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Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

Tucker Arensberg, P.C. on

The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #3

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Hendershot Cowart P.C.

GLP-1 Shortage Ended: Can You Still Legally Prescribe or Compound Semaglutide and Tirzepatide?

Hendershot Cowart P.C. on

For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more

Burr & Forman

The FDA Removes Semaglutide from the Drug Shortage List

Burr & Forman on

The Food and Drug Administration (“FDA”) has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand. On February 21, 2025, the FDA updated...more

Baker Donelson

HHS and HRSA Defend 340B Discount Model Against Pharma Rebate Plan

Baker Donelson on

Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

Hendershot Cowart P.C. on

Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more

McDermott Will & Schulte

Trending in Telehealth: February 2025

Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

Dinsmore & Shohl LLP

Ohio Board of Pharmacy Takes Aim at Dispensing Errors

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The Ohio Board of Pharmacy (“Board”) published two new rules aimed at preventing and rooting out dispensing errors. The first new rule requires pharmacies to implement quality assurance programs for dispensing errors. The...more

McDermott Will & Schulte

California Introduces Bill to Protect 340B Contract Pharmacy Arrangements

California legislators recently introduced AB 1460, which would prohibit prescription drug manufacturers from engaging in discriminatory practices aimed at providers participating in the 340B drug pricing program (covered...more

McDermott Will & Schulte

Semaglutide Shortage Resolved

On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more

ArentFox Schiff

FDA Announces End to Semaglutide Shortage, Impacting Compounders and Telehealth Providers Offering Injectable GLP-1 Drugs

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Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more

Fox Rothschild LLP

End of Semaglutide Shortage Means Big Changes for Prescribers and Compounders

Fox Rothschild LLP on

On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - February 2025 #2

News Briefs - More States Taking Steps to Control P.E. in Healthcare Settings - An increasing number of states are looking to control private healthcare operations transactions, even as the Trump administration appears likely...more

Roetzel & Andress

Prescribing GLP-1 Medications: Be Aware of Legal Limitations

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On this episode of HealthLawHotSpot, Roetzel attorneys Ericka Adler and Christina Kuta discuss the potential pitfalls and best practices in dispensing GLP-1 medications.Christina shares her insights on the surge in demand,...more

McDermott Will & Schulte

This Week in 340B: January 28 – February 3, 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

Blake, Cassels & Graydon LLP

Des développements législatifs touchent le secteur québécois des soins de santé

Une nouvelle politique fédérale et des modifications législatives au Québec amènent des changements au sein du secteur québécois des soins de santé. Un éventail varié d’entreprises dans ce secteur pourrait devoir s’adapter en...more

Blake, Cassels & Graydon LLP

Legal Updates in the Quebec Healthcare Sector

A recent federal policy update and Quebec legislative changes are changing the healthcare landscape in Quebec, and may impact a variety of businesses operating in this sector....more

Verrill

Prescription for Change: Massachusetts Pharmacies Undergo Regulatory Revamp

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Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, V 2, Issue 1, January 2025

Welcome to our second volume and first issue of 2025 of The Health Record - our healthcare law insights e-newsletter. We hope you enjoyed our Volume 1 issues in 2024 and look forward to continuing to provide information about...more

McDermott Will & Schulte

California Ballot Proposition 34 Targets Spending by Certain 340B Covered Entities

McDermott Will & Schulte on

Proposition 34 requires certain California healthcare providers to spend at least 98% of their net drug sale revenue on direct patient care. The measure targets certain providers who benefit from a federal drug discount...more

McDermott Will & Schulte

This Week in 340B: November 12 – 18, 2024

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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

Trending in Telehealth: October 29 – November 11, 2024

McDermott Will & Schulte on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

McDermott Will & Schulte

This Week in 340B: October 29 – November 4, 2024

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

This Week in 340B: October 15 – 21, 2024

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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

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