Current through Register Vol. 54, No. 12, March 23, 2024
(a)
The Department will base its drug cost for compensable legend and nonlegend
drugs on the lower of:
(1) The EAC established
by the Department.
(i) For brand name drugs,
the EAC is established by the Department as one of the following:
(A) The lowest WAC listed for the drug in
available Nationally recognized pricing services, plus 3.2%.
(B) If WAC data are not available from a
Nationally recognized pricing service, the lowest AWP listed for the drug in
available Nationally recognized pricing services, minus 14%.
(C) If both WAC and AWP cost data are
available for the drug from a Nationally recognized pricing service, the lower
of the two amounts.
(ii)
For generic drugs, the EAC is established by the Department as one of the
following:
(A) The lowest WAC listed for the
drug in available Nationally recognized pricing services.
(B) If WAC data are not available from a
Nationally recognized pricing service, the lowest AWP listed for the drug in
available Nationally recognized pricing services, minus 25%.
(C) If both WAC and AWP cost data are
available for the drug from a Nationally recognized pricing service, the lower
of the two amounts.
(2) The State MAC established by the
Department.
(b) The
Department will update the EAC for individual drugs at least on a monthly basis
as it appears in available Nationally recognized pricing services.
(c) CMS establishes lists that identify and
set Federal upper limits for CMS multisource drugs and provides the listing of
these drugs and revisions to the list to the Department through Medicaid manual
transmittals on a periodic basis.
(d) The Department will determine the State
MAC by one of the following methods:
(1) For
multisource drugs, the Department will set the State MAC at the lower of the
following:
(i) The upper payment limit
established by the CMS.
(ii)
Provided that the generic product is available at the price established by the
Department from at least two wholesalers:
(A)
If the generic product is available from more than one manufacturer, the base
price of 150% of the lowest acquisition cost for the generic product, unless
150% of the lowest acquisition cost is not at least 120% of the second lowest
acquisition cost, in which case the base price will be set at 120% of the
second lowest acquisition cost.
(B)
If the generic product is available from only one manufacturer, the base price
is 120% of the acquisition cost for the generic product.
(2) For disposable insulin
syringes, the Department will set the State MAC at the amount listed in the MA
Program Fee Schedule.
(e)
The Department will update the State MAC:
(1)
If the State MAC for a multisource drug is set at the Federal upper payment
limit established by CMS, the Department will apply the Federal upper limits
for CMS multisource drugs to be effective on the date established by CMS and
will describe the update to each pharmacy enrolled in the MA Program when it is
available.
(2) The Department will
apply the price for all other State MAC multisource drugs every 3 months, and
will distribute the update to each pharmacy enrolled in the MA
Program.
(f) With the
exception of the CMS multisource drugs, the Department will make further
additions to the list of State MAC drugs after consultation with the Medical
Assistance Advisory Committee as to whether the application of a State MAC is
cost effective to the Department for a particular multisource drug. The
Department will add the CMS multisource drugs to the State MAC list effective
as of the effective date established by CMS.
(g) With the exception of disposable insulin
syringes, the State MAC does not apply if the conditions are met as described
in §
1121.53(b)(1) and
(2) (relating to limitations on
payment).
(h) The most common
package size for the purposes of determining the product cost is one of the
following:
(1) For capsules, tablets and
liquids available in breakable package sizes:
(i) The listed package size if only one
package size is listed.
(ii) The
100 or pint package size if more than one package size is listed.
(iii) The next smaller package size from the
100 or pint size, excluding a drug company's unit-dose package size, if more
than one package size is listed other than the 100 or pint package
size.
(iv) The package size closest
to the 100 or pint package size, excluding a drug company's unit-dose package
size, if the next smaller package is the unit-dose package size.
(2) The listed package size for
all dosage forms available for all nonlegend drug products.
(3) The smallest package size for all dosage
forms available in nonbreakable packages.
This regulation was promulgated under section 6(b) of the
Regulatory Review Act (71 P. S. §
745.6(b)).
The provisions of this §
1121.56 amended under sections
201, 403, 403.1 and 443.4 of the Public Welfare Code (62 P. S.
§§
201,
403,
403.1 and
443.4).
This section cited in 55 Pa. Code §
1121.51 (relating to general
payment policy).
