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This planned deregulatory action would revise 42 CFR part 8 to reduce outmoded requirements.  First, SAMSHA may streamline the regulation by deleting now outdated requirements pertaining to transitional certification for opioid treatment  programs (OTPs).  This change will help make the regulation less confusing by removing a provision that no longer applies.

Second, SAMSHA may alter requirements pertaining to interim maintenance treatment program approval.

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SAMHSA plans to promulgate a rule to remove the transitional certification provisions that are now outdated.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.

This planned deregulatory action would revise 42 CFR Part 8 to reduce outmoded requirements.  First, SAMSHA may streamline the regulation by deleting now outdated requirements pertaining to transitional certification for opioid treatment  programs (OTPs).  This change will help make the regulation less confusing by removing a provision that no longer applies.

 Second, SAMSHA may alter requirements pertaining to interim maintenance treatment program approval

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.

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:

The transition provisions are outdated and no longer apply. SAMSHA anticipates most stakeholders will support permitting private, for-profit entities to serve as OTPs but some may be skeptical of these entities as compared to nonprofits. Rescinding the reporting requirements for providers treating up to 275 patients should hold minimal risk since these providers still are bound by other certification requirements such as recordkeeping, etc.  These reporting requirements initially were added in July 2016 (81 FR 66191).