(June 29, 2017): Deaths resulting from a drug overdose have grown considerably in recent years. The results of a study published in “Morbidity and Mortality Weekly Report” by the Centers for Disease Control and Prevention (CDC) found that 63.1% of the overdose-related deaths in 2015 involved opioids. Notably, this was a significant increase from the 60.9% figure recorded in 2014. The CDC has noted that overdoses from prescription opioids have been a “driving problem” contributing to this problem. In an effort to further address the opioid overdose crisis, in March 2016, the CDC published “CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016.”  Many states have also taken affirmative steps to ensure that their licensed prescribers of opioids are taking additional steps to safeguard both their patients and the public (from the illegal diversion of prescription drugs). Indiana has recently passed legislation in this regard. This article examines the actions that the Indiana opioid prescribing requirements that have recently been implemented to protect the citizens of its state from opioid-related drug death.
I. Recent Legislative Action Taken to Address Indiana Opioid Prescribing Practices:
On April 26, 2017, Indiana Governor Eric Holcomb signed Senate Enrolled Act 226 (SEA 226) into law. Notably, this legislation followed similar restrictive measures taken in neighboring Ohio and Kentucky to require that their state professional licensing boards act to ensure that licensees qualified to prescribe opioids were doing so in a manner that is consistent with the CDC’s March 2016 guideline.
II. Overview of Indiana Opioid Prescribing Requirements:
The provisions of SEA 226 have been codified as a new chapter to the Indiana Code and is effective on July 1, 2017. The new chapter is Chapter 9.7 Prescribing and Dispensing of Opioids. As Sec. 1 of Chapter 9.7 provides, the term “prescriber” refers to a practitioner who maintains an Indiana controlled substance registration AND a federal Drug Enforcement Administration registration.
Except as provided under Sec. 2(b), an Indiana qualified prescriber may only issue a prescription for an opioid if the following requirements under Sec. 2(a) are met:
“(1) If the prescription is for an adult who is being prescribed an opioid for the first time by the prescriber, the initial prescription may not exceed a seven (7) day supply.
(2) If the prescription is for a child who is less than eighteen (18) years of age, the prescription may not exceed a seven (7) day supply.”
Notably, the restrictions set out under Sec. 2(a) above do not apply if one of the following circumstances outlined under Sec. 2(b)(1) or (2) is met:
“(1) The prescriber is issuing the prescription for the treatment or provision of any of the following:
(B) Palliative care.
(C) Medication-assisted treatment for a substance use disorder.
(D) A condition that is adopted by rule by the medical licensing board under IC 25-22.5-13-8 to be necessary to be exempted from subsection (a).
(2) If, in the professional judgment of a prescriber, a patient requires more than the prescription limitations specified in subsection (a).”
As the code provisions further reflect, an Indiana prescriber must take care whenever issuing a prescription under the exceptions discussed above in Sec. 2(b)(1) and Sec. 2(b)(2). Under the provisions of Sec.2(c), if a prescriber:
“(1) determines that a drug other than an opioid is not appropriate; and
(2) uses an exemption specified in subsection (b)(1)(B) or (b)(2) and issues a prescription for a patient that exceeds the limitations set forth in subsection (a);”
The prescriber is required to carefully document in the patient’s medical record the reasons(s) why a drug other than an opiate was not appropriate in the care and treatment of a particular patient. Additionally, the prescriber must document that the patient is receiving palliative care or that the decision is based on the prescriber’s professional judgment that the exemption is reasonable and appropriate.
An interesting component of the Indiana opioid prescribing requirements is that a prescriber is obligated, if requested by a patient, the patient’s legal representative or guardian, to issue an opioid prescription for a lesser amount that the prescriber initially intended to prescribe. The prescriber must also document in the patient’s medical records that such a request was made and who made it.
Physicians, nurse practitioners and physician assistants authorized to prescribe controlled substances (especially opioids) need to review both the CDC guidance and any state requirements that have been issued to protect both patients and the public from abuse and diversion. Your prescribing practices are continuously being monitored by Medicare, Medicaid and private payors. You should monitor and audit your practices as part of your overall Compliance Program. To the extent that your prescribing practices are different from those of your peers, there is a significant likelihood in today’s enforcement environment that you will be audited.
Should you receive an audit request from a NBI MEDIC, UPIC or ZPIC we strongly recommend that you contract a qualified health lawyer to advise you regarding the records submission and appeals process. This initial level of the audit is a provider’s best opportunity to present his / her arguments in support of payment in a positive light.
Robert W. Liles is Managing Partner at the health law firm, Liles Parker, PLLC. With offices in Washington, DC, Houston, TX, and Baton Rouge, LA, our attorneys represent pain management physicians and practices around the country in connection with Medicare / Medicaid audits, Compliance Plan reviews and state peer review actions. Should you have any questions, please call us for a free consultation. Robert can be reached at: 1 (800) 475-1906.
 Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths — United States, 2010–2015. MMWR Morb Mortal Wkly Rep. ePub: 16 December 2016. DOI: http://dx.doi.org/10.15585/mmwr.mm6550e1
State of Ohio, Board of Pharmacy. “FAQ: New Limits on Prescription Opiates for Acute Pain, Updated 4/3/2017.” http://www.pharmacy.ohio.gov/Documents/Pubs/Special/ControlledSubstances/New%20Limits%20on%20Prescription%20Opiates%20for%20Acute%20Pain%20-%20Frequently%20Asked%20Questions.pdf
 See Kentucky House Bill 333 http://www.lrc.ky.gov/recorddocuments/bill/17RS/HB333/bill.pdf
 HHS OIG. “High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns” (OEI-02-16-00290)(Page 4). 6/21/2016. https://oig.hhs.gov/oei/reports/oei-02-16-00290.pdf
 Lembke A, Chen J. Use of Opioid Agonist Therapy for Medicare Patients in 2013. JAMA Psychiatry. 2016; 73(9): 990-992.
 Ghate SR, Haroutiunian S, Winslow R, McAdam-Marx C. Cost and comorbidities associated with opioid abuse in managed care and Medicaid patients in the United States: a comparison of two recently published studies. Journal of Pain & Palliative Care Pharmacotherapy. 2010 Sep; 24(3): 251-8.