Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: This rule describes the specific functions,
policies, and practices required for certified opioid treatment
programs.
PUBLISHER'S NOTE: The secretary of state has
determined that the publication of the entire text of the material which is
incorporated by reference as a portion of this rule would be unduly cumbersome
or expensive. This material as incorporated by reference in this rule shall be
maintained by the agency at its headquarters and shall be made available to the
public for inspection and copying at no more than the actual cost of
reproduction. This note applies only to the reference material. The entire text
of the rule is printed here.
(1) Certification Requirements. Prior to
delivering services, the organization must be certified as an opioid treatment
program (OTP) by the department.
(A) The
program shall comply with applicable federal, state, and local laws and
regulations, including those under the jurisdiction of the U.S. Food and Drug
Administration (FDA), U.S. Drug Enforcement Administration (DEA), Department of
Health and Human Services, Substance Abuse and Mental Health Services
Administration (HHS/SAMHSA), and the Department of Health and Senior Services,
Bureau of Narcotics and Dangerous Drugs (DHSS/BNDD).
(B) The organization shall comply with 9 CSR
10-5 General Program Procedures, 9 CSR 10-7 Core Rules for Psychiatric and
Substance Use Disorder Treatment Programs, and 9 CSR 30-3 Substance Use
Disorder Prevention and Treatment Programs, as applicable.
(2) Medication Administration, Dispensing,
and Use. OTPs shall only utilize medications approved by the FDA for the
treatment of opioid use disorder.
(A) Opioid
agonist, partial agonist, and antagonist treatment medications shall be
administered and dispensed by a practitioner licensed in Missouri and
registered under the appropriate state and federal laws to administer or
dispense opioid drugs.
(B) Written
policies and procedures shall be maintained to ensure the following dosage form
and initial dosing requirements are met:
1.
Methadone is prescribed by a qualified prescriber, administered and dispensed
only in oral form, and formulated in a manner to reduce its potential for
parenteral abuse;
2. For newly
admitted individuals, the initial dose of methadone does not exceed thirty (30)
milligrams and the total dose for the first day does not exceed forty (40)
milligrams, unless the program physician documents in the individual record
that forty (40) milligrams did not suppress opioid abstinence symptoms;
and
3. Each opioid agonist
medication is administered and dispensed in accordance with its approved
product labeling. Dosing and administration decisions shall be made by a
qualified prescriber familiar with the most up-to-date product labeling. These
procedures must ensure any significant deviations from the approved labeling,
including deviations with regard to dose, frequency, or the conditions of use
described in the approved labeling, are specifically documented in the
individual record.
(C)
If a prescription drug monitoring program (PDMP) is available, the program
physician and other staff, as permitted, shall register and utilize the PDMP in
accordance with federal, state, and local regulations. Policies and procedures
shall be maintained regarding use of the PDMP information for diversion control
planning.
(D) Individuals admitted
to an OTP may be provided with naloxone or, if insured, a prescription for
naloxone.
(3) Program
Administration. The OTP shall have a program sponsor and a medical director.
(A) The program sponsor shall be responsible
for the general establishment, certification, accreditation, and operation of
the program, ensuring it is in continuous compliance with all federal, state,
and local laws and regulations related to the use of opioid agonist and partial
agonist treatment medications in the treatment of opioid use
disorder.
(B) The medical director
must be a physician licensed in Missouri and is responsible for overseeing all
medical services provided by the OTP, performing them directly or by delegating
specific responsibilities to an authorized program physician and healthcare
professionals functioning under his/her direct supervision. The medical
director shall ensure all medical, psychiatric, nursing, pharmacy, toxicology,
and other services offered by the OTP are conducted in compliance with federal,
state, and local regulations at all times. Other responsibilities of the
medical director include, but are not limited to:
1. Ensuring individuals meet admission
criteria and receive the required physical examination(s) and laboratory
testing;
2. Prescribing methadone
and other FDA-approved medications with the individual's input, ensuring the
prescribed dosage of medication is appropriate to his/her needs;
3. Reviewing and signing each individual's
initial treatment plan and reviewing and updating the plan based on his/her
needs; and
4. Coordinating care and
consulting with each individual's clinical treatment team on a regular
basis.
(4)
Service Delivery Requirements. A range of treatment and rehabilitation services
shall be provided to address the therapeutic needs of persons served. All
medications approved by the FDA for treatment of opioid use disorder shall be
available to meet individual needs.
