1 TAC §354.3047, §354.3092
The Texas Health and Human Services Commission (HHSC) adopts
new Chapter 354, §354.3047 and §354.3092, concerning Medicaid Health
Services. New §354.3047 establishes quantity limitations on refills for
drugs reimbursed by the Medicaid Vendor Drug Program (VDP). The new rule is
adopted with changes from the proposed text as published in the January 25,
2002, issue of the
Texas Register
(27 TexReg
545). New §354.3092 describes information required of drug manufacturers
in order to include their products in the Texas Drug Code Index (TDCI). This
rule is adopted without changes form the proposed text.
Under rules that previously governed the VDP, a pharmacy provider was eligible
for reimbursement dispensed refills only after a minimum of 50 percent of
the previous dispensing of the drug was, or based on the prescribing health
care professional's orders, should have been used. The adopted §354.2047
requires that at least 75 percent of the previous dispensing of the product
be used before the VDP will reimburse a refill. A product that is subject
to abuse or overuse may be subject to a higher percentage.
HHSC received one comment concerning proposed §354.3047 during the
public comment period. The Coalition for Nurses in Advanced Practice recommended
substitution of the word "prescriber" for the words "physician " and " doctor"
in the proposed rule. This phrase is consistent with other rules that regulate
the VDP. The Commission agrees with this comment and modifies the language
accordingly.
Under rules that previously governed the VDP, a drug manufacturer is required
to provide VDP with information concerning direct and wholesale costs to purchasers
of each drug offered by the manufacturer through the VDP and selling prices
for such drugs. The adopted §354.3092 requires a manufacturer to supply
the Average Manufacturer's Price (AMP) for each covered drug, as defined in
42 U.S.C. §1396r-8(k), in addition to the pricing information previously
required of manufacturers.
As a result of adopting these rules, HHSC will be able to better prevent
stockpiling and other potential waste and abuse of prescription drugs dispensed
through the VDP. HHSC will also be able to compare the AMP, a national, audited
figure for retail pricing, to other pricing information received by the VDP
staff. This should ensure that Texas best estimate of acquisition costs will
be closely aligned with this weighted average of prices in the retail class
of trade.
The new rule is adopted under Texas Government Code §531.021,
which designates the Health and Human Services Commission as the state agency
responsible for administering federal medical assistance (Medicaid) funds;
Texas Government Code §531.033, which provides the commissioner of health
and human services with authority to adopt rules necessary to carry out the
duties prescribed by chapter 531; and Human Resources Code §32.021, which
provides the Health and Human Services Commission with authority to adopt
rules necessary for the proper and efficient administration of the State's
medical assistance program.
The adopted rule affects the Human Resources Code, Chapter 32, and the
Texas Government Code, Chapter 531.
§354.3047. Quantity Limitations.
The quantity of drugs prescribed depends on the prescribing practice
of the prescriber and the needs of the patient. The Vendor Drug program reimburses
the provider for the prescribed quantity, provided the quantity does not exceed
a six-month supply. The dispensing of authorized refills must be consistent
with the prescribed dosage schedule and existing federal and state laws. To
be reimbursed by the Vendor Drug Program, a refill must be dispensed only
after 75% of a previous dispensing of the same prescription would have been
used if taken according to the accompanying prescriber's orders. A higher
percentage limit may be required for a drug that has been determined to be
subject to abuse or overuse. A recipient may obtain an early medication refill
for a justifiable reason. A justifiable reason includes, but is not limited
to, a dosage increase or an anticipated prolonged absence from the community.
The reason must be noted on the prescription. Unless specific authorization
is obtained from the prescriber, breakage, spillage, or loss of a medication
are not considered justifiable reasons. The prescription obtained under this
authorization is considered a new prescription.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on April 1, 2002.
TRD-200202063
Marina S. Henderson
Executive Deputy Commissioner
Texas Health and Human Services Commission
Effective date: April 21, 2002
Proposal publication date: January 25, 2002
For further information, please call: (512) 424-6630