SAMHS Adopted Rules

14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications WORD  PDF 
Concise Summary: Please note that this rule becomes effective 30 days after it is filed with the Secretary of State’s Office. 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 State of Maine 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, 2016. In order to comply with the Legislature’s mandates, including the January 1, 2017 effective date, 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. The Department engaged in rulemaking to make permanent the emergency routine technical rule provisions of the January 1, 2017 emergency rule. That rulemaking also provisionally adopted the emergency major substantive rule provisions of the January 1, 2017 emergency rule. This rulemaking was submitted to the Maine Legislature for its review. The routine technical provisions of the rule, which were made finally effective by the emergency rulemaking, are bolded in the rule text, and also marked “routine technical” in the left hand margin. The Department held a public hearing on February 16, 2017. Additionally, 89 written comments were submitted during the comment period. This finally adopted rulemaking makes the following changes: (16) 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”; (17) 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; (18) Requires prescribers, dispensers, and veterinarians to register as PMP data requesters; (19) Requires prescribers to include a designation on the prescription as to whether the prescription is for the treatment of acute or chronic pain. (20) Indicates the statutory requirement regarding electronic prescriptions and waivers of such; (21) Requires that dispensers report information to the PMP by electronic means and indicates the statutory waivers of such; (22) Requires prescribers, dispensers and veterinarians to check the PMP system; (23) Indicates the statutory limits on opioid medication prescribing; (24) Defines exemptions to limits on opioid medication prescribing; (25) 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; (26) Establishes civil violations for prescribers and dispensers; (27) Establishes administrative sanctions for prescribers and dispensers; (28) Establishes standards for immunity from liability for disclosure of information; (29) 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; and (30) Authorizes the Department to verify and audit prescriber and dispenser compliance with the rules. Additionally, 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. The Maine State Legislature conducted a major substantive review of this rulemaking following the provisional adoption on March 31, 2017, and made additional changes to the rule, per Resolves 2017, Ch. 16. Those changes include: (7) In Section 4, subsection A, paragraph 4, subparagraph b, division (i) in the portion of the rule that is a routine technical rule, Exemption Code A for active and aftercare cancer treatment, the 6-month limit for aftercare cancer treatment post remission has been removed; (8) In Section 4, subsection A, paragraph 4, subparagraph b, division (i) in the portion of the rule that is a routine technical rule, Exemption Code H has been amended to provide that if an individual is prescribed a 2nd opioid after proving unable to tolerate a first opioid, the individual is not required to return the initial prescription to a pharmacy for collection prior to dispensation of the 2nd prescription. Language has also been added requiring dispensers to provide patients with guidance on proper disposal of the first opioid prescription; (9) In Section 4, subsection B of the rule, a new paragraph 3 has been added to allow for dispensers to provide an early refill of a prescription to an individual before the refill date if, in the judgment of the dispenser, the early refill does not represent a pattern of early refill requests by the individual; (10) In Section 4, subsection B of the rule, a new paragraph 4 has been added to allow for dispensers to contact prescribers by telephone to verify and document information about prescriptions; (11) In Section 4, subsection B of the rule, a new paragraph 5 has been added to establish a process for a dispenser who receives a prescription for an opioid medication from an out-of-state prescriber that does not comply with Department rules. The section allows the dispenser to fill the prescription if the dispenser records an oral confirmation with the validity of the prescription from the out-of-state prescriber and documents any missing information such as diagnosis code, exemption code, and acute or chronic pain notation and the dispenser makes a reasonable effort to determine that the oral confirmation came from the prescriber or prescriber's agent, which may include a telephone call to the prescriber's telephone number listed in a telephone directory or other directory; and (12) In Section 5, subsection C, paragraph 1, subparagraph n of the rule, the requirement for dispensers to provide information to the Prescription Monitoring Program on the exemption code and ICD-10 code has been delayed until July 1, 2018 and a provision was added to authorize a waiver after that date from the Department for dispensers who are unable with good cause to comply with the requirement. Finally, the Maine Legislature enacted PL 2017, ch. 213, on June 16, 2017. This legislation amended sections of Maine Statute that govern these Ch. 11 rules. Those changes include: (Please note that because there are section in the rule that reference statute, no changes to the rule text were made in those instances, however the underlying statutory language changes will impact operation of this rule.) (8) Amending the statutory definitions of palliative care, serious illness, and dispenser. (9) Removing the statutory requirement that dispensers must submit Prescription Monitoring Program (PMP) information to the Department regarding controlled substances that are dispensed by a hospital emergency department for use during a period of forty-eight (48) hours or less. (10) Amending the statute to clarify that the requirement to check the PMP does not apply for surgical procedures. (11) Adding language to the statute clarifying that directly ordering or administering an opioid or benzodiazepine in connection with surgical procedures is exempt from the one hundred (100) morphine milligram equivalents limitation. (12) Adding to the list of statutorily allowed individuals who can access PMP information. (13) Removing the statutory requirement that dispensers must notify the PMP program if the dispenser has reason to believe the prescription is fraudulent or duplicative, while maintaining the requirement that the dispenser contact the prescriber. (14) Clarifying that an opioid medication that, according to federal Food and Drug Administration labeling, is to be dispensed only in a stock bottle with a supply exceeding 7 days, may be dispensed in accordance with the stock supply, so long as the amount dispensed does not exceed a 14 day supply. As a result of final legal review by the Office of the Attorney General the necessary corrections and additions to the rule were made to be consistent with Maine law as explained above. These finally adopted major substantive rule changes will be effective 30 days after the rule is filed with the Secretary of State, or at a later date as specified by the Department. http://www.maine.gov/dhhs/oms/rules/index.shtml for rules and related rulemaking documents.
Effective Date: September 16, 2017
View Comments: COMMENTS  Posted: August 22, 2017
 

