August 23, 2017

WEEKLY NOTICES OF STATE RULEMAKING
Public Input for Proposed and Adopted Rules

Notices are published each Wednesday to alert the public regarding state agency rulemaking. You may obtain a copy of any rule by notifying the agency contact person. You may also comment on the rule, and/or attend the public hearing. If no hearing is scheduled, you may request one -- the agency may then schedule a hearing, and must do so if 5 or more persons request it. If you are disabled or need special services to attend a hearing, please notify the agency contact person at least 7 days prior to it. Petitions: you can petition an agency to adopt, amend, or repeal any rule; the agency must provide you with petition forms, and must respond to your petition within 60 days. The agency must enter rulemaking if the petition is signed by 150 or more registered voters, and may begin rulemaking if there are fewer. You can also petition the Legislature to review a rule; the Executive Director of the Legislative Council (115 State House Station, Augusta, ME 04333, phone (207) 287-1615) will provide you with the necessary petition forms. The appropriate legislative committee will review a rule upon receipt of a petition from 100 or more registered voters, or from "...any person who may be directly, substantially and adversely affected by the application of a rule..." (Title 5 Section 11112). World-Wide Web: Copies of the weekly notices and the full texts of adopted rule chapters may be found on the internet at: http://www.maine.gov/sos/cec/rules. There is also a list of rulemaking liaisons, who are single points of contact for each agency.

PROPOSALS: no proposals this week

 

ADOPTIONS

AGENCIES:
01-672 - Department of Agriculture, Conservation & Forestry (DACF), Maine Land Use Planning Commission (LUPC)
06-096 - Maine Department of Environmental Protection (DEP)
CHAPTER NUMBERS AND TITLE: Ch. 11 (LUPC) and Ch. 450 (DEP), Administrative Regulations for Hydropower Projects (identical rule texts)
ADOPTED RULE NUMBER: 2017-124, 125
CONCISE SUMMARY: The purpose of the revisions to the Department of Environmental Protection's (the Department or DEP) Ch. 450 rules and the Land Use Planning Commission's (the Commission or the LUPC) Ch. 11 rules is to:
1. Ensure consistency with the authorizing statutes and the DEP's Rules Concerning the Processing of Applications and Other Administrative Matters, 06-096 CMR 2 (Ch. 2);
2. Re-organize to reference the jurisdiction of the Department, including removing any reference to the Board of Environmental Protection;
3. Update to replace references to the Land Use Regulation Commission with the Land Use Planning Commission of the Maine Department of Agriculture, Conservation, and Forestry,
4. Update to include language associated with tidal or wave action; and
5. Clarify the jurisdiction between the Department and Commission.
The rule amendment is also intended to correct outdated and obsolete references and remove ambiguities and redundancies.
EFFECTIVE DATE: November 2, 2017
AGENCY CONTACT PERSONS:
LUPC: Naomi Kirk-Lawlor, Maine Land Use Planning Commission, 22 State House Station, Augusta, Maine 04333-0022. Telephone: (207) 287-4936. Email: Naomi.E.Kirk-Lawlor@Maine.gov .
DEP: Erle Townsend, Department of Environmental Protection, 17 State House Station, Augusta, Maine 04333. Telephone: (207) 287-6115. Email: Erle.Townsend@Maine.gov .
DACF RULEMAKING LIAISON: Mari.Wells@Maine.gov .
DEP RULEMAKING LIAISON: Jeff.S.Crawford@Maine.gov .
LUPC WEBSITE: http://www.maine.gov/dacf/lupc/index.shtml .
DEP WEBSITE: http://www.maine.gov/dep/ .

AGENCY: 14-118 - Department of Health and Human Services (DHHS), Maine Office of Substance Abuse & Mental Health Services (SAMHS)
CHAPTER NUMBER AND TITLE: Ch. 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications
ADOPTED RULE NUMBER: 2017-126 (Final adoption, major substantive)
CONCISE SUMMARY: In an effort to combat the Maine opioid epidemic, the Maine Legislature enacted PL 2015 ch. 488 (An Act to Prevent Opiate Abuse by Strengthening the Controlled Substances Prescription Monitoring Program (PMP)) (Title 22 ch. 1603) to include prescriber limits on opioid medication prescribing, effective January 1, 2017. PL 2015 ch. 488 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 MRS  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 MRS  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:
(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 to 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; and
(15) 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:
(1) 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;
(2) 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;
(3) 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;
(4) 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;
(5) 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
(6) 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.)
(1) Amending the statutory definitions of palliative care, serious illness, and dispenser.
(2) 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.
(3) Amending the statute to clarify that the requirement to check the PMP does not apply for surgical procedures.
(4) 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.
(5) Adding to the list of statutorily allowed individuals who can access PMP information.
(6) 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.
(7) 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.
See http://www.maine.gov/dhhs/oms/rules/index.shtml for rules and related rulemaking documents.
EFFECTIVE DATE: September 16, 2017
AGENCY CONTACT PERSON: Thomas M Leet, Comprehensive Health Planner, Division of Policy, 242 State Street, 11 State House Station, Augusta, Maine 04333-0011. Telephone: (207) 624-4068. Fax: (207) 287-1864. TTY users call Maine relay 711. Email: Thomas.Leet@Maine.gov .
SAMHS WEBSITE: http://www.maine.gov/dhhs/samhs/osa/ .
DHHS RULEMAKING LIAISON: Kevin.Wells@Maine.gov .

