TITLE 8 SOCIAL
SERVICES
CHAPTER 321 SPECIALIZED
BEHAVIORAL HEALTH SERVICES
PART 10 OPIOID TREATMENT PROGRAMS
8.321.10.1 ISSUING
AGENCY: New Mexico Health Care Authority.
[8.321.10.1 NMAC - N, 7/1/2024]
8.321.10.2 SCOPE: This rule is applicable to
opioid treatment programs. These
regulations are not intended to preempt county or municipal ordinances that
supplement and do not conflict with these regulations. County and municipal ordinances are preempted
when they conflict with these regulations.
[8.321.10.2 NMAC - N, 7/1/2024]
8.321.10.3 STATUTORY
AUTHORITY: Section 9-8-1 et seq. NMSA 1978 establishes
the health care authority (authority) as a single, unified department to
administer laws and exercise functions relating to health care facility
licensure and health care purchasing and regulation.
[8.321.10.3 NMAC - N, 7/1/2024]
8.321.10.4 DURATION: Permanent.
[8.321.10.4 NMAC - N, 7/1/2024]
8.321.10.5 EFFECTIVE
DATE: July 1, 2024, unless a later
date is cited at the end of a section.
[8.321.10.5 NMAC - N, 7/1/2024]
8.321.10.6 OBJECTIVE: This rule establishes standards
for opioid treatment programs to be consistent with the SAMHSA/CSAT regulations
and the OTP accreditation requirements of nationally recognized accreditation
bodies approved by SAMSA/CSAT, such as CARF and JCAHO. The intent is to:
A. be consistent with, and
complimentary to, the substance abuse and mental health services
administration/center for substance abuse treatment (SAMHSA/CSAT) regulations,
and the OTP accreditation requirements of nationally recognized accreditation
bodies approved by SAMHSA/CSAT, such as commission on accreditation of
rehabilitation facilities (CARF) and the joint commission on accreditation of
healthcare organizations (JCAHO);
B. reduce the stigma sometimes
associated with opioid dependency treatment and ensure access to it comparable
to treatment availability for other chronic medical conditions;
C. consider the possible adverse impact
on communities in which OTP providers are located in making application
approval decisions, and to provide measures to promote mutually satisfactory
relationships between OTP providers and their communities.
[8.321.10.6 NMAC - N, 7/1/2024]
8.321.10.7 DEFINITIONS:
A. “Accrediting bodies” means
nationally recognized organizations, such as the joint commission on
accreditation of healthcare organizations (JCAHO) and the commission on
accreditation of rehabilitation facilities (CARF), which promulgate standards
for OTPs that are approved by the substance abuse and mental health services
administration/center for substance abuse treatment (SAMHSA/CSAT), and offer
accreditation to programs that meet these standards.
B. “Administrative withdrawal”
means the procedure for withdrawal of a patient’s opioid treatment medication
coinciding with the patient’s involuntary discharge from opioid treatment,
typically resulting from non-payment of fees, violent or disruptive behavior or
incarceration or other confinement.
C. “Application form”
means the form created by the health care authority, which must be completed by
a program sponsor who wishes to obtain approval to operate an opioid treatment
program.
D. “Approval” and “approval to operate” means the written permission
given by the health care authority to a program sponsor to operate an opioid
treatment program.
E. “Behavioral health services division” (BHSD) is the division of the New
Mexico health care authority that is the single state authority for mental
health and substance use treatment and prevention programs and methadone
authority.
F. “Comprehensive initial
assessment” means the collection and analysis of a patient’s social,
medical, psychological and treatment history.
G. “Comprehensive maintenance treatment”
means a program designed with the intention of lasting longer than six months,
for the purpose of maintaining the patient such that they will be free of
opioid withdrawal and cravings; such programs are typified by:
(1) dispensing or administering an opioid
treatment medication at stable dosage levels for a period in excess of 21 days
to an individual for opioid addiction; and
(2) providing medical, therapeutic and
supportive services to the individual with opioid dependence.
H. “Dispense” has the same meaning as
in Subsection I of Section 61-11-2 NMSA 1978 as amended or renumbered.
I. “Diversion” means
the unauthorized transfer of an opioid agonist treatment medication, such as a
street sale.
J. “Dosage” means the
amount, frequency and number of doses of medication for an individual.
K. “Dose” means a single unit of
opioid treatment medication.
L. “Illicit opioid drug” means an
illegally obtained opioid drug, such as heroin, that causes dependence and
reduces or destroys an individual’s physical, social, occupational, or
educational functioning, or misuse of legally prescribed medication.
M. “Intake screening” means
determining whether an individual meets the initial criteria for receiving
opioid treatment.
N. “Long-term opioid treatment withdrawal
procedure” means a treatment program designed to dispense opioid
treatment medication to a patient in decreasing doses, after first possibly
achieving a stable dose, for a period of more than 30 days but less than 180
days as a method of bringing the individual to a drug-free state.
O. “Medical practitioner” means an
individual who:
(1) has been accredited through
appropriate national procedures as a health professional;
(2) fulfills the national requirements on
training and experience for prescribing procedures;
(3) is a registrant or a licensee, or a
worker who has been designated by a registered or licensed employer for the
purpose of prescribing procedures;
(4) may be a physician, physician’s
assistant, registered nurse, nurse practitioner, or licensed practical nurse.
P. “Opioid treatment” means:
(1) opioid treatment withdrawal
procedure/treatment; and
(2) comprehensive maintenance treatment.
Q. “Opioid treatment medication” means
a prescription medication that is approved by the U.S. food and drug
administration under 21 U.S.C. section 355 and by the code of federal
regulations title 42, part 8.12 for use in the treatment of opiate addiction.
R. “Opioid treatment program” (OTP)
means a single location at which opioid dependence treatment medication, such
as methadone and rehabilitative services, are provided to patients as a
substantial part of the activity conducted on the premises.
