Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more
3/22/2013 - Affordable Care Act CMS Disclosure Requirements Healthcare Manufacturers Medical Devices Pharmaceutical Physicians Prescription Drugs Reporting Requirements Sunshine Act
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more
2/13/2013 - Biologics CHIP CMS Common Ownership Covered Recipients Drug Manufacturers GPOs Medicaid Medical Devices Medical Supplies Medicare Payment Records Penalties Reporting Requirements Sunshine Act
On November 29, 2012, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a report raising concerns about the Centers for Medicare and Medicaid Services’ (CMS) oversight of the...more
12/7/2012 - Electronic Health Record Incentives HHS Medicaid Medicare
On December 3, 2012, in United States v. Caronia, a three-judge panel of the Second Circuit reversed a drug salesperson’s conviction for conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor...more
12/7/2012 - FDCA First Amendment Off-Label Promotion Off-Label Use Pharmaceutical
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