Documentation (1 - 10 of 61 items)
Medical Devices: Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling
GAO-17-231: Published: Feb 7, 2017. Publicly Released: Feb 8, 2017.
Between 1991 and 2014, the Food and Drug Administration (FDA)—the federal agency responsible for the oversight of medical devices—cleared 25 submissions for laparoscopic power morcellators for the U.S. market. FDA cleared the submissions for these devices, which cut tissue into small pieces to facilitate removal through small incision sites of gynecological and other types of minimally invasiv...
FDA Facilities: Planning Efforts for White Oak Campus Should Further Incorporate Leading Practices to Address Ongoing Challenges
GAO-17-87: Published: Dec 7, 2016. Publicly Released: Jan 6, 2017.
Officials from the Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS) described various benefits and challenges related to the consolidation of about 10,500 FDA staff and contractors at a campus in White Oak, Maryland. As of 2016, the campus was partially complete, with 9 of the 10 planned office buildings constructed and 27 percent more staff than the 8,2...
Veterans Health Care: Improvements Needed in Operationalizing Strategic Goals and Objectives
GAO-17-50: Published: Oct 21, 2016. Publicly Released: Nov 21, 2016.
The Department of Veterans Affairs' (VA) Veterans Health Administration (VHA) uses a multi-step strategic planning process to develop its strategic goals and objectives, which includes two key steps—(1) identifying and assessing factors that may affect health care delivery, which is referred to as environmental scanning, and (2) holding the annual National Leadership Council (NLC) Strategic Plan...
VA Health Care: Processes to Evaluate, Implement, and Monitor Organizational Structure Changes Needed
GAO-16-803: Published: Sep 27, 2016. Publicly Released: Oct 27, 2016.
Recent internal and external reviews of Veterans Health Administration (VHA) operations have identified deficiencies in its organizational structure and recommended changes that would require significant restructuring to address, including eliminating and consolidating program offices and reducing VHA central office staff. However, VHA does not have a process that ensures recommended organizationa...
Veterans' Health Care: Improved Oversight of Community Care Physicians' Credentials Needed
GAO-16-795: Published: Sep 19, 2016. Publicly Released: Sep 19, 2016.
GAO found that the Department of Veterans Affairs' (VA) contractors—Health Net Federal Services (Health Net) and TriWest Healthcare Alliance (TriWest)—complied with contractual requirements to verify the credentials of physicians under one community care program, but were deficient in doing so under another program. Based on GAO's review of selected physicians, GAO found that the contractors a...
Health Care: Results of Recent Undercover Testing for Patient Protection and Affordable Care Act Coverage, and Review of Market Concentration in the Private Insurance Markets
GAO-16-882T: Published: Sep 14, 2016. Publicly Released: Sep 14, 2016.
The Patient Protection and Affordable Care Act (PPACA) requires health-insurance marketplaces to verify application information, such as citizenship or immigration status and household income, to determine eligibility for enrollment and, if applicable, eligibility for income-based subsidies. While inconsistencies between the information provided by the applicant and by government sources are being...
Patient Protection and Affordable Care Act: Results of Undercover Enrollment Testing for the Federal Marketplace and a Selected State Marketplace for the 2016 Coverage Year
GAO-16-784: Published: Sep 12, 2016. Publicly Released: Sep 12, 2016.
The Patient Protection and Affordable Care Act (PPACA) requires health-insurance marketplaces to verify application information to determine eligibility for enrollment and, if applicable, determine eligibility for income-based subsidies. Verification steps include validating the applicant's Social Security number, if one is provided; citizenship or immigration status; and household income. PPACA r...
Veterans Crisis Line: Additional Testing, Monitoring, and Information Needed to Ensure Better Quality Service
GAO-16-373: Published: May 26, 2016. Publicly Released: Jun 27, 2016.
GAO found that the Department of Veterans Affairs (VA) did not meet its call response time goals for the Veterans Crisis Line (VCL), although extended call wait times were not common. VA's goal is to answer 90 percent of VCL calls at the VCL primary center within 30 seconds. Currently, calls not answered within 30 seconds route to VCL backup call centers; however, for 5 months of fiscal year 2015,...
Veterans' Health Care: Proper Plan Needed to Modernize System for Paying Community Providers
GAO-16-353: Published: May 11, 2016. Publicly Released: May 11, 2016.
To help ensure that veterans are provided timely and accessible health care services, the Veterans Health Administration (VHA) of the Department of Veterans Affairs (VA) has purchased care from non-VA community providers through its care in the community programs since as early as 1945. VHA's agency-wide data show that in fiscal year 2015, it processed about 66 percent of claims within the agency'...
Patient Protection and Affordable Care Act: CMS Should Act to Strengthen Enrollment Controls and Manage Fraud Risk
GAO-16-506T: Published: Mar 17, 2016. Publicly Released: Mar 17, 2016.
The Patient Protection and Affordable Care Act (PPACA) requires applicant information be verified to determine eligibility for enrollment or income-based subsidies. To implement this verification process, the Centers for Medicare & Medicaid Services (CMS) created an electronic system called the “data services hub” (data hub), which, among other things, provides a single link to federal sources...