SAMHS Provisionally Adopted Rules

14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications WORD  PDF 
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: (1) 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”; (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) Requires prescribers include a designation on the prescription as to whether the prescription is for the treatment of acute or chronic pain. (5) Indicates the statutory requirement regarding electronic prescriptions and waivers of such; (6) Requires that dispensers report information to the PMP by electronic means and indicates the statutory waivers of such; (7) Requires prescribers, dispensers and veterinarians to check the PMP system; (8) Indicates the statutory limits on opioid medication prescribing; (9) Defines exemptions to limits on opioid medication prescribing; (10) 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; (11) Establishes civil violations for prescribers and dispensers; (12) Establishes administrative sanctions for prescribers and dispensers; (13) Establishes standards for immunity from liability for disclosure of information; (14) 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; (15) 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
View Comments: COMMENTS  Posted: March 31, 2017
 

SAMHS Proposed Rulemaking

POSSIBLE RESCHEDULE OF 14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications WORD PDF   
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.
Submit Comments (Opens in new window) - Comment Deadline: February 26, 2017 Posted: February 14, 2017
 
POSSIBLE RESCHEDULE OF 14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications WORD PDF   
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.
Submit Comments (Opens in new window) - Comment Deadline: February 23, 2017 or February 26, 2017 if hearing is rescheduled Posted: February 10, 2017
 
14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications WORD PDF   
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.
Submit Comments (Opens in new window) - Comment Deadline: February 23, 2017 Posted: January 23, 2017
 

SAMHS Emergency Rulemaking

14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications WORD PDF   
Concise Summary: Pursuant to 5 M.R.S. Sections 8054 and 8073, the Department has determined that immediate adoption of this rule is necessary to avoid an immediate threat to public health, safety or general welfare and the Department’s findings of emergency are as follows: There is an opioid epidemic facing the State of Maine and the nation as a whole. In 2015, Maine experienced an unprecedented 272 overdose related fatalities. 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, 2016, 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. This, together with the opioid epidemic facing the State of Maine, constitutes an emergency that can only be remedied by the immediate adoption of this emergency rule. This emergency rule is effective January 1, 2017. This emergency rule 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; and (14) Authorizes the Department to verify and audit prescriber and dispenser compliance with the rules. 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, this emergency 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 intends to engage 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. HTTP://WWW.MAINE.GOV/DHHS/OMS/RULES/INDEX.SHTML for rules and related rulemaking documents.
Submit Comments (Opens in new window) - No comment deadline Posted: January 1, 2017