(A) At a
minimum, the following services as defined in 9 CSR 303.110 or as specified in
another regulation, must be available to all individuals based on needs and
treatment goals:
1. Communicable disease
counseling;
2. Community
support;
3. Continuing recovery and
discharge planning, as defined in
9 CSR
10-7.030(8);
4. Crisis prevention and
intervention;
5. Drug
testing;
6. Family
conference;
7. Family
therapy;
8. Group counseling,
including trauma and co-occurring disorders;
9. Group rehabilitative support;
10. Individual counseling, including trauma
and co-occurring disorders;
11.
Medication services;
12. Medication
services support; and
13. Medical
evaluations, as specified in this rule.
(B) The services must be available at the
OTP's primary location or through a documented collaborative referral
arrangement with another qualified service provider. Services shall be offered
at least six (6) days per week. Medical and psychosocial services shall be
available during the early morning and/or evening to ensure individuals have
access to services.
(C) All medical
services shall be offered and occur simultaneously with clinical therapy,
education, development of positive social supports, and ongoing treatment and
rehabilitation for substance use disorders and related life problems.
(D) OTPs shall directly provide, or make
available through referral to adequate and reasonably accessible community
resources, other support services including, but not limited to,
rehabilitation, education, and employment for individuals who request such
services or have been determined by program staff to be in need of these
services.
(E) Information and
education shall be provided in areas such as community resources, substance use
disorders, and behavioral health disorders.
(F) Services may be provided via telehealth
to enhance accessibility for individuals served.
(5) Admission Criteria. Individuals shall be
admitted to maintenance treatment by qualified staff who use accepted medical
criteria, such as those listed in the Diagnostic and Statistical Manual for
Mental Disorders (DSM-5), 2013, to determine the person is currently addicted
to an opioid drug and he/she became addicted at least one (1) year before
admission for treatment. The DSM-5 is hereby incorporated by reference and made
a part of this rule, as published by the American Psychiatric Association, 1000
Wilson Boulevard, Suite 1825, Arlington VA 22209-3901. This rule does not
incorporate any subsequent amendments or additions to this publication.
(A) The program physician shall ensure each
individual voluntarily chooses maintenance treatment, all relevant facts
concerning the use of the opioid drug are clearly and adequately explained to
him/her, and each individual provides informed, written consent to
treatment.
(B) Documentation in the
individual record must indicate clinical signs and symptoms of opioid use
disorder.
(C) Decisions regarding
the most appropriate medication shall be individualized, based on personal
needs and goals, throughout the individual's engagement in treatment.
(D) If clinically appropriate, the program
physician may waive the requirement of a one- (1-) year history of addiction
for-
1. Women who are pregnant;
2. Individuals released from a correctional
facility with a documented history of opioid use disorder, within six (6)
months after release; and
3.
Individuals who have been previously treated, up to two (2) years after
discharge.
(E)
Individuals under the age of eighteen (18) are required to have had two (2)
documented unsuccessful attempts at short-term medical withdrawal
(detoxification) or drug-free treatment within a twelve-(12-) month period to
be eligible for methadone maintenance treatment.
1. Individuals under the age of eighteen (18)
shall not be admitted to maintenance treatment unless a parent/guardian or
responsible adult designated by the relevant state authority consents in
writing to such treatment. This requirement is applicable to methadone and does
not pertain to buprenorphine.
(6) Admission for Priority Populations. OTPs
that have a contract with the department shall ensure priority admission for-
(A) Women who are pregnant and use
intravenous drugs;
(B) Women who
are pregnant or postpartum, up to one (1) year after delivery;
(C) Individuals who use intravenous
drugs;
(D) Women who have children
and are at risk of losing custody or are attempting to regain
custody;
(E) Individuals who test
positive for the human immunodeficiency virus (HIV);
(F) Individuals determined to be high risk
and are referred for treatment by Department of Corrections' institutions and
the Division of Probation and Parole via the designated referral form and
protocol, as well as individuals referred from federal correctional
institutions; and
(G) Individuals
who are applying for or receiving Temporary Assistance for Needy Families
(TANF) and are referred for treatment by the Department of Social Services,
Family Support Division, via the designated electronic referral process and
protocol.
1. Women who are pregnant shall
receive immediate admission.
2.
