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Tuesday, January 11, 2022

Feds’ booster push shows public-health decisions aren’t data-driven

 The push to boost every person in the United States has a scientific problem. New data show that vaccine booster efficacy against getting COVID can plummet to 35% with the Pfizer booster and 45% with the Moderna booster just 10 weeks after that third shot.

So will public-health officials recommend boosters every three months in perpetuity?

The public has no appetite for that. Nor do many experts. Antibodies represent one line of defense against early infection, but cellular immunity with B and T cells confers strong protection against severe disease. That’s why tracking antibody levels is a medically imprecise way to study immunity — and why public-health officials must make decisions driven by data.

To be clear, a single booster dose reduces the risk of hospitalization in older people. But with many vaccines in medicine, robust memory B and T cell immunity is sufficiently achieved after two or three doses, spaced apart properly.

Yet Moderna’s CEO has already suggested annual boosters, with no supporting clinical data. While his shareholders love that news, many experts do not. Dr. Vinay Prasad of the University of California this week nicely summarized the problem with using efficacy as the ultimate metric to evaluate a vaccine. In a recent Kaiser Southern California study, the efficacy of two doses of the mRNA vaccines went to essentially zero at 6 months, despite a lot of data showing that these same vaccines provide strong protection against hospitalization in younger people.

Yet as many of us predicted, the Centers for Disease Control and Prevention officially changed the lexicon from “Did you get a booster?” to “Are you up to date?” COVID vaccines are not software.

Booster recommendations are nuanced and need to be tailored to each person’s age and health situation. They should be medically precise. That’s the art of medicine.

To date, the clinical benefit of boosters has not been reported in younger people or people with natural immunity from prior infection. In fact, young healthy people have a strong immune system and develop strong immunity from the primary vaccine series. A large Israeli population study published in the New England Journal of Medicine found that the risk of COVID death in a fully vaccinated, non-boosted person under age 30 was zero. A booster cannot lower that risk further. A recent German population study found that no healthy child 5 to 17 years old died of COVID over a 15-month period when the vast majority were unvaccinated.

Many of us have been alarmed by the CDC and Food and Drug Administration pushing boosters for young people, despite zero clinical data to support this recommendation and concerns of unintended harm from myocarditis, which can affect as many as one in 1,860 young men, ages 18 to 24.

COVID-19 Vaccination Record Card with syringes
New data show that vaccine booster efficacy against getting COVID can plummet to 35% with the Pfizer booster and 45% with the Moderna booster just 10 weeks after that third shot.
Getty Images

Booster enthusiasts point to surges in antibody levels after each additional vaccine dose. To date, those increases in older people help activate immunity against hospitalization and death, but in young people, who are intrinsically low risk, they may just be the equivalent of a sugar high.

Scientific discourse on the topic of boosters has been corrupted. Two top FDA officials, including the head of the FDA’s vaccine center, resigned over this very issue — political pressure to authorize boosters in young people. Defiant of concern around their departures, the FDA last week chose to bypass its expert advisory committee and authorize boosters for children between 12 and 15 years of age. Not putting the issue to a committee vote, as the FDA routinely does, captures how the agency now conducts its business: Pre-set agendas undermine the scientific process.

More concerning, we are moving backwards in transparency. The CDC informed its Advisory Committee on Immunization Practices members that because it asked for 24 days of their time last year, the CDC will do most of the work internally, saying that “we are really hoping this year that we will have a more feasible and sustainable approach to meetings.” In other words, we won’t be meeting much in the future.

Health professional prepares syringe.
Booster enthusiasts point to surges in antibody levels after each additional vaccine dose.
Getty Images

Remarkably, despite having 21,000 employees, the CDC is still unable to provide the key COVID statistics we need to inform public policy. The agency has not released data on natural-immunity reinfections, and chief Rochelle Walensky falsely said on “Fox News Sunday” that with Omicron, “prior infection protects you less well” than vaccination. I’d love to see that data.

Most alarming, two years into the pandemic, the CDC has not been able to tell us how many people are in the hospital for COVID versus with COVID. Reports from New York City and Miami Jackson Memorial Hospital are among many finding that the majority of COVID hospitalizations are primarily for other conditions — but when patients are admitted and tested, they’re found to have an incidental COVID infection.

Public-health officials need to shift their focus from antibody levels to real-world clinical outcomes data. Otherwise, we’ll be getting a booster every Monday morning when we show up at work.

Dr. Marty Makary is a professor at the Johns Hopkins School of Medicine and author of “The Price We Pay: What Broke American Health Care and How to Fix It.”

https://nypost.com/2022/01/10/the-feds-booster-push-shows-public-health-decisions-arent-data-driven/

Monday, January 10, 2022

Powell, Brainard hearings may shine light on inflation risks, broader Fed debates

 

A U.S. Senate committee holds hearings this week for Federal Reserve Chair Jerome Powell and vice chair nominee Lael Brainard that could provide new details about the U.S. central bank's plans to tighten monetary policy, but also kick off a broader debate in coming weeks about its role in addressing issues as disparate as climate change and racial inequality.

