News & Analysis as of

Medicare Health Insurance Drug Pricing

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

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

Brownstein Hyatt Farber Schreck

Summary of Health Care Provisions in the “One Big Beautiful Bill Act”

On May 22, the U.S. House of Representatives passed the One Big Beautiful Bill Act (H.R. 1), an extensive budget reconciliation package that advances President Trump’s plan to enact his economic agenda. After a series of...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

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

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

McDermott+

Healthcare Preview for the Week of: March 31, 2025

McDermott+ on

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

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

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

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

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

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

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

Groom Law Group, Chartered

CMS Proposes Update to Simplified Prescription Drug Creditable Coverage Determination Methodology

When Congress created the Part D benefit for Medicare beneficiaries, it also required group health plan sponsors and certain other entities to notify Medicare-eligible participants and the Centers for Medicare & Medicaid...more

McGuireWoods Consulting

Rescission of a Biden Executive Order on Healthcare

Among the many rescissions of Biden administration Executive Orders, signed by President Trump on his administration’s first day, was a rescission of an Executive Order that encouraged Medicare to lower drug costs and makes...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

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

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

McDermott+

McDermott+ Check-Up: November 8, 2024

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Republicans Win Control of White House and Senate, Seem Poised to Maintain Control of House. Former President Donald Trump will return to the White House, and Republicans also gained control of the Senate. Some toss-up House...more

The Volkov Law Group

Teva Pharmaceuticals Pays $450 Million to Resolve Anti-Kickback and False Claims Act Violations

The Volkov Law Group on

Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is...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

2024 Pre-Election Analysis: Health Care Issues

In recent elections, health care has been one of the most hot-button issues with consequences for millions of Americans, and this election is no exception. The next administration and the 119th Congress have the potential to...more

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