together more closely. 

The initiative aims to provide government and employer customers with more comprehensive offerings, Mr. Witty said Dec. 2, according to Forbes. 

Mr. Witty pointed to developing mental health strategies as one avenue for combined growth.

That makes sense to the FEHBlog.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, Rx coverage–

From the Capitol Hill front, Roll Call reports that

The Senate looks set to clear a House-passed a temporary spending bill Thursday night that would keep the lights on at federal agencies through Feb. 18, buying 11 more weeks to try to resolve partisan disputes over funding levels and policy riders that have stalled progress on fiscal 2022 appropriations.

The stopgap measure passed the House on a 221-212 vote earlier in the evening. The Senate timeline cleared up once it became apparent a group of GOP conservatives would get an up-or-down vote on an amendment to bar funding to implement a new private sector vaccine mandate.

“I think we’re gonna get our amendment at a 50-vote threshold,” Sen. Roger Marshall, R-Kan., told reporters after the House vote. 

A Senate GOP leadership aide said the vote would occur in that chamber Thursday evening. With three absences on the Republican side, senators expected Marshall’s amendment to be defeated, which would set up a vote on clearing the stopgap bill for President Joe Biden’s signature ahead of a midnight Friday deadline to avert a partial government shutdown.

So as the FEHBlog expect, no government shutdown which is good news.

From the Delta variant front —

STAT News informs us that

Health officials on Thursday reported the country’s second Covid-19 infection from the Omicron variant in a Minnesota resident who notably did not travel internationally recently, unlike the first case.

The case in Minnesota is an adult male who had been vaccinated and, in early November, received a booster shot. He lives in Hennepin County, which includes Minneapolis, state health officials said. He developed mild symptoms on Nov. 22, was tested on Nov. 24, and no longer has symptoms. 

The man had been in New York City in the days leading up to feeling sick and attended the Anime NYC 2021 convention at the Javits Center from Nov. 19 to Nov. 21. Minnesota health officials are collaborating with New York City authorities and the Centers for Disease Control and Prevention on their case investigation.

Bloomberg adds

In some of the first data to come back on the omicron variant of the coronavirus, researchers in South Africa, where it was first identified, say the mutation is spreading faster than the delta strain. There also seems to be a greater risk of reinfection—where previously infected people get the virus again. Three times higher, in fact. But scientists also said hospitalizations in South Africa remain muted, a sign that may be attributable in part to vaccinations. Shabir Madhi, a vaccinologist at the University of the Witwatersrand, said he’s “optimistic that in this resurgence, while the total number of cases will probably be greater, hospitalizations and deaths will be lower.” —David E. Rovella

The Wall Street Journal reports that

Early laboratory studies suggest that a Covid-19 antibody treatment developed byGlaxoSmithKline GSK 0.24% PLC and Vir Biotechnology Inc. VIR -2.19% is effective against the Omicron variant, the companies said, setting it apart from similar therapies that appear to work less well against the highly mutated strain.

The companies said Thursday that they had tested the drug, called sotrovimab, against certain individual mutations found in Omicron, which has now been detected in at least 24 countries, including the U.S. Glaxo and Vir said the findings were preliminary and they would need to test the treatment against the whole of the mutated spike protein found in the variant to confirm the result. The companies published the preliminary research, which hasn’t yet been peer reviewed.

From the White House, the President announced a bevy of new COVID control measures today. Of particular interest to health plans is the following one:

Providing health plan coverage of no-cost rapid, over-the-counter (OTC) COVID-19 tests:  To expand access and affordability of at-home COVID-19 tests, the Departments of Health and Human Services, Labor and the Treasury will issue guidance by January 15th to clarify that individuals who purchase OTC COVID-19 diagnostic tests will be able to seek reimbursement from their group health plan or health insurance issuer and have insurance cover the cost during the public health emergency. Workplace screening would remain consistent with current guidance. 

