On August 7, the US Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-09, providing significant guidance for physician-owned medical device companies (PODs)....more
On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more
6/30/2025
/ Advisory Opinions ,
Anti-Kickback Statute ,
Compliance ,
Contract Terms ,
Department of Health and Human Services (HHS) ,
Documentation ,
Fair Market Value ,
Fees ,
Health Care Providers ,
Medicaid ,
Medicare ,
OIG ,
Professional Corporation ,
Reimbursements ,
Safe Harbors ,
Telehealth ,
Written Agreements
Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
In the final days of the Biden Administration, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the Security Rule under the Health...more
2/10/2025
/ Artificial Intelligence ,
Audits ,
Compliance ,
Cybersecurity ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Emerging Technologies ,
Encryption ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
Proposed Rules ,
Risk Management ,
Technology
On December 30, 2024, the Massachusetts state legislature passed House Bill 4653 (the Act), which significantly enhances regulatory oversight in the Massachusetts health care market. As signed into law by Governor Maura Healy...more
1/10/2025
/ Compliance ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Infrastructure ,
Investors ,
New Legislation ,
Private Equity ,
Real Estate Transactions ,
REIT ,
State and Local Government ,
State Attorneys General