From the Omicron front, STAT News offers an article about forecasting the Omicron winter, and it’s cloudy.
Which immediate future plays out will be a function of a few big unknowns — some already baked into Omicron’s biology and some that can be altered based on how people behave in the coming days and weeks. Further out, the models get fuzzier still. But though they differ in the details, all of them point to SARS-CoV-2 being here to stay.
“I think we may be in for a longer road than we had hoped,” said Jeffrey Shaman, an infectious disease forecaster at Columbia University’s Mailman School of Public Health.
In an encouraging development, the Centers for Disease Control have announced changes to their 10 day quarantine requirement for folks who contract COVID:
Given what we currently know about COVID-19 and the Omicron variant, CDC is shortening the recommended time for isolation from 10 days for people with COVID-19 to 5 days, if asymptomatic, followed by 5 days of wearing a mask when around others. The change is motivated by science demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after. Therefore, people who test positive should isolate for 5 days and, if asymptomatic at that time, they may leave isolation if they can continue to mask for 5 days to minimize the risk of infecting others.
Additionally, CDC is updating the recommended quarantine period for those exposed to COVID-19. For people who are unvaccinated or are more than six months out from their second mRNA dose (or more than 2 months after the J&J vaccine) and not yet boosted, CDC now recommends quarantine for 5 days followed by strict mask use for an additional 5 days. Alternatively, if a 5-day quarantine is not feasible, it is imperative that an exposed person wear a well-fitting mask at all times when around others for 10 days after exposure. Individuals who have received their booster shot do not need to quarantine following an exposure, but should wear a mask for 10 days after the exposure. For all those exposed, best practice would also include a test for SARS-CoV-2 at day 5 after exposure. If symptoms occur, individuals should immediately quarantine until a negative test confirms symptoms are not attributable to COVID-19.
For a little holiday humor, Mary Norris in the New Yorker provides a linguistic look at Omicron. Of note,
Having reached omicron (ο), we are already more than halfway through the alphabet.
If this seems to be happening too fast, it’s partly because scientists have skipped some letters. They got to mu (μ), which is right in the middle, and then left out nu (ν), because it sounds confusingly like “new”; we can’t go around talking about a new Nu variant of interest. They also skipped the next letter, xi (ξ), not because it looks so exotic, sitting there between “N” and “O,” but because Xi is a Chinese surname and, one cannot help but notice, the surname of the guy who runs China.
In other healthcare news, the Department of Health and Human Services today
release[d] the annual update to the Department’s National Plan to Address Alzheimer’s Disease, which for the first time includes a new goal focused on work being done to promote healthy aging and reduce the risks that may contribute to the onset of Alzheimer’s disease and related dementias.
Although these diseases cannot yet be prevented, there is growing evidence that addressing certain risk factors for dementia, such as high blood pressure, physical inactivity, and chronic medical conditions such as diabetes and depression, may lower the chances of developing the disease or delay its onset. * * *
Under the plan’s new goal, the federal government will accelerate research on risk factors for Alzheimer’s disease and related dementias, and strengthen the infrastructure that is necessary to rapidly translate and disseminate information about risk factors, interventions to reduce the burden of risk factors, and related health promotion activities to health care providers, community-based providers, caregivers, and public health networks.
STAT News peered into its crystal ball to identify three pharma trends to watch next year:
The FEHBlog trusts that his readers had a Merry Christmas.
Congress is on a break until next week when the second session of the 117th Congress kicks off.
On Saturday, January 1, 2022, the surprise billing protections of the federal No Surprises Act take effect.
From the Omicron front, Bloomberg’s Prognosis informs us that
The coronavirus that causes Covid-19 can spread within days from the airways to the heart, brain and almost every organ system in the body, where it may persist for months, a study found.
In what they describe as the most comprehensive analysis to date of the SARS-CoV-2 virus’s distribution and persistence in the body and brain, scientists at the U.S. National Institutes of Health said they found the pathogen is capable of replicating in human cells well beyond the respiratory tract.
