105 CMR, § 164.251

Current through Register 1536, December 6, 2024
Section 164.251 - Provision of Services
(A)Admission.
(1)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.
(2) Prior to initiating treatment, the Licensed or Approved Provider shall:
(a) complete an assessment of patient's current prescription medications prior to prescribing, dispensing or administering an FDA-approved medication for opioid dependence to ensure the approved medication is not contraindicated by the patient's current prescribed medications or health status;
(b) for women of child bearing age, complete a pregnancy test before dispensing or administering or prescribing an FDA-approved medication for opioid dependence; and (c) review the patient's prescription history through the MassPAT.
(3)Consent to Treatment. The Licensed or Approved Provider shall ensure the patient voluntarily chooses treatment. The information listed in 105 CMR 164.251(A)(3)(a) through (f) shall be provided to the patient and recorded on a consent form, which shall be signed by the patient, and a copy shall be provided to the patient. 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) approximate length of each type of treatment;
(c) a clear statement of the goals of each type of treatment, and the tasks necessary to reach those goals;
(d) need for the patient to inform the Licensed or Approved Provider of current medical conditions and medications the patient is currently taking;
(e) acknowledgement the patient may withdraw voluntarily from treatment and discontinue use of medications; and
(f) 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.
(4)Consent to Treatment by Minors. Minors 12 through 17 years of age may consent to treatment without the consent of the parent or guardian upon a finding of two or more physicians that the minor is drug dependent.
(B)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.
(C)Initial Medical Examination. In addition to the assessment required by 105 CMR 164.072, the Licensed or Approved Provider shall ensure each patient has an initial medical examination by a physician, or by a qualified health-care professional under the supervision of a program physician prior to administration of the first dose of medication. Licensed or approved providers may utilize a medical examination conducted within the last 12 months, provided there are no medical issues or changes that require examination per the clinical discretion of the facility provider and review of such a medical examination is documented in the patient's record. 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; and
(3) an assessment of pulmonary, liver, and cardiac abnormalities; dermatological and neurological sequelae of addiction; possible infectious serologies if indicated; possible concurrent surgical problems as clinically indicated; and any other relevant laboratory studies as clinically indicated. The assessment shall include the following laboratory tests, results of which must be returned no later than 14 calendar days after admission.

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. Evidence of direct referrals to address findings shall be properly documented. The Licensed or Approved Provider shall ensure such laboratory tests are completed by licensed facilities, which comply with all applicable federal and state laboratory licensure and certification requirements.

(D)Documentation. In addition to the requirements of 105 CMR 164.083, a Practitioner shall:
(1) ensure evidence of current physiological dependence is entered in the patient record;
(2) ensure a medical evaluation, including a medical history, is recorded;
(3) ensure appropriate laboratory results are documented;
(4) ensure 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 management, when applicable, are documented in the record;
(5) sign or countersign all medical orders;
(6) document program verifications made in accordance with 105 CMR 164.305(B)(3)(a); and
(7) document status of initial and periodic MassPAT review.
(E) Upon Department approval, a Licensed or Approved opioid treatment provider may provide interim maintenance in accordance with federal requirements.

105 CMR, § 164.251

Adopted by Mass Register Issue 1482, eff. 11/11/2022.