Federal Reports

When Congress established average sales price (ASP) as the basis for Medicare Part B drug reimbursement, it also provided a mechanism for monitoring market prices and limiting potentially excessive payment amounts. The Social Security Act mandates that OIG compares ASPs with average manufacturer prices (AMPs). If OIG finds that the ASP for a drug exceeds the AMP by a certain percentage (currently 5 percent), the Act directs the Secretary of Health and Human Services to substitute the ASP-based payment amount with a lower calculated rate. Through regulation, CMS outlined that it would make this substitution only if the ASP for a drug exceeds the AMP by 5 percent in the 2 previous quarters or 3 of the previous 4 quarters.

OIG conducted a healthcare inspection at the request of Congressman Mike Coffman to assess allegations received in 2014 regarding delays in scheduling diagnostic studies and other quality of care concerns at the William S. Middleton Memorial Veterans Hospital (facility), Madison, WI. After beginning our review, we also received a request from Senator Tammy Baldwin to review the same issues. We substantiated delays in scheduling in-house echocardiograms, stress tests, and sleep studies for patients in 2013 and 2015. We determined that two patients had an increased risk for sudden cardiac death due to a delay in scheduling an echocardiogram in 2013. After several months delay, both patients underwent echocardiograms followed by surgical procedures to treat their life-threatening conditions. We substantiated that a small number of 2013 and 2015 echocardiogram consults were discontinued within 30 days then later resubmitted as new consults without explanatory documentation. We could not determine that echocardiogram consults were discontinued within 30 days and resubmitted to appear timely. We did not substantiate that facility managers refused to approve non-VA echocardiograms and stress tests as a cost savings decision. We reviewed 2013 and 2015 non-VA echocardiogram and stress test consult requests to determine if facility managers refused to approve non-VA care. We substantiated that a cardiologist did not sign cardiac catheterization reports timely; however, we did not substantiate that untimely signing of cardiac catheterization reports resulted in delayed care for three identified patients. We did not substantiate that a cardiologist did not timely review an event monitor tracing strip, which resulted in a patient undergoing an invasive surgical procedure. We did not substantiate that pharmacy staff refused to give veterans a 90-day supply of clopidogrel and instead only gave a 30-day supply, and that this contributed to missed doses. We did not find evidence that giving three patients a 30-day supply of clopidogrel contributed to missed dosages for those patients. We made three recommendations.

Bisphenol-A (BPA), a chemical often used to produce food and drink packaging, has been linked to a variety of adverse health conditions, including cancer. The National Institute of Environmental Health Sciences (NIEHS) funds studies that test substances, including BPA, for carcinogenicity and other harmful biological effects. OIG received a congressional request to review the extent to which NIEHS funds research on the safety of BPA and the processes NIEHS used in planning and funding that research.