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Medicare Regulatory Agenda Pharmaceutical Industry

Skadden, Arps, Slate, Meagher & Flom LLP

Trump Attempts To Rein In Drug Prices With Most-Favored-Nation Approach

On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more

Holland & Knight LLP

Holland & Knight Health Dose: April 8, 2025

Holland & Knight LLP on

Looking Ahead: House to Vote on Compromise Budget Resolution On the heels of the U.S. Senate's passage of a compromise budget resolution, the U.S. House of Representatives is expected to consider the budget resolution on the...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

Holland & Knight LLP

Holland & Knight Health Dose: February 19, 2025

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Mintz - Health Care Viewpoints

Mintz IRA Update — Fourth Edition: Q1 2025

Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The Future of the Medicare Drug Price Negotiation Program

The Centers for Medicare and Medicaid Services (CMS) and pharmaceutical drug manufacturers are gearing up for the second round of negotiations as part of the Medicare Drug Price Negotiation Program (the Negotiation Program),...more

DLA Piper

Keeping Watch on Medicare as the IRA is Implemented: Formulary Management Practices

DLA Piper on

The Inflation Reduction Act (IRA), passed in 2022, made changes to the way drugs are covered and reimbursed in Medicare. While some of the changes taking effect this year could save the government money, beneficiaries may...more

Skadden, Arps, Slate, Meagher & Flom LLP

Health Care: Trump Focuses on Drug Pricing Experiments, ACA and Research Grants

In his first week in office, President Donald Trump issued executive orders and took other actions with significant implications for the life sciences and health care industries that mark substantial departures from the...more

Jones Day

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

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The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more

Alston & Bird

Health Care Week in Review: President Trump Issues a Series of Executive Orders; Senate Committees Announce Hearing Dates for HHS...

Alston & Bird on

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

McDermott+

McDermott+ Check-Up: December 20, 2024

McDermott+ on

118th Congress Continues to Grapple with Contentious CR. With the collapse of Republican support for the negotiated continuing resolution (CR) package, as of the time of publication on Friday at 3:00 PM EST, Congress is still...more

McDermott+

Regulatory Implications of the Continuing Resolution Healthcare Package

McDermott+ on

Earlier this week, Congress released the text of a continuing resolution that includes a more-robust-than-anticipated healthcare package. While the bill’s primary purpose is to keep the government open through March 14, 2025,...more

DLA Piper

CMS Releases New Proposed Rule for Medicare Advantage and Part D

DLA Piper on

On December 10, 2024, the Centers for Medicare and Medicaid Services (CMS) released a Proposed Rule for revisions to the regulations governing the Medicare Advantage (MA) program, Medicare Prescription Benefit (Part D),...more

McDermott+

McDermott+ Check-Up: December 6, 2024

McDermott+ on

Congress Negotiates Healthcare Extenders, Continues to Plan for 2025. Lawmakers continue negotiations to wrap up the 118th Congress and pass remaining must-do policies, including government funding, likely through a...more

McDermott+

Another Trip to the Buffet: Highlights from the CY 2025 OPPS Final Reg

McDermott+ on

As mentioned last week, the Centers for Medicare & Medicaid Services (CMS) recently put out a large buffet of regs – too many to digest in one blog post. While we focused on the Calendar Year (CY) 2025 Physician Fee Schedule...more

McDermott+

Virtual Care Policy Update: What to Expect in Lame Duck

McDermott+ on

The Consolidated Appropriations Act (CAA), 2023 (Public Law 117-328), signed into law on December 29, 2022, extended certain key virtual care flexibilities instituted during the COVID-19 public health emergency (PHE) through...more

McDermott+

McDermott+ Check-Up: September 13, 2024

McDermott+ on

House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

Quarles & Brady LLP

The Lower Costs More Transparency Act of 2023

Quarles & Brady LLP on

The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more

McDermott+

Healthcare Preview for the Week of: November 27, 2023

McDermott+ on

Limited Time Before the End of the Year and January 19 First, welcome back from what was hopefully a wonderful and restful Thanksgiving break. Although this year will not entail a year-end government funding package, we are...more

McDermott+

McDermottPlus Check-Up: November 10, 2023

McDermott+ on

CONGRESS - Senate Finance Committee Holds Markup on Better Mental Health Care, Lower-Cost Drugs, and Extenders Act. The bipartisan package includes Medicare and Medicaid extenders, provisions to expand the mental health...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | June 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | May 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more

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