Posts tagged with "HHS"

Biden Administration works with industry to develop COVID-19 vaccination ‘passports’

March 30, 2021

Along with private technology and travel companies, the Biden Administration is working to develop credentials—referred to as passports, health certificates or travel passes—showing proof of vaccination as individuals and businesses emerge from lockdown, The Washington Post reports.

The effort has gained momentum amid President Joe Biden’s pledge that the nation will start to regain normalcy this summer; and with a growing number of companies—from cruise lines to sports teams—saying they will require proof of vaccination before opening their doors again.

The Administration’s initiative has been driven largely by efforts of the Department of Health and Human Services, including an office devoted to health information technology, said five officials who spoke on the condition of anonymity to discuss the effort. The White House this month took on a bigger role managing government agencies involved in the work, led by Coronavirus Coordinator Jeff Zients, with a goal of announcing updates in coming days, said one official.

 “Our role is to help ensure that any solutions in this area should be simple, free, open source, accessible to people both digitally and on paper, and designed from the start to protect people’s privacy,” Zients said at a March 12 briefing.

According to the Post, the passports offer a glimpse of a future after months of COVID-19 restrictions. Officials say getting vaccinated and having proper documentation will smooth the way to travel, entertainment and other social gatherings in a post-pandemic world. But it also raises concerns about dividing the world along the lines of wealth and vaccine access—creating ethical and logistical issues for decision-makers around the world.

“A chaotic and ineffective vaccine credential approach could hamper our pandemic response by undercutting health safety measures, slowing economic recovery, and undermining public trust and confidence,” reads one slide at a March 2  conference prepared by the Office of the National Coordinator for Health Information Technology.

There are several private-sector initiatives creating passports. Among them is the trade group for global airlines, the International Air Transport Association, which is testing a version it calls Travel Pass.

It is not clear, however, whether any of the passports under development will be accepted broadly around the world, and the result could be confusion among travelers and disappointment for the travel industry.

Vaccine passports will be most common on international flights. Some countries already require proof of vaccination for diseases such as yellow fever, and the United States now requires a negative test for COVID-19 to enter the country.

The U.S. Centers for Disease Control and Prevention still recommends against travel even as the agency has relaxed other guidelines for people who have been vaccinated.

The Vaccination Credential Initiative is a coalition trying to standardize tracking data of vaccination records in an attempt to speed up a return to normal, Fox News reports.

“The busboy, the janitor, the waiter that works at a restaurant, [want] to be surrounded by employees that are going back to work safely—and [want] to have the patrons ideally be safe as well,” said Brian Anderson, a physician at Mitre, a company helping lead the initiative. “Creating an environment for those vulnerable populations to get back to work safely—and to know that the people coming back to their business are ‘safe,’ and vaccinated— would be a great scenario.”

Research contact: @washingtonpost

Trump moves to manipulate COVID-19 case data; tells hospitals to bypass CDC and report to HHS

July 16, 2020

The Trump Administration—which has been anything but happy about the rising COVID-19 case numbers nationwide—now is positioning itself to manipulate the data on cases, recoveries, and deaths by having hospitals send it to a third party instead of the Centers for Disease Control and Prevention (CDC).

Hospitals will begin sending coronavirus-related information directly to the Department of Health and Human Services (HHS)—not the CDC—under new instructions from Trump. The move will take effect on Wednesday, July 15, according to a new guidance and FAQ document for hospitals and clinical labs quietly posted on the HHS website, according to a report by The Hill.

Previously, hospitals reported to the CDC’s National Healthcare Safety Network, which the agency describes as the nation’s most widely used health care-associated infection tracking system. 

In addition to the number of COVID-19 cases, the CDC tracked such vital information as how many hospital ICU beds are open and the number of ventilators available.

According to HHS, the goal is to streamline data collection, which will be used to inform decisions at the federal level such as allocation of supplies, treatments and other resources, The Hill says.

But the move comes amid concerns that the White House has been sidelining the CDC and after Trump administration officials attacked Anthony Fauci, the nation’s top infectious disease expert and a member of the White House coronavirus task force.

Research contact: @thehill

Trump Administration cuts off funding to 13 drive-thru COVID-19 testing sites in five states

June 25, 2020

The Trump Administration is doing its level best to close—or at the very least, slow down—coronavirus testing nationwide by cutting off support to 13 drive-thru COVID-19 testing sites on June 30; and leaving operation and funding of those sites to the states—even as cases spike in several parts of the country, Politico reports.

This is not the first time that the Administration has tried to offload control of the drive-thru sites to the states—but the last effort was suspended in April when governors in the states affected objected strongly.