High-risk referrals from correctional institutions and probation and parole
shall be assessed and admitted within five (5) working days of initial contact
or scheduled release date, including weekends and holidays.
3. If the OTP is unable to assess and admit
an individual who uses intravenous drugs within forty-eight (48) hours of
receiving such a request, interim services shall be available in accordance
with department contract requirements.
(H) Interim maintenance treatment, as defined
in section (16) of this rule, shall be available for individuals who are
eligible for treatment but cannot be immediately admitted to the OTP where
services are being sought or through referral arrangements with another
OTP.
(I) Individuals seeking
treatment who are participants in the MO HealthNet program and do not meet
priority population criteria shall be given an appointment in a timely manner
and shall not be placed on a wait list.
(7) Admission Protocol. Prior to admission,
staff shall verify and document the individual seeking services is not
currently enrolled in another opioid treatment program utilizing a central
registry, if available, or other client enrollment/admission database, such as
the department's Customer Information, Management, Outcomes, and Reporting
(CIMOR) system, for verification purposes.
(A)
An individual currently enrolled in an OTP shall not be permitted to obtain
treatment in any other OTP except in exceptional circumstances.
1. If the medical director or program
physician of the OTP where the individual is currently enrolled determines
exceptional circumstances exist, the individual may be granted permission to
seek treatment at another OTP. Justification for the exceptional circumstances
must be included in the individual record at both program locations.
(B) Each individual shall undergo
a complete and fully documented physical evaluation prior to admission by a
program physician, primary care physician, or authorized healthcare
professional working under the supervision of a program physician. The full
physical examination, including the results of serology and other tests, must
be completed within fourteen (14) days following admission.
1. Women should have a pregnancy test as
deemed clinically appropriate.
(C) Screening shall determine the risk of
undiagnosed conditions such as hepatitis C, HIV, sexually transmitted
infections, cardiopulmonary disease, and sleep apnea to determine if further
diagnostic testing such as laboratory analysis, a cardiogram, or others are
needed.
1. Positive screening results or
disease risks should have a care coordination plan that is seen through to
completion, regardless of whether this is accomplished via services provided
directly by the OTP or through referral to another provider.
(D) A complete medical history,
physical examination, and laboratory testing shall not be required for an
individual who has had such medical evaluation within the prior thirty (30)
days. The program shall have documentation of the medical evaluation and any
significant findings in the individual record.
(8) Pregnant and Postpartum Women. Written
policies and procedures shall be maintained and implemented to address the
needs of women who are pregnant and postpartum. Prenatal care and other
gender-specific services for women who are pregnant must be provided by the OTP
or by referral to an appropriate healthcare provider.
(A) For pregnant women who are receiving
methadone or buprenorphine, the program shall have written policies and
procedures in place to ensure-
1. The initial
dose of medication for a newly admitted woman who is pregnant, and the
subsequent induction and maintenance dosing strategy, reflect the same
effective dosing protocols used for all other individuals;
2. The methadone dose is carefully monitored,
especially during the third (3rd) trimester when pregnancy induces changes such
as the rate at which methadone is metabolized or eliminated from the system,
potentially necessitating either an increased or a split dose; and
3. Women who become pregnant during treatment
are maintained at their pre-pregnancy dosage, if effective, and are managed
with the same dosing principles used with women who are not pregnant.
(B) Women who are pregnant are
eligible to receive ongoing maintenance treatment up to one (1) year
post-partum, including evaluation of their current dose to determine if an
adjustment is needed during the postpartum period. Women shall be offered
education about signs and symptoms of oversedation which may occur after
delivery.
(C) Medically supervised
withdrawal after pregnancy shall occur as clinically indicated and documented,
or is requested by the individual.
(D) When a planned discharge occurs, OTP
staff shall document the contact information of the physician or other
authorized healthcare professional to whom the individual has been referred,
including the reason for discharge.
(E) Mothers shall be educated about neonatal
abstinence syndrome, its symptoms, potential effects on their infant, and need
for treatment if it occurs.
