News & Analysis as of

Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Coronavirus/COVID-19

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Three

Public Health - Withdrawing from the World Health Organization (WHO)...more

Alston & Bird

Health Care Week in Review | Senate Passes First Budget Resolution; DOJ Opts to Continue Defense in Braidwood SCOTUS Case

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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

Alston & Bird

Health Care Week in Review: Biden Administration Submits Disaster Aid Request; Senators Propose New Health Care Cybersecurity...

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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

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

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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

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Alston & Bird

Health Care Week in Review: House Held a Markup of 23 Bills; Senators Announced a Proposal on Primary Care Payment Reform

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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

McGuireWoods Consulting

Washington Healthcare Update - March 2024

This Week in Washington: Congress averts government shutdown; President issues executive order concerning foreign exploitation of health data; Sen. McConnell announces he is stepping down as leader at the end of the term;...more

Holland & Knight LLP

Holland & Knight Health Dose: January 24, 2024

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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....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

McGuireWoods Consulting

Washington Healthcare Update - September 2023 #3

This Week in Washington: House appropriations talks continue, Senate vote to advance mini omnibus fails; Lower Costs, More Transparency Act pulled from House consideration; House Budget Committee marks up budget resolution...more

McDermott+

McDermottPlus Check-Up: September 15, 2023

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CONGRESS - Senators Sanders and Marshall Release Bipartisan Primary Care and Health Workforce Act. Released on September 14, the legislation would reauthorize funding for a number of healthcare workforce programs that are...more

McGuireWoods Consulting

Washington Healthcare Update - September 2023 #2

This Week in Washington: House stalls on defense spending bill, but begins negotiations among Republicans on appropriations; Senate was expected to move forward on three appropriations bills, but has now stalled; House to...more

Alston & Bird

Health Care Week In Review: HHS Selects the First 10 Drugs for Medicare Drug Price Negotiation

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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

Akin Gump Strauss Hauer & Feld LLP

10 Health Issues to Watch as Congress Returns from August Recess

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

Jones Day

Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

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Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more

King & Spalding

CMS Issues IPPS and LTCH PPS Final Rule for FY 2024

King & Spalding on

On August 1, 2023, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule for FY 2024 (the Final Rule). In the Final Rule, CMS,...more

Alston & Bird

Health Care Week In Review: CMS Releases SNF and IPPS Final Rules

Alston & Bird on

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

Alston & Bird

Health Care Week in Review: Emerging Technology Coverage Pathway, Long COVID Advisory

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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

Alston & Bird

Health Care Week in Review: HHS Coverage Flexibilities and MedPAC/MACPAC Reports

Alston & Bird on

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

Alston & Bird

Health Care Week In Review: Fifth Circuit Review of ACA Requirement and HRSA Funds Health Centers

Alston & Bird on

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

King & Spalding

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

King & Spalding on

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

Dorsey & Whitney LLP on

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

McGuireWoods Consulting

Washington Healthcare Update - May 2023 #2

This Week in Washington: Debt Ceiling Continues to Loom Over the Capitol; DEA Extends COVID-19 Controlled Medications Prescribing Telehealth Flexibilities...more

Alston & Bird

Health Care Week In Review: COVID-19 PHE Expires, DEA Issues Final Rule

Alston & Bird on

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

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