Triggers and Exclusions: When do the Indiana requirements for chronic pain patients apply?
Indiana’s requirements for managing opioid prescriptions apply to almost all chronic pain patients. But, there are exceptions for terminal patients and certain grandfathered situations.
The rule applies to all chronic pain patients for which controlled opioid substances are being prescribed or are being considered as a course of treatment. There are some exceptions. These inclusion and exclusion criteria are set forth in 844 IAC 5-6-3. Let’s take a look at the specifics.
Exclusions based on diagnosis or treatment facility
The rule is not applicable to:
- Patients with a terminal condition.
- Residents of a health facility licensed under IC 16-28.
- Patients enrolled in a hospice program licensed under IC 16-25.
- 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.
So, all chronic pain patients except those that are primarily end-of-life, terminal, or cancer patients. But do the rules apply to all pain patients? No, acute pain patients are not covered by the rules, though many of the rules would be a good idea, as we will see. The rules apply to chronic pain patients prescribed opioids. Let’s look at what that means as defined in the Indiana opioid prescribing rules.
Triggers for the Requirements: Duration * Dose
For all other chronic pain patients as identified in this section of the rule, the requirements only apply if a patient has been prescribed any of the following:
- More than sixty (60) opioid-containing pills a month for more than three (3) consecutive months
- A morphine equivalent dose of more than fifteen (15) milligrams per day; for more than three (3) consecutive months
- A transdermal opioid patch for more than three (3) consecutive months;
- 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
- A hydrocodone-only extended release medication that is not in an abuse deterrent form
Note that for the purposes of determine the 3 month calculations, any period of time that a patient who was, but is no longer, a resident or patient as described the exclusion section above shall be included in the calculations under subsection. That is, for example, if a patient was receiving opioid controlled substances as treatment in a facility licensed under IC 16-28, hospice, or palliative care, and would therefore have been excluded, but they are no longer under that care, then the duration of prescription while in that care counts toward the trigger requirements above.
Impact on the Initial Evaluation
So, you will see later in this course that an initial evaluation is required and that this evaluation itself has some specific requirements. The triggers and exclusions here affect this evaluation in a couple of ways that impact practice.
Initial Evaluation Requirements Don’t Start Until Triggers are Met
First, because all the remaining requirements for the rule do not come into play until the criteria under the trigger section above are met, that means that the requirements for the ‘initial’ evaluation do not apply until those conditions are met. That is, you do not have to do the required elements for an initial evaluation of the patient for the purposes of sections 4, 7(a), and 8(a) until such time as the patient meets any one of the 3 trigger requirements related to dose, duration, and type.
Do it anyway, for every patient?
Second, however, the rule goes on to state that regardless of the status of the triggers, 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.
Summary of Triggers and Exclusions: Who and when?
So, in a nutshell, if your patient is terminal and under hospice or palliative care, the rules do not apply. For all other chronic pain patients, the rules apply to pain patients who are being treated for 3 consecutive months (or more), or with an abusable hydrocodone only extended release opioid. All the remaining requirements in sections 4-11 of the rule then come into play.
Of course, if you believe at treatment onset that you are going to be prescribing opioid controlled substances for the patients chronic pain, and doing so for over a period of time, then you really should follow all of the requirements at the onset of treatment. Starting immediately will be more efficient, likely reduce patient risk, and prevent you from having to do the full requirements of the initial evaluation during a followup visit.