Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 101 - MAINECARE BENEFITS MANUAL (FORMERLY MAINE MEDICAL ASSISTANCE MANUAL) › Chapter II - Specific Policies By Service › Section 144-101-II-80 - Pharmacy Services › Subsection 144-101-II-80.04 - PHARMACY COMMITTEES

Current through 2024-29, July 17, 2024
80.04-1
Drug
					 Utilization Review (DUR) Committee
A.
Purpose
The purpose of the Drug Utilization Review (DUR)
						Committee is to provide advice to the OMS on prescription drug utilization with
						the goal of assuring that prescriptions are appropriate, medically necessary,
						and not likely to result in adverse results. The DUR Committee is created in
						compliance with OBRA 90 as amended (Title XIX, Section 1927 ).
B.
Membership
The Director of the OMS will appoint DUR Committee
						members. The Committee shall consist of at least the following members, to be
						composed as follows:
1. A minimum of
					 four members shall be allopathic physicians currently licensed and actively
					 practicing medicine in Maine.
2.
					 One member shall be an osteopathic physician currently licensed and actively
					 practicing medicine in Maine.
3.
					 Three members shall be pharmacists currently licensed and actively practicing
					 pharmacy in Maine.
4. One member
					 shall be a designated pharmacy physician consultant.
5. One member shall be either a hospital
					 pharmacist who is currently licensed and actively practicing pharmacy in Maine
					 or a pharmacist with pharmacy benefit management experience. The OMS Director
					 may also require a hospital pharmacy background.
6. One pharmacist shall have been nominated
					 by the DUR.
7. The Department shall
					 be represented by at least one person employed by the Department and may
					 include the MaineCare Medical Director or MaineCare Pharmacy Director.
					 Department representatives will be available to provide information on policy
					 and legislative changes, and assist the Board as needed.
The Department representative will support the DUR in
						assuring that DUR initiated policy, programmatic and system configuration
						changes are implemented. Department representatives are not considered voting
						members.
C.
Method of Selection
The Director of the OMS shall choose appointed members of
						the DUR Committee from lists of nominees presented by the following groups. The
						Director may elect not to appoint from a list if no nominee on the list is
						acceptable to the Director. (These lists shall contain sufficient numbers of
						nominees in order to allow the OMS Director flexibility in selecting a
						Committee with diverse membership):
1.
					 The physicians may be nominated by the Maine Medical Association, the DUR
					 Committee, and other state medical societies including the Nursing Home Medical
					 Director Association.
2. The
					 osteopathic member may be nominated by the Maine Osteopathic Association, other
					 medical societies, or the DUR Committee.
3. The pharmacists shall be nominated by the
					 Maine Pharmacy Association or the DUR Committee.
4. The hospital pharmacist or pharmacist with
					 pharmacy benefit management (PBM) experience shall be nominated by the Maine
					 Society of Hospital Pharmacists or the DUR Committee.
5. The Committee may nominate candidates for
					 ad-hoc specialty committees to offer advice on an as needed basis.
D.
Terms of
					 Appointment
Members of the DUR Committee shall be appointed to terms
						as follows:
1. All physician and
					 pharmacist members are appointed for three-year terms.
2. All vacancies shall be filled by the
					 appointment of a person to fill the remainder of the term. Such person shall be
					 from the same category as the person replaced.
3. No appointed person may serve more than
					 three terms, except that appointees with initial terms of less than three years
					 may be reappointed for three subsequent full three-year terms.
4. Except as otherwise noted, all subsequent
					 appointments shall be for three-year terms.
5. In order to ensure the successful,
					 uninterrupted operation of the DUR Committee, if no qualified and willing
					 candidates are found, Committee members with expired appointments may have
					 their term extended at the discretion of the OMS Director until such time as a
					 suitable replacement is obtained.
E.
Operation of the DUR
					 Committee
The DUR Committee shall develop and adopt formal policies
						and procedures for its use. These policies shall include but not be limited
						to:
1. Selection of a
					 chairperson;
2. Setting a schedule
					 for regular meetings, (at least quarterly);
3. Setting quorum requirements;
4. Publishing notices of meetings;
5. Ensuring that all DUR activities will be
					 consistent with confidentiality requirements of the DHHS, including 42 C.F.R.
					 431, sub part F;
6. Establishing,
					 as needed, regional DUR committees to assist the DUR Committee in its
					 evaluations;
7. Establishing
					 procedures for appeal of its decisions;
8. Preparing and disseminating its
					 minutes;
9. Agreeing to use a
					 consensus process to resolve differences between source materials;
					 and
10. Providing direction for the
					 preparation and approval of its annual report.
F.
Functions and
					 Responsibilities
The DUR Committee shall be responsible for the following
						duties and functions:
1. In compliance
					 with Federal and State requirements, the DUR Committee shall determine policy,
					 procedures, and standards for the implementation of MaineCare DUR process, the
					 primary focus of which shall be the utilization of drugs and education of
					 providers and members to maximize the quality of care provided. The DUR may
					 also review drug utilization from other pharmacy benefits. The DUR will make
					 recommendations to the Department as to which drugs require prior authorization
					 and the prior authorization criteria for those drugs. The DUR Committee will
					 also review new drugs for Preferred Drug List (PDL) status.
