Life Science Compliance Update Co-Payment & Deductible Waivers as Illegal Inducements Thomas Sullivan Jan 20, 2017 0 Health insurance providers and out-of-network providers, have found themselves in murky water by providing waivers of co-payments,…
FDA Interim FDA Commissioner Announced Thomas Sullivan Jan 19, 2017 0 Dr. Robert Califf’s tenure as commissioner of the United States Food and Drug Administration (FDA) is slated to come to an end…
FDA FDA Releases Draft Guidance for Medical Product Communications Consistent… Thomas Sullivan Jan 18, 2017 0 The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product…
Life Science Compliance Update Planning for the Future – HHS OIG’s 2017 Work Plan Thomas Sullivan Jan 18, 2017 0 Health and Human Services Office of Inspector General has released their 2017 Work Plan. The updated work plan includes some new…
Congress Democrat Senators Send Letter to Trump On Drug Pricing Thomas Sullivan Jan 17, 2017 0 United States Senators Sherrod Brown (D-OH) and Al Franken (D-MN) led the charge to send a letter to President-Elect Donald Trump,…
Congress U.S. House Introduces Updated Value-Based Incentive Legislation Thomas Sullivan Jan 16, 2017 0 The House Ways & Means Health Subcommittee recently released updated draft legislation that would establish value-based…
Life Science Compliance Update Sailing with a New Safe Harbor in Sight: The EU-U.S. Privacy Shield Thomas Sullivan Jan 16, 2017 0 Beginning August 1, 2016, the United States Department of Commerce began accepting self-certifications to the EU-U.S. Privacy…
Congress FDA Issues Guidance on REMS Thomas Sullivan Jan 13, 2017 0 With the passage of the long-awaited 21st Century Cures legislation, we saw Senator Mike Lee (R-UT) vote “no” because the bill did…
Life Science Compliance Update Managing Medical Inquiries in an Era of Data Analytics Thomas Sullivan Jan 13, 2017 0 Although compliance professionals tend to view Corporate Integrity Agreements (“CIAs”) as setting the basic compliance standards,…
Drug Prices President-Elect Donald Trump on the Pharmaceutical Industry Thomas Sullivan Jan 12, 2017 0 On Wednesday, January 11, 2017, President-Elect Donald Trump held a news conference in New York; a conference that was held out…