News & Analysis as of

Covered Entities Administrative Procedure Act

Bass, Berry & Sims PLC

Chevron No More: The Impact on Benefit Plans

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On June 28, 2024, the Supreme Court issued its opinion in Loper Bright Enterprises v. Raimondo, Secretary of Commerce and Relentless, Inc. v. Department of Commerce (Loper Bright), overturning Chevron U.S.A. Inc v. Natural...more

Jones Day

Delegation Dilemma: CFTC Rule Allows Staff to Circumvent Notice and Comment Rulemaking

Jones Day on

The Commodity Futures Trading Commission ("CFTC") published a final rule on April 30, 2024, altering how covered entities fulfill their large trader reporting obligations ("the LTR Rule") and granting CFTC staff significant...more

Bricker Graydon LLP

Federal court sides with Eli Lilly challenge to HHS expansion of 340B discounts

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On March 16, 2021, the United States District Court in Indiana granted plaintiff Eli Lilly’s request for a preliminary injunction to halt implementation of a Department of Health and Human Services (HHS) rule published in...more

ArentFox Schiff

340B Entities Sue HHS Over Lack of Dispute Resolution Process

ArentFox Schiff on

Three organizations serving primarily HIV and AIDS patients and who each are also considered “Covered Entities” under the 340B Drug Pricing Program (the Plaintiffs) filed a lawsuit against Department of Health and Human...more

Baker Donelson

District Court Ruling Impacts HIPAA Access Request Permissible Charges

Baker Donelson on

On January 23, 2020, the United States District Court for the District of Columbia declared sections of the 2013 Omnibus Rule unlawful. The Court found that the Department of Health and Human Services (HHS) impermissibly...more

Polsinelli

CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

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This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more

Arnall Golden Gregory LLP

District Court in D.C. Vacates HHS’ Interpretive Rule Regarding Orphan Drug Exclusion from 340B Discount Pricing

In what amounts to a victory for the pharmaceutical industry, on October 14, 2015, the U.S. District Court for the District of Columbia vacated the interpretive rule issued by the U.S. Department of Health and Human Services...more

Foley & Lardner LLP

Court Strikes Down 340B Orphan Drug Rule Again: Will This Impact the “Mega Guidance”?

Foley & Lardner LLP on

A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more

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