Part D formulary changes
Executive Summary
CMS will accept negative formulary change requests from Medicare Part D plan sponsors for the 2007 benefit year until July 31, but the agency can only guarantee that what are considered to be "maintenance" change requests will be reviewed, according to a June 20 1memo to sponsors. Maintenance revisions might include moving a brand name product to a less preferred tier after a generic version is approved or changes for safety reasons. The agency also will allow sponsors to request certain types of changes from Aug. 8-10 in the Part D formularies that have already been submitted for 2008. "Allowable" changes specified in the memo include deletion of a drug along with the corresponding addition of a drug within the same USP class at the same, or lower, beneficiary cost-sharing level...
You may also be interested in...
Roche/Genentech Keeps Commitment To External Cancer Innovation
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
Unprecedented To Lawful: Regulatory Precedent Needed For Cannabinoids’ Use In Supplements?
“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: