News & Analysis as of

Health Insurance Drug Pricing Pharmaceutical Industry

Jones Day

HHS Pilot Program to Evaluate 340B Drug Pricing Program Rebate Models

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The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

Quarles & Brady LLP on

The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...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

Jones Day

Congress Expands Orphan Drug Exemptions From Medicare Price Negotiations

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The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Seyfarth Shaw LLP

States Seeking Remedies for the Rising Costs of Prescription Drugs

Seyfarth Shaw LLP on

As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q1

Goodwin on

While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

Jones Day on

No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

DLA Piper

Medicare Drug Price Negotiation: Saving Money for Medicare, but What About Patients?

DLA Piper on

Evaluating current formulary access for the 25 drugs selected for Drug Price Negotiation in Medicare Part D shows several selected drugs have higher co-pays in 2025 relative to 2024 - Introduction - The Inflation Reduction...more

Hogan Lovells

French supreme Court, March 20, 2025, Alexion Pharma France: a historic turnaround for the financial regulation of French...

Hogan Lovells on

In a decision of 20 March 2025 (Appeal No. N 22-23.927), the FR supreme Court ruled that the “product clawbacks” negotiated with the Economic Committee for Health Products (‘CEPS’) on the price of pharmaceutical products...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 33 - March 2025

The Georgia House of Representatives achieved the trifecta on Thursday, combining three favorite legislative traditions in one moment on the floor: recognition of a local novelty with an invite resolution, the appearance of a...more

Wiley Rein LLP

[Podcast] Pharmacy Benefit Segmentation: Emerging Models for Health Plans

Wiley Rein LLP on

In this episode of The Wiley Contracting Chronicles, hosts Jordan Ross and Brooke DeLoatch discuss the growing trend of pharmacy benefit segmentation among health plans. They outline three emerging models identified at Wiley:...more

Stikeman Elliott LLP

British Columbia and Prince Edward Island Sign Pharmacare Agreement with Canada Under New Pharmacare Act

Stikeman Elliott LLP on

On February 27, 2025, the Government of Canada and Manitoba signed the first national pharmacare agreements under Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”), which received royal assent on October...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - March 2025

The giant firms  that track trends for big businesses have glum news for all of us: Health care costs are spiking anew this year. The rise, one consultancy predicts, will be the highest in 13 years....more

Alston & Bird

Health Care Week in Review | The House of Representatives Approved a Budget Resolution and President Trump Signed an EO on...

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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

ArentFox Schiff

Massachusetts Enacts Drug Pricing Legislation: Introducing PBM Licensure, Mandatory Cost Reporting, and Consumer Cost-Sharing...

ArentFox Schiff on

On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug...more

Ankura

Bona Fide Service Fees, Government Price Reporting, and the Inflation Reduction Act

Ankura on

“Manufacturers are responsible for meeting all four parts of the definition of bona fide service fee before a fee can qualify as a bona fide service fee.” ...more

Goldberg Segalla

FDA Approved Journavx, a Non-Opioid Drug for Pain Management

Goldberg Segalla on

On January 30, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. It is the first new type...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Biosimilars at the Crossroads: A $234 Billion Opportunity or a Missed Chance for Healthcare Savings?

The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more

Quarles & Brady LLP

Proposed Legislation Indicative of Continued Congressional Efforts to Expand PBM Oversight

Quarles & Brady LLP on

On December 11, 2024, a bill was introduced in the U.S. House of Representatives that, if enacted, would have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country. Titled the...more

Morgan Lewis

US Administration Signals Potential Changes to Inflation Reduction Act Drug Price Negotiations

Morgan Lewis on

In what appears to be a response to manufacturer complaints regarding “black box” Inflation Reduction Act (IRA) drug price negotiations, the US administration issued a statement on January 29, 2025, stating it planned to...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

Mintz - Health Care Viewpoints

Massachusetts Aligns with National Trends and Enacts Sweeping Legislation to Regulate Pharmaceutical Benefit Managers

On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more

Mintz - Antitrust Viewpoints

PBM Update: Special Edition - FTC Releases Second Interim Staff Report in PBM Inquiry

On January 14, 2025, the Federal Trade Commission (FTC) Office of Policy Planning released a second Interim Staff Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit...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

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