The results, released online Saturday in a manuscript under review for publication in the journal Nature, point to delayed viral clearance as a potential contributor to the persistent symptoms wracking so-called long Covid sufferers. Understanding the mechanisms by which the virus persists, along with the body’s response to any viral reservoir, promises to help improve care for those afflicted, the authors said.
An opinion piece in STAT News discusses a trend in COVID weekly new death statistics in the U.S. that the FEHBlog noticed in last Thursday’s post:
Several colleagues and I [Duane Schulthess] at Vital Transformation began closely following the data on Covid-19 early in the pandemic.
Since that time, we’ve kept a keen eye on the relationship between cases and deaths, particularly during the recent waves, which have been influenced by improved treatments and vaccines, as well as by new variants. There are legitimate concerns about the trajectory of the newest variant, Omicron, and public health experts are paying close attention to the exponentially mounting cases, particularly in the United Kingdom, which in the past has functioned as a canary in the Covid-19 coal mine for the U.S.
While early reports from South Africa suggested that Omicron might cause less-severe Covid-19, the rapidly mounting case numbers and overall transmissibility have been alarming, particularly in the U.K. According to a Dec. 10 government technical briefing(see page 17), Omicron cases were expanding by 35% per day.
But there’s something else different this time around, at least in the U.K.: the statistical relationship between Covid-19 cases and deaths appears to have broken down with Omicron.
Looking at daily death rates in the U.K. from May 15 — essentially from the point at which the Delta wave began — to Sept. 15, there is a highly statistically significant relationship between daily new cases and deaths. In short, case rates accurately predict death rates. But beginning the analysis on Sept. 15, coinciding with flattening of the Delta curve and the onset of Omicron, shows no statistical relationship between Covid-19 case rates and deaths. * * *
It’s still, of course, early days. While it is possible that death rates due to Omicron may rise later, at the moment in the U.K., Covid-19 daily cases no longer meaningfully link to deaths. So, according to the math, Omicron cases rising no longer automatically means impending doom and gloom
In healthcare M&A news, Healthcare Dive tells us that
— Tenet and its subsidiary USPI completed a $1.1 billion acquisition of SurgCenter Development, giving the ambulatory surgery unit an ownership stake in 86 more surgery centers and related support services.
— Tenet said it’s willing to buy additional interests of up to $250 million from physician owners. This process is expected to continue over the coming months, Tenet said Wednesday.
— As part of the deal, USPI will have exclusivity on developing new centers — at minimum 50 — with SCD during a five-year period.
Fierce Healthcare peers into its crystal ball to let us know about
From the FDA new drug approval front, MedCity News reports that
The FDA has approved a new cholesterol-lowering drug from Novartis that addresses the same target as two commercialized medicines from Amgen and Regeneron, but with a different approach and a key dosing advantage—just two injections per year.
The drug, inclisiran, is part of a relatively new class of genetic medicines that work by stopping production of a problem protein. In the case of the Novartis drug, which will be marketed under the name Leqvio, the target is PCSK9, a liver protein that in high amounts, impedes the body’s ability to clear low-density lipoprotein cholesterol, the “bad” form of cholesterol. Leqvio is comprised of small-interfering RNA that harnesses a cellular mechanism called RNA interference to stop a gene from producing PCSK9.
The way that Leqvio and other RNAi drugs work is sometimes referred to as gene silencing. It’s a different approach than PCSK9 inhibitors, antibody drugs that bind to this protein to block it. The FDA approved two of these drugs, Amgen’s Repatha and Regeneron’s Praluent, in 2015. They’re both given as subcutaneous injections every two weeks or monthly. However, their high price tags made them a tough sell to payers, and revenue fell short of initial expectations. In 2018, Amgen slashed Repatha’s price by nearly 60%, making the drug available at list price of $5,850 per year. Months later, Regeneron matched the pricing move for its PCSK9-blocking drug.
The benefits of competition do apply to prescription drug development.
Last week, the U.S. Census Bureau released its “Vintage 2021 national and state population estimates and components of change.” In sum,
Since April 1, 2020 (Census Day), the nation’s population increased from 331,449,281 to 331,893,745, a gain of 444,464, or 0.13%.
