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Saturday, June 19, 2021

Manchin calls on Biden to nominate permanent FDA commissioner

 Sen. Joe Manchin (D-W.Va.) on Thursday called on President Biden to nominate a permanent Food and Drug Administration (FDA) commissioner following the agency’s controversial decision to approve a new Alzheimer’s drug.

In a letter, the West Virginia senator requested Biden move forward with selecting an official to obtain Senate confirmation and lead the FDA. 

Janet Woodcock has served as the acting commissioner since Biden's inauguration.

Manchin argued that a confirmed commissioner is needed as the agency reviews COVID-19 vaccine manufacturers’ applications for full approvals and strives to gain back public trust in the FDA. 

“We need urgency as the world emerges from the COVID-19 pandemic,” he wrote. “You need to nominate a commissioner suited to address our public health challenges immediately, to set your agenda at this crucial agency for your first year, and give the Senate time to consider your nominee.”

Manchin specifically cited the FDA’s decision to approve the drug Aduhelm as reasoning for Woodcock to be replaced. 

While the senator acknowledged that the approval gave hope to Alzheimer’s patients, he also pointed out that the FDA’s independent advisory panel overwhelmingly rejected Aduhelm, saying there was a lack of evidence to prove that it worked. 

The FDA’s approval led to backlash, including the resignations of at least three scientists from the advisory committee.  

“This brings into question the current interim leadership of Dr. Woodcock, at a time when strong, trusted leadership at our health agencies is most important,” Manchin wrote. 

“Having a permanent agency head in charge to answer patients and doctors questions on this approval, as well as assure the general public of the FDA’s commitment to public health, is imperative, and Dr. Woodcock is not the right person to lead the FDA,” the senator added. 

He also expressed concerns about the opioid crisis after the U.S. recorded a jump in overdose deaths last year, saying the epidemic is “headed in the wrong direction.” Manchin accused the FDA of playing “a critical role” in the opioid epidemic by approving drugs.

“While industry has benefited from the status quo over the last 35 years of Dr. Woodcock’s tenure at the FDA, the people, patients and families suffering from the opioid epidemic have not,” he said.  

With Biden’s budget requesting a nearly 8 percent increase in FDA funding, Manchin also said a confirmed commissioner was essential to make sure the funding is “spent wisely and provides the resources our nation needs to recover from the pandemic, combat the opioid crisis, and restore public trust in the agency.”

https://thehill.com/policy/healthcare/559067-manchin-calls-on-biden-to-nominate-permanent-fda-commissioner

46% of unvaccinated say they will definitely not get vaccine

 Nearly half of Americans who are unvaccinated say they will definitely not get the coronavirus vaccine, according to a new poll.

The Associated Press-NORC Center for Public Affairs Research poll reported that 46 percent of the unvaccinated said they will definitely not get the vaccine and 29 percent said they will probably not get the vaccine. 

President Biden and other officials have stressed the need to reach out to Americans who are hesitant to get vaccinated as the number of daily vaccinations in the U.S. has slowed in recent weeks.

Only 7 percent of those who are not vaccinated said they definitely will get the shot and 15 percent say they probably will, according to the poll. 

Biden is still aiming for 70 percent of the U.S. adult population to have one dose of the vaccine by the Fourth of July. 

With a little over two weeks until July 4, 65 percent of U.S. adults have one shot of the coronavirus vaccine. 

States have been opening up vaccine lotteries and giving out cash prizes as incentives for their residents to get the vaccine. 

“Ultimately, this is going to be up to individuals to get shots in their arms. We can take every creative step we possibly can take. We also understand we don't have 100 percent control here, but we're going to do everything we can from the federal government to reach that goal,” White House press secretary Jen Psaki said. 

The poll surveyed 1,125 U.S. adults June 10-14. The margin of error is 4.2 percentage points.

https://thehill.com/policy/healthcare/559122-poll-46-percent-of-unvaccinated-say-they-will-definitely-not-get-vaccine

UnitedHealth CMOs target lower-cost sites of service, care gaps

 Richard Migliori, MD, executive vice president of medical affairs and chief medical officer at UnitedHealth Group, and Margaret-Mary Wilson MD, executive vice president and associate chief medical officer at UnitedHealth, outlined several long-term care strategies during a June 16 call.