Powell appears before the Senate Banking Committee on Tuesday for consideration to a second four-year term as head of the Fed; Brainard, currently a Fed governor, will be questioned by the same panel on Thursday for promotion to a four-year term as Fed vice chair. The positions require majority approval by the full Senate, which is narrowly controlled by President Joe Biden's Democrats, with the committee hearings a first step.

The jobs are among the two most important in the U.S. and global economies, and top of mind at the hearings will be the Fed's plans for raising interest rates and possibly reducing its more than $8 trillion in bond holdings to curb inflation that has sped far beyond the central bank's 2% target.

Powell, in prepared remarks for delivery at the hearing that were released by the Fed on Monday, pledged to use the central bank's full suite of policy tools "to prevent higher inflation from becoming entrenched."

"The economy is expanding at its fastest pace in many years, and the labor market is strong," Powell said. But the strength of the recovery is "giving rise to persistent supply and demand imbalances and bottlenecks, and thus to elevated inflation. We know that high inflation exacts a toll, particularly for those less able to meet the higher costs of essentials."

The issue has become politically troubling for Biden, with price increases undermining wage gains for many workers, cited by Republicans as stemming from Biden's ambitious spending, and acknowledged by Democrats as evidence the reopening of the economy is not going so smoothly.

The Fed in December flagged plans to tighten policy faster than expected in response, with a rate hike perhaps as soon as March. But that was before it became clear just how fast the Omicron variant of the coronavirus would spread, with this week's hearings the first opportunity for Powell and Brainard to say how the current outbreak of the disease and the consequent disruptions to school and commerce have influenced their outlook.

Economists, if anything, have tilted in a hawkish direction, and in recent days intensified their view that the Fed would move sooner and at a quicker pace to tame price increases that show no sign of moderating on their own. The Consumer Price Index is expected to have increased around 7% in December from a year earlier, according to a Reuters poll of economists, a level not seen since the high inflation scares of the late 1970s and early 1980s. The data will be released on Wednesday.

"The Fed's growing discomfort with higher inflation is currently outweighing any concerns about downside risks from the Omicron variant," Oxford Economics economists Nancy Vanden Houten and Kathy Bostjancic wrote recently.

Financial markets are clearly positioning for a Fed that is prepared to be more aggressive in its response to inflation.

Bond markets are rapidly repricing for a higher interest rate environment, with yields on Treasury securities marching upward and bondholders suffering deep losses in the first week of 2022. Riskier assets like stocks and even cryptocurrencies - a relatively new asset class with scant experience confronting a Fed tightening cycle - have also nosedived in the early days of the year.

FAMILIAR FACES

Biden's decision to appoint two Washington and Fed policy veterans to the central bank's top jobs was in part a vote for continuity and bipartisanship at a critical moment for the U.S. recovery from the pandemic - incomplete in many ways but bedeviled by rising prices, disruptions to the supply chain for goods, and constrained by some workers' reluctance to take jobs.

Powell, a Republican, and Brainard, a Democrat, are familiar personalities on Capitol Hill who have cleared prior votes in the Senate, worked closely on the Fed's massive response to the coronavirus crisis, and more lately collaborated on plans to exit those support programs as inflation surged.

But the nominations also signal change. Brainard has been vocal as a Fed governor about the central bank's need to analyze and ultimately address the potential impact climate change could have on financial institutions, equity values and other aspects of the economy - views that align with Biden and which she would be in a stronger position to advocate as vice chair.

Other coming Fed appointments by Biden, including to the open position of vice chair for financial regulation, are expected to reinforce the importance at the central bank of climate and other issues like the impact of inequality on the economy, and possibly produce the first majority-female Fed board in the central bank's history.

Republicans may focus questions to Brainard about her climate views; Powell may face tough questions from some Democrats, notably Senator Elizabeth Warren, who has already announced plans to oppose his nomination for what she sees as a too-lax approach to regulating big banks.

https://www.marketscreener.com/news/latest/Powell-Brainard-hearings-may-shine-light-on-inflation-risks-broader-Fed-debates--37510701/

NRx Pharma to Present New Details for Planned Investigational BriLife COVID-19 Vaccine

 NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage, biopharmaceutical company, today announced its Chairman of the Board and Chief Executive Officer, Prof Jonathan Javitt, MD, MPH, will be presenting updates to the Company’s business, including new details regarding late-stage trials of the investigational BriLife™ COVID-19 vaccine at the H.C. Wainwright BioConnect Virtual Conference.

