Acute pain management and the opioid crisis addressed at FDA committee meeting

Practice Management

There were 63,632 American drug overdose deaths in 2016, and 66 percent involved an opioid, according to the CDC. More than 130 people die each day from opioid-related drug overdoses, according to HHS, and nearly 80 percent of heroin users report misusing prescription opioids before using heroin.

Clinicians have a crucial role to play in combating this epidemic. At the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee Meeting in Silver Spring, Md., Nov. 15, experts discussed assessing opioid analgesic-sparing outcomes in acute pain clinical trials. Three industry experts who presented included: 

  • Pacira Pharmaceuticals CMO Richard Scranton, MD, discussing methodologies for determining opioid–sparing in acute pain models. 
  • Randall Stevens, MD, CMO of Centrexion Therapeutics, speaking about a composite approach to outcome measure of opioid-sparing treatments in chronic pain. 
  • Flexion Therapeutics CMO Scott Kelley, MD, discussing opioid-sparing considerations in chronic pain trials using osteoarthritis as a model indication. 

In its 2019 final payment rule for hospital outpatient surgery departments and ambulatory surgery centers, CMS aims to address the issue by making separate payments for non-opioid pain management drugs for ASCs. The only HCPCS code falling into this category is Pacira Pharmaceuticals’ Exparel, which will now receive separate payment when used in the ASC setting.

To learn more about the new CMS rule as well as hear from ASC owners, administrators and leaders in ASC billing and coding on their experiences with Exparel, register for a webinar titled "CMS Reimburses Non-Opioid Postsurgical Pain Management in the ASC: Review of the New CMS Rules and Opportunity for ASCs" on Dec. 4, from 12:00 p.m. to 1:00 p.m.

Recently published studies in peer-reviewed journals show arthroscopic rotator cuff repair patients treated with Exparel consumed 64 percent fewer opioids and reduced opioid consumption in total knee replacement patients.

Spine surgeons can also use Exparel as part of a multimodal pain management approach to surgical patients. At the Jeffries London Healthcare Conference Nov. 14, Pacira Pharmaceuticals CEO David Stack said, "If you are treating spine patients, you want to get them out of the PACU and mobile as quickly as possible. If we can [achieve this] without opioids, you can make spine an outpatient procedure." 

Through CMS' proposed changes, the agency could pay more for Exparel in ASCs than in hospitals, the Utilization Review Accreditation Commission reported.

 

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