News & Analysis as of

Medicare Regulatory Agenda Prescription Drugs

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+

2026 Medicare Advantage and Part D Final Rate Notice: What to Expect

McDermott+ on

Key Takeaways - - CMS is expected to issue the 2026 final rate notice for Medicare Advantage (MA) and Part D plans by April 7, 2025. - The January 2025 advance notice proposed policies that would increase payments to MA...more

Epstein Becker & Green

Sitting Atop a Telehealth Cliff?

Once again, Congress is quickly approaching a telehealth cliff. Without passing additional legislation, current Medicare telehealth flexibilities will expire on March 31, 2025....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

McDermott Will & Schulte

HHS OIG Releases Updated Nursing Facility Compliance Program Guidance: Quality and Safety Lessons

Nursing facilities and skilled nursing facilities that participate in the Medicare and Medicaid programs must comply with certain mandatory compliance program requirements of participation (ROPs). Under the Biden...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+

Healthcare Preview for the Week of: January 21, 2025

McDermott+ on

First Official Week of Trump 2.0 - President Trump officially began his second term yesterday. He briefly discussed healthcare in his first inaugural speech, committing to tackle chronic disease and keep children safe,...more

Nelson Mullins Riley & Scarborough LLP

Federal Regulatory Update: CMS Releases CY 2026 Advance Notice for Medicare Advantage and Part D Programs

The Centers for Medicare & Medicaid Services (CMS) has issued the Calendar Year (CY) 2026 Advance Notice, proposing updates to payment policies for Medicare Advantage (MA) and Medicare Part D Prescription Drug Programs. This...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

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

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...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+

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

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

White & Case LLP

Five Drug Pricing Issues to Watch in 2023

White & Case LLP on

Despite a busy 2022, drug pricing remains a hot topic at the federal and state levels, with a number of recent developments and trends worth monitoring heading into 2023. In the past year, the FTC increasingly focused on the...more

Sheppard Mullin Richter & Hampton LLP

Elijah E. Cummings Lower Drug Costs Now Act: The Long and Winding Road to Drug Pricing Reform

As reintroduced in the U.S. House of Representatives by Rep. Frank Pallone, Jr. (D-NJ-6) on April 22, 2021 after originally being introduced on September 19, 2019, H.R. 3, also known as known as the Elijah E. Cummings Lower...more

Hogan Lovells

Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

Hogan Lovells on

The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more

Sheppard Mullin Richter & Hampton LLP

CMS Proposes Changes to the Medicare Advantage and Part D Programs for CY 2021 and 2022

In an evening email that is sure to ruin the weekend for many, CMS announced on February 5, 2020, that it is proposing changes to the Medicare Advantage and Part D Programs for CY 2021 and 2022. CMS will not issue a Call...more

Baker Donelson

A Flurry of Recent Activity Highlights Continued Interest in 340B Program Oversight

Baker Donelson on

Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more

Foley & Lardner LLP

HHS Proposes New Rules To Eliminate Drug Rebates and Encourage Direct Discounts for Federal Beneficiaries

Foley & Lardner LLP on

On January 31, 2019, the United States Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) announced a proposed rule, which would eliminate certain drug rebates and encourage direct discounts for...more

McDermott Will & Schulte

HHS Proposes to Revise Discount Safe Harbor Protection for Drug Rebates

On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify...more

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