The General Accounting Office (GAO) took three major federal departments to task today on their coronavirus responses and gave some pointed advice for the future. In a wide-ranging report, the GAO told the Department of Health and Human Services (HHS), the Federal Emergency Management Agency (FEMA) and the Department of Defense (DoD) how to better manage coronavirus-related […]
Feds unveil COVID-19 vaccine distribution plan
The Trump administration today released a plan to distribute an eventual COVID-19 vaccine free of charge, initially to targeted groups and more broadly as supply increases. The government is planning a phased distribution using a contract awarded to McKesson in August. The first recipients could include: Healthcare personnel likely to be exposed to or treat […]
CMS agrees to cover ‘breakthrough’ medical devices
Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning. Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date a breakthrough device’s FDA market authorization would begin and continue for 4 years. […]
BREAKING: U.S. to reportedly pay Abbott $750M for new COVID-19 tests
Multiple reports have said President Trump will announce a $750 million deal with Abbott (NYSE:ABT) for 150 million of its rapid COVID-19 antigen tests. As first reported by Politico before being confirmed by other outlets, a White House official said that Trump will announce the deal tonight, using his speech at the Republican National Convention to […]
Labor unions, environmental groups demand federal action on PPE
A group of labor unions and environmental organizations is petitioning the Trump Administration to mandate production of personal protective equipment (PPE) using the Defense Production Act. The petition, submitted Aug. 11 to the U.S. departments of Health and Human Services and Homeland Security, dovetails with the FDA’s issuance on Monday of its first list of PPE shortages, […]
HHS puts $6.5M more toward COVID-19 testing
The U.S. Department of Health and Human Services (HHS) said today it will provide a total of $6.5 million to help two commercial diagnostic laboratories to expand capacity to conduct up to 4 million additional diagnostic tests for COVID-19 per month. The investments in Aegis Sciences (Nashville, Tenn.) and in Sonic Healthcare USA (Austin, Texas) […]
Ventec to take over ventilator production at GM plant
Ventec Life Systems and General Motors have delivered more than 20,000 ventilators they built together at a GM plant, and GM plans to turn over production to the medtech company once their federal contract is completed, Ventec announced this week. Production of Ventec’s V+Pro critical care ventilators at the Kokomo, Ind., GM plant began in […]
Report: Will Dr. Hahn crack under political pressure?
Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration, according to a New York Times report. Hahn […]
More than $500m wasted on Philips ventilator contract, House report says
A Congressional report today accused the Trump administration of bungling plans to obtain ventilators early in the coronavirus pandemic and claimed that federal officials squandered more than $500 million in a contract with Philips (NYSE:PHG). The House Subcommittee on Economic and Consumer Policy began an investigation in April into a federal contract with Philips to […]
HHS seeks 20m point-of-care COVID-19 antibody tests per month
The federal government wants U.S. diagnostics companies to develop rapid point-of-care COVID-19 antibody tests — using only materials made in the USA. The Department of Health and Human Services (HHS) on Thursday issued the call for submissions from companies that can quickly begin production of more than 20 million such tests per month. The tests must […]
340 organizations ask Congress for telehealth to stay
Today, 340 companies signed a letter sent to Congress to urge leaders to make COVID-19-related telehealth flexibilities permanent. Representing all 50 states, Washington, D.C., and Puerto Rico, the signees are seeking to stop the potential for telehealth flexibilities to disappear, should Congress fail to act before the COVID-19 public health emergency expires, according to a […]
