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Medicare Inflation Reduction Act (IRA)

Ropes & Gray LLP

HRSA Announces 340B Rebate Model Pilot Program

Ropes & Gray LLP on

On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited...more

Morgan Lewis - As Prescribed

Orphan Drugs, Big Breaks: The Quiet Carve-Out in the 'One Big Beautiful Bill Act'

The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be...more

DLA Piper

Keeping Watch on Medicare: Formulary Assessment Shows Large Declines in Access for Certain Rare Disease Treatments

DLA Piper on

The Inflation Reduction Act (IRA) changed how drugs are covered and reimbursed in Medicare. It is anticipated that this may lead to more restrictive formularies in drug plans....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

ArentFox Schiff

Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know

ArentFox Schiff on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These...more

Hogan Lovells

Medicare proposed rules include government pricing surprises: ASP changes and maximum fair price, new bona fide service fee and...

Hogan Lovells on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025

Latham & Watkins LLP on

On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act, his signature policy legislation. Two aspects of this legislation are particularly relevant for drug pricing....more

DLA Piper

Keeping Watch on the IRA: Co-pays Increasing for Diabetes Medications

DLA Piper on

The Inflation Reduction Act (IRA) made changes to the way drugs are covered and reimbursed in Medicare. It has been anticipated that this could result in more restrictive formularies in drug plans or higher co-pays for...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #3

Latham & Watkins LLP on

Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

American Conference Institute (ACI)

[Virtual Conference] Inaugural Summit on GLP-1 Law & Policy - July 24th, 8:15 am - 5:15 pm ET

The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #2

Latham & Watkins LLP on

Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more

American Conference Institute (ACI)

[Virtual Conference] 19th Annual BIG FOUR Pharmaceutical Pricing Boot Camp - June 23rd - 24th, 9:00 am - 5:30 pm EDT

Attend ACI's 19th Annual BIG FOUR Pharmaceutical Pricing Boot Camp for an intensive online bootcamp that will provide you with a thorough understanding of essential government contracting processes and pricing concepts for...more

McGuireWoods Consulting

Energy, Health Care And Housing Key Provisions Summary: House Ways And Means Committee Budget Reconciliation

On May 14, 2025, the House Ways and Means Committee passed their section of the budget reconciliation bill that is commonly referred to as “The One, Big, Beautiful Bill” following a markup. No further amendments were added to...more

Holland & Knight LLP

Trump Administration Revives Most-Favored-Nation Drug Pricing: Here's What to Know

Holland & Knight LLP on

President Donald Trump on May 12, 2025, issued an executive order (EO) titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients" and an accompanying Fact Sheet, "President Donald J. Trump...more

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

Epstein Becker & Green

Medicare Drug Price Negotiation Program: The Inflation Reduction Act “Pill Penalty” and Other IRA Reforms on the Horizon for 2026

Epstein Becker & Green on

When Congress adopted the Inflation Reduction Act (IRA) in 2022, creating the Medicare Drug Price Negotiation Program (MDPNP), the bill did not receive support from any Republican senators....more

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

Groom Law Group, Chartered

CMS Finalizes Annual Medicare Advantage and Part D Rulemaking Updates

In April 2025, the Centers for Medicare and Medicaid Services (“CMS”) issued multiple pieces of guidance related to Medicare Advantage plans and Medicare Part D prescription drug coverage, including the Final CY 2026 Part D...more

Groom Law Group, Chartered

CMS Finalizes Updates to the Prescription Creditable Coverage Methodology Determination

In April 2025, the Centers for Medicare and Medicaid Services (“CMS”) issued multiple pieces of guidance related to Medicare Part D prescription drug coverage, including the Final CY 2026 Part D Redesign Program Instructions....more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - May 2025

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Brownstein Hyatt Farber Schreck

Reflections on the Inflation Reduction Act’s Pill Penalty

The Medicare drug price negotiation provision in the 2022 Inflation Reduction Act treats small molecule drugs and biological products differently. For small molecules, drug price negotiations can start seven years after Food...more

Mintz - Health Care Viewpoints

Trump Administration Issues Drug Pricing Executive Order

On April 15, 2025, President Trump issued an Executive Order instructing federal agencies to implement a variety of drug pricing reforms. The Executive Order addresses drug pricing from several different angles, including...more

Polsinelli

Drug Pricing and Payment Executive Order Shows Trump Administration’s Cards

Polsinelli on

On April 15, 2025, President Trump signed the Lowering Drug Prices by Once Again Putting Americans First Executive Order (Executive Order). The Executive Order revives and expands several pharmaceutical pricing and payment...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - April 2025 #2

Latham & Watkins LLP on

On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order includes various provisions that are relevant to the pharmaceutical industry,...more

Fish & Richardson

Trump’s Drug Price Executive Order: What Drugmakers Should Know

Fish & Richardson on

On April 15, 2025, President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order reaffirms and seeks to expand on policy initiatives introduced during the president’s...more

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