News & Analysis as of October 18, 2024

Final Rules

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The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +

HHS Issues 340B Administrative Dispute Resolution Final Rule

McDermott Will & Emery on 4/24/2024

On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more

Agencies Provide Guidance on Transparency in Coverage Rule Implementation

McDermott Will & Emery on 4/26/2022

On April 19, 2022, the US Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) released Frequently Asked Questions (FAQs) regarding the implementation of certain reporting...more

You Are Here: A Mall Directory for Healthcare Transparency Requirements

Verrill on 11/10/2021

The old adage “you can’t get where you’re going unless you know where you are” has never seemed more true than when applied to the current mélange of healthcare transparency guidance. Fortunately, a fading relic from...more

Departments Delay Enforcement of Transparency Disclosure Requirements

Fisher Phillips on 9/7/2021

Group health plan sponsors soon will face daunting new disclosure and transparency requirements under multiple laws including the Affordable Care Act (ACA), the No Surprises Act (the Act) and the Consolidated Appropriations...more

Agencies Issue Final Employer Healthcare Price Transparency Rule

McDermott Will & Emery on 11/11/2020

On October 29, 2020, the US Departments of Health and Human Services, Labor and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth...more

ML Strategies Health Care Preview - May 2019 #4

Mintz - Health Care Viewpoints on 5/22/2019

We are a few legislative days from the Memorial Day recess with the trajectory of issues like drug pricing and surprise medical billing still emerging. The House has passed several drug pricing bills in the past month, with...more

K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

K&L Gates LLP on 1/31/2019

As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more

340B Update: HRSA Delays Final Rule on 340B Pricing and Manufacturer CMPs Yet Again

K&L Gates LLP on 8/24/2017

On August 21, 2017, the Health Resources and Services Administration (“HRSA”) published a Notice of Proposed Rulemaking to further delay the effective date of final rules on drug pricing calculations and civil monetary...more

HRSA Releases Ceiling Price and CMP Final Rule

Hogan Lovells on 1/9/2017

The Health Resources and Services Administration (HRSA) released its Final Rule regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties (CMPs) on manufacturers that knowingly and...more

Deciphering the Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers

Mintz on 2/12/2016

In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more

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Patient Protection and Affordable Care Act (PPACA) › Drug Pricing › Final Rules

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