That workplace guidance currently requires the employer to fund the cost of testing, e.g., in programs that require vaccinations or weekly testing / masking. However, I think that once this Pandora’s box is open, employers will be telling their employees to pick up a test at the local pharmacy if they need to be tested. What’s stopping them? Healthcare Dive explains that the mandate will remove the market incentive currently on manufacturers to lower costs.

The plan is a potential boon for medtech companies that produce at-home tests. With insurers on the hook for payment, it may drive up demand, particularly among those who were sensitive to prices before. Abbott, BD and Quidel are big players in the at-home testing space.

Furthermore the FEHBlog doesn’t see the sense in taking this step before the Food and Drug Administration give emergency use authorization to Merck and Pfizer COVID pills to treat COVID at its onset.

From the COVID vaccine mandate front, Beckers Hospital Review reports that

HHS is appealing a federal court’s decision to temporarily block the start of its vaccination mandate for healthcare workers, according to Bloomberg Law. 

U.S. District Judge Terry Doughty in Louisiana granted a preliminary injunction Nov. 30 halting the vaccination rule for healthcare workers until legal challenges are resolved.  * * *

HHS Secretary Xavier Becerra and other defendants filed an appeal Dec. 1. The U.S. Court of Appeals for the 5th Circuit will hear the appeal. 

From the pharmacy front —

Healthcare Dive informs us that

CVS Health and Microsoft are forming a strategic alliance to co-develop products around the areas of personalized care and digital health, the two companies announced Thursday.

CVS said it plans to use Microsoft’s computing capabilities to deliver more customized health recommendations when and where consumers need them as the retail pharmacy giant continues to focus on digitally enabled and consumer-centric health services. The two will also look for new ways to leverage technology and machine learning to automate CVS operations and reduce waste.

Fierce Healthcare tells us that

CVS Pharmacy is expanding an in-app feature for visually impaired patients, which reads prescription information out loud, to all of its nearly 10,000 U.S. locations.

The solution, called Spoken Rx, was designed in collaboration with the American Council of the Blind. Patients enrolled in the program can scan the labels on their prescription containers and have their information, including the medication’s name and directions for use, read out loud to them in either English or Spanish.

* * * The feature is free to all patients who enroll. CVS can provide a standalone speaker device to read prescription labels if the patient doesn’t have a smartphone.

CVS also offers ScripTalk on its website, which allows patients who get their medications delivered to their homes to have their prescriptions read aloud through the separate ScripTalk app. The pharmacy giant first made the service available in 2014.

The company has options for braille and large-print prescription labels through their online pharmacy too.

Midweek Update

David Ermer–Congress, COVID vaccine mandate, COVID-19, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–

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.

Monday Roundup

David Ermer–COVID treatment, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
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.1 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.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID treatment, COVID-19, Federal employment benefits, OPM, Rx coverage, Telehealth–
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.

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Medicare, Rx coverage–
Photo by Sven Read on Unsplash

From the Capitol Hill front, Roll Call reports that an extension of the continuing resolution currently funding the federal government appears to be on tap.

Senate Democrats and Republicans are eyeing a two- to three-month continuing resolution that would punt final decisions on fiscal 2022 appropriations into February or March, according to sources familiar with the talks.

That decision, if blessed by House Democrats and the Biden administration, would decouple a complicated omnibus spending bill covering every federal agency from thorny negotiations over budget reconciliation and the debt limit.

But it wasn’t yet clear Democrats across the Capitol were unified behind that strategy, with some pushing a much shorter stopgap measure running for two weeks, to Dec. 17. That would keep the pressure on for a spending deal before the winter holiday season and allow lawmakers to clear the decks for next year’s agenda.

Another possibility is lawmakers try out a stopgap bill to Dec. 17, see how much progress is possible, and then pass another CR, this time through the end of February or March.

From the Delta variant vaccine mandate front —

  • It’s worth noting that the Federal Acquisition Regulation Council is expected to consider a draft proposed rule implementing the mandate for federal government contractors this coming Wednesday November 17.
  • With regard to OSHA’s large business mandate, the Society for Human Resource Management tells us that “

OSHA stated that it “has suspended activities related to the implementation and enforcement of the ETS pending future developments in the litigation,” although it “remains confident in its authority to protect workers in emergencies.” OSHA noted that the court ordered it to take no steps to implement or enforce the ETS until further court order.

