Federal Reports

The OIG received a hotline complaint about delays by staff at the Martinsburg VA Medical Center in processing and scheduling veterans’ community care consults. These consults are referrals to non-VA providers for clinical services. The OIG substantiated that as of February 28, 2023, there were over 5,000 active consults (meaning staff were working to process them), that staff took more than 100 days to make the first contact attempt with the veteran, and that staff took longer than 45 days on average to schedule veterans for care in the community (well in excess of the seven-day requirement). While evaluating the merits of the specific complaints, the OIG learned that, in an effort to make staff aware of the repercussions of untimely scheduling, the chief of community care had sent her whole team a list of veterans who had passed away with unscheduled consults. The list contained personally identifiable information. The OIG determined that community care scheduling delays occurred because of (1) ineffective processes used to manage community care consults, (2) shortages of specialty care providers, such as in otolaryngology, gastroenterology, radiology, orthopedics, and cardiology, and (3) a lack of controls to ensure manager accountability for consult timeliness. The OIG recommended ensuring that personal information of veterans is only shared on a need-to-know basis, evaluating alternative workflows to improve consult processing and scheduling, exploring ways to increase the availability of specialty care providers, and adding to the community care chief’s performance plan standards related to the metrics for community care.

Endo Health Solutions Inc. (EHSI) was ordered May 2, 2024, to pay $1.086 billion in criminal fines and an additional $450 million in criminal forfeiture—the second-largest set of criminal financial penalties ever levied against a pharmaceutical company—for violations of the federal Food, Drug and Cosmetic Act (FDCA), according to the U.S. Department of Justice.EHSI pleaded guilty April 18, 2024, to one misdemeanor count of introducing misbranded drugs into interstate commerce. In its plea, EHSI admitted that from April 2012 through May 2013, some of its sales representatives marketed Opana ER with INTAC (Opana ER) to prescribers by touting the drug’s purported abuse deterrence, tamper resistance, and/or crush resistance despite a lack of clinical data supporting those claims. In addition, approved labeling for Opana ER did not provide adequate information for healthcare providers to safely prescribe Opana ER for use as an opioid that is abuse deterrent. According to the plea agreement, EHSI was responsible for the misbranding of Opana ER by marketing the drug with a label that failed to include adequate directions for its claimed abuse deterrence, in violation of the FDCA. EHSI withdrew Opana ER from the market in 2017. The investigation, supported by our office, found that some Amtrak employees and dependents were prescribed the misbranded drug.

16th Quarterly Report to Congress

This Office of Inspector General (OIG) Comprehensive Healthcare Inspection Program report describes the results of a focused evaluation of the quality of care delivered in the inpatient and outpatient settings of the Harry S. Truman Memorial Veterans’ Hospital, which includes multiple outpatient clinics in Missouri. This evaluation focused on five key operational areas:• Leadership and organizational risks• Quality, safety, and value• Medical staff privileging• Environment of care• Mental health (suicide prevention initiatives)The OIG issued seven recommendations for improvement in three areas:1. Medical staff privileging• Ongoing Professional Practice Evaluationo Completiono Service-specific criteria• Professional practice evaluation data2. Environment of care• Mental health inpatient unit over-the-door alarm testing3. Mental health• Comprehensive Suicide Risk Evaluation completion• Suicide prevention outreach activities• Reporting suicide behaviors to the suicide prevention team