News & Analysis as of

Fifth Amendment › Department of Health and Human Services (HHS)

Kramer Levin Naftalis & Frankel LLP

Just Opt Out! Boehringer Ingelheim’s IRA Challenge Is Latest To Fail

Kramer Levin Naftalis & Frankel LLP on

Since its enactment in 2022, the validity of the Inflation Reduction Act (IRA) and its drug price negotiation program (Program) has been repeatedly challenged in District Court, with little success. Boehringer Ingelheim’s...more

Goodwin

IRA Drug Price Negotiation Program Litigation Updates - Denial of PI Motion and Motion to Dismiss in Chambers of Commerce Case and...

Goodwin on

Denial of Motion to Dismiss and Motion for Preliminary Injunction in Chambers of Commerce case - On Friday, September 29, the court in Dayton Area Chamber of Commerce et al. v. Becerra et al. (S.D. Ohio, Judge Newman)...more

MoFo Life Sciences

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

MoFo Life Sciences on

In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the...more

Constangy, Brooks, Smith & Prophete, LLP

Judge shuts down LGBT guidance

Constangy, Brooks, Smith & Prophete, LLP on

And opens up a can of worms. In June 2021, the Equal Employment Opportunity Commission (or, to be more precise, EEOC Chair Charlotte Burrows, a Democrat*) issued non-binding guidance about LGBT workers. ...more

King & Spalding

HHS Expands Categories of Persons Covered Under the PREP Act Who Can Administer COVID-19 Vaccine

King & Spalding on

On January 28, 2021, HHS issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), expanding the categories of persons able to prescribe, dispense, and administer...more

Mintz - Health Care Viewpoints

Decision Expected Soon in Ongoing Risk Corridors Litigation

Mintz - Health Care Viewpoints on

Many provisions of the Affordable Care Act (“ACA”) have been the subject of litigation over the last decade, with several high-profile Supreme Court cases including: NFIB v. Sebelius, King v. Burwell, and Burwell v. Hobby...more

Proskauer Rose LLP

The ERISA Litigation Newsletter - June 2016

Proskauer Rose LLP on

Editor's Overview - In this month’s newsletter, our colleagues focus on two sets of legislative updates. First is a discussion of the IRS’s proposed Treasury Regulations prescribing rules under Section 457 of the...more

Sheppard Mullin Richter & Hampton LLP

A (Second) Lawsuit Seeks to Compel Statutory Timeframe for Administrative Law Judge Review of Medicare Claims Appeals

Sheppard Mullin Richter & Hampton LLP on

On August 26th, the Center for Medicare Advocacy filed a nationwide class action lawsuit against the Secretary of Health and Human Services. The complaint alleges that, as implemented, the Medicare administrative review...more

The Volkov Law Group

Congressional Investigations: Unique And Significant Risks

The Volkov Law Group on

We have all watched the familiar scene on Capitol Hill – the latest public scandal like officials from the Internal Revenue Service are dragged up to Capitol Hill to appear before a Committee, raise their right hands, take...more

Sheppard Mullin Richter & Hampton LLP

False Press Release Leads To Exclusion From Federal Programs

Sheppard Mullin Richter & Hampton LLP on

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

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