“As the Omicron variant of the Coronavirus continues to surge, NRx has focused on whether the BriLife® investigational vaccine is effective against this latest variant of COVID-19. Last month, our early data showed BriLife to be effective against the Delta variant,” said Prof Jonathan Javitt, Chairman and CEO of NRx Pharmaceuticals. “Yesterday, NRx leaders met with scientists of the Israel Institute for Biological Research to review data on the effectiveness of the BriLife vaccine against the Omicron variant of the SARS-CoV-2 virus. We will provide preliminary findings and discuss enhancements to the planned clinical trials for the BriLife investigational vaccine at the upcoming HC Wainwright BioConnect Conference.”

Details of the presentation can be found below:

What: H.C. Wainwright BioConnect Virtual Conference

Date: Monday, January 10, 2022

Time: 9:00 AM EST

Link to Presentation: https://journey.ct.events/view/1464b340-bd79-4a96-ae16-572a470d569b

Earlier today, NRx issued a press release announcing that the presentation would be available starting at 7:00 AM EST on Monday, January 10, 2022. The time of the presentation has changed and will now be available at 9:00 AM EST on January 10.


https://www.streetinsider.com/Corporate+News/NRx+Pharmaceuticals+%28NRXP%29+to+Present+New+Details+for+Planned+Investigational+BriLife+COVID-19+Vaccine/19438594.html

JPM 2022: Teladoc projects $2.03B in 2021 revenue, above prior guide, after stock plunged last year

 Teladoc expects its full-year 2021 revenue to hit $2.03 billion, up from previous guidance of $2.015 billion to $2.025 billion, nearly doubling its 2020 revenue.

The telehealth provider estimates it delivered more than 14.7 million virtual visits in 2021, up from 10.6 million visits in 2020. The company also anticipates between $260 million and $265 million in full-year adjusted EBITDA.

For 2022, Teladoc is projecting full-year revenue of around $2.6 billion.

Despite the company’s strong financial performance, Teladoc’s shares plummeted 54% in 2021, compared to the S&P 500’s strong gain of approximately 27%. The telehealth giant isn’t yet profitable and reported a loss of $84.3 million in the third quarter of 2021, deeper than its year-prior loss of $36 million.

Shares of Teladoc stock fell 6.2% on Monday as of 10:47 a.m. in New York.

During the company’s third-quarter earnings call in October, CEO Jason Gorevic said that Teladoc plans to take on financial risk with its virtual primary care offerings. Presenting on Monday at the annual J.P. Morgan Healthcare Conference, he reaffirmed their commitment to “move along that continuum” of risk.

“This is not new for us,” he said, noting that Teladoc has been taking on forms of risk for years, originally by guaranteeing utilization rates.

The company announced in October that it would expand its primary care pilot, Primary360, to commercial health plans, employers and other payers in 2022, starting with CVS-owned insurer Aetna as well as Centene’s virtual-first health plans.

The telehealth giant plans to continue building on its model of whole-person value-based care. As the pandemic has forced increased demands on the virtual healthcare system, an integrated care platform can deliver more benefits to consumers than the many point solutions on the market are able to provide, Gorevic said.

“We provide the front door to all of the consumer’s healthcare needs because all of a consumer’s needs are fundamentally connected,” he said.

The Purchase, New York-based company has set a top-line growth goal of 25% to 30% through 2024.

Gorevic said investors can look to increasing revenue per member, now at $68 per member per month on average, and product penetration metrics for perspective on the company’s demonstrated progress.

“I’m hopeful that we’ll be rewarded for keeping our promises when it comes to our financial metrics,” he said.

Competition has been heating up in the virtual care space, from established telehealth players like Amwell to payers now offering virtual primary care like UnitedHealth and Cigna.

Gorevic said Teladoc remains unique in its holistic service model and wide client base.

“We’ve been at this a long time. We think that we’re uniquely positioned to take advantage of that opportunity, and quite frankly, we welcome more entrants because it really highlights our differentiation,” he said.

https://www.fiercehealthcare.com/digital-health/jpm22-teladoc-projects-2-03b-2021-revenue-up-from-previous-guidance-after-stock

JPM 2022: Humana tries to soothe investors as MA enrollment projections disappoint

 Humana executives sought to ease investor concerns about a filing last week that significantly slashed its membership growth outlook in Medicare Advantage.

CEO Bruce Broussard said during the J.P. Morgan Healthcare Conference on Monday afternoon that the company is working to develop new strategies to retain members in the long term but that Humana remains confident in its ability to drive long-term earnings growth despite the disappointing numbers coming out of Medicare open enrollment.

The company, he said, is also continuing to focus on areas like its clinical services to drive growth amid the membership declines.

"We continue to see that it's serving us well," Broussard said.

The insurer issued a filing with the Securities and Exchange Commission on Thursday that decreased its outlook for MA enrollment from between 325,000 and 375,000 new members to between 150,000 and 200,000 new members. 

