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Administrative Procedure Act Covered Entities

ArentFox Schiff

HIPAA Reproductive Privacy Rule Takes Effect Amid Legal and Political Uncertainties

ArentFox Schiff on

As of December 23, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) must comply with new reproductive health care privacy...more

BakerHostetler

DSIR Deeper Dive: Tracking the Crackdown on Tracking/Pixel Technologies: Web Litigation and Regulatory Landscape - Part 2

BakerHostetler on

In the first part of this blog post, we looked into the OCR and FTC’s focus on third-party tracking technologies. We also reviewed the AHA Lawsuit and its impact for the use of tracking technologies. In this blog post, we...more

Proskauer - Health Care Law Brief

Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal

On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more

Bass, Berry & Sims PLC

Chevron No More: The Impact on Benefit Plans

Bass, Berry & Sims PLC on

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

Bricker Graydon LLP on

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

Polsinelli on

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

Harris Beach Murtha PLLC

Health Care Group News: Texas District Court Preliminarily Enjoins Partial Enforcement of Section 1557

In May of last year, the United States Department of Health and Human Services ("HHS") enacted regulations implementing Section 1557 of the Affordable Care Act. These regulations aimed to enhance language assistance and...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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