Many allied health professionals are subject to state-level licensing requirements that can vary from jurisdiction-to-jurisdiction. What may be required in New York to hold a medical professional license may differ...more
The use of telehealth continues to grow rapidly across the U.S. Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely...more
9/13/2021
/ Artificial Intelligence ,
Business Associates ,
Business Associates Agreement (BAA) ,
Corporate Practice of Medicine ,
Data Privacy ,
Data Protection ,
Data Security ,
Disparate Impact ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Machine Learning ,
Medical Malpractice ,
PHI ,
Physicians ,
Professional Liability ,
Telehealth
I. OVERVIEW -
The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more
Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False...more
8/13/2021
/ Co-payments ,
Department of Justice (DOJ) ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medical Supplies ,
Medicare ,
Settlement Agreements
In recent months, the Kaiser Health Network (part of the Kaiser Family Foundation) has issued three reports scrutinizing the orthopedic industry and its practices. Each report articulates the stakeholder group’s concerns over...more
8/11/2021
/ Best Practices ,
Centers for Medicare & Medicaid Services (CMS) ,
Conflicts of Interest ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Physician Payments ,
Physicians ,
Policies and Procedures ,
Sunshine Act
PhRMA, the pharmaceutical manufacturer trade association, announced on Fri. August 6 that it has revised its longstanding Code on Interactions with Health Care Professionals. The revisions, which relate to the Code’s...more
The Centers for Medicare & Medicaid Services (CMS) released its proposed 2022 Physician Fee Schedule rule (Proposed Rule) on July 13, 2021. Included in the rule are several proposed updates to the CMS Open Payments Program,...more
7/28/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Delays ,
Health Care Providers ,
Open Payments ,
Ownership Interest ,
Physician Fee Schedule ,
Physician-Owned Distributors ,
Physicians ,
Proposed Rules ,
Public Comment ,
Short-Term Loans ,
Sunshine Act ,
Teaching Hospitals
On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more
7/14/2021
/ Biden Administration ,
Biosimilars ,
Competition ,
Drug Pricing ,
Executive Orders ,
Generic Drugs ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Hospitals ,
Industry Consolidation ,
Life Sciences ,
Medical Equipment ,
Mergers ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Price Transparency