A Look at Recent Federal Trade Commission and Consumer Financial Protection Bureau Initiatives Concerning Privacy and Data Security
2BInformed: Engaging with EPA, OSHA’s New Regulation, and Asbestos
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more
On December 14, 2020, the Health Resources and Services Administration (HRSA) published in the Federal Register a final regulation to implement a 340B drug pricing program administrative dispute resolution (ADR) process. The...more
On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more
On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more
The Big Picture - In the latest election year action to address politically salient concerns with high drug costs, President Trump on Sunday signed an “Executive Order on Lowering Drug Prices by Putting America First.”...more
• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals. • The proposed structure, called the International Pricing Index (IPI)...more
Another Presidential Administration Attempts to Change Part B Payment for Physician-Administered Drugs - On October 25, 2018, the Trump Administration released an Advance Notice of Proposed Rulemaking (“ANPRM”) entitled...more
On Wednesday, October 25th, President Trump, along with HHS Secretary Alex Azar, introduced the administration’s new proposal to lower drug prices through Medicare Part B. The announcement follows ASPE’s morning release of a...more
On October 25, 2018, the Centers for Medicare and Medicaid Services (CMS) announced an Advance Notice of Proposed Rulemaking with Comment (ANPRM) proposing to implement an international pricing index (IPI) model for Medicare...more
On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more
President Trump yesterday touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing options to test Medicare reimbursement based on...more
Lawmakers returned from their Independence Day recess prepared for more legislative fireworks over a slew of outstanding agenda items, including a showdown over the Supreme Court nomination of Judge Brett Kavanaugh to replace...more