“OSHA’s course of action should give some comfort to employers taking a wait-and-see approach,” said Kyle Johnson, an attorney with Frost Brown Todd in Louisville, Ky., Jeff Shoskin, an attorney with Frost Brown Todd in Cincinnati, and Catherine Burgett and Anne Duprey, attorneys with Frost Brown Todd in Columbus, Ohio, in a firm legal update. “Because the future of the order is uncertain, employers should keep apprised of the status of the legal challenges ahead and have a plan to comply with the ETS should the order be modified or dissolved.” 

The Centers for Disease Control reminds us that Antibiotic Awareness Week begins this Thursday November 18. “USAAW is an annual observance that raises awareness of the threat of antibiotic resistance and the importance of appropriate antibiotic use.”

Following up on the large increase in Medicare Part B premiums for 2022, Healthcare Dive informs us that “CMS said the hike is mostly due to potential use of Biogen’s Aduhelm, a drug for Alzheimer’s disease that’s drawn criticism for carrying a high price tag despite unclear effectiveness, along with ongoing uncertainty from the coronavirus pandemic.” That’s puzzling as the Biogen drug has been a colossal sales flop. What’s more, STAT News broke the news tonight that

Al Sandrock, Biogen’s top scientist and the face of its years-long campaign to develop a treatment for Alzheimer’s disease, is leaving the company after more than two decades, STAT has learned.

The surprise departure of Sandrock, who oversees all of Biogen’s research and development, leaves a void in the company’s upper ranks. And it comes as Biogen is facing a worsening business outlook, saddled with a string of setbacks to its research pipeline and forced to defend its scientific integrity after the approval of the polarizing Alzheimer’s treatment Aduhelm.

STAT News also offers an interesting story about the two anti-viral drugs that could become Flonase for COVID. For example,

At the headline level, Pfizer’s pill reduced the risk of hospitalization and death by 89%,while Merck showed a reduction of 50%. But neither firm has disclosed detailed data from its pivotal studies, and the trials were not identically designed.

The studies enrolled similar populations — unvaccinated people with mild to moderate Covid-19 and at least one risk factor for severe disease — but they had slightly different measures of efficacy. Pfizer’s 89% figure comes from patients who started getting its pill, Paxlovid, within three days of their first Covid-19 symptoms. Merck’s 50% applies to patients who began treatment within five days. In the Paxlovid study, patients who started treatment within five days saw an 85% improvement in hospitalization or death versus placebo. Merck has not shared data on patients who got its drug within three days of symptom onset.

We will have to keep our fingers crossed while the Food and Drug Administration considers granting these drugs emergency use authorization.

Monday Roundup

David Ermer–COVID-19, COVID-19 testing, Federal employment benefits, Medicare, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the FEHB Open Season front, consultant Tammy Flanagan reports on the new trend of FEHB plans to offer Medicare Part B premium reimbursement contingent upon joining a related Medicare Advantage plan.

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

The Food and Drug Administration Friday authorized another over-the-counter COVID-19 diagnostic test for emergency use. The iHealth COVID-19 Antigen Rapid Test delivers results in 15 minutes. The company anticipates producing 100 million tests per month, with capacity increasing to 200 million per month in early 2022, FDA said.

STAT News offers an interesting snapshot of the now diminishing Delta variant surge.

Chart comparing hospitalizations by vaccine status

The chart truly speaks for itself.

In the maternal health field, the Health and Human Services Department announced that “200+ hospitals that are participating in the HHS Perinatal Improvement Collaborative, a contract with Premier, Inc. This new network is focused on improving maternal and infant health outcomes by reducing disparities. Comprised of hospitals from all 50 states, the collaborative is the first to evaluate how pregnancy affects overall population health by linking inpatient data of newborns to their mothers.” A list of the participating hospitals may be found at the bottom of the HHS press release.

