In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute.
Chevron reflected the view...more
7/15/2024
/ Chevron Deference ,
Chevron v NRDC ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Hospitals ,
Judicial Review ,
Loper Bright Enterprises v Raimondo ,
Medicaid ,
Medicare ,
National Marine Fisheries Service ,
Regulatory Agenda ,
Reimbursements ,
Relentless Inc v US Department of Commerce ,
Rulemaking Process ,
SCOTUS
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
6/27/2024
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
HRSA ,
Interstate Commerce ,
Manufacturers ,
Medicaid ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B
In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...more
8/15/2023
/ Advisory Opinions ,
Algorithms ,
Anti-Kickback Statute ,
Federal Health Care Programs (FHCP) ,
Fees ,
Fraud and Abuse ,
Health Care Providers ,
Health Technology ,
Kickbacks ,
Medicaid ,
Medicare ,
OIG
The Centers for Medicare and Medicaid Services (CMS) has withdrawn its proposed Medicaid Fiscal Accountability Regulation (MFAR), according to a September 14, 2020, announcement via Twitter by Administrator Seema...more
On September 17, 2019, the US District Court for the District of Columbia ruled in American Hospital Association, et al. v. Alex Azar, II, et al that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory...more
10/2/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Hospitals ,
Medicaid ,
Medicare ,
Off-Campus Departments ,
Outpatient Prospective Payment System (OPPS) ,
Secretary of HHS ,
Statutory Authority ,
Vacated