Tag:regulatory compliance
Compliance and Aducanumab – How Should Providers Balance FDA and CMS Guidance?
As my colleague at Inside Compliance discussed here in September, the FDA approved Aducanumab for the treatment of Alzheimer’s Disease on June 7, 2021. Aducanumab, marketed as Aduhelm, is intended to reduce beta-amyloid levels. This compound is responsible for forming a “plaque” which inhibits neuron function and eventually triggers neuronal apoptosis (death of neurons). Now, a recent decision by CMS on insurance reimbursement for aducanumab has increased the compliance responsibilities of providers.
Delivering the Nuclear Promise . . . Revisited
I authored a post last year regarding the nuclear energy industry’s current initiative to reduce operational costs to compete with the ever-dropping cost of energy production. Coined “Delivering the Nuclear Promise,” the initiative aims to enlist cost-cutting initiatives such as reducing staffing and removing superfluous requirements that maintain large margin to regulatory thresholds. Companies have set hefty goals to bring the cost of nuclear energy production down to values that would make nuclear energy competitive against less expensive, highly backed, and not-as-clean, forms of energy. This all needs to be done without sacrificing safety.
In order to achieve these drastic measures, I will set forth the case for on-the-rise technologies, that while the nuclear energy industry does not currently have the infrastructure to support, will aide in this transition, and as I argue, ultimately be required in order to sustain this clean and necessary form of energy.