Current through Register Vol. 24-18, September 15, 2024
(1) Opioid treatment programs (OTP) may
order, possess, dispense, and administer medications approved by the United
States Food and Drug Administration for the treatment of opioid use disorder,
alcohol use disorder, tobacco use disorder, and reversal of opioid overdose.
OTP services include withdrawal management and maintenance treatment along with
evidence-based therapy.
(2) An
agency providing opioid treatment program services must ensure that the
agency's individual record system complies with all federal and state reporting
requirements relevant to opioid drugs approved for use in treatment of opioid
use disorder, alcohol use disorder, tobacco use disorder, and reversal of
opioid overdose.
(3) An agency
must:
(a) Use evidence-based therapy in
addition to medication in the treatment program;
(b) Identify individual mental health needs
during assessment process and refer them to appropriate treatment if not
available on-site;
(c) Provide
education to each individual admitted, totaling no more than fifty percent of
treatment services, on:
(i) Alcohol, other
drugs, and substance use disorder;
(ii) Relapse prevention;
(iii) Infectious diseases including human
immunodeficiency virus (HIV) and hepatitis A, B, and C;
(iv) Sexually transmitted infections;
and
(v) Tuberculosis
(TB);
(d) Provide
information to each individual on:
(i)
Emotional, physical, and sexual abuse;
(ii) Nicotine use disorder;
(iii) The impact of substance use during
pregnancy, risks to the developing fetus before prescribing any medications to
treat opioid use disorder, the risks to both the expecting parent and fetus of
not treating opioid use disorder, and the importance of informing medical
practitioners of substance use during pregnancy; and
(iv) Family planning.
(e) Create and implement policies and
procedures for:
(i) Diversion control that
contains specific measures to reduce the possibility of the diversion of
controlled substances from legitimate treatment use, and assign specific
responsibility to the medical and administrative staff members for carrying out
the described diversion control measures and functions;
(ii) Urinalysis and drug testing, to include
:
(A) Obtaining specimen samples from each
individual, at least eight times within twelve consecutive months;
(B) Documentation indicating the clinical
need for additional urinalysis;
(C) Random samples, without notice to the
individual;
(D) Samples in a
therapeutic manner that minimizes falsification;
(E) Observed samples, when clinically
appropriate; and
(F) Samples
handled through proper chain of custody techniques.
(iii) Laboratory testing;
(iv) The response to medical and psychiatric
emergencies; and
(v) Verifying the
identity of an individual receiving treatment services, including maintaining a
file in the dispensary with a photograph of the individual and updating the
photographs when the individual's physical appearance changes
significantly.
(4) An agency must ensure that an individual
is not admitted to opioid treatment withdrawal management services more than
two times in a twelve-month period following admission to services.
(5) An agency providing services to a
pregnant woman must have a written procedure to address specific issues
regarding their pregnancy and prenatal care needs, and to provide referral
information to applicable resources.
(6) An agency providing youth opioid
treatment program services must:
(a) Ensure
that before admission the youth has had two documented attempts at short-term
withdrawal management or drug-free treatment within a twelve-month period, with
a waiting period of no less than seven days between the first and second
short-term withdrawal management treatment; and
(b) Ensure that when a youth is admitted for
maintenance treatment, written consent by a parent or if applicable, legal
guardian or responsible adult designated by the relevant state authority, is
obtained.
(7) An agency
providing opioid treatment program services must ensure:
(a) That notification to the federal
Substance Abuse and Mental Health Services Administration (SAMHSA) and the
department is made within three weeks of any replacement or other change in the
status of the program, program sponsor as defined in 42 C.F.R. Part 8, or
medical director;
(b) Treatment is
provided to an individual in compliance with 42 C.F.R. Part 8;
(c) The individual record system complies
with all federal and state reporting requirements relevant to opioid drugs
approved for use in treatment of opioid use disorder; and
(d) The death of an individual enrolled in an
opioid treatment program is reported to the department within forty-eight
hours.