(9) Safety and Health. The program shall
implement written policies, procedures, and practices which ensure access to
services and address the safety and health of individuals served. The provider
shall-
(A) Ensure continued opioid treatment
for individuals in the event of an emergency, pandemic, or natural disaster by
cooperating with other OTPs, including those in surrounding states, to develop
and maintain medication dosing arrangements;
(B) Utilize a central registry, if available,
or other client enrollment/admission system such as the department's CIMOR
system, to coordinate services;
(C)
Ensure treatment to persons regardless of serostatus, HIV-related conditions,
tuberculosis (TB), or hepatitis C;
(D) Provide information and education to
individuals on prevention and transmission of HIV-related conditions;
(E) Provide or arrange HIV testing and pre-
and post-test counseling for individuals;
(F) Provide or arrange testing for TB,
hepatitis C, and sexually transmitted infections upon admission and at least
annually thereafter;
(G) Provide
medical evaluations to individuals upon admission and at least annually
thereafter, including cardiac risk assessment;
(H) Utilize infection control procedures in
accordance with federal, state, and local regulations; and
(I) Arrange medical care for women during
pregnancy, if necessary, and document the arrangements made and action taken by
the individual.
(10)
Staff Training. All direct service staff and medical staff shall complete four
(4) clock hours of training relevant to service delivery in an opioid treatment
setting during a two- (2-) year period. This training applies to the required
thirty-six (36) clock hours of training during a two- (2-) year period
specified in 9 CSR
10-7.110(2)(F) 1.
(11) Testing and Screening for Drug Use. The
program shall use drug testing as a as a clinical tool for purposes such as
diagnosis and treatment planning.
(A) Each
individual shall have an initial toxicology test as part of the admission
process. At a minimum, admission samples shall be analyzed for opiates,
methadone, marijuana, cocaine, barbiturates, benzodiazepines, buprenorphine,
amphetamines, fentanyl, and alcohol.
(B) If there is a history of misuse of
prescription opioid analgesics, an expanded toxicology panel that includes
these opioids shall be administered. Additional testing shall be based on
individual needs and local drug use patterns and trends.
(C) Random drug testing of each individual in
maintenance treatment shall be conducted at least eight (8) times during a
twelve-(12-) month period.
(D)
Individuals engaged in long-term detoxification treatment (medical withdrawal)
shall receive an initial drug test and a monthly random test.
(E) Individuals engaged in short-term
detoxification treatment (medical withdrawal) shall have at least one (1)
initial drug test.
(12)
Unsupervised Approved Use (Take-Home) of Medication. The medical director shall
ensure policies and procedures for approval of take-home methadone do not
create barriers to individuals in maintenance treatment. The dispensing
restrictions set forth in this section of this rule do not apply to
buprenorphine and buprenorphine products.
(A)
Any individual in comprehensive maintenance treatment may receive a single
take-home dose of methadone for a day the program is closed for business,
including Sundays and state and federal holidays.
(B) Decisions on dispensing methadone to
individuals for unsupervised use, beyond that set forth in this rule, shall be
determined by the medical director. In determining which individuals may be
approved for unsupervised use, the medical director shall consider the
following:
1. Absence of recent misuse of
drugs (opioid or non-narcotic), including alcohol;
2. Regularity of program
attendance;
3. Absence of serious
behavioral issues at the program;
4. Absence of known recent involvement in the
justice system, such as drug dealing;
5. Stability of the individual's home
environment and social relationships;
6. Length of time in comprehensive
maintenance treatment;
7. Assurance
that take-home medication can be safely stored within the individual's home;
and
8. Whether the rehabilitative
benefit the individual derives from decreasing the frequency of program
attendance outweighs the potential risks of diversion.
(C) Determinations for unsupervised use of
methadone and the basis for such determinations, consistent with the criteria
outlined in paragraphs (12)(B)1. to 8. of this rule, shall be documented in the
individual record.
(D) Take-home
doses dispensed to individuals beyond that specified in subsection (12)(A) of
this rule, shall be subject to the following:
1. During the first ninety (90) days of
treatment, the take-home supply is limited to one (1) dose each week and the
individual must ingest all other doses under appropriate supervision at the
program;
2. In the second ninety
(90) days of treatment, the take-home supply is limited to two (2) doses per
week;
3. In the third ninety (90)
days of treatment, the take-home supply is limited to three (3) doses per
week;
4. In the remaining months of
the first year of treatment, the individual is limited to a maximum six- (6-)
day supply of take-home medication;
5. After one (1) year of continuous
treatment, the individual may receive a maximum two- (2-) week supply of
take-home medication; and
6. After
two (2) years of continuous treatment, the individual may receive a maximum
one- (1-) month supply of take-home medication and he/she must make monthly
visits to the program.
