CMS Wants Broader Use of Abuse-Deterrent Opioids – But Needs Help From Congress
Executive Summary
Abuse-deterrent formulations are 'potentially useful tool,' but CMS believe it lacks authority to mandate favorable coverage in Part D plans. House E&C committee has nearly three dozen Medicare & Medicaid proposals under consideration – but none that specifically gives CMS the authority it says it needs.
You may also be interested in...
Pacira Sees Big Opportunity In Exparel's Narrow Nerve Block Indication
Brachial plexus indication for long-acting bupivacaine liposome will launch in US with combined 2,000-rep sales force under copromotion with J&J; although Pacira did not get the broad claim requested, company sees significant commercial opportunity for an indication that is expected to encompass 60% of all nerve block procedures within the next two years.
Senate Draft Bill On Opioids Tasks US FDA With Clarifying Its Regulation Of New Treatments
Discussion draft released by Senate HELP Committee directs agency to hold at least one public meeting and issue four guidances on a range of issues.
New US FDA Powers On Rx Abuse Could Be 'Tailored' By Congress, Gottlieb Suggests
At House hearing on opioid epidemic, FDA Commissioner responds to range of legislative proposals, including those aimed at agency's drug approval and safety monitoring activities.