News & Analysis as of

Emergency Use Authorization (EUA) Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS)

McDermott+

McDermott+ Check-Up – September 5, 2025

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Congress returns. Government funding runs out on September 30, 2025, and several healthcare programs and flexibilities expire, including Medicare telehealth flexibilities, Medicare disproportionate share funding for safety...more

Morgan Lewis

How the End of the PHE Will Impact the Healthcare Industry

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The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more

McGuireWoods Consulting

Washington Healthcare Update - January 2022

Upcoming Hearings/Markups - January 11 - Senate Health, Education and Labor Committee Hearing: “Addressing New Variants: A Federal Perspective on the COVID-19 Response” 10:00 a.m....more

McGuireWoods Consulting

Washington Healthcare Update - October 2021 #4

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Upcoming Hearings/Markups - October 26 - House Education and Labor Committee, Subcommittee on Workforce Protections and the Subcommittee on Civil Rights and Human Services Hearing: “Protecting Lives and Livelihoods:...more

McGuireWoods Consulting

Washington Healthcare Update - October 2021 #3

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This week in Washington: Debt ceiling measure signed by President Biden; default averted for at least a month. Discussions about budget reconciliation continue....more

McGuireWoods Consulting

Washington Healthcare Update - October 2021 #2

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This week in Washington: Reconciliation delayed; short-term debt ceiling fix passed....more

McGuireWoods Consulting

Washington Healthcare Update - September 2021 #3

Upcoming Hearings/Markups - September 27 - House Rules Committee Meeting: to discuss H.R. 3110 — PUMP for Nursing Mothers Act, H.R. 3992 — Protect Older Job Applicants (POJA) Act and H.R. 2119 — Family Violence Prevention...more

Alston & Bird

Alston & Bird Health Care Week in Review - September 2021 #4

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

Alston & Bird

Alston & Bird Health Care Week in Review - September 2021 #1

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

Alston & Bird

Alston & Bird Health Care Week in Review - August 2021 #1

Alston & Bird on

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

McGuireWoods Consulting

Washington Healthcare Update - March 2021 #4

This week in Washington: Becerra confirmed 50-49 to be Secretary of Health and Human Services...more

Alston & Bird

Alston & Bird Health Care Week in Review - February 2021 #2

Alston & Bird on

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

Jones Day

Vital Signs Digital Health Law Update | Winter 2021

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Note from the Editors - Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more

McGuireWoods Consulting

Washington Healthcare Update - November 2020 #3

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This week in Washington: Congress gets organized for next Congress; House passes health care bills; COVID-19 vaccine is the talk of the town....more

Mintz - Health Care Viewpoints

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

Maynard Nexsen

How Confident Should Consumers Be? Types of Tests and Recent Regulatory Actions to Enhance COVID-19 Testing Integrity

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Entrepreneurs, scientists, and politicians all recognize the important role of testing for the Coronavirus Disease 2019 (COVID-19). Manufacturers and laboratories commenced the development of various types of tests almost as...more

Foley & Lardner LLP

EUAs for LDTs no Longer Required, but at the Expense of PREP Act Immunity

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On August 20, 2020, the Department of Health & Human Services (HHS) released a statement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, which announced that...more

Bass, Berry & Sims PLC

Thinking of Using Serology Testing for COVID-19? Don’t Overlook CLIA Certification Rules

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With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable tests to diagnose infection....more

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