S. “Opioid treatment withdrawal procedure” is
dispensing or administering an opioid dependence treatment medication in
decreasing medication levels to an individual to alleviate adverse physical or
psychological effects of withdrawal from the continuous or sustained use of an
opioid drug and as a method of bringing the individual to a drug-free state.
T. “Physiologically dependent” means
physically addicted to an opioid drug, as manifested by the symptoms of
withdrawal in the absence of the opioid drug.
U. “Program clinician” means a
behavioral health clinician practicing at an opioid treatment program who is
licensed to practice substance abuse treatment in New Mexico
V. “Program medical director” means
a physician licensed to practice medicine in New Mexico, who assumes
responsibility for administering all medical services, either by performing
them directly or by delegating specific responsibility to authorized program
medical practitioners functioning under the medical director’s direct
supervision.
W. “Program sponsor” means the person
named in the application as responsible for the operation of the opioid
treatment program and who assumes responsibility directly, by personal
oversight, or through policy and procedure, or a combination of both, for the
acts and omissions of staff members or employees of the opioid treatment
program.
X. “Short-term
opioid treatment withdrawal procedure” means a treatment program designed to dispense opioid treatment
medication to a patient in decreasing doses, over a continuous period of 30
days or less, as a method of bringing the individual to a drug-free state.
Y. “State methadone authority,” (SMA) means
the single state agency for substance abuse designated by the governor or
another appropriate official designated by the governor to exercise authority
within the state for governing treatment of opiate addiction with an opioid
drug. In New Mexico it is the health
care authority, behavioral health services division.
Z. “Take-home medication” means one or
more doses of an opioid treatment medication dispensed to a patient for use off
the premises.
[8.321.10.7 NMAC - N, 7/1/2024]
8.321.10.8 Approval to Operate an Opioid Treatment Program Required: Providers who receive written
approval by the health care authority, shall be permitted to provide opioid
dependency treatment services.
[8.321.10.8 NMAC - N, 7/1/2024]
8.321.10.9 Eligibility
for Approval to Operate an Opioid Treatment Program:
Only applicants who possess all of
the following shall be eligible to receive approval to operate from the New
Mexico health care authority (HCA):
A. drug enforcement agency (DEA)
approval to operate an OTP;
B. SAMHSA/CSAT approval to operate an
OTP;
C. accreditation by a
SAMHSA/CSAT-approved nationally recognized accreditation body, such as JCAHO or
CARF, to operate an OTP:
(1) if the applicant is a start-up
program unable to obtain such accreditation prior to beginning operation
because the accreditation body requires a period of program operation,
typically six months, before it will grant accreditation:
(a) the HCA shall grant provisional
approval to operate pending accreditation, provided that all other requirements
of these regulations are met; and
(b) the program demonstrates in its
application to the HCA that it is taking the steps necessary to become
accredited as quickly as possible, and provides a timeline for the anticipated
accreditation;
(2) during this interim period, the
provisional approval to operate is contingent on the ongoing progress of the
program, as determined by the HCA, to obtain accreditation within the timeline
contained in the application; the program shall immediately inform the HCA of
anything that will delay or prevent accreditation according to that timeline;
(3) the HCA shall withdraw its
provisional approval if it concludes that accreditation will not be
forthcoming; in any event, the program shall obtain accreditation within 12
months of beginning operation, or the provisional approval shall be withdrawn,
unless the HCA elects to extend the provisional approval period after
consultation with the appropriate federal and accrediting entities.
D. a license from the New Mexico state
board of pharmacy to operate an OTP;
E. other permits and licenses such as a
business license from the applicant’s local governmental entity, as required by
local ordinances;
F. evidence of appropriate liability
insurance coverage for the program and its employees.
[8.321.10.9 NMAC - N, 7/1/2024]
8.321.10.10 Application
for Approval to Operate an Opioid Treatment Program:
A. Each OTP sponsor applicant shall
submit to the HCA an application for approval to operate an opioid treatment
program application using the form provided by the HCA. This application shall be in addition to the
application to drug enforcement agency, SAMHSA/CSAT, the NM board of pharmacy,
local government, etc.
B. The HCA shall approve or deny the
application within 45 working days of submission, unless the HCA and applicant
mutually agree to extend the application review period.
C. The HCA may require the applicant to
provide additional written or verbal information in order to reach its decision
to grant or deny approval. Such further
information shall be considered an integral part of the application.
D. Approval shall be for a duration of three
years, except as otherwise provided below for initial grandfathered approvals.
E. The HCA shall not grant approval to
operate an OTP to any program sponsor who has been convicted of any crime
related to controlled substances laws or any felony within the last five years.
No person who has been convicted of any
felony in the last five years shall be employed by the OTP in any capacity that
gives that person access to controlled medications.
F. The HCA shall not grant approval to
any entity that poses a risk to the health and safety of the public based on a
history of noncompliance with state and federal regulations as verified by the
DEA, New Mexico state board of pharmacy, FDA, SAMSHA approved accreditation
bodies, or the state licensure agency in any state in which the program sponsor
currently operates.
G. The HCA may deny approval if there
is a documented history of repeated and serious negative neighborhood impact
with respect to other OTP programs currently operated by the program sponsor or
by any corporation, LLC or partnership with whom the program sponsor has been
associated in the past five years.
H. As a condition of approval to
operate an OTP, the OTP must maintain or obtain accreditation with a
SAMHSA/CSAT-approved nationally recognized accreditation body, (e.g. CARF or
JCAHO.) In the event that such accreditation
lapses, or approval of an application for accreditation becomes doubtful, or
continued accreditation is subject to any formal or informal finding of need
for improvement, the OTP program will notify the HCA within two business days
of such event. The OTP program will
furnish the HCA with all information related to its accreditation status, or
the status of its application for accreditation, upon request.