Humana added 130,000 members during the annual enrollment period for MA last fall. It said in the filing that it saw higher than expected terminations during the enrollment window and expects an elevated number of terminations through 2022.

The insurer's stock tumbled late last week as a result. Broussard said much of the churn is among members who were only enrolled in Humana plans for one year, which did not allow enough time for them to fully reap the benefits of the company's suite of additional services.

Chief Financial Officer Susan Diamond said during the session that the company is awaiting final enrollment numbers from the Centers for Medicare & Medicaid Services, which are expected this month, and then it will mull areas of investment to reorient its growth trajectory.

She said Humana took a conservative approach to its 2022 plans, building in the impacts of the COVID-19 pandemic. But the AEP projections are coming in short of their conservative estimates, she said.

"Now that we've had the benefit of seeing AEP results, we will certainly need to evaluate overall investment," Diamond said.

Broussard said Humana does much of its MA enrollment outreach telephonically, and its sales approach still focuses largely on price rather than articulating the broader value of a plan design or the MA program as a whole.

He said evolving to sell beyond price is going to be critical not just for Humana but for competitors as well.

"The total value of Medicare is something that really differentiates not only MA but differentiates a plan," he said.

https://www.fiercehealthcare.com/payer/jpm-2022-humana-execs-try-to-soothe-skittish-investors-as-new-ma-enrollment-disappoints

JPM22, Day 1: JPMorgan partners with Vera Whole Health; Humana addresses lower MA enrollment outlook and more

 Get ready for four days of virtual presentations and Zoom meetings.

This year's virtual J.P. Morgan Healthcare Conference has officially kicked off. It marks the second year that the big investor conference, where business leaders often announce major deals and collaborations, has gone completely digital in the midst of the COVID-19 pandemic. Instead of expensive hotels and crowded meeting spaces, conference attendees and reporters will be watching it all from our desks.

We've already kicked off the 2022 conference with a nine-figure funding deal.

Fierce Healthcare will be covering the day's biggest news as it happens. Check back here for updates, and catch Fierce Biotech's coverage here and Fierce Pharma's reporting here.

UPDATED: Monday, Jan. 10 at 5 p.m. ET

JPMorgan Chase is partnering with healthcare startup Vera Health Whole to test the company's services for 38,000 employees.

Vera, which recently announced it was combining with healthcare data company Castlight Health in a $370 million all-cash deal, offers a holistic primary care model with quality outcomes and efficient costs for payers and providers.

During a virtual keynote interview at the J.P. Morgan Healthcare Conference Monday, Jamie Dimon, JPMorgan Chase chairman and chief executive officer, said the bank would be testing Vera's services with its employees based out of a regional hub in Columbus, Ohio.

In August, Morgan Health, the healthcare-focused arm of JPMorgan Chase, invested $50 million into Vera Whole Health, the firm’s first investment in a coordinated care model. JPMorgan launched the new firm after the collapse of Haven, its joint venture with Amazon and Berkshire Hathaway, with the goal of improving the quality and cost of employer healthcare

The partnership aims to improve outcomes for workers and reduce costs for companies by making primary care teams accountable for the health of employees. It's part of the company's effort to reduce healthcare costs—JPMorgan spends roughly $2 billion a year on employee healthcare—and better manage employees' chronic conditions, Dimon said.

"It's what we call accountable care," Dimon said. "It's basically primary care physicians using both physical and digital care to get people the care they need, to get to the doctor they need. If you can fix my blood pressure before it causes damage, if you can take cancer and treat it properly, it will reduce healthcare costs and lead to better outcomes for people."

He added, "The test in Columbus is, if we give you a primary care physician and better digital access and navigation, can we give you better medicine? I’m convinced that we will be able to."

It marks the first time a large corporate employer has partnered with Vera. The company's primary care model aims to address patient overall health, including physical, mental and social health while providing cost efficiency for employers and payers.

Vera operates a network of primary care providers i 10 states—Alaska, Arizona, California, Idaho, Kansas, Missouri, Nevada, Oregon, Texas and Washington—and serves clients like Seattle Children’s and Blue Cross Blue Shield of Kansas City.

The company also inked a deal last year with Central Ohio Primary Care, the largest physician-owned primary care group in the country.

During the keynote interview, Dimon said the healthcare industry and policymakers need to take steps to improve the healthcare system, such as eliminating surprise billing and enabling price transparency. Employers also need to be involved to ensure their employees get access to better care at lower cost, he said.

Dimon also seems bullish on the potential for technology to improve the healthcare system.

"I do think telemedicine, digital and big data are going to make a huge difference in the next five to 10 years," he said.

UPDATED: Monday, Jan. 10 at 4:23 p.m. ET

Humana caused a stir among investors last week after it posted a filing with the Securities and Exchange Commission that slashed its estimates for new 2022 Medicare Advantage enrollment.

