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 June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more
6/28/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Fraud and Abuse ,
Health Insurance ,
Healthcare ,
Life Sciences ,
Medicaid ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs
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
Effective December 21, 2023, the Centers for Medicare & Medicaid Services (CMS) has directed A/B MACs to not make downward adjustments to claims for CPT Codes for complex therapy administration (96401-96549) based solely on...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
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 August 28, 2023, amendments to Drug Enforcement Agency (DEA) regulation 21 CFR 1306.08 will go into effect, which amend the regulations allowing the transfer of initial electronic prescriptions for schedule II-V controlled...more
On February 23, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion 23-02, approving a pharmaceutical company’s program to provide a free 14-day supply of an...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
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 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
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
Starting next summer, California licensed pharmacies offering automatic prescription refill programs will be subject to new constraints and limitations. California recently approved new Board of Pharmacy regulations, which go...more
On June 3, the U.S. Food and Drug Administration (FDA) issued a series of four documents (two final guidance documents and two draft documents) to provide trading partners guidance on its interpretation of certain...more
On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more
4/8/2021
/ Advisory Opinions ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Manufacturers ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
REMS ,
Specialty Healthcare
On November 16, the Department of Health and Human Services Office of Inspector General (OIG) took a shot across the bow of the healthcare industry when it published a Special Fraud Alert highlighting some of the fraud and...more
The U.S. Food and Drug Administration (FDA) announced October 26 the availability for the signing of the final standard Memorandum of Understanding Addressing Certain Distribution of Compounded Human Drug Products (MOU)...more
Specialty pharmacies should carefully evaluate their relationships with drug manufacturers and charitable assistance programs in light of an August $3.5 million settlement between the United States Department of Justice (DOJ)...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
Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more