I. The application for approval shall
be accompanied by a needs assessment, specifying the proposed geographical area
to be served, estimated number of patients anticipated, and such other
information as may assist the HCA in review of the application. The HCA shall take into consideration in
making its decision the need for an OTP in a given geographic area and the
impact on the community.
J. The HCA shall perform on-site
inspection of the proposed OTP facility as part of the review and approval
process.
K. In the event of change of ownership
of an approved opioid treatment program, the HCA approval is not transferable;
the new ownership must institute an application for approval as a new program,
in accordance with these regulations.
[8.321.10.10 NMAC - N, 7/1/2024]
8.321.10.11 Denial of HCA Approval to Operate; Appeal of Denial:
A. The HCA shall not deny approval to
operate until the applicant has been notified in writing of the deficiency in
the application resulting in the contemplated denial, and given opportunity to
remedy the application deficiency within a specified time period.
B. The HCA shall provide a written
explanation for any denied application. Denial
may be appealed to the secretary of the HCA, whose decision shall be final.
C. An applicant who is denied approval
may re-apply by submitting a new application 90 days or more after notification
of denial.
D. Failure to complete the application
form in its entirety, including requests for additional information as
specified above, shall be grounds for denial of approval.
[8.321.10.11 NMAC - N, 7/1/2024]
8.321.10.12 Renewal of HCA Approval to Operate:
A. OTP providers who wish to renew
their approval shall submit an application form and requested documentation no
less than 90 calendar days, and no more than 180 calendar days, before its
expiration date.
B. The HCA shall consider the operating
history of the OTP provider in making its determination to grant or deny an
application to a previously approved provider.
[8.321.10.12 NMAC - N, 7/1/2024]
8.321.10.13 Approval for OTPs in existence prior to these
Regulations: Opioid
treatment programs operating in New Mexico prior to the effective date of these
regulations shall be granted approval on the effective date of these
regulations (“grandfathered in”).
A. The term of these initial
grandfathered approvals shall be not less than 24 months nor more than 36
months, and may have staggered expiration dates to avoid simultaneous
expiration.
B. “Grandfathered” opioid treatment
programs shall provide the HCA with all written policies, procedures and other
documentation required of new opioid treatment programs under these regulations
within 45 days of the effective date of these regulations.
[8.321.10.13 NMAC - N, 7/1/2024]
8.321.10.14 Renewal of Grandfathered Operating Permits: Renewal
of grandfathered approvals shall follow the ordinary renewal process. Such approvals shall have a term of 36
months.
[8.321.10.14 NMAC - N, 7/1/2024]
8.321.10.15 Inspection
Authority: The HCA shall have the authority
to conduct inspections of the records, policies, procedures, physical plant or
any other aspect of an OTP for the purpose of determining its compliance with
these regulations or the presence of any factor posing a danger to the health
or welfare of its patients or the public. Failure of an OTP to cooperate with such
inspection shall be grounds for immediate suspension of the approval.
[8.321.10.15 NMAC - N, 7/1/2024]
8.321.10.16 Noncompliance with Regulations:
A. If an inspection conducted by the HCA
shows that an OTP is not in compliance with these regulations, the HCA shall
deliver to the program a written notice of the deficiencies identified.
B. The program shall respond to the
notification of deficiencies within 30 days of the notification. The program
response shall include a corrective action plan together with timeline for
implementation, or an explanation, satisfactory to the HCA, of the reason for
any deviations from the requirements of these regulations.
C. Failure of the OTP to respond within
30 days of receipt of the notification of deficiencies shall be grounds for
immediate suspension of the approval.
[8.321.10.16 NMAC - N, 7/1/2024]
8.321.10.17 Immediate Suspension of OTP Operating Approval:
A. The HCA, at its discretion, may
immediately suspend the approval of any OTP found to be in a substantial
violation of this regulation that results in danger to the health and welfare
of any patient or of the public, until such time as the violation(s) are corrected
to the satisfaction of the HCA.
B. In the event of such suspension, the
OPT shall immediately:
(1) cease accepting new patients; and
(2) consult with the HCA regarding the
orderly transfer of patients to other OTPs and implementation of the program
closure action plan required under the “preparedness planning” section of these
regulations in order to minimize adverse impact on its patients;
notwithstanding the suspension of the approval, the HCA may allow the OTP to
conduct limited operations of its program as the HCA finds necessary to
minimize adverse impact on patients.
