SAMHSA issues guidance on take-home flexibility extensions

The Substance Abuse and Mental Services Administration (SAMHSA) this month (March 2022) issued guidance on its extensions of exemptions for methadone take-home rules going beyond the COVID-19 public health emergency. Under the new guidance, SAMHSA is “pre-emptively granting OTPs [opioid treatment programs] an exemption, effective upon the expiration of the COVID-19 Public Health Emergency, and subject to the conditions identified below, from the unsupervised take-home medication requirements,” which now allow:

  • up to 28 days of take-homes “to stable patients if the OTP believes the patient can safely handle this amount of take-home medication”
  • up to 14 days of take-home doses “to less stable patients if the OTP believes the patient can safely handle this amount of take-home medication.”

The extension means that the “temporary” rules put in place in March 2020 are probably on their way to becoming permanent. Research has shown that when OTPs decide who is stable, who is “less stable,”and who gets how many take-homes, diversion and overdose is virtually nonexistent. This is because of the expertise of OTPs in methadone pharmacology and in knowing their patients.

“Stable patients” within the meaning of this exemption are defined as patients who have completed a minimum of 60 days in treatment, and whose medical record fully documents the following:

  • that the benefits of providing unsupervised doses to an individual outweigh the risks
  • that the individual demonstrates total adherence per the OTP’s discretion with their treatment plan for at least 60 days
  • negative toxicology tests for 60 calendar days
  • an absence of serious behavioral problems
  • stability in their living arrangements and social relationships
  • an absence of substance misuse–related behaviors
  • an absence of recent diversion activity
  • assurance that the medication can be safely stored

Patients who do not meet all eight criteria listed above are not eligible for treatment as “stable” patients under this exemption.

“Less stable” patients within the meaning of this exemption are defined as patients who have completed a minimum of 30 days in treatment, and whose medical record fully documents the following:

  • that the benefits of providing unsupervised doses of methadone to the individual outweigh the risks
  • that the patient demonstrates partial adherence with their treatment plan for at least 30 days
  • 30 days of negative toxicology tests
  • an absence of recent diversion activity
  • assurance that the medication can be safely stored

Patients who do not meet all five criteria listed above are not eligible for treatment as “less stable” patients under this exemption.

Liability is still the OTP’s.

For the SAMHSA information, go to https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines/methadone-guidance

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