News & Analysis as of

Regulatory Agenda Medicare Part D

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

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

McDermott+

The Future of Medicare Advantage: Q&A with McDermott+’s Lynn Nonnemaker

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A few weeks ago, Regs & Eggs provided insights into Medicare Advantage (MA), the private insurance option under Medicare, and explored both short- and long-term actions that the Trump administration could take to modify MA...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

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 Will & Emery

New Year Brings Material Changes to Medicare Overpayment Rule

McDermott Will & Emery on

The Centers for Medicare and Medicaid Services (CMS) finalized material changes to the overpayment rules for Medicare Parts A, B, C, and D effective January 1, 2025. These changes create new ambiguity and practical challenges...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 Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

Foley Hoag LLP on

On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

King & Spalding

New Medicare Advantage Regulations Add Provider and Beneficiary Protections Against Plan Utilization Management Policies

King & Spalding on

On April 5, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (CMS-4201-F) regarding the Medicare Advantage (MA) and Part D programs. The Final Rule includes changes related to various aspects of...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

Foley & Lardner LLP

Priorities of the 118th Congress and the Biden Administration

Foley & Lardner LLP on

As the final votes of the 2022 Midterm Elections are counted, Republicans have taken back control of the House of Representatives, while the Democrats will retain control of the Senate. Both chambers will be held by extremely...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | October 2022 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between September 21 and October 20, 2022. We review several criminal and civil enforcement actions related to Anti-Kickback Statute...more

White & Case LLP

2022 Drug Pricing Update: States Continue Legislative Push Even As Congress Passes Long Sought Changes

White & Case LLP on

States remain at the forefront of legislative efforts on a range of issues relating to drug pricing, such as increasing price transparency, capping out-of-pocket costs for insulin, and limiting certain PBM practices. These...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

Mintz - Health Care Viewpoints

ML Strategies Health Care Preview - May 2019

This week, the full House is poised to take its first action on drug pricing, voting on a pair of bills that would improve access to drug patents. The first bill is H.R. 1520, the Purple Book Continuity Act of 2019, which...more

Hogan Lovells

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

Hogan Lovells on

In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...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 & Emery

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

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

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