The U.S. Department of Health and Human Services (HHS) posted an interim final rule with comment period regarding a revised regulation for COVID-19 reporting requirements for long-term care (LTC) hospitals. HHS said the Centers for Medicare and Medicaid Services will have more enforcement capability with regard to weekly reports from LTC hospitals, thanks to the addition of a specification for civil monetary penalties for failure to provide electronic reports, which are mandated for both suspected and confirmed cases. Critical access hospitals will be required to file routine reports for the pandemic, the statement noted. Separately, HHS said Perryn Ashmore will take the position of acting chief information officer at HHS following the departure of Jose Arrieta, whose resignation was announced Aug. 28. Arrieta took the post in May 2019 and was responsible for development of HHS Protect, the COVID-19 reporting database that was intended to provide a superset of the CDC’s hospital pandemic reporting mechanism.
The International Contrast Ultrasound Society (ICUS) recommended the FDA remove boxed warnings from contrast agents for ultrasound use, stating that these agents’ use is backed by scientific data “demonstrating their safety and lifesaving potential.” The related citizen’s petition, which does not yet appear in the FDA citizen petition database, makes the case that ultrasound contrast agents (UCAs) can reduce hospital stays and costs, as well as improve patient outcomes. The ICUS statement said that there are no known risks of kidney or liver damage, and no anesthesia is required for their use. ICUS vice president Michael Main, co-executive director of St. Luke’s Mid-America Heart Institute, said, “it is now abundantly clear that UCAs are extremely safe,” while ICUS co-president, Steve Feinstein said, “the current labeling is outdated and may harm patients by unduly deterring the use of UCAs in patients who would benefit from an enhanced ultrasound scan.”