News & Analysis as of

Health Insurance Healthcare Prescription Drugs

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

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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

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

Seyfarth Shaw LLP

States Seeking Remedies for the Rising Costs of Prescription Drugs

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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

Seyfarth Shaw LLP

Cutting Out the Middle Man

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Arkansas has become the first state in the nation to enact legislation, effective starting in 2026, prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. We take a look at...more

Quarles & Brady LLP

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

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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

Wiley Rein LLP

[Podcast] Contracting for Success: Key Legal Considerations When Segmenting Pharmacy Benefit Programs

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In this episode of The Wiley Contracting Chronicles, co-hosts Jordan Ross and Brooke DeLoatch take a deeper dive into program segmentation within pharmacy benefit programs. After outlining the concept in their previous...more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

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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

McDermott+

Healthcare Preview for the Week of: March 31, 2025

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Reconciliation Watch - Reports indicate that the Senate will move as soon as Wednesday to begin advancing a unified budget plan. The Senate hopes to be able to advance the budget resolution by having the two chambers...more

Groom Law Group, Chartered

Plaintiffs Double Down on Challenges to PBM Arrangements in Class Action Lawsuits Involving Johnson & Johnson and JPMorganChase

On March 10, 2024, the plaintiffs filed an amended complaint in a much-followed putative class action lawsuit against Johnson & Johnson (“J&J”) alleging that the plan fiduciaries for J&J’s group health plan violated ERISA by...more

Smart & Biggar

Government of Canada announces first pharmacare agreements

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Update: The Government of Canada announced an agreement with the Yukon ($9.5 million over four years). The agreement text is available in the updated National pharmacare bilateral agreements resource....more

Stikeman Elliott LLP

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

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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

Stikeman Elliott LLP

Canada and Manitoba Sign Pharmacare Agreement Under New Pharmacare Act

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Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received royal assent on October 10, 2024 and established a framework for national pharmacare. On February 27, 2025, the Hon. Mark Holland, Canada’s...more

Ankura

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

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“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

DLA Piper

Keeping Watch on Medicare as the IRA is Implemented: Formulary Management Practices

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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

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

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

McDermott+

Healthcare Preview for the Week of: January 21, 2025

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First Official Week of Trump 2.0 - President Trump officially began his second term yesterday. He briefly discussed healthcare in his first inaugural speech, committing to tackle chronic disease and keep children safe,...more

Alston & Bird

Health Care Week in Review: HHS Releases Notice of Benefit and Payment Parameters for 2026 and CMS Identifies Drugs for Second...

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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

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

Ankura

Beyond the Prescription: Ozempic's Influence on Health, Retail, and Consumer Behavior

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Ozempic's meteoric rise has reshaped the landscape of healthcare, retail, and consumer behavior. Its initial popularity as a weight loss medication has sparked a broader conversation around health, wellness, and body image....more

Sheppard Mullin Richter & Hampton LLP

The Legal and Economic Realities of Medicare Drug Pricing: Navigating Opportunities and Challenges

The rising cost of prescription drugs under Medicare continues to pose significant challenges for seniors, a population that relies heavily on consistent and affordable access to medications. This issue underscores broader...more

Bass, Berry & Sims PLC

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

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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

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