OCR amends HIPAA Privacy Rule guidance for convalescent plasma

The Office for Civil Rights at the U.S. Department of Health and Human Services this week issued new amended guidance related to the HIPAA Privacy Rule.

Specifically, the agency noted that the rule allows health plans, in addition to other HIPAA-covered entities – hospitals, pharmacies and laboratories – to contact plan members to inform those who have recovered from COVID-19 about how they can donate their plasma to help treat others.

OCR had issued previous guidance in June, emphasizing that HIPAA permits providers to contact their patients who have recovered from COVID-19, to alert them to opportunities for convalescent plasma donation.

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“We’re making sure misconceptions about HIPAA do not get in the way of a promising COVID-19 response,” said OCR Director Roger Severino at the time. “This guidance explains how health care providers can connect COVID-19 survivors with blood and plasma donation opportunities and further public health consistent with patient privacy.”

In the updated guidance, OCR says health plans can also identify and contact recovered beneficiaries under HIPAA to alert them about donation opportunities and for individual and population-based case management or care coordination.

But the agency emphasized that, without individuals’ authorization, providers and health plans cannot receive any payment – from, or on behalf of, a plasma donation center – in exchange for such communications.

This announcement comes as President Trump has been touting the therapeutic benefits of convalescent plasma for COVID-19, and is meant to complement the Food and Drug Administration’s recent issuance of an emergency use authorization for its use, according to OCR.

“The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients,” said FDA in a news release.


“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 in a statement. “We will continue to use every tool at our disposal to beat this virus and keep Americans healthy.”

Twitter: @MikeMiliardHITN
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