Democrats Request Information from Kushner on Health Data Collection

On April 10, Sens. Mark Warner (D-VA) and Richard Blumenthal (D-CT) and Rep. Anna Eshoo (D-CA) sent a letter requesting information from the Trump administration on White House Senior Advisor Jared Kushner’s working with technology companies to use health data for a national coronavirus surveillance system. The letter supports the Department of Health and Human Services’s (HHS) recent move to ease the Health Insurance Portability and Accountability Act’s (HIPAA) rules, but notes “these extraordinary measures could undermine the confidentiality and security of our health information and become the new status quo.” Find the letter here.

HHS Notice of Benefit and Payment Parameters for 2021 Reaches OMB

As of April 17, the Department of Health and Human Services (HHS) Notice of Benefit and Payment Parameters for 2021 is under review at the Office of Management and Budget (OMB). Find more information here.

FDA Wants to Develop Master Protocol for COVID-19 Vaccine Trials; Adds COVID-19 Could Affect User Fee Goals

On April 16, the Food and Drug Administration (FDA) Commissioner, Stephen Hahn, announced that the FDA wants to develop a master protocol for COVID-19 vaccine clinical trials so that multiple vaccines can be developed more efficiently. Hahn added that the FDA might consider relaxing direct-to-consumer (DTC) advertising for any future FDA-approved COVID-19 drugs, if it is decided that the value and the benefits outweigh the risks. Hahn also commented that the FDA continues to meet its user fee commitments but signaled that could change due to staffers’ focusing on COVID-19, coming as FDA is unable to hold in-person user fee negotiations and has postponed indefinitely its medical device user fee meeting.

Read more in McGuireWoods Consulting’s Washington Healthcare Update.