FDA FDA Guidance Responding to Unsolicited Request for Off-Label Information… Thomas Sullivan Jan 9, 2012 0 Recently, the Food and Drug Administration (FDA) released a Guidance for Industry, entitled “Responding to Unsolicited Requests…
CMS CMS and OMB Announce New Fraud Measures Thomas Sullivan Jan 6, 2012 0 In 2010, the President announced three goals for cutting improper payments in federal health programs by 2012: reducing overall…
Uncategorized Life Science Businesses Calling for Changes to the Foreign Corrupt… Thomas Sullivan Jan 5, 2012 1 The Foreign Corrupt Practices Act of 1977 (FCPA), was enacted for the purpose of making it unlawful for certain classes of persons…
Uncategorized AMA CEJA Webinars Offered Clarity to a Confusing Report on CME Thomas Sullivan Jan 4, 2012 0 Recently, the American Medical Association (AMA) Council on Ethical and Judicial Affairs (CEJA) held it’s two webinars to discuss…
CME Reductions in Commercial Support for Continuing Medical Education Results… Thomas Sullivan Jan 3, 2012 4 In light of the recent report from the American Medical Association (AMA) Council on Ethical and Judicial Affairs (CEJA), as well…
CMS CMS Answers Questions on Electronic Health Records Thomas Sullivan Jan 2, 2012 0 The Centers for Medicare & Medicaid Services (CMS) recently released eight new answers to frequently asked questions (FAQs) to…
FDA FDA the Headache of Developing a Biosimilar Pathway Thomas Sullivan Dec 30, 2011 0 A recent article from MedPage Today explored a provision in the healthcare reform bill that called on the Food and Drug…
CMS CMS Final Rule on Hospital Meaningful Use and Quality Reporting Thomas Sullivan Dec 29, 2011 0 The Centers for Medicare & Medicaid Services' final rule updating the hospital outpatient prospective payment system (OPPS)…
Affordable Care Act Institute of Medicine Report on Essential Benefits Thomas Sullivan Dec 28, 2011 0 The Patient Protection and Affordable Care Act of 2010 (ACA) was enacted to help uninsured Americans obtain health insurance. As…
CMS CMS Turns Medicare Cuts into Bonus Payments Based on Patient Experience Thomas Sullivan Dec 27, 2011 1 The Affordable Care Act includes a number of policies to help physicians, hospitals, and other caregivers improve the safety and…