News & Analysis as of

Department of Health and Human Services (HHS) New Guidance Prescription Drugs

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

Quarles & Brady LLP on

The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Holland & Knight LLP

Holland & Knight Health Dose: March 21, 2023

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ... ...more

Faegre Drinker Biddle & Reath LLP

Holiday Rush Brings Health Plans Eagerly Awaited RxDC Reporting Guidance and Relief

In FAQs Part 56, issued on December 23, 2022, the Treasury Department and the Departments of Labor and Health and Human Services (collectively, Departments) issued important guidance on prescription drug benefit and cost...more

BakerHostetler

HHS OCR Guidance to 60,000 Retail Pharmacies: Refusal to Fill Rx Based on Potential Pregnancy Termination Concerns Is a Civil...

BakerHostetler on

On July 13, the Department of Health & Human Services (HHS) Office for Civil Rights (OCR) issued guidance to retail pharmacies that refusing to dispense a prescribed medication or making a determination on the suitability of...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Federal Agencies Issue HIV Preventive Services Guidance for Health Benefit Plans

The U.S. Department of Labor, U.S. Department of Health and Human Services, and U.S. Department of the Treasury recently issued regulatory guidance on the requirement that health plans cover pre-exposure prophylaxis (PrEP)...more

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

HHS Proposed Guidance Would Clarify Rules for Drug Manufacturer Coupons

The Department of Health and Human Services (HHS) revisited the treatment of prescription drug manufacturer coupons in a proposed rule, published on February 6, 2020, that could be welcome news for employers that have been...more

Foley Hoag LLP - Medicaid and the Law

CMS Issues Guidance to States on 340B Duplicate Discounts

Late last year, we noted that the Massachusetts Medicaid program had proposed regulations to address issues related to the prohibition on duplicate discounts in the 340B program. The Massachusetts solution was relatively...more

ArentFox Schiff

Investigations Newsletter: DOJ Issues Guidance on Ability-to-Pay in False Claims Act Cases

ArentFox Schiff on

DOJ Issues Guidance on Ability-to-Pay in False Claims Act Cases - On October 8, 2019, Assistant Attorney General Brian Benczkowski announced new guidance for federal prosecutors evaluating whether a corporation is unable...more

Baker Donelson

CMS Issues Updated Medicare Payment and Billing Policies for 340B Hospitals

Baker Donelson on

On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts...more

Buchalter

OIG Finalizes New and Expanded Anti-Kickback Safe Harbors, Issues Guidance Regarding Nominal Gifts

Buchalter on

In an uncertain health care environment following the presidential election, the Department of Health & Human Services Office of Inspector General (“OIG”) finalized a new rule expanding existing safe harbors to the federal...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

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Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

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