Section 164.305 - Provision of Services - Opioid Treatment Programs(A)Central Registry System. (1) All Opioid Treatment Programs shall participate in the Central Registry System to expedite the admission process by verification of medication and dose, prevent a patient's simultaneous enrollment in more than one Opioid Treatment Program, facilitate disaster response and allow access to treatment during emergencies throughout the State, and ensure accurate dispensing of medication in accordance with state and federal laws and regulations.(2) The Program Director and at least two other employees designated by the Program Director shall have access to the Central Registry System and be properly trained in the Central Registry System.(3) Each Opioid Treatment Program must: (a) Upon admission, inform all patients of the Opioid Treatment Program's participation in the Central Registry System;(b) Prior to initiating a Central Registry System inquiry, obtain the patient's written consent;(c) Include information about the Central Registry System in the Client Handbook and as part of patient orientations;(d) Ensure evidence of the written consent and orientation is included in the patient's medical record;(e) Initiate a clearance inquiry to the Central Registry System by submitting all information required by the State Opioid Treatment Authority prior to admitting a patient to the Opioid Treatment Program;(f) Verify with the Central Registry System that the prospective patient is not presently enrolled in another Opioid Treatment Program, and document this verification in the patient's record;(g) Report any other information required by the Department; and(h) Report all admissions, transfers, and discharges, and any other required information as soon as possible, but not more than 72 hours later into to the Central Registry System.(4) No person who is reported by the Central Registry System to be participating in another Opioid Treatment Program shall be admitted to an Opioid Treatment Program. In the event a dual enrollment is found by either Opioid Treatment Program in which the patient is participating, the patient shall be discharged from one Opioid Treatment Program in order to continue enrollment at another Opioid Treatment Program.(5) The Opioid Treatment Program shall notify the State Opioid Treatment Authority within 24 hours of any patient who is found by an Opioid Treatment Program to be simultaneously enrolled in another Opioid Treatment Program.(6) Information made available by the Central Registry System to Opioid Treatment Programs as approved by the State Opioid Treatment Authority shall also be treated as confidential in accordance with all state and federal regulations including, but not limited to, 42 CFR Part 2 and shall not be shared with others, including state or federal agencies, unless permitted by confidentiality laws and regulations.(7) Opioid Treatment Programs shall not disclose any information to a treating provider that is a non-member of the Central Registry System regardless of whether there is a treating provider relationship, unless there is a patient specific authorized consent which complies with 42 CFR Part 2.(8) The Opioid Treatment Program shall develop policies and procedures for: (a) Orienting patients and staff to the Central Registry System; and(b) Training for staff to ensure compliance with 105 CMR 164.305(A). Evidence of this training shall be documented in staff's personnel files.(9)All Hazard and Emergency Planning and Procedures plan. Opioid Treatment Programs shall include use of the Central Registry System to ensure patient access to care, accuracy and efficiency in dosing services during an emergency by ensuring medication dosing information can be shared between licensed and/or certified Opioid Treatment Programs and the State Opioid Treatment Authority and/or their delegate.(B)Admission. (1) Prior to admitting a patient into treatment, the Licensed or Approved Provider shall determine that the patient has a current physiologic dependence on opioids of at least a 12-month duration. If the exact term of physiologic dependence cannot be determined, the medical director, or designee, may admit the patient to treatment if there is sufficient evidence to reasonably conclude that there was physiologic dependence one year prior to admission. The 12-month duration may be waived if the patient:(b) is seeking opioid withdrawal services;(c) has been released from a penal institution within the previous six months; or(d) has been discharged from opioid treatment within the previous two years.(2)Evidence of Physiologic Opioid Dependence. The Licensed or Approved Provider shall obtain evidence of a diagnosis of opioid use disorder through reliable methods such as physical examination, laboratory tests and substance use history.(3) Prior to initiating treatment, the Licensed or Approved Provider shall:(a) verify that the patient with a positive drug screen for methadone is not enrolled in an opioid treatment program;(b) complete an assessment of patient's current prescription medications prior to prescribing, dispensing or administering an FDA-approved medication for opioid dependence to ensure that the approved medication is not contraindicated by the patient's current prescribed medications or health status;(c) for women of child bearing age, complete a pregnancy test before dispensing or administering or prescribing an FDA-approved medication for opioid dependence; and(d) review the patient's prescription history through the MassPAT.