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This rule is needed to improve the national response to the rise in prescribed opioid misuse and heroin use and related morbidity and mortality by proposing an approach to increasing access to buprenorphine treatment while protecting against diversion. Medication assisted treatment (MAT) using buprenorphine, in combination with counseling and other support services, is one important tool for treating opioid addiction. To address this need and help close the gap in treatment services, SAMHSA would propose to address restrictions in the use of buprenorphine imposed by the Drug Addiction Treatment Act (DATA 2000).

Statement of Need:

The Drug Addiction Treatment Act of 2000 (DATA) provided the means for physicians to obtain a waiver from the Controlled Substances Act in order to treat opioid use disorders with buprenorphine, an opioid partial opioid-agonist, without certification from SAMHSA as an Opioid Treatment Program (OTP). However, since the implementation of this act, the nation finds itself in the midst of a public health crisis of prescribed opioid misuse and heroin use and related morbidity and mortality. Every day in the United States 105 people die as a result of drug overdose and another 6,748 are treated in emergency departments for the misuse or abuse of drugs.

Responses to this public health problem include: education of physicians in the appropriate management of pain and the role of opioid analgesics; implementation of effective prescription drug monitoring programs and other strategies to promote patient safety while reducing fraud and abuse; and promoting access to effective treatment for opioid use disorders. Medical and clinical evidence indicates medication-assisted treatment with pharmacotherapies approved for the treatment of substance use disorders are most effective for the treatment of opioid use disorders in particular. The medication-assisted treatment of opioid use disorders reduces all-cause mortality and reduces the morbidity, social dysfunction and criminality often associated with this condition. However, access to effective treatment has always encountered significant concrete obstacles such as: lack of awareness of substance use disorders, lack of coverage for needed services, and inadequate treatment capacity. To help close this gap, SAMHSA would like to address restrictions in the use of buprenorphine imposed by the Drug Addiction Treatment Act (DATA 2000).

Summary of the Legal Basis:

21 U.S.C. 823(g)(2)

Alternatives:

OTPs expansion of buprenorphine, use of naltrexone, expansion of methadone; dose limitations, formulation limitations.

Anticipated Costs and Benefits:

As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks:

As we move toward publication, risks of these provisions will be included in the rule.