From the Rx coverage front, STAT News tells us

Nearly a dozen of the highest-rated hospitals in the U.S. charged commercial health insurers and cash-paying patients significantly more than what Medicare has recently paid for 10 infused medicines on which the government spends the most money, according to a new analysis.

Median prices exceeded the Medicare Part B payment limit by a low of 169% at Rush University Medical Center in Chicago, while the Mayo Clinic Hospital in Phoenix exceeded the payment limit by 344%. Among cash-paying customers, the prices ranged from 149% of the Medicare payment limit at Rush to 306% at Brigham and Women’s Hospital and Massachusetts General Hospital, both based in Boston.

The Part B infused medicines for which Medicare Part B spent the most money were Rituxan, Orencia, Enbrel, Prolia, Eylea, Opdivdo, Keytruda, Avastin, Lucentis, Neulasta, and Remicade, but the list did not include biosimilar versions. These medications are variously used to treat conditions including cancer, rheumatoid arthritis, and macular degeneration.

Medicare Part B already sets Part B drug prices which tend to be injectables administered at facilities. Democrat legislators in Congress also want Medicare Part D to fix prices for certain drugs distributed by pharmacies. Government price fixing has never worked successfully in the American economy in the FEHBlog’s understanding.

Also from the healthcare pricing front, Health Payer Intelligence informs

Outcomes-based contracts continue to be popular for certain therapies as healthcare costs mount, an Avalere study found.

Avalere’s findings draw on survey responses from 51 insurers and pharmacy benefit managers. Altogether, the survey participants cover approximately 59 million members. The survey was fielded from September 27 to October 8, 2021 and it is Avalere’s fifth annual survey on the subject.

“OBCs typically include an agreement between health plans and drug or device manufacturers that ties product reimbursement to specific clinical, quality, or utilization outcomes,” Avalere researchers explained.

Let’s go.

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From the Delta variant front —

  • The Wall Street Journal reports “Federal officials said they would do more to get over-the-counter Covid-19 tests to consumers, after some manufacturers have struggled to meet demand after the Delta surge drove increased demand from individuals, schools and businesses.” Better late, etc. Here’s a link to the HHS press release.
  • The Journal also reports that “Moderna Inc.’s MRNA 7.05% Covid-19 vaccine was generally safe and induced the desired immune responses in children ages 6 to 11 in a clinical trial, according to the company. The Cambridge, Mass., company said Monday that it would submit the results to health regulators in the U.S., Europe and elsewhere in seeking authorization to widen the use of its shots to include this younger age group. The company announced the interim data in a press release, and results haven’t yet been published in a peer-reviewed medical journal. * * * An FDA decision on the Pfizer vaccine in children [ages 5 to 11] could come soon, following an advisory panel meeting scheduled for Tuesday. 
  • The Centers for Disease Control informs us in a newly issued study on Delta variant cases

What is already known about this topic?

The SARS-CoV-2 B.1.617.2 (Delta) variant is highly transmissible; however, whether it causes more severe disease in adults has been uncertain.

What is added by this report?

Analysis of COVID-NET data from 14 states found no significant increases in the proportion of hospitalized COVID-19 patients with severe outcomes during the Delta period. The proportion of hospitalized unvaccinated COVID-19 patients aged 18–49 years significantly increased during the Delta period.

What are the implications for public health practice?

Lower vaccination coverage in adults aged 18–49 years likely contributed to the increase in hospitalized patients during the Delta period. COVID-19 vaccination is critical for all eligible adults, including adults aged <50 years who have relatively low vaccination rates compared with older adults.

From the COVID vaccine mandate front

  • The Equal Employment Opportunity Commission released new FAQ guidance on “Vaccinations – Title VII and Religious Objections to COVID-19 Vaccine Mandates.”
  • The Senate today confirmed the President’s nominee, Douglas Parker as Assistant Secretary of Labor in charge of the Occupational Health and Safety Administration by a 50 to 41 vote. Govexec adds that “Douglas Parker, most recently chief of California’s Division of Occupational Safety and Health, [will lead] the workplace safety agency that has about 1,800 employees. Parker previously served as deputy assistant secretary for policy in the Labor Department’s Mine Safety and Health Administration under the Obama administration and was part of the Biden transition team on worker health and safety issues.” OSHA is responsible for the pending vaccination screening program rule applicable to private sector employers with 100 or more employees.