The 13 sites—in Illinois, Colorado, Pennsylvania, New Jersey, and Texas—are the last federally run sites out of 41 originally established across the country. Seven sites are in hard-hit Texas, where cases are climbing.

Taking the offensive on Thursday, June 24, Assistant Secretary for Health Brett Giroir told Roll Call that the sites were always meant to be a temporary solution as the country worked to ramp up testing capacity in traditional health care settings.

What he didn’t mention was that, with a looming election challenge, Trump has seen the pandemic as a drag on the economy that he simply wants to go away.

Indeed, in early March, the president transferred responsibility for flattening the line on the coronavirus pandemic to the states—and, specifically, to the governors. He will neither wear a mask nor recommend one; and he has been unwilling to release nearly $14B in Congressional funding for testing and tracing efforts to combat COVID-19. However, he continues to brag that his pandemic effort is the best ever executed.

Already protesters are piling on: Scott Becker, CEO of the Association of Public Health Laboratories, tells Politico that it’s not the right time to shift responsibility for the sites to the states—especially those near emerging hot spots in Texas

“The federally supported testing sites remain critically needed, and in some place like Houston and Harris County, TX and in other hotspots, are needed now more than ever,” Becker said in an email. “This is not the time for the federal government to walk back prior commitments on testing.”

Even Senator John Cornyn (R-Texas) is critical of the plan, noting,. “It’s pretty clear to me, and I think it’s clear to all of us, that with the uptick of cases, now is not the time to retreat from our vigilance in testing,” he said. “I believe that they need to extend that federal support in Texas, at least until we get this most recent uptick in cases addressed.”

So what will be the outcome? HHS says there is no going back: Gigroir recommends that the state governors can use CARES Act funding to maintain operations at the current federally supported testing sites.

Research contact: @politico

Lilly to offer insulin at 50% lower price in U.S. pharmacies

March 5, 2019

About 1.25 million Americans suffer from Type 1 diabetes—a serious condition in which the body fails to properly regulate blood sugar—and for them, buying insulin is a “do or die” decision.

Thus, when the price of prescription insulin at U.S. pharmacies began to rise rapidly within the past few years—more than tripling from $300 for a 90-day prescription to $1,000 or more today—they and their families began having to choose between other necessities and the price of the life-saving hormone.

N o generic version of the drug existed, and three manufacturers—Eli Lilly (Indianapolis), Sanofi (Paris), and Novo Nordisk (Bagsværd, Denmark)—control 99% of the market

Now, Eli Lilly has announced that it will step up to help patients nationwide-offering a 50% lower-priced generic version of Humalog (insulin lispro injection 100 units/mL) at pharmacies in the United States.

“We’ve engaged in discussions about the price of insulin with many different stakeholders in America’s health care system: people living with diabetes, caregivers, advocacy groups, health care professionals, payers, wholesalers, lawmakers, and leading health care scholars,” said Lilly’s CEO David A. Ricksin a company release, adding, “Solutions that lower the cost of insulin at the pharmacy have been introduced in recent months, but more people need help. We’re eager to bring forward a low-priced rapid-acting insulin.

“The significant rebates we pay on insulins do not directly benefit all patients. This needs to change,” Ricks said. “There are numerous ideas, including the rebate reform proposal from HHS. For people with diabetes, a lower-priced insulin can serve as a bridge that addresses gaps in the system until a more sustainable model is achieved.”

The lower-priced version will be called Insulin Lispro—the same molecule as Humalog—and will be available in vial and pen options. The list price of a single vial will be $137.35. The list price of a five-pack of KwikPens will be $265.20.

Vials and pens of the lower-priced insulin have been manufactured, and Lilly will now work with supply chain partners to make them available in pharmacies as quickly as possible. It will be made available as an authorized generic through a Lilly subsidiary, ImClone Systems.

Humalog also will remain available for people who want to continue accessing it through their current insurance plans. Introducing an alternative insulin option allows Lilly to provide a lower-priced insulin more quickly while providing payers time to renegotiate downstream contracts and adjust to new system economics.

“While this change is a step in the right direction, all of us in the health care community must do more to fix the problem of high out-of-pocket costs for Americans living with chronic conditions,” Ricks said. “We hope our announcement is a catalyst for positive change across the U.S. healthcare system.”

Lilly’s Insulin Lispro is one of many initiatives the company has introduced to deliver lower out-of-pocket options to people living with diabetes. After exploring the logistics and feasibility of an authorized generic, Lilly began preparing manufacturing, labeling, and shipping plans last year for the possibility of Lilly’s Insulin Lispro. People should call the Lilly Diabetes Solution Center at (833) 808-1234 to learn whether Lilly’s Insulin Lispro, or another option, is the best financial choice for them.

Humalog and Insulin Lispro are available by prescription only.

Research contact: @LillyPad