News & Analysis as of

Vaccinations Department of Health and Human Services (HHS)

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Epstein Becker & Green

Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast

Epstein Becker & Green on

Important changes are unfolding in the vaccine space. How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health...more

Alston & Bird

Health Care Week in Review | HHS Announces Significant Workforce Reductions and Reorganization; FDA and NIH Nominees are Confirmed

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

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

Skadden, Arps, Slate, Meagher & Flom LLP

Make America Healthy Again Commission Aims To Combat Chronic Disease and Reform Health Policies

On February 13, 2025, at the swearing-in of Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr., President Donald Trump signed Executive Order “Establishing the President’s Make America Healthy Again...more

Skadden, Arps, Slate, Meagher & Flom LLP

Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts

Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more

Holland & Knight LLP

RFK Jr.'s 2 Days in the Spotlight: Food Additives, Vaccines and Clinical Trials

Holland & Knight LLP on

Although Robert F. Kennedy Jr.'s nomination hearings to be the Secretary of the U.S. Department of Health and Human Services (HHS) focused on a variety of areas, his testimony and questions from U.S. senators focused on a few...more

Cozen O'Connor

COVID Vaccine No Longer Required for Adjustment of Status Applicants

Cozen O'Connor on

On January 22, 2025, USCIS posted an alert pertaining to the I-693 immigration medical exam required for most individuals applying to become lawful permanent residents. USCIS indicates that they now “waive[s] any and all...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Vaccination Program

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more

Alston & Bird

Health Care Week in Review: CMS Releases Mandatory TEAM Hospital Participants and Issues RFI on Medicare Administrative Contractor...

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

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: HHS Finalizes 340B ADR Rule; House and Senate Hold Hearings on President’s FY 2025 HHS Budget

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

McCarter & English, LLP

New Informed Consent Guidance and Pharmacy Immunity

New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for Medicare or Medicaid...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

McGuireWoods Consulting

Washington Healthcare Update - December 2023 #3

McGuireWoods Consulting on

This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final...more

Kohrman Jackson & Krantz LLP

Current Considerations About COVID-19 in the Workplace

The COVID-19 Public Health Emergency officially ended on May 11, 2023, when the Department of Health and Human Services allowed the federal Public Health Emergency for COVID-19 to expire, but people are still getting...more

Alston & Bird

Health Care Week in Review: CMS Announces Details to Pay Drug Costs on Installment Plan

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

Dentons

OIG Estimates COVID-19 Uninsured Program Paid Almost $784 Million in Ineligible Claims

Dentons on

Are you a health care provider who received funds from the Health Resources and Services Administration's ("HRSA' s") COVID-19 Uninsured Program? If so, more inquiries and repayment demands may be coming....more

McDermott+

McDermottPlus Check-Up: July 21, 2023

McDermott+ on

The House and Senate were both in session this week, with healthcare activity at the committee level. The House Energy and Commerce Committee held a hearing on innovation and a markup of 15 healthcare bills. The Senate...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2023 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more

Bradley Arant Boult Cummings LLP

Vax Requirement Sacked in TN: Medicare Providers Lose Exemption from COVID-19 Laws

The federal government says healthcare employers can soon stop requiring employees to get the COVID-19 vaccine. Yes — the U.S. Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) is...more

Stevens & Lee

Final Rule Ends COVID Vaccine Mandate in CMS-Certified Facilities

Stevens & Lee on

The United States Department of Health and Human Services (“HHS”), through the Centers for Medicare and Medicaid Services (“CMS”), published a final rule on June 5 (the “Final Rule”), which, among other important actions,...more

Lathrop GPM

COVID-19: Is the Pandemic Really Over for Employers?

Lathrop GPM on

On May 9, 2023, the United States Department of Health and Human Services issued a press release announcing that the federal Public Health Emergency for COVID-19 would expire on May 11, 2023. The Public Health Emergency has...more

Zuckerman Spaeder LLP

Whither Insurance Coverage for Preventive Health Services? District Court Decision Striking Down Affordable Care Act’s Preventive...

Zuckerman Spaeder LLP on

On May 15, 2023, the Fifth Circuit temporarily stayed a district-court ruling that struck down a key part of the Affordable Care Act (ACA). As a result of the stay, the ACA’s health insurance coverage requirements for...more

ArentFox Schiff

EEOC Updates COVID-19 Technical Assistance

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On May 11, the US Department of Health and Human Services ended its COVID-19 federal public health emergency declaration. Days later, the US Equal Employment Opportunity Commission (EEOC) followed up by updating its COVID-19...more

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