May 2014 – Page 2 – Policy & Medicine

Supreme Court Declines to Review Important False Claims Act Issue

FDA Seeks Comment on New Draft Guidance for Biosimilars: “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product”

Physician Payments Sunshine Act: No Word Yet From CMS on Phase 2, Which Will “Start in May”

Maintenance of Certification: Petition to Recall ABIM’s MOC Requirements Hits 15,000 Signatures; Recertification Pass Rates Drop Below 80% for Internal Medicine

ACO Update: Total ACOs Top 520; Concentrated in Florida, California, and Northeast

Connecticut Requires Pharmaceutical and Device Companies to Report Payments and Transfers of Value Made To Nurse Practitioners and other APRNs

Jonathan Blum Makes Final Plug for Transparency Before Leaving CMS

FDA: Draft Guidance for Industry Fees for Human Drug Compounding Outsourcing Facilities

HHS OIG: Medicare and State Healthcare Programs: Fraud and Abuse – OIG Proposes Revisions to Civil Monetary Penalties

FDA Proposed Rule: Medical Device Classification Procedures