Current through Register No. 40, October 3, 2024
(a) The OTP shall
have a designated medical director who shall be responsible for all medical
services.
(b) The medical director
shall ensure that, for every client:
(1)
Treatment plans are prepared and updated pursuant to (f) -(i) below;
(2) The client's need for
methadone/buprenorphine maintenance is evaluated at least every 6
months;
(3) Any controlled
substances prescribed for a client are clinically justified and documented in
accordance with all applicable regulations, statutes, and rules; and
(4) A determination is made regarding the
client's need for any other specialized services, such as treatment for other
substance use disorders, medical services, or psychiatric services, and any
such conditions are identified and treated or a referral is made to an
appropriate service provider.
(c) Upon a client's admission, the OTP shall
conduct a client orientation, either individually or by group, to include the
following:
(1) Rules, policies, and
procedures of the OTP and facility;
(2) Obtaining consent, which is compliant
with 42 CFR Part 2, relative to the OTP reporting to law enforcement that a
client may be operating a motor vehicle while impaired in as described in
He-A 304.14(e)
;
(3) Requirements for successfully completing
the program;
(4) The administrative
discharge policy and the grounds for administrative discharge;
(5) All applicable laws regarding
confidentiality, including the limits of confidentiality and mandatory
reporting requirements; and
(6)
Requiring the client to sign a receipt that the orientation was
conducted.
(d) Pregnancy
testing shall be conducted as follows:
(1)
Unless contraindicated by sexual orientation or physiological factors, a OTP
shall test monthly for pregnancy any female client of childbearing age who is
using methadone/buprenorphine;
(2)
If pregnancy is confirmed, the OTP shall:
a.
Refer the client for health care for her pregnancy; and
b. Coordinate her treatment with all health
care providers involved in her prenatal care; and
(3) If a pregnant client refuses to obtain
primary care for her pregnancy, staff shall ask the client to sign a statement
indicating she has refused such care, or shall document the client's refusal of
care and refusal to sign.
(e) A licensed counselor or unlicensed
counselor under the supervision of a licensed supervisor shall develop and
maintain a written treatment plan for each client in accordance with SAMHSA's
"TAP 21: Addiction Counseling Competencies" (2015 edition), available as noted
in Appendix A, which addresses all ASAM Criteria (2013), available as noted in
Appendix A, domains.
(f) Treatment
plans shall be developed in the first session following the
evaluation.
(g) Individual
treatment plans shall contain, at a minimum, the following elements:
(1) Goals, objectives, and interventions
written in terms that are specific, measurable, attainable, realistic, and
timely.
(2) Identifies the
recipient's clinical needs, treatment goals, and objectives;
(3) Identifies the client's strengths and
resources for achieving goals and objectives in (1) and (2) above;
(4) Defines the strategy for providing
services to meet those needs, goals, and objectives;
(5) Identifies referral to outside providers
for the purpose of achieving a specific goal or objective when the service
cannot be delivered by the OTP;
(6)
Provides the criteria for terminating specific interventions;
(7) Includes specification and description of
the indicators to be used to assess the individual's progress;
(8) Documentation of participation by the
client in the treatment planning process or the reason why the client did not
participate; and
(9) Signatures of
the client and the counselor agreeing to the treatment plan, or if applicable,
documentation of the client's refusal to sign the treatment plan.
(h) Treatment plans shall be
reviewed no less frequently than every 4 sessions or every 4 weeks, whichever
is less frequent and updated based on any changes in any of the ASAM Criteria
(2013) domains, available as noted in Appendix A.
(i) Treatment plan updates shall include:
(1) Documentation of the degree to which the
client is meeting treatment plan goals and objectives;
(2) Modification of existing goals or
addition of new goals based on changes in the client's functioning relative to
ASAM Criteria (2013), available as noted in Appendix A, domains and treatment
goals and objectives;
(3)
Documentation that the ASAM Criteria (2013), available as noted in Appendix A,
transfer, discharge, and continuing care criteria were reviewed with the client
in each of the ASAM Criteria (2013), available as noted in Appendix A, domains
and that the client, counselor and licensed practitioner have jointly concluded
that:
a. The client requires continued
treatment at the current level of care; or
b. The client requires treatment at a higher
or lower level of care and the updated treatment plan reflects transition to
that level of care; and
(4) The signature of the client and the
counselor agreeing to the updated treatment plan, or if applicable,
documentation of the client's refusal to sign the treatment plan.
