California Laws

Requirements for Licensure and Operations of Medications for Opioid Use Disorder Treatment

Question:

Does the state regulate the licensure of medications for opioid use disorder (MOUD) services?

Answer:
Yes
This answer is derived from 4 section of law
Citation:
  • citation 1: see full citation
    The department has the sole authority in state government to license adult alcoholism or drug abuse recovery or treatment facilities.(a)  In administering this chapter, the department shall issue new licenses for a period of two years to those programs that meet the criteria for licensure set forth in Section 11834.03.(b)  Onsite program visits for compliance shall be conducted at least once during the license period.(c)  The department may conduct announced or unannounced site visits to facilities licensed pursuant to this chapter for the purpose of reviewing for compliance with all applicable statutes and regulations. see full law
  • citation 2: see full citation
    (a) (1) As a condition of providing incidental medical services, as defined in subdivision (a) of Section 11834.026, at a facility licensed by the department, the facility, within a reasonable period of time, as defined by the department in regulations, shall obtain from each program participant, a signed certification described in subdivision (b) from a health care practitioner.(2) For purposes of this chapter, “health care practitioner” means a person duly licensed and regulated under Division 2 (commencing with Section 500) of the Business and Professions Code, who is acting within the scope of practice of his or her license or certificate.(b) The department shall develop a standard certification form for use by a health care practitioner. The form shall include, but not be limited to, a description of the alcoholism and drug abuse recovery or treatment services that an applicant needs.(c) (1) The department shall adopt regulations, on or before July 1, 2018, to implement this section. The regulations shall be adopted in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code).(2) Notwithstanding the rulemaking provisions of the Administrative Procedure Act, the department may, if it deems appropriate, implement, interpret, or make specific this section by means of provider bulletins, written guidelines, or similar instructions from the department only until the department adopts regulations. see full law
  • citation 3: see full citation
    (a) (1) Each narcotic treatment program authorized to use narcotic replacement therapy in this state, except narcotic treatment research programs approved by the Research Advisory Panel, shall be licensed by the department.(2) Each narcotic treatment program, other than a program owned and operated by the state, county, city, or city and county, shall, upon application for licensure and for renewal of a license, pay an annual license fee to the department. July 1 shall be the annual license renewal date.(3) The department shall set the licensing fee at a level sufficient to cover all departmental costs associated with licensing incurred by the department, but the fee shall not, except as specified in this section, increase at a rate greater than the Consumer Price Index. The fees shall include the department’s share of pro rata charges for the expenses of state government. The fee may be paid quarterly in arrears as determined by the department. Fees paid quarterly in arrears shall be due and payable on the last day of each quarter except for the fourth quarter for which payment shall be due and payable no later than May 31. A failure of a program to pay renewal license fees by the due date shall give rise to a civil penalty of one hundred dollars ($100) a day for each day after the due date. Second and subsequent inspection visits to narcotic treatment programs that are operating in noncompliance with the applicable laws and regulations shall be charged a rate of one-half the program’s annual license fee or one thousand dollars ($1,000), whichever is less, for each visit.(4) Licensing shall be contingent upon determination by the department that the program is in compliance with applicable laws and regulations and upon payment of the licensing fee. A license shall not be transferable.(5) (A) As used in this chapter, “quarter” means July, August, and September; October, November, and December; January, February, and March; and April, May, and June.(B) As used in this chapter, “license” means a basic permit to operate a narcotic treatment program. The license shall be issued exclusively by the department and operated in accordance with a patient capacity that shall be specified, approved, and monitored solely by the department.(b) Each narcotic treatment program, other than a program owned and operated by the state, county, city, or city and county, shall be charged an application fee that shall be at a level sufficient to cover all departmental costs incurred by the department in processing either an application for a new program license, or an application for an existing program that has moved to a new location.(c) Any licensee that increases fees to the patient, in response to increases in licensure fees required by the department, shall first provide written disclosure to the patient of that amount of the patient fee increase that is attributable to the increase in the licensure fee. This provision shall not be construed to limit patient fee increases imposed by the licensee upon any other basis. see full law
  • citation 4: see full citation
    In addition to the duties authorized by other provisions, the department shall be responsible for licensing narcotic treatment programs to use narcotic replacement therapy and medication-assisted treatment in the treatment of addicted persons whose addiction was acquired or supported by the use of alcohol or a narcotic drug or drugs, not in compliance with a physician and surgeon’s legal prescription. No narcotic treatment program shall be authorized to use narcotic replacement therapy and medication-assisted treatment without first obtaining a license as a narcotic treatment program as provided in this chapter. The department may license narcotic treatment programs on an inpatient or outpatient basis, or both. The department may also grant a state narcotic treatment license. see full law