At JPM late Monday, CEO Bruce Broussard and CFO Susan Diamond addressed the disappointing results, which sent their stocks tumbling. Diamond said that once the company has its hands on full figures from the Centers for Medicare and Medicare & Services, which are expected later this month, it will determine where it needs to invest to get back on its growth trajectory.

The company added 130,000 members during the MA enrollment period, cutting its guidance from between 325,000 and 375,000 new members to between 150,000 and 200,000 new members for 2022.

Broussard said that much of the churn was among members who had only been with Humana for one year. Story — Paige Minemyer 

UPDATED: Monday, Jan. 10 at 3:45 p.m. ET

Children’s Hospital of Philadelphia (CHOP) CEO Madeline Bell outlined a handful of investments the pediatric care organization made prior to the pandemic and in the years to come, but it was the provider’s recent push into data, analytics and digital health that has been the “gamechanger” in its COVID-19 response and recovery.

“We really made significant investments—including hiring an executive [and a] large team of people—and that helped us make real-time, data-driven decisions throughout the pandemic on everything from [personal protective equipment] and available labor,” the chief executive said Monday during a virtual presentation at the J.P. Morgan Healthcare Conference.

“We’re now investing in advanced analytics that will help us not only predict future outcomes for patients but future utilization. So pretty exciting tools that are on the horizon for our data and analytics investments,” she said.

Similarly, virtual and digital health capabilities have become a core component of today and tomorrow’s care experience, Bell continued.

CHOP, like other providers, accelerated its telehealth reach during the early days of the pandemic and has seen an uptick in utilization of these virtual services during the heavy-hitting omicron wave, she said.

However, the system wants to go further and scale an end-to-end digital experience where patients and families will use digital technologies “from the accessing and pre-visiting all the way through wayfinding navigation and, ultimately, ongoing communication with us.”

“This is most important for children’s hospitals because our patients and many of their parents are digital natives. And [so it’s] a really important area of investment for us,” she said. — Dave Muoio

UPDATED: Monday, Jan. 10 at 3:15 p.m. ET

After Oak Street Health announced in November that they faced an investigation by the Department of Justice, the tech-enabled primary care group offered more information about the purpose of the civil investigative demand.

The DOJ previously stated the inquiry would consider whether Oak Street Health had violated the False Claims Act. CEO and co-founder Mike Pykosz said Monday the agency is looking into Oak Street’s relationship with insurance agents and advisors, according to statements he made during a virtual presentation at the J.P. Morgan Healthcare Conference.

“We compensate some agents to help educate older adults about Oak Street, and when it is requested by the older adult, they will connect the older adult to our teams if they’re interested in learning more about Oak Street Health,” he said.

The program is less than a year old, he said, and less than 10% of new patients come to Oak Street this way. Still, Pykosz said the program, like the company’s partnership with the AARP, set out to build trust since “we don’t have a well-known brand,” he said.

Oak Street faced many pressures in 2021, but expects its 2021 revenue to reach $1.42 billion, at the upper end of its previous guidance.

The company also bought RubiconMD in October for $130 million, an addition that it hopes will help it drive down medical costs in the long term, though the acquisition isn’t expected to significantly impact revenue. 

The primary care network opened 50 new health centers last year, now boasting 129 centers in 19 markets. Pykosz said the company expects to open 70 new centers in 2022— Rebecca Torrence

UPDATED: Monday, Jan. 10 at 12:05 p.m. ET 

Intermountain Healthcare came to J.P. Morgan touting its acquisition-fueled shift away from fee-for-service care and outlining its plans to grow across new geographies in the coming years.

“We did not slow down, we did not hunker down. We accelerated. We grew and continue to grow, and we are doing well,” Chief Financial Officer Bert Zimmerli said during a Monday virtual presentation.

Zimmerli highlighted the nonprofit system’s upward EBITDA growth over the past half decade and the impact of three recent acquisitions—HealthCare Partners Nevada (now Intermountain Nevada), Saltzer Health and air transport company Classic Air Medical.

Those purchases have helped push the system into new markets, he said, and in the case of HealthCare Partners Nevada taught Intermountain how to responsibly pivot a greater share of its business into value-based care arrangements.

“Expect us, by the way, to put some of that cash to use over the next year or two to continue to grow the Intermountain way,” he said.

A key component of that future growth is the system’s ongoing merger with SCL Health.

Intermountain President and CEO Marc Harrison, M.D., said that the partners are already integrating the non-competitive areas of their respective businesses in the run-up to an April 1 close. The organizations have agreed to a single new board and a leadership team, he said, and announcements regarding those decisions “will be forthcoming.”

Harrison said that Intermountain is pleased with the current operations that both organizations are bringing to the table and so far have no plans to trim any fat.

