News & Analysis as of

Public Readiness and Emergency Preparedness Act (PREP Act) Public Health Emergency

King & Spalding

HHS Announces the End of the COVID-19 Public Health Emergency

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On May 9, 2023, HHS released a fact sheet announcing the expiration of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. HHS also provided information on changes to the healthcare flexibilities issued during the...more

Dorsey & Whitney LLP

HHS and FDA Take Additional Measures to Aid Post-PHE Transition for Pharmacy Providers

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For the last three years, the federal government has taken considerable steps to aid providers in the fight against COVID-19. Although many of the waivers and flexibilities initiated in response to the pandemic have since...more

Harris Beach Murtha PLLC

PREP Act COVID 19 Liability Protections Continue Through HHS Amended Declaration

With the implementation of the largest adult vaccination program in U.S. history, with over 270 million people receiving at least one shot of a COVID-19 vaccine and 15 million courses of COVID-19 treatment administered, the...more

Holland & Hart LLP

Public Health Emergency Ends May 11, 2023: Check Your Readiness

Holland & Hart LLP on

After three years, the federal public health emergency (PHE) will expire May 11, 2023. Most of the relaxed regulatory and payor standards will end on or within a few months after the deadline, including many relating to: ...more

Quarles & Brady LLP

Ninth Circuit Ruling Expands Nursing Home COVID-19 Venue Fight

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On February 22, 2022, the Ninth Circuit ruled a COVID-19 wrongful death suit brought against a nursing home is not preempted by a federal health emergency law. The court affirmed a district court’s remand order which stated...more

Harris Beach Murtha PLLC

PREP Act Preemption: “There is no COVID-19 Exception to Federalism”

Harris Beach Murtha PLLC on

When the estates of nursing home residents who died from COVID-19 brought negligence and wrongful death lawsuits in New Jersey state court, defendant nursing homes removed the suits to federal court under the Public Readiness...more

Harris Beach Murtha PLLC

HHS Further Amends Declaration Under the PREP Act to Address Influenza and COVID-19 Impact and Add Pharmacist Vaccinators

The Secretary of the U.S. Department of Health and Human Services (HHS) has issued the Eighth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for Medical Countermeasures...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Renewal of Federal COVID-19 Public Health Emergency

On July 19, 2021, the U.S. Department of Health & Human Services (HHS) issued a Renewal of Determination that a Public Health Emergency Exists extending the federal COVID-19 public health emergency (PHE) for another ninety...more

Morgan Lewis - Health Law Scan

Additional PREP Act Amendments Accommodate Vaccination Administration Needs

Given the significant push to vaccinate the public since the start of 2021, the increasing availability of vaccines, and the need to recruit additional personnel to administer vaccinations, the secretary of the US Department...more

Rivkin Radler LLP

HHS Relaxes Rules On Administering COVID-19 Vaccines

Rivkin Radler LLP on

On January 28, the U.S. Department of Health and Human Services (HHS) announced that it has amended the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand the types of providers that...more

Robinson+Cole Health Law Diagnosis

COVID-19 Vaccine Update: HHS Expands Pool of Eligible Vaccinators under PREP Act

On January 28, 2021, the Department of Health and Human Services (HHS) issued a Fifth Amendment to HHS’s Declaration under the Public Health Readiness and Emergency Preparedness Act (PREP Act) that provides liability immunity...more

Holland & Knight LLP

The PREP Act and Vaccines Immunize, But Equally Well?

Holland & Knight LLP on

The executive and judicial branches do not see eye-to-eye on the scope of PREP Act immunity. The U.S. Department of Health and Human Services (HHS), under the current administration, has taken umbrage at how lower courts have...more

Foley & Lardner LLP

Top 5 Telehealth Law Predictions for 2021

Foley & Lardner LLP on

With 2020 officially behind us, what does 2021 have in store for telemedicine and digital health policy? A year ago, our team predicted 2020 would bring “notable expansions in Medicare and Medicaid coverage” and “the...more

Faegre Drinker Biddle & Reath LLP

HHS Issues New PREP Act Immunity to Marburgvirus Countermeasures

On December 9, 2020, the Department of Health and Human Services (HHS) Secretary Alex Azar issued a new notice of declaration under the Public Readiness and Emergency Preparedness (PREP) Act (the Declaration) to provide...more

Holland & Knight LLP

COVID-19 Vaccinations Are Coming, But What Will the PREP Act Immunize?

Holland & Knight LLP on

The Public Readiness and Emergency Preparedness Act, Public Law 109-148, Div. C, § 2 (2005) (PREP Act), as amended, authorizes the Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to...more

Seyfarth Shaw LLP

Two New HHS Advisory Opinions Dramatically Illuminate the Wide Scope of PREP Act Immunity

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The U.S. Department of Health and Human Services (HHS) recently issued two new advisory opinions dramatically illuminating the wide scope of the PREP Act and its immunities for organizations using covered countermeasures in...more

Seyfarth Shaw LLP

Third Amendment to PREP Act Declaration Further Expands Scope of Liability Immunity for Medical Countermeasures Against COVID-19

Seyfarth Shaw LLP on

To assist in the response of the nation’s health care providers to the COVID-19 pandemic, on August 24, 2020, the Secretary for the U.S. Department of Health and Human Services (HHS) issued a Third Amendment to his March 10,...more

BCLP

U.S. Liability Considerations for Product Manufacturers Shifting Production to New Products to Assist in Pandemic Response

BCLP on

An issue of concern for some manufacturers during the COVID-19 outbreak is the issue of potential liability in a product liability lawsuit if they switch their manufacturing process to produce items they don’t normally...more

Akin Gump Strauss Hauer & Feld LLP

Federal Protections Against Liability for Businesses Combatting COVID-19

- Federal emergency authorities targeting COVID-19 provide important protections to businesses for certain actions in connection with the national response to the public health crisis. - The protections include immunity...more

Foley & Lardner LLP

Liability Immunity for Qualified Coronavirus Countermeasures — How the PREP Act and HHS Declaration Apply

Foley & Lardner LLP on

On March 17, 2020, the Secretary of the Department of Health and Human Services (HHS) issued a Declaration energizing the PREP Act, which provides legal immunity for manufacturers, distributors, suppliers and administrators...more

Hogan Lovells

Liability immunity under the PREP Act for COVID-19 countermeasures: what manufacturers need to know

Hogan Lovells on

The Secretary of HHS issued a public health emergency declaration, effective February 4, 2020, regarding COVID-19. The impact of that declaration is to trigger certain targeted liability immunity provisions under the Public...more

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