[8.321.10.17 NMAC - N, 7/1/2024]
8.321.10.18 Administration: The
program sponsor shall ensure that:
A. a physician licensed to practice in
New Mexico is designated to serve as medical director and to have authority
over all medical aspects of opioid treatment;
B. the medical director is responsible
for ensuring that the OTP is in compliance with all applicable federal, state
and local laws and regulations;
C. the OTP shall be open for patients
every day of the week except for federal and state holidays, and Sundays, and
be closed only as allowed in advance in writing by CSAT and the state methadone
authority;
D. written policies and procedures are
developed, implemented, complied with and maintained at the OTP and include:
(1) procedures to prevent a patient from
receiving opioid dependency treatment from more than one agency or physician
concurrently;
(2) procedures to meet the unique needs
of diverse populations, such as pregnant women, children, individuals with
communicable diseases, (e.g. hepatitis C, tuberculosis, HIV or AIDS), or
individuals involved in the criminal justice system;
(3) procedures for conducting a physical
examination, assessment and laboratory tests;
(4) procedures for establishing substance
abuse counselor caseloads, based on the intensity and duration of counseling
required by each patient;
(5) criteria for when the patient’s blood
serum levels should be tested and procedures for having the test performed;
(6) procedures for performing laboratory
tests, such as urine drug screens or toxicological tests, including procedures
for collecting specimens for testing;
(7) procedures for addressing and
managing a patient’s concurrent use of alcohol or other drugs;
(8) procedures for providing take home medication to patients;
(9) procedures for conducting opioid
treatment withdrawal;
(10) procedures for conducting an administrative
withdrawal;
(11) procedures for voluntary discharge,
including a requirement that a patient discharged voluntarily be provided or
offered follow-up services, such as counseling or a referral for medical
treatment;
(12) procedures for making temporary or
permanent transfer of a patient from the OTP to another OTP;
(13) procedures for receiving the temporary
or permanent transfer of a patient from another OTP to the OTP;
(14) procedures to minimize the following
adverse events:
(a) a patient’s loss of ability to
function;
(b) a medication error;
(c) harm to a patient’s family member or
another individual resulting from ingesting a patient’s medication;
(d) sales of illegal drugs on the
premises;
(e) diversion of a patient’s medication;
(f) harassment or abuse of a patient by
a staff member or another patient; and
(g) violence on the premises;
(15) procedures to respond to an adverse
event, including:
(a) a requirement that the program
sponsor immediately investigate the adverse event and the surrounding
circumstances;
(b) a requirement that the program
sponsor develop and implement a plan of action to prevent a similar adverse
event from occurring in the future; monitor the action taken; and take
additional action, as necessary, to prevent a similar adverse event;
(c) a requirement that action taken under
the plan of action be documented; and
(d) a requirement that the documentation
be maintained at the agency for at least two years after the date of the
adverse event;
(16) procedures for infection control;
(17) criteria for determining the amount and
frequency of counseling that is provided to a patient; procedures to ensure
that the facility’s physical appearance is clean and orderly;
(18) a process for resolution of patient
complaints, including a provision that complaints which cannot be resolved
through the clinic’s process may be referred by either party to the HCA:
(a) the complaint process shall be
explained to the patient at admission;
(b) the patient complaint process shall
be posted prominently in its waiting area or other location where it will be
easily seen by patients, and include the HCA contact information for use in the
event that the complaint cannot be resolved through the clinic’s process.
E. a written quality assurance plan is
developed and implemented;
F. all information and instructions for
the patient are provided in the patient’s primary language, and, when provided
in writing, are clear and easily understandable by the patient.
[8.321.10.18 NMAC - N, 7/1/2024]
8.321.10.19 ADMISSION:
A. The program sponsor shall ensure
through policy and procedure that an individual is only admitted for opioid
dependency treatment after the program medical director determines and
documents that:
(1) the individual meets the definition
of opioid dependence using generally accepted medical criteria such as those
contained in the diagnostic and statistical manual for mental disorders (DSM-IV
or subsequent editions);
(2) the individual has received a
physical examination as required by Subsection D of 8.321.10.19 NMAC below; and
(3) if the individual is requesting
maintenance treatment, the individual has been addicted for at least 12 months
before the admission, unless the individual receives a waiver of this
requirement from the program medical director because the individual:
(a) was released from a penal institution
within the last six months;
(b) is pregnant, as confirmed by the
agency physician;
(c) was treated for opioid dependence
within the last 24 months; or
(d) is under the age of 18, has had two
documented unsuccessful attempts at short term opioid treatment withdrawal
procedures or drug-free treatment within a 12-month period, and has informed
consent for treatment provided by a parent, guardian, custodian or responsible
adult designated by the relevant state authority.
B. A program sponsor shall ensure that
an individual requesting long-term or short-term opioid treatment withdrawal
treatment who has had two or more unsuccessful opioid treatment withdrawal
treatment episodes within a 12-month period is assessed by the program medical
director for other forms of treatment.
C. The OTP shall ensure that each
patient at the time of admission:
(1) provides written, voluntary,
program-specific informed consent to treatment;
(2) is informed of all services that are
available to the patient through the program and of all policies and procedures
that impact the patient’s treatment; and
(3) is informed of the following:
(a) the progression of opioid dependency
and the patient’s apparent stage of opioid dependence;
(b) the goal and benefits of opioid
dependency treatment;
(c) the signs and symptoms of overdose
and when to seek emergency assistance;
(d) the characteristics of opioid
dependency treatment medication, such as its effects and common side effects,
the dangers of exceeding the prescribed dose, and potential interaction effects
with other drugs, such as other non-opioid agonist treatment medications,
prescription medications, and illicit drugs;
(e) the requirement for a staff member to
report suspected or alleged abuse or neglect of a child or an incapacitated or
vulnerable adult according to state law;
(f) the requirement for a staff member
to comply with the confidentiality requirements of title 42 CFR part 2 of the
code of federal regulations, incorporated by reference;
(g) drug screening and toxicological
testing procedures;
(h) requirements to receive take-home
medication;
(i) testing and treatment available for
HIV and other communicable diseases, the availability of immunization for
hepatitis A and B, and the availability of harm reduction services;
(j) availability of counseling on
preventing exposure to and transmission of human immunodeficiency virus (HIV),
sexually transmitted diseases, and blood-born pathogens;
(k) the patient’s right to file a
complaint with the program for any reason, including involuntary discharge, and
to have the patient’s complaint handled in a fair and timely manner.
D. A program sponsor shall ensure that
the program medical director or medical practitioner designee conducts a
complete, fully documented physical examination of an individual who requests
admission to the program before the individual receives a dose of opioid
dependency treatment medication, and that the physical examination includes:
(1) reviewing the individual’s bodily
systems;
(2) obtaining a medical and family
history and documentation of current information to determine chronic or acute
medical conditions such as diabetes, renal diseases, hepatitis, HIV infection,
tuberculosis, sexually transmitted disease, pregnancy or cardiovascular
disease;
(3) obtaining a history of behavioral
health issues and treatment, including any diagnoses and medications;
(4) initiating the following laboratory
tests:
(a) a mantoux skin test;
(b) a test for syphilis;
(c) a laboratory drug detection test for
at least opioids, methadone, amphetamines, cocaine, barbiturates,
benzodiazepines and other substances as may be appropriate, based upon patient
history and prevailing patterns of availability and use in the local area;
(5) recommending additional tests based
upon the individual’s history and physical condition, such as:
(a) complete blood count;
(b) EKG, chest X-ray, pap smear or
screening for sickle cell disease;
(c) a test for hepatitis B and C; or
(d) HIV testing.
