Legal Alert: USPTO Proposes Major Change to Terminal Disclaimer Practice
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
The FTC’s Rule Banning Non-Compete Agreements | What You Need to Know
An In-Depth Analysis of the CFPB’s Proposed Overdraft Rule - The Consumer Finance Podcast
The FTC Takes Initiative to Stop Junk Fees
Understanding the CFPB's Proposed Digital Payments Larger Participants Rule and Its Implications for Digital Assets — The Consumer Finance Podcast
Instant Decline, Instant Relief? Unpacking the CFPB's Proposed Rule on NSF Fees — Payments Pros: The Payments Law Podcast
Redefining Banking: A Conversation on the CFPB's Proposed 1033 Rule — Payments Pros: The Payments Law Podcast
DE Under 3: FAR Council Submitted for OMB Approval Proposed Rule on “Pay Equity and Transparency in Federal Contracting”
The FTC Announces Three Important Developments
Exploring the Future of Open Banking: A Discussion on CFPB's 1033 Proposed Rule – Crossover Episode With Regulatory Oversight Podcast – The Consumer Finance Podcast
Exploring the Future of Open Banking: A Discussion on CFPB's 1033 Proposed Rule — Regulatory Oversight Podcast
The Future of Digital Consumer Payment Applications: CFPB's Proposed Larger Participant Rule – The Consumer Finance Podcast and Payments Pros Podcast
Alternatives to Noncompetes: Intellectual Property Alternatives to Noncompetes
Employment Law Now VII-135-Summer 2023 Wrap-Up Part 1 (NEW DOL OVERTIME RULE)
Podcast - Insights on the FTC's Approach to Digital Health Companies
Podcast - SEC's Oversight on Cybersecurity Requirements
The FTC's Proposed Rule to Fight Impersonation Scams
CFPB's Larger Participant Rule for Consumer Payments - The Consumer Finance Podcast
Podcast - The Latest on Antitrust and Non-Compete Agreements in Healthcare
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more
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
This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
340B Covered Entities (CEs) are getting a glimpse into what they can expect to be repaid due the fallout from CMS’ unlawful 340B payment reduction that was struck down by the U.S. Supreme Court in June 2022. CMS discussed a...more
Earlier today, the US Court of Appeals for the Third Circuit issued a much-anticipated decision in one of the 340B contract pharmacy cases. The decision is a win for drug manufacturers who have sought to restrict access to...more
On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more
The Centers for Medicare & Medicaid Services (CMS) has issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (HOPPS) (the Proposed Rule)....more
In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B...more
In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more
This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...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
This week, the Health Resources and Services Administration (HRSA) issued a Proposed Rule (Proposed Rule) to cease any further delay of the 340B Ceiling Price and Civil Monetary Penalties regulation (CMP Final Rule) and...more