News & Analysis as of

Healthcare Medicare Part D

Sheppard Mullin Richter & Hampton LLP

HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

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The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more

Holland & Knight LLP

HHS Secretary Kennedy Dismisses Entire CDC Vaccine Advisory Panel

Holland & Knight LLP on

In a surprising move, the U.S. Department of Health and Human Services (HHS) announced it is reconstituting the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), removing...more

McDermott+

A Deep Dive Into the CMS Program Management FY 2026 Budget Request

McDermott+ on

As discussed in last week’s Regs & Eggs blog post, the US Department of Health and Human Services (HHS) recently released additional budget documents to support the department’s fiscal year (FY) 2026 discretionary request....more

Holland & Knight LLP

Holland & Knight Health Dose: May 13, 2025

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U.S. House of Representatives committees are scheduled to begin markups on additional portions of the budget reconciliation package on May 13, 2025. Both the House Committee on Ways and Means and the House Committee on Energy...more

Quarles & Brady LLP

Part D Pharmacies Required to Enroll in Data Exchange Module to Help Drug Price Negotiation Cash Flow Issue

Quarles & Brady LLP on

On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues CY 2026 Medicare Advantage and Part D Final Rule

On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more

Holland & Knight LLP

CMS Final Rule on CY 2026: Policy and Technical Changes

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The Centers for Medicare & Medicaid Services (CMS) released on April 4, 2025, the final rule for contract year (CY) 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more

McDermott+

An MA Extravaganza: Overview of the Final Rule and Rate Announcement

McDermott+ on

This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...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

Alston & Bird

Health Care Week in Review | Oz Confirmed as CMS Administrator; CMS finalizes CY 2026 MA/Part D Final Rule

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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

Woods Rogers

Employee Benefits Likely Impacted by Executive Orders

Woods Rogers on

During the first weeks of the second Trump Administration, a number of executive orders and other actions have been implemented, with some having potential implications for employee benefits. Executive Orders can, and do,...more

McDermott+

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

McDermott+ on

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

DLA Piper

Keeping Watch on Medicare: Access Prescription Drug Plans and Premiums

DLA Piper on

The Inflation Reduction Act (IRA) significantly changed the popular Medicare drug programs. While an IRA policy goal is to reduce the out-of-pocket drug spending, beneficiaries may experience higher drug plan premiums and...more

McCarter & English, LLP

FTC Issues PBM Report Signaling Consolidation Is Impacting Pharmaceutical Prices

At a public meeting held on January 15, 2025, the Federal Trade Commission (FTC) summarized the Second Interim Staff Report (Second Report) stemming from its investigation into pharmacy benefit managers (PBMs) and their...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

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

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

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Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Cozen O'Connor

Whistleblower Watch - A quarterly update on FCA Enforcement and Qui Tam Litigation

Cozen O'Connor on

Whistleblower Watch is a critical resource for in-house counsel and compliance professionals. Each quarter, Cozen O’Connor summarizes the most notable False Claims Act (FCA) enforcement actions, settlements, and legal trends,...more

Pullman & Comley, LLC

Substantially Increased Medicare Benefits For Prescription Drugs in 2025 – What You Need to Know

Pullman & Comley, LLC on

There are important new rules this year relating to prescription drug coverage which may be relevant to your Medicare plan beginning January 1, 2025. The “Open Enrollment” period this year during which eligible individuals...more

Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Alston & Bird

Health Care Week in Review: CMS Released Negotiated Medicare Part D Prices for 10 Drugs and ARPA-H Awarded $150 Million in Funding...

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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 Will & Schulte

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

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

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