“We will be an operating company from day 1 and will have as much harmonization as possible,” Harrison said. “This is not one of those back-office plays where we’re magically going to take out a ton of cost. We’re going to responsibly join the teas and we think hopefully we can do that without losing any people, because our people are precious to us.” Story — Dave Muoio

UPDATED: Monday, Jan. 10 at 11:45 a.m. ET 

Ascension is ready to take more risk when it comes to value-based payment models and wants to grow its offerings in the value-based care space.

However, given how government payers are structured and how difficult it has been to receive risk-based payment methodologies, Ascension CFO Liz Foshage said, the system still expects to see 90% or more of its revenue from fee-for-service over the next three years. The system has prioritized quarterly rolling forecasts, as opposed to long-term projections, to be most flexible to any adoptions of new financial strategies.

Given the rising demand for ambulatory and at-home care services, Ascension is investing heavily in those areas, Foshage noted. Outpatient physical therapy has also been identified as a key area of growth, one where Ascension expects to double its footprint in the coming years. 

“In the early months of the pandemic, we proved that by working together, that we were well equipped to handle the current challenges,” Foshage said. But Ascension wanted to be better prepared for a “new future,” so the system developed a mission statement that commits to improving health outcomes with a particular focus on the poor and vulnerable.

Part of that commitment is eliminating disparities in care by addressing things like social determinants of health, and also creating a diverse and inclusive culture among employees. — Anastassia Gliadkovskaya

UPDATED: Monday, Jan. 10 at 11:00 a.m. ET

Teladoc expects its full-year 2021 revenue to hit $2.03 billion, nearly doubling its 2020 revenue and exceeding its previous guidance.

The telehealth giant announced Monday that it delivered over 14.7 million virtual visits in 2021, at the top end of its projections. The company also expects between $260 and $265 million in adjusted EBITDA, and is now projecting full-year revenue for 2022 at around $2.6 billion.

Despite the company's strong financial performance, Teladoc's shares plummeted 54% last year. CEO Jason Gorevic said investors should look to the company's increasing revenue per member, now at $68 per member per month on average, and multi-product penetration metrics for the provider's demonstrated growth.

Gorevic also reaffirmed the company's plan to take on financial risk with its virtual primary care offerings, which the company has said gives it more opportunities to increase per-member revenue.

Teladoc will expand its primary care pilot, Primary 360, to commercial health plans, employers, and other payers, starting with Aetna and Centene in 2022. While other telehealth players are picking up steam, Teladoc's whole-person service model puts it ahead of the competition, Gorevic said.

“We’ve been at this a long time. We think that we’re uniquely positioned to take advantage of that opportunity, and quite frankly, we welcome more entrants because it really highlights our differentiation,” he said. Story — Rebecca Torrence

UPDATED: Monday, Jan. 10 at 10:45 a.m. ET

Revenue cycle management company R1 RCM on Monday announced it plans to acquire Cloudmed in an all-stock transaction that values the software company at roughly $4.1 billion.

Cloudmed serves more than 400 of the largest health systems in the U.S., including 47 of the top 50 hospital systems. The company uses artificial intelligence and automation to analyze large volumes of medical records, payment data and complex medical insurance models to identify opportunities to deliver additional revenue for healthcare providers. The company partners with more than 3,100 healthcare providers and says it has recovered more than $1.5 billion of underpaid or unidentified revenue for its clients annually. 

R1 has made several acquisitions in the past two years to build its capabilities and technology in the RCM market. Last year, the company picked up patient financial engagement company VisitPay for $300 million in cash.

In 2020, R1 bought health IT giant Cerner's revenue cycle business for $30 million. Story — Heather Landi

UPDATED: Monday, Jan. 10 at 10:20 a.m. ET

Advocate Aurora is hoping to pivot from a non-profit hospital chain to also be a health-related company and gave a rundown of its latest moves to do so.

The system is continuing its pivot this year to “become more evolved in healthcare and beyond just hospitals and doctors,” CEO Jim Skogsbergh said during the chain’s presentation Monday.

Advocate Aurora detailed how it is buying stakes in innovative consumer health tools. This includes a 20% stake in the telenutrition business FoodSmart and the full acquisition of the home care and wellness company Senior Helpers. The system also bought a 17% stake in the digital and analytics platform Xealth.

Skogsbergh added that the chain is also hoping to increase its integration with Medicare Advantage plans and take on more financial risk.

“We have been big believers in assuming risk. We have had some success and its clearly a big part of our future,” he said. — Robert King

UPDATED: Monday, Jan. 10 at 9:55 a.m. ET

Leaders from Detroit-based Henry Ford Health System warned that elevated costs, labor constraints, inflation and an unexpectedly sustained fourth wave of COVID-19 will likely lead to service constraints and higher downstream prices in the months to come.

The nonprofit integrated system saw its costs increase 9% over the last 12 months, placing strain on its financials despite increased productivity and the heavy implementation of novel technologies intended to lighten the load, executives said.

