Medicaid, Covered Entities

Healthcare & Life Sciences: Drug Pricing Digest - September 2025

Latham & Watkins LLP on 9/8/2025

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

OPA Announces 340B Rebate Model Pilot Program

King & Spalding on 8/8/2025

On July 31, 2025, HRSA’s Office of Pharmacy Affairs (OPA) announced a voluntary 340B Rebate Model Pilot Program (Pilot Program). Currently, under the 340B program, covered entities purchase outpatient drugs at a discounted...more

The 340B Rebate Pilot: Voluntary for Manufacturers, Costly for 340B Covered Entities

Polsinelli on 8/7/2025

Key Takeaways - HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more

Manufacturer Rebate Models: The Next 340B Program Battleground

Quarles & Brady LLP on 8/5/2025

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

340B Drug Pricing Program Is on a Slippery Slope

Shipman & Goodwin LLP on 8/5/2025

On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

HRSA issues notice regarding 340B Rebate Model Pilot Program, limited to drugs subject to a maximum fair price (MFP) for 2026

Hogan Lovells on 8/4/2025

On July 31, 2025, the Health Resources and Services Administration (HRSA) published a notice in the Federal Register (Rebate Model Notice) announcing a 340B Rebate Model Pilot Program (Pilot Program). Notably, the Pilot...more

This Week in 340B: January 21 – 27, 2025

McDermott Will & Schulte on 1/30/2025

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

District Court Affirms Louisianas Protection of 340B Contract Pharmacy Arrangements

Morgan Lewis - As Prescribed on 10/21/2024

340B litigation remains full speed ahead. Manufacturer and covered entity (CE) disputes, not all of which are being actively litigated, include, but are not limited to, federal and state regulation of contract pharmacies,...more

This Week in 340B: July 2 – 8, 2024

McDermott Will & Schulte on 7/10/2024

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

The 340B ‘Saga’ Continued: HRSA, States, and Drug Manufacturers Contest 340B Contract Pharmacy Restrictions in Court

ArentFox Schiff on 6/27/2024

In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more

New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive...

Proskauer - Health Care Law Brief on 6/24/2024

On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...more

California Prohibits PBM Discriminatory Practices Against 340B Program Covered Entities and Contract Pharmacies

Hinshaw & Culbertson - Health Care on 12/15/2023

The 340B Drug Program requires pharmaceutical manufacturers participating in the Medicaid program to provide covered outpatient drugs at significantly reduced prices to certain health care organizations and programs, referred...more

Looming CTA Disclosure Requirements and Healthcare Providers

Venable LLP on 12/8/2023

The Federal Corporate Transparency Act (the CTA), 31 U.S.C. §5336, will soon require certain entities to disclose to the U.S. Treasury's Financial Crimes Enforcement Network (FinCEN) certain pieces of identifying information...more

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on 9/15/2023

The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

This Week in 340B: August 2023 #2

McDermott Will & Schulte on 8/22/2023

This weekly series provides brief summaries 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

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Health Care Compliance Association (HCCA) on 8/8/2023

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more