(6) the full medical examination
including test results must be completed within 14 days of admission to the
program;
(7) a patient re-admitted within three
months after discharge does not require a repeat physical examination unless
requested by the program medical director.
E. A program sponsor shall ensure that
the results of a patient’s physical examination are documented in the patient
record.
F. A patient may not be enrolled in
more than one OTP program except under exceptional circumstances, such as
residence in one city and employment that requires extended absences from that
city, which must be documented in the patient chart by the medical directors of
both programs:
(1) an OTP shall make and document good
faith efforts to determine that a patient seeking admission is not receiving
opioid dependency treatment medication from any other source, within the bounds
of all applicable patient confidentiality laws and regulations;
(2) the OTP shall confirm that the
patient is not receiving treatment from any other OTP, except as provided in
Subsection F of 8.321.10.19 NMAC, within a 50 mile radius of its location, by
contacting any such other program, or by using the central registry described
in Subsection G of 8.321.10.19 NMAC, when established.
G. The HCA may establish an
internet-based central registry of all persons in New Mexico who are current
patients of a New Mexico OTP program, for the purpose of creating a system that
prevents patients from surreptitiously receiving medication from more than one OTP.
Each OTP as a condition of approval to
operate shall participate in the central registry as directed by the HCA.
[8.321.10.19 NMAC - N, 7/1/2024]
8.321.10.20 Assessment
and Treatment Plans: The
program sponsor shall ensure that:
A. each patient receives a
comprehensive intake assessment upon admission, conducted by a qualified
professional, to determine the most appropriate combination of services and
treatment, which results in an intake treatment plan based on the patient’s
goals; the results of the comprehensive intake assessment and the intake
treatment plan are documented in the patient record within 24 hours of
admission;
B. an individualized treatment plan
shall replace the intake treatment plan within 30 days of admission or the
third face-to-face contact with the client, and be documented in the patient
record;
C. all updates or revisions to any
treatment plan or assessment shall be documented in the patient record within seven
working days;
D. all assessments and treatment plans
shall include, but not necessarily be limited to:
(1) a description of the patient’s
presenting issue, identification of the patient’s behavioral health symptoms
and the behavioral health issue or issues that require treatment;
(2) a list of the medical services,
including medication, needed by the patient, as identified in the physical
examination;
(3) recommendations for further
assessment or examination of the patient’s needs if indicated;
(4) recommendations for treatment needed
by the patient, such as psychosocial counseling or mental health treatment, if
indicated;
(5) recommendations for ancillary
services or other services needed by the patient, if indicated;
(6) the signature, professional
credential, printed name, and date signed of the staff member conducting and
developing the assessment, treatment plan, update or revision;
(7) in the case of updated or revised
treatment plans, a summary of the patient’s progress or lack of progress toward
each goal on the previous plan and the program’s response; and any new goals;
(8) the signature and date signed, or
documentation of the refusal to sign, of the patient or the patient’s guardian
or agent or, if the patient is a child, the patient’s parent, guardian, or
custodian;
E. treatment plans shall be reviewed at
least every 90 days for the first two years of continuous treatment, and at
least every 6 months thereafter, in accordance with the program’s established
policy and procedure, and the treatment plan modified accordingly, except
initial treatment plans must be replaced with individualized plans as provided
for in Subsection B of 8.321.10.20 NMAC above;
F. adequate medical, psychosocial
counseling, mental health, vocational, educational and other assessment and
treatment services are fully and reasonably available to patients, either by
the program directly, or through formal, documented referral agreements with
other providers.
[8.321.10.20 NMAC - N, 7/1/2024]
8.321.10.21 DOSAGE:
The
program sponsor shall ensure that:
A. a dose of opioid dependency
treatment medication is administered only after an order from the program
medical director;
B. a patient’s dosage of opioid
dependency treatment medication is individually determined;
C. a dose of opioid dependency
treatment medication is sufficient to produce the desired response in a patient
for the desired duration of time and with consideration for patient safety;
D. a dose of opioid dependency
medication is prescribed to meet a patient’s treatment needs by:
(1) preventing the onset of subjective or
objective signs of withdrawal for 24 hours or more;
(2) reducing or eliminating the drug
craving that is experienced by opioid dependent individuals who are not in
opioid treatment;
(3) a patient receiving comprehensive
maintenance treatment receives an initial dose of opioid dependency treatment
medication based upon the program medical director or medical practitioner
designee’s physical examination and with consideration for local issues, such
as the relative purity of available illicit opioid drugs;
(4) a patient receiving methadone in
comprehensive maintenance treatment receives an initial dose of methadone that
does not exceed 30 milligrams; and
(a) if the patient’s withdrawal symptoms
are not suppressed after the initial dose of 30 milligrams, a patient receives
an additional dose that does not exceed 10 milligrams only if a program
clinician documents in the patient record that 30 milligrams did not suppress
the patient’s withdrawal symptoms; and
(b) if the patient’s withdrawal symptoms
are not suppressed by a total dose of 40 milligrams, a patient receives an
additional dose only if the program medical director or medical practitioner
designee documents in the patient record that 40 milligrams did not suppress
the patient’s withdrawal symptoms;
(5) a patient receiving buprenorphine in
opioid treatment withdrawal procedure or comprehensive maintenance treatment
receive an initial dose according to the instructions on the opioid dependency
treatment medication package insert, and any deviation from the instructions is
documented by the program clinician in the patient record;
(6) a patient receives subsequent doses
of opioid dependency treatment medication:
(a) based on the patient’s individual
needs and the results of the physical examination and assessment;
(b) sufficient to achieve the desired
response for at least 24 hours, with consideration for day-to-day fluctuations
and elimination patterns;
(c) that are not used to reinforce
positive behavior or punish negative behavior;
(d) as long as the patient benefits from
and desires comprehensive maintenance treatment; and
(e) that are adjusted if a provider
changes from one type of opioid dependency
treatment medication to another.
