On February 1, 2018, CMS released its 2019 Draft Call Letter. AMCP prepared in initial summary of the highlights contained in the Draft Call Letter. Of particular interest to AMCP members, CMS proposed new strategies for identifying potential opioid abuse which will work with the proposed codification of the current Opioid Monitoring System (OMS) under the Comprehensive Addiction and Recovery Act of 2015 (CARA).
On January 30, 2018, AMCP delivered remarks to the FDA at an opioid policy steering committee meeting. AMCP commended the FDA for establishing the OPSC and for seeking public input to help identify key areas of focus that the FDA can address. AMCP focused on the following three areas; REMS; Labeling, Packaging, Storage, and Disposal; and Additional Focus Areas where AMCP feels that the FDA can be actively involved in combating the opioid epidemic.