FDA Warning Letter Over Facebook, Testimonials, Metatags

The Food and Drug Administration (FDA) recently released a warning letter to Vibrant Life, stating that claims made on Vibrant Life’s Facebook page and its other websites violate the Federal Food, Drug, and Cosmetic Act (FDCA).  In its warning letter, the FDA cites a number of improper claims made by the […]

Mobile Doctors Charged with Health Care Fraud

The Department of Justice (DOJ) and Federal Bureau of Investigation (FBI) announced that the CEO of Mobile Doctors USA LLC was arrested and charged with health care fraud and one physician associated with Mobile Doctors was arrested and charged with making false statements related to health care benefits.  Additionally, search warrants were executed at Mobile […]

Launch of Cooley’s CMS Sunshine FAQ Tracking Chart

The Centers for Medicare and Medicaid Services (CMS) has issued several rounds of frequently asked questions (FAQs) related to Open Payments regarding the tracking and reporting of payments and other items of value provided by applicable manufacturers and group purchasing organizations (GPOs) to physicians and teaching hospitals.  In an effort to make the FAQs more accessible, we created […]

Theft of Personal Data of 4 Million Patients in Illinois

On August 23, 2013,  Advocate Medical Group (“AMG”), Illinois’s largest health care network, announced that four computers housing the personal information of over four million patients were stolen in the burglary of an administrative building on July 15, 2013.  Upon discovering the burglary, AMG immediately notified local police, who are […]

Sunshine Act Brochures Provide Highlights for Patients and Physicians

The National Physician Payment Transparency Program, also known as Open Payments, affects many health care industry participants.  Accordingly, even though applicable manufacturers and applicable group purchasing organizations (GPOs) are the only entities required to report data under the program, the Centers for Medicare & Medicaid Services (CMS) is not overlooking patients […]

Do Exchanges Protect Data Privacy? State Officials Worry

During the last several weeks, officials in multiple states including Alabama, Florida, Georgia, Kansas, Louisiana, Michigan, Montana, Nebraska, North Dakota, Oklahoma, South Carolina, Texas, and West Virginia have expressed concerns regarding data privacy risks presented by programs that assist consumers with enrollment in health insurance via the Health Insurance Exchanges […]

CMS Open Payments User Guide Released

The Open Payments User Guide for Applicable Manufacturers and Applicable Group Purchasing Organizations (GPOs) has been released by the Centers for Medicare and Medicaid Services (CMS).  CMS announced the release of this User Guide during a recent teleconference with pharmaceutical, biotechnology and medical device manufacturers.  According to CMS, the User […]