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Regulatory Oversight Medicare Pharmaceutical Industry

Mintz - Health Care Viewpoints

HHS Restructuring and Workforce Reductions – Key Implications for the Health Care Industry

As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s...more

McDermott Will & Schulte

This Week in 340B: February 4 – 10, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Schulte

[Webinar] 340B… Or Not 340B: Oversight, Compliance and Enforcement - July 15th, 9:00 am - 10:00 am PT

The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more

Troutman Pepper Locke

HHS to Require Manufacturers to Disclose Drug Pricing in Television Advertisements

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U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more

Hogan Lovells

CMS considers linking Medicare drug payment rates to international prices

Hogan Lovells on

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more

Hogan Lovells

CMS proposes requiring drug prices in TV ads

Hogan Lovells on

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more

Bricker Graydon LLP

340B litigation update: Both Ceiling Price Rule delay and 340B rate cuts face legal challenges

Bricker Graydon LLP on

On September 11, 2018, the American Hospital Association (AHA) and other major health care industry groups sued the Department of Health and Human Services (HHS), seeking to have the U.S. District Court for the District of...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

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The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

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