SAMHSA Reporting Requirements to Reduce Risk of Diversion for Controlled Medications

With an estimated 2.1 million people in the United States suffering from substance use disorders related to prescription opioid pain relievers in 2012 and an estimated 467,000 addicted to heroin,[1] medication-assisted treatment (MAT) is at the vanguard of America’s fight back against increasingly pervasive opioid and opiate misuse. The use of medications, in combination with behavioral therapies, and alongside family and community support aims to provide a whole-patient approach to the treatment of substance use disorders. Individuals receiving MAT often demonstrate dramatic improvement in addiction-related behaviors and psychosocial functioning. The most common medications approved for use in the treatment of Opioid Use Disorder are Naltrexone, Methadone and Buprenorphine, of these, Methadone and Buprenorphine are controlled medications under the Controlled Substances Act, 1970.


On July 8th 2016, the Department of Health and Human Services issued a Final Rule that increased access to medication-assisted treatment for substance users, by allowing eligible physicians in office-based settings to request approval to treat up to 275 patients. Prior to this, the number of patients was regulated by the Act which allowed qualified practitioners to file an initial notification on intent (NOI) and treat a maximum of 30 patients at a time. After 1 year, the practitioner was able to file a second NOI indicating his intent to treat up to 100 patients at a time. The increase to 275 was an attempt to mitigate unmet clinical need amid the opioid epidemic in the United States, however, due to the risk of medications being misused or diverted, reporting requirements have been introduced at the higher level.

The Final Rule effective on October 27th 2016, sets out the reporting requirements which physicians must meet to maintain authorization to prescribe to up to 275 patients. Eligible practitioners may make a request to the Substance Abuse and Mental Health Services Administration (SAMHSA) for patient limit increase. If the practitioner is approved, they must submit a report with data, to SAMHSA every year, and provide any other information that SAMHSA asks for. The report must be submitted within 30 days following the anniversary date of the time when the practitioner was approved, and annually thereafter. The report comprises data retrieved directly from the patient’s electronic or paper health record, and must include information concerning:


1.       The annual caseload of patients by month;

2.       The numbers of patients provided behavioral health services and referred to behavioral health services;

3.       Features of the practitioner’s diversion control plan.


SAMHSA then reviews that information and cross reference it for discrepancies with other data sources available to them. If practitioner’s fail to produce the annual reports, then SAMHSA may withdraw approval for that practitioner to prescribe to a case load at the higher level.



[1] Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.