Current through Register Vol. 18, September 20, 2024
(1)
These requirements are in addition to those contained in ARM
37.85.401
through
37.85.415.
(2) For purposes of Medicaid reimbursement,
outpatient drugs may not be filled or refilled without the authorization of the
physician or other licensed practitioner who is authorized by law to prescribe
drugs and is recognized by the Medicaid program.
(3) The department will only participate in
the payment of legend and over-the-counter drugs listed on the department drug
formulary, as determined by the Medicaid Drug Formulary Committee established
by the department. The formulary committee is the Drug Use Review Board,
established and operating in accordance with
42 USC
1396r-8 (2016), which governs Medicaid drug
programs. The drug formulary includes a preferred drug list. Prescribers must
prescribe from the preferred drug list if medically appropriate.
(a) The PDL includes drugs subject to a
Centers for Medicare and Medicaid Services (CMS) approved supplemental rebate
agreement between the manufacturer and the department. Drugs in the same
therapeutic class as those identified on the preferred drug list but not
identified as a preferred drug are subject to prior authorization as outlined
in (6)(c).
(4) The
inappropriate use of drugs, as determined by professional review, may result in
the imposition of a limitation upon the quantities of medications which are
payable by the medical assistance program. Retroactive limitation is not
applied, unless the involved pharmacy has knowledge or can reasonably be
expected to have had knowledge of the inappropriate use of drugs by the
member.
(5) Each prescription must
be dispensed in the quantity ordered except that:
(a) Prescriptions for which a specific
quantity has not been ordered must be dispensed in sufficient quantities to
cover the period of time for which the condition is being treated except for
injectable antibiotics, which may be dispensed in sufficient quantities to
cover a three-day period.
(b)
Notwithstanding the above, maintenance medications may be dispensed in
quantities sufficient for a 90-day supply or 100 units, whichever is greater.
Other medications may not be dispensed in quantities greater than a 34-day
supply. The department maintains a list of current drug classes which are
considered maintenance medications and are posted on the department's web site
at http://medicaidprovider.mt.gov.
(c) Prescriptions for opioids shall be
dispensed in accordance with ARM
37.86.1103.
(6) The department does not
participate in the payment of a prescription drug:
(a) which the Secretary of Health and Human
Services (HHS) has determined is less than effective for all conditions of use
prescribed, recommended or suggested in the drug's labeling;
(b) that is not subject to a rebate agreement
between the manufacturer and the secretary of HHS as required by
42 USC
1396r-8 (2016); and
(c) that does not meet prior authorization
criteria as determined by the Medicaid Drug Formulary Committee, established
and operating in accordance with
42 USC
1396r-8 (2016), without the existence of a
prior authorization request approved by the department or its designated
representative. A list of drugs subject to prior authorization, known as the
prior authorization drug list, will be provided to interested Medicaid
providers.
(7) The
department may pay for nonrebatable API bulk powders and excipients compounded
in accordance with ARM
37.86.1105(5).
(8) The drug formulary, PDL, and
the prior authorization drug list is updated by the department on a monthly
basis, on the last day of each month. A copy of the most current listings may
be obtained from the department web site at www.dphhs.mt.gov, or by writing to
the Department of Public Health and Human Services, Health Resources Division,
Allied Health Services Bureau, 1400 Broadway, P.O. Box 202951, Helena, MT
59620-2951.
(9) The department has
a drug rebate program administered in accordance with
42 USC
1396r-8 (2016) and CMS drug program state
releases, CMS drug manufacturer releases, and the National Drug Rebate
Agreement in effect in 2008. The department adopts and incorporates by
reference the National Drug Rebate Agreement (2008). A copy of all documents
incorporated by reference in this rule may be obtained from the department web
site at www.dphhs.mt.gov, or by writing to the Department of Public Health and
Human Services, Health Resources Division, Allied Health Services Bureau, 1400
Broadway, P.O. Box 202951, Helena, MT 59620-2951.
(a) Pharmaceutical manufacturers, hereafter
referred to as the manufacturer, must make rebate payments to the department
for each calendar quarter within 30 days after receiving from the department
the Medicaid utilization information defined in their federal rebate agreement.
The manufacturer is responsible for timely payment of the rebate within 30 days
of receiving, at a minimum, information on the number of units paid, by NDC
number.
(b)
42 USC
1396r-8 (2016) establishes the requirements
that must be met by the department, drug manufacturers, and providers in order
for providers to receive reimbursement for outpatient drugs that have been
dispensed. This statute describes rebate agreements, covered drugs, prior
authorization, reimbursement limits, and drug use review programs.
(10) A provider must maintain a
signature log to act as proof that the dispensed medication has been received
by the member or an individual acting on behalf of the member. The member, or
an individual acting on behalf of the member, must sign the log each time that
they receive a prescription drug from a pharmacy provider. For prescription
drugs delivered to a nursing facility, the individual charged with ensuring the
security of pharmaceutical supplies may sign the log after verifying delivery
of all prescription drugs.
(11)
The department uses the following procedures to develop the preferred drug list
(PDL):
(a) The department performs a
pharmacoeconomic analysis of the Medicaid Pharmacy Program and identifies
therapeutic classes of drugs for possible PDL inclusion.
(b) The department and the Drug Use Review
(DUR) Board/Formulary Committee members consider recommendations and determine
which therapeutic drug classes will be reviewed at a meeting of the committee.
Notice of the meeting and the therapeutic drug class to be considered is posted
on the department's web site in advance of the meeting date.
(c) The department performs drug class
reviews using peer-reviewed literature, established evidence-based practice
methods, and local clinicians to interpret and apply practical experience to
the structured evidence reviews. The department also conducts supplemental
rebate negotiations.
(d) The
committee combines its members' evaluations and the evaluations from the
department to consider equivalent products within the drug class. Information
used by the department and its contractors is available to the public prior to
the meeting. During the meeting, the committee also hears comments from
interested parties.
(e) The
committee recommends to the department which preferred agents should be
selected for the specific therapeutic class.
(f) The department makes a final decision and
posts its decision on the department's web site.
AUTH:
53-2-201,
53-6-113,
MCA; IMP:
53-2-201,
53-6-101,
53-6-113,
53-6-141,
MCA
