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Regulatory Focus™ > News Articles > Opioids: GAO Calls on HHS to Assess Effectiveness of Expanding Medication-Assisted Treatment

Opioids: GAO Calls on HHS to Assess Effectiveness of Expanding Medication-Assisted Treatment

Posted 31 October 2017 | By Zachary Brennan 

Opioids: GAO Calls on HHS to Assess Effectiveness of Expanding Medication-Assisted Treatment

The Government Accountability Office on Tuesday issued a report calling on the US Department of Health and Human Services (HHS) to assess the effectiveness of efforts to expand the use of medication-assisted treatment (MAT) for opioid addiction.

The report follows a House hearing last week in which FDA Commissioner Scott Gottlieb announced several steps the agency will take to promote the development and use of MAT.


The report and Gottlieb's testimony last week come as overdoses claimed the lives of over 52,000 people in 2015 and even more in 2016, according to the US Centers for Disease Control and Prevention (CDC).

MAT is an approach that combines behavioral therapy and certain medications, such as methadone and buprenorphine.

Since 2015, HHS has implemented five key efforts focused on expanding access to MAT for opioid use disorders—four grant programs that focus on expanding access to MAT in various settings (including rural primary care practices and health centers) and regulatory changes that expand treatment capacity by increasing patient limits for buprenorphine prescribers and allowing nurse practitioners and physician assistants to prescribe buprenorphine.


GAO said in its new report that while HHS has some information that could be used in a future evaluation of the effectiveness of its efforts to expand access to MAT, "It has not adopted specific performance measures with targets specifying the magnitude of the increases HHS hopes to achieve through its efforts."

GAO recommends two actions, both of which HHS concurred with: (1) that HHS establish performance measures with targets related to expanding access to MAT, and (2) establish timeframes for its evaluation of its efforts to expand access to MAT.

The GAO report also comes as FDA late Monday announced a two-day public workshop on 11 and 12 December to address novel packaging ideas that might be used to help combat the opioid crisis.

"For example, it's possible that a defined, short-term supply of medication could be packaged in a manner that limits the number of pills dispensed," Gottlieb said in a statement. "This might be achieved, for example, through a blister pack that has a defined duration of use that might be for only a limited number of doses. Other packaging innovations could make it easier to track the number of doses that have been taken."

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