Authority: IC 25-22.5-2-7; IC 25-22.5-13-2

Affected: IC 16-21; IC 16-25; IC 16-28; IC 25-1-9; IC 25-22.5

Sec. 3. (a) This section and sections 4 through 10 of this rule establish requirements concerning the use of opioids for chronic pain management for patients.

(b) Notwithstanding subsection (a), this section and sections 4 through 10 of this rule shall not apply to the use of opioids for chronic pain management for the following:

1. (1) Patients with a terminal condition.
2. (2) Residents of a health facility licensed under IC 16-28.
3. (3) Patients enrolled in a hospice program licensed under IC 16-25.
4. (4) Patients enrolled in an inpatient or outpatient palliative care program of a hospital licensed under IC 16-21 or a hospice licensed under IC 16-25.

However, a period of time that a patient who was, but is no longer, a resident or patient as described in subdivisions (2) through (4) shall be included in the calculations under subsection (c).

(c) The requirements in the sections identified in subsection (a) only apply if a patient has been prescribed:

1. (1) more than sixty (60) opioid-containing pills a month for more than three (3) consecutive months;
2. (2) a morphine equivalent dose of more than fifteen (15) milligrams per day for more than three (3) consecutive months;
3. (3) a transdermal opioid patch for more than three (3) consecutive months;
4. (4) at any time it is classified as a controlled substance under Indiana law, tramadol, but only if the patient's tramadol dose reaches a morphine equivalent dose of more than sixty (60) milligrams per day for more than three (3) consecutive months; or
5. (5) an extended release opioid medication that is not in an abuse deterrent form for which an FDA-approved abuse deterrent form is available.

Subdivisions (1) and (2) do not apply to the controlled substances addressed by subdivisions (3) through (5).

(d) Because the requirements in the sections identified in subsection (a) do not apply until the time stated in subsection (c), the initial evaluation of the patient for the purposes of sections 4, 7, and 8(a) of this rule shall not be required to take place until that time.

(e) Notwithstanding subsection (d), the physician may undertake those actions earlier than required if the physician deems it medically appropriate and, if those actions meet the requirements, a further initial evaluation is not required. If the physician conducts actions earlier than required under this subsection, any subsequent requirements are determined by when the initial evaluation would have been required and not at the earlier date it actually was conducted.

(Medical Licensing Board of Indiana; 844 IAC 5-6-3; filed Oct 7, 2014, 12:27 p.m.: 20141105-IR-844140289FRA, eff Nov 1, 2014 [IC 4-22-2-36 suspends the effectiveness of a rule document for 30 days after filing with the Publisher. LSA Document #14-289 was filed Oct 7, 2014.]; filed Aug 22, 2016, 11:30 a.m.: 20160921-IR- 844150415FRA; readopted filed Nov 22, 2022, 12:22 p.m.: 20221221-IR-844220255RFA; readopted filed Feb 27, 2024, 10:19 a.m.: 20240327-IR-844230772RFA)