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This proposed rule would delete outmoded requirements for transitional certification and add new language permitting private, for-profit entities to serve as opioid treatment programs.

Statement of Need:

SAMHSA plans to promulgate a rule to remove the transitional certification provisions that are now outdated.  Additionally, updating language to permit private, for-profit entities to serve as opioid treatment programs could improve patient access to this treatment.

Summary of the Legal Basis:

Section 303(g) of the Controlled Substances Act (CSA) (21 U.S.C. 823(g) establishes procedures for determining whether a healthcare practitioner can dispense opioid drugs for the purpose of treating opioid use disorders. HHS has adopted regulations at 42 CFR Part 8 to provide additional details. These regulations were most recently substantively revised in July 2016 (81 FR 44712).

Alternatives:

The alternatives include not making these changes or making only one of the above changes rather than both (i.e., either updating the regulatory language to permit private, for-profit entities to serve as OTPs or removing the transitional certification provisions but not both of these changes).

Anticipated Costs and Benefits:

Eliminating outmoded transition regulations will make the regulations less confusing. In addition, permitting private, for-profit entities to qualify for certification potentially will broaden access to opioid treatment programs. SAMHSA is unsure how to quantify costs and benefits for these changes.

Risks:

Some advocates may argue that controversies about patient brokering raise questions about whether private, for-profit entities would best uphold the interests of patients but SAMHSA has no specific information that permitting private, for-profit entities to manage OTPs will increase risks to patients.