(E) Individuals in short-term detoxification
treatment or interim maintenance treatment shall not receive methadone for
unsupervised or take-home use.
(F)
OTPs must implement written procedures to identify theft or diversion of
take-home medications, including labeling containers with the OTP's name,
address, and telephone number. Programs must also ensure take-home supplies are
packaged in a manner designed to reduce the risk of accidental ingestion,
including use of child-proof containers.
(G) Program staff shall educate individuals
about safe transportation and storage of methadone, as well as emergency
procedures in case of accidental ingestion.
(H) Individuals approved for take-home doses
of methadone must have a lock box for safe transportation and home
storage.
(I) OTPs shall implement
written policies and procedures that address the responsibilities of
individuals who are approved for takehome doses of methadone, including methods
to assure appropriate use and storage of the medication.
(J) Staff shall regularly monitor each
individual's use of takehome medication to ensure security of the medication
and prevent diversion. When determined necessary, the medical director and
staff may review an individual's unsupervised use and may deny or rescind
take-home privileges. Such action shall be documented in the individual record,
including the rationale for denial or rescission of unsupervised use.
(K) The time in treatment requirements
outlined in paragraphs (12)(D)1. to 6. of this rule are minimum reference
points after which an individual may be considered for take-home medication
privileges. The time references do not mean an individual in treatment for a
particular time has a specific right for approval of take-home
medication.
(L) Any deviation from
the regulations for unsupervised use of methadone as specified in this rule
requires prior approval from the state opioid treatment authority (SOTA), or
his/her designee, and/or SAMHSA.
1. The
Exception Request and Record of Justification form SMA-168 must be submitted to
the SOTA/designee and/or SAMHSA as specified in section (24) of this rule.
Justification for an exception may include, but is not limited to,
transportation hardships, employment, vacation, medical or family emergencies,
or other unexpected circumstances.
(13) Guest Medication. Individuals who
travel, but do not meet the criteria for take-home medication as specified in
section (12) of this rule, should be considered for guest medication in
accordance with the 2020 Guidelines for Guest Medications hereby incorporated
by reference and made a part of this rule, as published by the American
Association for the Treatment of Opioid Dependence, 225 Varick St., Suite 402,
New York, NY 10014, (212) 566-5555. This rule does not incorporate any
subsequent amendments or additions to this publication.
(A) Guest medication provides a mechanism for
individuals to travel from their home program for business, pleasure, or family
emergencies. It also provides an option for individuals who need to travel for
a period of time that exceeds the amount of eligible takehome doses to do so
within regulatory requirements.
(B)
Individuals shall be on a stable dose of methadone and not be scheduled for a
dose increase or decrease during guest medication.
(C) Individuals approved for guest medication
must be medically and psychiatrically stable.
(14) Continuity of Care. The program shall
implement written policies and procedures to address continuity of care for
individuals who are unable to participate in regularly scheduled visits for
observed ingestion of medication due to illness, pregnancy, participation in
residential treatment, incarceration, lack of transportation, or other
situations.
(A) A chain-of-custody process
shall be implemented to document the transportation, delivery, administration,
and observation of medication when an individual is unable to report to the
program as required.
(15) Diversion Control. OTPs shall maintain
and implement a written diversion control plan as part of its performance
improvement process. The plan shall contain specific measures to reduce the
possibility of diversion of controlled substances from legitimate treatment
use. Medical and administrative staff of the program shall be assigned to
implement the diversion control measures and functions described in the
diversion control plan.
(16)
Interim Maintenance Treatment. The program sponsor of a public or private OTP
may place an individual who is eligible for admission to comprehensive
maintenance treatment into interim maintenance treatment, if he/she cannot be
placed in a public or nonprofit private comprehensive OTP within a reasonable
geographic area within fourteen (14) days of the individual's application for
admission to comprehensive maintenance treatment.
(A) An initial and at least two (2) other
urine screens shall be taken from an individual engaged in interim treatment
during the maximum one hundred twenty (120) days permitted for such
treatment.
(B) The OTP shall
maintain and implement written policies and procedures for transferring
individuals from interim maintenance to comprehensive maintenance treatment.
1. The transfer criteria shall include, at a
minimum, a preference for admitting women who are pregnant into interim
maintenance treatment and criteria for transferring individuals from interim
maintenance to comprehensive maintenance treatment.
