N.M. Admin. Code § 8.321.2.31

Current through Register Vol. 35, No. 23, December 10, 2024

Section 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

(h) guest dosing can be reimbursed at medicaid-enrolled agencies per 7.32.8 NMAC. Arrangements must be confirmed prior to sending the patient to the receiving clinic.

(3) For an IHS, tribal 638 facility or any other "Indian Health Care Provider (IHCP)" defined in 42 Code of Federal Regulations Section

(4) For a FQHC, MAD considers the bundled OTP services to be outside the FQHC all-inclusive rate and is therefore reimbursed at the MAD fee schedule utilizing the appropriate claim form designated by MAD; see 8.310.12 NMAC. Non-bundled services may be billed at the FQHC rate.

N.M. Admin. Code § 8.321.2.31

Adopted by New Mexico Register, Volume XXX, Issue 23, December 17, 2019, eff. 1/1/2020, Adopted by New Mexico Register, Volume XXXII, Issue 15, August 10, 2021, eff. 8/10/2021, Adopted by New Mexico Register, Volume XXXV, Issue 23, December 10, 2024, eff. 12/10/2024