C.M.R. 10, 144, ch. 101, ch. II, 144-101-II-80, subsec. 144-101-II-80.04

Current through 2024-51, December 18, 2024

Subsection 144-101-II-80.04 - PHARMACY COMMITTEES

80.04-1Drug 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.

80.04-2Formulary Committee

A.Purpose

The purpose of the Formulary Committee, if initiated, will be to establish a formulary for the MaineCare program to identify which prescription and over-the-counter drugs are subject to coverage under the MaineCare program in compliance with OBRA 90 as amended (Title XIX, Section 1927). The statutory authority to establish a Formulary Committee is found at 22 M.R.S.A. §3174-M.

B.Membership

The Director of OMS will appoint the Formulary Committee. The Committee shall consist of nine members, including three actively practicing pharmacists and three actively practicing physicians.

At least one pharmacist shall be a clinical hospital pharmacist. At least one physician shall be a doctor who specializes in infectious diseases, one in primary care, and one in surgery. The pharmacists and physicians shall be MaineCare providers and shall serve for staggered three-year periods of time at the pleasure of the Director of the OMS.

In addition to the members outlined above, the Director of the OMS or the Director's designee, as well as the Pharmacy Unit Manager employed by the OMS, and the Director of the Maine HHS Public Health or the Director's designee shall serve on the Committee. In addition to the nine voting members outlined above, the Formulary Committee will have at least two non-voting consumer members appointed by the MaineCare Advisory Committee, who shall not be included when determining a two-thirds majority. The committee shall choose a chairperson from among the voting members. The Director of the OMS will appoint a secretary.

C.Meetings

Meetings of the Drug Formulary Committee will be held at the discretion of the Director of the OMS or the Committee chairperson upon written petition of one-third of the Committee members.

D.Approval of New Drugs

Drugs will be added to the formulary, and will be deleted from the formulary, only upon a vote of two-thirds of the Formulary Committee members present, the procedure for which is described in Section 80.04-2(E). When a new drug does not meet the two-thirds vote for approval to be added to the formulary, requests for such drugs shall be reviewed on a prior authorization (PA) basis as outlined in Section 80.07-4.

E.Formulary Policy and Procedures

1. Drugs will be considered for addition to the formulary in one of four ways:

a. By the Formulary Committee, on the basis of evidence of sufficient requests for the drug through the PA process outlined in Section 80.07-4 to justify consideration for addition to the formulary.

The OMS may also request consideration of drugs based on the volume of inquiries received.

b. The Committee may initiate consideration of over-the-counter drugs, since such drugs are not generally approved through the PA process.

c. The Committee may also, through an on-going review of the formulary by therapeutic class, identify areas that are deficient or areas of possible deletion or restriction.

d. The drug manufacturer may initiate consideration of drugs for which there will be no fiscal impact as defined herein.

2. The steps to be followed for consideration by the Committee for the addition of drugs to the formulary are as follows:

a. The Department will prepare material for distribution to Committee members commenting on efficacy, therapeutic benefits, and current peer reviewed literature.

The Committee will arrange for specialty providers, as appropriate, to comment on this written material. The Department shall classify the drug(s) under consideration into one of three categories, described below, which shall trigger a predetermined procedure. The Committee shall review that determination and after review of the available material, may change the determination by a two-thirds majority vote of those members present.

Category A:

Therapeutic benefit and no projected fiscal impact or no therapeutic benefit and no projected fiscal impact.

Approval for drugs with no fiscal impact as defined herein shall be submitted to the next meeting of the Formulary Committee and shall be automatically recommended for addition to the formulary. No projected fiscal impact is defined as follows:

Reimbursement for the drug at the lowest adult daily dose for the primary indication will be compared to the average of the costs of the lowest adult daily dose for drugs within the same class, weighted by utilization for each drug within that class for the prior quarter. No consideration should be given to recommended course of therapy, improved, compliance, etc., for drugs in this category.