Three takeaways:

1. Gaps in care

UnitedHealth aims to close 600 million gaps in care by 2025. Dr. Wilson said UnitedHealth defines a gap in care as a moment when patient care falls short of clinical standards, such as a missed cancer screening.

The company plans to close gaps through multiple initiatives, including Optum's HouseCalls program — which connects patients in their home with primary care and virtual care services — and EHR-connected point of care assist tools.

2. Site of service 

UnitedHealth plans to move more than 55 percent of members' outpatient surgeries and radiology services from hospital-based sites to lower-cost ones by 2030. The CMOs said if more joint replacement surgeries were performed in ambulatory surgery centers, it could save the U.S. health system $3 billion annually and lead to 500,000 fewer hospitalizations.

3. Telehealth

Of the 57,000 physicians in OptumCare, only about 150 were using telemedicine before the pandemic, Dr. Migliori said. After the pandemic hit, more than 17,000 physicians got qualified to treat patients through virtual visits. OptumCare providers went from treating about 50,000 telehealth cases a year to more than 2 million in this first quarter alone, Dr. Migliori said.

Telehealth use has since fallen. While at one point 40 percent of visits were completed through telemedicine, that percentage has dropped to about 15 percent and seems to be holding, Dr. Migliori said. In behavioral health, though, 60 percent of visits are being done virtually.

https://www.beckershospitalreview.com/payer-issues/unitedhealth-cmos-target-lower-cost-sites-of-service-care-gaps.html

Pandemic Swells Medicaid Enrollment to 80M People, a 'High-Water Mark'

 The pandemic-caused recession and a federal requirement that states keep Medicaid beneficiaries enrolled until the national emergency ends swelled the pool of people in the program by more than 9 million over the past year, according to a report released Thursday.

The latest figures show Medicaid enrollment grew from 71.3 million in February 2020, when the pandemic was beginning in the U.S., to 80.5 million in January, according to a KFF analysis of federal data. (KHN is an editorially independent program of KFF.)

That's up from about 56 million in 2013, just before many states expanded Medicaid under the Affordable Care Act. And it's double the 40 million enrolled in 2001.

Medicaid, once considered the ugly duckling compared with the politically powerful and popular Medicare program, now covers nearly 1 in 4 Americans. In New Mexico, the ratio is more than 1 in 3.

Together, Medicaid and Medicare cover 43% of Americans.

More than three dozen states since 2014 have used billions in ACA funding to expand coverage beyond traditional Medicaid populations to cover adults with incomes below 138% of the federal poverty level, or about $17,800. At the end of 2020, 14.8 million newly eligible adults were enrolled in Medicaid because of the ACA.

States that have seen at least an 80% increase in Medicaid enrollment since 2013 are Kentucky (157%), Nevada (129%), Alaska (94%), Colorado (92%), Montana (88%), Oregon (85%) and New Mexico (80%).

Although Medicaid has often been criticized for having too few physicians who accept its low reimbursement rates, state officials say they have weathered the surge with few complaints from enrollees about accessing health services. One key reason is the dramatic downturn in people seeking medical care during the pandemic because they were mitigating their risks of contracting covid. Also, doctors were able to fit in more patients efficiently through telehealth appointments after federal rules expanded reimbursement for those services.

"We have no access issues," said Karen Kimsey, Virginia's Medicaid director. Since March 2020, Virginia Medicaid has added 308,000 members, a 20% increase, state officials said. With the exception of a shortage of some licensed mental health providers, state officials said they have enough providers to handle the increased demand.

Typically, a surge in Medicaid enrollment can cripple state budgets, but a covid relief package passed by Congress last year boosted the federal share of its funding for traditional Medicaid by 6.2 percentage points. Before the pandemic, Washington paid on average about 56% of Medicaid costs, with poorer states getting a larger share of federal funding.

However, the funding hike required states to not remove anyone from the program during the public health emergency unless they die or move out of state.

The increase in federal contributions does not apply to enrollees covered by the ACA Medicaid expansion. The federal government already pays for at least 90% of their expenses.

Among the big winners from the enlarged Medicaid rolls are private health plans, which most states use to cover their enrollees. Health plans such as those run by managed-care titans UnitedHealthcare, Molina Healthcare and Centene Corp. receive a payment from states each month based on enrollment. That means these insurers can profit if they control costs, but they lose money if expenses to treat enrollees are too high.

