N.M. Admin. Code § 8.321.2.31 - OPIOID TREATMENT PROGRAM (OTP)
MAD pays for coverage for medication assisted treatment for opioid use disorder to an eligible recipient through an opioid treatment center as defined in (42 CFR Part 8), certification of opioid treatment programs (OTP). Services include, but are not limited to, the administration of methadone to an individual for medically managed withdrawal from opioids and maintenance treatment. The administration/supervision must be delivered in conjunction with the overall treatment based upon a treatment plan that reflects shared decision making between the patient and health care practitioner or counselor, to include availability of counseling as well as, case review, drug testing, and medication monitoring. Availability of counseling is a required OTP service however access to medication for an enrolled recipient is not contingent upon receipt of counseling services. See Subsections A and B of 8.321.2.9 NMAC for MAD general provider requirements.
A.
Eligible providers and practitioners:
(1) Provider requirements:
(a) Accreditation with a substance use and
mental health services administration (SAMHSA)/CSAT approved nationally
recognized accreditation body, (e.g., commission on accreditation of
rehabilitation facilities (CARF), joint commission (JC) or council on
accreditation of services for families and children (COA).
(b) Behavioral health services division
(BHSD) approval. As a condition of approval to operate an OTP, the OTP must
maintain above accreditation. 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 alleged finding of need for
improvement, the OTP program will notify the BHSD within two business days of
such event. The OTP program will furnish the BHSD with all information related
to its accreditation status, or the status of its application for
accreditation, upon request.
(c)
The BHSD shall grant approval or provisional approval to operate pending
accreditation, provided that all other requirements of these regulations are
met.
(2) Staffing
requirements:
(a) Both clinical services and
supervision by licensed practitioners must be in accord with their respective
licensing board regulations. Provider staff members must be culturally
competent.
(b) Programs must be
staffed by:
(i) medical director (MD licensed
to practice in the state of NM or a DO licensed to practice in the State of
NM);
(ii) clinical supervisor (must
be one of the following: licensed psychologist, or licensed independent social
worker; or certified nurse practitioner in psychiatric nursing; or licensed
professional clinical mental health counselor; or licensed marriage and family
therapist;
(iii) licensed
behavioral health practitioner; registered nurse; or licensed practical nurse;
and
(iv) full time or part time
pharmacist.
(c) Programs
may also be staffed by:
(i) licensed substance
abuse associate (LSAA); and
(ii)
certified peer support worker (CPSW).
B.
Coverage criteria:
(1) A physician licensed to practice in NM is
designated to serve as medical director and to have authority over all medical
aspects of opioid treatment.
(2)
The OTP shall formally designate a program sponsor who shall agree on behalf of
the OTP to adhere to all federal and state requirements and regulations
regarding the use of opioid agonist treatment medications in the treatment of
opioid use disorder which may be promulgated in the future.
(3) The OTP shall be open for patients every
day of the week with an option for closure for federal and state holidays, and
Sundays, and be closed only as allowed in advance in writing by CSAT and the
state opioid treatment authority. Clinic hours should be conducive to the
number of patients served and the comprehensive range of services
needed.
(4) Written policies and
procedures outlined in the BH policy and billing manual are developed,
implemented, compiled, and maintained at the OTP.
(5) OTP programs will not deny a reasonable
request for transfer.
(6) The OTP
will maintain criteria for determining the amount and frequency of counseling
that is provided to a patient.
(7)
Referral or transfer of recipients to a suitable alternative treatment program.
Because of the risks of relapse following medically managed withdrawal from
medication or other opioids, patients must be offered a relapse prevention
program that includes, but is not limited to, counseling, naloxone, and
medication for opioid use disorder.
(8) Provision of unscheduled treatment or
counseling to patients.
(9)
Established counselor caseloads based on the intensity and duration of
counseling required by each patient. Counseling can be provided in person or
via telehealth. Counselor to patient ratios should be sufficient to ensure that
patients have reasonable and prompt access to counselors and receive counseling
services at the required levels of frequency and intensity.
(10) Preparedness planning: the program has a
list of all patients and the patients' dosage requirements available and
accessible to program on call staff members.
(11) Patient records: 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.
(12) Diversion control: 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 division of medication to the relevant
regulatory agencies, and law enforcement authorities.
(13) Prescription monitoring program (PMP): a
written plan is developed, implemented, and complied with to ensure that all
OTP physicians and other health care providers, as permitted, are registered to
use the NM PMP. The PMP should be checked quarterly through the course of each
patient's treatment.
(14) HIV/AIDS,
hepatitis, and other sexually transmitted infection (STI) testing and education
are available to patients either at the provider or through referral, including
treatment, peer group or support group and to social services either at the
provider or through referral to a community group.