2. The DUR shall develop and maintain a
					 working agreement with related Boards, agencies or societies, including, but
					 not limited to: the Board of Commissioners of the Profession of Pharmacy, the
					 Maine Board of Osteopathic Medicine, the Board of Registration in Medicine,
					 Program Integrity staff, the Maine Medical Association, the Maine Osteopathic
					 Association, and the staff of the Office of MaineCare Services, in order to
					 clarify the areas of responsibility for each.
3. The DUR Committee shall develop a drug
					 utilization review process in accordance with the following:
a. The DUR Committee shall develop parameters
					 in accordance with Federal guidelines to perform on-going periodic examination
					 of claims data and other records in order to identify patterns of fraud, abuse,
					 gross overuse or inappropriate or medically unnecessary care among physicians,
					 pharmacists, and MaineCare members.
b. The DUR Committee shall establish
					 standards of review based upon compendia that shall consist of at least the
					 following:
i. American Society of Hospital
					 Pharmacists Formulary Service;
ii.
					 United States Pharmacopoeia Drug Information;
iii. American Medical Association Drug
					 Evaluations; and
iv. Current
					 peer-reviewed literature.
c. The DUR Committee shall resolve, by
					 consensus, any discrepancies in the compendia.
4. The DUR Committee shall:
a. Submit recommendations to the OMS for
					 policy changes for more efficient management of services,
b. Provide for on-going intervention for
					 members, physicians, and pharmacists targeted toward therapy problems,
					 including individuals identified in the course of drug reviews performed under
					 this section. Such interventions shall include in the appropriate instances the
					 following:
i. Information to physicians and
					 pharmacists concerning the DUR Committee's duties and the profile for its
					 standards;
ii. Written, oral, or
					 electronic reminders concerning patient-specific or drug-specific (or both)
					 information with suggested changes in prescribing or dispensing practices,
					 communicated in a manner designated to ensure the privacy of member related
					 information.
c. Use
					 face-to-face discussions between health care professionals who are experts in
					 rational drug therapy and selected prescribers and pharmacists who have been
					 targeted for educational intervention, including discussion of optimal
					 prescribing, dispensing, or pharmacy care practices, and follow-up face-to-face
					 discussions;
d. Provide intensified
					 review or monitoring of selected members, prescribers or dispensers;
					 and
e. Reevaluate interventions
					 after an appropriate time to determine if the intervention improved the quality
					 of drug therapy, to evaluate the success of the interventions and to recommend
					 modifications as necessary.
5. The DUR Committee shall:
a. Review new drugs for Preferred Drug List
					 (PDL) status and make determinations no later than six (6) months after their
					 entry onto the market.
b. In making
					 a determination of PDL status, the DUR Committee shall consider whether a new
					 drug is:
i. therapeutically equivalent or
					 superior to existing preferred or non-preferred choices; and
ii. as safe or safer than existing preferred
					 or non-preferred choices; and
iii.
					 whether the net cost, adjusted for all rebates, is less expensive than all
					 existing PDL choices.
c.
					 The Department will designate new drug entities as follows:
i. If the FDA classifies a new medication as
					 a priority drug, the Department may indicate that such a drug is preferred
					 until the DUR Committee reviews the drug; or
ii. The Department may also decide to
					 designate a new drug as "draft preferred" and provide immediate temporary
					 access and increased therapeutic choice to physicians until the drug is
					 reviewed; or
iii. The Department
					 will designate new drug entities as non-preferred by default until the DUR
					 Committee has completed the PDL review.
6. The DUR Committee shall prepare and submit
					 a report to the OMS Director not less frequently than annually that shall
					 include a description of the Committee's activities, including the nature and
					 scope of the prospective and retrospective drug utilization review along with
					 the DUR Committee's recommendations, a summary of the interventions on quality
					 of care, and an estimate of the savings generated as result.
7. Other reports and data shall be provided
					 by the DUR Committee to the State at such time and in such format as the United
					 States Secretary of Health and Human Services shall require from the
					 State.
G.
Confidentiality
The DUR Committee shall perform its duties in compliance
						with the confidentiality policies and rules of the OMS, including 42 C.F.R. b
						431, sub part F and of other Maine boards of registration.
H.
Independence of the DUR
					 Committee
The DUR Committee's relationship to the OMS's Program
						Integrity Unit and to physician and pharmacist regulatory boards shall be as
						follows:
1. The DUR Committee shall
					 not directly participate in any Program Integrity Unit fraud or abuse operation
					 or activities except to the extent that educational materials prepared by the
					 DUR Committee are provided to the OMS, as they are provided, members, and to
					 the public.
2. The DUR Committee
					 shall not involve itself as an entity in any individual cases relating to
					 professional conduct or practice standards that may be before physicians' (MD
					 or DO), or pharmacists' regulatory or oversight boards.
3. The DUR Committee may, however, following
					 educational interventions and other educational assessments it may perform,
					 refer individual matters to the OMS or to the appropriate regulatory board if
					 in its judgment such referral is appropriate.