[8.321.10.21 NMAC - N, 7/1/2024]
8.321.10.22 DRUG
SCREENING: The program sponsor shall ensure that:
A. staff members have knowledge of the
benefits and limitations of laboratory drug detection tests and other
toxicological testing procedures;
B. a patient in comprehensive
maintenance treatment receives at least eight random laboratory drug detection
tests per year; short-term opioid treatment withdrawal procedure patients
receive at least one initial drug abuse test; long-term opioid treatment withdrawal
procedure patients receive an initial and monthly random tests; and other
toxicological tests are performed according to written orders from the program
medical director or medical practitioner designee;
C. laboratory drug detection tests and
other toxicological testing specimens are collected in a manner that minimizes
falsification;
D. laboratory drug detection tests for:
(1) opioids;
(2) methadone;
(3) amphetamines;
(4) cocaine;
(5) barbiturates;
(6) benzodiazepines; and
(7) other substances as may be
appropriate, based upon patient history and prevailing patterns of drug
availability and use in the local area;
E. the results of a patient’s
laboratory drug detection tests or other toxicological test and any action
taken relating to the results are documented in the patient record.
[8.321.10.22 NMAC - N, 7/1/2024]
8.321.10.23 TAKE-HOME
MEDICATIONS:
A. The program sponsor shall ensure
that policies and procedures are developed, implemented, and complied with for
the use of take-home medication and include:
(1) criteria for determining when a
patient is ready to receive take-home medication;
(2) criteria for when a patient’s
take-home medication is increased or decreased;
(3) a requirement that take-home
medication be dispensed according to federal and state law;
(4) a requirement that the program
medical director review a patient’s take-home medication regimen at intervals
of no less than 90 days and adjust the patient’s dosage, as needed;
(5) procedures for safe handling and
secure storage of take-home medication in a patient’s home; and
(6) criteria and duration of allowing a
physician to prescribe a split medication regimen.
B. Treatment program decisions on
dispensing OTP medications to patients for unsupervised use, beyond that set
forth in Subsection C of 8.321.10.23 NMAC below, shall be made by the program
medical director, based on the following criteria:
(1) absence of recent abuse of drugs,
including alcohol;
(2) regularity of program attendance;
(3) length of time in comprehensive
maintenance treatment;
(4) absence of known criminal activity;
(5) absence of serious behavioral
problems at the program;
(6) special needs of the patient such as
physical health needs;
(7) assurance that take-home medication
can be safely stored in the patient’s home;
(8) stability of the patient’s home
environment and social relationships;
(9) the patient’s work, school, or other
daily activity schedule;
(10) hardship experienced by the patient in
traveling to and from the program; and
(11) whether the benefit the patient would
receive by decreasing the frequency of program attendance outweighs the
potential risk of diversion.
C. A patient in comprehensive
maintenance treatment may receive a single dose of take-home medication for
each day that a provider is closed for business, including Sundays and state
and federal holidays.
D. A program sponsor shall ensure that
take-home medication is only issued to a patient in compliance with the
following restrictions:
(1) during the first 90 days of
comprehensive maintenance treatment, take-home medication is limited to a
single dose each week, in addition to any doses received as described in
Subsection C of 8.321.10.23 NMAC above;
(2) during the second 90 days of
comprehensive maintenance treatment, a patient may receive a maximum of two
doses of take-home medication each week in addition to any doses received as
described in Subsection C of 8.321.10.23 NMAC above;
(3) during the third 90 days of
comprehensive maintenance treatment, a patient may receive a maximum of three
doses of take-home medication each week in addition to any doses received as
described in Subsection C of 8.321.10.23 NMAC above;
(4) in the remaining months of the
patient’s first year, a patient may receive a maximum of six days of take-home
medication each week;
(5) after one year of continuous
treatment, a patient may receive a maximum two week supply of take-home
medication;
(6) after two years of continuous
treatment, a patient may receive a maximum of one month’s supply of take-home
medication but must make monthly visits;
(7) exceptions to the above take-home
medication restrictions shall be made only as provided for in center for
substance abuse treatment (CSAT) regulations and as approved by the state
methadone authority.
E. A program sponsor shall ensure that
a patient receiving take-home medication receives:
(1) take-home medication in a child-proof
container; and
(2) written and verbal information on the
patient’s responsibilities in protecting the security of take-home medication.
F. The program sponsor shall ensure
that the program medical director’s determination made under Subsection B of 8.321.10.23
NMAC and the reasons for the determination are documented in the patient
record.
G. In accordance with DEA regulations,
the program shall not use U. S. mail or express services such as fedex or
united parcel service to transport, furnish or transfer opioid treatment
medication to any patient, agency, facility or person.
H. The program shall establish policy
and procedure to provide for the safe and secure transportation of opioid
treatment medication from its facility to another agency where the program’s
patient temporarily resides, (e.g., from the university of New Mexico’s
addiction and substance abuse program (ASAP) to the turquoise lodge treatment
program.).
