Medicaid, Biosimilars

Mintz IRA Update — The First Anniversary of the Inflation Reduction Act: A Year in Review

Mintz - Health Care Viewpoints on 9/21/2023

August 16, 2023 marked the one-year anniversary of the enactment of the Inflation Reduction Act (“IRA”). The first 365 days since the IRA’s passage brought the implementation of a number of significant changes to the Medicare...more

Health Care & Life Sciences: Drug Pricing Digest - October 2022 #2

Latham & Watkins LLP on 10/26/2022

2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more

[Webinar] Implications Across the Health Care System of the New Federal Drug Price Regulation - September 22nd, 1:00 pm - 2:00 pm...

Manatt, Phelps & Phillips, LLP on 9/7/2022

The Inflation Reduction Act of 2022 (IRA) includes the most dramatic change to U.S. drug price regulation in history. The new law allows the federal government to “negotiate” the price of many drugs dispensed to Medicare...more

Demy-Colton panel explains importance of U.S. market access planning ahead of Phase III trials

Hogan Lovells on 5/10/2022

Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms, providing companies that are new to the U.S. market, or looking to launch in the...more

President Biden Issues Executive Order Including Provisions To Promote Generic Drug and Biosimilar Competition in the American...

Goodwin on 7/20/2021

On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions...more

Washington Healthcare Update - March 2020 #1

McGuireWoods Consulting on 3/3/2020

This week in Washington: Hearings scheduled on the U.S. response to the Coronavirus. ...more

Washington Healthcare Update - February 2020 #3

McGuireWoods Consulting on 2/18/2020

This week in Washington: The House and Senate will be in recess the week of Feb. 17 in observation of Presidents Day....more

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues - October 2019

Wilson Sonsini Goodrich & Rosati on 10/14/2019

In This Issue - 1. Drug Manufacturing: Sen. Grassley Pressures Company Over Data Manipulation - 2. Medical Product Innovation: Update to 21st Century Cures Act in the Works - 3. Drug Pricing: Senate Finance...more

Capitol Hill Healthcare Update

BakerHostetler on 6/17/2019

Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. GRASSLEY CONFIRMS DELAY ON DRUG BILL WHILE ANOTHER COMMITTEE PLANS VOTES - Senate Finance Committee Chairman...more

Is the Affordable Care Act a House of Cards? If Yes, What Does the Recent Texas Court Decision Mean for the US Health Insurance...

Epstein Becker & Green on 12/19/2018

In an unexpectedly broad ruling issued December 14, 2018, the U.S. District Court for the Northern District of Texas declared the Affordable Care Act (“ACA”) as unconstitutional in its entirety. This decision, if ultimately...more

Health Care Policy Newsletter - July 2018 #3

Foley & Lardner LLP on 7/24/2018

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we...more

Capitol Hill Healthcare Update

BakerHostetler on 6/26/2018

LAWMAKERS COOL TO TRUMP PLAN ON HHS, GOVERNMENT REORGANIZATION - The response from lawmakers on Capitol Hill to the White House plan to reorganize the federal government – including proposed changes to multiple healthcare...more

Healthcare Law Update: May 2018

Holland & Knight LLP on 5/30/2018

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Trump Administration Drug Pricing Blueprint: Overview and Analysis

Akin Gump Strauss Hauer & Feld LLP on 5/17/2018

• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. • Many of the more dramatic proposals would require federal rulemaking or...more

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

Holland & Knight LLP on 2/19/2018

The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more

White House Unveils Proposal on Drug Pricing

Holland & Knight LLP on 2/13/2018

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

New State Substitution Laws, and a Busy Spring for Biosimilars

Mintz - Health Care Viewpoints on 4/20/2017

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Washington Healthcare Update

McGuireWoods LLP on 4/12/2016

This Week: MedPAC votes on changes in Part D... Senate HELP Committee reports five “Cures” bills... One report shows uninsured number decreasing... Another says, but we still need the safety net. ...more

Health Care Update - April 2016

Mintz - ML Strategies on 4/6/2016

FDA Reform Tops Spring Work Period Agenda - The next work period basically runs from April 4 to May 27, with a both chambers adjourning for a week long recess the week of May 2nd. Following this work period, there will...more

A&B Healthcare Week in Review

Alston & Bird on 4/1/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more

A&B Healthcare Week in Review

Alston & Bird on 3/18/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

Washington Healthcare Update

McGuireWoods LLP on 3/8/2016

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

A&B Healthcare Week in Review, November 2015

Alston & Bird on 11/25/2015

I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

A&B Healthcare Week In Review, September 2015

Alston & Bird on 10/1/2015

On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System”. This proposed rule would...more

Health Update - July 2015

Manatt, Phelps & Phillips, LLP on 7/23/2015

Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more

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