Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here...more
On June 15, 2022, in a win for hospitals, the Supreme Court issued its opinion in American Hospital Association et. al. v. Becerra (“Becerra”), overturning massive reimbursement reductions in the 340B drug pricing program...more
Now approaching a year-long battle, drug manufacturers and 340B covered entities, which include hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to...more
On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a...more
1/11/2021
/ Administrative Procedure Act ,
Advisory Opinions ,
American Hospital Association ,
Data Reporting ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
HRSA ,
Manufacturers ,
Medicaid ,
Medicare Part B ,
Pharmacies ,
Pharmacist ,
Prescription Drugs ,
Section 340B
In a setback to hospitals challenging deep cuts to reimbursement for prescription drugs acquired through the 340B drug pricing program (“340B Program”), the U.S. Court of Appeals for the District of Columbia, on October 19,...more
On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”). One order – which has received the...more
When Alex Azar, the Secretary of the Department of Health and Human Services (“DHHS”), declared a national emergency on January 31, 2020 in response to the COVID-19 pandemic, he triggered an exception to the “in-person...more
In a rare act of bipartisanship, Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., introduced on July 23rd a chairman’s mark, the Prescription Drug Pricing Reduction Act (PDPRA)...more
7/26/2019
/ Ambulatory Surgery Centers ,
Conflicts of Interest ,
Congressional Budget Office ,
Drug Pricing ,
Health Insurance ,
Hospitals ,
Managed Care Contracts ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part D ,
Outpatient Services ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physician Fee Schedule ,
Prescription Drug Coverage ,
Prescription Drugs ,
Price Transparency ,
Public Disclosure ,
Rebates ,
Risk-Sharing
U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning...more
2/7/2019
/ Criminal Investigations ,
DEA ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Regulatory Oversight ,
Risk Mitigation ,
U.S. Attorney ,
Warning Letters
I. Introduction -
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the “SUPPORT Act”), passed at the end of October 2018, seeks to prohibit...more
1/9/2019
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Drug & Alcohol Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Investors ,
Kickbacks ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Safe Harbors ,
Substance Abuse
In our July 10, 2017 post regarding telemedicine prescribing, we wrote about the seven exceptions to the Haight Act’s requirement that a provider and patient have an-person visit before a prescriber/practitioner can prescribe...more