Four drug manufacturers have announced plans to offer discounted drug prices to safety net providers under the federal 340B program via rebates instead of upfront discounts, despite the federal government’s position that...more
12/18/2024
/ Commercial Litigation ,
Drug Pricing ,
HRSA ,
Inflation Reduction Act (IRA) ,
Legislative Agendas ,
Manufacturers ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B
On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug...more
5/24/2024
/ Appeals ,
Covered Entities ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Asembia’s 20th Annual Specialty Pharmacy Summit once again brought investors and operators in the specialty pharmacy ecosystem to Las Vegas for learning sessions and networking. Bass, Berry & Sims brought a team of four...more
5/15/2024
/ Acquisitions ,
Ambulatory Surgery Centers ,
Health Care Providers ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Investment ,
Investors ,
Life Sciences ,
Medicare ,
Mergers ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Technology Sector
W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more
1/9/2024
/ Acquisitions ,
Artificial Intelligence ,
Corporate Transparency Act ,
Department of Justice (DOJ) ,
Diversity ,
Equity Markets ,
FinCEN ,
Funding ,
Healthcare ,
Investment ,
Investors ,
Mergers ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Popular ,
Privacy Laws ,
Private Equity ,
Reporting Requirements ,
Restrictive Covenants ,
Risk Management ,
Safe Harbors ,
Section 340B ,
Self-Disclosure Requirements ,
Value-Based Care
On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more
11/6/2023
/ Audits ,
Comment Period ,
Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On October 26, the Health Resources and Services Administration (HRSA) issued a notice clarifying the registration requirements for offsite hospital outpatient facilities under the 340B drug pricing program. The Notice, which...more
On July 7, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to implement a remedy in response to last year’s Supreme Court decision finding the Medicare Part B payment policy for hospitals in the 340B...more
7/12/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Medicare Advantage ,
Medicare Part B ,
Medicare Payment Reform ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more
2/3/2023
/ Appeals ,
Distribution Rules ,
Drug Pricing ,
Enforcement Actions ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Policies and Procedures ,
Prescription Drugs ,
Section 340B
On November 3, the Centers for Medicare & Medicaid Services (CMS) issued an update to its Medicare Part B drug payment policy for hospitals participating in the 340B drug pricing program and reversed payment cuts in place...more
11/14/2022
/ American Hospital Association et al v Becerra Secretary Of Health And Human Services et al ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Reimbursements ,
Reversal ,
SCOTUS ,
Section 340B
The U.S. House of Representatives is expected today to pass legislation passed by the U.S. Senate that will significantly alter the landscape for pharmaceutical pricing and reimbursement under the Medicare program for certain...more
8/15/2022
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacies ,
Physician Medicare Reimbursements ,
Physicians ,
Prescription Drugs ,
Proposed Legislation ,
Section 340B
On June 15, the U.S. Supreme Court issued a unanimous decision finding Medicare payment cuts to hospitals participating in the 340B drug pricing program illegal. The decision in favor of 340B hospitals is the culmination of a...more
On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more
1/13/2022
/ Administrative Procedure Act ,
Appeals ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement ,
HRSA ,
Manufacturers ,
OIG ,
Pharmacies ,
Section 340B