On April 16, Arkansas Governor Sarah Huckabee Sanders signed into law HB1150 and HB1531, two significant pieces of legislation affecting pharmacy benefit managers (PBMs) and pharmaceutical manufacturers operating within the...more
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
On January 16, the Centers for Medicare & Medicaid Services (CMS) & the U.S. Department of Health and Human Services (HHS) withdrew an appeal to a recent copay accumulator court decision, HIV and Hepatitis Policy Institute et...more
The 42nd annual J.P. Morgan Healthcare Conference started with clear skies and overall optimism from investors. But with Jamie Dimon’s prediction of a recession in 2024 on Tuesday morning, the climate shifted to an on-again,...more
1/12/2024
/ Acquisitions ,
Asset Diversification ,
Chapter 11 ,
Health Technology ,
Healthcare ,
Home Health Care ,
Hospice ,
Initial Public Offering (IPO) ,
Investors ,
JPMorgan Chase ,
Medicaid ,
Mental Health ,
Mergers ,
Pharmaceutical Industry ,
Reimbursements ,
Takeovers ,
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 September 13, the Alaska Board of Pharmacy (Board) issued a notice summarizing a regulatory update stating that pharmacies, wholesale drug distributors, outsourcing facilities, third-party logistics providers, and...more
In January, a federal jury in the Northern District of Illinois convicted Mark Sorenson, owner of durable medical equipment (DME) pharmacy Symed Inc., for participating in a conspiracy to obtain $24.8 million in illegal...more
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
Even the threat of an unprecedented atmospheric river storm could not stop the tried and true from attending the 41st annual J.P. Morgan Healthcare Conference. With a break of sunshine on Monday, we found ourselves asking,...more
1/13/2023
/ Acquisitions ,
Debt ,
Federal Trade Commission (FTC) ,
Funding ,
Healthcare ,
Investment ,
Investors ,
Mergers ,
Non-Compete Agreements ,
Private Equity ,
Proposed Rules
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 May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more
5/26/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Co-payments ,
Deadlines ,
Drug Pricing ,
Final Rules ,
Manufacturers ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
PHRMA ,
Prescription Drugs ,
Vacated
2022 started strong for healthcare transactions with some reports suggesting a record-breaking January. Although deal activity cooled in February and March, transaction pipelines still indicate that 2022 is on pace to match...more
4/15/2022
/ Acquisitions ,
Ambulatory Surgery Centers ,
Dental Practice ,
Digital Health ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Hospitals ,
Investment ,
Investors ,
Life Sciences ,
Managed Service Providers (MSPs) ,
Mental Health ,
Mergers ,
Pharmaceutical Industry ,
Physicians ,
Popular ,
Private Equity
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
In mid-August, the Eastern District of Kentucky granted a preliminary injunction in favor of an interventional pain management physician (Physician) against CVS Pharmacy (CVS) based on allegations that CVS was refusing to...more
9/15/2021
/ Controlled Substances ,
CVS ,
DEA ,
Healthcare ,
Patient Rights ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Preliminary Injunctions ,
Prescription Drugs
For the fifth consecutive year, the Bass, Berry & Sims Healthcare Private Equity Team hosted BBS Connect, a forum to connect healthcare dealmakers during the annual J.P. Morgan Healthcare Conference.
Over three days –...more
2020 was a tumultuous year for the healthcare industry, which continues to confront the effects of the COVID-19 pandemic. Despite these unprecedented and unpredictable times, healthcare merger and acquisition (M&A) activity...more
1/11/2021
/ Acquisitions ,
Ambulatory Surgery Centers ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Health Information Technologies ,
Healthcare Facilities ,
Home Health Care ,
Hospice ,
Hospitals ,
Investors ,
Managed Care Contracts ,
Mergers ,
Pharmaceutical Industry ,
Physicians ,
Substance Abuse
Recent enforcement actions focus attention on the importance of fundamental operational processes to ensure only valid prescriptions and refills are processed. This month, Omnicare, Inc. (Omnicare), a subsidiary of CVS...more
The recent Centers for Medicare & Medicaid Services (CMS) memorandum to all Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans (CMS Memo) does not provide any express relief for specialty...more
In the face of these unprecedented times brought on by the COVID-19 pandemic, pharmacies are grappling to find ways to protect patients and employees. In response, state officials and boards of pharmacies have reacted in a...more
In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more
2/5/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Flat Fees ,
Health Care Providers ,
Health Insurance ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Rebates ,
Safe Harbors ,
Trump Administration
In a remarkable move, the Department of Justice (DOJ) recently sought dismissal of 11 False Claims Act (FCA) cases, each of which assert that patient assistance services supplied by pharmaceutical manufacturers constitute...more
On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....more
6/28/2017
/ Anti-Kickback Statute ,
Bribery ,
Criminal Prosecution ,
Guilty Pleas ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Indictments ,
Insurance Fraud ,
Kickbacks ,
Off-Label Use ,
Pharmaceutical Industry ,
PHI ,
Physicians ,
Prior Authorization