Consistent with recent attention from Congress and rhetoric from the Trump administration, the Calendar Year 2026 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule (the Proposed Rule) includes...more
7/28/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Physicians ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Reform ,
Trump Administration
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
7/9/2025
/ Appeals ,
Contract Disputes ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Litigation Strategies ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
6/18/2025
/ Antitrust Litigation ,
Appeals ,
Drug Pricing ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B ,
State and Local Government
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
In April 2025, we were proud to host the annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more
5/5/2025
/ Artificial Intelligence ,
Biologics ,
Biotechnology ,
Clinical Trials ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Investment ,
Investors ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Technology Sector ,
Venture Capital
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
2/27/2025
/ Appeals ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Litigation Strategies ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements ,
Section 340B
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more
11/21/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Convictions ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Regulatory Agenda
Proposition 34 requires certain California healthcare providers to spend at least 98% of their net drug sale revenue on direct patient care. The measure targets certain providers who benefit from a federal drug discount...more
11/20/2024
/ Ballot Measures ,
California ,
Covered Entities ,
Discount Pricing ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Patients ,
Pending Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
State Legislatures
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more
10/25/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Employer Liability Issues ,
False Claims Act (FCA) ,
Health and Welfare Plans ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
OIG ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Stark Law
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for August 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more
10/7/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
OIG ,
Regulatory Agenda ,
Stark Law
The California Department of Public Health (CDPH) proposed changes to regulations regarding general acute care hospital (GACH) licensing requirements related to clinical laboratory, dietetic, and pharmaceutical services....more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
9/6/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Information Blocking Rules ,
Medicare ,
OIG ,
Proposed Regulation ,
Regulatory Agenda ,
Telehealth
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
8/1/2024
/ AIDS ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
HIV ,
Hospitals ,
Medicare ,
Medicare Part B ,
MIPS ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Agenda ,
Stark Law
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more
6/25/2024
/ Anti-Kickback Statute ,
Appeals ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Dispute Resolution ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Manufacturers ,
No Surprises Act (NSA) ,
OIG ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Telehealth
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
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
4/24/2024
/ Appeals ,
Covered Entities ,
Cross Motions ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Litigation Strategies ,
Medicare ,
Medicare Advantage ,
Medicare Payment Reform ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Summary Judgment
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting...more
3/15/2024
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Confidential Information ,
Department of Health and Human Services (HHS) ,
Enforcement ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospitals ,
Machine Learning ,
Opioid ,
Patient Confidentiality Breaches ,
Substance Abuse ,
Telehealth ,
Texting
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
3/7/2024
/ Cross Motions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Mediation ,
Medicare Advantage ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
2/16/2024
/ Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Legislative Agendas ,
Life Sciences ,
Medicare Advantage ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Reform ,
Section 340B
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more