The U.S. FDA said May 29 that it has posted a template for at-home sample collection kits for COVID-19 testing, to include recommendations for labs and test kit manufacturers. At present, developers can offer a test for at-home self-collection under the emergency use authorization program, while tests that rely such sample collection kits can be used as part of a study approved by an institutional review board. Jeff Shuren, director of the FDA’s device center, said that the agency is concerned about whether such samples can “be shipped in a way that’s stable,” which is vital to ensure the accuracy of any test conducted on that sample.
The U.S. Federal Communications Commission (FCC) posted an approval of an additional 53 telehealth applications to address patient needs during the COVID-19 pandemic, which will account for an additional $18 million in funds to stand up telehealth capability. Health care provider organizations in Texas, New York and other states will join more than 130 other such organizations in providing FCC-enabled telehealth programs, which in the aggregate have received more than $68 million in funding.
The U.S. Department of Defense said it has signed a $2.2 million contract to boost domestic production of N95 ventilator filters and N95 respirator masks. The contractor is Hollingsworth & Vose Co., located in East Walpole, Mass., which will add more than 27 million filters and 3 million respirators to U.S. production starting in August 2020.
The U.S. Office of Inspector General (OIG) at the Department of Health and Human Services said it will study the practice of hospital upcoding for invoices submitted for Medicare beneficiaries as part of its current workplan. The OIG said the issue has been identified as a source of overpayment in the past, and that the report will be made public sometime in 2021. The first phase of this two-pronged effort will consist of an analysis of Medicare claims data for development of “landscape information about hospital billing,” while the second phase will examine specific billing codes in an effort to determine the extent to which hospitals file claims bearing incorrect codes.