Between July 1, 2020, and July 1, 2021, the nation’s growth was due to natural increase (148,043), which is the number of excess births over deaths, and net international migration (244,622). This is the first time that net international migration (the difference between the number of people moving into the country and out of the country) has exceeded natural increase for a given year.
The voting-age resident population, adults age 18 and over, grew to 258.3 million, comprising 77.8% of the population in 2021.
The South, with a population of 127,225,329, was the most populous of the four regions (encompassing 38.3% of the total national population) and was the only region that had positive net domestic migration of 657,682 (the movement of people from one area to another within the United States) between 2020 and 2021.The Northeast region, the least populous of the four regions with a population of 57,159,838 in 2021, experienced a population decrease of -365,795 residents due to natural decrease (-31,052) and negative net domestic migration (-389,638).
The West saw a gain in population (35,868) despite losing residents via negative net domestic migration (-144,941). Growth in the West was due to natural increase (143,082) and positive net international migration (38,347).
The Wall Street Journal reports that “The 2021 winter solstice [took] place on Tuesday, Dec. 21, at 3:59 p.m. Coordinated Universal Time (UTC), the international standard time used by astronomers. That is 7:59 a.m. Pacific Time and 10:59 a.m. Eastern Time. * * * On the winter solstice, our planet’s [23.5 degree] tilt brings the South Pole closest to the sun—and the Antarctic Circle gets 24 hours of daylight. The North Pole is tilted away from the sun, and the Arctic Circle is shrouded in darkness for nearly a full day. * * * The winter solstice in the Northern Hemisphere marks the point at which the season’s short days start to lengthen—continuing until the summer solstice in June, when there is the longest period of daylight and the shortest period of darkness there.”
Winter solstice 2019 was pre-pandemic. Winter solstice 2020 conincided with the introduction of the mRNA vaccines in the U.S. and this winter solstice is expected to coincide with the introduction of the early onset COVID pills from Pfizer and Merck.
The U.S. Food and Drug Administration is poised to authorize a pair of pills from Pfizer Inc. and Merck & Co. to treat Covid-19 as soon as this week, according to people familiar with the matter — a milestone in the fight against the pandemic that will soon expand therapies for the ill.
An announcement may come as early as Wednesday, according to three of the people. They asked not to be identified ahead of the authorization and cautioned that the plan could change.
Pfizer’s pill, Paxlovid, and Merck’s molnupiravir are intended for higher-risk people who test positive for the coronavirus. The treatments, in which patients take a series of pills at home over several days, could ease the burden on stretched hospitals with infections poised to soar through the winter in the U.S.
This is similar to the roll out of the mRNA vaccines which initially administered to higher-risk people as well as first responders. FiercePharma tells us that “Pfizer expects to make 80 million courses of COVID drug Paxlovid by the end of 2022.” Bloomberg adds that “’It’s the biggest thing to happen in the pandemic after vaccines,’” said Eric Topol, director of the Scripps Research Translational Institute.” For what it’s worth, the FEHBlog shares this sentiment.
In other COVID treatment news, Medscape reports that
A “definitive study” from Johns Hopkins University researchers and others shows that convalescent plasma can cut hospital admissions for COVID-19 by 54% if therapy is administered within 8 days of symptom onset.
In the study of 1181 adults randomly assigned to high-titer convalescent plasma or placebo, 2.9% of people receiving the therapy were hospitalized compared to 6.3% who received placebo control plasma.
This translates to a 54% risk reduction for hospitalization with convalescent plasma. * * *
Whereas many convalescent plasma studies were done in hospitalized patients, this is one of only a handful performed in outpatients, the researchers note.
There is a regulatory catch. The FDA restricted emergency use authorization (EUA) for convalescent plasma in February 2021 to include only high-dose titer plasma and to limit the therapy to hospitalized patients with early disease or for immunocompromised people who cannot mount an adequate antibody response.
[Dr. David] Sullivan and colleagues hope their findings will prompt the FDA to expand the EUA to include outpatients.
