N.Y. Comp. Codes R. & Regs. tit. 14 § 822.11

Current through Register Vol. 46, No. 45, November 2, 2024

Section 822.11 - Additional requirements for opioid treatment programs

(a) Central registry system. Each such program must participate in the central registry system established and maintained by the Office to prevent a patient's simultaneous enrollment in more than one such program and ensure accurate dispensing of medication in accordance with federal regulations. Each such program must:

(1) initiate a clearance inquiry to the central registry system by submitting all required information prior to admitting a patient;

(2) report all admissions, transfers, and discharges immediately to the central registry system;

(3) verify with the central registry system that the prospective patient is not presently enrolled in another such program and this verification must be documented in the clinical record; a program may not admit an applicant who is participating in another such program; and

(4) report any other information deemed necessary by the Office to comply with state and federal laws and regulations.

(b) Medication administration.

(1) A physician must determine a patient's initial medication dose and schedule of administration and document such orders in the patient's record. Another designated practitioner, such as a nurse practitioner or physician's assistant may determine a patient's initial medication dose and schedule of administration if a federal waiver has been approved.

(2) A prescribing professional may report such orders to the registered or licensed medical personnel supervising medication administration; any subsequent change in approved medications, dose or schedule must similarly be reported to the pharmacy or to the medical staff and documented in the record before administration. The prescribing professional may issue verbal orders in emergencies only and must document such orders in writing within seventy-two (72) hours.

(3) Patients must be properly stabilized with a therapeutic dose of approved medications; a therapeutic dose means an amount sufficient to maintain comfort for at least twenty-four (24) hours, alleviate opioid craving and stop continued opioid use. Split medication doses require prior Office approval.

(4) If any medical staff member observes any condition or behavior on the part of a patient that may contraindicate a regularly scheduled dose of medication, such staff member must contact the prescribing professional immediately and advise of the patient's condition which may warrant an approved medication delay, withholding or adjustment. The prescribing professional must:

(i) approve any medication delay, withholding or adjustment; and

(ii) provide follow up consistent with emergency verbal orders as otherwise required by this section.

(c) Unsupervised or take-home medication.

(1) Each patient must be on a visit schedule that is most appropriate to clinical need, conducive to treatment progress, and supportive of rehabilitation. A prescribing professional may reduce a patient's visit schedule, when clinically indicated, to accommodate patient changes in need, progress, or rehabilitation.

(2) Each patient's take-home schedule must comply with the federal regulatory time in treatment requirements (42 CFR Part 8.12), unless there is a clinical justification that takes into consideration the federal eight (8) point criteria, as to why the person is not stable enough to be granted the applicable take home schedule. The Medical Director must review and confirm the appropriateness for take-home medication. Federal time in treatment criteria do not apply to the provision of buprenorphine or naltrexone.

(3) Any patient may receive a single take-home dose for a day that the clinic is closed for business, including Sundays and State and Federal holidays.

(4) Such determinations shall be documented in the patient's medical record. Time-in-treatment requirements do not apply to buprenorphine take-home medication per federal rules.

(5) No medications shall be dispensed to patients in short-term detoxification treatment or interim maintenance treatment for unsupervised or take-home use.

(6) Notwithstanding the requirements of this subdivision, a provider may require a patient to visit the program when concerned with diversion of medication. When this occurs the patient shall be required to bring in all remaining take-home doses. Remaining doses must match the prescribed schedule.

(7) Holidays. Notwithstanding the requirements of this subdivision, a patient may be provided with extra medication without prior Office approval i f the patient's next regular visit falls on a legal or program holiday. Designation of a program holiday that is not a federal holiday must be approved annually by the Office at least thirty (30) days in advance.

(8) Exceptional circumstances. Notwithstanding the requirements of this subdivision, a prescribing professional, based on reasonable clinical judgment, may order up to thirty (30) takehome doses at any one time if a patient is unable to conform to the applicable mandatory schedule requirements due to exceptional circumstances such as illness, personal or family crisis, travel, employment, medical, or hardship, and the prescribing professional determines the patient is also responsible in handling approved medication. Such order shall not be a permanent schedule change. The prescribing professional must immediately document in the patient record the reasons for the order.

