|(a) Purpose. This section implements the provisions
of §531.072, Government Code, which directs the Health and Human
Services Commission (HHSC) to develop and implement a preferred drug
list (PDL) for the Texas Medical Assistance Program.
(b) Applicability. This section applies to drugs included
in the Texas Drug Code Index (TDCI) established under §354.1921
of this title (relating to Addition of Drugs to the Texas Drug Code
(c) Selection of drugs for the PDL. HHSC will include
a drug listed on the TDCI in the PDL on the basis of:
(1) The recommendations of the Drug Utilization Review
Board (DUR Board) established under §354.1941 of this subchapter
(relating to Drug Utilization Review Board);
(2) The clinical efficacy of the drug, consistent with
the determination of the Food and Drug Administration and the recommendations
of the DUR Board;
(3) Comparison of the price of the drug and the price
of competing drugs. For purposes of this section, the price of a drug
is determined by reference to the reimbursement for the drug established
under §355.8541 of this title (relating to Legend and Nonlegend
Medications) and after deducting Texas and federal rebates;
(4) A program benefit offered by the manufacturer or
labeler of the drug and accepted by HHSC in accordance with §531.070,
Government Code; and
(5) Written evidence offered by a manufacturer or labeler
supporting the inclusion of a product on the PDL.
(d) Distribution of PDL. HHSC will publish the PDL
on its Internet website (http://www.hhsc.state.tx.us/). A health care
provider may also request a copy of the PDL from HHSC by sending a
written request to the HHSC or its designee.
(e) Revisions to the PDL. Within 10 days following
HHSC's decision on the recommendations of the DUR Board, HHSC will
publish the revised PDL.
(f) Exclusion of a drug from the PDL. A drug that is
not included in the PDL will be subject to prior authorization by
HHSC or its designee in accordance with §354.1832 of this title
(relating to Prior Authorization Procedures).
(g) Agreement on supplemental rebate necessary. HHSC
will only include on the PDL drugs provided by a manufacturer or labeler
that reaches an agreement on a supplemental rebate with HHSC in accordance
with §531.070 of the Government Code. Such agreement may provide
for a program benefit offered by the manufacturer or labeler of the
drug and accepted by HHSC in accordance with §531.070, Government
(h) Notwithstanding subsection (g) of this section,
the preferred drug list may contain a drug provided by a manufacturer
or labeler that has not reached a supplemental rebate agreement with
HHSC if HHSC determines that inclusion of the drug on the preferred
drug list will have no negative cost impact to the state, in accordance
with §531.072 of the Government Code.
|Source Note: The provisions of this §354.1924 adopted to be effective November 16, 2003, 28 TexReg 9802; amended to be effective June 9, 2010, 35 TexReg 4659; amended to be effective February 9, 2016, 41 TexReg 960