Maine Office of Substance Abuse & Mental Health Services - Adopted Rule

The Maine Office of Substance Abuse and Mental Health Services has posted an Adopted rule on MaineCare’s Policy and Rules webpage.  Below, please find a copy of the Adopted 14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications.  You can access the complete rule at http://www.maine.gov/dhhs/oms/rules/index.shtml

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Notice of Agency Rule-making Adoption

AGENCY:  Department of Health and Human Services, Maine Office of Substance Abuse & Mental Health Services

CHAPTER NUMBER AND TITLE:  14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications

ADOPTED RULE NUMBER:

CONCISE SUMMARY:  

In an effort to combat the Maine opioid epidemic, the Maine Legislature enacted P.L. 2015, ch. 488 (An Act to Prevent Opiate Abuse by Strengthening the Controlled Substances Prescription Monitoring Program). P.L. 2015, ch. 488 to amend the Prescription Monitoring Program (PMP)(Title 22, Chapter 1603) to include prescriber limits on opioid medication prescribing, effective January 1, 2017; included veterinarians in the definition of prescribers; required electronic prescribing and required prescribers and dispensers to check the Prescription Monitoring Program (PMP) database. Ch. 488 required the Department to establish reasonable exceptions to prescriber limits, and ordered the Department to include prescribers in the process of drafting appropriate exceptions and in the drafting of draft rules. With the guidance of the Maine State Health Officer Dr. Christopher Pezzullo, the Department convened a PMP Stakeholder Group that included the Maine Medical Association, the Maine Hospital Association, the Maine Physician Assistant Association, the Maine Nurse Practitioners Association, the Maine Veterinary Medical Association, the Maine Pharmacy Association, and the Maine Osteopathic Association. This Group met at least once monthly, starting in June, 2016. The Maine Legislature mandated a January 1, 2017, effective date for the limits on opiate prescribing, but also mandated that the Department confer with the PMP Stakeholder Group, which continued to meet and confer until early December.

Although the Maine Legislature in P.L. 2011, ch. 657, Part AA, § 71, as codified in 22 M.R.S. § 7252, designated Prescription Monitoring Program (PMP) rulemaking as major substantive rules, P.L. 2015, ch. 488 designated some of its PMP rule changes as routine technical.

In order to comply with the Legislature’s mandates, including the January 1, 2017 effective date deadline, the Department adopted an Emergency Major Substantive/Routine Technical rule, with an effective date of January 1, 2017. 

Pursuant to 5 M.R.S. Sec. 8073, emergency major substantive rule provisions may be effective for up to twelve months or until the Legislature has completed review of the rules. Pursuant to 5 M.R.S. Sec. 8054, the emergency routine technical rule provisions are effective for up to 90 days.

This rulemaking makes permanent the emergency routine technical rule provisions of the January 1, 2017 emergency rule. 

This rulemaking also provisionally adopts the emergency major substantive rule provisions of the January 1, 2017 emergency rule. This rulemaking will be submitted to the Maine Legislature for its review. Until the Maine Legislature completes its review of this rule, the January 1, 2017 Emergency rule will remain in effect with regard to its major substantive provisions. 

The routine technical provisions of this rule, which are made finally effective by this rulemaking adoption, are bolded in the rule, and also marked “routine technical” in the left hand margin.

A public hearing was held by the Department on February 16, 2017. Additionally, 89 written comments were submitted during the comment period.

This adopted rulemaking makes the following changes:

• Adds definitions (including definitions for “administer”, “acute pain”, “Benzodiazepine”, “chronic pain”, “hospital”,  “opioid medication”, “serious illness” and also includes veterinarians in the definition of “prescribers”;
• Adds general requirements for prescribing and dispensing, including the requirement that all prescribers must acquire DEA numbers and include the DEA number on each prescription, and includes exemption codes to match the exemptions from the opioid limitations set forth in the rule;
• Requires prescribers, dispensers and veterinarians to register as PMP data requesters;
• Requires prescribers include a designation on the prescription as to whether the prescription is for the treatment of acute or chronic pain. 
• Indicates the statutory requirement regarding electronic prescriptions and waivers of such;
• Requires that dispensers report information to the PMP by electronic means and indicates the statutory waivers of such;
• Requires prescribers, dispensers and veterinarians to check the PMP system;
• Indicates the statutory limits on opioid medication prescribing;
• Defines exemptions to limits on opioid medication prescribing;
• Authorizes the Department to provide and receive PMP data from another state or Canadian province that has entered into an agreement with the Department for such sharing;
• Establishes civil violations for prescribers and dispensers;
• Establishes administrative sanctions for prescribers and dispensers;
• Establishes standards for immunity from liability for disclosure of information;
• Establishes standards for immunity from liability for a pharmacists which might result from dispensing medication in excess of the limit, if such dispensing was done in accordance with a prescription issued by a practitioner;
• Authorizes the Department to verify and audit prescriber and dispenser compliance with the rules; and

Finally, as a result of public comments and further review by the Department and the Office of the Attorney General, there were additional technical changes, formatting updates, and changes to language for clarity. The Summary of Public Comments and Department Responses document identifies any changes that were made to the final rule.

http://www.maine.gov/dhhs/oms/rules/index.shtml for rules and related rulemaking documents.

EFFECTIVE DATE:                          March 31, 2017

AGENCY CONTACT PERSON:      Thomas M Leet, Comprehensive Health Planner

AGENCY NAME:                              Division of Policy

ADDRESS:                                         11 State House Station

                                                            Augusta, Maine 04333-0011

            Email: Thomas.Leet@maine.gov

TELEPHONE:                                   (207)-624-4068 FAX: (207) 287-1864

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