From the White House front, the President spoke this afternoon about an enhanced federal government response to Omicron, including federal government run testing and vaccination sites and federally funded home delivery of rapid COVID tests.
The administration will launch federal testing sites around the country, standing up the first in New York City before Christmas. It will establish subsequent sites in states and communities where capacity is constrained, a senior administration official who spoke to reporters on the condition of anonymity said on Monday, with those going up in January and February. The government will once again deploy hundreds of federal personnel to boost vaccination capacity around the country, with the goal of boosting capacity by thousands of shots per week. The Federal Emergency Management Agency will oversee pop-up vaccination sites operated by the federal government, with the first ones going to Washington and New Mexico. * * *
The White House also announced it was purchasing 500 million tests and will soon set up a website for any Americans to order one for free. The tests will be available in January and delivered by mail for free, though the White House is still finalizing how many each individual will be entitled to order. The administration pledged to boost its use of the Defense Production Act to boost the supply of at-home, rapid tests.
It’s not yet clear whether this initiative replaces the earlier proposal to have health plans reimburse their members for these over the counter tests.
The San Franciso Chronicle seeks to put the transmissibility of Omicron in perspective
The reproductive number known as R0, pronounced “R naught,” measures a disease’s transmissibility at the beginning of a pandemic with no preexisting immunity, said Warner Greene, a virologist and senior investigator at the Gladstone Institutes in San Francisco. It represents how many people one sick person will infect.
According to a study released in October, the original COVID-19 strain that emerged from Wuhan has an R0 value of 2.79. The delta variant has a value of between 5 to 6 — about twice as contagious as the original strain.
Chicken pox has an R0 value of 9-10. The R0 value of measles is estimated at 12 to 18.
Greene said to really know the true R0 value of omicron, more information is needed. He cited an estimate from Martin Hibberd, a professor of emerging infectious diseases at the London School Of Hygiene & Tropical Medicine, that omicron could have an R0 of 10.
Chin-Hong said “a lot more fully vaccinated people will get breakthrough infections, but will not likely get very ill and are very unlikely to die.”
For unvaccinated people, the situation is much more serious.
“It will be very difficult to avoid getting infected with omicron,” Swartzberg said. “You may have been lucky with the other variants and the ancestral strain. It’s unlikely you will be with omicron. The unvaccinated will be the biggest spreaders of omicron and they will be the ones most likely hospitalized from it.”
No joke.
From the National Institutes of Health front —
“Yesterday the U.S. Food and Drug Administration announced its first approval of a long-acting HIV prevention medication. Developed by ViiV Healthcare, the medicine is long-acting cabotegravir injected once every two months. FDA has approved the medicine for use by adults and adolescents weighing at least 35 kilograms who are at risk of sexually acquiring HIV. This milestone marks a vital expansion of biomedical HIV prevention options available to people in the United States.”
“Despite important advances in the understanding and treatment of oral diseases and conditions, many people in the U.S. still have chronic oral health problems and lack of access to care, according to a report by the National Institutes of Health. OralHealth in America: Advances and Challenges, is a follow-up to the seminal 2000 Oral Health in America: A Report of the Surgeon General.” * * * “The authors make several recommendations to improve oral health in America, which include the need for health care professionals to work together to provide integrated oral, medical, and behavioral health care in schools, community health centers, nursing homes, and medical care settings, as well as dental clinics. They also identify the need to improve access to care by developing a more diverse oral health care workforce, addressing the rising cost of dental education, expanding insurance coverage, and improving the overall affordability of care.”
From the Affordable Care Act front, the Internal Revenue Service announced today that the applicable dollar amount that health plans must use to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2021, and before October 1, 2022, is $2.79″ per bellybutton. The immediately preceding years fee was $2.66 per bellybutton.
The Omicron variant now accounts for 73% of Covid-19 infections being diagnosed in the United States, and in some parts of the country 90% of infections are caused by viruses from the Omicron strain, the Centers for Disease Control and Prevention said late Monday.
Though it’s been clear from Omicron’s astonishing spread elsewhere that it would rapidly take over from Delta as the dominant variant in this country, the speed is nevertheless startling to witness.
