CMS Medical Device Parallel Review Program Made Permanent Thomas Sullivan Feb 24, 2017 0 A few months back, the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services announced they are…
HHS-OIG Are the Safe Harbors Still Safe? – OIG Issues Final Rule Thomas Sullivan Feb 24, 2017 0 The Department of Health and Human Services Office of Inspector General published a final rule, after considering various…
CMS Providers May Have More Time to Submit Electronic Clinical Quality Measures Thomas Sullivan Feb 23, 2017 0 Eligible hospitals and critical access hospitals participating in the Hospital Inpatient Quality Reporting program and/or the…
FDA Citizens Petition Challenges FDA’s Off-Label Rule Thomas Sullivan Feb 22, 2017 0 On February 8, 2017, three organizations called on the United States Food and Drug Administration (FDA) to overhaul a newly…
Life Science Compliance Update Valeant and Philidor Controversy Comes to a Head Thomas Sullivan Feb 22, 2017 0 Valeant Pharmaceuticals, Inc. has had quite the year - they have been under scrutiny since October 2015. However, in November…
CMS CMS Releases Report to Congress on CMMI Thomas Sullivan Feb 21, 2017 0 The Centers for Medicare and Medicaid Services (CMS) released a new report to Congress prepared by the CMS Innovation Center…
Affordable Care Act Newly Released CMS Payment Models – What is to Come? Thomas Sullivan Feb 20, 2017 0 Right before the inauguration of the new President, the Centers for Medicare & Medicaid Services (CMS) finalized new…
Life Science Compliance Update 2017 Trending Towards a Banner Year for Industry Compliance Thomas Sullivan Feb 20, 2017 0 There are strong indications that 2017 is already trending towards a banner year for industry compliance, including most…
Medicare MedPAC Reviews Part D Spending Trends Thomas Sullivan Feb 17, 2017 0 On January 12, 2017, during the second session of Medicare Payment Advisory Commission’s (MedPAC’s) January meeting, MedPAC…
International Anti-corruption: All roads lead to enforcement Thomas Sullivan Feb 17, 2017 0 Amy Greenstein, Senior Consultant and Veronique Monjardet, Polaris When it comes to corruption, Life Sciences companies…