HHS-OIG Supreme Court Declines to Review Important False Claims Act Issue Thomas Sullivan May 22, 2014 0 In our February article, Will Sunshine Data Help Qui Tam Whistleblowers and Their Attorneys?, we mentioned that while…
FDA FDA Seeks Comment on New Draft Guidance for Biosimilars: “Clinical… Thomas Sullivan May 21, 2014 0 The Affordable Care Act amended the Public Health Service Act (PHSA) to include an abbreviated approval pathway for biological…
Open Payments Physician Payments Sunshine Act: No Word Yet From CMS on Phase 2, Which… Thomas Sullivan May 21, 2014 0 As we've written numerous times now, the Centers for Medicare and Medicaid Services (CMS) split company submissions of…
CME Maintenance of Certification: Petition to Recall ABIM’s MOC Requirements… Thomas Sullivan May 20, 2014 1 The rally against Maintenance of Certification (MOC) continues as more and more doctors have signed a petition to recall…
Accountable Care Organizations ACO Update: Total ACOs Top 520; Concentrated in Florida, California, and… Thomas Sullivan May 20, 2014 0 New research from the consulting firm Oliver Wyman estimates there are now 522 accountable care organizations (ACOs) serving…
Physician Payment Disclosure Connecticut Requires Pharmaceutical and Device Companies to Report Payments… Thomas Sullivan May 19, 2014 0 For the first time in five years a state has passed legislation aimed at reporting payments from pharmaceutical and…
CMS Jonathan Blum Makes Final Plug for Transparency Before Leaving CMS Thomas Sullivan May 16, 2014 0 Late last month, the Centers for Medicare and Medicaid Services (CMS) announced that Jonathan Blum, Deputy Administrator…
FDA FDA: Draft Guidance for Industry Fees for Human Drug Compounding… Thomas Sullivan May 15, 2014 0 The US Food and Drug Administration (FDA) has published a new guidance document intended to establish user fees to fund…
HHS-OIG HHS OIG: Medicare and State Healthcare Programs: Fraud and Abuse – OIG… Thomas Sullivan May 14, 2014 0 The Department of Health and Human Services Office of Inspector General (OIG) has been busy lately with proposed rules…
FDA FDA Proposed Rule: Medical Device Classification Procedures Thomas Sullivan May 14, 2014 0 As recently reported, the U.S. Food and Drug Administration (FDA) is proposing to simplify the way it classifies and reclassifies…