August 24, 2020
Trump Administration Adds Health Plans to June 2020 Plasma Donation Guidance
Today, under the leadership of President Trump, the Office for Civil Rights (OCR) at the U.S Department of Health and Human Services (HHS) issued amended guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered health care providers (e.g., hospitals, pharmacies, laboratories) and health plans to contact their patients and beneficiaries who have recovered from COVID-19 to inform them about how they can donate their plasma containing antibodies (known as "convalescent plasma") to help treat others with COVID-19.
OCR added health plans to the June 2020 guidance that explains how HIPAA permits covered health care providers and health plans to identify and contact patients and beneficiaries who have recovered from COVID-19 for individual and population-based case management or care coordination. The guidance also emphasizes that, without individuals' authorization, the providers and health plans cannot receive any payment from, or on behalf of, a plasma donation center in exchange for such communications with recovered individuals.
This announcement builds upon President Trump's call to action and existing partnership with commercial labs, insurers, providers, and pharmacies to send communications to individuals who have recovered from COVID-19 encouraging them to donate their convalescent plasma. This guidance to health care providers and health plans also complements the Food and Drug Administration's (FDA) recent issuance of an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in some hospitalized patients. The FDA has concluded this product may be effective in treating COVID-19.
"In response to the President's call for Americans who have recovered from COVID-19 to donate their plasma, OCR clarified how HIPAA permits health plans to contact their beneficiaries about plasma donation opportunities," said Roger Severino, OCR Director. "We will continue to use every tool at our disposal to beat this virus and keep Americans healthy," he added.
The amended guidance may be found at: https://www.hhs.gov/sites/default/files/guidance-on-hipaa-and-contacting-former-covid-19-patients-about-blood-and-plasma-donation.pdf.
For more information related to HIPAA and COVID-19, please visit: https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-covid19/index.html.