"We are seeing plans' revenues go up and utilization of health services decline, which is a recipe for increased profits," said Massey Whorley, a Medicaid expert with the consulting firm Avalere.

Because of the way they are paid, health insurers benefited financially during the pandemic compared with other major health industry sectors, such as hospitals, physicians and nursing homes forced to stretch budgets for extra staffing and protective gear for workers while their revenues shrank due to waning demand.

Most health experts expect the Biden administration to maintain the nation's health emergency status until at least the end of the year. Administration officials have said they will give states at least 60 days' notice before ending the emergency so states can prepare to determine who is still eligible for Medicaid and help those who leave the program transition to other coverage.

"What we are seeing now is the high-water mark for Medicaid enrollment," Massey said.

Helping to drive Medicaid enrollment this year was the Biden administration's decision to reopen the ACA insurance marketplace from March until Aug. 15. About 331,000 people who applied as part of that special enrollment were eligible for Medicaid or the Children's Health Insurance Program.

Anthony Fiori, an analyst with the consulting firm Manatt Health, said some states likely have adjusted payments to health plans when annual contracts were negotiated to account for a drop in health care use. He noted many states have limits on how much health plans can make in profits.

Matt Salo, executive director of the National Association of Medicaid Directors, said some states are considering lowering the rates they pay insurers per person.

As more people get fully vaccinated, Salo said, states expect an uptick in enrollees seeking care that they have put off during the pandemic, which will increase costs. "There will be a lot of pent-up demand that might explode in the near future," he said.

Several health plans have told Wall Street investors that the pandemic has been good for their financial health.

Molina CEO Joseph Zubretsky said in April that the company's Medicaid enrollment at the end of March was 3.9 million members, an increase of 260,000 since December. Since the pandemic started, the company estimates, it has added more than 700,000 Medicaid members with no plateau in sight.

"For every month the national covid emergency gets extended, it would produce about $150 million of revenue to our annual total," he said.

Zubretsky predicted many will remain on Medicaid longer.

"The low-wage service economy, the sandwich shops, the restaurants, the dry cleaner shops aren't coming back real fast, and I still think there will be a significant amount of that membership that will be on Medicaid for an extended period of time," he said.

https://www.medscape.com/viewarticle/953405

COVID-19 Booster Shots Can Wait

 Vaccines against SARS-CoV-2 are proving quite safe and highly effective in the prevention of COVID-19, especially severe and/or fatal disease. Over half of the U.S. population has initiated immunization and more than three out of four people in the U.S. over the age of 65 have completed vaccination. The promising vaccine roll-out and reductions in the U.S. incidence of COVID-19 cases, hospitalizations, and deaths have led to an admixture of two competing reactions: optimism that we are nearing the end of this nightmare countered by concern about viral variants that are sprouting up with discomforting regularity.

An increasing refrain is that we need to get ready for vaccine boosters to prevent a resurgence in cases. While I certainly anticipate rolling up my sleeve for an anti-SARS-CoV-2 booster, we simply don't know when that will be. Right now, we need to focus on vaccinating more people nationally and globally and preventing the spread and emergence of variants.

While we do not know how long meaningful (clinically-relevant) vaccine-induced immunity against SARS-CoV-2 infection will last, it seems to be on the scale of 8 to 12 months, if not longer. Thus, if the pandemic were to completely end during the next year, we might be able to hold off on booster shots, firing them up only if any new COVID-19 hotspots arise. But, it seems clear from the ongoing activity of COVID-19 in many parts of the world that the pandemic is far from ending anytime soon. And SARS-CoV-2 variants just keep coming.

The latest cause for concern? The Delta variant (B.1.617.2, first recognized in India), which is now the predominant SARS-CoV-2 virus in the U.K. and gaining ground in the U.S. This variant appears to be more contagious and more dangerous, but fortunately, it appears that currently available two-dose vaccines provide good coverage against it. Regardless, vaccine manufacturers such as Moderna and Pfizer-BioNTech are launching programs and clinical studies to prepare for booster shots targeting variants of concern.

It might seem tempting to some, in the absence of formal recommendations, to get an "extra" (booster) vaccine dose (with existing vaccines currently in use) sometime in the 6 to 12 months following an initial vaccination regimen. Could this be a path toward longer and stronger immune protection against the threat of a new wave of COVID-19 activity? For now, I warn against this approach (outside of rare exceptions related to revaccination of immunocompromised persons who may require extra doses to stimulate measurable antibody responses). Here is why: we need to use our existing vaccine supply to immunize, rather than re-immunize, people both in the U.S. and abroad.

