Contracting News & Notes

Recent headlines and trends to keep an eye on

Baylor Scott & White Research Institute expands efforts in fight against COVID-19

Baylor Scott & White Research Institute, the research and development arm of Baylor Scott & White Health (Dallas, TX), announced it is accelerating its pace of bringing clinical trials online for research initiatives to combat COVID-19.

“Baylor Scott & White Research Institute continues to mobilize staff and resources, including components needed to integrate critical patient-safety measures at every participating site within the Baylor Scott & White system for industry sponsored drug trials, investigator-initiated drug trials research studies, and observational and data studies designed to help increase knowledge around case trends, viral epidemiology, and care best practices,” the health system said in a press release.

“After bringing five clinical trials online in the early days of the virus’ impact, our COVID-19 therapeutic task force and our four institutional review boards have now approved more than 20 COVID-19 research initiatives. We have an unwavering commitment to helping our communities navigate the uncertainty of this virus,” said Jaime Walkowiak, chief research executive, Baylor Scott & White.

Premier Inc. recommends FDA, DEA reforms to prevent drug shortages

Premier Inc. (Charlotte, NC) says it has provided the U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA) with a list of reforms and regulatory waivers that it believes should be extended beyond the COVID-19 pandemic and made permanent thereafter in order to prevent drug shortages.

Premier specifically recommended that 503B compounding facilities be allowed to continue producing specific drugs that are not on the drug shortage
list based on specific criteria, such as a short-term or regional shortages or demand surges for certain dosage strengths and/or packaging sizes. The GPO says that “this waiver proved particularly helpful during the pandemic, as it allowed 503B compounders to quickly and seamlessly fill capacity gaps and alleviate spot shortages before they became severe enough to spread nationwide and make it onto the FDA drug shortage list.”

Premier also recommends that the FDA permanently abandon the arbitrary geographical limitation known as the “one-mile radius” provision for hospital compounding. Moving forward, the company recommends that the FDA adopt a time-based standard rooted in scientific evidence for sterility and stability of the compounded product.

Additionally, Premier recommends a complete overhaul of the quota allocation process, abandoning quotas based on weight in favor of establishing quotas based on dosage form and differentiating between injectables and solid oral dosage forms.

Hospitals scramble with new national COVID-19 data reporting system

Hospitals and states are scrambling to adopt a new national COVID-19 data reporting system hastily implemented by the Trump administration last week that has left some, mostly rural, states in the dark about the severity of their own coronavirus outbreaks.

The White House abruptly instructed all hospitals to stop reporting their COVID-19 data to the CDC’s National Healthcare Safety Network. Instead, the U.S. Department of Health and Human Services (HHS) instructed hospitals to report the data to HHS through a new portal that went live this week. HHS gave hospitals only two days to comply and is withholding remdesivir, a vital drug used to treat COVID-19, from hospitals that do not comply.

Some states do not collect the data themselves and rely on the CDC to assemble and share the information, which public officials use to decide how to allocate key resources.

Vermont hospitals lost $107M due to COVID-19

Vermont state regulators called state losses of $107 million since the start of the fiscal year due to COVID-19 very troubling. Vermont’s 14 hospitals reported a combined $77 million in losses in March and April alone. Hospitals are holding onto cash, deferring bill payments, and taking on more debt in loans from the federal government to stay viable.

Cleveland Clinic Akron General expanding physician training programs by 30%

Cleveland Clinic Akron General says it is expanding several areas of its graduate medical education program which will result in a 30% increase in the number of physicians it trains each year, once the program becomes fully operationalized in 2024. Prior to 2018, 138 residents were training at Akron General. This grew to 153 in the 2020-2021 academic year, which began July 1, and will reach 177 by 2024. Cleveland Clinic says the biggest growth will come from Akron General’s decision to start a psychiatry residency program. Akron General had its own program many years ago, but shifted to participating in a shared program with several other local hospitals in the 1970s.

The new psychiatry program will have four residents in each of its four years of training, with the first group starting in July 2021. When it is fully implemented, with 16 participants, it will double the number of trained psychiatrists graduating in the Akron area each year. Akron General is also expanding its OB/GYN residency program, from four residents per year (in a four-year program) to five per year starting with this year’s class.

M2 drone system enables new delivery network at Wake Forest Baptist Health

Matternet (Mountain View, CA), a developer of an urban drone logistics platform, announced its M2 drone system is enabling a new hospital delivery network at Wake Forest Baptist Health (Winston-Salem, NC). The service, in collaboration with UPS Flight Forward (UPSFF), will use a hub-and-spoke routing model to provide rapid delivery of time-and-temperature-sensitive medicines and supplies, including PPE. Matternet and UPSFF have started operating on two routes from one location at Wake Forest Baptist Health to two other health system locations, marking one of the first hub-and-spoke operating models for the U.S. drone delivery industry. One route will transport scheduled deliveries of specialty infusion medicines. The second route will transport on-demand supplies of PPE.