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