Ind. Code ch. 12-23-20

Ind. Code § 12-23-20-1 Application of section; development of treatment protocol

Sec. 1. (a) This section applies to an office based opioid treatment provider who: (1) has obtained a waiver from the federal Substance Abuse and Mental Health Services Administration (SAMHSA) and meets the qualifying standards required to treat opioid addicted patients in an office based setting; and (2) has a valid federal Drug Enforcement Administration registration number and identification number that specifically authorizes treatment in an office based setting. (b) The office of the secretary and the division shall develop a treatment protocol containing best practice guidelines for the treatment of opiate dependent patients. The treatment protocol must require the minimal clinically necessary medication dose that includes, when appropriate, the goal of opioid abstinence, and the following: (1) Require an opioid treatment provider to periodically and randomly test a patient for the following before and during the patient's treatment by the provider: (A) Methadone. (B) Cocaine. (C) Opiates. (D) Amphetamines. (E) Barbiturates. (F) Tetrahydrocannabinol. (G) Benzodiazepines. (H) Any other suspected or known drug that may have been abused by the patient. (2) Require that if a patient tests positive under a test described in subdivision (1) for: (A) a controlled substance other than a drug for which the patient has a prescription or that is part of the patient's treatment plan with the provider; or (B) an illegal drug other than the drug that is part of the patient's treatment plan with the provider; the opioid treatment provider and the patient shall review the treatment plan and consider changes with the goal of opioid abstinence. (3) Require that an opioid treatment provider must determine that the benefit to the patient in receiving the take home opioid treatment medication outweighs the potential risk of diversion of the take home opioid treatment medication. (4) Develop clinical standards for: (A) the appropriate tapering of a patient on and off an opioid treatment medication; (B) relapse; and (C) overdose prevention. (5) Develop standards and protocols for an opioid treatment provider to do the following: (A) Assess new opioid treatment patients to determine the most effective opioid treatment medications to start the patient's opioid treatment. (B) Ensure that each patient voluntarily chooses maintenance treatment and that relevant facts concerning the use of opioid treatment medications, including nonaddictive medication options, are clearly and adequately explained to the patient. (C) Have appropriate opioid treatment patients who are receiving maintenance medications for opioid treatment move to receiving other approved opioid treatment medications. (c) Before December 31, 2016, the office of the secretary shall recommend the best practice guidelines required under subsection (b) to: (1) the Indiana professional licensing agency established under IC 25-1-5; (2) the office; and (3) a managed care organization that has contracted with the office. As added by P.L.37-2016, SEC.3.

Ind. Code § 12-23-20-2 Office based opioid treatment; requirements

Sec. 2. (a) This section does not apply to a health care provider providing services in any of the following: (1) An adult or juvenile correctional facility operated by the state or a local unit. (2) A hospital licensed under IC 16-21-2. (3) A facility that is certified by the division. (4) An opioid treatment program that has been certified or licensed by the division under IC 12-23-18. (5) A state institution. (6) A health facility licensed under IC 16-28. (7) The Indiana Veterans' Home. (b) A physician who is providing office based opioid treatment or who is acting in a supervisory capacity to other health care providers that are providing office based opioid treatment must: (1) have a valid federal Drug Enforcement Administration registration number and identification number; and (2) abide by all: (A) federal; and (B) state; laws and regulations concerning the prescribing of medications. (c) A health care provider that prescribes for a patient in an office based opioid treatment setting shall do and document the following: (1) Determine the patient's age. (2) Perform an initial assessment and a physical examination as appropriate for the patient's condition and the health care provider's scope of practice and obtain a medical history of the patient before treatment begins. (3) Obtain substance use history and any substance use disorder diagnosis of the patient. (4) Perform a mental health assessment. (5) Obtain informed consent for treatment and establish a treatment agreement with the patient that meets the requirements set forth in subsection (d). (6) If determined appropriate, prescribe office based opioid treatment for the patient and require office visits of the patient in person throughout treatment. (7) Evaluate the patient's progress and compliance with the treatment agreement and document the patient's progress with the treatment plan. (8) Perform toxicology screening for the following in accordance with rules adopted under IC 25-22.5-2-7(a)(14) in order to assess medication adherence and to screen for other substances: (A) Stimulants. (B) Alcohol. (C) Opioids, including: (i) oxycodone; (ii) methadone; and (iii) buprenorphine. (D) Tetrahydrocannabinol. (E) Benzodiazepines. (F) Cocaine. (9) Review INSPECT (as defined in IC 25-26-24-7) concerning controlled substance information for the patient before induction and at least four (4) times per year during treatment. (10) If the patient is a female and has child bearing potential: (A) perform a pregnancy test at the onset of treatment; (B) counsel the patient about the risks of treatment to a fetus, including fetal opioid dependency and neonatal abstinence syndrome; and (C) provide for or refer the patient to prenatal care, if the pregnancy test performed under clause (A) is positive. (11) Prescribe an overdose intervention drug and education on how to fill the prescription when buprenorphine is initiated on the patient. (12) Provide for an ongoing component of psychosocial supportive therapy, with direction from the health care provider on the amount of the therapy. (d) The treatment agreement required in subsection (c)(5) must include at least the following: (1) The goals of the treatment. (2) The patient's consent to drug monitoring testing. (3) The prescriber's prescribing policies that include at least the following: (A) A requirement that the patient take the medication as prescribed. (B) A prohibition on sharing or selling the medication. (C) A requirement that the patient inform the prescriber about any: (i) other controlled substances or other medication prescribed or taken by the patient; and (ii) alcohol consumed by the patient. (4) The patient's consent to allow the prescriber to conduct random pill counts for prescriptions. (5) Reasons that the office based opioid treatment of the patient may be changed or discontinued by the prescriber. The provider shall maintain a copy of the informed consent for treatment in the patient's medical record. (e) During the examinations required by subsection (c)(6), the prescriber shall do the following: (1) Evaluate and document patient progress and compliance with the patient's treatment plan. (2) Document in the patient's medical record whether the patient is meeting treatment goals. (3) Discuss with the patient the benefits and risks, if relevant, of ongoing buprenorphine treatment. (f) If a toxicology screening described in subsection (c)(8) shows an absence of a prescribed drug, the provider must discuss and implement a plan with the patient to optimize medication adherence and schedule an earlier follow up appointment with the patient. The provider shall document the discussion in the patient's medical record. (g) If a toxicology screening described in subsection (c)(8) shows a presence of an illegal or nonprescribed drug, the provider shall assess the risk of the patient to be successfully treated and document the results in the patient's medical record. (h) The provider may perform a subsequent confirmation toxicology screening of the patient if the provider considers it medically necessary or to clarify an inconsistent or unexpected toxicology screening result. As added by P.L.213-2019, SEC.1. Amended by P.L.32-2021, SEC.32; P.L.233-2023, SEC.4.