On a related note, Federal News Network tell us that

The federal workforce used just slightly more than half of the funds Congress set aside earlier this year for a special emergency leave program.

The American Rescue Plan Act, which Congress passed into law in March, created a $570 million emergency paid leave fund that allowed federal employees to take time off for a variety of pandemic-related reasons.

Employees were each eligible for 600 hours, or 15 weeks, of paid leave to quarantine, recover from a personal infection or care for a family member sick with COVID-19. They could also use the emergency paid leave to recover from adverse symptoms after receiving the COVID-19 vaccine.

The Office of Personnel Management was responsible for administering the fund on behalf of the executive branch and U.S. Postal Service. OPM formally launched the program at the end of April.

Eligible federal employees had until Sept. 30 to request emergency paid leave, per the sunset date in the American Rescue Plan, or earlier if the funds were exhausted before that date.

From the cost and frequency of healthcare front —

  • The American Hospital Association issued a report about the cost of healthcare over the past decade / the first decade of the Affordable Care Act, particularly the cost of hospital care versus health insurance premiums.
  • Fierce Healthcare reports that “Common elective surgeries are starting to recover volume lost during COVID-19 lockdown measures, according to a new study by Epic Health Research Network. No common elective surgery is back at pre-pandemic volumes, though some are nearing it, the study found.”

From the Rx coverage front —

  • Healthcare Dive informs us that “National employer group the Purchaser Business Group on Health is starting a new company to develop healthcare products for large employers, frustrated by unmet need and rising costs. The venture, called Emsana Health, launched on Monday with its first business unit, a pharmacy benefit manager called EmsanaRx. Emsana will develop products designed with and for PBGH member organizations, which include Walmart, Costco, Microsoft, Intel and Tesla, among others, but products will be available to outside companies as well, a PBGH spokesperson confirmed.”
  • Fierce Healthcare adds that “The Mark Cuban Cost Plus Drug Company PBC also launched its own PBM this week, The Wall Street Journal reported. Cuban’s company aims to sell generic drugs at a transparent, fixed rate, and to achieve this united manufacturing, distribution and pharmacy services under one roof, according to the article. Cuban, a billionaire investor, told the WSJ he agreed to back the venture after receiving a pitch via email from its now-CEO, Alex Oshmyansky M.D., Ph.D. The PBM will begin to bid for clients next year and aims to be fully up and running by 2023, Oshmyansky told WSJ. “The supply chain for distributing pharmaceuticals to patients is so cumbersome and broken,” he told the outlet. “We decided the only way to get our drugs to the people who need them is to build a parallel supply chain where we have control of all the intermediary players and ensure the same level of transparency at every level.”
  • Health Payer Intelligence reports that “Prescription digital therapeutics (PDTs) coverage remains nascent, as the adoption rate is only at 40 percent among the minority of payers who have familiarity with PDTs, according to a survey that Avalere conducted for Pear Therapeutics. A post from the Institute for Patient Access defined PDTs most succinctly. ‘Prescription digital therapeutics are software programs that physicians prescribe as a form of treatment,’ the post explained. ‘The software captures patients’ information about symptoms or progress that can then be shared or remotely accessed by their providers. The technology has been found to help patients adhere to their treatment plans.’”

From the FEHB Open Season front, OPM today released a spreadsheet identifying those FEHB plans for which the 2022 employee contribution for self and one coverage will be more than the 2022 employee contribution for self and family coverage. In all cases the total premium for self and family coverage is more the total premium for self plus one coverage. The employee contributions become upside down due to the vagaries of the government contribution formula. It was a Congressional mistake to add the self plus one tier to FEHB given the relatively small family size in FEHB plans.