SAMHS Rulemaking

Concise Summary:

: **PLEASE NOTE THAT SHOULD STATE OFFICES EXPERIENCE A DELAYED OPENING ON THURSDAY, FEBRUARY 16, 2017 DUE TO INCLEMENT WEATHER, THE START TIME FOR THE PUBLIC HEARING FOR THE RULES GOVERNING THE CONTROLLED SUBSTANCES PRESCRIPTION MONITORING PROGRAM AND THE PRESCRIPTION OF OPIOID MEDICATIONS CURRENTLY SCHEDULED FOR FEBRUARY 16, 2017 AT 9:00 A.M. WILL MOVE TO 1:00 P.M. IN THE EVENT STATE OFFICES ARE CLOSED DUE TO INCLEMENT WEATHER ON FEBRUARY 16, 2017, THE HEARING WILL BE RESCHEDULED FOR FRIDAY, FEBRUARY 17, 2017 AT 9:00 A.M. AND THE COMMENT DEADLINE WILL MOVE TO FEBRUARY 27, 2017.** 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). Ch. 488 included 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 Pezullo, 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. In response to all of this, the Department previously adopted an emergency major substantive/routine technical rule that became effective January 1, 2017. This proposed rulemaking makes the following changes: (1) Adds definitions (including definitions for "acute pain", Benzodiazepine, chronic pain, hospital, inpatient status, opioid medication, serious illness and also includes veterinarians in the definition of prescribers; (2) 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; (3) Requires prescribers, dispensers and veterinarians to register as PMP data requesters; (4) Indicates the statutory requirement regarding electronic prescriptions and waivers of such; (5) Requires that dispensers report information to the PMP by electronic means and indicates the statutory waivers of such; (6) Requires prescribers, dispensers and veterinarians to check the PMP system; (7) Indicates the statutory limits on opioid medication prescribing; (8) Defines exemptions to limits on opioid medication prescribing; (9) 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; (10) Establishes civil violations for prescribers and dispensers; (11) Establishes administrative sanctions for prescribers and dispensers; (12) Establishes standards for immunity from liability for disclosure of information; (13) 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; (14) Authorizes the Department to verify and audit prescriber and dispenser compliance with the rules; and (15) Additional minor technical edits. The Maine Legislature has designated the PMP regulations as major substantive rules. 22 M.R.S. Sec. 7252. However, Ch. 488 assigned some of its PMP rule changes as routine technical rules. Therefore, the proposed rule contains both major substantive provisions and routine technical provisions. The routine technical provisions are so labeled in the rule. Pursuant to 5 M.R.S. Sec. 8054, the emergency routine technical rule provisions are effective for up to 90 days. 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. The Department is now engaging in a single rulemaking which will make permanent the emergency routine technical rule provisions and which will also provisionally adopt the emergency major substantive rule provisions, which will then be submitted to the Maine Legislature for its review. See http://www.maine.gov/dhhs/oms/rules/index.shtml for rules and related rulemaking documents. STATUTORY AUTHORITY: 22 M.R.S. 7252, P.L. 2015, ch. 488 PUBLIC HEARING: Date: Thursday, February 16, 2017 **PLEASE NOTE THAT SHOULD STATE OFFICES EXPERIENCE A DELAYED OPENING ON THURSDAY, FEBRUARY 16, 2017, DUE TO INCLEMENT WEATHER THE START TIME FOR THE PUBLIC HEARING FOR THE RULES GOVERNING THE CONTROLLED SUBSTANCES PRESCRIPTION MONITORING PROGRAM AND THE PRESCRIPTION OF OPIOID MEDICATIONS CURRENTLY SCHEDULED FOR FEBRUARY 16, 2017 AT 9:00 A.M. WILL MOVE TO 1:00 P.M. IN THE EVENT STATE OFFICES ARE CLOSED DUE TO INCLEMENT WEATHER ON FEBRUARY 16, 2017, THE HEARING WILL BE RESCHEDULED FOR FRIDAY, FEBRUARY 17, 2017 AT 9:00 A.M.** Time: 9:00 AM Location: Conference Room 209B Augusta Armory, 179 Western Avenue Augusta, ME 04330 The Department requests that any interested party requiring special arrangements to attend the hearing contact the agency person listed below before February 5, 2017.

