The Department of Health and Human Services Office for Civil Rights today issued guidance that allows health plans to contact recovered COVID-19 patients with information about how they can donate their convalescent plasma to help treat other COVID-19 patients.
The amended guidance extends the Health Insurance Portability and Accountability Act of 1998 (HIPAA) Privacy Rule, which aims to protect individuals' health information while allowing for the flow of certain information related to public health, according to the Centers for Disease Control and Prevention.
WHAT'S THE IMPACT?
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Under the rule, OCR added health plans to the June 2020 guidance to HIPAA so they can identify and contact beneficiaries who have recovered from COVID-19 for "individual and population-based case management or care coordination."
The guidance prohibits providers and health plans from receiving any payment from, or on behalf of, plasma donation centers in exchange for communication with recovered COVID-19 patients.
It also allows for this activity so long as it doesn't constitute marketing, which HHS defines as "communication about a product or service that encourages the recipient of the communication to purchase or use the product or service."
While this rule gives HIPAA covered-entities the opportunity to reach out to recovered COVID-19 patients, they cannot disclose that information to a third-party, according to HHS. Meaning, healthcare providers and health plans are not allowed to give protected health information to a plasma donation center for the center's own purposes without patient authorization.
THE LARGER TREND
"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that COVID-19 convalescent plasma may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of COVID-19 convalescent plasma when used to treat COVID19 outweigh the known and potential risks of such products," the EUA says.
The use of convalescent plasma has been studied for its effectiveness in treating other respiratory outbreaks including the 2003 SARS epidemic, the 2009 H1N1 influenza virus pandemic, and the 2012 MERS epidemic, according to the FDA.
This announcement follows a July 30 roundtable, where President Trump asked individuals who have recovered from COVID-19 to donate plasma.
"My administration is partnering with commercial labs, insurers, and healthcare providers to encourage those who have had the virus to donate plasma. So if you've had the virus, if you donate, it would be a terrific thing," he said during the roundtable.
ON THE RECORD
"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."
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