The pandemic remains red hot and active in many countries where a majority of people are unvaccinated (and vaccine supplies are limited in many regions). Recent efforts from well-vaccine-resourced countries (like the U.S.) to deploy vaccine supplies to these vaccine-limited settings are critically important. Controlling the pandemic will translate into lower chances that new SARS-CoV-2 variants emerge and spread. In this way, vaccinating the far corners of the globe will delay or defray our need to get boosters here.

When it comes to the U.S., if new or existing SARS-CoV-2 variants gain a foothold here, we need to be sure that as many people as possible have completed vaccination. Knowing that currently available vaccines are protecting against severe disease and death caused by recently emerged variants should motivate us to get as many eligible people immunized as we can. And while we don't yet have a complete understanding of the extent to which the single-dose J&J shot protects against the Delta variant, it is still important to keep our eye on the ball with our available vaccines: get them into people who have yet to initiate vaccination. A major goal of mass vaccination is to make it hard for the SARS-CoV-2 virus to find susceptible victims. Unfortunately, many eligible persons in the U.S. have yet to initiate vaccination. This is a much more important population for our focus than boosting fully vaccinated people.

How best can we do that? Well, certainly we need to get the vaccines to the people; that means mobile vaccine units, pop-up clinics, and empowering more clinics, pharmacies, and public health facilities to provide shots. As recent data inform us, we also need to change the minds of young people who remain reluctant to get immunized, dispel myths about the vaccines (they do not cause us to become magnetic, by the way!), and work to depoliticize both the disease and the solutions.

There may come a time when we are strongly compelled to begin administering booster shots, either with existing vaccines or new variant-targeting ones. But that time is not now. Let's help get the unimmunized in the U.S. and abroad protected as soon as we can. Slowing the pandemic through widespread immunization is our key to delaying the need for booster shots.

David M. Aronoff, MD, is Director of the Division of Infectious Diseases in the Department of Medicine at Vanderbilt University Medical Center.

https://www.medpagetoday.com/opinion/second-opinions/93165

Shenzhen Airport Cancels Hundreds Of Flights Amid New COVID Cases

 The southern coastal province of Guangdong appears to be the epicenter of new coronavirus cases as Shenzhen airport has canceled hundreds of flights and tightened entry controls. 

Shenzhen health officials said a restaurant employee at Shenzhen Baoan International Airport had been infected with the "Delta strain, a variant described as fast-spreading, with a high viral load and a short incubation period," according to South China Morning Post

The woman tested positive during a test for airport staff conducted Thursday, according to health officials. 

China on Friday reported 30 new infections, including six local transmissions in the southern province of Guangdong, where Shenzhen is located.

As we've noted, infections at neighboring Yantian International Container Terminal, a deepwater port in Shenzhen, about an hour east of the airport, has been operating at 40% capacity after a recent surge in infections. This has resulted in significant port congestion. The world's largest container line, Maersk, warned last week congestion at Yantian is worse than the shutdown of the Suez Canal in March.

Data from flight tracker VariFlight shows 400 inbound and outbound flights were canceled Friday. More are expected Saturday. 

Chen Bin, deputy director of Guangzhou's health commission, said there was still an elevated threat of a community outbreak. He warned against an easing of lockdown measures and said residents in locked-down areas would be tested regularly to prevent a spread. 

So if you were hoping the logistical nightmare in China would be over in the intermediate timeframe, think again. 

More than 60,000 factories are situated in Guangdong, and about a third of China's exports and one-third of the world's production of shoes, textiles, and toys move through airports and seaports in the region.

https://www.zerohedge.com/covid-19/shenzhen-airport-cancels-hundreds-flights-amid-new-covid-case-s

Brain imaging before and after COVID-19 in UK Biobank

 Gwenaëlle Douaud, Soojin Lee, Fidel Alfaro-Almagro, Christoph Arthofer, Chaoyue Wang, Frederik Lange, Jesper L.R. Andersson, 

Ludovica GriffantiEugene DuffSaad JbabdiBernd TaschlerAnderson WinklerThomas E. NicholsRory CollinsPaul M. MatthewsNaomi AllenKarla L. MillerStephen M. Smith