News & Analysis as of

New Guidance Department of Health and Human Services (HHS) Proposed Rules

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Seyfarth Shaw LLP

My Insurance Doesn’t Cover That? Agency Guidance on “Junk Insurance”

Seyfarth Shaw LLP on

Seyfarth Synopsis: Fresh on the heels of the IRS Chief Counsel Memorandum on wellness and indemnity products, discussed in our prior post here, the agencies have weighed in with more formal and more expansive guidance...more

Foley & Lardner LLP

HHS Gives New Guidance on Drug Manufacturer Coupons and Out-of-Pocket Maximums

Foley & Lardner LLP on

In April 2019, the Department of Health and Human Services (HHS) released guidance indicating that a health plan must include the value of financial assistance received from a drug manufacturer (often referred to as a...more

Holland & Knight LLP

Religious Institutions Update: January 2018 - Lex Est Sanctio Sancta

Holland & Knight LLP on

Timely Topics - By Shannon B. Hartsfield - The U.S. Department of Health and Human Services (HHS) announced on Jan. 18, 2018, the creation of a new division within its Office for Civil Rights (OCR). OCR is described as...more

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