(C) Interim maintenance treatment shall be
provided in a manner consistent with all applicable federal and state laws,
including sections 1923, 1927(a), and 1976 of the Public Health Service Act (
21 U.S.C. 300x-23, 300x-27(a), and 300y-11).
(D) The program shall notify the SOTA when an
individual begins interim maintenance treatment, when he/she leaves interim
maintenance treatment, and before the date of mandatory transfer to
comprehensive maintenance treatment, documenting all notifications in the
individual record.
(E) SAMHSA may
revoke the interim maintenance authorization for a program that fails to comply
with the provisions of this section of this rule.
(F) SAMHSA will consider revoking the interim
maintenance authorization of a program if the state in which the program
operates is not in compliance with the provisions of
42 CFR section
8.11(g).
(G) All requirements for comprehensive
maintenance treatment apply to interim maintenance treatment with the following
exceptions:
1. The opioid agonist treatment
medication is required to be administered daily under observation;
2. Unsupervised (take-home) use is not
allowed;
3. An initial treatment
plan and periodic treatment plan reviews are not required;
4. A primary counselor is not required to be
assigned to the individual;
5.
Interim maintenance treatment shall not be provided for longer than one hundred
twenty (120) days in any twelve- (12-) month period; and
6. The rehabilitative, educational, and other
counseling services specified in section (4) of this rule are not required to
be provided to the individual.
(17) Medically Supervised Withdrawal. The
program shall maintain and implement written policies and procedures to ensure
individuals are admitted to short- or long-term detoxification treatment (as
defined in
42
CFR section 8.2.) by qualified staff, such as
the program physician, who determines such treatment is appropriate by applying
established diagnostic criteria. Medically supervised withdrawal may be
voluntary or involuntary, as specified in sections (18) and (20) of this rule.
(A) The individual's treatment plan and
continuing recovery plan shall include a strategy to transition to another form
of medication, if needed. Review of the risks and benefits of withdrawal from
maintenance therapy shall be provided, and informed written consent shall be
obtained from individuals who voluntarily choose this treatment
option.
(B) Individuals shall be
educated about the risks of a recurrence of symptoms and potential for fatal
overdose following medically supervised withdrawal, and be offered relapse
prevention services that includes counseling, naloxone, and opioid antagonist
therapy.
(C) OTPs shall offer a
variety of supportive options as part of the transition from opioid agonist
therapy, such as increased counseling sessions prior to discharge, and
individuals shall be encouraged to attend a twelve- (12-) step or other
mutual-help program sensitive to the needs of individuals receiving treatment
with medication.
(D) Individuals
with two (2) or more unsuccessful detoxification episodes within a twelve-
(12-) month period must be assessed by the program physician for other forms of
treatment. A program shall not admit an individual for more than two (2)
detoxification episodes in one (1) year.
(18) Voluntary Medically Supervised
Withdrawal. Voluntary medically supervised withdrawal may be initiated by the
person served or the program physician in collaboration with the individual as
part of individualized treatment planning.
(A) As deemed clinically appropriate, women
shall have a pregnancy test and the results reviewed prior to initiation of
medically supervised withdrawal.
(B) For women who are pregnant, the physician
shall not initiate withdrawal before fourteen (14) weeks or after thirty-two
(32) weeks of pregnancy.
(C) If an
individual experiences intolerable withdrawal symptoms or actual or potential
return to use, the physician shall consider stopping the withdrawal process and
restoring the individual to a previously effective dose. In collaboration with
the individual served, the physician shall determine if an additional period of
maintenance is necessary before further medically supervised withdrawal is
attempted.
(D) Regardless of
whether medically supervised withdrawal is conducted with or against medical
advice (AMA), careful review of the risks and benefits of withdrawal from
maintenance treatment must be provided to the individual and informed written
consent obtained from those who choose to initiate medically supervised
withdrawal.
(19)
Withdrawal Against Medical Advice (AMA). Individuals who request voluntary
medically supervised withdrawal from medication treatment AMA of the physician
or program staff, may receive it. Individuals have the right to leave treatment
when they choose to do so.
(A) The same
services that are available to individuals engaged in voluntary medically
supervised withdrawal shall be offered to individuals choosing medically
supervised withdrawal AMA.
(B) The
program must fully document the issue(s) that caused the individual to seek
discharge, steps taken to avoid discharge, and the circumstances of
readmission, as applicable.
(C) In
the case of a woman who is pregnant, the program must keep the physician or
agency providing prenatal care informed, consistent with the privacy standards
of 42 CFR section 2.
