News & Analysis as of

Department of Health and Human Services (HHS) Infectious Diseases

Perkins Coie

BARDA BioMaP-Consortium Up and Running

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In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more

Perkins Coie

BARDA Shares Details About Innovative BioMaP Consortium at BARDA Industry Day 2023

Perkins Coie on

The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more

Alston & Bird

Health Care Week in Review: PAHPA Reauthorization Bills Receive House and Senate Markups

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Sands Anderson PC

COVID-19: Vaccine Injury Compensation Status

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On May 5, 2023, the World Health Organization declared an end to the global health emergency caused by the SARS-CoV-2 virus, known as COVID-19. While the emergency has, in many ways, waned, the virus and the need for COVID-19...more

Littler

CMS Plans to Unwind Mandatory COVID-19 Vaccination Requirement for Healthcare Employers

Littler on

On November 4, 2021, the Biden administration and the Centers for Medicare and Medicaid Services (CMS) at the Department of Health and Human Services (HHS) issued an interim final rule which required certain workers at...more

Manatt, Phelps & Phillips, LLP

Upcoming Regulatory Changes Associated With the End of the PHE

At 11:59 p.m. on Thursday, May 11, 2023, the COVID-19 public health emergency (PHE) declaration will conclude, more than three years after taking effect in January 2020. The PHE declaration has enabled the U.S. Department of...more

McGuireWoods LLP

End of an Era: White House Ends Many Federal COVID-19 Vaccine Requirements

McGuireWoods LLP on

On May 1, 2023, the White House announced it would end the COVID-19 vaccine requirements for federal employees, federal contractors and international air travelers effective May 11, the same day the federally declared...more

McGuireWoods LLP

End of COVID-19 Emergency: Legal Implications for Healthcare Providers

McGuireWoods LLP on

On Jan. 30, 2023, President Joe Biden announced that the COVID-19 public health emergency (PHE) will end May 11, 2023. Under the PHE, the federal government implemented a range of modifications and waivers impacting Medicare,...more

Manatt, Phelps & Phillips, LLP

Executive Summary: Tracking Telehealth Changes State-by-State in Response to COVID-19 - April 2023 #2

As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access...more

Epstein Becker & Green

Full HIPAA Enforcement to Resume as the COVID-19 Public Health Emergency Ends

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On April 11, 2023, U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced its plan for termination of the existing notifications of enforcement discretion related to the expiration of the...more

Bodman

One Month Until May 11, 2023 – the Expiration Date for the COVID-19 Public Health Emergency

Bodman on

The Secretary of the U.S. Department of Health and Human Services (HHS) first declared the existence of a public health emergency (PHE) on January 31, 2020. The PHE allowed HHS to implement a number of regulatory waivers and...more

Manatt, Phelps & Phillips, LLP

Executive Summary: Tracking Telehealth Changes State-by-State in Response to COVID-19 - April 2023

As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access...more

Burr & Forman

Hot Topics in Health Care March 2023

Burr & Forman on

HHS Releases Cybersecurity Guide - On March 8, 2023 the Department of Health and Human Services released a cybersecurity implementation guide for the health care industry—the HPH Sector Cybersecurity Framework...more

Bricker Graydon LLP

What to expect now that we’re expecting: What the end of the public health emergency means for healthcare providers

Bricker Graydon LLP on

On January 30, 2023, President Biden announced that both the COVID-19 national emergency and the public health emergency (PHE) will end May 11, 2023. This announcement has left many healthcare providers considering how the...more

Manatt, Phelps & Phillips, LLP

What Changes if the COVID-19 Public Health Emergency Ends May 11

The Biden Administration has announced that May 11, 2023, will be the final day of the COVID-19 public health emergency (PHE) declaration, which has been in effect since January 2020. Following the White House’s announcement...more

Holland & Knight LLP

What's In and Out for Healthcare in the Year-End Funding Package

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Lawmakers unveiled their long-awaited $1.7 trillion government funding package on Dec. 20, 2022. As of publishing, it seems likely that a vote on final passage in the U.S. Senate will occur at some point on Dec. 22, with a...more

Holland & Knight LLP

Holland & Knight Health Dose: November 29, 2022

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include . . ....more

Venable LLP

Return to "Normalcy" - Bracing for the End of the Public Health Emergency

Venable LLP on

In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more

Mintz - Health Care Viewpoints

FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence

The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...more

Akin Gump Strauss Hauer & Feld LLP

COVID-19 Policy Updates and Implications for the Workplace

On August 11, the U.S. Centers for Disease Control and Prevention (CDC) issued updated COVID-19 guidance “to help people better understand their risk, how to protect themselves and others, what actions to take if exposed to...more

Holland & Knight LLP

With Inflation Reduction Act Signed, Other Health Policy Issues Ahead for Congress

Holland & Knight LLP on

Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more

McDermott Will & Emery

Monkeypox Declared a National Public Health Emergency

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On August 4, 2022, the Biden administration declared monkeypox a public health emergency (PHE), a step that will allow the federal government to work with more agility to combat the spreading outbreak, including via expedited...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Monkeypox Outbreak Declared a Public Health Emergency

​​​​​​​On August 4, 2022, the Biden administration declared the monkeypox outbreak a public health emergency. This comes at a time where the number of cases in the United States are rapidly rising and with cases found in...more

Epstein Becker & Green

COVID-19 Vaccine and Monoclonal Coverage: A Focus of the 2023 Medicare Physician Fee Schedule Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) recently issued the Medicare Physician Fee Schedule (PFS) proposed rule for calendar year (CY) 2023, which clarified the timeline for increased COVID-19 vaccine...more

Akerman LLP - Health Law Rx

OCR Releases Guidance on HIPAA Compliance When Providing Audio-Only Telehealth

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) recently released new guidance (the “Guidance”) to help ensure that individuals may continue to benefit from audio-only telehealth...more

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