[8.321.10.23 NMAC - N, 7/1/2024]
8.321.10.24 WITHDRAWAL
TREATMENT AND MEDICALLY SUPERVISED DOSE REDUCTION:
The program sponsor shall ensure that:
A. policies and procedures are
developed, implemented, and complied with for withdrawal treatment and:
(1) are designed to promote successful
withdrawal treatment;
(2) require that dose reduction occur at
a rate deemed medically appropriate by the program medical director;
(3) require that a variety of ancillary
services, such as self-help groups, be available to the patient through the
program or through referral;
(4) require that the amount of counseling
available to the patient be increased before discharge; and
(5) require that a patient be re-admitted
to the program or referred to another program if relapse occurs;
B. a patient’s withdrawal treatment:
(1) for a patient involved in
comprehensive maintenance treatment, is only initiated as administrative
withdrawal, or when voluntarily requested by the patient and approved by a
program medical director; and
(2) is planned and supervised by the
program medical director;
C. before a patient begins withdrawal
treatment, whether with or against the advice of the program medical director,
the patient:
(1) is informed by the program medical
director or a medical practitioner designee:
(a) that the patient has the right to
leave opioid treatment at any time; and
(b) of the risks of withdrawal treatment;
and
(2) upon request, receives a schedule for
withdrawal treatment that is developed by the program medical director with
input from the patient;
(3) receives a copy of the program policy
regarding withdrawal of opioid medication against medical advice and a verbal
explanation of that policy;
D. if a patient who is receiving
withdrawal treatment, other than a patient experiencing administrative
withdrawal, appears to a staff member to relapse, the patient is permitted to
begin comprehensive maintenance treatment, if otherwise eligible;
E. if a patient who has completed
withdrawal treatment within the past 30 days appears to a staff member to
relapse, the patient may be re-admitted without a physical examination or
assessment with the consent of the program medical director;
F. a patient experiencing
administrative withdrawal is referred or transferred to any program that is
capable of or more suitable for meeting the patient’s needs, and the referral
or transfer is documented in the patient record;
G. the following information is
documented in the patient record:
(1) the reason that the patient sought
withdrawal treatment or was placed on administrative withdrawal; and
(2) the information and assistance
provided to the patient in medical withdrawal or administrative withdrawal.
[8.321.10.24 NMAC - N, 7/1/2024]
8.321.10.25 COUNSELING
AND MEDICAL SERVICES: The
program sponsor shall ensure that:
A. substance abuse counseling and
behavioral health treatment planning is provided by a practitioner licensed in
the state of New Mexico to provide behavioral health treatment services to each
patient based upon the patient’s individual needs, treatment plan and stage of
readiness to change behavior;
B. the program has substance abuse
counselors in a number sufficient:
(1) to ensure that patients have access
to counselors;
(2) to provide the treatment in patients’
treatment plans; and
(3) to provide unscheduled treatment or
counseling to patients;
C. each patient seeking opioid
treatment is screened for the presence of a co-occurring mental health disorder
by means approved by the HCA, and if indicated, referred for assessment and
possible treatment if the program is not able to provide mental health
services; an OTP referring a patient to another provider for mental health
assessment shall make and document its good faith efforts to follow up with
that provider on the results of the referral, and to co-ordinate its treatment
with any subsequent treatment by other providers, within the limits of all
applicable laws and regulations pertaining to release of patient information
and confidentiality;
D. a program sponsor shall ensure that
a patient is offered medical, psychiatric and psychological services, if
needed, either at its program or through referral:
(1) if a patient receives medical,
psychiatric or psychological services, from provider(s) not affiliated with the
program, program staff members shall make a good faith effort to communicate
and coordinate its treatment services with such provider, including monitoring
and evaluating interactions between the patient’s opioid treatment medication
and medications used to treat the patient’s mental disorder, if any;
(2) the OTP shall have a procedure to
ensure that such good faith coordination efforts are made, in accordance with
all state and federal laws and regulations for the release of patient records
or information;
E. a program sponsor shall make good
faith efforts to establish effective working relationships with the relevant
behavioral health treatment providers in its patient catchment area in order to
facilitate patient access to the services available through those providers;
F. a program sponsor shall ensure that
a patient has access to a self-help group or support group, such as narcotics
anonymous, either at the agency or through referral to a community group;
G. treatment services are provided by
appropriately licensed staff.
[8.321.10.25 NMAC - N, 7/1/2024]
8.321.10.26 DIVERSE
POPULATIONS:
A. The program sponsor shall ensure
that:
(1) opioid treatment is provided
regardless of race, ethnicity, gender, age, or sexual orientation;
(2) the program facility is compliant
with the Americans with Disabilities Act (ADA);
(3) opioid treatment is provided with
consideration for a patient’s individual needs, cultural background, and
values;
(4) provider staff members are culturally
competent;
(5) unbiased language is used in the
provider’s print materials, electronic media, and other training or educational
materials;
(6) HIV testing and education are
available to patients either at the provider or through referral;
(7) a patient who is HIV-positive and who
requests treatment for HIV or AIDS:
(a) is offered treatment for HIV or AIDS
either at the provider or through referral; and
(b) has access to an HIV- or AIDS-related
peer group or support group and to social services either at the provider or
through referral to a community group; and
(8) for patients with a communicable
disease such as HIV, AIDS, or hepatitis C, the provider has a procedure for
transferring a patient’s opioid treatment to a non-program medical practitioner
treating the patient for the communicable disease when it becomes the patient’s
primary health concern;
(9) an individual who requires
administration of opioid treatment medication only for relief of chronic pain
is:
(a) identified during the physical
examination or assessment;
(b) not admitted for opioid medication
treatment; and
(c) referred for medical services; and
(d) for a patient with a chronic pain
disorder who is also physically dependent the OTP makes a good faith effort to
coordinate treatment and services with the medical practitioner treating the
patient for pain management.
B. A program sponsor shall ensure that
a policy and procedure is developed, implemented, and complied with for the
treatment of female patients, to include requirements that:
(1) pregnancy tests shall be administered
and reviewed for all women of childbearing age prior to initiating a opioid
treatment withdrawal procedure or medically supervised withdrawal;
(2) appropriate staff members be educated
in the unique needs of female patients; and
(3) each female patient be informed about
or referred to an appropriate support group, at the provider or in the
community.