(20) Involuntary Withdrawal from Treatment
(Administrative Withdrawal). Individuals shall be retained in treatment for as
long as they can benefit from it and express a desire to continue treatment.
Administrative withdrawal is typically involuntary and shall be used only when
all other therapeutic options have been exhausted by program staff. OTPs may
refer or transfer individuals to a suitable alterative treatment program, as
clinically indicated.
(A) Missing scheduled
appointments and/or continued drug use shall not be the sole reason for
initiating involuntary withdrawal for an individual being served.
(B) If involuntary withdrawal is initiated
for an individual, the program shall follow the criteria included in the
January, 2015 Federal Guidelines for Opioid Treatment Programs incorporated by
reference and made a part of this rule as published by SAMHSA, Center for
Substance Abuse Treatment, 1 Choke Cherry Rd., Rockville MD 20857, (877)
726-4727, publication number (SMA) PEP15-FEDGUIDEOTP. This rule does not
incorporate any subsequent amendments or additions to this
publication.
(21)
Medication Storage and Security. The program shall ensure the security of its
medication supply and shall account for all medications kept on site at all
times.
(A) The program shall meet the
requirements of the DEA and BNDD.
(B) The program shall maintain an acceptable
security system, and the system shall be checked on a quarterly basis to ensure
continued safe operation.
(C) The
program shall physically separate the narcotic storage and dispensing area from
other parts of the facility used by individuals.
(D) The program shall implement written
policies and procedures to ensure positive identification of all individuals
before any medication is administered. Verification shall include a minimum of
two (2) forms of identification.
(E) The program shall implement written
policies and procedures for recording each individual's medication intake and
maintaining a daily medication inventory.
(22) Medication Units. Certified OTPs may
establish medication units that are authorized to dispense opioid agonist
treatment medications for observed ingestion. Services provided at the
medication unit must comply with
42 CFR section
8.12.
(A)
Prior to establishing a medication unit, the OTP must notify and receive prior
approval from the SOTA/designee and SAMHSA by submitting form SMA-162. The
required documents include, but are not limited to:
1. A description of how the medication unit
will receive its medication supply;
2. An affirmative statement that the
medication unit is limited to administering and dispensing the narcotic
treatment drug and collecting samples for drug testing or analysis;
3. An affirmative statement that the program
sponsor agrees to retain responsibility for individual treatment and
care;
4. A diagram and description
of the facility to be used as a medication unit;
5. Total number of individuals to be served
by the primary OTP and medication unit;
6. Total number of individuals that will be
served only at the medication unit;
7. A justification for the need to establish
a medication unit; and
8. The name
and address of any other active medication unit(s) attached to the primary
OTP.
(B) A DEA
inspection and approval must be obtained prior to opening a medication unit. A
medication unit must have a separate and unique DEA registration.
(C) The OTP must comply with the provisions
of 21 CFR part 1300 prior to establishing a mediation unit.
(D) Medication units are not required to be
free-standing entities and may be located at a hospital or community pharmacy,
for example.
(E) The certified OTP
shall be responsible for all operations of an approved medication
unit.
(23) Mobile Units.
A mobile unit, for the purpose of dispensing opioid agonist treatment
medications to individuals for observed ingestion, may be established if
approval is granted by the DEA allowing such units to be considered a
coincidental activity of the registered OTP. OTPs shall follow all federal,
state, and local regulations regarding the operation of a mobile
unit.
(24) Exception Requests and
Records of Justification. Any deviation from these regulations requires prior
approval from the SOTA/designee and/or SAMHSA. Requests must be submitted on
the Exception Request and Record of Justification form (SMA-168), SAMHSA, 5600
Fishers Ln., Rockville, MD 20857, (240) 2762710.
(A) OTPs shall follow department requirements
for submitting form SMA-168 to the SOTA/designee and or/SAMHSA. Failure to
submit the completed form and obtain prior approval from the SOTA/designee
and/or SAMHSA constitutes a regulatory violation which may jeopardize the OTP's
accreditation and certification status.
(B) SAMHSA and the SOTA/designee must be
notified of any change to the OTP sponsor or medical director within three (3)
weeks of the change by submitting SAMHSA form SMA-162 in accordance with
established procedures.
*Original authority: 630.655, RSMo 1980 and 631.102, RSMo
1997.
