BioSimilar FDA Finalizes Guidance on Assigning Non-Proprietary Names to Biologics and… Thomas Sullivan Feb 10, 2017 0 Recently, the Food and Drug Administration (FDA) finalized guidance detailing its approach to assigning non-proprietary names to…
CMS CMS Missing Critical QPP Infrastructure Thomas Sullivan Feb 9, 2017 0 The United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published a report,…
BioSimilar 2017 Biosimilar Update Thomas Sullivan Feb 8, 2017 0 We have taken an interest in the growing biosimilars market in the United States. Recently, we covered the Friends of Cancer…
FDA FDA Announces Safety Labeling Changes Program Thomas Sullivan Feb 7, 2017 0 As reported by Regulatory Focus, the FDA announced the “safety labeling changes” (SLC) program. It will be reportedly…
Conflict of Interest Discussion on Open Payments by Philadelphia-Region Doctors Thomas Sullivan Feb 6, 2017 0 An article in the Philadelphia Business Journal published in early January 2017 focused on Open Payments and payment…
DOJ Department of Justice Increases FCA Civil Penalties, Again Thomas Sullivan Feb 6, 2017 0 On February 3, 2017, the Department of Justice (DOJ) announced that False Claims Act (FCA) penalties will once again be…
HHS Tom Price on MACRA and Value-Based Care Thomas Sullivan Feb 5, 2017 0 During the last weeks of the Obama Administration, CMS continued to roll out new mandatory bundled payments models. Rep. Tom Price…
Anti Kickback Walgreens to Pay $50M to Settle Anti-Kickback Suit Thomas Sullivan Feb 3, 2017 0 Walgreen Co. (“Walgreens”) has agreed to pay $50 million to settle allegations that it gave kickbacks to government health care…
DOJ Zimmer Biomet Pays $30 Million to Resolve New FCPA Charges Thomas Sullivan Feb 2, 2017 0 Medical device maker Zimmer Biomet Holdings, Inc., agreed to pay $30.5 million to resolve Department of Justice (DOJ) and…
Anti Kickback Stark Law Regulatory Changes for 2017 Thomas Sullivan Feb 1, 2017 0 The Centers for Medicare and Medicaid Services (CMS finalized) the 2017 Medicare Physician Fee Schedule (PFS) rule. This rule,…