C. The program sponsor shall ensure
that a policy and procedure is developed, implemented, and complied with for
the treatment of pregnant patients, to include:
(1) a requirement that priority be given
to pregnant individuals seeking opioid treatment;
(2) a requirement that the reasons for a
pregnant individual’s denial of admission to a provider be documented;
(3) a requirement that a pregnant patient
be offered prenatal care to include fetal assessment either at the program or
through referral to a non-program medical practitioner;
(4) a requirement that the program
communicate with any non-program medical practitioners who are providing
prenatal care to a pregnant patient, to coordinate opioid treatment and
prenatal care, in accordance with all state and federal laws and regulations for
the release of patient records or information; and document all such
communications in the patient records;
(5) a requirement that a staff member
make a good faith effort to educate a pregnant patient who refuses prenatal
care services on the importance of prenatal care;
(6) a requirement that a staff member
obtain a written refusal of prenatal care services that are offered either
directly by the program or by referral, from a pregnant patient who refuses
such services or referral to such services;
(7) a requirement that a pregnant patient
receiving comprehensive maintenance treatment before pregnancy be maintained at
the pre-pregnancy dose of opioid
medication, if effective;
(8) a requirement that a pregnant patient
be monitored by the program medical director to determine if pregnancy-induced
changes in the elimination or metabolization of opioid treatment medication may
necessitate an increased or split dose;
(9) a requirement that withdrawal
treatment:
(a) is strongly advised against before 14
weeks or after 32 weeks of gestation;
(b) the program medical director reviews
the case before initiating withdrawal and monitor it until withdrawal is
complete;
(10) a requirement that a pregnant patient
discharged from the program be referred to a non-program medical practitioner
and that a staff member document the name, address, and telephone number of the
medical practitioner in the patient record.
D. A program sponsor who is officially
notified by a correctional facility that a patient is in their custody shall
ensure that the program:
(1) makes efforts to obtain approval from
the criminal justice system for the continued treatment of the patient by the
program while the patient is incarcerated; and
(2) if approval is obtained the program
continues to treat the patient while the patient is incarcerated , within the
limits of the program’s ability to provide such treatment to the incarcerated
patient; and
(3) if approval is not obtained, the
program’s attempts to obtain approval are documented in the patient’s record.
[8.321.10.26 NMAC - N, 7/1/2024]
8.321.10.27 PREPAREDNESS
PLANNING:
A. The program sponsor shall ensure
that the program has:
(1) a written plan to ensure
uninterrupted dispensing of medication in the event of dispensing staff
turnover; and
(2) a written agreement with at least one
other provider for the provision of opioid treatment medication to program
patients in the event that the program is unable to provide services;
(3) 24-hour telephone answering service
or other method to reach the program at all times; and
(4) a list of all patients and the
patients’ dosage requirements available and accessible to program on-call staff
members.
B. A program sponsor shall ensure that
a written plan is developed and implemented for continuity of patient services
if the program is voluntarily or involuntarily closed. Such planning shall
include a disaster plan that addresses unforeseeable circumstances such as
natural disaster or involuntary closure from any cause, and:
(1) includes steps for the orderly
transfer of patients to other programs, individuals, or entities that provide
opioid treatment;
(2) includes procedures for securing,
maintaining, and transferring patient records according to federal and state
law; and
(3) the plan is reviewed and updated, as
appropriate, at least once every 12 months.
[8.321.10.27 NMAC - N, 7/1/2024]
8.321.10.28 PATIENT
RECORDS:
A. The OTP program shall establish and
maintain a recordkeeping system that is adequate to document and monitor
patient care. The system shall comply with all federal and state requirements
relevant to OTPs and to confidentiality of patient records.
B. Each patient record shall include:
(1) the results of the physical
examination;
(2) the results of all assessments;
(3) the treatment plan and all updates or
revisions;
(4) the results of laboratory tests and a
description of any action taken based upon the results;
(5) documentation of the patient’s
current dose and dosage history;
(6) documentation of counseling provided
to the patient;
(7) dates and results of meetings or
conferences regarding the patient’s treatment;
(8) documentation of the process used and
factors considered in making decisions that impact a patient’s treatment, such
as whether to allow take-home medication and the frequency of laboratory drug
detection tests; and
(9) documentation of the agency’s efforts
to learn of multiple opioid treatment program enrollment;
(10) documentation that the patient has
received and understood information regarding the harmful effects of diversion
of opioid treatment medication.
[8.321.10.28 NMAC - N, 7/1/2024]
8.321.10.29 COMMUNITY
RELATIONS:
A. A program sponsor shall ensure that
policies and procedures are developed, implemented, and complied with to
educate and promote understanding in the community about opioid treatment and
include:
(1) a mechanism for eliciting input from
the community about the provider’s impact on the community;
(2) a requirement that the program
sponsor or designee interface with community leaders to foster positive
relations;
(3) a requirement that the program
sponsor or designee establish a liaison with community representatives to share
information about the program;
(4) a requirement that the agency have
information on substance abuse and related health and social issues available
to the public;
(5) a mechanism for addressing and
resolving community concerns about opioid treatment or the program’s presence
in the community; and
(6) a mechanism that addresses getting
approval for continued treatment in treatment or care facilities and
correctional facilities.
B. A program sponsor shall ensure that
community relations efforts are documented and are evaluated at least once
every six months.
C. A program sponsor shall comply with
all valid county and municipal ordinances regarding community relations, and
the HCA may consult with local governmental entities when enforcing this
section.
[8.321.10.29 NMAC - N, 7/1/2024]
8.321.10.30 DIVERSION
CONTROL: The
program sponsor shall ensure that a written plan is developed, implemented, and
complied with to prevent diversion of opioid treatment medication from its
intended purpose to illicit purposes.
This plan shall assign specific responsibility to licensed and
administrative staff for carrying out the diversion control measures and
functions described in the plan. The
program shall develop and implement a policy and procedure providing for the
reporting of theft or diversion of medication to the relevant regulatory
agencies, and law enforcement authorities.
[8.321.10.30 NMAC - N, 7/1/2024]
HISTORY
OF 8.321.10 NMAC: [RESERVED]