Current through Register 2024 Notice Reg. No. 12, March 22, 2024
(a) The Director shall use the following
criteria when evaluating drugs to add to and to delete from the Medi-Cal List
of Contract Drugs. The Director may restrict usage of any drug or therapeutic
category of drugs on the Medi-Cal List of Contract Drugs.
The Director's decision shall be made upon consideration
of all of the five criteria specified below in items (1) through (5), without
regard to the order in which the criteria are presented. The examples recited
under each criterion shall not be exhaustive of those factors which may be
considered.
(1) Cost. For the purpose
of this section, cost means the potential fiscal impact of the proposed change
on the Medi-Cal drug program or the Medi-Cal program. Evaluation of cost may
involve a single drug or comparison between two or more drugs, and may take
into account, but is not limited to, differences of unit cost, differences of
cost of total treatment, or cost of alternative methods of treatment.
(2) Efficacy. For the purposes of this
section, efficacy means the speed, duration, and extent to which a drug will
alleviate, control or cure a medical condition. Evaluation of efficacy may
involve a single drug or comparisons between two or more drugs, and may take
into account such factors as efficacy of alternative methods of
treatment.
(3) Essential Need. For
the purpose of this section, essential need means that the availability of a
drug through the Medi-Cal List of Contract Drugs is necessary to protect life
or to prevent significant disability. Evaluation of essential need may involve
a single drug or comparisons between two or more drugs, and may take into
account such facts as the availability of alternative methods of treatment, the
incidence, severity and prognosis of the medical conditions for which a drug is
indicated; whether a drug is a lifesaving agent or palliative in effect; or
whether a drug may provide treatment for a medical condition not adequately
treated by any marketed drug.
(4)
Misuse Potential. For the purpose of this section, misuse potential means the
opportunity for unjustified, inappropriate, irresponsible, or improper use of a
drug. Evaluation of unjustified, inappropriate, or irresponsible use may
involve a single drug or comparisons between two or more drugs, and may take
into account such factors as utilization of a drug where there is insufficient
medical necessity for its use; continued utilization of a drug despite loss of
effectiveness; utilization of a drug where more efficacious or more safe drugs
are available; utilization of a drug where the drug is a mixture and less than
the total number of active ingredients may suffice; or utilization of a drug
where a less costly but equally safe and efficacious drug may be used.
Evaluation of improper use may involve a single drug or comparisons between two
or more drugs, and may take into account such factors as utilization of a drug
in a manner that deviates from approved medical, legal, or social
standards.
(5) Safety. For the
purpose of this section, safety means relative freedom from side effects and is
determined by reviewing the contraindications, precautions, warnings, adverse
effects, and drug interactions associated with the use of a drug. Evaluation of
safety may involve a single drug or comparisons between two or more drugs, and
may take into account such factors as safety of alternative methods of
treatment, or the relationship of safety of a drug to the severity of prognosis
of the medical conditions for which the drug is indicated.
1. New
section filed 5-22-91 as an emergency pursuant to Statutes of 1990, chapter
456, section
36, p. 1658-1659; operative
5-22-91 (Register 91, No. 27). A Certificate of Compliance must be transmitted
to OAL by 9-19-91 or emergency language will be repealed by operation of law on
the following day.
2. New section refiled 9-19-91 as an emergency;
operative 9-20-91 (Register 92, No. 4). A Certificate of Compliance must be
transmitted to OAL 1-20-92 or emergency language will be repealed by operation
of law on the following day.
3. New section refiled 1-23-92 as an
emergency; operative 1-17-92 (Register 92, No. 25). A Certificate of Compliance
must be transmitted to OAL 5-22-92 or emergency language will be repealed by
operation of law on the following day.
4. Certificate of Compliance
as to 1-23-92 order transmitted to OAL 5-22-92 and filed 7-6-92 (Register 92,
No. 28).
5. Change without regulatory effect amending subsection
(a)(1) and NOTE filed 1-26-2009 pursuant to section
100, title 1, California Code of
Regulations (Register
2009,
No. 5).
Note: Authority cited: Section
20, Health and Safety Code; and
Sections
14105
and
14124.5,
Welfare and Institutions Code. Reference: Sections
14105,
14105.39
and
14132,
Welfare and Institutions Code.
