News & Analysis as of

Healthcare Food and Drug Administration (FDA) HRSA

Alston & Bird

Health Care Week in Review: Agencies issued Requirements Related to the Mental Health Parity and Addiction Equity Act final rules;...

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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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2024 #4

News Briefs - Statistics Show Upward Trend in Healthcare Data Breaches - Healthcare data breach statistics clearly show there has been an upward trend in data breaches over the past 14 years, with 2021 seeing more data...more

Alston & Bird

Health Care Week in Review: Texas Judge Blocked FTC Rule Banning Noncompetes; Biden Administration Announced $1.4 Billion for HIV...

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: CMS Finalizes the TCET Pathway for Breakthrough Technologies; HRSA Awards Health Centers Funding for...

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

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

King & Spalding

White House’s FY 2023 Budget Request Includes Healthcare Provisions

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President Biden submitted his Fiscal Year (FY) 2023 budget request to Congress on March 28, 2022. The budget request is not binding on Congress. Rather, it may serve as a guide for both Congress and the administration as they...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Below is Alston & Bird’s Healthcare 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

A&B Healthcare Week in Review, November 2015

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I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

K&L Gates LLP

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

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In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

K&L Gates LLP on

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Mintz - Health Care Viewpoints

Health Update - June 2014

In This Issue: - Judge Rules Against 340B Drug Authority - FDA Approves Skin Infection Drug - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

McDermott Will & Emery

HRSA Finalizes 340B Program Orphan Drug Exclusion Rules

McDermott Will & Emery on

On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program (340B Program) orphan drug...more

Littler

Tenth Circuit Rules in Favor of Religious For-Profit Corporations in Birth Control Litigation under the Affordable Care Act

Littler on

In Hobby Lobby Stores, Inc. et al. v. Sebelius, et al.,1 an en banc panel of the U.S. Court of Appeals for the Tenth Circuit held that Hobby Lobby Stores Inc. and Mardel Inc., two for-profit corporations owned and operated by...more

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