On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more
5/14/2024
/ Administrative Procedure Act ,
Biden Administration ,
Cannabis Products ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Final Rules ,
Food and Drug Administration (FDA) ,
IRS ,
Judicial Review ,
Marijuana ,
Medical Marijuana ,
Notice and Comment ,
NPRM ,
OMB ,
Popular ,
Regulatory Reform ,
Schedule I Drugs
On Friday, November 3, 2023, the U.S. District Court for the District of South Carolina issued a long-awaited decision in Genesis Health Care, Inc. v. Becerra—a case dating back to 2017 contesting HRSA’s definition of...more
This morning the Centers for Medicare & Medicaid Services (CMS) published, for the first time, a list of drugs subject to price negotiation under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation program....more
On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more
12/7/2022
/ Comment Period ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Section 340B
As my colleague Tom wrote about in a recent post, the Centers for Medicare & Medicaid Services (CMS) has finally responded to a growing chorus of stakeholders that government price reporting requirements, particularly...more
On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more
11/30/2020
/ Anti-Kickback Statute ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Rulemaking Process ,
Stark Law ,
Trump Administration