Concise Summary:

In the event that State offices are closed on Monday, February 13, 2017, due to inclement weather, the Public Hearing for the Rules Governing the Controlled Substances Prescription Monitoring Program and the Prescription of Opioid Medications, currently scheduled for February 13, 2017, at 9:00 a.m. will be postponed until Thursday, February 16th, 2017, at 9:00 a.m. The hearing will be held in Conference Room 209B, Augusta Armory, 179 Western Ave, Augusta ME, 04330. 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). Ch. 488 included 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 Pezullo, 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. In response to all of this, the Department previously adopted an emergency major substantive/routine technical rule that became effective January 1, 2017. This proposed rulemaking makes the following changes: (1) Adds definitions (including definitions for "acute pain", Benzodiazepine, chronic pain, hospital, inpatient status, opioid medication, serious illness and also includes veterinarians in the definition of prescribers; (2) 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; (3) Requires prescribers, dispensers and veterinarians to register as PMP data requesters; (4) Indicates the statutory requirement regarding electronic prescriptions and waivers of such; (5) Requires that dispensers report information to the PMP by electronic means and indicates the statutory waivers of such; (6) Requires prescribers, dispensers and veterinarians to check the PMP system; (7) Indicates the statutory limits on opioid medication prescribing; (8) Defines exemptions to limits on opioid medication prescribing; (9) 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; (10) Establishes civil violations for prescribers and dispensers; (11) Establishes administrative sanctions for prescribers and dispensers; (12) Establishes standards for immunity from liability for disclosure of information; (13) 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; (14) Authorizes the Department to verify and audit prescriber and dispenser compliance with the rules; and (15) Additional minor technical edits. The Maine Legislature has designated the PMP regulations as major substantive rules. 22 M.R.S. Sec. 7252. However, Ch. 488 assigned some of its PMP rule changes as routine technical rules. Therefore, the proposed rule contains both major substantive provisions and routine technical provisions. The routine technical provisions are so labeled in the rule. Pursuant to 5 M.R.S. Sec. 8054, the emergency routine technical rule provisions are effective for up to 90 days. 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. The Department is now engaging in a single rulemaking which will make permanent the emergency routine technical rule provisions and which will also provisionally adopt the emergency major substantive rule provisions, which will then be submitted to the Maine Legislature for its review. See http://www.maine.gov/dhhs/oms/rules/index.shtml for rules and related rulemaking documents. STATUTORY AUTHORITY: 22 M.R.S. § 7252, P.L. 2015, ch. 488 PUBLIC HEARING: Date: Monday, February 13, 2017 **PLEASE NOTE THAT IN THE EVENT OF SEVERE WEATHER THE HEARING WILL BE RESCHEDULED FOR THURSDAY, FEBRUARY 16, 2017 AT THE SAME TIME AND LOCATION.** Time: 9:00 AM Location: Conference Room 209B Augusta Armory, 179 Western Avenue Augusta, ME 04330 The Department requests that any interested party requiring special arrangements to attend the hearing contact the agency person listed below before February 5, 2017. DEADLINE FOR COMMENTS: Comments must be received by 11:59 PM on February 23, 2017 **PLEASE NOTE THAT IN THE EVENT THAT THE HEARING IS RESCHEDULED TO THURSDAY, FEBRUARY 16TH DUE TO SEVERE WEATHER, THE COMMENT DEADLINE WILL BE 11:59 PM ON FEBRUARY 26, 2017.