AGENCY: 09-137 – Department of Inland Fisheries and Wildlife (IFW)
CHAPTER NUMBER AND TITLE: Ch. 4, Hunting and Trapping: 4.03, Deer Hunting Seasons, C., Special Deer Hunting Districts
ADOPTED RULE NUMBER: 2017-127
CONCISE SUMMARY: In accordance with 12 MRS  11152 sub- 3, the Commissioner of Inland Fisheries and Wildlife has adopted antlerless deer permit numbers for the 2017 regular deer hunting season and special muzzle-loading season by setting specific permit allocations for the 29 Wildlife Management Districts (WMD) as follows:
WMD 1 - 0 permits
WMD 2 - 50 permits
WMD 3 - 75 permits
WMD 4 - 0 permits
WMD 5 - 0 permits
WMD 6 - 225 permits
WMD 7 - 850 permits
WMD 8 - 575 permits
WMD 9 - 200 permits
WMD 10 - 0 permits
WMD 11 - 0 permits
WMD 12 – 725 permits
WMD 13 – 625 permits
WMD 14 - 400 permits
WMD 15 – 2,375 permits
WMD 16 – 4,550 permits
WMD 17 – 6,075 permits
WMD 18 – 150 permits
WMD 19 - 0 permits
WMD 20 – 9,650 permits
WMD 21 – 9,550 permits
WMD 22 – 7,700 permits
WMD 23 – 7,725 permits
WMD 24 – 7,875 permits
WMD 25 – 4,950 permits
WMD 26 – 175 permits
WMD 27 - 50 permits
WMD 28 - 0 permits
WMD 29 –1,500 permits
TOTAL – 66,050
A complete copy of the rule can be obtained from the rulemaking contact person listed below.
EFFECTIVE DATE: August 23, 2017
AGENCY CONTACT PERSON / IFW RULEMAKING LIAISON: Becky Orff, Inland Fisheries and Wildlife, 284 State Street, 41 State House Station, Augusta, ME 04333. Telephone: (207) 287-5202. Email: Becky.Orff@Maine.gov .
IFW WEBSITE: http://www.maine.gov/ifw/ .

AGENCY: 02-313 - Maine Board of Dental Practice (affiliated with the Department of Professional and Financial Regulation)
CHAPTER NUMBER AND TITLE: Ch. 14, Rules for the Use of Sedation and General Anesthesia (repeal and replace)
ADOPTED RULE NUMBER: 2017-128
CONCISE SUMMARY: This effort is a complete repeal and replace of the existing Board Rule and adopts changes as follows:
* Eliminates site permits.
* Eliminates temporary permits.
* Eliminates a board-required inspection prior to issuing permits.
* Eliminates the anesthesia committee.
* Identifies a new permit type to be issued to qualifying dentists such that they can provide itinerate dental sedation and/or general anesthesia services.
* Identifies the dentist's responsibilities when either providing the sedation services or when utilizing a sedation provider (e.g. patient monitoring, equipment, drugs, documentation, certifications, and personnel requirements.
* Requires dentist applicants to self-certify compliance with the sedation rule upon application to the Board.
* Requires 14 day notification to the Board prior to providing services as sedation provider licensed by the Board.
* Permit issued by the Board to transition to a two year permit to align with the dentist licensure cycle.
EFFECTIVE DATE: August 27, 2017
AGENCY CONTACT PERSON / BOARD RULEMAKING LIAISON: Penny Vaillancourt, Executive Director, Maine Board of Dental Practice, 143 State House Station, Augusta, ME 04333-0143. Telephone: (207) 287-3333. Email: Penny.Vaillancourt@Maine.gov .
BOARD WEBSITE: http://www.maine.gov/dental/ .