(4)Consent to Treatment. The Licensed or Approved Provider shall ensure that the patient voluntarily chooses treatment. The information listed in 105 CMR 164.305(B)(4)(a) through (h) shall be provided to the client and recorded on a consent form, which shall be signed by the patient, and a copy shall be provided to the patient. If the patient is younger than 18 years old, the consent form shall be signed by the patient and the patient's parent or legal guardian. The information shall also be provided orally:(a) the nature of FDA-approved medication used in opioid treatment, including benefits and risks, and the benefits and risks of not receiving treatment;(b) the distinction between withdrawal and maintenance and the availability of shortterm withdrawal treatment for a period not less than 30 calendar days nor more than 180 calendar days;(c) approximate length of each type of treatment;(d) a clear statement of the goals of each type of treatment, and the tasks necessary to reach those goals;(e) need for the patient to inform the Licensed or Approved Provider of current medical conditions and medications the patient is currently taking;(f) acknowledgement that the patient may withdraw voluntarily from treatment and discontinue use of medications;(g) the options available to both the patient and the program as a result of either a voluntary or involuntary termination, including medically supervised withdrawal; and (h) for women of child-bearing age, acknowledgement of the benefits and risks of treatment during pregnancy, and importance of informing the Licensed or Approved Provider if she is or becomes pregnant.(C)Assessment. Pursuant to 105 CMR 164.072(B), the Licensed or Approved Provider may initiate patient treatment prior to completion of the assessment required by 105 CMR 164.072 upon obtaining sufficient information to initiate treatment for the acute problem at the time of presentation and that the assessment is subsequently completed in a reasonable timeframe, provided that a Qualified Healthcare Professional must see such a patient prior to initiating an FDA-approved medication for treatment of addiction.(D)Initial Medical Examination. In addition to the assessment required by 105 CMR 164.072, the Licensed or Approved Provider shall ensure that each patient has an initial medical examination by a Practitioner, or by a qualified healthcare professional under the supervision of a program physician prior to administration of the first dose of medication. The examination shall include: (1) a brief mental status exam;(2) tests for the presence of opioids including, but not be limited to, buprenorphine, methadone, and fentanyl; alcohol; benzodiazepines; cocaine; and any other drugs the Licensed or Approved Provider determines are clinically indicated or as approved by the Commissioner and listed in Department guidance;(3) an assessment of pulmonary, liver, and cardiac abnormalities; dermatological and neurological sequelae of addiction; possible infectious serologies if indicated; possible concurrent surgical problems; and any other relevant laboratory studies as clinically indicated. The full medical examination including the results of serology and other tests must be returned no later than 14 calendar days after admission.(4) These laboratory tests are not required to be completed prior to the initiation of medication for addiction treatment. Any relevant laboratory findings shall be documented and reviewed with the patient and Medical Director and findings reviewed with the patient. Evidence of direct referrals to address findings shall be properly documented. The Licensed or Approved Provider shall ensure that such laboratory tests are completed by licensed facilities which comply with all applicable federal and state laboratory licensure and certification requirements.(E)Treatment Plan. In addition to the requirements of 105 CMR 164.073, the treatment plan shall include the following information:(1)Dosage. The Medical Director shall ensure all dosing of an opioid agonist treatment medication is ordered in accordance with federal requirements; and(2)Services. The Licensed or Approved Provider shall provide services as specified in 105 CMR 164.074.(F)Documentation. In addition to the requirements of 105 CMR 164.083, the Medical Director, or other authorized health care professional, shall: (1) ensure that evidence of current physiological dependence is entered in the patient record;(2) ensure that a medical evaluation, including a medical history, is recorded;(3) ensure that appropriate laboratory results are documented;(4) ensure that a list of prescription medication, prescribed dosage(s) of all medications, the plan for changing prescribed medications if necessary, including the planned rate of withdrawal, when applicable, are documented in the record;(5) sign or countersign all medical orders;(6) review and countersign treatment plans at least annually;(7) ensure that the reasons for any changes in dosage and changes in the permitted number of take-home doses are documented;(8) document program verifications made in accordance with 105 CMR 164.305(B)(3)(a); and(9) document status of initial and periodic MassPAT review.(G) Upon Department approval, a Licensed or Approved opioid treatment provider may provide interim maintenance in accordance with federal requirements.Amended by Mass Register Issue 1305, eff. 1/29/2016.Amended by Mass Register Issue 1482, eff. 11/11/2022.