At the same time, pockets within the state of Michigan with exceptionally low vaccine and booster coverage have placed more strain on Henry Ford’s team during this COVID-19 surge than prior waves, President and CEO Wright Lassiter said. The “unexpected” impact and duration of this wave will have a negative impact on the system’s financial performance for the coming quarters, he said.  

Chief Financial Officer Robin Damschroder noted that the system saw more new hires than it did resignations or departures during November and December, but that the workforce situation remains an area of concern for the provider.

Alongside greater adoption of novel technologies, she said the system is looking into “aggressive short and long-term strategies” such as working with nearby universities, deepening “longstanding” nurse recruitment efforts from Canada and welcoming its first group of 50 to 100 Filipino nurses in the next couple of months, Damschroder said.

Not all of the nonprofit system’s news was dire, Damschroner noted. Enhanced reimbursement, some “very modest” Provider Relief Funds received in late 2021 and roughly $100 million in yet-to-be-recognized FEMA relief all offer “a little bit of silver lining” to the system’s bottom line.

However, “it’s not going to be enough” to offset the other financial and capacity pressures, she said.

“In a market like Michigan with already substantially lower payment rates than the rest of the country, we expect these costs will indeed need to turn into increases in consumer premiums and provider rate increases,” she said. — Dave Muoio

UPDATED: Monday, Jan. 10 at 8:55 a.m. ET

Non-profit hospital chain AdventHealth shared that labor disruptions such as early retirements led to an additional $440 million in operating costs for 2021. 

“The healthcare workforce has seen significant disruption, this includes early retirements, a surge in remote work, the mobility of nursing labor and the resetting of wage rates across numerous job categories,” said Terry Shaw, president and CEO of AdventHealth, during the virtual conference.

The system has also worked to implement stronger recruitment and retention plans and new care models intended to support the medical team.

“There are digital-based nursing tools … that can do specific tasks that a nurse or others would have to do at the bedside,” Shaw said. “We are exploring and have implemented multiple models for team-based care and digital-based nursing to help alleviate the pressure on [registered nurses].” Story — Robert King

UPDATED: Monday, Jan. 10 at 8:30 a.m. ET

Centene Corporation kicked the JPM festivities off for major insurers early Monday, and executives told investors that they're feeling confident in their results coming out of the enrollment period for Medicare Advantage as well as the waning open enrollment period on the Affordable Care Act's exchanges.

Chief financial officer Drew Asher said that the results reflect ongoing work at the company to harness the strengths of its WellCare acquisition, which closed in January 2020. Over 2020 and 2021, Centene's MA business has grown by nearly 50%, which is a significant baseline to continue expanding on, he said.

"Every year that goes by, you further hone that and get the benefits of that merger," Asher said. Story — Paige Minemyer

UPDATED: Monday, Jan. 10 at 8 a.m. ET

Biotech company EQRx ink is teaming up with retail pharmacy giant CVS Health to accelerate the commercial availability of lower-cost specialty therapeutics. EQRx entered into a memorandum of understanding with CVS to explore a long-term, strategic partnership and the companies initially plan to work together to support access to and adoption of EQRx’s two lead oncology products, contingent upon FDA approval.

CVS Health is looking to create cost savings for its clients, patients and members through the adoption of EQRx medicines granted approval by the FDA, the company said in an announcement.

The partnership includes CVS Caremark, the leading pharmacy benefit manager in the U.S., covering nearly 110 million lives.

EQRx launched two years ago and went public in December in a $1.8 billion deal with a special purpose acquisition company.

The biotech company and CVS Health will also explore opportunities for collaboration in support of their mutually aligned goal of bringing other innovative, lower-cost specialty medications to market in order to significantly reduce overall drug spend.

Alan Lotvin, president of CVS Caremark, said in a statement that EQRx brings a "novel approach to drug discovery and commercialization and if successful, will bring us another tool to lower specialty drugs costs, which remains the largest area of concern for our clients.”

The news follows last week's announcement of EQRx's MOU with Geisinger, which has the potential to provide access to affordable treatments in areas of high-cost burden for more than 1 million people within Geisinger health systems. —Heather Landi

 UPDATED: Monday, Jan. 10 at 12:01 a.m. ET

At-home acute care company Medically Home has picked up another $110 million in a funding round headlined by new strategic investors Baxter International and Global Medical Response.

Prior backers Mayo Clinic, Kaiser Permanente and healthcare logistics firm Cardinal Health also participated in the funding round, which brings the company’s lifetime haul up to roughly $275 million.

Baxter, a medtech company, Cardinal Health and Mayo Clinic are all presenting at the conference this week.

The investments from Baxter and medical transportation and mobile medic company GMR provide Medically Home with several new strategic inroads that will help scale its decentralized care capabilities nationwide, according to CEO Rami Karjian. Dave Muoio's story 

https://www.fiercehealthcare.com/hospitals/jpm22-day-1-medically-home-nabs-110m-from-baxter-mayo-clinic

CDC leader faces precarious political moment

 Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky is under fire for failing to adequately communicate agency guidance as the U.S. enters the third year of the pandemic and the Biden administration struggles to control the rapidly spreading omicron variant. 