(9) Release of medication to designated third party. Program medical staff may release medication to a designated third party other than the patient only when the patient is physically unable to attend the program. The decision to permit such release to a designated third party must be based on the clinical judgment of the prescribing professional and with the consent of the patient, both of which must be documented in the patient's record. All designated third parties must also receive prior Office approval.

(10) Patients readmitted to a program after an approved voluntary discharge may be granted the same take-home schedule at the time of discharge provided all criteria other than length of treatment are satisfied.

(d) Medication security.

(1) Access to controlled substances, including approved medications, shall be limited to authorized persons in accordance with applicable state and federal law. The areas where controlled medication stocks are maintained, dispensed, or administered must be physically separated and secure from patient areas in accordance with applicable state and federal law.

(2) Immediately after administration, drug containers must be purged by rinsing, inversion, or by an acceptable alternative method that must effectively prevent the accumulation of residual medication. Containers used in the program or for take-home medications must be in child resistant packaging, may not be reused and must be destroyed. Each program must assure patients' take-home bottles and used containers are disposed of properly. Patients should return take-home bottles before receiving any subsequent take-home medication.

(3) Any theft or loss of approved medications must be immediately reported in accordance with applicable state and federal law.

(e) Residential programs providing opioid full agonist treatment medications. Such a residential program shall:

(1) comply with all applicable requirements of this Part;

(2) comply with all requirements of this Title applicable to substance use disorder residential services;

(3) not dispense take-home medications to any patient; and

(4) include material and schedules for development and review of treatment/recovery plans as required by regulations applicable to substance use disorder residential services, rather than the requirements of this Part.

(f) Opioid taper.

(1) MAT is the standard of care for OUD; however an opioid taper may be appropriate in limited clinical situations and upon patient request.

(2) Voluntary Taper. Each program must provide an opioid taper at the program or arrange for taper at another program or in a facility approved to provide tapering as is medically and clinically appropriate:

(i) Patients may request a voluntary taper at any time and may discuss reasons and circumstances with program staff who must provide clinical feedback regarding patient readiness. No reasonable request shall be denied;

(ii) Each program must administer a voluntary taper at a pace tailored to the patient's individual needs, based on clinical judgment, medical evaluation, patient input and feedback at the start of the taper and continuously throughout.

(g) Opioid medical maintenance (OMM).

(1) An OMM program requires federal and state approval. Patients admitted to OMM must meet specific criteria including:

(i) four (4) years of continuous treatment in a program providing opioid full agonist treatment;

(ii) three (3) years of no substance use including alcohol;

(iii) three (3) years of no criminal involvement;

(iv) three (3) years of continuous gainful employment or productive activity;

(v) three (3) years of emotional stability;

(vi) intent to continue maintenance treatment; and

(vii) verified stability in the Prescription Monitoring Program ("PMP").

(2) The individual patient record for a patient in OMM must be updated at least monthly and toxicology tests and/or a check of the PMP must be conducted as clinically indicated.

(3) The 30-day medication supply may be dispensed in dry tablet form in a single bottle.

(4) An OMM patient must return to a program when, in the prescribing professional's clinical judgment, the patient needs maintenance treatment services.

(5) An OMM program has no Office-certified capacity.

(h) Specialized opioid services. Specialized opioid services are those not defined in this Part and are generally research-oriented in nature. Such specialized services shall be reviewed and approved by the Office prior to implementation and operation in accordance with Office policy, procedures, and requirements.

N.Y. Comp. Codes R. & Regs. Tit. 14 § 822.11

Adopted New York State Register December 9, 2015/Volume XXXVII, Issue 49, eff. 11/20/2015

Amended New York State Register December 6, 2017/Volume XXXIX, Issue 49, eff. 12/6/2017

Adopted New York State Register March 27, 2019/Volume XLI, Issue 13, eff. 3/27/2019

Amended New York State Register January 27, 2021/Volume XLIII, Issue 04, eff. 1/27/2021

Amended New York State Register September 14, 2022/Volume XLIV, Issue 37, eff. 10/1/2022