Current through Register Vol. 48, No. 39, March 25, 2024
Subpart
1.
Definitions.
The following terms used in this part have the meanings given
to them.
A. "Actual acquisition cost"
means the cost to the provider including quantity and other special discounts
except time and cash discounts.
B.
"Compounded prescription" means a prescription prepared under part
6800.3100.
C. "Dispensing fee" means the amount allowed
under the medical assistance program as payment for the pharmacy service in
dispensing the prescribed drug.
D.
"Maintenance drug" means a prescribed drug that is used by a particular
recipient for a period greater than two consecutive months.
E. "Pharmacist" means a person licensed under
Minnesota Statutes, chapter 151, to provide services within the scope of
pharmacy practice.
F. "Pharmacy"
means an entity registered by the Minnesota Board of Pharmacy under Minnesota
Statutes, chapter 151.
G. "Pharmacy
service" means the dispensing of drugs under Minnesota Statutes, chapter 151 or
by a physician under subpart
2, item B.
H. "Prescribed drug" means a drug as defined
in Minnesota Statutes, section
151.01, subdivision
5, and ordered by a practitioner.
I. "Practitioner" means a physician,
osteopath, dentist, or podiatrist licensed under Minnesota Statutes or the laws
of another state or Canadian province to prescribe drugs within the scope of
his or her profession.
J. "Usual
and customary charge" refers to the meaning in part
9505.0175, subpart 49, whether the
drug is purchased by prescription or over the counter, in bulk, or unit dose
packaging. However, if a provider's pharmacy is not accessible to, or
frequented by, the general public, or if the over the counter drug is not on
display for sale to the general public, then the usual and customary charge for
the over the counter drug shall be the actual acquisition cost of the product
plus a 50 percent markup based on the actual acquisition cost. In this event,
this calculated amount must be used in billing the department for an over the
counter drug.
Amounts paid in full or in part by third-party payers shall
be included in the calculation of the usual and customary charge only if a
third-party payer constitutes 51 percent or more of the pharmacy's business
based on the number of prescriptions filled by the pharmacy on a quarterly
basis.
Subp. 2.
Eligible providers.
The following providers are eligible for payment under the
medical assistance program for dispensing prescribed drugs:
A. a pharmacy that is licensed by the
Minnesota Board of Pharmacy;
B. an
out-of-state vendor under part
9505.0195, subpart 9;
and
C. a physician located in a
local trade area where there is no enrolled pharmacy. The physician to be
eligible for payment shall personally dispense the prescribed drug according to
Minnesota Statutes, section
151.37,
and shall adhere to the labeling requirements of the Minnesota Board of
Pharmacy.
Subp. 3.
Payment limitations.
Payments for pharmacy services under the medical assistance
program are limited as follows.
A. The
prescribed drug must be a drug or compounded prescription that is approved by
the commissioner for inclusion in the department's drug formulary. The drug
formulary committee established under Minnesota Statutes, sections
256B.02, subdivision
8 and 256B.0625, shall recommend to the commissioner the inclusion of a drug or
compounded prescription in the drug formulary. The commissioner may add or
delete a drug or compounded prescription from the drug formulary. A provider,
recipient, or seller of prescription drugs or compounded prescriptions may
apply to the department on the form specified in the drug formulary to add or
delete a drug from the drug formulary.
B. A prescribed drug must be dispensed in the
quantity specified on the prescription unless the pharmacy is using unit dose
dispensing or the specified quantity is not available in the pharmacy when the
prescription is dispensed. Only one dispensing fee is allowed for dispensing
the quantity specified on the prescription.
C. The dispensed quantity of a prescribed
drug must not exceed a three month supply unless prior authorization is
obtained by the pharmacist or dispensing physician.
D. An initial or refill prescription for a
maintenance drug shall be dispensed in not less than a 30 day supply unless the
pharmacy is using unit dose dispensing. No additional dispensing fee shall be
paid until that quantity is used by the recipient.
E. Except as in item F, the dispensing fee
billed by or paid to a particular pharmacy or dispensing physician for a
maintenance drug for a recipient is limited to one fee per 30-day
supply.
F. More than one dispensing
fee per calendar month for a maintenance drug for a recipient is allowed if the
record kept by the pharmacist or dispensing physician documents that there is a
significant chance of overdosage by the recipient if a larger quantity of drug
is dispensed, and if the pharmacist or dispensing physician writes a statement
of this reason on the prescription.
G. A refill of a prescription must be
authorized by the practitioner. Refilled prescriptions must be documented in
the prescription file, initialed by the pharmacist who refills the
prescription, and approved by the practitioner as consistent with accepted
pharmacy practice under Minnesota Statutes, chapters 151 and 152.