The criticisms, most recently about the agency's guidelines on isolation and quarantine, are coming from people both outside and inside the agency, reflecting rising frustration during a precarious moment for both Walensky and the CDC.  

Coronavirus infections are rising exponentially as the omicron variant spreads, and there's growing concern that Walensky and the agency's stumbles are contributing to Americans' confusion about the path forward. 

During an interview on “CNN Newsroom” Monday, Health and Human Services Secretary Xavier Becerra defended Walensky but acknowledged she's not the best at selling the agency's actions to the public  

“Dr. Rochelle Walensky is an infectious disease expert. She has a medical license, and she also has a degree in public health. She doesn’t have a degree in marketing,” Becerra said. “Who do I want running CDC? Someone who knows infectious diseases. Someone who understands this stuff. So while we may have issues with some of the marketing that’s been done, I guarantee you Dr. Walensky is someone we need at the CDC.” 

In prepared remarks shared ahead of a Senate hearing with Walensky and other officials on Tuesday, Sen. Patty Murray (D-Wash.) said her constituents are frustrated. 

“People back in Washington state, and across the country, are frustrated and worried about the course of this pandemic, and its persistent challenges — like how hard it still is to get a test. ... I’ve also heard from people who have found the communication about new isolation and quarantine guidance confusing and frustrating,” Murray will say. 

Public health messaging during a global pandemic is complicated enough, but experts say Walensky and the Biden administration as a whole need to be better at making clear that the situation is evolving constantly. 

On Friday, Walensky held the agency's first solo press briefing since taking the helm, despite a promise from the Biden White House to put career scientists first.  

“We’re in an unprecedented time with the speed of omicron cases rising and we are working really hard to get information to the American public and balancing that with the realities of what we’re all living with,” Walensky said. 

She noted that over the last year she has taken reporters’ questions in more than 80 briefings. However, most of them have come as part of the White House's COVID-19 task force press conferences, where she appears with other administration officials rather than with agency scientists. 

The agency decided to hold Friday's briefing, Walensky said, because “we had heard clearly over the last week that there was interest in hearing from us independently.” 

Walensky started the CDC job with a reputation as a savvy communicator, tasked with salvaging the reputation of an agency that took a beating under the Trump administration.  

But there have been some very public missteps. Just after Christmas, the CDC cut in half the recommended isolation period for someone who tests positive for COVID-19. The update came from a press release, with no accompanying data or media briefing.  

Confusion and criticism ensued, as public experts said the agency erred by not specifying the need for a negative test before leaving isolation. Walensky and the administration spent the next week fielding criticism, and top officials hinted that a change was coming.  

But Walensky did not back away from her initial guidance, and last week said a negative test was not necessary to leave isolation — a person could take a test if they wanted, but should extend isolation if they continue to test positive.   

To some, the agency's explanation only served to muddy the waters further. Walensky's clarification was slammed as convoluted and mocked by late night hosts. 

Tom Frieden, a former CDC director during the Obama administration, said there needs to be a briefing any time there's a policy update.  

“We will all be better off when we're hearing more from the CDC directly,” Frieden said.  

“Currently, CDC really is kind of a scapegoat where a bunch of people from outside public health or outside of governmental public health can criticize, because the airwaves have been empty when they issued new guidance. You can't just post new guidance on the website at 10 o'clock at night and think people are going to understand it. Even if it was the best guidance in the world. It's not going to go well,” Frieden said. 

Experts said Walensky is still the best person to be delivering the administration's message, but she needs to recognize the consequences of unclear guidance. 

“CDC’s loss of trust is real. It’s no longer just anti-vaxxers and Trump supporters who mistrust the agency. People who are worried about omicron and determined to do the right thing are public health’s ‘home team’ — and they too are losing trust in the agency,” Peter Sandman, a crisis communications expert, said in an email. 

“It’s not too late for CDC to rebuild trust. It’s never too late. But a precondition for getting another chance is telling the truth about your prior screw-ups,” Sandman said. 

Judith Auerbach, a professor in the University of California San Francisco School of Medicine who previously worked with Walensky on HIV research, said Walensky hasn't been clear enough that uncertainty is the rule. 

The message from the CDC needs to be that “we're experiencing viral evolution in real time. It's complex, and it's nuanced. And what we know about it changes on a daily basis,” Auerbach said.  

“We'll continue to provide the best information we have at this moment based on the scientific evidence, clinical experience, and even epidemiologic modeling. But please understand that this information may be moot the next day as we continue to learn more,” Auerbach added.

https://thehill.com/policy/healthcare/589097-cdc-leader-faces-precarious-political-moment