(15) Requirements for health care
practitioners who prescribe, distribute or dispense opioid analgesics:
(a) A health care practitioner who
prescribes, distributes or dispenses an opioid analgesic for the first time to
a patient shall advise the patient on the risks of overdose and inform the
patient of the availability of an opioid antagonist.
(b) For a patient to whom an opioid analgesic
has previously been prescribed, distributed or dispensed by the health care
practitioner, the health care practitioner shall advise the patient on the
risks of overdose and inform the patient of the availability of an opioid
antagonist on the first occasion that the health care practitioner prescribes,
distributes or dispenses an opioid analgesic each calendar year.
(c) A health care practitioner who prescribes
an opioid analgesic for a patient shall co-prescribe an opioid antagonist if
the amount of opioid analgesic being prescribed is at least a five-day supply.
The prescription for the opioid antagonist shall be accompanied by written
information regarding the temporary effects of the opioid antagonist and
techniques for administering the opioid antagonist. That written information
shall contain a warning that a person administering the opioid antagonist
should call 911 immediately after administering the opioid
antagonist.
C.
Identified population:
(1) An eligible recipient is treated for
opioid dependency only after the agency's medical director or licensed
practitioner determines and documents that:
(a) the recipient meets the definition of
opioid use disorder using generally accepted medical criteria, such as those
contained in the current version of the DSM;
(b) the recipient has received an initial
medical examination as required by
7.32.8.19 NMAC which may be
conducted either in-person or via telehealth; and
(c) informed consent for treatment must be
provided by a parent, guardian, custodian or responsible adult designated by
the relevant state authority if the recipient is under the age of 18. Consent
may be provided electronically.
(2) OTPs must maintain current policies and
procedures that reflect the special needs and priority for treatment of
recipients with opioid use disorder who are pregnant. Evidence-based treatment
protocols for pregnant patients, such as a split dosing regimen, may be
instituted after assessment by an OTP practitioner. Prenatal care and other
sex-specific services, including reproductive health services for pregnant and
postpartum patients must be provided, and documented, by either the OTP or by
referral to an appropriate healthcare practitioner.
D.
Covered services:
(1) Withdrawal treatment and medically
supervised dose reduction.
(2) A
biopsychosocial assessment will be conducted by a licensed behavioral health
professional or a LADAC under the supervision of an independently licensed
clinician, as defined by the NM RLD within 14 days of admission.
(3) A comprehensive, patient centered,
individualized treatment plan, reflecting shared decision making between the
patient and the licensed practitioner, shall be conducted within 30 days of
admission and be documented in the patient record.
(4) Each OTP will ensure that adequate
medical, psychosocial counseling, mental health, vocational, educational, and
other services identified in the initial and ongoing treatment plans are fully
and reasonably available to patients, either by the program directly, or
through formal, documented referral agreements with other providers.
(5) Drug screening: A recipient in
comprehensive maintenance treatment receives one random urine drug detection
test per month; short-term opioid treatment withdrawal procedure patients
receive at least one initial drug use 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. Samples that are
sent out for confirmatory testing (by internal or external laboratories) are
billed separately by the laboratory.
(6) Initiation of the following mandatory
laboratory tests:
(a) a mantoux skin
test;
(b) a test for
syphilis;
(c) hepatitis screening
in accordance with the most current CDC guidelines; and
(d) 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.
(7) Medication units:
(a) interested applicants shall submit to the
BHSD for approval to add a medication unit to their existing registration:
(i) a written letter of intent that
demonstrates how this service will increase access to methadone in rural
communities and avoid duplication with other OTP services;
(ii) standard operating procedure;
(iii) approval from the drug enforcement
administration;
(iv) approval from
the NM board of pharmacy; and
(v)
application to SAMHSA/CSAT following BHSD approval.
(b) BHSD shall approve or deny the
application within 30 working days of submission, unless the BHSD and applicant
mutually agree to extend the application review period.
(c) BHSD may require the applicant to provide
additional written or verbal information in order to reach its decision. Such
further information shall be considered an integral part of the application and
may extend the application review period.
(d) the following services may be provided
where space allows for quality patient care in mobile medication units,
assuming compliance with all applicable federal, state, and local law:
(i) administering and dispensing medications
for opioid use disorder treatment;
(ii) collecting samples for drug testing or
analysis;
(iii) dispensing of
take-home medications;
(iv) in
units that provide appropriate privacy and adequate space, intake/initial
psychosocial and appropriate medical assessments (with a full physical
examination to be completed or provided within 14-days of admission);
(v) initiating methadone or buprenorphine
after an appropriate medical assessment has been performed;
(vi) in units that provide appropriate
privacy and have adequate space, other OTP services, such as counseling, may be
provided directly or when permissible through use of telehealth
services.
