Beginning on January 1, 2017, the Maine Department of Health and Human Services (“DHHS”) issued emergency rules implementing significant changes to the Prescription Monitoring Program (“PMP”) and imposing opioid prescribing requirements created by the Legislature. Since then, DHHS and the Legislature have been busy with DHHS gathering comments on the rules and revising the rules, and the Legislature reviewing the rules and making additional changes to the PMP and opioid prescribing statutes.
The latest activity occurred on August 14, when DHHS issued a Finally Adopted Major Substantive Rule and Routine Technical Rule (“Final Rule”) concerning the PMP and opioid prescribing (available at: http://www.maine.gov/tools/whatsnew/attach.php?id=764394&an=2). This round of rulemaking is intended to incorporate legislative activity from the most recent legislative session and incorporate comments submitted by the public to the original January 1 emergency rules. The Final Rule goes into effect on September 16. However, the legislative changes underlying the changes to the Final Rules are already effective. Providers should be following the statutes even though their incorporation into the Final Rule is not yet effective.
To set the stage, these statutes and rules impose the following general requirements on prescribers and dispensers with respect to opioids:
- Individual patients are limited to an aggregate daily level of 100 morphine milligram equivalent (“MME”), unless an exception applies, such as certain prescribing for palliative care.
- Prescribers may not prescribe more than a 30-day supply of opioids for chronic pain, nor more than a 7-day supply of opioids for acute pain.
- Prescribers and dispensers must register with the PMP. Except in limited circumstances, prescribers and dispensers must check the PMP to ensure that the patient is not exceeding the daily MME limit, if applicable, and to see how many prescribers are prescribing controlled substances to the patients and the number of pharmacies filling these prescriptions. Dispensers must also contact the prescriber if the dispenser has reason to believe the prescription is fraudulent or duplicative.
- Prescribers must prescribe opioids electronically and dispensers must process electronic prescriptions. A waiver from DHHS may be available for those who lack the capability to prescribe electronically or process electronic prescriptions.
The changes in the statute and Final Rule do not alter the overall regulatory scheme, but the changes should be reviewed by providers. The primary changes are the following:
- The definition of “dispenser” is narrowed to only include pharmacists. Previously, it included health care providers who dispensed and administered medications, which created confusion among the provider community. Providers who are not pharmacists are no longer required to check the PMP as a dispenser in addition to checking the PMP as a prescriber.
- The definitions of “palliative care” and “serious illness” have been changed, which implicates the palliative care daily MME exemption (“palliative care in conjunction with a serious illness”). The “palliative care” definition has been revised to clarify that such care does not need to be provided in conjunction with hospice care or spiritual needs. The “serious illness” definition is broadened to include “chronic, unremitting or intractable pain such as neuropathic pain.” Taken together, it appears the intent of the Legislature is to give providers more flexibility to go over the daily 100 MME limit for patients with chronic pain.
- If a patient is prescribed a second, different opioid after showing an intolerance of an initial opioid prescription, the patient no longer needs to bring the unused medication to the pharmacy. Now, the pharmacist only needs to counsel the patient on proper disposal of the initial prescription.
- Dispensers may provide early refills if the dispenser determines that the early refill does not represent a pattern of early refill requests by the patient.
- The Final Rule confirms that dispensers may contact prescribers by phone to confirm prescription information. This change does not really change the legal landscape: dispensers generally could already do this.
- With respect to prescriptions issued by out-of-state prescribers that do not meet Maine’s prescribing requirements, a dispenser may fill the prescription by obtaining verbal confirmation of the prescription’s validity from the prescriber. The dispenser must make a reasonable effort to verify the identity of the prescriber or the prescriber’s agent that gave the confirmation.
- The requirement that dispensers provide the PMP with ICD-10 codes for prescriptions that exceed the MME daily limit under the palliative care exemption is suspended until July 1, 2018.
- Controlled substances dispensed by hospital emergency departments for use by a patient within 48 hours no longer need to be reported to the PMP by the dispenser.
- Authorized staff members of physician practices may access the PMP on behalf of a prescriber in the practice to obtain PMP information for a practice patient.
- The daily MME exemption for pain associated with cancer care no longer expires six months post-remission.
- The daily MME limit does not apply to ordering or administering opioids and benzodiazepines in connection with a surgical procedure.
- The PMP no longer needs to be checked for surgical procedures in a hospital.
- Providers may prescribe more than a 7-day supply of opioids for acute pain if the opioid product is labeled by the Food and Drug Administration to be dispensed only in a stock bottle that exceeds a 7-day supply, in which case up to a 14-day supply may be dispensed.
Health care providers are strongly encouraged to study these revisions carefully and implement necessary changes into their policies and procedures, train prescribers and dispensers, and take other necessary steps to ensure compliance. Providers should also continue to monitor the PMP website for new information. It is likely that clarifications will be issued to address questions raised by providers, patients, and advocacy groups concerning the Final Rule.
Should you have any questions about the legal issues associated with the Final Rule or legislative changes to these prescribing statutes, please contact Ben Townsend (email@example.com), Mike Burian (firstname.lastname@example.org), Taylor Fawns (email@example.com), or Steve Johnson (firstname.lastname@example.org) by email or at 207-621-4390.