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.
80.04-2
Formulary 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
Procedures1. 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.
80.04-3
Academic 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) .
