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Centers for Medicare & Medicaid Services (CMS) Prescription Drugs Regulatory Agenda

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

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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

Holland & Knight LLP

Holland & Knight Health Dose: February 25, 2025

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Holland & Knight Health Dose 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 — 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

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

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

Bass, Berry & Sims PLC

CMS CY 2026 Parts C and D Proposals Focus on Informed Choice

Bass, Berry & Sims PLC on

On December 10, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule, which, if finalized as proposed, has potentially significant implications for Medicare Advantage (MA) plans and Medicare...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

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...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

McDermott+

McDermottPlus Check-Up: May 19, 2023

McDermott+ on

The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...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

Polsinelli

CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

Polsinelli on

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

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – January 2019 #4

The shutdown is over for now and Congress is hitting the ground running this week. Most priorities have been on standby with the shutdown taking center stage, so this week in a sense represents the first week of the 116th...more

Latham & Watkins LLP

Drug Pricing and Payment Policy: Key 2018 Developments and Potential 2019 Changes and Challenges

Latham & Watkins LLP on

Following a number of drug pricing reforms implemented or proposed in 2018, 2019 likely will bring more action from HHS and Congress to reduce drug prices. Key Points: ..In 2018, the Administration implemented and...more

Robinson+Cole Health Law Diagnosis

CMS Proposes Revised Prescription Drug Regulations to Lower Drug Prices and Reduce Out of Pocket Expenses

The Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule to amend Medicare Advantage (MA) regulations and Prescription Drug Benefit program (Part D) regulations. The Proposed Rule will be published on...more

Mintz - Health Care Viewpoints

Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed...more

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