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). Ch. 488 included 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 Pezullo, 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. In response to all of this, the Department previously adopted an emergency major substantive/routine technical rule that became effective January 1, 2017. This proposed rulemaking makes the following changes: (1) Adds definitions (including definitions for "acute pain", Benzodiazepine, chronic pain, hospital, inpatient status, opioid medication, serious illness and also includes veterinarians in the definition of prescribers; (2) 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; (3) Requires prescribers, dispensers and veterinarians to register as PMP data requesters; (4) Indicates the statutory requirement regarding electronic prescriptions and waivers of such; (5) Requires that dispensers report information to the PMP by electronic means and indicates the statutory waivers of such; (6) Requires prescribers, dispensers and veterinarians to check the PMP system; (7) Indicates the statutory limits on opioid medication prescribing; (8) Defines exemptions to limits on opioid medication prescribing; (9) 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; (10) Establishes civil violations for prescribers and dispensers; (11) Establishes administrative sanctions for prescribers and dispensers; (12) Establishes standards for immunity from liability for disclosure of information; (13) 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; (14) Authorizes the Department to verify and audit prescriber and dispenser compliance with the rules; and (15) Additional minor technical edits. The Maine Legislature has designated the PMP regulations as major substantive rules. 22 M.R.S. Sec. 7252. However, Ch. 488 assigned some of its PMP rule changes as routine technical rules. Therefore, the proposed rule contains both major substantive provisions and routine technical provisions. The routine technical provisions are so labeled in the rule. Pursuant to 5 M.R.S. Sec. 8054, the emergency routine technical rule provisions are effective for up to 90 days. 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. The Department is now engaging in a single rulemaking which will make permanent the emergency routine technical rule provisions and which will also provisionally adopt the emergency major substantive rule provisions, which will then be submitted to the Maine Legislature for its review. See http://www.maine.gov/dhhs/oms/rules/index.shtml for rules and related rulemaking documents. STATUTORY AUTHORITY: 22 M.R.S. § 7252, P.L. 2015, ch. 488 PUBLIC HEARING: Date: Monday, February 13, 2017 Time: 9:00 AM Location: Conference Room 209B Augusta Armory 179 Western Ave Augusta, ME 04330 The Department requests that any interested party requiring special arrangements to attend the hearing contact the agency person listed below before February 5, 2017.

: **PLEASE NOTE THAT SHOULD STATE OFFICES EXPERIENCE A DELAYED OPENING ON THURSDAY, FEBRUARY 16, 2017 DUE TO INCLEMENT WEATHER, THE START TIME FOR THE PUBLIC HEARING FOR THE RULES GOVERNING THE CONTROLLED SUBSTANCES PRESCRIPTION MONITORING PROGRAM AND THE PRESCRIPTION OF OPIOID MEDICATIONS CURRENTLY SCHEDULED FOR FEBRUARY 16, 2017 AT 9:00 A.M. WILL MOVE TO 1:00 P.M. IN THE EVENT STATE OFFICES ARE CLOSED DUE TO INCLEMENT WEATHER ON FEBRUARY 16, 2017, THE HEARING WILL BE RESCHEDULED FOR FRIDAY, FEBRUARY 17, 2017 AT 9:00 A.M. AND THE COMMENT DEADLINE WILL MOVE TO FEBRUARY 27, 2017.** 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). Ch. 488 included 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 Pezullo, 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. In response to all of this, the Department previously adopted an emergency major substantive/routine technical rule that became effective January 1, 2017. This proposed rulemaking makes the following changes: (1) Adds definitions (including definitions for "acute pain", Benzodiazepine, chronic pain, hospital, inpatient status, opioid medication, serious illness and also includes veterinarians in the definition of prescribers; (2) 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; (3) Requires prescribers, dispensers and veterinarians to register as PMP data requesters; (4) Indicates the statutory requirement regarding electronic prescriptions and waivers of such; (5) Requires that dispensers report information to the PMP by electronic means and indicates the statutory waivers of such; (6) Requires prescribers, dispensers and veterinarians to check the PMP