News & Analysis as of

Prescription Drug Coverage Food and Drug Administration (FDA)

Wilson Sonsini Goodrich & Rosati

Biden Administration Inks Bills to Increase Drug Competition

Also Codifies FDA's Longstanding "Active Moiety" Approach for New Chemical Entity Exclusivity - In April 2021, President Biden signed two bipartisan bills that aim to promote drug competition and to reduce prescription...more

Foley Hoag LLP - Medicaid and the Law

Paying for Value in Medicaid Prescription Drug Coverage

My colleague Ross Margulies has already told our readers about a provision of the new proposed Medicaid regulation governing how the program pays for outpatient prescription drugs under the Medicaid Drug Rebate Program, or...more

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

Smart & Biggar on

Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

Highlights this week: Democrats’ takeover of the House will yield big changes for healthcare policy in 2019; several GOP lawmakers active in healthcare policy are defeated; pharma pushes for Part D changes in the lame duck;...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Goodwin

FDA Commissioner Gottlieb Gives Speech on Biosimilars

Goodwin on

Earlier today, FDA Commissioner Scott Gottlieb, MD, gave a speech focusing on biosimilars at America’s Health Insurance Plans’ National Health Policy Conference in Washington, D.C. In his speech, Commissioner Gottlieb...more

Alston & Bird

Updates on Biosimilar Reimbursement Pathways in the Face of a Changing Market

Alston & Bird on

Though the biosimilars market has evolved, and more companies are seizing the opportunities, reimbursement regulations have been unclear at best. Our Health Care Group untangles the latest rules from the Centers for Medicare...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: The Affordable Care Act turned 6 years old on March 23... Four in ten voters say health care is extremely important when picking a President, according to a Kaiser Family Foundation’s new tracking poll......more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: Medicaid program takes financial hits as the House looks for “savers” and acts on a budget... while the Senate sees no reason to do a budget... The Senate focuses on ACA oversight and mental health and opioid abuse...more

Mintz - ML Strategies

Health Care Update - February 2016 #4

Mintz - ML Strategies on

What to Expect from Congress this Work Period - The next Hill work period basically runs from February 22nd to March 23rd. As Congress returns, here’s a brief look at the pending health care issues on the radar for this...more

Alston & Bird

A&B Healthcare Week in Review - January 2016

Alston & Bird on

On January 5, 2016, the Office of Management and Budget (OMB) received for review a final rule from the Centers for Medicare & Medicaid Services (CMS) entitled Covered Outpatient Drugs (CMS-2345-F). The rule had previously...more

Alston & Bird

A&B Healthcare Week In Review, September 2015

Alston & Bird on

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

Mintz - ML Strategies

Health Care Update - August 2015 #2

Mintz - ML Strategies on

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more

Manatt, Phelps & Phillips, LLP

Health Update - July 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

BakerHostetler

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

BakerHostetler on

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more

BakerHostetler

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

BakerHostetler on

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

Mintz - Health Care Viewpoints

Health Care Update

In This Issue: - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other Health Care News - Upcoming Hearings and Markups -...more

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