(j) In addition to the
individualized treatment planning in (d) above, all OTPs shall provide client
education on:
(1) Substance use
disorders;
(2) Relapse
prevention;
(3) Infectious diseases
associated with injection drug use, including but not limited to, HIV,
hepatitis, and TB;
(4) Sexually
transmitted diseases;
(5)
Emotional, physical, and sexual abuse;
(6) Nicotine use disorder and cessation
options;
(7) The impact of drug and
alcohol use during pregnancy, risks to the fetus, and the importance of
informing medical practitioners of drug and alcohol use during
pregnancy;
(8) Education around
neonatal abstinence syndrome (NAS) for pregnant women to include significant
others and/or care givers as appropriate;
(9) Working with family or significant
others;
(10) Living and coping
skills;
(11) Medication and drug
education;
(12) Dealing with a
positive drug screen;
(13)
Education, vocational training, employment, or any combination thereof;
and
(14) Education about acquired
immunodeficiency syndrome (AIDS) and human immunodeficiency virus (HIV)
.
(k) Based on the
client's treatment plan, methadone/buprenorphine maintenance treatment shall
include medication and clinical services as detailed in Table 304.01.
(l) The OTP shall maintain the client with a
dose adequate to alleviate all withdrawal symptoms;
(m) The OTP shall establish client dosing
based on individual need, as detailed in the client's treatment plan;
and
(n) The OTP shall provide
flexible dosage tapering at the client's request.
(o) Upon a client's compliance with required
treatment and counseling and the negative results for all drug screens
conducted, the required number of hours of counseling shall be reduced and the
allowed number of take-home doses shall be increased, in accordance with Table
304.01 below:
Table 304.1 Treatment, Counseling, and
Take-Home Schedule
|
Consecutive Days in Compliance with He-A 304.24(o)
|
Required Hours of Counseling per Month
|
Allowed days supply of Take-Home Doses per
Week
|
|
1-90
|
8
|
0
|
|
91-180
|
8
|
1
|
|
181-364
|
6
|
2
|
|
365-540
|
4
|
3
|
|
541-730
|
4
|
4
|
|
731-909
|
2
|
5
|
|
910+
|
1
|
6
|
(p)
For clients who are required to engage in 8 hours of counseling per month, the
OTP may reduce the number of hours by up to 4 hours if clinical staff determine
that such a reduction will not result in an increased risk assessment in any of
the ASAM Criteria (2013), available as noted in Appendix A,
dimensions.
(q) An OTP shall not
issue more than a 6-day supply of take-home doses to a client in one
week.
(r) Required substance use
disorder counseling shall be based on the client's individualized treatment
plan and be consistent with ASAM Criteria (2013), available as noted in
Appendix A, and SAMHSA's TIPS and TAPS standards, as applicable, and include,
at a minimum:
(1) Any combination of
individual, group, or family substance use disorder treatment
services;
(2) Case management
services, which may be substituted on an hour-for-hour basis for up to 25% of
the required counseling hours; and
(3) Discussion between clinical staff and the
client regarding the commencement of a methadone/buprenorphine discontinuance
plan, with projected target dates for implementation, which may:
a. Be short-term or long-term in nature based
on the client's need and preference; and
b. Include intermittent periods of
methadone/buprenorphine maintenance between discontinuance attempts.
(s) If the licensed
practitioner determines that split dosing is medically necessary, the OTP shall
request a split-dose exception on-line, using the SAMHSA OTP Exception Request
website at https://otp-extranet.samhsa.gov/login.aspx?ReturnUrl=%2f.
(t) Such requests shall include, as
appropriate:
(1) OTP identification
number;
(2) Patient identification
number;
(3) OTP name;
(4) OTP contact information;
(5) Requestor information;
(6) Patient admission date;
(7) Patient's current dosage;
(8) Medication type;
(9) Patient's attendance schedule;
(10) Employment status;
(11) Nature of the change request;
(12) Start date of the requested
change;
(13) End date of the
requested change;
(14) Number of
doses to be dispensed during the exception period;
(15) Justification for the change
request;
(16) Regulatory compliance
information; and
(17) Submitting
physician information and dated signature.
(u) The OTP shall provide group education and
counseling as follows:
(1) The OTP shall
maintain an outline of each educational and group therapy session provided;
and
(2) All group counseling
sessions shall be limited to 12 clients or fewer per counselor.
(v) All client activities and
services shall be documented in accordance with SAMHSA's "TAP 21: Addiction
Counseling Competencies" (2015 edition), available as noted in Appendix A, and
He-A
304.18.
