As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently,...more
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
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