News & Analysis as of

Medicare Health Insurance Prescription Drugs

Jones Day

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

Jones Day on

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

Jones Day on

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

Vedder Price

DOJ Charges 324 Defendants in Unprecedented Health Care Fraud Takedown

Vedder Price on

On June 30, 2025, the Department of Justice (DOJ) filed criminal charges against 324 defendants across the country alleging participation in various health care fraud schemes. The DOJ identified the operation as the 2025...more

Epstein Becker & Green

The First National Health Care Fraud Takedown of the Second Trump Administration: What Stayed the Same and What is New?

Epstein Becker & Green on

On June 30, 2025, the U.S. Department of Justice (“DOJ”), together with the U.S. Department of Health and Human Services Office of Inspector General (“HHS OIG”) and other law enforcement partners, announced the results of the...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

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

Alston & Bird

Health Care Week in Review | Congress Passes Government Funding Package; HHS Nominee Confirmation Process Heats Up

Alston & Bird on

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

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

Stikeman Elliott LLP on

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

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

Morgan Lewis - As Prescribed

Patient Assistance Programs – The Dos and Don’ts from HHS OIG

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The IRA in 2025: The Future of Medicare Part D

Last year was a pivotal year for the pharmaceutical industry. Under the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program), the US government negotiated the prices of 10 selected high-expenditure,...more

Woodruff Sawyer

Reminder: RxDC Reporting Due June 1st

Woodruff Sawyer on

With the 2024 reference year RxDC reporting deadline approaching in June, plan sponsors should re-familiarize themselves with the reporting requirements. The 2024 reference year RxDC Reporting Instructions have been released,...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

Mintz

[Podcast] Health Law Diagnosed – New Year's Gratitude

Mintz on

In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of...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

Faegre Drinker Biddle & Reath LLP

Assessing the Impact of a Revoked Executive Order on a Medicaid Drug Demonstration Project

Of the scores of day-one executive orders (EOs) issued by President Trump, the order rescinding a Biden administration executive order on lowering prescription drug costs is receiving much attention, given implications the...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

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