New restrictions on opioid prescribing begin July 1, Include exceptions June 12

A law passed during the 2017 legislative session imposes new restrictions on opioid prescribing for Indiana physicians starting July 1. Primarily because of ISMA’s efforts, the law contains exceptions, and the Medical Licensing Board of Indiana (MLB) is considering several more.

Gov. Eric Holcomb sought the law, known as Senate Enrolled Act (SEA) 226, as part of his plan to address what many consider to be an opioid epidemic in Indiana. The measure applies to all physicians and other practitioners, such as dentists, nurse practitioners, physician assistants and podiatrists, who have a state and federal (DEA) controlled substance registration.

Under SEA 226, a physician writing an initial opioid prescription for a patient may not prescribe more than a seven-day supply, unless an exception applies. For an adult patient age 18 or older, there are no quantity limits on subsequent opioid prescriptions written by that physician. For patients younger than 18, unless an exception applies, all opioid prescriptions are limited to a seven-day supply.

When the bill was introduced, ISMA immediately began to work with the governor’s office and other stakeholders to include important amendments. As a result, the law contains the following exceptions to the seven-day limit:

1. The physician is treating the patient for cancer.

2. The physician is providing medication-assisted treatment for a substance-abuse disorder.

3. The physician is providing palliative care for the patient.

4. In the physician’s professional judgment, the patient requires more than the seven-day supply of opioids.

5. The Medical Licensing Board of Indiana (MLB) may create additional exceptions by Dec. 1, 2017, in consultation with the Indiana State Department of Health, the Indiana Family and Social Services Administration and other stakeholder representatives.

The first three provisions are fairly standard for such legislation, but the professional-judgment and MLB-created exceptions secured by ISMA’s advocacy are unusual, said ISMA Director of Advocacy Mike Brady. The MLB has discussed several additional exceptions to the prescribing limits, including for postoperative and trauma-related care, and plans to review a draft rule at its June 22 meeting. ISMA will continue to provide input and monitor the MLB’s progress.

Under the palliative care exception or the professional judgment exception, if a physician issues a first-time opioid prescription for more than seven days to an adult or any opioid prescription to a minor, the physician must document in the patient’s medical record that a non-opiate was not appropriate. The physician must also document that the patient is receiving palliative care or that the physician is using his or her professional judgment to prescribe for longer than the seven-day limit.

Another provision of SEA 226 requires a physician to comply if a patient or the patient’s legally authorized representative requests a smaller amount of an opioid than the physician initially planned to prescribe. In that instance, a physician must document the request, as well as who made it, in the patient’s medical record.

Finally, SEA 226 allows Indiana pharmacies to partially fill a prescription at the request of a patient or a patient’s legally authorized representative. Under a recent change to 21 U.S.C. 829, the unfilled portion of an original Schedule II prescription may be filled up to 30 days after the date of the original prescription.