FDA Approves Remdesivir for Infants, Surprise Billing Battle Persists
The Food and Drug Administration (FDA) issued approval for expanded use of Remdesivir, and the Department of Health and Human Services (HHS) is engaged in a surprise billing legal fight.
Source: Getty Images
By - The FDA is promoting the use of an antiviral, Remdesivir, to treat COVID-19-infected infants after the drug was shown to be effective in a small clinical trial.
Meanwhile, HHS asked a federal appeals court for a hold on a lawsuit it is engaged in until later this summer, when the final version of its surprise billing rule is published. And in Pennsylvania, UPenn is opening a virtual clinic that will provide immediate buprenorphine prescriptions to opioid addicts.
Pennsylvania Partnership to Fight Opioid Addiction
The University of Pennsylvania Medicine and the Pennsylvania Department of Public Health (PDPH) have teamed up to fight opioid addiction using a new virtual clinic. The clinic offers patients same-day buprenorphine prescriptions and virtual visits with healthcare professionals. Buprenorphine is a drug that helps mitigate symptoms of opioid withdrawal in part by mimicking the effects of opioids; it is the gold standard in OUD treatment. UPenn’s partnership with the PDPH aims to hasten the prescribing process and increase the number of patient navigators available to patients. READ MORE.
FDA Approves Remdesivir for Newborns
The FDA has approved Remdesivir to treat COVID-19 in newborns older than 28 days. Approval came after a clinical trial where 53 pediatric patients infected with COVID-19 were given the drug.
"As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population," Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, said in an announcement.
FDA officials stressed that Remdesivir is not a replacement for vaccination. READ MORE.
Legal Fight Over Surprise Billing Continues
HHS is requesting a hold on an appeal it filed in April, hoping a federal court will delay proceedings until the surprise billing final rule is published this summer. The department was appealing a case that it lost in the state of Texas after a judge ruled in favor of the Texas Medical Association (TMA). TMA had argued that the independent review process included in the interim surprise billing rule violated policies under the No Surprises Act. READ MORE.
DOJ Rules in $12M Medicare Fraud in California
Donald Woo Lee, MD, was found guilty of seven counts of healthcare fraud and received an eight-year prison sentence for his role in a Medicare upcoding scheme. The doctor overperformed vein ablation procedures under circumstances that did not require the costly practice, and Lee went on to reuse ablation catheters against the recommendations of the FDA. The process of upcoding is one of the most common forms of fraud and accounts for millions in Medicare spending each year. READ MORE.
Telehealth Bills Boom Post-Pandemic
Alabama, Kentucky, New Hampshire, and Pennsylvania introduced bills to solidify telehealth in their states during the pandemic. Almost every state in the union has now protected telehealth through legislation, and states are moving forward to include additional types of care within the telehealth umbrella. New Hampshire’s Senate is now considering expanding its telehealth services to out-of-state providers who offer mental health services. And Pennsylvania is considering removing a stipulation that requires psychiatric treatment to be conducted in person. READ MORE.
