On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more
9/19/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Employer Group Health Plans ,
Health Insurance ,
Healthcare ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
OIG ,
Shared Savings Program
We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
2/27/2024
/ Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Settlement ,
Stark Law ,
Telemedicine
W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more
1/9/2024
/ Acquisitions ,
Artificial Intelligence ,
Corporate Transparency Act ,
Department of Justice (DOJ) ,
Diversity ,
Equity Markets ,
FinCEN ,
Funding ,
Healthcare ,
Investment ,
Investors ,
Mergers ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Popular ,
Privacy Laws ,
Private Equity ,
Reporting Requirements ,
Restrictive Covenants ,
Risk Management ,
Safe Harbors ,
Section 340B ,
Self-Disclosure Requirements ,
Value-Based Care
On November 16, the Centers for Medicare & Medicaid Services (CMS) published its Medicare Physician Fee Schedule (PFS) final rule for calendar year 2024 (PFS Final Rule). According to the CMS press release, the PFS Final Rule...more
11/21/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Medical Reimbursement ,
Medicare ,
Mental Health ,
New Regulations ,
Outpatient Prospective Payment System (OPPS) ,
Outpatient Services ,
Physician Fee Schedule ,
Physicians ,
Psychological Counseling ,
Telehealth
On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more
On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more
10/25/2021
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational Device Exemptions ,
Investigations ,
IRB ,
Life Sciences ,
Medical Devices ,
Research and Development ,
The Common Rule
Private equity investors’ interest in gastroenterology (GI) practices continues to remain strong, despite some headwinds that GI practices have experienced as a result of the COVID-19 pandemic and further investment in this...more
After a drawn-out drafting-and-review process, the hotly contested No Surprises Act (Act) has made its way into law after being tucked into the 5,500+ pages of the Consolidated Appropriations Act, 2021, signed into law on...more
2/8/2021
/ Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Health Care Providers ,
Healthcare ,
Medical Billing Codes ,
Notice and Comment ,
Patients ,
Price Transparency ,
Proposed Rules ,
Reimbursements ,
Reporting Requirements ,
Stakeholder Engagement ,
Surprise Medical Bills ,
Telehealth
On Wednesday, March 18, 2020, President Trump signed into law the Families First Coronavirus Response Act (FFCRA) which allocates billions of dollars to aid Americans impacted by the novel coronavirus disease (COVID-19)...more
In the wave of physician practice management transactions, urology is poised to be one of the next hot sectors. In addition to the issues to consider in connection with any physician practice transaction, below we discuss...more
6/26/2019
/ Anti-Kickback Statute ,
False Billing ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Medical Devices ,
Pharmaceutical Industry ,
Physician-Owned Hospitals ,
Physicians ,
Private Equity ,
Safe Harbors ,
Stark Law ,
Value-Based Care