On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) released new guidance for compliance with the hospital price transparency rule and published a request for information (RFI) seeking ways to bolster hospital...more
6/10/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Disclosure Requirements ,
Enforcement Actions ,
Executive Orders ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
New Guidance ,
Price Transparency ,
Regulatory Requirements ,
Reporting Requirements ,
Trump Administration
On January 21, 2025, New York Governor Kathy Hochul released the FY 2026 New York State Executive Budget, which proposed to impose a “cost market impact review” (CMIR) for certain “material transactions” involving “health...more
1/23/2025
/ Competition ,
Disclosure Requirements ,
Healthcare ,
Legislative Agendas ,
Mergers ,
New Legislation ,
New York ,
Proposed Legislation ,
Public Health ,
Regulatory Agenda ,
Regulatory Authority ,
Regulatory Requirements ,
State and Local Government
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2024. We discuss several US Department of Justice (DOJ) enforcement actions involving the False Claims Act (FCA) and the...more
1/3/2025
/ Acute Facilities ,
Anti-Kickback Statute ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Legislative Agendas ,
Medicare Payment Reform ,
OIG ,
Pharmaceutical Industry ,
Price Transparency ,
Regulatory Agenda ,
Regulatory Reform ,
Stark Law
Until recently, Massachusetts was the only state that did not maintain a licensing regime for nonresident pharmacies (i.e., out-of-state pharmacies shipping drugs into the state). On December 6, 2024, the Massachusetts Board...more
The 2024 election results will create significant tailwinds for Republican legislative and regulatory priorities in US Congress, federal agencies, and state houses across the country. This On the Subject considers the outlook...more
12/6/2024
/ Biosimilars ,
Corporate Governance ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Pharmaceutical Industry ,
Presidential Elections ,
Regulatory Agenda ,
Stakeholder Engagement ,
Transparency ,
Trump Administration ,
Vaccinations
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more
4/24/2024
/ Anti-Kickback Statute ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
OIG ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Stark Law
On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The...more
11/17/2023
/ Covered Entities ,
Enforcement Actions ,
Genesis HealthCare ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Litigation Strategies ,
MDRP ,
Patients ,
Rulemaking Process ,
Section 340B
On October 26, 2023, the Health Resources and Services Administration (HRSA) issued a Notice to “inform and remind” 340B Program covered entities that to be considered eligible for the 340B program, an off-site outpatient...more
On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed...more
10/30/2023
/ Coronavirus/COVID-19 ,
Covered Entities ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Medicare ,
Minors ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Emergency ,
Registration Requirement ,
Section 340B
On July 26, 2023, two days after the Centers for Medicare and Medicaid Services (CMS) issued its second largest civil monetary penalty for noncompliance with the hospital price transparency rule, CMS hosted a webinar...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more
7/31/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Emerging Technologies ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Securities and Exchange Commission (SEC) ,
Telehealth ,
Telemedicine