Medicaid, Biosimilars, Centers for Medicare & Medicaid Services (CMS)

Health Care Week in Review | Congress Passes Recissions Package, CMS Releases CY 2026 PFS and OPPS Proposed Rules

Alston & Bird on 7/21/2025

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

[Virtual Conference] Inaugural Summit on GLP-1 Law & Policy - July 24th, 8:15 am - 5:15 pm ET

American Conference Institute (ACI) on 6/30/2025

The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more

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

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

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

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

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

Washington Healthcare Update

McGuireWoods LLP on 7/15/2015

This Week: 21st Century Cures Legislation Passes House in Bipartisan Vote... CMS Releases Proposed CY 2016 Home Health Prospective Pay Rule... CMS Releases Final CY 2016 Hospital Outpatient Prospective Payment System (OPPS)...more

Washington Healthcare Update

McGuireWoods LLP on 5/5/2015

This Week: House E&C Releases Discussion Draft of 21st Century Cures Legislation Ahead of Legislative Hearing... FDA Finalizes Biosimilar Guidance Documents... CMS Updates Wage Index and Payment Rates for the Medicare Hospice...more

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

BakerHostetler on 4/23/2015

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

King & Spalding on 4/16/2015

Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more

CMS Takes Initial Steps to Address Medicare & Medicaid Coverage for Biosimilars

Mintz - Health Care Viewpoints on 4/10/2015

On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more

Washington Healthcare Update

McGuireWoods LLP on 4/7/2015

This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

Medicaid › Biosimilars › Centers for Medicare & Medicaid Services (CMS)

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