News & Analysis as of October 18, 2024

Pharmaceutical Industry

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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 +

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on 5/9/2024

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...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

Washington Healthcare Update - January 2022

McGuireWoods Consulting on 1/11/2022

Upcoming Hearings/Markups - January 11 - Senate Health, Education and Labor Committee Hearing: “Addressing New Variants: A Federal Perspective on the COVID-19 Response” 10:00 a.m....more

Washington Healthcare Update - October 2021 #2

McGuireWoods Consulting on 10/12/2021

This week in Washington: Reconciliation delayed; short-term debt ceiling fix passed....more

Washington Healthcare Update - April 2021 #3

McGuireWoods Consulting on 4/27/2021

This week in Washington: Andrea Palm’s nomination for HHS Deputy Secretary Advances out of Senate Finance Committee, Chiquita Brooks-LaSure’s nomination deadlocked....more

Proposed ‘Kitchen Sink’ Medicaid Rule Could Bring Changes for Pharmaceutical Manufacturers

ArentFox Schiff on 6/24/2020

The Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule on June 19, 2020 (the Proposed Rule) which, among other things, suggests updates to Medicaid policies and practices related to drug pricing and...more

New Risks, New Rewards, New Exposure

King & Spalding on 6/24/2020

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Hogan Lovells on 8/16/2019

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Trump Administration: 2017 Recap and 2018 Outlook

Akin Gump Strauss Hauer & Feld LLP on 1/17/2018

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

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Patient Protection and Affordable Care Act (PPACA) › Proposed Rules › Pharmaceutical Industry

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