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 April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
5/29/2024
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Enforcement ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Laboratory Developed Tests ,
Medical Devices ,
Medicare Advantage ,
Medicare Fraud ,
Medicare Part D ,
Non-Compete Agreements ,
Nursing Homes ,
OCR ,
OIG ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Sentencing ,
Settlement ,
Telemedicine
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
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
On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more
On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more
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
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
4/17/2024
/ Breach of Contract ,
Covered Entities ,
Insurance Industry ,
Litigation Strategies ,
Medicare ,
Medicare Advantage ,
Motion to Dismiss ,
Payment Systems ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B
On April 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released the Announcement of Calendar Year (CY) 2025 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, otherwise known as the...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
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
4/3/2024
/ Covered Entities ,
Cross Motions ,
Healthcare ,
HRSA ,
Medicare ,
Medicare Advantage ,
Medicare Payment Reform ,
Motion to Dismiss ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Summary Judgment
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
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
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
On January 1, 2024, Assembly Bill 853 (AB 853) went into effect in California. It requires parties to a transaction involving retail grocery firms or retail drug firms to file a notice with the California attorney general 180...more
This report reviews notable areas for government enforcement actions during 2023 that were discussed in our monthly Healthcare Regulatory Check-Up reports. In the past year, we saw the relevant federal government enforcement...more
2/29/2024
/ Anti-Kickback Statute ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
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
2/27/2024
/ Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
HRSA ,
Medicare ,
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more
2/26/2024
/ 1115 Waivers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medicaid ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Prior Authorization ,
Regulatory Agenda ,
Regulatory Reform ,
Self-Referral
On February 2, 2024, six senators known as the “Gang of Six” – John Thune, Debbie Stabenow, Shelley Moore Capito, Tammy Baldwin, Jerry Moran and Ben Cardin – released a discussion draft bill intended to preserve the 340B...more