Corporate Integrity Agreements Boehringer Ingelheim Settlement and Corporate Integrity Agreement Thomas Sullivan Nov 8, 2012 0 While it has been a few months since the last large settlement involving the off-label promotion of pharmaceutical products, the…
FDA FDA REMS: Mycophenolate Class Wide REMS Thomas Sullivan Nov 8, 2012 1 Over the past few months, we have seen increased activity at the Food and Drug Administration (FDA) with respect to the issuance…
HHS-OIG HHS OIG Summary of 2nd 2012 Roundtable on Corporate Integrity Agreements Thomas Sullivan Nov 7, 2012 0 The Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) recently released the summary of a…
Affordable Care Act Health Care Regulations After the Election — Implementation at Light… Thomas Sullivan Nov 6, 2012 0 Sometime tonight or early tommorow, the 2012 Presidential election will be decided, and according to a recent article from…
CMS Payment Penalties May Not Curb Hosptial Aquired Infections Thomas Sullivan Nov 6, 2012 1 In October 2008 the Centers for Medicare & Medicaid Services (CMS) discontinued additional payments for preventable…
Affordable Care Act Affordable Care Act: Medical Device Tax a Problem for Innovation Thomas Sullivan Nov 5, 2012 2 One of the most controversial provisions from the Patient Protection and Affordable Care Act (ACA) is a provision that will impose…
ACRE Association of Clinical Researchers and Educators Releases Statement on… Thomas Sullivan Nov 2, 2012 0 Over the years, we have written about the relationships between the life sciences industry—manufacturers of pharmaceuticals,…
Accountable Care Organizations Early Results Show Need for Improvement in ACO Clinical Outcomes and… Thomas Sullivan Nov 1, 2012 0 One of the central pieces of the Patient Protection and Affordable Care act was Section 3022, which created the added a new…
Drug Shortages Johnson and Johnson Requests Manufacturing Permit to Reduce Shortage of… Thomas Sullivan Oct 31, 2012 0 Over the past year, we have written several stories about the troubling drug shortages that have been occurring. This summer,…
CMS CMS Chooses Seven Nursing Facilities to Reduce Hospitalizations Thomas Sullivan Oct 30, 2012 1 Nursing facility residents often experience potentially avoidable inpatient hospitalizations. These hospitalizations are…