H. A generically equivalent drug as defined
in Minnesota Statutes, section
151.21, subdivision
2, must be dispensed in place of the prescribed drug if:
(1) the generically equivalent drug is
approved by the United States Food and Drug Administration and is also
determined as therapeutically equivalent by the United States Food and Drug
Administration; and
(2) in the
professional judgment of the pharmacist, the substituted drug is
therapeutically equivalent to the prescribed drug; and
(3) the charge for the substituted
generically equivalent drug does not exceed the charge for the drug originally
prescribed.
However, a substitution must not be made if the practitioner
has written in his or her own handwriting "Dispense as Written" or "DAW" on the
prescription, as provided in the Minnesota Drug Selection Act, Minnesota
Statutes, section
151.21. The pharmacy
must notify the recipient and the department when a generically equivalent drug
is dispensed. The notice to the recipient may be given orally or by appropriate
labeling on the prescription's container. The notice to the department must be
by appropriate billing codes.
I. Unless otherwise established by the
legislature, the amount of the dispensing fee shall be set by the commissioner.
The fee shall be the lower of the average dispensing fee set by third-party
payers in the state or the average fee determined by a cost of operation survey
of pharmacy providers reduced by the yearly Consumer Price Index (urban) for
the Minneapolis-Saint Paul area to the base year set by the legislature for
other provider fees.
J. The cost of
delivering a drug is not a covered service.
Subp. 4.
Payment limitations; unit dose
dispensing.
Drugs dispensed under unit dose dispensing in accordance with
part
6800.3750 shall be subject to the
medical assistance payment limitations in items A to C.
A. Dispensing fees for drugs dispensed in
unit dose packaging as specified in part
6800.3750 shall not be billed or
paid more often than once per calendar month or when a minimum of 30 dosage
units have been dispensed, whichever results in the lesser number of dispensing
fees, regardless of the type of unit dose system used by the pharmacy or the
number of times during the month that the pharmacist dispenses the drug. If the
recipient's drug supply is dispensed in small increments during the calendar
month, the pharmacy must keep a written record of each dispensing act that
shows the date, National Drug Code, and the quantity of the drug
dispensed.
B. Only one dispensing
fee per calendar month shall be billed or paid for each maintenance drug
regardless of the type of unit dose system used by the pharmacy or the number
of times during the month that the pharmacist dispenses the drug. If the
recipient's drug supply is dispensed in small increments during the month, the
pharmacy must keep a written record of each dispensing act that shows the date,
National Drug Code, and the quantity of drug dispensed.
C. The date of dispensing must be reported as
the date of service on the claim to the department except when the recipient's
drug supply is dispensed in small increments during the month. For this
exception, the last dispensing date of the calendar month must be reported on
the claim to the department as the date of service. In the case of an
exception, the quantity of drug dispensed must be reported as the cumulative
total dispensed during the month or a minimum amount as required in item A,
whichever results in the lesser number of dispensing fees.
Subp. 5.
Return of drugs.
Drugs dispensed in unit dose packaging under part
6800.3750, subpart
2, shall be returned to a
pharmacy as specified in items A to C when the recipient no longer uses the
drug.
A. A provider of pharmacy
services using a unit dose system must comply with part
6800.2700.
B. A long-term care facility must return
unused drugs dispensed in unit dose packaging to the provider that dispensed
the drugs.
C. The provider that
receives the returned drugs must repay medical assistance the amount billed to
the department as the cost of the drug.
Subp. 6.
Billing procedure.
Providers of pharmacy services shall bill the department
their usual and customary charge for the dispensed drug. All pharmacy claims
submitted to the department must identify the National Drug Code printed on the
container from which the prescription is actually filled. If a National Drug
Code is not printed on the manufacturer's container from which the prescription
is filled, the claim must name the code required by the department under the
drug formulary, or identify either the generic or brand name of the drug.
Except as provided in subpart
4, item C, the date reported
as the date dispensed must be the date on which the quantity reported on the
billing claim was dispensed.
Subp.
7.
Maximum payment for prescribed drugs.
The maximum payment for a prescribed drug or compounded
prescription under the medical assistance program must be the lowest of the
following rates:
A. The maximum
allowable cost for a drug established by the department or the Centers for
Medicare and Medicaid Services of the United States Department of Health and
Human Services plus a dispensing fee.
B. The actual acquisition cost for a drug
plus a dispensing fee.
C. The
pharmacy's usual and customary charge.
Statutory Authority: MS s
256B.04