For combination drugs, the billed amount should be less than the combined prices of its components to have no fiscal impact.

Category B:

Therapeutic benefit and a projected fiscal impact.

Therapeutic benefit is defined as a clinically (not pharmacologically) more effective drug and/or a less toxic drug than alternative therapies currently on the formulary.

A drug for which the sole advantage is convenience or compliance is not considered to have a therapeutic benefit.

Therapeutic benefit will be addressed by the clinician assigned the particular drug through his or her review with a final determination made by the Committee.

Drugs with an estimated fiscal impact shall normally be added to the formulary only in one of two ways:

i. a specific appropriation of funds from the Legislature with approval of the Governor; or

ii. a deletion of other drugs from the formulary to maintain budget neutrality.

The therapeutic benefit of the drug being considered should be weighed against the therapeutic benefit of drugs already on the formulary. If the value of the drug under consideration is not thought to be great enough to justify an offsetting deletion and if no funds are appropriated for the addition, the drug shall be put on a pending list of drugs to be added to the formulary once funds become available.

Category C:

No therapeutic benefit and a projected fiscal impact.

Drugs determined to be of no therapeutic benefit that have a projected fiscal impact shall not be added to the formulary. Such drugs would be available only through the PA process to the extent necessary for a specific individual.

b. At the conclusion of discussion of all drugs being considered at a meeting, the Committee members shall record their vote for each drug on a form to be supplied at each meeting. The Chair person will tally the votes and announce the Committee's preliminary determination. Written documentation of the vote will be kept on file at the OMS.

c. The Department shall promulgate as a rule any additions or deletions to the formulary. After any hearing or comment period has expired, the Committee shall review any comments and take a final vote on the addition or deletion of any drugs.

Any preliminary or final determination by the Committee requires a two-thirds majority vote of the members present. Inclusion of a drug on the formulary will automatically include all conventional dosage forms of that drug, with the exception of transdermal systems, sustained release and injectable dosage forms, unless specifically approved by the Formulary Committee.

d. All drugs added to the formulary will be referred to the Drug Utilization Review Committee for monitoring.

80.04-3Academic Detailing Committee

A.Purpose

The purpose of the Academic Detailing Committee is to provide evidence based education to providers to enhance the health of residents of the State, to improve the quality of decisions regarding drug prescribing, to encourage better communication between the department and health care practitioners participating in publicly funded health programs and to reduce the health complications and unnecessary costs associated with inappropriate drug prescribing.

B.Membership Committee

The Director of Health Care Management will appoint the Academic Detailing Committee. The Committee shall consist of at least one prescriber, pharmacist and one private insurance agency representative. Others may be asked to join based on specialty. The Committee will meet quarterly to review the status of the work group projects. The term of an appointment shall be up to four (4) years.

Work Group

The workgroup will consist of the detailers, the Department and its contractors.

C.Meetings

Meetings of the Academic Detailing Committee will be held no less than quarterly.

The work group will meet monthly. Each quarter the group will report to the Committee on the work performed, results of detailing and next steps.

D.Funding

Funding for this program will be made available through the collection of fees under Maine statute, 22 M.R.S.A. §2700-A, governing clinical drug trials.

E.Outreach

The work group with the Committee's guidance, will create an outreach and prescription drugs as issued in peer reviewed, scientific, medical and academic research publications. Results and recommendations will be made available to prescribers and dispensers of drugs in the State through written information and through personal visits from staff. Program components, to the extent possible, must include information regarding clinical trials, pharmaceutical efficiency, adverse effects of drugs, evidence based treatment options and drug marketing approaches that are intended to circumvent competition from generic and therapeutically equivalent drugs. All components of the program will be reviewed and agreed upon by the Committee. The Committee shall ensure that the program adheres to standards of conduct required by 22 MRSA 26853) .

C.M.R. 10, 144, ch. 101, ch. II, 144-101-II-80, subsec. 144-101-II-80.04