Insulin pump coverage criteria
This article was originally published in The Gray Sheet
Executive Summary
Review of Medtronic MiniMed's April 1 request that CMS remove the C-peptide testing requirement from insulin pump national coverage criteria will be complete by Oct. 1. The American Association of Clinical Endocrinologists and other opinion leaders plan to send letters supporting the change. CMS maintains that C-peptide level assesses "residual beta-cell function by measuring insulin secretory ability and ensuring appropriateness of the infusion pump"...
You may also be interested in...
Caregivers Weigh In On CMS Insulin Pump Coverage: C-peptide Test Must Go
CMS should eliminate its requirement that all patients seeking coverage for insulin pumps demonstrate abnormally low C-peptide levels, according to the American Association of Clinical Endocrinologists
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.