RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • With Drugs Scarce, Attention Turns to Labeling Regulations

    Worsening shortages of some critical drugs are causing some groups to criticize US Food and Drug Administration (FDA) and Center for Medicare and Medicaid Services (CMS) regulations that the groups claim are causing providers to dispose of potentially useful medications. MSNBC reports that "organizations such as the Institute for Safe Medication Practices and the American Society of Health-System Pharmacists are raising questions about federal rules they belie...
  • Feature ArticlesFeature Articles

    Sunshine Comes to Clinical Trials: Sponsors, CROs, Physicians and Teaching Hospitals Need to Prepare for Federal Financial Disclosure

    A provision of the healthcare reform law has created a new need for clinical trial sponsors and other participants to be open about financial relationships. On 19 December 2011, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that would require applicable manufacturers, including many clinical trial sponsors, to disclose certain financial relationships with physicians and teaching hospitals. The concept is nothing new, as the rule implement...
  • DHHS Releases New Regulations on Medicaid Covered Outpatient Drugs

    The US Department of Health and Human Services (DHHS) released new draft regulations on Friday, 27 January that would implement portions of the Patient Protection and Affordable Care Act (PPACA) by revising reimbursement methodologies for outpatient drugs covered by Medicaid. Medicaid currently allows states to provide coverage of outpatient drugs to patients. Under the PPACA , DHHS is required to adjust the requirements for rebate agreements, drug pricing submission ...
  • 86% of Adverse Patient Events Go Unreported in Hospitals

    • 09 January 2012
    The US Department of Health and Human Services' (DHHS) Officer of the Inspector General (OIG) released a report on Friday, 6 January indicating that six in seven adverse events (AEs) that take place in hospitals go unreported. The OIG's Director, Daniel Levinson, noted that all hospitals being paid under Medicare are obligated to "track medical errors and adverse patient events, analyze their causes" and make improvements to reduce future incidence of AEs. Levinson fur...