Health Plans Added to June 2020 OCR Plasma Donation Guidance

In June 2020, the U.S Department of Health and Human Services (HHS) issued guidance explaining how HIPAA permits covered health care providers such as hospitals, laboratories, and pharmacies to contact their patients who have contracted COVID-19 and have recovered to advise them about plasma donation opportunities.

The plasma of recovered COVID-19 patients contains antibodies generated by the patient’s immune system which can help to fight a future infection. Convalescent plasma has previously been used as a treatment for Ebola and other diseases, and research suggests that convalescent plasma can benefit some patients and can reduce the mortality rate from COVID-19.

On August 23, 2020, the Food and Drug Administration’s (FDA) issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 for certain hospitalized patients.

On August 24, 2020, following on from the FDA announcement, the HHS’ Office for Civil Rights (OCR) updated its June 2020 guidance to include health plans. The amended guidance explains how healthcare providers and health plans are permitted by HIPAA to contact patients and beneficiaries who have contracted COVID-19 and recovered to provide information about how they can donate convalescent plasma to be used as a treatment for other individuals who have contracted COVID-19.

OCR explained that a HIPAA authorization is not required from a patient for communications about plasma donation. HIPAA permits healthcare providers and health plans to contact patients and beneficiaries for individual and population-based case management or care coordination.

However, HIPAA-covered entities are not permitted to receive any payment from, or on behalf of, a plasma donation center for communications with recovered individuals.

President Trump recently called on commercial labs, insurers, providers, and pharmacies to contact individuals who have recovered from COVID-19 to encourage them to make a plasma donation to help others.

“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 OCR Director Roger Severino. “We will continue to use every tool at our disposal to beat this virus and keep Americans healthy,” he added.