(e) any
required services not provided in mobile and non-mobile medication units must
be conducted at the OTP, including medical, counseling, vocational,
educational, and other assessment, and treatment services (42 CFR
8.12(f)(1)).
(8) Take home medication: active
OTP recipients, regardless of the length of time in treatment, may receive take
home doses for days during which the clinic is closed including one weekend day
as well as state and federal holidays. Beyond the standing approval to allow
take home doses when the clinic is closed OTP decisions on dispensing
medication for opioid use disorder (MOUD) to recipients for unsupervised use
shall be determined by an appropriately licensed OTP medical practitioner or
the medical director.
(a) the OTP medical
practitioner or medical director shall consider, among other pertinent factors
that indicate that the therapeutic benefits of unsupervised doses outweigh the
risks, the following criteria:
(i) absence of
active substance use disorders, other physical or behavioral health conditions
that increase the risk of patient harm as it relates to the potential for
overdose, or the ability to function safely;
(ii) regularity of attendance for supervised
medication administration;
(iii)
absence of serious behavioral problems that endanger the patient, the public or
others;
(iv) absence of known
recent diversion activity;
(v)
whether take-home medication can be safely transported and stored;
and
(vi) any other criteria that
the medical director or medical practitioner considers relevant to the
patient's safety and the public's health.
(b) the program sponsor shall ensure that
policies and procedures are developed, implemented, and complied with for the
use of take-home medication and include:
(i)
criteria for determining when a patient is ready to receive take-home
medication;
(ii) criteria for when
a patient's take-home medication is increased or decreased;
(iii) a requirement that take-home medication
be dispensed according to federal and state law;
(iv) 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;
(v) procedures for safe handling and secure
storage of take-home medication in a patient's home; and
(vi) criteria and duration of allowing a
physician to prescribe a split medication regimen.
(c) during the first 14 days of treatment,
the take-home supply is limited to seven days. It remains within the OTP
practitioner's discretion to determine the number of take-home doses up to
seven days, but decisions must be based on the criteria listed in Subparagraph
(a) of Paragraph (8) of Subsection D of
8.321.2.31 NMAC.
(d) from 15 days of treatment, the take-home
supply is limited to 14 days. It remains within the OTP practitioner's
discretion to determine the number of take-home doses up to 14 days, but this
determination must be based on the criteria listed in Subparagraph (a) of
Paragraph (8) of Subsection D of
8.321.2.31 NMAC.
(e) from 31 days of treatment, the take-home
supply to a patient is not to exceed 28 days. It remains within the OTP
practitioner's discretion to determine the number of take-home doses up to 28
days, but this determination must be based on the criteria listed in
Subparagraph (a) of Paragraph (8) of Subsection D of
8.321.2.31 NMAC.
(f) a program sponsor shall ensure that a
patient receiving take-home medication receives:
(i) take home medication in a child-proof
container: and
(ii) written and
verbal information regarding the recipient's responsibility in the protection
and security of take-home mediation.
(g) the rationale underlying the decision to
provide or withdraw unsupervised doses of methadone must be documented in the
patient's clinical record.
E.
Non-covered services: Blood
samples collected and sent to an outside laboratory.
F.
Reimbursement:
(1) The bundled reimbursement rate for
administration and dispensing includes the cost of methadone, administering and
dispensing methadone, and urine dipstick testing conducted within the
agency.
(2) Other services
performed by the agency as listed below are reimbursed separately and are
required by (42 CFR Part 8.12 (f)), or its successor.
(a) a narcotic replacement or agonist drug
item other than methadone that is administered or dispensed;
(b) behavioral health prevention and
education services to affect knowledge, attitude, or behavior can be rendered
by a licensed substance use disorder associate or certified peer support worker
in addition to independently licensed practitioners;
(c) outpatient therapy other than substance
use disorder and HIV counseling required by (42 CFR Part 8.12 (f)) is
reimbursable when rendered by a MAD approved independently licensed provider
that meets Subsection H of
8.321.2.9 NMAC;
(d) an eligible recipient's initial medical
examination, which may be conducted in person or via telehealth when rendered
by a MAD enrolled licensed practitioner who meets 8.310.2 and 8.310.3 NMAC
requirements;
(e) full medical
examination, prenatal care and gender specific services for a pregnant
recipient; if they are referred to a provider outside the agency, payment is
made to the provider of the service;
(f) medically necessary services provided
beyond those required by (42 CFR Part 8.12 (f)), to address the medical issues
of the eligible recipient; see 8.310.2 and 8.310.3 NMAC;
(g) the quantity of service billed in a
single day can include, in addition to the drug items administered that day,
the number of take-home medications dispensed that day; and
(3) For an IHS, tribal 638 facility or any
other "Indian Health Care Provider (IHCP)" defined in 42 Code of Federal
Regulations Section
Notes
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