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Coronavirus March 31 Update: House Previews Next Bill, HHS Prepares for Vaccine Trials, and the Latest Actions Taken in the EU
House previews next COVID-19 bill; CMS moves to boost hospital capacity
House Speaker Nancy Pelosi said Monday that House Democrats will prioritize establishing temporary protective standards for frontline health care workers through the Occupational Safety and Health Administration as they work to craft another bill to respond to the COVID-19 pandemic.
Education and Labor Committee Chairman Robert C. Scott said he would try to broaden those protections to other at-risk workers, including first responders, grocery workers and Transportation Security Administration agents. Scott said Republicans in the Senate and administration had objected to efforts to include the provision in earlier legislation.
"The next coronavirus package must include a requirement that OSHA issue an emergency temporary standard within seven days that requires employers to implement protection for at-risk workers," Scott told reporters.
Democrats have sought to include such provisions in previous legislation to respond to the virus. Nurses unions have pushed for their inclusion, but the American Hospital Association had lobbied against them, saying that such restrictions could create confusion because they would differ from Centers for Disease Control and Prevention guidelines.
CMS details waivers and flexibilities
The Centers for Medicare and Medicaid Services also made a series of announcements on Monday related to COVID-19. "We owe those frontline workers every ounce of flexibility that we can muster," said CMS Administrator Seema Verma, in a call with reporters Monday night.
The agency announced it would waive several regulations on hospitals and health care providers to increase their capacity and boost the number of providers at hospitals and health care systems.
CMS also announced it would allow hospitals and other entities to perform COVID-19 tests on homebound people in their homes. The agency also said it would allow for more than 80 additional services to be provided by telehealth and would allow physicians to supervise other clinical staff using telehealth.
Lawmakers push FDA to loosen hand sanitizer guidelines
As the liquor industry moves to produce hand sanitizer to fill shortages during the pandemic, lawmakers are urging the Food and Drug Administration to loosen its guidelines.
The FDA requires alcohol in the product to be denatured, or made with chemicals that make it more or less undrinkable. But distillers want to use their drinkable alcohol to make sanitizer. Kentucky Reps. John Yarmuth and Andy Barr led 87 lawmakers in a letter to FDA Commissioner Stephen Hahn urging him to allow the use of the undenatured product during the emergency.
"We strongly urge the agency to update its guidance to recognize the use of undenatured alcohol ... and work with industry on reasonable safeguards to keep hand sanitizer out of the hands of children," the lawmakers wrote.
The FDA has already adjusted its hand sanitizer guidelines twice in the last week, but it hasn't lifted the denaturing requirement. "Denaturing is critical because there have been reports of adverse events, including deaths, from unintentional ingestion of hand sanitizer, particularly in young children," Friday's guidance said. The FDA has said it will review the lawmakers' request.
HHS prepares for trials with partner companies on potential COVID-19 vaccines
The Department of Health and Human Services is expanding its work with private pharmaceutical partners to speed up the development of a COVID-19 vaccine.
HHS' Biomedical Advanced Research and Development Authority announced Monday that it's supporting Janssen Research & Development, part of Johnson & Johnson, in setting up Phase I clinical trials for a potential vaccine.
The company started research earlier in the year using the same platform that helped develop an Ebola vaccine. Together they aim to start Phase I trials by September, and estimate with the sped-up process, a vaccine could be ready for use in early 2021. Johnson & Johnson also said it's ramping up its production capabilities to produce doses of the vaccine when it's available.
BARDA is also working with Massachusetts-based Moderna Therapeutics to prepare for Phase 2 and 3 clinical trials of its potential vaccine being developed with the National Institutes of Health. That includes funding to manufacture vaccine doses to be used in the trials.
Setting up the later trials earlier in the process "potentially shaves months off the timeline for vaccine development," according to an HHS release.
Blockchain could transform supply chains, aid in COVID-19 fight
Companies that specialize in moving goods from one place to another are starting to use the technology that powers cryptocurrency to streamline their work, and they say it could help hospitals stay stocked and staffed during pandemics like the one caused by COVID-19.
Blockchain technology, as it's called, is already being adopted in the movement of goods from producers to suppliers, to stores, and to consumers. The technology is a form of distributed ledger, which stores encrypted information accessible to users. It can be public, as with cryptocurrencies, or permissioned, where information is visible only to network members that want to see it. Data kept on a blockchain, which is stored and verified by users across the network, can't be changed or destroyed.
Those working with the technology see it's potential to quickly locate vital supplies, the importance of which is being shown by shortages in protective equipment facing hospitals across the world.
While the technology is best known for its role powering cryptocurrencies such as bitcoin, its characteristics make it an apt tool in supply chain management, said Mary Lacity, a professor who runs the University of Arkansas Blockchain Center of Excellence.
In addition to moving goods and services, supply chains move information about those goods, which is where blockchain comes in, Lacity told CQ Roll Call in an interview. In traditional logistics systems, every link in the chain records and stores its own information on a separate system — meaning everyone has his or her own version of the truth, she said.
Each time a good moves along that chain, information needs to be reconciled. Sometimes data gets left behind or corrupted along the way. Blockchain gives users one system, creating "a receipt that everybody agrees to," she said.
This has the added benefit of reducing costs by eliminating the need to reconcile data along the way, while shortening settlement times, and speeding payments. It would provide cybersecurity and mean greater transparency for consumers about where their goods come from, she said.
It's already being adopted in the supply of food.
Luis Macias, founder and CEO of GrainChain Inc., uses a blockchain system to empower small farmers. The company has partnered with coffee farmers in Honduras and connected them directly to shippers, distributors, retailers and financial institutions.
That's reduced reliance on predatory middlemen known as coyotes, who provide high-interest loans and transport goods at exorbitant prices. The end result is more money for farmers and possibly lower costs for consumers, Macias said in an interview.
Read the full story on RollCall.com.