Tag Archives: HHS

U.S. Pharmacists and Pharmacies Authorized to Order and Administer COVID-19 Diagnostic Tests

In further clarification to pharmacists and pharmacies around the country, on May 19, 2020, the Department of Health and Human Services (HHS) issued an advisory opinion determining that pharmacies in the United States, regardless of state or local requirements, are authorized to order and administer COVID-19 diagnostic tests under the Public Readiness and Emergency Preparedness (PREP) Act.

To read the full text of this Duane Morris Alert, please visit the firm website.

Department of Health & Human Services Clarifies Broad Scope of Immunity Protection Under the PREP Act

The Department of Health & Human Services (HHS) has provided an omnibus advisory opinion in response to various requests for clarification of the scope of tort immunity provided by the declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act declaration provides immunity from tort liability for various persons, products and activities in response to COVID-19, as explained in our March 17, 2020, Alert. The Coronavirus Aid, Relief and Economic Security Act (CARES Act) subsequently expanded these protections.

To read the full text of this Duane Morris Alert, please visit the firm website.

HHS Announces Initial $30 Billion Distribution from CARES Act Provider Relief Fund

Immediate funds are now available for providers to receive a cash influx at a critical time. The challenge will not be receiving the funds, but rather keeping the funds after a future audit of compliance with the terms and conditions.

On April 10, 2020, the United States Department of Health and Human Services (HHS) announced the immediate distribution of an initial $30 billion in relief funding to providers in support of the nationwide COVID-19 response. The distribution is part of the $100 billion provider relief fund included in the Coronavirus Aid, Relief and Economic Security (CARES) Act recently passed by Congress. Importantly, HHS has noted that these are payments, not loans, to healthcare providers, and will not need to be repaid unless the provider does not comply with the terms and conditions.

To read the full text of this Duane Morris Alert, please visit the firm website.

CARES Act Expands Immunity Protections for Covered Countermeasures and Healthcare Volunteers

As discussed in our March 18 Alert, the Secretary of Health and Human Services has issued a declaration authorizing drugs, devices and biologics used to treat or mitigate COVID-19 as covered countermeasures under the Public Readiness and Emergency Preparedness (PREP) Act. Following Secretary Azar’s declaration of a public health emergency, covered persons may obtain immunity under federal law for all claims arising from manufacturing, distributing or administering covered countermeasures, subject to the conditions laid out at 42 U.S.C. § 247d-6d, the declaration and other applicable regulations.

Subsequent to our previous Alert, President Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (CARES Act), which expanded the covered countermeasure protections offered by the PREP Act.

To read the full text of this Duane Morris Alert, please visit the firm website.

HHS Activates DEA Exemption to Allow Remote Prescribing of Controlled Substances

In order to facilitate social distancing measures during the COVID-19 pandemic, state and federal regulatory agencies are moving quickly to permit providers to continue to provide medical care through telemedicine. On March 16, 2020, Alex Azar, the Secretary of Health and Human Services, has declared a public health emergency and, therefore, activated the telemedicine allowance under 21 U.S.C. § 802(54)(D). Per the Secretary, this applies to all schedule II-V controlled substances in all areas of the United States for as long as the public health emergency declaration is in place so long as certain conditions are met.

To read the full text of this post by Duane Morris attorney Ryan Wesley Brown, please visit the Duane Morris Health Law Blog.