The U.S. FDA posted a new policy for interruptions to or discontinuation of production of devices for the duration of the public health emergency for the COVID-19 pandemic, an authority provided by the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020. The scope of the document is limited to devices deemed critical to public health during the public health emergency, but is not explicitly limited to devices used directly in connection with the pandemic. The document defines manufacturer as the holder of the marketing authorization or the holder of registration for devices not requiring premarket submissions, including surgical gowns. Manufacturers must notify the agency six months in advance of any planned termination of or interruption to manufacture of a device, or as soon as is practicable if the six-month deadline cannot be met. The term “as soon as practicable” is defined as no later than seven days after production is interrupted or terminated. Manufacturers must keep the FDA updated biweekly on interruptions of manufacture. The guidance is immediately in effect, but remains subject to comment in accordance with FDA good guidance practices (docket no. FDA-2020-D-1138-0083).
The U.S. Office of Inspector General at the Department of Health and Human Services said the Medicare program made roughly $11.7 million in overpayments for non-physician outpatient services that were furnished just prior to or during inpatient stays in 2016 and 2017. Previous OIG audits had disclosed such overpayments to outpatient providers, and the Centers for Medicare and Medicaid Services implemented a series of claims edits designed to tamp down on overpayments, but OIG said this latest evaluation suggests the Common Working File (CWF) edits had failed to exhaustively identify all potentially incorrect claims. This latest audit covered nearly 41,000 claims for services rendered within three days of admission or during inpatient stays (not including day of discharge), and OIG said beneficiaries were billed for more than $2.7 million in related coinsurance and deductibles. CMS said it will update its CWF edits to address the discrepancy.
Sens. Bernie Sanders (D-Vt.) and Ro Khanna (D-Calif.) said their new legislation, the Emergency Medical Supplies Procurement Act, would direct the U.S. federal government to take measures to close the gap in the production of health care equipment and supplies used in the COVID-19 pandemic. The two senators said the Trump administration should have addressed supply shortages by more frequently invoking special authorities such as the Defense Production Act (DPA), and that testing for the SARS-CoV-2 virus has plateaued at between 100,000 and 200,000 per day. They also note that some public health experts have argued that as many as one million Americans will have to be tested daily before social distancing and stay-home measures can be relaxed. The bill would provide $75 billion for production under the DPA, which would be applied toward items such as N95 masks, ventilators and supplies needed for testing. Sanders said, “the United States is the richest country in the world,” and that “there is no excuse for our medical professionals and essential workers not to have the masks, gloves, gowns and tests they need to keep safe, treat their patients and stop the spread of this deadly pandemic.” The legislation does not yet have an index number.