system; (7) Indicates the statutory limits on opioid medication prescribing; (8) Defines exemptions to limits on opioid medication prescribing; (9) 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; (10) Establishes civil violations for prescribers and dispensers; (11) Establishes administrative sanctions for prescribers and dispensers; (12) Establishes standards for immunity from liability for disclosure of information; (13) 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; (14) Authorizes the Department to verify and audit prescriber and dispenser compliance with the rules; and (15) Additional minor technical edits. The Maine Legislature has designated the PMP regulations as major substantive rules. 22 M.R.S. Sec. 7252. However, Ch. 488 assigned some of its PMP rule changes as routine technical rules. Therefore, the proposed rule contains both major substantive provisions and routine technical provisions. The routine technical provisions are so labeled in the rule. Pursuant to 5 M.R.S. Sec. 8054, the emergency routine technical rule provisions are effective for up to 90 days. 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. The Department is now engaging in a single rulemaking which will make permanent the emergency routine technical rule provisions and which will also provisionally adopt the emergency major substantive rule provisions, which will then be submitted to the Maine Legislature for its review. See http://www.maine.gov/dhhs/oms/rules/index.shtml for rules and related rulemaking documents. STATUTORY AUTHORITY: 22 M.R.S. 7252, P.L. 2015, ch. 488 PUBLIC HEARING: Date: Thursday, February 16, 2017 **PLEASE NOTE THAT SHOULD STATE OFFICES EXPERIENCE A DELAYED OPENING ON THURSDAY, FEBRUARY 16, 2017, DUE TO INCLEMENT WEATHER THE START TIME FOR THE PUBLIC HEARING FOR THE RULES GOVERNING THE CONTROLLED SUBSTANCES PRESCRIPTION MONITORING PROGRAM AND THE PRESCRIPTION OF OPIOID MEDICATIONS CURRENTLY SCHEDULED FOR FEBRUARY 16, 2017 AT 9:00 A.M. WILL MOVE TO 1:00 P.M. IN THE EVENT STATE OFFICES ARE CLOSED DUE TO INCLEMENT WEATHER ON FEBRUARY 16, 2017, THE HEARING WILL BE RESCHEDULED FOR FRIDAY, FEBRUARY 17, 2017 AT 9:00 A.M.** Time: 9:00 AM Location: Conference Room 209B Augusta Armory, 179 Western Avenue Augusta, ME 04330 The Department requests that any interested party requiring special arrangements to attend the hearing contact the agency person listed below before February 5, 2017.

In the event that State offices are closed on Monday, February 13, 2017, due to inclement weather, the Public Hearing for the Rules Governing the Controlled Substances Prescription Monitoring Program and the Prescription of Opioid Medications, currently scheduled for February 13, 2017, at 9:00 a.m. will be postponed until Thursday, February 16th, 2017, at 9:00 a.m. The hearing will be held in Conference Room 209B, Augusta Armory, 179 Western Ave, Augusta ME, 04330. 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). Ch. 488 included 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 Pezullo, 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. In response to all of this, the Department previously adopted an emergency major substantive/routine technical rule that became effective January 1, 2017. This proposed rulemaking makes the following changes: (1) Adds definitions (including definitions for "acute pain", Benzodiazepine, chronic pain, hospital, inpatient status, opioid medication, serious illness and also includes veterinarians in the definition of prescribers; (2) 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; (3) Requires prescribers, dispensers and veterinarians to register as PMP data requesters; (4) Indicates the statutory requirement regarding electronic prescriptions and waivers of such; (5) Requires that dispensers report information to the PMP by electronic means and indicates the statutory waivers of such; (6) Requires prescribers, dispensers and veterinarians to check the PMP system; (7) Indicates the statutory limits on opioid medication prescribing; (8) Defines exemptions to limits on opioid medication prescribing; (9) 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; (10) Establishes civil violations for prescribers and dispensers; (11) Establishes administrative sanctions for prescribers and dispensers; (12) Establishes standards for immunity from liability for disclosure of information; (13) 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; (14) Authorizes the Department to verify and audit prescriber and dispenser compliance with the rules; and (15) Additional minor technical edits. The Maine Legislature has designated the PMP regulations as major substantive rules. 