On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more
7/31/2025
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
Hospitals ,
Manufacturers ,
Medicare ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B
The Department of Justice has launched a number of enforcement actions targeting pharmacies for alleged violations of the False Claims Act (FCA). Recently, Walgreens has been the subject of two noteworthy government...more
6/10/2025
/ Controlled Substances ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicaid ,
Pharmacies ,
Prescription Drugs ,
Retailers ,
Settlement ,
Walgreens
On February 8, 2024, the U.S. Department of Health and Human Services (HHS) issued a final rule (Final Rule) updating federal “Part 2” regulations to more closely align the requirements applicable to substance use disorder...more
On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more
10/30/2023
/ Coronavirus/COVID-19 ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
HRSA ,
Medicaid ,
Office of Pharmacy Affairs Information System (OPAIS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Registration Requirement ,
Section 340B ,
Waivers
On June 27, 2023, Connecticut Governor Ned Lamont signed into law Public Act 23-171“An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (Act), which includes changes to the state’s implementation of the...more
7/13/2023
/ Connecticut ,
Drug Pricing ,
Healthcare ,
Healthcare Costs ,
Healthcare Reform ,
Medical Reimbursement ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Public Acts ,
Section 340B
We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary...more
10/6/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medical Reimbursement Plans ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
SCOTUS ,
Section 340B
On June 15, 2022, the U.S. Supreme Court unanimously ruled in favor of “340B” hospitals in a notable statutory interpretation case concerning how the federal Medicare program reimburses hospitals for prescription drugs. The...more
6/16/2022
/ American Hospital Association ,
American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Appeals ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Medical Reimbursement ,
Medicare ,
Medicare Act ,
Prescription Drugs ,
SCOTUS ,
Section 340B ,
Statutory Interpretation
A federal court in Delaware recently determined that the Health Resources and Services Administration (HRSA) – the federal agency responsible for administering the 340B drug pricing program – did not comply with the...more