“What we are watching unfold is microbial evolution. This is remarkable,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. “But this is what these viruses can do.”
The Centers for Disease Control updated its Omicron website today.
This Wall Street Journal article indicates the obtaining an mRNA booster (Moderna or Pfizer) will provide protection against Omicron as well as Delta.
The Centers for Medicare and Medicare Services today updated their “vaccine toolkit designed for issuers of group and individual health insurance and Medicare Advantage health plans.”
From the COVID vaccine mandate litigation front, the American Hospital Association reports that
Over the weekend, and as of this writing, eight groups of challengers to the OSHA vaccine mandate filed emergency applications with the U.S. Supreme Court asking the high court to once again stay the mandate following the Sixth Circuit’s Dec. 17 decision to lift the Fifth Circuit’s previously entered stay.
Today, the Supreme Court asked the federal government for a response to the challengers’ applications by Dec. 30 by 4 p.m. If that sounds familiar, it is because Dec. 30 at 4 p.m. is also the date and time the challengers to the CMS vaccine mandate will be filing their responses to the federal government’s Supreme Court application asking the court to stay the Missouri and Louisiana preliminary injunctions enjoining the CMS mandate. Both sets of applications will be briefed at the same time and the Supreme Court will have the opportunity to rule on the fate of both the CMS and OSHA vaccine mandates at the same time, if it so chooses.
The FEHBlog can find no word about whether the government has appealed to the Supreme Court the 11th Circuit’s decision last Friday to maintain in force the stay on the federal government contractor COVID vaccine mandate. The FEHBlog will keep looking.
From the healthcare business front —
Fierce Healthcare informs us that “Amazon has consolidated its healthcare efforts under one central organization and tapped a former Prime executive to run the businesses. The tech giant elevated Neil Lindsay to the new role of senior vice president of health and brand within Amazon’s worldwide consumer business, an Amazon spokesperson confirmed to Fierce Healthcare.”
mHealth Intelligence reports that “Supermarket retailer Hy-Vee, Inc. has launched a telehealth platform that allows individuals to receive treatments and prescriptions through the mail. The new service, RedBox Rx, offers virtual health consultations through a partnership with Reliant Immune Diagnostics’ telehealth platform MDbox.”
Software giant Oracle is acquiring EHR vendor Cerner for $28.3 billion, the two companies announced Monday. The deal is expected to close sometime next year.
It will be Oracle’s largest acquisition to date, with the next highest being the 2005 purchase of PeopleSoft Inc. for $10 billion. The deal further pushes Oracle into the healthcare market, where its presence is mostly in data use efficiency for payers and providers. Oracle’s areas of focus include database software and cloud systems.
Cerner will be a dedicated business unit within Oracle, according to the Monday press release. Voice-enabled user interfaces will be a key focus with a goal to “deliver zero unplanned downtime in the medical environment.”
From the too little too late front, STAT News tells us that
Biogen said Monday that it has reduced the price of its Alzheimer’s drug Aduhelm by half and is planning a series of cost-cutting measures across the company next year that aim to save $500 million.
The new, lower price for Aduhelm is $28,200, or roughly half what the drug cost when it launched in June. Insurance companies balked at its original list price, averaging $56,000 a year per patient, while physicians have fervently questioned whether Biogen’s supporting evidence merited the drug’s approval by the Food and Drug Administration, let alone widespread use. * * *
Biogen is announcing the Aduhelm price cut less than one month before Medicare is expected to make an all-important decision on whether and how widely to pay for the drug. A draft ruling is expected in January, followed by a final decision in the spring.
But with Aduhelm delivering paltry revenue, Biogen is also being forced to downsize the company. On Monday, Biogen said it would implement a series of cost-cutting measures in 2022 that are expected to total approximately $500 million. Details will be announced in the first quarter.
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 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 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.
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.
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.
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.
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.
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.
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 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.
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 trendedupward.” 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.
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.
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.
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
Early laboratory studies suggest that a Covid-19 antibody treatment developed byGlaxoSmithKlineGSK 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.
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.
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.
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).
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.
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.
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.”
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.
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