22 M.R.S. Sec. 7252. However, Ch. 488 assigned some of its PMP rule changes as routine technical rules. Therefore, the proposed rule contains both major substantive provisions and routine technical provisions. The routine technical provisions are so labeled in the rule. Pursuant to 5 M.R.S. Sec. 8054, the emergency routine technical rule provisions are effective for up to 90 days. 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. The Department is now engaging in a single rulemaking which will make permanent the emergency routine technical rule provisions and which will also provisionally adopt the emergency major substantive rule provisions, which will then be submitted to the Maine Legislature for its review. See http://www.maine.gov/dhhs/oms/rules/index.shtml for rules and related rulemaking documents. STATUTORY AUTHORITY: 22 M.R.S. § 7252, P.L. 2015, ch. 488 PUBLIC HEARING: Date: Monday, February 13, 2017 **PLEASE NOTE THAT IN THE EVENT OF SEVERE WEATHER THE HEARING WILL BE RESCHEDULED FOR THURSDAY, FEBRUARY 16, 2017 AT THE SAME TIME AND LOCATION.** Time: 9:00 AM Location: Conference Room 209B Augusta Armory, 179 Western Avenue Augusta, ME 04330 The Department requests that any interested party requiring special arrangements to attend the hearing contact the agency person listed below before February 5, 2017. DEADLINE FOR COMMENTS: Comments must be received by 11:59 PM on February 23, 2017 **PLEASE NOTE THAT IN THE EVENT THAT THE HEARING IS RESCHEDULED TO THURSDAY, FEBRUARY 16TH DUE TO SEVERE WEATHER, THE COMMENT DEADLINE WILL BE 11:59 PM ON FEBRUARY 26, 2017.

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). Ch. 488 included 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 Pezullo, 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. In response to all of this, the Department previously adopted an emergency major substantive/routine technical rule that became effective January 1, 2017. This proposed rulemaking makes the following changes: (1) Adds definitions (including definitions for "acute pain", Benzodiazepine, chronic pain, hospital, inpatient status, opioid medication, serious illness and also includes veterinarians in the definition of prescribers; (2) 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; (3) Requires prescribers, dispensers and veterinarians to register as PMP data requesters; (4) Indicates the statutory requirement regarding electronic prescriptions and waivers of such; (5) Requires that dispensers report information to the PMP by electronic means and indicates the statutory waivers of such; (6) Requires prescribers, dispensers and veterinarians to check the PMP system; (7) Indicates the statutory limits on opioid medication prescribing; (8) Defines exemptions to limits on opioid medication prescribing; (9) 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; (10) Establishes civil violations for prescribers and dispensers; (11) Establishes administrative sanctions for prescribers and dispensers; (12) Establishes standards for immunity from liability for disclosure of information; (13) 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; (14) Authorizes the Department to verify and audit prescriber and dispenser compliance with the rules; and (15) Additional minor technical edits. The Maine Legislature has designated the PMP regulations as major substantive rules. 22 M.R.S. Sec. 7252. However, Ch. 488 assigned some of its PMP rule changes as routine technical rules. Therefore, the proposed rule contains both major substantive provisions and routine technical provisions. The routine technical provisions are so labeled in the rule. Pursuant to 5 M.R.S. Sec. 8054, the emergency routine technical rule provisions are effective for up to 90 days. 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. The Department is now engaging in a single rulemaking which will make permanent the emergency routine technical rule provisions and which will also provisionally adopt the emergency major substantive rule provisions, which will then be submitted to the Maine Legislature for its review. See http://www.maine.gov/dhhs/oms/rules/index.shtml for rules and related rulemaking documents. STATUTORY AUTHORITY: 22 M.R.S. § 7252, P.L. 2015, ch. 488 PUBLIC HEARING: Date: Monday, February 13, 2017 Time: 9:00 AM Location: Conference Room 209B Augusta Armory 179 Western Ave Augusta, ME 04330 The Department requests that any interested party requiring special arrangements to attend the hearing contact the agency person listed below before February 5, 2017.